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Over 12,000 home health agencies served 5 million disabled and older Americans in 2018 buy cipro with prescription. Home health aides help their clients with the tasks of daily living, like eating and showering, as well as with clinical tasks, like taking blood pressure and leading physical therapy exercises. Medicare relies on home health care services because they help patients discharged from the hospital and skilled nursing facilities recover but at a much lower buy cipro with prescription cost.

Together, Medicare and Medicaid make up 76% of all home health spending.Home health care workers serve a particularly important role in rural areas. As rural areas lose physicians and hospitals, home health buy cipro with prescription agencies often replace primary care providers. The average age of residents living in rural counties is seven years older than in urban counties, and this gap is growing.

The need for home health agencies serving the elderly in rural areas will continue to grow over the coming decades.Rural home health agencies face unique challenges. Low concentrations of people are dispersed buy cipro with prescription over large geographic areas leading to long travel times for workers to drive to clients’ homes. Agencies in rural areas also have difficulties recruiting and maintaining a workforce.

Due to these difficulties, agencies may not be able to serve all rural beneficiaries, initiate care on buy cipro with prescription time, or deliver all covered services.Congress has supported measures to encourage home health agencies to work in rural areas since the 1980s by using rural add-on payments. A rural add-on is a percentage increase on top of per visit and episode-of-care payments. When a home buy cipro with prescription health aide works in a rural county, Medicare pays their home health agency a standard fee plus a rural add-on.

With a 5% add-on, Medicare would pay $67.78 for an aide home visit in a city and $71.17 for the same care in a rural area.Home health care workers serve a particularly important role in rural areas. As rural areas lose physicians and hospitals, home health agencies often replace primary care providers.Rural add-on payments have fluctuated based on Congressional budgets and political priorities. From 2003 to 2019, the amount Medicare paid agencies changed eight buy cipro with prescription times.

For instance, the add-on dropped from 10% to nothing in April 2003. Then, in April 2004, Congress set the rural add-on to 5%.The variation in payments created a natural experiment for researchers buy cipro with prescription. Tracy Mroz and colleagues assessed how rural add-ons affected the supply of home health agencies in rural areas.

They asked if the number of agencies in urban and rural counties varied depending on the presence and dollar amount of rural add-ons between 2002 and 2018. Though rural add-ons have been in place for over 30 years, researchers had not previously investigated their effect on the availability of home healthcare.The researchers found that buy cipro with prescription rural areas adjacent to urban areas were not affected by rural add-ons. They had similar supply to urban areas whether or not add-ons were in place.

In contrast, isolated rural buy cipro with prescription areas were affected substantially by add-ons. Without add-ons, the number of agencies in isolated rural areas lagged behind those in urban areas. When the add-ons were buy cipro with prescription at least 5%, the availability of home health in isolated rural areas was comparable to urban areas.In 2020, Congress implemented a system of payment reform that reimburses home health agencies in rural counties by population density and home health use.

Under the new system, counties with low population densities and low home health use will receive the greatest rural add-on payments. These payments aim to increase and maintain the availability of care in the most vulnerable rural home health markets. Time will tell if this approach gives sufficient incentive to buy cipro with prescription ensure access to quality care in the nation’s most isolated areas.Photo via Getty ImagesStart Preamble Correction In proposed rule document 2020-13792 beginning on page 39408 in the issue of Tuesday, June 30, 2020, make the following correction.

On page 39408, in the first column, in the DATES section, “August 31, 2020” should read “August 24, 2020”. End Preamble [FR Doc buy cipro with prescription. C1-2020-13792 Filed 7-17-20.

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Masks slow the spread cipro and milk of SARS-CoV-2 by reducing Website how much infected people spray the virus into the environment around them when they cough or talk. Evidence from laboratory experiments, hospitals and whole countries show that masks work, and the cipro and milk Centers for Disease Control and Prevention recommends face coverings for the U.S. Public.

With all this evidence, mask wearing has become the norm in many places.I am an infectious disease doctor and a professor of medicine at the University cipro and milk of California, San Francisco. As governments and workplaces began to recommend or mandate mask wearing, my colleagues and I noticed an interesting trend. In places where most people wore masks, those who did get infected seemed dramatically less likely to get severely ill compared to places with less mask-wearing.It seems people get less sick if they wear a mask.When you wear a mask – even a cloth mask – you cipro and milk typically are exposed to a lower dose of the coronavirus than if you didn’t.

Both recent experiments in animal models using coronavirus and nearly a hundred years of viral research show that lower viral doses usually means less severe disease.No mask is perfect, and wearing one might not prevent you from getting infected. But it might be the difference between a case of COVID-19 cipro and milk that sends you to the hospital and a case so mild you don’t even realize you’re infected.Exposure Dose Determines Severity of DiseaseWhen you breathe in a respiratory virus, it immediately begins hijacking any cells it lands near to turn them into virus production machines. The immune system tries to stop this process to halt the spread of the virus.The amount of virus that you’re exposed to – called the viral inoculum, or dose – has a lot to do with how sick you get.

If the exposure dose is very high, the immune response can cipro and milk become overwhelmed. Between the virus taking over huge numbers of cells and the immune system’s drastic efforts to contain the infection, a lot of damage is done to the body and a person can become very sick.On the other hand, if the initial dose of the virus is small, the immune system is able to contain the virus with less drastic measures. If this happens, the person experiences fewer symptoms, if any.This concept of viral dose being related to disease severity has been around cipro and milk for almost a century.

Many animal studies have shown that the higher the dose of a virus you give an animal, the more sick it becomes. In 2015, cipro and milk researchers tested this concept in human volunteers using a nonlethal flu virus and found the same result. The higher the flu virus dose given to the volunteers, the sicker they became.In July, researchers published a paper showing that viral dose was related to disease severity in hamsters exposed to the coronavirus.

Hamsters who were given a higher viral dose got more sick than hamsters given a lower dose.Based cipro and milk on this body of research, it seems very likely that if you are exposed to SARS-CoV-2, the lower the dose, the less sick you will get.So what can a person do to lower the exposure dose?. Masks Reduce Viral DoseMost infectious disease researchers and epidemiologists believe that the cipro and milk coronavirus is mostly spread by airborne droplets and, to a lesser extent, tiny aerosols. Research shows that both cloth and surgical masks can block the majority of particles that could contain SARS-CoV-2.

While no mask is perfect, the goal is not to block all of the virus, cipro and milk but simply reduce the amount that you might inhale. Almost any mask will successfully block some amount.Laboratory experiments have shown that good cloth masks and surgical masks could block at least 80% of viral particles from entering your nose and mouth. Those particles and other contaminants will get trapped in the fibers of the mask, so the CDC recommends washing your cloth mask after each use if possible.The cipro and milk final piece of experimental evidence showing that masks reduce viral dose comes from another hamster experiment.

Hamsters were divided into an unmasked group and a masked group by placing surgical mask material over the pipes that brought air into the cages of the masked group. Hamsters infected with the coronavirus were placed in cages next to the masked and unmasked hamsters, and air cipro and milk was pumped from the infected cages into the cages with uninfected hamsters.As expected, the masked hamsters were less likely to get infected with COVID-19. But when some of the masked hamsters did get infected, they had more mild disease than the unmasked hamsters.Masks Increase Rate of Asymptomatic CasesIn July, the CDC estimated that around 40% of people infected with SARS-CoV-2 are asymptomatic, and a number of other studies have confirmed this number.However, in places where everyone wears masks, the rate of asymptomatic infection seems to be much higher.

In an outbreak on an Australian cruise ship called the Greg Mortimer in late March, the passengers were all given surgical masks and cipro and milk the staff were given N95 masks after the first case of COVID-19 was identified. Mask usage was apparently very high, and even though 128 of the 217 passengers and staff eventually tested positive for the coronavirus, 81% of the infected people remained asymptomatic.Further evidence has come from two more recent outbreaks, the first at a seafood processing plant in Oregon and the second at a chicken processing plant in Arkansas. In both places, the workers were provided masks cipro and milk and required to wear them at all times.

In the outbreaks from both plants, nearly 95% of infected people were asymptomatic.There is no doubt that universal mask wearing slows the spread of the coronavirus. My colleagues and I believe that evidence from laboratory experiments, case studies like the cruise ship and food processing plant outbreaks and long-known biological cipro and milk principles make a strong case that masks protect the wearer too.The goal of any tool to fight this pandemic is to slow the spread of the virus and save lives. Universal masking will do both.Monica Gandhi is a Professor of Medicine with the Division of HIV, Infectious Diseases and Global Medicine at the University of California, San Francisco.

This article originally appeared on The Conversation and is republished under a Creative Commons license cipro and milk. Read the original here..

Masks slow the spread of SARS-CoV-2 by reducing how much infected people spray the virus into the environment around them when they cough or talk buy cipro with prescription. Evidence from laboratory experiments, hospitals and whole countries show that masks work, and the Centers for Disease Control and Prevention recommends face coverings for the buy cipro with prescription U.S. Public.

With all this evidence, mask wearing has become the norm buy cipro with prescription in many places.I am an infectious disease doctor and a professor of medicine at the University of California, San Francisco. As governments and workplaces began to recommend or mandate mask wearing, my colleagues and I noticed an interesting trend. In places where most people wore masks, those who did get infected seemed dramatically less likely to get severely ill compared to places with less mask-wearing.It seems people get less buy cipro with prescription sick if they wear a mask.When you wear a mask – even a cloth mask – you typically are exposed to a lower dose of the coronavirus than if you didn’t.

Both recent experiments in animal models using coronavirus and nearly a hundred years of viral research show that lower viral doses usually means less severe disease.No mask is perfect, and wearing one might not prevent you from getting infected. But it might be the difference between a case of COVID-19 that sends you to the hospital and a case so mild you don’t even realize you’re infected.Exposure Dose Determines Severity of DiseaseWhen you breathe in a respiratory virus, it immediately begins hijacking any cells it lands near to turn them into virus production machines buy cipro with prescription. The immune system tries to stop this process to halt the spread of the virus.The amount of virus that you’re exposed to – called the viral inoculum, or dose – has a lot to do with how sick you get.

If the exposure dose is very high, the immune response can buy cipro with prescription become overwhelmed. Between the virus taking over huge numbers of cells and the immune system’s drastic efforts to contain the infection, a lot of damage is done to the body and a person can become very sick.On the other hand, if the initial dose of the virus is small, the immune system is able to contain the virus with less drastic measures. If this happens, the person experiences fewer symptoms, if any.This concept of viral dose being related to disease severity has buy cipro with prescription been around for almost a century.

Many animal studies have shown that the higher the dose of a virus you give an animal, the more sick it becomes. In 2015, researchers tested this concept in human volunteers using a nonlethal flu virus and found buy cipro with prescription the same result. The higher the flu virus dose given to the volunteers, the sicker they became.In July, researchers published a paper showing that viral dose was related to disease severity in hamsters exposed to the coronavirus.

Hamsters who were given a higher viral dose got more sick than hamsters given a lower dose.Based on this body of research, it seems very likely that if you are exposed to SARS-CoV-2, the lower the dose, the less sick you will get.So what can a person do to buy cipro with prescription lower the exposure dose?. Masks Reduce Viral DoseMost infectious disease researchers and epidemiologists believe that the coronavirus is mostly spread buy cipro with prescription by airborne droplets and, to a lesser extent, tiny aerosols. Research shows that both cloth and surgical masks can block the majority of particles that could contain SARS-CoV-2.

While no mask is perfect, the goal is not to block buy cipro with prescription all of the virus, but simply reduce the amount that you might inhale. Almost any mask will successfully block some amount.Laboratory experiments have shown that good cloth masks and surgical masks could block at least 80% of viral particles from entering your nose and mouth. Those particles and other contaminants will get trapped in the fibers of the mask, so the CDC recommends washing your cloth mask after each use if possible.The final piece of experimental evidence showing that masks reduce buy cipro with prescription viral dose comes from another hamster experiment.

Hamsters were divided into an unmasked group and a masked group by placing surgical mask material over the pipes that brought air into the cages of the masked group. Hamsters infected with the coronavirus were placed in cages next to the masked and unmasked hamsters, and air was pumped from the infected cages into the cages with uninfected hamsters.As expected, the masked hamsters were less likely to get infected buy cipro with prescription with COVID-19. But when some of the masked hamsters did get infected, they had more mild disease than the unmasked hamsters.Masks Increase Rate of Asymptomatic CasesIn July, the CDC estimated that around 40% of people infected with SARS-CoV-2 are asymptomatic, and a number of other studies have confirmed this number.However, in places where everyone wears masks, the rate of asymptomatic infection seems to be much higher.

In an outbreak on an Australian cruise ship called the Greg Mortimer in late March, the passengers were all given surgical masks and the staff were given N95 masks buy cipro with prescription after the first case of COVID-19 was identified. Mask usage was apparently very high, and even though 128 of the 217 passengers and staff eventually tested positive for the coronavirus, 81% of the infected people remained asymptomatic.Further evidence has come from two more recent outbreaks, the first at a seafood processing plant in Oregon and the second at a chicken processing plant in Arkansas. In both places, the workers were buy cipro with prescription provided masks and required to wear them at all times.

In the outbreaks from both plants, nearly 95% of infected people were asymptomatic.There is no doubt that universal mask wearing slows the spread of the coronavirus. My colleagues and I believe that evidence from laboratory experiments, case studies like the cruise ship and food processing plant outbreaks and long-known biological principles make a strong case that masks protect the wearer too.The goal of any tool to fight this buy cipro with prescription pandemic is to slow the spread of the virus and save lives. Universal masking will do both.Monica Gandhi is a Professor of Medicine with the Division of HIV, Infectious Diseases and Global Medicine at the University of California, San Francisco.

This article originally appeared on The Conversation buy cipro with prescription and is republished under a Creative Commons license. Read the original here..

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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Trial Population cipro and pseudomonas cipro for sinus infection Table 1. Table 1. Characteristics of the Participants in the mRNA-1273 Trial at Enrollment cipro and pseudomonas. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig. S1).

Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected Covid-19 while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1. Vaccine Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination.

Figure 1. Figure 1. Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2).

Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events. None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common.

Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). SARS-CoV-2 Binding Antibody Responses Table 2. Table 2. Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens.

Figure 2. Figure 2. SARS-CoV-2 Antibody and Neutralization Responses. Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live virus PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively.

Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants. Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively.

Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A). Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B). For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens.

The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). SARS-CoV-2 Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50]. Figure 2C, Fig. S8, and Table 2.

80% inhibitory dilution [ID80]. Fig. S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43.

The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43). These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens. Before vaccination, no participant had detectable 80% live-virus neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type virus–neutralizing activity capable of reducing SARS-CoV-2 infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. SARS-CoV-2 T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >. Interleukin 2 >.

Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Patients Figure 1. Figure 1. Enrollment and Randomization.

Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were assigned to the remdesivir group and 522 to the placebo group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as assigned.

Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2). As of April 28, 2020, a total of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29, recovered, or died. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group and 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit. The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group).

Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1. Table 1. Demographic and Clinical Characteristics at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1).

On the basis of the evolving epidemiology of Covid-19 during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported. 249 (23.4%) were Hispanic or Latino. Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12).

Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined in the Supplementary Appendix. 272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4. There were 46 (4.3%) patients who had missing ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group. Primary Outcome Figure 2.

Figure 2. Kaplan–Meier Estimates of Cumulative Recoveries. Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation.

Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E). Table 2. Table 2. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population.

Figure 3. Figure 3. Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by the patients.

Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days. Rate ratio for recovery, 1.32. 95% confidence interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table 2).

Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant.

An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54. 1017 patients). Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe.

Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81. 380 patients) (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91.

P=0.001. 844 patients) (Table 2 and Fig. S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04.

1059 patients). The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10). Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3).

4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients). Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4).

The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]). Pyrexia (27 events [5.0%], as compared with 17 [3.3%]). Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]).

Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Announced on May 15, Operation Warp Speed (OWS) — a partnership of the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector — aims to accelerate control of the Covid-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. OWS is providing support to promising candidates and enabling the expeditious, parallel execution of the necessary steps toward approval or authorization of safe products by the Food and Drug Administration (FDA).The partnership grew out of an acknowledged need to fundamentally restructure the way the U.S. Government typically supports product development and vaccine distribution. The initiative was premised on setting a “stretch goal” — one that initially seemed impossible but that is becoming increasingly achievable.The concept of an integrated structure for Covid-19 countermeasure research and development across the U.S. Government was based on experience with Zika and the Zika Leadership Group led by the National Institutes of Health (NIH) and the assistant secretary for preparedness and response (ASPR).

One of us (M.S.) serves as OWS chief advisor. We are drawing on expertise from the NIH, ASPR, the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), and the DOD, including the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Defense Advanced Research Projects Agency. OWS has engaged experts in all critical aspects of medical countermeasure research, development, manufacturing, and distribution to work in close coordination.The initiative set ambitious objectives. To deliver tens of millions of doses of a SARS-CoV-2 vaccine — with demonstrated safety and efficacy, and approved or authorized by the FDA for use in the U.S. Population — beginning at the end of 2020 and to have as many as 300 million doses of such vaccines available and deployed by mid-2021.

The pace and scope of such a vaccine effort are unprecedented. The 2014 West African Ebola virus epidemic spurred rapid vaccine development, but though preclinical data existed before the outbreak, a period of 12 months was required to progress from phase 1 first-in-human trials to phase 3 efficacy trials. OWS aims to compress this time frame even further. SARS-CoV-2 vaccine development began in January, phase 1 clinical studies in March, and the first phase 3 trials in July. Our objectives are based on advances in vaccine platform technology, improved understanding of safe and efficacious vaccine design, and similarities between the SARS-CoV-1 and SARS-CoV-2 disease mechanisms.OWS’s role is to enable, accelerate, harmonize, and advise the companies developing the selected vaccines.

The companies will execute the clinical or process development and manufacturing plans, while OWS leverages the full capacity of the U.S. Government to ensure that no technical, logistic, or financial hurdles hinder vaccine development or deployment.OWS selected vaccine candidates on the basis of four criteria. We required candidates to have robust preclinical data or early-stage clinical trial data supporting their potential for clinical safety and efficacy. Candidates had to have the potential, with our acceleration support, to enter large phase 3 field efficacy trials this summer or fall (July to November 2020) and, assuming continued active transmission of the virus, to deliver efficacy outcomes by the end of 2020 or the first half of 2021. Candidates had to be based on vaccine-platform technologies permitting fast and effective manufacturing, and their developers had to demonstrate the industrial process scalability, yields, and consistency necessary to reliably produce more than 100 million doses by mid-2021.

Finally, candidates had to use one of four vaccine-platform technologies that we believe are the most likely to yield a safe and effective vaccine against Covid-19. The mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform.OWS’s strategy relies on a few key principles. First, we sought to build a diverse project portfolio that includes two vaccine candidates based on each of the four platform technologies. Such diversification mitigates the risk of failure due to safety, efficacy, industrial manufacturability, or scheduling factors and may permit selection of the best vaccine platform for each subpopulation at risk for contracting or transmitting Covid-19, including older adults, frontline and essential workers, young adults, and pediatric populations. In addition, advancing eight vaccines in parallel will increase the chances of delivering 300 million doses in the first half of 2021.Second, we must accelerate vaccine program development without compromising safety, efficacy, or product quality.

Clinical development, process development, and manufacturing scale-up can be substantially accelerated by running all streams, fully resourced, in parallel. Doing so requires taking on substantial financial risk, as compared with the conventional sequential development approach. OWS will maximize the size of phase 3 trials (30,000 to 50,000 participants each) and optimize trial-site location by consulting daily epidemiologic and disease-forecasting models to ensure the fastest path to an efficacy readout. Such large trials also increase the safety data set for each candidate vaccine.With heavy up-front investment, companies can conduct clinical operations and site preparation for these phase 3 efficacy trials even as they file their Investigational New Drug application (IND) for their phase 1 studies, thereby ensuring immediate initiation of phase 3 when they get a green light from the FDA. To permit appropriate comparisons among the vaccine candidates and to optimize vaccine utilization after approval by the FDA, the phase 3 trial end points and assay readouts have been harmonized through a collaborative effort involving the National Institute of Allergy and Infectious Diseases (NIAID), the Coronavirus Prevention Network, OWS, and the sponsor companies.Finally, OWS is supporting the companies financially and technically to commence process development and scale up manufacturing while their vaccines are in preclinical or very early clinical stages.

To ensure that industrial processes are set, running, and validated for FDA inspection when phase 3 trials end, OWS is also supporting facility building or refurbishing, equipment fitting, staff hiring and training, raw-material sourcing, technology transfer and validation, bulk product processing into vials, and acquisition of ample vials, syringes, and needles for each vaccine candidate. We aim to have stockpiled, at OWS’s expense, a few tens of millions of vaccine doses that could be swiftly deployed once FDA approval is obtained.This strategy aims to accelerate vaccine development without curtailing the critical steps required by sound science and regulatory standards. The FDA recently reissued guidance and standards that will be used to assess each vaccine for a Biologics License Application (BLA). Alternatively, the agency could decide to issue an Emergency Use Authorization to permit vaccine administration before all BLA procedures are completed.Of the eight vaccines in OWS’s portfolio, six have been announced and partnerships executed with the companies. Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein).

These candidates cover three of the four platform technologies and are currently in clinical trials. The remaining two candidates will enter trials soon.Moderna developed its RNA vaccine in collaboration with the NIAID, began its phase 1 trial in March, recently published encouraging safety and immunogenicity data,1 and entered phase 3 on July 27. Pfizer and BioNTech’s RNA vaccine also produced encouraging phase 1 results2 and started its phase 3 trial on July 27. The ChAdOx replication-defective live-vector vaccine developed by AstraZeneca and Oxford University is in phase 3 trials in the United Kingdom, Brazil, and South Africa, and it should enter U.S. Phase 3 trials in August.3 The Janssen Ad26 Covid-19 replication-defective live-vector vaccine has demonstrated excellent protection in nonhuman primate models and began its U.S.

Phase 1 trial on July 27. It should be in phase 3 trials in mid-September. Novavax completed a phase 1 trial of its recombinant-subunit-adjuvanted protein vaccine in Australia and should enter phase 3 trials in the United States by the end of September.4 Sanofi/GSK is completing preclinical development steps and plans to commence a phase 1 trial in early September and to be well into phase 3 by year’s end.5On the process-development front, the RNA vaccines are already being manufactured at scale. The other candidates are well advanced in their scale-up development, and manufacturing sites are being refurbished.While development and manufacturing proceed, the HHS–DOD partnership is laying the groundwork for vaccine distribution, subpopulation prioritization, financing, and logistic support. We are working with bioethicists and experts from the NIH, the CDC, BARDA, and the Centers for Medicare and Medicaid Services to address these critical issues.

We will receive recommendations from the CDC Advisory Committee on Immunization Practices, and we are working to ensure that the most vulnerable and at-risk persons will receive vaccine doses once they are ready. Prioritization will also depend on the relative performance of each vaccine and its suitability for particular populations. Because some technologies have limited previous data on safety in humans, the long-term safety of these vaccines will be carefully assessed using pharmacovigilance surveillance strategies.No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices we’ve made, the support the government has provided, and the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor.Trial Design and Oversight We conducted a randomized, double-blind, placebo-controlled trial to evaluate postexposure prophylaxis with hydroxychloroquine after exposure to Covid-19.12 We randomly assigned participants in a 1:1 ratio to receive either hydroxychloroquine or placebo. Participants had known exposure (by participant report) to a person with laboratory-confirmed Covid-19, whether as a household contact, a health care worker, or a person with other occupational exposures. Trial enrollment began on March 17, 2020, with an eligibility threshold to enroll within 3 days after exposure.

The objective was to intervene before the median incubation period of 5 to 6 days. Because of limited access to prompt testing, health care workers could initially be enrolled on the basis of presumptive high-risk exposure to patients with pending tests. However, on March 23, eligibility was changed to exposure to a person with a positive polymerase-chain-reaction (PCR) assay for SARS-CoV-2, with the eligibility window extended to within 4 days after exposure. This trial was approved by the institutional review board at the University of Minnesota and conducted under a Food and Drug Administration Investigational New Drug application. In Canada, the trial was approved by Health Canada.

Ethics approvals were obtained from the Research Institute of the McGill University Health Centre, the University of Manitoba, and the University of Alberta. Participants We included participants who had household or occupational exposure to a person with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Participants were excluded if they were younger than 18 years of age, were hospitalized, or met other exclusion criteria (see the Supplementary Appendix, available with the full text of this article at NEJM.org). Persons with symptoms of Covid-19 or with PCR-proven SARS-CoV-2 infection were excluded from this prevention trial but were separately enrolled in a companion clinical trial to treat early infection. Setting Recruitment was performed primarily with the use of social media outreach as well as traditional media platforms.

Participants were enrolled nationwide in the United States and in the Canadian provinces of Quebec, Manitoba, and Alberta. Participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.13 After participants read the consent form, their comprehension of its contents was assessed. Participants provided a digitally captured signature to indicate informed consent. We sent follow-up e-mail surveys on days 1, 5, 10, and 14. A survey at 4 to 6 weeks asked about any follow-up testing, illness, or hospitalizations.

Participants who did not respond to follow-up surveys received text messages, e-mails, telephone calls, or a combination of these to ascertain their outcomes. When these methods were unsuccessful, the emergency contact provided by the enrollee was contacted to determine the participant’s illness and vital status. When all communication methods were exhausted, Internet searches for obituaries were performed to ascertain vital status. Interventions Randomization occurred at research pharmacies in Minneapolis and Montreal. The trial statisticians generated a permuted-block randomization sequence using variably sized blocks of 2, 4, or 8, with stratification according to country.

A research pharmacist sequentially assigned participants. The assignments were concealed from investigators and participants. Only pharmacies had access to the randomization sequence. Hydroxychloroquine sulfate or placebo was dispensed and shipped overnight to participants by commercial courier. The dosing regimen for hydroxychloroquine was 800 mg (4 tablets) once, then 600 mg (3 tablets) 6 to 8 hours later, then 600 mg (3 tablets) daily for 4 more days for a total course of 5 days (19 tablets total).

If participants had gastrointestinal upset, they were advised to divide the daily dose into two or three doses. We chose this hydroxychloroquine dosing regimen on the basis of pharmacokinetic simulations to achieve plasma concentrations above the SARS-CoV-2 in vitro half maximal effective concentration for 14 days.14 Placebo folate tablets, which were similar in appearance to the hydroxychloroquine tablets, were prescribed as an identical regimen for the control group. Rising Pharmaceuticals provided a donation of hydroxychloroquine, and some hydroxychloroquine was purchased. Outcomes The primary outcome was prespecified as symptomatic illness confirmed by a positive molecular assay or, if testing was unavailable, Covid-19–related symptoms. We assumed that health care workers would have access to Covid-19 testing if symptomatic.

However, access to testing was limited throughout the trial period. Covid-19–related symptoms were based on U.S. Council for State and Territorial Epidemiologists criteria for confirmed cases (positivity for SARS-Cov-2 on PCR assay), probable cases (the presence of cough, shortness of breath, or difficulty breathing, or the presence of two or more symptoms of fever, chills, rigors, myalgia, headache, sore throat, and new olfactory and taste disorders), and possible cases (the presence of one or more compatible symptoms, which could include diarrhea).15 All the participants had epidemiologic linkage,15 per trial eligibility criteria. Four infectious disease physicians who were unaware of the trial-group assignments reviewed symptomatic participants to generate a consensus with respect to whether their condition met the case definition.15 Secondary outcomes included the incidence of hospitalization for Covid-19 or death, the incidence of PCR-confirmed SARS-CoV-2 infection, the incidence of Covid-19 symptoms, the incidence of discontinuation of the trial intervention owing to any cause, and the severity of symptoms (if any) at days 5 and 14 according to a visual analogue scale (scores ranged from 0 [no symptoms] to 10 [severe symptoms]). Data on adverse events were also collected with directed questioning for common side effects along with open-ended free text.

Outcome data were measured within 14 days after trial enrollment. Outcome data including PCR testing results, possible Covid-19–related symptoms, adherence to the trial intervention, side effects, and hospitalizations were all collected through participant report. Details of trial conduct are provided in the protocol and statistical analysis plan, available at NEJM.org. Sample Size We anticipated that illness compatible with Covid-19 would develop in 10% of close contacts exposed to Covid-19.9 Using Fisher’s exact method with a 50% relative effect size to reduce new symptomatic infections, a two-sided alpha of 0.05, and 90% power, we estimated that 621 persons would need to be enrolled in each group. With a pragmatic, Internet-based, self-referral recruitment strategy, we planned for a 20% incidence of attrition by increasing the sample size to 750 participants per group.

We specified a priori that participants who were already symptomatic on day 1 before receiving hydroxychloroquine or placebo would be excluded from the prophylaxis trial and would instead be separately enrolled in the companion symptomatic treatment trial. Because the estimates for both incident symptomatic Covid-19 after an exposure and loss to follow-up were relatively unknown in early March 2020,9 the protocol prespecified a sample-size reestimation at the second interim analysis. This reestimation, which used the incidence of new infections in the placebo group and the observed percentage of participants lost to follow-up, was aimed at maintaining the ability to detect an effect size of a 50% relative reduction in new symptomatic infections. Interim Analyses An independent data and safety monitoring board externally reviewed the data after 25% and 50% of the participants had completed 14 days of follow-up. Stopping guidelines were provided to the data and safety monitoring board with the use of a Lan–DeMets spending function analogue of the O’Brien–Fleming boundaries for the primary outcome.

A conditional power analysis was performed at the second and third interim analysis with the option of early stopping for futility. At the second interim analysis on April 22, 2020, the sample size was reduced to 956 participants who could be evaluated with 90% power on the basis of the higher-than-expected event rate of infections in the control group. At the third interim analysis on May 6, the trial was halted on the basis of a conditional power of less than 1%, since it was deemed futile to continue. Statistical Analysis We assessed the incidence of Covid-19 disease by day 14 with Fisher’s exact test. Secondary outcomes with respect to percentage of patients were also compared with Fisher’s exact test.

Among participants in whom incident illness compatible with Covid-19 developed, we summarized the symptom severity score at day 14 with the median and interquartile range and assessed the distributions with a Kruskal–Wallis test. We conducted all analyses with SAS software, version 9.4 (SAS Institute), according to the intention-to-treat principle, with two-sided type I error with an alpha of 0.05. For participants with missing outcome data, we conducted a sensitivity analysis with their outcomes excluded or included as an event. Subgroups that were specified a priori included type of contact (household vs. Health care), days from exposure to enrollment, age, and sex.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with Covid-19 at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

(Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020. Pregnant or breast-feeding women were eligible.

Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net. The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee.

The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan. Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial.

For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first.

Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death). In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months. Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death.

Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the Covid-19 pandemic. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio.

Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period. Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio.

Table 1. Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1). To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years).

This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk. (One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest.

Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle. The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford..

Trial Population click here to find out more Table buy cipro with prescription 1. Table 1. Characteristics of the Participants in the buy cipro with prescription mRNA-1273 Trial at Enrollment. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig.

S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected Covid-19 while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1.

Vaccine Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.

Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events.

None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common.

Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). SARS-CoV-2 Binding Antibody Responses Table 2. Table 2.

Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2. SARS-CoV-2 Antibody and Neutralization Responses.

Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live virus PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively. Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants.

Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A). Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B).

For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens. The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). SARS-CoV-2 Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50].

Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80]. Fig.

S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43).

These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens. Before vaccination, no participant had detectable 80% live-virus neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type virus–neutralizing activity capable of reducing SARS-CoV-2 infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. SARS-CoV-2 T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >.

Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Patients Figure 1.

Figure 1. Enrollment and Randomization. Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were assigned to the remdesivir group and 522 to the placebo group (Figure 1).

Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as assigned. Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2).

As of April 28, 2020, a total of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29, recovered, or died. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group and 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit. The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group).

Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1. Table 1. Demographic and Clinical Characteristics at Baseline.

The mean age of patients was 58.9 years, and 64.3% were male (Table 1). On the basis of the evolving epidemiology of Covid-19 during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported. 249 (23.4%) were Hispanic or Latino.

Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12). Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined in the Supplementary Appendix. 272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4.

There were 46 (4.3%) patients who had missing ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group. Primary Outcome Figure 2. Figure 2.

Kaplan–Meier Estimates of Cumulative Recoveries. Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation.

Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E). Table 2. Table 2.

Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population. Figure 3. Figure 3. Time to Recovery According to Subgroup.

The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by the patients. Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days. Rate ratio for recovery, 1.32.

95% confidence interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table 2). Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84).

Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant.

An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54. 1017 patients).

Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81. 380 patients) (Figure 3).

Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91. P=0.001. 844 patients) (Table 2 and Fig.

S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04. 1059 patients).

The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10). Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3).

4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients). Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators.

Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4). The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]). Pyrexia (27 events [5.0%], as compared with 17 [3.3%]).

Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Announced on May 15, Operation Warp Speed (OWS) — a partnership of the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector — aims to accelerate control of the Covid-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. OWS is providing support to promising candidates and enabling the expeditious, parallel execution of the necessary steps toward approval or authorization of safe products by the Food and Drug Administration (FDA).The partnership grew out of an acknowledged need to fundamentally restructure the way the U.S.

Government typically supports product does cipro contain penicillin development and vaccine distribution. The initiative was premised on setting a “stretch goal” — one that initially seemed impossible but that is becoming increasingly achievable.The concept of an integrated structure for Covid-19 countermeasure research and development across the U.S. Government was based on experience with Zika and the Zika Leadership Group led by the National Institutes of Health (NIH) and the assistant secretary for preparedness and response (ASPR). One of us (M.S.) serves as OWS chief advisor.

We are drawing on expertise from the NIH, ASPR, the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), and the DOD, including the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Defense Advanced Research Projects Agency. OWS has engaged experts in all critical aspects of medical countermeasure research, development, manufacturing, and distribution to work in close coordination.The initiative set ambitious objectives. To deliver tens of millions of doses of a SARS-CoV-2 vaccine — with demonstrated safety and efficacy, and approved or authorized by the FDA for use in the U.S. Population — beginning at the end of 2020 and to have as many as 300 million doses of such vaccines available and deployed by mid-2021.

The pace and scope of such a vaccine effort are unprecedented. The 2014 West African Ebola virus epidemic spurred rapid vaccine development, but though preclinical data existed before the outbreak, a period of 12 months was required to progress from phase 1 first-in-human trials to phase 3 efficacy trials. OWS aims to compress this time frame even further. SARS-CoV-2 vaccine development began in January, phase 1 clinical studies in March, and the first phase 3 trials in July.

Our objectives are based on advances in vaccine platform technology, improved understanding of safe and efficacious vaccine design, and similarities between the SARS-CoV-1 and SARS-CoV-2 disease mechanisms.OWS’s role is to enable, accelerate, harmonize, and advise the companies developing the selected vaccines. The companies will execute the clinical or process development and manufacturing plans, while OWS leverages the full capacity of the U.S. Government to ensure that no technical, logistic, or financial hurdles hinder vaccine development or deployment.OWS selected vaccine candidates on the basis of four criteria. We required candidates to have robust preclinical data or early-stage clinical trial data supporting their potential for clinical safety and efficacy.

Candidates had to have the potential, with our acceleration support, to enter large phase 3 field efficacy trials this summer or fall (July to November 2020) and, assuming continued active transmission of the virus, to deliver efficacy outcomes by the end of 2020 or the first half of 2021. Candidates had to be based on vaccine-platform technologies permitting fast and effective manufacturing, and their developers had to demonstrate the industrial process scalability, yields, and consistency necessary to reliably produce more than 100 million doses by mid-2021. Finally, candidates had to use one of four vaccine-platform technologies that we believe are the most likely to yield a safe and effective vaccine against Covid-19. The mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform.OWS’s strategy relies on a few key principles.

First, we sought to build a diverse project portfolio that includes two vaccine candidates based on each of the four platform technologies. Such diversification mitigates the risk of failure due to safety, efficacy, industrial manufacturability, or scheduling factors and may permit selection of the best vaccine platform for each subpopulation at risk for contracting or transmitting Covid-19, including older adults, frontline and essential workers, young adults, and pediatric populations. In addition, advancing eight vaccines in parallel will increase the chances of delivering 300 million doses in the first half of 2021.Second, we must accelerate vaccine program development without compromising safety, efficacy, or product quality. Clinical development, process development, and manufacturing scale-up can be substantially accelerated by running all streams, fully resourced, in parallel.

Doing so requires taking on substantial financial risk, as compared with the conventional sequential development approach. OWS will maximize the size of phase 3 trials (30,000 to 50,000 participants each) and optimize trial-site location by consulting daily epidemiologic and disease-forecasting models to ensure the fastest path to an efficacy readout. Such large trials also increase the safety data set for each candidate vaccine.With heavy up-front investment, companies can conduct clinical operations and site preparation for these phase 3 efficacy trials even as they file their Investigational New Drug application (IND) for their phase 1 studies, thereby ensuring immediate initiation of phase 3 when they get a green light from the FDA. To permit appropriate comparisons among the vaccine candidates and to optimize vaccine utilization after approval by the FDA, the phase 3 trial end points and assay readouts have been harmonized through a collaborative effort involving the National Institute of Allergy and Infectious Diseases (NIAID), the Coronavirus Prevention Network, OWS, and the sponsor companies.Finally, OWS is supporting the companies financially and technically to commence process development and scale up manufacturing while their vaccines are in preclinical or very early clinical stages.

To ensure that industrial processes are set, running, and validated for FDA inspection when phase 3 trials end, OWS is also supporting facility building or refurbishing, equipment fitting, staff hiring and training, raw-material sourcing, technology transfer and validation, bulk product processing into vials, and acquisition of ample vials, syringes, and needles for each vaccine candidate. We aim to have stockpiled, at OWS’s expense, a few tens of millions of vaccine doses that could be swiftly deployed once FDA approval is obtained.This strategy aims to accelerate vaccine development without curtailing the critical steps required by sound science and regulatory standards. The FDA recently reissued guidance and standards that will be used to assess each vaccine for a Biologics License Application (BLA). Alternatively, the agency could decide to issue an Emergency Use Authorization to permit vaccine administration before all BLA procedures are completed.Of the eight vaccines in OWS’s portfolio, six have been announced and partnerships executed with the companies.

Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein). These candidates cover three of the four platform technologies and are currently in clinical trials. The remaining two candidates will enter trials soon.Moderna developed its RNA vaccine in collaboration with the NIAID, began its phase 1 trial in March, recently published encouraging safety and immunogenicity data,1 and entered phase 3 on July 27. Pfizer and BioNTech’s RNA vaccine also produced encouraging phase 1 results2 and started its phase 3 trial on July 27.

The ChAdOx replication-defective live-vector vaccine developed by AstraZeneca and Oxford University is in phase 3 trials in the United Kingdom, Brazil, and South Africa, and it should enter U.S. Phase 3 trials in August.3 The Janssen Ad26 Covid-19 replication-defective live-vector vaccine has demonstrated excellent protection in nonhuman primate models and began its U.S. Phase 1 trial on July 27. It should be in phase 3 trials in mid-September.

Novavax completed a phase 1 trial of its recombinant-subunit-adjuvanted protein vaccine in Australia and should enter phase 3 trials in the United States by the end of September.4 Sanofi/GSK is completing preclinical development steps and plans to commence a phase 1 trial in early September and to be well into phase 3 by year’s end.5On the process-development front, the RNA vaccines are already being manufactured at scale. The other candidates are well advanced in their scale-up development, and manufacturing sites are being refurbished.While development and manufacturing proceed, the HHS–DOD partnership is laying the groundwork for vaccine distribution, subpopulation prioritization, financing, and logistic support. We are working with bioethicists and experts from the NIH, the CDC, BARDA, and the Centers for Medicare and Medicaid Services to address these critical issues. We will receive recommendations from the CDC Advisory Committee on Immunization Practices, and we are working to ensure that the most vulnerable and at-risk persons will receive vaccine doses once they are ready.

Prioritization will also depend on the relative performance of each vaccine and its suitability for particular populations. Because some technologies have limited previous data on safety in humans, the long-term safety of these vaccines will be carefully assessed using pharmacovigilance surveillance strategies.No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices we’ve made, the support the government has provided, and the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor.Trial Design and Oversight We conducted a randomized, double-blind, placebo-controlled trial to evaluate postexposure prophylaxis with hydroxychloroquine after exposure to Covid-19.12 We randomly assigned participants in a 1:1 ratio to receive either hydroxychloroquine or placebo. Participants had known exposure (by participant report) to a person with laboratory-confirmed Covid-19, whether as a household contact, a health care worker, or a person with other occupational exposures. Trial enrollment began on March 17, 2020, with an eligibility threshold to enroll within 3 days after exposure.

The objective was to intervene before the median incubation period of 5 to 6 days. Because of limited access to prompt testing, health care workers could initially be enrolled on the basis of presumptive high-risk exposure to patients with pending tests. However, on March 23, eligibility was changed to exposure to a person with a positive polymerase-chain-reaction (PCR) assay for SARS-CoV-2, with the eligibility window extended to within 4 days after exposure. This trial was approved by the institutional review board at the University of Minnesota and conducted under a Food and Drug Administration Investigational New Drug application.

In Canada, the trial was approved by Health Canada. Ethics approvals were obtained from the Research Institute of the McGill University Health Centre, the University of Manitoba, and the University of Alberta. Participants We included participants who had household or occupational exposure to a person with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Participants were excluded if they were younger than 18 years of age, were hospitalized, or met other exclusion criteria (see the Supplementary Appendix, available with the full text of this article at NEJM.org).

Persons with symptoms of Covid-19 or with PCR-proven SARS-CoV-2 infection were excluded from this prevention trial but were separately enrolled in a companion clinical trial to treat early infection. Setting Recruitment was performed primarily with the use of social media outreach as well as traditional media platforms. Participants were enrolled nationwide in the United States and in the Canadian provinces of Quebec, Manitoba, and Alberta. Participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.13 After participants read the consent form, their comprehension of its contents was assessed.

Participants provided a digitally captured signature to indicate informed consent. We sent follow-up e-mail surveys on days 1, 5, 10, and 14. A survey at 4 to 6 weeks asked about any follow-up testing, illness, or hospitalizations. Participants who did not respond to follow-up surveys received text messages, e-mails, telephone calls, or a combination of these to ascertain their outcomes.

When these methods were unsuccessful, the emergency contact provided by the enrollee was contacted to determine the participant’s illness and vital status. When all communication methods were exhausted, Internet searches for obituaries were performed to ascertain vital status. Interventions Randomization occurred at research pharmacies in Minneapolis and Montreal. The trial statisticians generated a permuted-block randomization sequence using variably sized blocks of 2, 4, or 8, with stratification according to country.

A research pharmacist sequentially assigned participants. The assignments were concealed from investigators and participants. Only pharmacies had access to the randomization sequence. Hydroxychloroquine sulfate or placebo was dispensed and shipped overnight to participants by commercial courier.

The dosing regimen for hydroxychloroquine was 800 mg (4 tablets) once, then 600 mg (3 tablets) 6 to 8 hours later, then 600 mg (3 tablets) daily for 4 more days for a total course of 5 days (19 tablets total). If participants had gastrointestinal upset, they were advised to divide the daily dose into two or three doses. We chose this hydroxychloroquine dosing regimen on the basis of pharmacokinetic simulations to achieve plasma concentrations above the SARS-CoV-2 in vitro half maximal effective concentration for 14 days.14 Placebo folate tablets, which were similar in appearance to the hydroxychloroquine tablets, were prescribed as an identical regimen for the control group. Rising Pharmaceuticals provided a donation of hydroxychloroquine, and some hydroxychloroquine was purchased.

Outcomes The primary outcome was prespecified as symptomatic illness confirmed by a positive molecular assay or, if testing was unavailable, Covid-19–related symptoms. We assumed that health care workers would have access to Covid-19 testing if symptomatic. However, access to testing was limited throughout the trial period. Covid-19–related symptoms were based on U.S.

Council for State and Territorial Epidemiologists criteria for confirmed cases (positivity for SARS-Cov-2 on PCR assay), probable cases (the presence of cough, shortness of breath, or difficulty breathing, or the presence of two or more symptoms of fever, chills, rigors, myalgia, headache, sore throat, and new olfactory and taste disorders), and possible cases (the presence of one or more compatible symptoms, which could include diarrhea).15 All the participants had epidemiologic linkage,15 per trial eligibility criteria. Four infectious disease physicians who were unaware of the trial-group assignments reviewed symptomatic participants to generate a consensus with respect to whether their condition met the case definition.15 Secondary outcomes included the incidence of hospitalization for Covid-19 or death, the incidence of PCR-confirmed SARS-CoV-2 infection, the incidence of Covid-19 symptoms, the incidence of discontinuation of the trial intervention owing to any cause, and the severity of symptoms (if any) at days 5 and 14 according to a visual analogue scale (scores ranged from 0 [no symptoms] to 10 [severe symptoms]). Data on adverse events were also collected with directed questioning for common side effects along with open-ended free text. Outcome data were measured within 14 days after trial enrollment.

Outcome data including PCR testing results, possible Covid-19–related symptoms, adherence to the trial intervention, side effects, and hospitalizations were all collected through participant report. Details of trial conduct are provided in the protocol and statistical analysis plan, available at NEJM.org. Sample Size We anticipated that illness compatible with Covid-19 would develop in 10% of close contacts exposed to Covid-19.9 Using Fisher’s exact method with a 50% relative effect size to reduce new symptomatic infections, a two-sided alpha of 0.05, and 90% power, we estimated that 621 persons would need to be enrolled in each group. With a pragmatic, Internet-based, self-referral recruitment strategy, we planned for a 20% incidence of attrition by increasing the sample size to 750 participants per group.

We specified a priori that participants who were already symptomatic on day 1 before receiving hydroxychloroquine or placebo would be excluded from the prophylaxis trial and would instead be separately enrolled in the companion symptomatic treatment trial. Because the estimates for both incident symptomatic Covid-19 after an exposure and loss to follow-up were relatively unknown in early March 2020,9 the protocol prespecified a sample-size reestimation at the second interim analysis. This reestimation, which used the incidence of new infections in the placebo group and the observed percentage of participants lost to follow-up, was aimed at maintaining the ability to detect an effect size of a 50% relative reduction in new symptomatic infections. Interim Analyses An independent data and safety monitoring board externally reviewed the data after 25% and 50% of the participants had completed 14 days of follow-up.

Stopping guidelines were provided to the data and safety monitoring board with the use of a Lan–DeMets spending function analogue of the O’Brien–Fleming boundaries for the primary outcome. A conditional power analysis was performed at the second and third interim analysis with the option of early stopping for futility. At the second interim analysis on April 22, 2020, the sample size was reduced to 956 participants who could be evaluated with 90% power on the basis of the higher-than-expected event rate of infections in the control group. At the third interim analysis on May 6, the trial was halted on the basis of a conditional power of less than 1%, since it was deemed futile to continue.

Statistical Analysis We assessed the incidence of Covid-19 disease by day 14 with Fisher’s exact test. Secondary outcomes with respect to percentage of patients were also compared with Fisher’s exact test. Among participants in whom incident illness compatible with Covid-19 developed, we summarized the symptom severity score at day 14 with the median and interquartile range and assessed the distributions with a Kruskal–Wallis test. We conducted all analyses with SAS software, version 9.4 (SAS Institute), according to the intention-to-treat principle, with two-sided type I error with an alpha of 0.05.

For participants with missing outcome data, we conducted a sensitivity analysis with their outcomes excluded or included as an event. Subgroups that were specified a priori included type of contact (household vs. Health care), days from exposure to enrollment, age, and sex.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with Covid-19 at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network. (Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor.

Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020. Pregnant or breast-feeding women were eligible.

Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net.

The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan. Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site.

Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial. For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report.

The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first. Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death).

In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months. Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death.

Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the Covid-19 pandemic. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients.

For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio. Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period.

Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1. Table 1.

Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1). To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years). This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent.

Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk. (One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest.

Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle. The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford..

Cipro hypoglycemia

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This story also ran on Fortune. This story can be republished for free (details). Donella Pogue has trouble finding dentists in her rural area willing to accommodate her 21-year-old son, Justin, who is 6 feet, 8 cipro hypoglycemia inches tall, is on the autism spectrum and has difficulty sitting still when touched.And this summer, he had a cavity and his face swelled. Pogue, of Bristol, New York, reached out to the Eastman Institute for Oral Health in Rochester, which cipro hypoglycemia offers teledentistry.Dr. Adela Planerova looked into his mouth from 28 miles away as Pogue pointed her laptop’s camera into her son’s mouth. Planerova determined they did not need to make an emergency one-hour drive to her clinic cipro hypoglycemia. Instead, the dentist prescribed antibiotics and anti-inflammatory drugs, and weeks later he had surgery.Teledentistry allows dental professionals like Planerova to remotely review records and diagnose patients over video.

Some smile about its cipro hypoglycemia promise, seeing it as a way to become more efficient, to reach the one-third of U.S. Adults who federal figures from 2017 estimate hadn’t seen a dentist in the previous year and to practice more safely during the pandemic.But others see it as lesser-quality care that’s cheaper for dental professionals to provide, allowing them to make more money. At the cipro hypoglycemia same time, widespread adoption is hindered by issues such as spotty internet and insurance companies unwilling to reimburse for teledentistry procedures. Don't Miss A Story Subscribe to KHN’s free Weekly Edition newsletter. Dr cipro hypoglycemia.

Christina Carter, an orthodontist in Morristown, New Jersey, said teledentistry has its place but shouldn’t replace time in the dental chair.“It cannot be used for a full diagnosis because we need other tools, like X-rays,” she said. €œWe have all tried to see things on our phone or even on a Zoom call, and there is cipro hypoglycemia still just a different feel.”Still, as the pandemic curbs in-person visits and reduces dentists’ revenue, more dentists are seeking guidance from Dr. Nathan Suter, a leading teledentistry advocate who owns the consulting company Access Teledentistry. Since March, he said, he’s done webinars for about 9,000 dental professionals, up from fewer than 1,000 in the three years before the pandemic.Teledentistry providers trace the practice to 1994, when the Army launched a pilot program in which health care providers used an intra-oral camera to take photos of a patient’s mouth at a fort in Georgia and then sent them over the internet to a dental clinic at a fort 120 miles away.Over the next two decades, dentists in upstate New York and the San Francisco Bay Area led teledentistry pilot programs for underserved children, some of whom were cipro hypoglycemia in preschool and already had cavities. The number of children who completed the prescribed dental treatment rose significantly.Supporters say teledentistry can help reach cipro hypoglycemia the 43% of rural Americans who lack access to dental care.

Medicaid and the Children’s Health Insurance Program will pay for many dental procedures for those enrolled in those programs, but only 38% of dentists participate in those programs, according to the American Dental Association. One reason. Medicaid typically reimburses at a significantly lower rate than those of private insurance plans.Teledentistry could help dentists treat more patients and make more money a number of ways. If dentists remotely review data captured by hygienists, they can see more patients. Because video appointments save them time, dentists then have room for the people “who need the more expensive services” while also focusing on preventive care, said Kirill Zaydenman, vice president of innovation for DentaQuest, an administrator of dental insurance and oral health care provider.Donella Pogue says that teledentistry was the best option for her 21-year-old son, Justin, when he had a cavity this summer that caused his face to swell.

Justin has special needs and was able to see the dentist from the comfort of home. (Donella Pogue)But dentists have not widely adopted teledentistry — mainly because they’ve had difficulty getting insurers to pay for it, said Dr. Dorota Kopycka-Kedzierawski, a Rochester dentist. That’s partly because of insurers’ concerns about fraud. Dr.

Paul Glassman, who started the Virtual Dental Home project to reach underserved preschool children in the Bay Area, considers those fears “completely incorrect.”“If you want to bill for something you didn’t do,” he said, “you can do that just as easily in an in-person environment as you can using teledentistry.”Since March, as the pandemic descended, most, if not all, private dental plans have been reimbursing for teledentistry, said Tom Meyers, vice president of public policy for America’s Health Insurance Plans, a trade organization. And all state Medicaid programs now reimburse for teledentistry in some form, Glassman said, though policies differ by state and some practices may not be covered in some places.But teledentistry isn’t reimbursable under Medicare. (Most dentistry isn’t.) Another obstacle to widespread adoption. Some dentists and lawmakers connect teledentistry to companies offering at-home teeth aligners with little or no in-person contact with a dentist. Glassman has promoted teledentistry throughout the United States and reviewed proposed legislation or regulations in states such as Idaho, Massachusetts and Texas.

He said he hears concerns from dentists about the lack of an in-person exam during which X-rays are taken. Such concerns are reflected in some legislation.SmileDirectClub, an at-home teeth-aligner company, has argued in statehouse testimony that in-person care is not always needed. The company opposed a 2019 bill in Texas that aimed to improve access to dentistry in rural areas because it included a number of restrictions on teledentistry, including one that would have required an in-person dentist’s examination if a teledentistry provider treated that patient for more than 12 months.SmileDirect’s attorney argued at a hearing the rule “could interrupt the course of a patient’s treatment.”The measure failed.Proponents argue teledentistry isn’t just about making more money. Pogue, the New York woman, said it was the best option for her son with special needs.“He is really afraid of dentistry, so when he goes to see someone, he is really tense and really jumpy, so that’s another reason the teledentistry was nice was because he was in my bedroom doing it, so he was really comfortable,” said Pogue, 53, whose son is covered by Medicaid.A few weeks later, Justin did have to have surgery, which went “perfect,” his mom said.Some dentists say teledentistry faces particular stumbling blocks in rural areas. Dr.

Mack Taylor, 36, a dentist who grew up in the small town of Dexter, Missouri, now practices in a health center just down the road. Twenty years ago, he said, Dexter had eight dentists. Now there are only three.Technology is a major obstacle for local residents, many of whom lack reliable internet service. Taylor recently applied for a U.S. Department of Agriculture grant that would give him $26,500 to buy equipment so that, for example, a hygienist can take photos inside the mouths of nursing home residents and send them to Taylor to review.“It’s not like medicine where you can discuss someone’s ailments and have a good idea what’s going on,” Taylor said.

€œMaybe all you can tell me is ‘I have a broken tooth,’ but I can’t physically see what’s going on and prescribe the right treatment.” Related Topics COVID-19 Dental Health TelemedicineEarly assessment can save rural patients with chest pain a hospital trip - North Carolina Health News Read our Coronavirus Coverage Here [email][email][zip][zip][listGroups][listGroups][email][email][zip][zip][listGroups][listGroups].

This story also ran on Fortune. This story can be republished for free (details). Donella Pogue has trouble finding dentists in her rural area willing to buy cipro with prescription accommodate her 21-year-old son, Justin, who is 6 feet, 8 inches tall, is on the cipro for sinus infection autism spectrum and has difficulty sitting still when touched.And this summer, he had a cavity and his face swelled. Pogue, of Bristol, New York, reached out to the Eastman Institute for Oral Health in Rochester, buy cipro with prescription which offers teledentistry.Dr. Adela Planerova looked into his mouth from 28 miles away as Pogue pointed her laptop’s camera into her son’s mouth. Planerova determined buy cipro with prescription they did not need to make an emergency one-hour drive to her clinic. Instead, the dentist prescribed antibiotics and anti-inflammatory drugs, and weeks later he had surgery.Teledentistry allows dental professionals like Planerova to remotely review records and diagnose patients over video.

Some smile about its buy cipro with prescription promise, seeing it as a way to become more efficient, to reach the one-third of U.S. Adults who federal figures from 2017 estimate hadn’t seen a dentist in the previous year and to practice more safely during the pandemic.But others see it as lesser-quality care that’s cheaper for dental professionals to provide, allowing them to make more money. At the same time, widespread adoption is hindered by issues such as buy cipro with prescription spotty internet and insurance companies unwilling to reimburse for teledentistry procedures. Don't Miss A Story Subscribe to KHN’s free Weekly Edition newsletter. Dr buy cipro with prescription.

Christina Carter, an orthodontist in Morristown, New Jersey, said teledentistry has its place but shouldn’t replace time in the dental chair.“It cannot be used for a full diagnosis because we need other tools, like X-rays,” she said. €œWe have all tried to see things on our phone or even on a Zoom call, and there is still just a different feel.”Still, as the pandemic curbs in-person visits and reduces dentists’ revenue, more dentists are seeking buy cipro with prescription guidance from Dr. Nathan Suter, a leading teledentistry advocate who owns the consulting company Access Teledentistry. Since March, he said, he’s done webinars for about 9,000 dental professionals, up from fewer than 1,000 in the three years before the pandemic.Teledentistry providers trace the practice to 1994, when the Army launched a pilot program in which health care providers used an intra-oral camera to take photos of a patient’s mouth buy cipro with prescription at a fort in Georgia and then sent them over the internet to a dental clinic at a fort 120 miles away.Over the next two decades, dentists in upstate New York and the San Francisco Bay Area led teledentistry pilot programs for underserved children, some of whom were in preschool and already had cavities. The number of children who completed the prescribed dental treatment rose significantly.Supporters say teledentistry can help buy cipro with prescription reach the 43% of rural Americans who lack access to dental care.

Medicaid and the Children’s Health Insurance Program will pay for many dental procedures for those enrolled in those programs, but only 38% of dentists participate in those programs, according to the American Dental Association. One reason buy cipro with prescription. Medicaid typically reimburses at a significantly lower rate than those of private insurance plans.Teledentistry could help dentists treat more patients and make more money a number of ways. If dentists remotely review data captured buy cipro with prescription by hygienists, they can see more patients. Because video appointments save them time, dentists then have room for the people “who need the more expensive services” while also focusing on preventive care, said Kirill Zaydenman, vice president of innovation for DentaQuest, an administrator of dental insurance and oral health care provider.Donella Pogue says that teledentistry was the best option for her 21-year-old son, Justin, when he had a cavity this summer that caused his face to swell.

Justin has special needs and was able to see the dentist from the http://sw.keimfarben.de/buying-cipro-in-usa/ comfort of home. (Donella Pogue)But dentists have not widely adopted teledentistry — mainly because they’ve had difficulty getting insurers to pay for it, said Dr. Dorota Kopycka-Kedzierawski, a Rochester dentist. That’s partly because of insurers’ concerns about fraud. Dr.

Paul Glassman, who started the Virtual Dental Home project to reach underserved preschool children in the Bay Area, considers those fears “completely incorrect.”“If you want to bill for something you didn’t do,” he said, “you can do that just as easily in an in-person environment as you can using teledentistry.”Since March, as the pandemic descended, most, if not all, private dental plans have been reimbursing for teledentistry, said Tom Meyers, vice president of public policy for America’s Health Insurance Plans, a trade organization. And all state Medicaid programs now reimburse for teledentistry in some form, Glassman said, though policies differ by state and some practices may not be covered in some places.But teledentistry isn’t reimbursable under Medicare. (Most dentistry isn’t.) Another obstacle to widespread adoption. Some dentists and lawmakers connect teledentistry to companies offering at-home teeth aligners with little or no in-person contact with a dentist. Glassman has promoted teledentistry throughout the United States and reviewed proposed legislation or regulations in states such as Idaho, Massachusetts and Texas.

He said he hears concerns from dentists about the lack of an in-person exam during which X-rays are taken. Such concerns are reflected in some legislation.SmileDirectClub, an at-home teeth-aligner company, has argued in statehouse testimony that in-person care is not always needed. The company opposed a 2019 bill in Texas that aimed to improve access to dentistry in rural areas because it included a number of restrictions on teledentistry, including one that would have required an in-person dentist’s examination if a teledentistry provider treated that patient for more than 12 months.SmileDirect’s attorney argued at a hearing the rule “could interrupt the course of a patient’s treatment.”The measure failed.Proponents argue teledentistry isn’t just about making more money. Pogue, the New York woman, said it was the best option for her son with special needs.“He is really afraid of dentistry, so when he goes to see someone, he is really tense and really jumpy, so that’s another reason the teledentistry was nice was because he was in my bedroom doing it, so he was really comfortable,” said Pogue, 53, whose son is covered by Medicaid.A few weeks later, Justin did have to have surgery, which went “perfect,” his mom said.Some dentists say teledentistry faces particular stumbling blocks in rural areas. Dr.

Mack Taylor, 36, a dentist who grew up in the small town of Dexter, Missouri, now practices in a health center just down the road. Twenty years ago, he said, Dexter had eight dentists. Now there are only three.Technology is a major obstacle for local residents, many of whom lack reliable internet service. Taylor recently applied for a U.S. Department of Agriculture grant that would give him $26,500 to buy equipment so that, for example, a hygienist can take photos inside the mouths of nursing home residents and send them to Taylor to review.“It’s not like medicine where you can discuss someone’s ailments and have a good idea what’s going on,” Taylor said.

€œMaybe all you can tell me is ‘I have a broken tooth,’ but I can’t physically see what’s going on and prescribe the right treatment.” Related Topics COVID-19 Dental Health TelemedicineEarly assessment can save rural patients with chest pain a hospital trip - North Carolina Health News Read our Coronavirus Coverage Here [email][email][zip][zip][listGroups][listGroups][email][email][zip][zip][listGroups][listGroups].

Cipro class action lawsuit

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Latest Sleep how to get cipro prescription News By Dennis ThompsonHealthDay ReporterTHURSDAY, cipro class action lawsuit Aug. 27, 2020A frequent need to nap could be a red flag for future heart problems and a higher risk cipro class action lawsuit of early death, a new analysis concludes.Long naps lasting more than an hour are associated with a 34% elevated risk of heart disease and a 30% greater risk of death, according to the combined results of 20 previous studies.Overall, naps of any length were associated with a 19% increased risk of premature death, a Chinese research team found. The study results were released Wednesday for presentation at the virtual annual meeting of the European Society of Cardiology."If you want to take a siesta, our study indicates it's safest to keep it under an hour," lead researcher Zhe Pan of Guangzhou Medical University said in a society news release. "For those cipro class action lawsuit of us not in the habit of a daytime slumber, there is no convincing evidence to start."For their study, the researchers analyzed data from 20 studies involving more than 313,000 participants. About two in five people in the studies said they nap.The investigators found that the connection was more pronounced in people aged 65 and older.

These older folks had a 27% higher risk of death associated with napping cipro class action lawsuit and a 36% greater risk of heart disease. Women also had a stronger association between napping and poor health, cipro class action lawsuit with a 22% greater risk of death and a 31% greater risk of heart problems.Interestingly, long naps were linked with an increased risk of death in people who sleep more than six hours a night. That would seem to rule out poor sleep as an explanation for the increased risk of death and heart health issues.Adults who get less than seven hours of sleep each night are more likely to say they've had a heart attack, according to the U.S. Centers for Disease Control cipro class action lawsuit and Prevention. Poor sleep also has been linked to high blood pressure, type 2 diabetes and obesity, all of which increase the risk of heart disease, heart attack and stroke.Pan speculated that long naps might affect the body because they are associated with higher levels of inflammation.But heart health experts said that just because you're sleeping through the night doesn't mean you've gotten a good night's sleep -- something for which this study doesn't account.Regarding how well you're resting at night, napping "might be a sign that there's something else going on," said Dr.

Nieca Goldberg, a cardiologist and director of the NYU Langone Center for Women's Health, in cipro class action lawsuit New York City."What kind of sleep were these individuals getting?. " Goldberg said cipro class action lawsuit of the study participants. "Were they waking up at night?. Did they have cipro class action lawsuit sleep apnea?. "Dr.

Matthew Tomey, a cardiologist with Mount Sinai Morningside in New York City, agreed that these folks might be suffering from poor cipro class action lawsuit sleep."Some people take naps as a matter of habit, or they take a power nap," Tomey said. "For others, they're taking potentially longer naps during the daytime because of too little or too poor quality sleep at night."People should take a nap when they feel like it, but if they regularly need naps that could be a sign of trouble, Tomey said."If they notice that they feel excessively sleepy during the daytime, needing multiple or long naps, that's a wake-up call to pay attention to the quality and quantity of their nighttime sleep," he added.People who frequently nap should talk with their doctor about their sleep issues, since they might be suffering from sleep apnea or some other issue that disrupts quality sleep, Tomey and Goldberg said.Good sleep habits, according to the CDC, include:Sticking to a regular sleep schedule.Getting enough natural light during the day, to positively influence brain chemicals related to sleep.Exercising regularly, but not within a few hours of bedtime.Avoiding artificial light near bedtime.Keeping your bedroom cool, dark and quiet.Copyright © 2020 HealthDay. All rights cipro class action lawsuit reserved. SLIDESHOW cipro class action lawsuit Sleep Disorders. Foods That Help Sleep or Keep You Awake See Slideshow References SOURCES.

Nieca Goldberg, MD, cardiologist and director, NYU Langone Center for cipro class action lawsuit Women's Health, New York City. Matthew Tomey, MD, cardiologist, Mount Sinai Morningside, New York City. European Society cipro class action lawsuit of Cardiology, annual meeting.Latest Heart News By Serena McNiffHealthDay ReporterWEDNESDAY, Aug. 26, 2020 (HealthDay News)Most strokes strike when an artery in the brain suddenly becomes blocked, but new research shows a rarer cause of strokes is becoming more common.It's called cerebral venous thrombosis (CVT), and it happens when a vein in the brain is clogged. While CVT is estimated to cause less than 1% of all strokes, scientists discovered it is now more prevalent and affecting a different demographic than previously thought.Study author Dr cipro class action lawsuit.

Fadar Otite and his colleagues pored over years of hospital records from New York and Florida to find out how many cases of CVT occurred in these states cipro class action lawsuit between 2006 and 2016. Otite is an assistant professor of neurology at SUNY Upstate Medical University in Syracuse, N.Y.Based on the data they analyzed, the researchers estimated that the number of CVT cases in the United States rose from around 14 cases per million in 2006 to 20 cases per million in 2014."We still find that the incidence of CVT is less than 1% of all strokes, even across our study period, but the incidence increased by 70% over time," Otite said. "In 2006, the proportion of all strokes cipro class action lawsuit that were CVT was 0.47%. At the end of our study, which was in 2016, that proportion increased to 0.80%."CVT causes blood clots to form in the veins of the brain. These veins drain blood that has already been used by cipro class action lawsuit brain cells, sending it back to the heart to be replenished with oxygen.

If a clot forms in one of these veins, it may leak into the surrounding brain tissue and could cause a stroke, cipro class action lawsuit the researchers explained.While CVT is still most common in young women -- about two-thirds of all CVT hospitalizations included in the study were in females -- the researchers found that the number of cases among this demographic did not increase over the 10-year study period. Instead, they saw increases in CVT among men and older women."Part of the message is that we agree that CVT is still more common in women, but because of the diverse clinical presentation of CVT, when other symptoms that may be attributable to CVT are present in other demographics, we should take them with more seriousness," Otite said.Another major finding was that CVT incidence in Black people was significantly higher than in other races. But why that is cipro class action lawsuit the case remains unknown. "We have no clear explanation, because this is truly the first study to ever relate the incidence of CVT between races," he added.Several factors may put one at a higher risk of developing CVT, including pregnancy and taking hormonal birth control pills, which may be why it is more common in younger women, the researchers noted.And many of the risk factors for CVT -- like blood clotting disorders or medications that cause clotting, severe dehydration, infections of the ear, face or neck, head trauma, obesity and cancer -- are somewhat different from the triggers typically associated with stroke.It is important for clinicians to be aware of this rise in CVT incidence because the condition can easily be confused as something else, Otite said. Patients with CVT may have unspecific complaints such as headaches, blurry vision or seizures.Around 3% cipro class action lawsuit of patients in a prior study who had CVT and went to the hospital were diagnosed with something else and sent home, according to Otite.

"So, it's important to recognize this from the start, because by the next time the clinical condition may be worse," he said.CVT can be treated with medication to thin the blood and help prevent further clotting, which may not be prescribed if the condition isn't properly diagnosed, he added.Dr. Jose Biller, chair of the neurology department at Loyola University Medical Center in cipro class action lawsuit Hines, Ill., said the takeaway from this study is that more attention should be paid to jay cipra CVT."I think that there should be an increased awareness of cerebral venous thrombosis because, by and large, when people think about stroke, they don't think about it," Biller said. "There should be an cipro class action lawsuit increasing level of awareness because this is a condition that has a specific treatment."The study was published online Aug. 26 in the journal Neurology.Copyright © 2020 HealthDay. All rights reserved cipro class action lawsuit.

SLIDESHOW Stroke Causes, Symptoms, and Recovery See Slideshow References SOURCES. Fadar Oliver Otite, MD, assistant professor, neurology, State University cipro class action lawsuit of New York (SUNY) Upstate Medical University, Syracuse, N.Y.. Jose Biller, MD, chair, cipro class action lawsuit department of neurology, Loyola University Medical Center, Hines, Ill.. Neurology, Aug. 26, 2020, onlineLatest Hearing cipro class action lawsuit News WEDNESDAY, Aug.

26, 2020 (HealthDay News)Even if they appear unresponsive, dying people may still be able to hear.That's the takeaway from a Canadian analysis of hospice patients in Vancouver.Researchers compared electroencephalography (EEG) data -- a measure of electrical activity in the brain -- collected when patients were conscious and when they became unresponsive at the end of life. Those patients were compared to a healthy control group.The study looked at brain response to various patterns of common and rare sounds that changed frequency, and found that responses of some of the dying patients were similar to those of healthy people -- even hours before death."In the last hours before an expected natural death, many people enter a period of unresponsiveness," said lead author Elizabeth Blundon, a doctoral student in psychology at the University of British Columbia at the time of the study."Our data shows that a dying brain can respond to sound, even in an unconscious state, up to the last hours of cipro class action lawsuit life," she said in a university news release.Co-author Lawrence Ward, a professor of psychology, said researchers were able to identify specific mental processes in both groups of participants."We had to look very carefully at the individual control participants' data, to see if each one of them showed a particular type of brain response before we felt confident that the unresponsive patient's brain reacted similarly," he said in the release.The findings were recently published in the journal Scientific Reports."This research gives credence to the fact that hospice nurses and physicians noticed that the sounds of loved ones helped comfort people when they were dying," said study co-author Dr. Romayne Gallagher, a now-retired palliative care physician at St. John Hospice in Vancouver."And to me, it adds significant meaning to the last days and hours of life and shows that being present, in person or by cipro class action lawsuit phone, is meaningful," she said. "It is a comfort to be able to say goodbye and express love."While the evidence of brain activity supports the idea that dying people might hear, it's not known if they're aware of what they're hearing, Blundon noted."Their brains responded to the auditory stimuli, but we can't possibly know if they're remembering, identifying voices, or understanding cipro class action lawsuit language," she said.

"There are all these other questions that have yet to be answered. This first glimpse supports the idea that we have to keep talking to people when they are dying because cipro class action lawsuit something is happening in their brain."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved. QUESTION cipro class action lawsuit What is hearing loss?. See cipro class action lawsuit Answer References SOURCE.

University of British Columbia, news release, July 8, 2020Latest Pregnancy News THURSDAY, Aug. 27, 2020 (HealthDay News)A new case study adds to growing evidence that the new coronavirus can be transmitted from a pregnant woman to her fetus."It's very important to bring to the forefront this finding that mothers and infants can be affected by COVID-19, transmission can occur during pregnancy, and pregnant mothers need to protect themselves," said Dr. Amanda Evans, senior author of the report."We don't know whether there are any long-term effects of COVID-19 infection in babies," she added. Evans is an assistant professor of pediatrics specializing in infectious diseases at UT Southwestern (UTSW) Medical Center in Dallas.The case involved a woman who was 34 weeks pregnant. She visited the emergency department at Parkland Memorial Hospital in Dallas with signs of premature labor and was admitted when she tested positive for SARS-CoV-2, the virus that causes COVID-19.Though the patient didn't have the typical respiratory symptoms associated with COVID-19, she did have a fever and diarrhea, suggesting possible viral infection.

Before going to the hospital, she didn't know she had the coronavirus.After a few days in the hospital, the woman gave birth in early May to a 7-pound, 3-ounce girl who initially appeared healthy. After 24 hours, however, the baby developed a fever and signs of respiratory distress, including an abnormally high breathing rate and lower blood-oxygen levels. Tests showed that she had COVID-19.Study first author Dr. Julide Sisman, an associate professor of pediatrics who cared for the newborn, said, "At that time, the knowledge we had was that transmission doesn't occur in utero, so we really weren't expecting that at all."Further investigation showed the baby was infected while in the womb. Both mother and baby fully recovered, according to the case study published online recently in The Pediatric Infectious Disease Journal.More than 20 million people worldwide have been infected with the new coronavirus, but data on how it affects pregnant women have been limited, the authors noted in a UTSW news release."The fact that this can occur, even if rare, illustrates how important it is to limit exposure for mothers and newborns," said Dr.

Wilmer Moreno, an assistant professor of obstetrics and gynecology at UTSW. "Anything, like telemedicine visits, that can eliminate the need for mom to be around other people will be very helpful."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved. SLIDESHOW Conception. The Amazing Journey from Egg to Embryo See Slideshow References SOURCE.

UT Southwestern Medical Center, news release, Aug. 24, 2020.

Latest Sleep News By buy cipro with prescription Dennis ThompsonHealthDay ReporterTHURSDAY, Aug. 27, 2020A frequent need to nap could be a red flag for future heart problems and a higher risk of early death, a new analysis concludes.Long naps lasting more than an hour are associated with buy cipro with prescription a 34% elevated risk of heart disease and a 30% greater risk of death, according to the combined results of 20 previous studies.Overall, naps of any length were associated with a 19% increased risk of premature death, a Chinese research team found. The study results were released Wednesday for presentation at the virtual annual meeting of the European Society of Cardiology."If you want to take a siesta, our study indicates it's safest to keep it under an hour," lead researcher Zhe Pan of Guangzhou Medical University said in a society news release. "For those of us not in the buy cipro with prescription habit of a daytime slumber, there is no convincing evidence to start."For their study, the researchers analyzed data from 20 studies involving more than 313,000 participants.

About two in five people in the studies said they nap.The investigators found that the connection was more pronounced in people aged 65 and older. These older folks had a buy cipro with prescription 27% higher risk of death associated with napping and a 36% greater risk of heart disease. Women also had a stronger association between napping and poor health, with a 22% greater risk of death and a 31% greater risk of heart problems.Interestingly, long naps were linked with an increased risk of death in people buy cipro with prescription who sleep more than six hours a night. That would seem to rule out poor sleep as an explanation for the increased risk of death and heart health issues.Adults who get less than seven hours of sleep each night are more likely to say they've had a heart attack, according to the U.S.

Centers for buy cipro with prescription Disease Control and Prevention. Poor sleep also has been linked to high blood pressure, type 2 diabetes and obesity, all of which increase the risk of heart disease, heart attack and stroke.Pan speculated that long naps might affect the body because they are associated with higher levels of inflammation.But heart health experts said that just because you're sleeping through the night doesn't mean you've gotten a good night's sleep -- something for which this study doesn't account.Regarding how well you're resting at night, napping "might be a sign that there's something else going on," said Dr. Nieca Goldberg, a cardiologist and director of the NYU Langone Center for Women's Health, in New York City."What kind buy cipro with prescription of sleep were these individuals getting?. " Goldberg said of the study buy cipro with prescription participants.

"Were they waking up at night?. Did buy cipro with prescription they have sleep apnea?. "Dr. Matthew Tomey, a cardiologist with Mount Sinai Morningside in New buy cipro with prescription York City, agreed that these folks might be suffering from poor sleep."Some people take naps as a matter of habit, or they take a power nap," Tomey said.

"For others, they're taking potentially longer naps during the daytime because of too little or too poor quality sleep at night."People should take a nap when they feel like it, but if they regularly need naps that could be a sign of trouble, Tomey said."If they notice that they feel excessively sleepy during the daytime, needing multiple or long naps, that's a wake-up call to pay attention to the quality and quantity of their nighttime sleep," he added.People who frequently nap should talk with their doctor about their sleep issues, since they might be suffering from sleep apnea or some other issue that disrupts quality sleep, Tomey and Goldberg said.Good sleep habits, according to the CDC, include:Sticking to a regular sleep schedule.Getting enough natural light during the day, to positively influence brain chemicals related to sleep.Exercising regularly, but not within a few hours of bedtime.Avoiding artificial light near bedtime.Keeping your bedroom cool, dark and quiet.Copyright © 2020 HealthDay. All rights buy cipro with prescription reserved. SLIDESHOW buy cipro with prescription Sleep Disorders. Foods That Help Sleep or Keep You Awake See Slideshow References SOURCES.

Nieca Goldberg, MD, cardiologist buy cipro with prescription and director, NYU Langone Center for Women's Health, New York City. Matthew Tomey, MD, cardiologist, Mount Sinai Morningside, New York City. European Society of Cardiology, annual meeting.Latest Heart News By buy cipro with prescription Serena McNiffHealthDay ReporterWEDNESDAY, Aug. 26, 2020 (HealthDay News)Most strokes strike when an artery in the brain suddenly becomes blocked, but new research shows a rarer cause of strokes is becoming more common.It's called cerebral venous thrombosis (CVT), and it happens when a vein in the brain is clogged.

While CVT is estimated to cause less than 1% of all strokes, scientists discovered it is now more prevalent and affecting a different buy cipro with prescription demographic than previously thought.Study author Dr. Fadar Otite and his colleagues pored over years of hospital records from New York and Florida to find out how many cases of CVT occurred in these states between 2006 and 2016 buy cipro with prescription. Otite is an assistant professor of neurology at SUNY Upstate Medical University in Syracuse, N.Y.Based on the data they analyzed, the researchers estimated that the number of CVT cases in the United States rose from around 14 cases per million in 2006 to 20 cases per million in 2014."We still find that the incidence of CVT is less than 1% of all strokes, even across our study period, but the incidence increased by 70% over time," Otite said. "In 2006, the proportion buy cipro with prescription of all strokes that were CVT was 0.47%.

At the end of our study, which was in 2016, that proportion increased to 0.80%."CVT causes blood clots to form in the veins of the brain. These veins drain blood that has already been used by brain cells, sending it buy cipro with prescription back to the heart to be replenished with oxygen. If a clot buy cipro with prescription forms in one of these veins, it may leak into the surrounding brain tissue and could cause a stroke, the researchers explained.While CVT is still most common in young women -- about two-thirds of all CVT hospitalizations included in the study were in females -- the researchers found that the number of cases among this demographic did not increase over the 10-year study period. Instead, they saw increases in CVT among men and older women."Part of the message is that we agree that CVT is still more common in women, but because of the diverse clinical presentation of CVT, when other symptoms that may be attributable to CVT are present in other demographics, we should take them with more seriousness," Otite said.Another major finding was that CVT incidence in Black people was significantly higher than in other races.

But why that is the case buy cipro with prescription remains unknown. "We have no clear explanation, because this is truly the first study to ever relate the incidence of CVT between races," he added.Several factors may put one at a higher risk of developing CVT, including pregnancy and taking hormonal birth control pills, which may be why it is more common in younger women, the researchers noted.And many of the risk factors for CVT -- like blood clotting disorders or medications that cause clotting, severe dehydration, infections of the ear, face or neck, head trauma, obesity and cancer -- are somewhat different from the triggers typically associated with stroke.It is important for clinicians to be aware of this rise in CVT incidence because the condition can easily be confused as something else, Otite said. Patients with CVT may have unspecific complaints such as headaches, blurry vision or seizures.Around 3% of patients in a prior study who had CVT and went to the hospital were diagnosed with something else and sent buy cipro with prescription home, according to Otite. "So, it's important to recognize this from the start, because by the next time the clinical condition may be worse," he said.CVT can be treated with medication to thin the blood and help prevent further clotting, which may not be prescribed if the condition isn't properly diagnosed, he added.Dr.

Jose Biller, chair of the neurology department at Loyola University Medical Center in Hines, Ill., said the takeaway from this study is that more attention should be paid to CVT."I think that there should be an increased awareness of cerebral venous thrombosis because, by and large, buy cipro with prescription when people think about stroke, they don't think about it," Biller said. "There should be an increasing level of awareness because this is a condition that buy cipro with prescription has a specific treatment."The study was published online Aug. 26 in the journal Neurology.Copyright © 2020 HealthDay. All rights buy cipro with prescription reserved.

SLIDESHOW Stroke Causes, Symptoms, and Recovery See Slideshow References SOURCES. Fadar Oliver Otite, MD, assistant professor, neurology, State University of New buy cipro with prescription York (SUNY) Upstate Medical University, Syracuse, N.Y.. Jose Biller, MD, chair, department of neurology, Loyola University Medical Center, Hines, buy cipro with prescription Ill.. Neurology, Aug.

26, 2020, buy cipro with prescription onlineLatest Hearing News WEDNESDAY, Aug. 26, 2020 (HealthDay News)Even if they appear unresponsive, dying people may still be able to hear.That's the takeaway from a Canadian analysis of hospice patients in Vancouver.Researchers compared electroencephalography (EEG) data -- a measure of electrical activity in the brain -- collected when patients were conscious and when they became unresponsive at the end of life. Those patients were compared to a healthy control group.The study looked at brain response to various patterns of common and rare sounds that changed frequency, and found that responses of some of the dying patients were similar to those of healthy people -- even hours before death."In the last hours before an expected natural death, many people enter a period of unresponsiveness," said lead author Elizabeth Blundon, a doctoral student in psychology at the University of British Columbia at the time of the study."Our data shows that a dying brain can respond to sound, even in an unconscious state, up to the last hours of life," she said in a university news release.Co-author Lawrence Ward, a professor of psychology, said researchers were able to identify specific mental processes in both groups of participants."We had to look very carefully at the individual control participants' data, to see if each one of them showed a particular type of brain response before we felt confident that the unresponsive patient's brain reacted similarly," he said in the release.The findings were recently published in the journal Scientific Reports."This research gives credence to the buy cipro with prescription fact that hospice nurses and physicians noticed that the sounds of loved ones helped comfort people when they were dying," said study co-author Dr. Romayne Gallagher, a now-retired palliative care physician at St.

John Hospice in Vancouver."And buy cipro with prescription to me, it adds significant meaning to the last days and hours of life and shows that being present, in person or by phone, is meaningful," she said. "It is buy cipro with prescription a comfort to be able to say goodbye and express love."While the evidence of brain activity supports the idea that dying people might hear, it's not known if they're aware of what they're hearing, Blundon noted."Their brains responded to the auditory stimuli, but we can't possibly know if they're remembering, identifying voices, or understanding language," she said. "There are all these other questions that have yet to be answered. This first buy cipro with prescription glimpse supports the idea that we have to keep talking to people when they are dying because something is happening in their brain."-- Robert PreidtCopyright © 2020 HealthDay.

All rights reserved. QUESTION What buy cipro with prescription is hearing loss?. See Answer References buy cipro with prescription SOURCE. University of British Columbia, news release, July 8, 2020Latest Pregnancy News THURSDAY, Aug.

27, 2020 (HealthDay News)A new case study adds to growing evidence that the new coronavirus can be transmitted from a pregnant woman to her fetus."It's very important to bring to the forefront this finding that mothers and infants can be affected by COVID-19, transmission can occur during pregnancy, and pregnant buy cipro with prescription mothers need to protect themselves," said Dr. Amanda Evans, senior author of the report."We don't know whether there are any long-term effects of COVID-19 infection in babies," she added. Evans is an assistant professor of pediatrics specializing in infectious diseases at UT Southwestern (UTSW) Medical Center in Dallas.The case involved a woman who was 34 weeks buy cipro with prescription pregnant. She visited the emergency department at Parkland Memorial Hospital in Dallas with signs of premature labor and was admitted when she tested positive for SARS-CoV-2, the virus that causes COVID-19.Though the patient didn't have the typical respiratory symptoms associated with COVID-19, she did have a fever and diarrhea, suggesting possible viral infection.

Before going to the hospital, she didn't know buy cipro with prescription she had the coronavirus.After a few days in the hospital, the woman gave birth in early May to a 7-pound, 3-ounce girl who initially appeared healthy. After 24 hours, however, the baby developed a fever buy cipro with prescription and signs of respiratory distress, including an abnormally high breathing rate and lower blood-oxygen levels. Tests showed that she had COVID-19.Study first author Dr. Julide Sisman, an associate professor of pediatrics who cared for the newborn, said, "At that time, buy cipro with prescription the knowledge we had was that transmission doesn't occur in utero, so we really weren't expecting that at all."Further investigation showed the baby was infected while in the womb.

Both mother and baby fully recovered, according to the case study published online recently in The Pediatric Infectious Disease Journal.More than 20 million people worldwide have been infected with the new coronavirus, but data on how it affects pregnant women have been limited, the authors noted in a UTSW news release."The fact that this can occur, even if rare, illustrates how important it is to limit exposure for mothers and newborns," said Dr. Wilmer Moreno, an buy cipro with prescription assistant professor of obstetrics and gynecology at UTSW. "Anything, like telemedicine visits, that can eliminate the need for mom to be buy cipro with prescription around other people will be very helpful."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved.

SLIDESHOW Conception. The Amazing Journey from Egg to Embryo See Slideshow References SOURCE. UT Southwestern Medical Center, news release, Aug. 24, 2020.

Is cipro a cephalosporin

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Start Preamble is cipro a cephalosporin Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is is cipro a cephalosporin effective as of August 24, 2020. Start Further Info Robert P.

Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department is cipro a cephalosporin of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act.

Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C.

247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act.

42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed.

Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations.

Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks.

The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates. We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations.

Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience. What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination.

In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e.

Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.

All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with. V.

Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency.

(b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met.

The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2.

Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated. August 19, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20.

4:15 pm]BILLING CODE 4150-03-PToday, the U.S. Department of Health and Human Services released Healthy People 2030, the nation's 10-year plan for addressing our most critical public health priorities and challenges. Since 1980, HHS's Office of Disease Prevention and Health Promotion has set measurable objectives and targets to improve the health and well-being of the nation.This decade, Healthy People 2030 features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19. For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health."Healthy People was the first national effort to lay out a set of data-driven priorities for health improvement," said HHS Secretary Alex Azar.

"Healthy People 2030 adopts a more focused set of objectives and more rigorous data standards to help the federal government and all of our partners deliver results on these important goals over the next decade."Healthy People has led the nation with its focus on social determinants of health, and continues to prioritize economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context as factors that influence health. Healthy People 2030 also continues to prioritize health disparities, health equity, and health literacy."Now more than ever, we need programs like Healthy People that set a shared vision for a healthier nation, where all people can achieve their full potential for health and well-being across the lifespan," said ADM Brett P. Giroir, MD, Assistant Secretary for Health. "COVID-19 has brought the importance of public health to the forefront of our national dialogue.

Achieving Healthy People 2030's vision would help the United States become more resilient to public health threats like COVID-19."Healthy People 2030 emphasizes collaboration, with objectives and targets that span multiple sectors. A federal advisory committee of 13 external thought leaders and a workgroup of subject matter experts from more than 20 federal agencies contributed to Healthy People 2030, along with public comments received throughout the development process.The HHS Office of Disease Prevention and Health Promotion leads Healthy People in partnership with the National Center for Health Statistics at the Centers for Disease Control and Prevention, which oversees data in support of the initiative.HHS Secretary Alex M. Azar II, ADM Brett P. Giroir, MD, Assistant Secretary for Health, and U.S.

Surgeon General Jerome M. Adams, MD, MPH, and others from HHS and CDC will launch Healthy People 2030 during a webcast on August 18 at 1 pm (EDT) at https://www.hhs.gov/live. No registration is necessary. For more information about Healthy People 2030, visit https://healthypeople.gov..

Start Preamble http://sw.keimfarben.de/buy-cipro/ Notice of buy cipro with prescription amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration buy cipro with prescription published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020.

Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department buy cipro with prescription of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201. Telephone.

202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act.

On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020.

On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr.

15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S.

Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits.

When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations.

Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms.

Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience.

What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination.

In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements.

The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule.

All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII.

Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.

Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act.

(c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met.

The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.

The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures.

2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C.

247d-6d. End Authority Start Signature Dated. August 19, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc.

2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-PToday, the U.S. Department of Health and Human Services released Healthy People 2030, the nation's 10-year plan for addressing our most critical public health priorities and challenges.

Since 1980, HHS's Office of Disease Prevention and Health Promotion has set measurable objectives and targets to improve the health and well-being of the nation.This decade, Healthy People 2030 features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19. For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health."Healthy People was the first national effort to lay out a set of data-driven priorities for health improvement," said HHS Secretary Alex Azar. "Healthy People 2030 adopts a more focused set of objectives and more rigorous data standards to help the federal government and all of our partners deliver results on these important goals over the next decade."Healthy People has led the nation with its focus on social determinants of health, and continues to prioritize economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context as factors that influence health.

Healthy People 2030 also continues to prioritize health disparities, health equity, and health literacy."Now more than ever, we need programs like Healthy People that set a shared vision for a healthier nation, where all people can achieve their full potential for health and well-being across the lifespan," said ADM Brett P. Giroir, MD, Assistant Secretary for Health. "COVID-19 has brought the importance of public health to the forefront of our national dialogue.

Achieving Healthy People 2030's vision would help the United States become more resilient to public health threats like COVID-19."Healthy People 2030 emphasizes collaboration, with objectives and targets that span multiple sectors. A federal advisory committee of 13 external thought leaders and a workgroup of subject matter experts from more than 20 federal agencies contributed to Healthy People 2030, along with public comments received throughout the development process.The HHS Office of Disease Prevention and Health Promotion leads Healthy People in partnership with the National Center for Health Statistics at the Centers for Disease Control and Prevention, which oversees data in support of the initiative.HHS Secretary Alex M. Azar II, ADM Brett P.

Giroir, MD, Assistant Secretary for Health, and U.S. Surgeon General Jerome M. Adams, MD, MPH, and others from HHS and CDC will launch Healthy People 2030 during a webcast on August 18 at 1 pm (EDT) at https://www.hhs.gov/live.

No registration is necessary. For more information about Healthy People 2030, visit https://healthypeople.gov..