Hundreds of thousands of U.S. troops remain unvaccinated

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Tue, 10/12/2021 - 15:20

Hundreds of thousands of U.S. service members are unvaccinated or only partially vaccinated against COVID-19 as the first vaccine mandate deadlines approach, according to data analyzed by The Washington Post.
 

Overall, the military’s vaccination rate has climbed since August, when the Pentagon announced that COVID-19 immunization would become mandatory for the nation’s 2.1 million troops, the newspaper reported. Acting on a directive from President Joe Biden, leaders said exemptions would be rare and unvaccinated service members would face consequences.

But compliance has varied across the services, the newspaper found. About 90% of the active-duty Navy is fully vaccinated, compared with 76% of the active-duty Marine Corps. Both have a November 28 deadline to show proof of full vaccination.

About 81% of the active-duty Air Force is fully vaccinated, leaving more than 60,000 personnel about 3 weeks to get a shot before a November 2 deadline.

Military officials said the variance in vaccination rates is related to the different deadlines, the newspaper reported. As the dates approach, most troops are expected to meet the order.

At the same time, some deadlines are spaced farther out, with the Army Reserve and National Guard required to be fully vaccinated by next summer. About 40% of the Army Reserve and 38% of the National Guard are fully vaccinated. Combined, they account for a quarter of the U.S. military and 40% of the COVID-19 deaths among service members.

“The Army’s policy is incentivizing inaction until the latest possible date,” Katherine Kuzminski, a military policy expert at the Center for a New American Security, told the Post.“The way we’ve seen the virus evolve tells us looking out to June 30 may need to be reconsidered,” she said.

COVID-19 deaths have surged in some of the services in recent months, the newspaper reported. More military personnel died from COVID-19 in September than in all of 2020. None of those who died were fully vaccinated.

Throughout the pandemic, more than 246,000 COVID-19 cases have been reported among service members, according to the latest data from the Defense Department. More than 2,200 have been hospitalized, and 62 personnel died, including 32 in August and September.

For the Army Reserve and National Guard, the June deadline allows “necessary time to update records and process exemption requests,” Lt. Col. Terence Kelley, an Army spokesman, told the Post.

Lt. Col. Kelley noted that the extended date reflects how large the groups are, compared to the other services and their military reserves, as well as the broad geographic distribution of its members. Still, vaccine mandates will apply.

“We expect all unvaccinated soldiers to receive the vaccine as soon as possible,” Lt. Col. Kelley said. “Individual soldiers are required to receive the vaccine when available.”

A version of this article first appeared on Medscape.com.

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Hundreds of thousands of U.S. service members are unvaccinated or only partially vaccinated against COVID-19 as the first vaccine mandate deadlines approach, according to data analyzed by The Washington Post.
 

Overall, the military’s vaccination rate has climbed since August, when the Pentagon announced that COVID-19 immunization would become mandatory for the nation’s 2.1 million troops, the newspaper reported. Acting on a directive from President Joe Biden, leaders said exemptions would be rare and unvaccinated service members would face consequences.

But compliance has varied across the services, the newspaper found. About 90% of the active-duty Navy is fully vaccinated, compared with 76% of the active-duty Marine Corps. Both have a November 28 deadline to show proof of full vaccination.

About 81% of the active-duty Air Force is fully vaccinated, leaving more than 60,000 personnel about 3 weeks to get a shot before a November 2 deadline.

Military officials said the variance in vaccination rates is related to the different deadlines, the newspaper reported. As the dates approach, most troops are expected to meet the order.

At the same time, some deadlines are spaced farther out, with the Army Reserve and National Guard required to be fully vaccinated by next summer. About 40% of the Army Reserve and 38% of the National Guard are fully vaccinated. Combined, they account for a quarter of the U.S. military and 40% of the COVID-19 deaths among service members.

“The Army’s policy is incentivizing inaction until the latest possible date,” Katherine Kuzminski, a military policy expert at the Center for a New American Security, told the Post.“The way we’ve seen the virus evolve tells us looking out to June 30 may need to be reconsidered,” she said.

COVID-19 deaths have surged in some of the services in recent months, the newspaper reported. More military personnel died from COVID-19 in September than in all of 2020. None of those who died were fully vaccinated.

Throughout the pandemic, more than 246,000 COVID-19 cases have been reported among service members, according to the latest data from the Defense Department. More than 2,200 have been hospitalized, and 62 personnel died, including 32 in August and September.

For the Army Reserve and National Guard, the June deadline allows “necessary time to update records and process exemption requests,” Lt. Col. Terence Kelley, an Army spokesman, told the Post.

Lt. Col. Kelley noted that the extended date reflects how large the groups are, compared to the other services and their military reserves, as well as the broad geographic distribution of its members. Still, vaccine mandates will apply.

“We expect all unvaccinated soldiers to receive the vaccine as soon as possible,” Lt. Col. Kelley said. “Individual soldiers are required to receive the vaccine when available.”

A version of this article first appeared on Medscape.com.

Hundreds of thousands of U.S. service members are unvaccinated or only partially vaccinated against COVID-19 as the first vaccine mandate deadlines approach, according to data analyzed by The Washington Post.
 

Overall, the military’s vaccination rate has climbed since August, when the Pentagon announced that COVID-19 immunization would become mandatory for the nation’s 2.1 million troops, the newspaper reported. Acting on a directive from President Joe Biden, leaders said exemptions would be rare and unvaccinated service members would face consequences.

But compliance has varied across the services, the newspaper found. About 90% of the active-duty Navy is fully vaccinated, compared with 76% of the active-duty Marine Corps. Both have a November 28 deadline to show proof of full vaccination.

About 81% of the active-duty Air Force is fully vaccinated, leaving more than 60,000 personnel about 3 weeks to get a shot before a November 2 deadline.

Military officials said the variance in vaccination rates is related to the different deadlines, the newspaper reported. As the dates approach, most troops are expected to meet the order.

At the same time, some deadlines are spaced farther out, with the Army Reserve and National Guard required to be fully vaccinated by next summer. About 40% of the Army Reserve and 38% of the National Guard are fully vaccinated. Combined, they account for a quarter of the U.S. military and 40% of the COVID-19 deaths among service members.

“The Army’s policy is incentivizing inaction until the latest possible date,” Katherine Kuzminski, a military policy expert at the Center for a New American Security, told the Post.“The way we’ve seen the virus evolve tells us looking out to June 30 may need to be reconsidered,” she said.

COVID-19 deaths have surged in some of the services in recent months, the newspaper reported. More military personnel died from COVID-19 in September than in all of 2020. None of those who died were fully vaccinated.

Throughout the pandemic, more than 246,000 COVID-19 cases have been reported among service members, according to the latest data from the Defense Department. More than 2,200 have been hospitalized, and 62 personnel died, including 32 in August and September.

For the Army Reserve and National Guard, the June deadline allows “necessary time to update records and process exemption requests,” Lt. Col. Terence Kelley, an Army spokesman, told the Post.

Lt. Col. Kelley noted that the extended date reflects how large the groups are, compared to the other services and their military reserves, as well as the broad geographic distribution of its members. Still, vaccine mandates will apply.

“We expect all unvaccinated soldiers to receive the vaccine as soon as possible,” Lt. Col. Kelley said. “Individual soldiers are required to receive the vaccine when available.”

A version of this article first appeared on Medscape.com.

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Merck seeks FDA authorization for antiviral COVID-19 pill

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Tue, 10/12/2021 - 15:36

Drugmaker Merck announced today that it submitted an application to the Food and Drug Administration for the emergency use authorization of molnupiravir, an experimental antiviral COVID-19 treatment.

If the FDA grants authorization, the drug would be the first oral antiviral treatment for COVID-19. The capsule, made by Merck and Ridgeback Biotherapeutics, is intended to treat mild to moderate COVID-19 in adults who are at risk of having severe COVID-19 or hospitalization.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert Davis, CEO and president of Merck, said in a statement. On Oct. 1, Merck and Ridgeback released interim data from its phase III clinical trial, which showed that molnupiravir reduced the risk of hospitalization or death by about 50%. About 7% of patients who received the drug were hospitalized within 30 days in the study, as compared with 14% of patients who took a placebo, the company said.

No deaths were reported in the group that received the drug, as compared with eight deaths in the group that received the placebo. None of the trial participants had been vaccinated.

“Medicines and vaccines are both essential to our collective efforts,” Mr. Davis said. “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

Merck has been producing molnupiravir in anticipation of the clinical trial results and FDA authorization. The company expects to produce 10 million courses of treatment by the end of the year, with more expected for 2022.

In June, Merck signed an agreement with the United States to supply 1.7 million courses of molnupiravir once the FDA authorizes the drug. The company has agreed to advance purchase agreements with other countries as well.

Earlier in the year, Merck also announced voluntary licensing agreements with several generics manufacturers in India to provide molnupiravir to more than 100 low- and middle-income countries after approval from local regulatory agencies.

Data from the company’s late-stage clinical trial has not yet been peer-reviewed or published.

Last week, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the clinical trial results were “very encouraging” but noted that the FDA should closely scrutinize the drug, CNN reported.

“It is very important that this now must go through the usual process of careful examination of the data by the Food and Drug Administration, both for effectiveness but also for safety, because whenever you introduce a new compound, safety is very important,” Dr. Fauci said, adding that vaccines remain “our best tools against COVID-19.”


A version of this article firsts appeared on WebMD.com.

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Drugmaker Merck announced today that it submitted an application to the Food and Drug Administration for the emergency use authorization of molnupiravir, an experimental antiviral COVID-19 treatment.

If the FDA grants authorization, the drug would be the first oral antiviral treatment for COVID-19. The capsule, made by Merck and Ridgeback Biotherapeutics, is intended to treat mild to moderate COVID-19 in adults who are at risk of having severe COVID-19 or hospitalization.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert Davis, CEO and president of Merck, said in a statement. On Oct. 1, Merck and Ridgeback released interim data from its phase III clinical trial, which showed that molnupiravir reduced the risk of hospitalization or death by about 50%. About 7% of patients who received the drug were hospitalized within 30 days in the study, as compared with 14% of patients who took a placebo, the company said.

No deaths were reported in the group that received the drug, as compared with eight deaths in the group that received the placebo. None of the trial participants had been vaccinated.

“Medicines and vaccines are both essential to our collective efforts,” Mr. Davis said. “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

Merck has been producing molnupiravir in anticipation of the clinical trial results and FDA authorization. The company expects to produce 10 million courses of treatment by the end of the year, with more expected for 2022.

In June, Merck signed an agreement with the United States to supply 1.7 million courses of molnupiravir once the FDA authorizes the drug. The company has agreed to advance purchase agreements with other countries as well.

Earlier in the year, Merck also announced voluntary licensing agreements with several generics manufacturers in India to provide molnupiravir to more than 100 low- and middle-income countries after approval from local regulatory agencies.

Data from the company’s late-stage clinical trial has not yet been peer-reviewed or published.

Last week, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the clinical trial results were “very encouraging” but noted that the FDA should closely scrutinize the drug, CNN reported.

“It is very important that this now must go through the usual process of careful examination of the data by the Food and Drug Administration, both for effectiveness but also for safety, because whenever you introduce a new compound, safety is very important,” Dr. Fauci said, adding that vaccines remain “our best tools against COVID-19.”


A version of this article firsts appeared on WebMD.com.

Drugmaker Merck announced today that it submitted an application to the Food and Drug Administration for the emergency use authorization of molnupiravir, an experimental antiviral COVID-19 treatment.

If the FDA grants authorization, the drug would be the first oral antiviral treatment for COVID-19. The capsule, made by Merck and Ridgeback Biotherapeutics, is intended to treat mild to moderate COVID-19 in adults who are at risk of having severe COVID-19 or hospitalization.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert Davis, CEO and president of Merck, said in a statement. On Oct. 1, Merck and Ridgeback released interim data from its phase III clinical trial, which showed that molnupiravir reduced the risk of hospitalization or death by about 50%. About 7% of patients who received the drug were hospitalized within 30 days in the study, as compared with 14% of patients who took a placebo, the company said.

No deaths were reported in the group that received the drug, as compared with eight deaths in the group that received the placebo. None of the trial participants had been vaccinated.

“Medicines and vaccines are both essential to our collective efforts,” Mr. Davis said. “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

Merck has been producing molnupiravir in anticipation of the clinical trial results and FDA authorization. The company expects to produce 10 million courses of treatment by the end of the year, with more expected for 2022.

In June, Merck signed an agreement with the United States to supply 1.7 million courses of molnupiravir once the FDA authorizes the drug. The company has agreed to advance purchase agreements with other countries as well.

Earlier in the year, Merck also announced voluntary licensing agreements with several generics manufacturers in India to provide molnupiravir to more than 100 low- and middle-income countries after approval from local regulatory agencies.

Data from the company’s late-stage clinical trial has not yet been peer-reviewed or published.

Last week, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the clinical trial results were “very encouraging” but noted that the FDA should closely scrutinize the drug, CNN reported.

“It is very important that this now must go through the usual process of careful examination of the data by the Food and Drug Administration, both for effectiveness but also for safety, because whenever you introduce a new compound, safety is very important,” Dr. Fauci said, adding that vaccines remain “our best tools against COVID-19.”


A version of this article firsts appeared on WebMD.com.

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Federal judge pauses strict Texas abortion law

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Fri, 10/08/2021 - 08:00

A federal judge has paused the recent Texas abortion law that bans nearly all abortions in the state.

Robert Pitman, a federal district court judge in Austin, sided with the Biden administration and granted the Justice Department’s request to halt enforcement of the new law. The Biden administration sued to stop the law, and Mr. Pitman’s decision pauses the law while it moves through federal courts, The New York Times reported.

In a 113-page ruling, Mr. Pitman criticized the law, also known as Senate Bill 8, for delegating enforcement to private individuals, who can sue anyone who performs abortions or “aids and abets” them. Plaintiffs are encouraged to file lawsuits because they recover legal fees and $10,000 if they win.

“From the moment S.B. 8 went into effect, women have been unlawfully prevented from exercising control over their own lives in ways that are protected by the Constitution,” Mr. Pitman wrote in the ruling.

“This court will not sanction one more day of this offensive deprivation of such an important right,” he said.

The Texas law bans abortions once fetal cardiac activity can be detected, which is usually around 6 weeks of pregnancy. Women may not know they’re pregnant yet during that time frame.

It’s not yet clear what effect Mr. Pitman’s ruling will have on women in Texas, the Times reported. Since the law went into effect about a month ago, women have sought abortion providers in other states. Mr. Pitman’s ruling pauses the enforcement of the law, but clinics may still face retroactive lawsuits for abortions provided while the law was temporarily suspended.

Whole Woman’s Health, which operates four clinics in Texas, said Wednesday that it was “making plans to resume abortion care up to 18 weeks as soon as possible,” the newspaper reported. The Center for Reproductive Rights also said that clinics “hope to resume full abortion services as soon as they are able.”

Late Oct. 6, Texas said it would appeal the ruling. The U.S. Court of Appeals for the Fifth Circuit is one of the most conservative in the country, according to the Times, and another decision could come soon.

A version of this article first appeared on WebMD.com.

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A federal judge has paused the recent Texas abortion law that bans nearly all abortions in the state.

Robert Pitman, a federal district court judge in Austin, sided with the Biden administration and granted the Justice Department’s request to halt enforcement of the new law. The Biden administration sued to stop the law, and Mr. Pitman’s decision pauses the law while it moves through federal courts, The New York Times reported.

In a 113-page ruling, Mr. Pitman criticized the law, also known as Senate Bill 8, for delegating enforcement to private individuals, who can sue anyone who performs abortions or “aids and abets” them. Plaintiffs are encouraged to file lawsuits because they recover legal fees and $10,000 if they win.

“From the moment S.B. 8 went into effect, women have been unlawfully prevented from exercising control over their own lives in ways that are protected by the Constitution,” Mr. Pitman wrote in the ruling.

“This court will not sanction one more day of this offensive deprivation of such an important right,” he said.

The Texas law bans abortions once fetal cardiac activity can be detected, which is usually around 6 weeks of pregnancy. Women may not know they’re pregnant yet during that time frame.

It’s not yet clear what effect Mr. Pitman’s ruling will have on women in Texas, the Times reported. Since the law went into effect about a month ago, women have sought abortion providers in other states. Mr. Pitman’s ruling pauses the enforcement of the law, but clinics may still face retroactive lawsuits for abortions provided while the law was temporarily suspended.

Whole Woman’s Health, which operates four clinics in Texas, said Wednesday that it was “making plans to resume abortion care up to 18 weeks as soon as possible,” the newspaper reported. The Center for Reproductive Rights also said that clinics “hope to resume full abortion services as soon as they are able.”

Late Oct. 6, Texas said it would appeal the ruling. The U.S. Court of Appeals for the Fifth Circuit is one of the most conservative in the country, according to the Times, and another decision could come soon.

A version of this article first appeared on WebMD.com.

A federal judge has paused the recent Texas abortion law that bans nearly all abortions in the state.

Robert Pitman, a federal district court judge in Austin, sided with the Biden administration and granted the Justice Department’s request to halt enforcement of the new law. The Biden administration sued to stop the law, and Mr. Pitman’s decision pauses the law while it moves through federal courts, The New York Times reported.

In a 113-page ruling, Mr. Pitman criticized the law, also known as Senate Bill 8, for delegating enforcement to private individuals, who can sue anyone who performs abortions or “aids and abets” them. Plaintiffs are encouraged to file lawsuits because they recover legal fees and $10,000 if they win.

“From the moment S.B. 8 went into effect, women have been unlawfully prevented from exercising control over their own lives in ways that are protected by the Constitution,” Mr. Pitman wrote in the ruling.

“This court will not sanction one more day of this offensive deprivation of such an important right,” he said.

The Texas law bans abortions once fetal cardiac activity can be detected, which is usually around 6 weeks of pregnancy. Women may not know they’re pregnant yet during that time frame.

It’s not yet clear what effect Mr. Pitman’s ruling will have on women in Texas, the Times reported. Since the law went into effect about a month ago, women have sought abortion providers in other states. Mr. Pitman’s ruling pauses the enforcement of the law, but clinics may still face retroactive lawsuits for abortions provided while the law was temporarily suspended.

Whole Woman’s Health, which operates four clinics in Texas, said Wednesday that it was “making plans to resume abortion care up to 18 weeks as soon as possible,” the newspaper reported. The Center for Reproductive Rights also said that clinics “hope to resume full abortion services as soon as they are able.”

Late Oct. 6, Texas said it would appeal the ruling. The U.S. Court of Appeals for the Fifth Circuit is one of the most conservative in the country, according to the Times, and another decision could come soon.

A version of this article first appeared on WebMD.com.

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New York’s largest health care provider fires 1,400 unvaccinated employees

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Thu, 10/07/2021 - 15:11

Northwell Health, the largest hospital system in New York state, fired 1,400 employees Oct. 3 for not complying with the state’s COVID-19 vaccine mandate.

The employees represented less than 2% of Northwell’s 76,000 employees, who are now all fully vaccinated against COVID-19, Joe Kemp, the assistant vice president of public relations for the company, told The Hill.

“Northwell Health is proud to announce that our workforce -- the largest in New York State -- is 100% vaccinated,” the company said in a statement to several news outlets.

“This allows us to continue to provide exceptional care at all of our facilities, without interruption and remain open and fully operational,” Northwell Health said.

Having a fully vaccinated workforce is part of the health system’s duty to protect others, the company said. Northwell Health includes 23 hospitals and more than 830 outpatient facilities, according to ABC News.

“Northwell regrets losing any employee under such circumstances,” the company said. “We owe it to our staff, our patients, and the communities we serve to be 100% vaccinated against COVID-19.”

Former New York Gov. Andrew Cuomo announced in August that the state would require health care workers to receive at least one COVID-19 vaccine shot by Sept. 27. Employees didn’t have the option for weekly testing or religious exemptions, which is being challenged in several lawsuits, according to The New York Times.

The order went into effect last week, prompting tens of thousands of employees to get vaccinated. As of last week, 87% of hospital staff were fully vaccinated, and 92% of hospital and retirement home workers had received at least one dose, according to state health data.

Northwell announced its own vaccine mandate in August as well, which sparked protests among some workers. The order applied to both clinical and non-clinical staff.

A few thousand Northwell employees got vaccinated as the deadline approached, Mr. Kemp told The New York Times. Some who lost their jobs at first were able to return to work, and those who have been terminated can interview for reinstatement for 30 days. The hospital system is also “openly recruiting” for the vacant positions.

“The goal was to get people vaccinated, not to get people terminated,” Mr. Kemp said.

Hospitalized COVID-19 patients in New York hit a low of 350 in mid-July, according to state hospitalization data. Now, about 2,200 people are hospitalized throughout the state, most of whom are unvaccinated.

As of Oct. 3, nearly 72% of New York residents had received at least one vaccine dose, according to the latest state data. About 64% are fully vaccinated.

A version of this article first appeared on WebMD.com.

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Northwell Health, the largest hospital system in New York state, fired 1,400 employees Oct. 3 for not complying with the state’s COVID-19 vaccine mandate.

The employees represented less than 2% of Northwell’s 76,000 employees, who are now all fully vaccinated against COVID-19, Joe Kemp, the assistant vice president of public relations for the company, told The Hill.

“Northwell Health is proud to announce that our workforce -- the largest in New York State -- is 100% vaccinated,” the company said in a statement to several news outlets.

“This allows us to continue to provide exceptional care at all of our facilities, without interruption and remain open and fully operational,” Northwell Health said.

Having a fully vaccinated workforce is part of the health system’s duty to protect others, the company said. Northwell Health includes 23 hospitals and more than 830 outpatient facilities, according to ABC News.

“Northwell regrets losing any employee under such circumstances,” the company said. “We owe it to our staff, our patients, and the communities we serve to be 100% vaccinated against COVID-19.”

Former New York Gov. Andrew Cuomo announced in August that the state would require health care workers to receive at least one COVID-19 vaccine shot by Sept. 27. Employees didn’t have the option for weekly testing or religious exemptions, which is being challenged in several lawsuits, according to The New York Times.

The order went into effect last week, prompting tens of thousands of employees to get vaccinated. As of last week, 87% of hospital staff were fully vaccinated, and 92% of hospital and retirement home workers had received at least one dose, according to state health data.

Northwell announced its own vaccine mandate in August as well, which sparked protests among some workers. The order applied to both clinical and non-clinical staff.

A few thousand Northwell employees got vaccinated as the deadline approached, Mr. Kemp told The New York Times. Some who lost their jobs at first were able to return to work, and those who have been terminated can interview for reinstatement for 30 days. The hospital system is also “openly recruiting” for the vacant positions.

“The goal was to get people vaccinated, not to get people terminated,” Mr. Kemp said.

Hospitalized COVID-19 patients in New York hit a low of 350 in mid-July, according to state hospitalization data. Now, about 2,200 people are hospitalized throughout the state, most of whom are unvaccinated.

As of Oct. 3, nearly 72% of New York residents had received at least one vaccine dose, according to the latest state data. About 64% are fully vaccinated.

A version of this article first appeared on WebMD.com.

Northwell Health, the largest hospital system in New York state, fired 1,400 employees Oct. 3 for not complying with the state’s COVID-19 vaccine mandate.

The employees represented less than 2% of Northwell’s 76,000 employees, who are now all fully vaccinated against COVID-19, Joe Kemp, the assistant vice president of public relations for the company, told The Hill.

“Northwell Health is proud to announce that our workforce -- the largest in New York State -- is 100% vaccinated,” the company said in a statement to several news outlets.

“This allows us to continue to provide exceptional care at all of our facilities, without interruption and remain open and fully operational,” Northwell Health said.

Having a fully vaccinated workforce is part of the health system’s duty to protect others, the company said. Northwell Health includes 23 hospitals and more than 830 outpatient facilities, according to ABC News.

“Northwell regrets losing any employee under such circumstances,” the company said. “We owe it to our staff, our patients, and the communities we serve to be 100% vaccinated against COVID-19.”

Former New York Gov. Andrew Cuomo announced in August that the state would require health care workers to receive at least one COVID-19 vaccine shot by Sept. 27. Employees didn’t have the option for weekly testing or religious exemptions, which is being challenged in several lawsuits, according to The New York Times.

The order went into effect last week, prompting tens of thousands of employees to get vaccinated. As of last week, 87% of hospital staff were fully vaccinated, and 92% of hospital and retirement home workers had received at least one dose, according to state health data.

Northwell announced its own vaccine mandate in August as well, which sparked protests among some workers. The order applied to both clinical and non-clinical staff.

A few thousand Northwell employees got vaccinated as the deadline approached, Mr. Kemp told The New York Times. Some who lost their jobs at first were able to return to work, and those who have been terminated can interview for reinstatement for 30 days. The hospital system is also “openly recruiting” for the vacant positions.

“The goal was to get people vaccinated, not to get people terminated,” Mr. Kemp said.

Hospitalized COVID-19 patients in New York hit a low of 350 in mid-July, according to state hospitalization data. Now, about 2,200 people are hospitalized throughout the state, most of whom are unvaccinated.

As of Oct. 3, nearly 72% of New York residents had received at least one vaccine dose, according to the latest state data. About 64% are fully vaccinated.

A version of this article first appeared on WebMD.com.

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Johnson & Johnson requests FDA approval for vaccine booster doses

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Tue, 10/05/2021 - 13:36

Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

A version of this article first appeared on WebMD.com.

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Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

A version of this article first appeared on WebMD.com.

Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

A version of this article first appeared on WebMD.com.

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Pfizer COVID vaccine antibodies may disappear in 7 months, study says

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Mon, 10/04/2021 - 16:27

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

A version of this article first appeared on WebMD.com.

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Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

A version of this article first appeared on WebMD.com.

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

A version of this article first appeared on WebMD.com.

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COVID vaccination rates among pregnant people remain low

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Thu, 09/30/2021 - 09:34

COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.

About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.

The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.

“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.

“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”

Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.

Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.

“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.

Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.

“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.

“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”

A version of this article first appeared on Medscape.com.

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COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.

About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.

The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.

“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.

“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”

Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.

Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.

“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.

Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.

“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.

“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”

A version of this article first appeared on Medscape.com.

COVID vaccination rates among pregnant people remain low, despite data that shows the vaccines can prevent the high risk of severe disease during pregnancy.

About 30% of pregnant people are vaccinated, according to the latest CDC data, with only 18% obtaining a dose during pregnancy. Health officials have been tracking the timing of vaccination before and during pregnancy.

The vaccination rates are even lower among pregnant Black people, CDC data shows. About 15% are fully vaccinated, compared with 25% of pregnant Hispanic and Latino people, 34% of pregnant White people, and 46% of pregnant Asian people.

“This puts them at severe risk of severe disease from COVID-19,” Rochelle Walensky, MD, the CDC director, said during a news briefing with the White House COVID-19 Response Team.

“We know that pregnant women are at increased risk of severe disease, of hospitalization and ventilation,” she said. “They’re also at increased risk for adverse events to their baby.”

Those who give birth while infected with COVID-19 had “significantly higher rates” of intensive care unit admission, intubation, ventilation, and death, according to a recent study published in JAMA Network Open.

Dr. Walensky said on Sept. 28 that studies show COVID-19 vaccines can be taken at any time while pregnant or breastfeeding. She noted that the vaccines are safe for both mothers and their babies.

“We’ve actually seen that some antibody from the vaccine traverses [the placenta] to the baby and, in fact, could potentially protect the baby,” she said.

Public health officials say the low vaccination rates can be attributed to caution around the time of pregnancy, concern for the baby, barriers to health care, and misinformation promoted online.

“Pregnancy is a precious time. It’s also a time that a lot of women have fear,” Pam Oliver, MD, an obstetrics and gynecology doctor and executive vice president of North Carolina’s Novant Health, told USA Today.

“It is natural to have questions,” she said. “So, let’s talk about what we know, let’s put it in perspective.”

A version of this article first appeared on Medscape.com.

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Supreme Court sets date for case that challenges Roe v. Wade

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Tue, 09/21/2021 - 16:56

The Supreme Court will hear arguments in a major Mississippi abortion case on Dec. 1, which could challenge the landmark Roe v. Wade decision that guarantees a woman’s right to an abortion.

On Sept. 20, the court issued its calendar for arguments that will be heard in late November and early December, The Associated Press reported.

The Mississippi case, Dobbs v. Jackson Women’s Health Organization, is seeking to overturn Roe v. Wade by asking the Supreme Court to uphold a ban on most abortions after the 15th week of pregnancy. The state also said the court should overrule the 1992 decision in Planned Parenthood v. Casey that prevents states from banning abortion before viability, which is around 24 weeks of pregnancy.

Earlier in September, the Supreme Court allowed a Texas law to take effect that bans abortions after cardiac activity can be detected, which is around 6 weeks of pregnancy and often before many women know they’re pregnant. The court, which was split 5-4, didn’t rule on the constitutional nature of the law, instead declining to block its enforcement.

Hundreds of legal briefs have been filed on both sides of the case, the AP reported. On Sept. 20, more than 500 women athletes, including members of the Women’s National Basketball Players Association, the National Women’s Soccer League Players Association, and Olympic medalists, filed a brief that said an abortion ban would be devastating for female athletes.

The Mississippi law was enacted in 2018 but was blocked after a challenge at the federal court level. The state’s only abortion clinic, Jackson Women’s Health Organization, remains open and offers abortions up to 16 weeks of pregnancy, the AP reported. About 100 abortions a year are completed after 15 weeks, the organization said.

More than 90% of abortions in the United States occur in the first 13 weeks of pregnancy, the AP said.

The Supreme Court justices will return to the courtroom in October to hear arguments now that all of them have been vaccinated, the AP reported. The justices had been hearing cases by phone during the pandemic.

The public won’t be able to attend sessions, but the court will allow live audio of the session. 

 

A version of this article first appeared on WebMD.com.

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The Supreme Court will hear arguments in a major Mississippi abortion case on Dec. 1, which could challenge the landmark Roe v. Wade decision that guarantees a woman’s right to an abortion.

On Sept. 20, the court issued its calendar for arguments that will be heard in late November and early December, The Associated Press reported.

The Mississippi case, Dobbs v. Jackson Women’s Health Organization, is seeking to overturn Roe v. Wade by asking the Supreme Court to uphold a ban on most abortions after the 15th week of pregnancy. The state also said the court should overrule the 1992 decision in Planned Parenthood v. Casey that prevents states from banning abortion before viability, which is around 24 weeks of pregnancy.

Earlier in September, the Supreme Court allowed a Texas law to take effect that bans abortions after cardiac activity can be detected, which is around 6 weeks of pregnancy and often before many women know they’re pregnant. The court, which was split 5-4, didn’t rule on the constitutional nature of the law, instead declining to block its enforcement.

Hundreds of legal briefs have been filed on both sides of the case, the AP reported. On Sept. 20, more than 500 women athletes, including members of the Women’s National Basketball Players Association, the National Women’s Soccer League Players Association, and Olympic medalists, filed a brief that said an abortion ban would be devastating for female athletes.

The Mississippi law was enacted in 2018 but was blocked after a challenge at the federal court level. The state’s only abortion clinic, Jackson Women’s Health Organization, remains open and offers abortions up to 16 weeks of pregnancy, the AP reported. About 100 abortions a year are completed after 15 weeks, the organization said.

More than 90% of abortions in the United States occur in the first 13 weeks of pregnancy, the AP said.

The Supreme Court justices will return to the courtroom in October to hear arguments now that all of them have been vaccinated, the AP reported. The justices had been hearing cases by phone during the pandemic.

The public won’t be able to attend sessions, but the court will allow live audio of the session. 

 

A version of this article first appeared on WebMD.com.

The Supreme Court will hear arguments in a major Mississippi abortion case on Dec. 1, which could challenge the landmark Roe v. Wade decision that guarantees a woman’s right to an abortion.

On Sept. 20, the court issued its calendar for arguments that will be heard in late November and early December, The Associated Press reported.

The Mississippi case, Dobbs v. Jackson Women’s Health Organization, is seeking to overturn Roe v. Wade by asking the Supreme Court to uphold a ban on most abortions after the 15th week of pregnancy. The state also said the court should overrule the 1992 decision in Planned Parenthood v. Casey that prevents states from banning abortion before viability, which is around 24 weeks of pregnancy.

Earlier in September, the Supreme Court allowed a Texas law to take effect that bans abortions after cardiac activity can be detected, which is around 6 weeks of pregnancy and often before many women know they’re pregnant. The court, which was split 5-4, didn’t rule on the constitutional nature of the law, instead declining to block its enforcement.

Hundreds of legal briefs have been filed on both sides of the case, the AP reported. On Sept. 20, more than 500 women athletes, including members of the Women’s National Basketball Players Association, the National Women’s Soccer League Players Association, and Olympic medalists, filed a brief that said an abortion ban would be devastating for female athletes.

The Mississippi law was enacted in 2018 but was blocked after a challenge at the federal court level. The state’s only abortion clinic, Jackson Women’s Health Organization, remains open and offers abortions up to 16 weeks of pregnancy, the AP reported. About 100 abortions a year are completed after 15 weeks, the organization said.

More than 90% of abortions in the United States occur in the first 13 weeks of pregnancy, the AP said.

The Supreme Court justices will return to the courtroom in October to hear arguments now that all of them have been vaccinated, the AP reported. The justices had been hearing cases by phone during the pandemic.

The public won’t be able to attend sessions, but the court will allow live audio of the session. 

 

A version of this article first appeared on WebMD.com.

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FDA could authorize COVID-19 vaccine for ages 5-11 in October

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Thu, 09/16/2021 - 14:05

Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

A version of this article first appeared on WebMD.com.

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Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

A version of this article first appeared on WebMD.com.

Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.

The timeline is based on the expectation that Pfizer will have enough data from clinical trials to request Food and Drug Administration emergency use authorization for the age group near the end of September. Then the FDA would likely make a decision about the vaccine’s safety and effectiveness in children within about 3 weeks, two sources told Reuters.

Anthony Fauci, MD, chief medical adviser to President Joe Biden and director of the National Institute of Allergy and Infectious Diseases, spoke about the timeline during an online town hall meeting Friday, Reuters reported. The meeting was attended by thousands of staff members at the National Institutes of Health.

If Pfizer submits paperwork to the FDA by the end of September, the vaccine could be available for kids around mid-October, Dr. Fauci said, and approval for the Moderna vaccine could come in November. Moderna will take about 3 weeks longer to collect and analyze data for ages 5-11.

Pfizer has said it would have enough data for ages 5-11 in September and would submit its documentation for FDA authorization soon after. Moderna told investors on Sept. 9 that data for ages 6-11 would be available by the end of the year.

On Sept. 10, the FDA said it would work to approve COVID-19 vaccines for children quickly once companies submit their data, according to Reuters. The agency said it would consider applications for emergency use, which would allow for faster approval.

Pfizer’s vaccine is the only one to receive full FDA approval, but only for people ages 16 and older. Adolescents ages 12-15 can receive the Pfizer vaccine under the FDA’s emergency use authorization.

For emergency use authorization, companies must submit 2 months of safety data versus 6 months for full approval. The FDA said on Sept. 10 that children in clinical trials should be monitored for at least 2 months to observe side effects.

BioNTech, Pfizer’s vaccine manufacturing partner, told a news outlet in Germany that it plans to request authorization globally for ages 5-11 in coming weeks, according to Reuters.

“Already over the next few weeks, we will file the results of our trial in 5- to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Oezlem Tuereci, MD, the chief medical officer for BioNTech, told Der Spiegel.

The company is completing the final production steps to make the vaccine at lower doses for the younger age group, she said. Pfizer and BioNTech will also seek vaccine approval for ages 6 months to 2 years later this year.

“Things are looking good, everything is going according to plan,” Ugur Sahin, MD, the CEO of BioNTech, told Der Spiegel.

A version of this article first appeared on WebMD.com.

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Florida doctor won’t treat unvaccinated patients in person

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Thu, 09/09/2021 - 16:16

A doctor in South Miami says she will no longer treat unvaccinated patients in person as COVID-19 cases remain high in Florida.

Linda Marraccini, MD, sent a letter to patients that said those who aren’t vaccinated won’t be allowed to book in-person appointments at her practice now that the Food and Drug Administration has fully approved the Pfizer vaccine for general use, according to NBC Miami.

“This is a public health emergency – the health of the public takes priority over the rights of any given individual in this situation,” she wrote in the letter, which was obtained by NBC Miami.

“It appears that there is a lack of selflessness and concern for the burden on the health and well-being of our society from our encounters,” she wrote.

Dr. Marraccini said the policy is in the best interest of her other patients and doesn’t violate the Hippocratic oath. Patients who are having chemotherapy or who have weak immune systems face higher risks of being infected with the coronavirus.

“It’s not fair for people who are unvaccinated to harm other people,” she told Newsweek  Sept. 4.

“The Hippocratic oath is very science based,” she said. “I am following the science. I’m applying this to the benefit of the sick.”

Dr. Marraccini said her new policy goes into effect on Sept. 15, and she will continue to see unvaccinated patients virtually during the next month until they find another health care provider.

She said that the response to her decision has been “99.9% favorable” and that she will make exceptions if patients can’t receive a shot because of hardships. Her office also provides the Johnson & Johnson vaccine.

“We’re not going to leave them out there in the cold,” she told Newsweek.

During the past month, COVID-19 cases have surged in Florida, reaching record-level highs of more than 20,000 cases per day. Cases began rising in the summer because of the more contagious Delta variant.

In late August, a group of doctors in southern Florida urged people to get vaccinated, citing their exhaustion and frustration with unvaccinated patients who make up the large majority of COVID-19 hospitalizations, according to Newsweek.

Other doctors have declined to treat unvaccinated patients in recent weeks. Jason Valentine, MD, a doctor in Mobile, Ala., said he would no longer see unvaccinated patients as of Oct. 1, according to AL.com.

Dr. Marraccini urged people to become informed about COVID-19 vaccines, as well as their role in reducing the surge of cases in the state. The pandemic “did not have to go on this long,” she said.

“Responsibility has to do with each individual,” she told Newsweek. “This is a global health issue, and everyone owns part of that responsibility.”

A version of this article first appeared on WebMD.com.

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A doctor in South Miami says she will no longer treat unvaccinated patients in person as COVID-19 cases remain high in Florida.

Linda Marraccini, MD, sent a letter to patients that said those who aren’t vaccinated won’t be allowed to book in-person appointments at her practice now that the Food and Drug Administration has fully approved the Pfizer vaccine for general use, according to NBC Miami.

“This is a public health emergency – the health of the public takes priority over the rights of any given individual in this situation,” she wrote in the letter, which was obtained by NBC Miami.

“It appears that there is a lack of selflessness and concern for the burden on the health and well-being of our society from our encounters,” she wrote.

Dr. Marraccini said the policy is in the best interest of her other patients and doesn’t violate the Hippocratic oath. Patients who are having chemotherapy or who have weak immune systems face higher risks of being infected with the coronavirus.

“It’s not fair for people who are unvaccinated to harm other people,” she told Newsweek  Sept. 4.

“The Hippocratic oath is very science based,” she said. “I am following the science. I’m applying this to the benefit of the sick.”

Dr. Marraccini said her new policy goes into effect on Sept. 15, and she will continue to see unvaccinated patients virtually during the next month until they find another health care provider.

She said that the response to her decision has been “99.9% favorable” and that she will make exceptions if patients can’t receive a shot because of hardships. Her office also provides the Johnson & Johnson vaccine.

“We’re not going to leave them out there in the cold,” she told Newsweek.

During the past month, COVID-19 cases have surged in Florida, reaching record-level highs of more than 20,000 cases per day. Cases began rising in the summer because of the more contagious Delta variant.

In late August, a group of doctors in southern Florida urged people to get vaccinated, citing their exhaustion and frustration with unvaccinated patients who make up the large majority of COVID-19 hospitalizations, according to Newsweek.

Other doctors have declined to treat unvaccinated patients in recent weeks. Jason Valentine, MD, a doctor in Mobile, Ala., said he would no longer see unvaccinated patients as of Oct. 1, according to AL.com.

Dr. Marraccini urged people to become informed about COVID-19 vaccines, as well as their role in reducing the surge of cases in the state. The pandemic “did not have to go on this long,” she said.

“Responsibility has to do with each individual,” she told Newsweek. “This is a global health issue, and everyone owns part of that responsibility.”

A version of this article first appeared on WebMD.com.

A doctor in South Miami says she will no longer treat unvaccinated patients in person as COVID-19 cases remain high in Florida.

Linda Marraccini, MD, sent a letter to patients that said those who aren’t vaccinated won’t be allowed to book in-person appointments at her practice now that the Food and Drug Administration has fully approved the Pfizer vaccine for general use, according to NBC Miami.

“This is a public health emergency – the health of the public takes priority over the rights of any given individual in this situation,” she wrote in the letter, which was obtained by NBC Miami.

“It appears that there is a lack of selflessness and concern for the burden on the health and well-being of our society from our encounters,” she wrote.

Dr. Marraccini said the policy is in the best interest of her other patients and doesn’t violate the Hippocratic oath. Patients who are having chemotherapy or who have weak immune systems face higher risks of being infected with the coronavirus.

“It’s not fair for people who are unvaccinated to harm other people,” she told Newsweek  Sept. 4.

“The Hippocratic oath is very science based,” she said. “I am following the science. I’m applying this to the benefit of the sick.”

Dr. Marraccini said her new policy goes into effect on Sept. 15, and she will continue to see unvaccinated patients virtually during the next month until they find another health care provider.

She said that the response to her decision has been “99.9% favorable” and that she will make exceptions if patients can’t receive a shot because of hardships. Her office also provides the Johnson & Johnson vaccine.

“We’re not going to leave them out there in the cold,” she told Newsweek.

During the past month, COVID-19 cases have surged in Florida, reaching record-level highs of more than 20,000 cases per day. Cases began rising in the summer because of the more contagious Delta variant.

In late August, a group of doctors in southern Florida urged people to get vaccinated, citing their exhaustion and frustration with unvaccinated patients who make up the large majority of COVID-19 hospitalizations, according to Newsweek.

Other doctors have declined to treat unvaccinated patients in recent weeks. Jason Valentine, MD, a doctor in Mobile, Ala., said he would no longer see unvaccinated patients as of Oct. 1, according to AL.com.

Dr. Marraccini urged people to become informed about COVID-19 vaccines, as well as their role in reducing the surge of cases in the state. The pandemic “did not have to go on this long,” she said.

“Responsibility has to do with each individual,” she told Newsweek. “This is a global health issue, and everyone owns part of that responsibility.”

A version of this article first appeared on WebMD.com.

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