FDA approves Pfizer’s Covid booster shots for people over the age of 65 and other vulnerable Americans

13-year-old Trung Nguyen was vaccinated with a second coronavirus disease (COVID-19) vaccine at the Philadelphia Zoo in Philadelphia, Pennsylvania, on September 7, 2021.

Rachel Wisniewski | Reuters

Approved Food and Drug Administration Pfizer When BioNTechCovid-19 booster shots are taken six months after people over the age of 65 and other vulnerable Americans complete their first two doses, so many Americans receive shots now. Qualified.

The FDA’s decision closely follows the recommendations given by the major vaccine advisory boards on Friday. 8 hour agency meeting.. The Vaccine and Related Biopharmaceutical Advisory Board opposed the distribution of vaccines to Americans over the age of 16 and voted 16-2. He then unanimously adopted an alternative plan to boost older Americans and those at high risk of getting a serious illness if infected with the virus. ..

According to the US Centers for Disease Control and Prevention, Americans over the age of 65 make up about 17% of the US population, but more than 77% of all Covid deaths.

The FDA is an emergency use to administer shots to older Americans, people aged 18-64 with so-called comorbidities, front-line healthcare workers, and other people at high risk of exposure. I gave you permission. To the virus.

“The FDA has reached today’s decision by taking into account the Commission’s opinion and conducting its own in-depth review of the data submitted,” said Dr. Peter Marks, FDA’s premier vaccine regulator. Said in a statement. “We will continue to analyze the data submitted to the FDA regarding the use of booster doses of the COVID-19 vaccine and make further decisions based on the data as needed.”

Non-binding decision by Vaccine Advisory Board Expected to be controversial As the Biden administration said it would like to start offering booster shots to the general public as early as this week, waiting for approval from US health regulators.

Agencies do not always follow the advice of the Commission, but they often do. Still, Marks reminded the panel after the vote that federal regulators did not have to accept written recommendations.

He asked the group for suggestions on other groups that the FDA should consider for boosters, such as front-line healthcare professionals and other occupations facing more exposure to Covid. “We are not bound by the FDA by your vote, because you understand it. We can fine-tune this if needed,” he said. rice field.

Some health experts speculated that authorities could at least a little deviate from the Commission’s advice.Some scientists including At least two in the FDASaid that not all Americans who received the Pfizer vaccine are completely convinced that they need additional doses at this time. However, top U.S. health regulators, including CDC director Rochelle Walensky, FDA commissioner Janet Woodcock, and White House chief medical adviser Anthony Fauci, have already announced a Biden booster plan in August. approved.

Dr. Bruce Farber, Head of Infectious Diseases at Northwell Health, has already announced that the government will begin distributing boosters this month prior to the panel’s recommendation, so the commission is “in a mess” by voting. Said to be placed in.

Before the two votes late Friday afternoon, some members of the committee were concerned that there wasn’t enough data to make a recommendation, while the third shot was over 60. Some argued that it should be limited to a specific group, such as the people of. People who are known to be at high risk of severe illness. Some members expressed concern about the risk of myocarditis in young people, saying more research was needed.

FDA vaccine regulator Phil Klaus, who leaves the authorities under pressure to approve shots from the Biden administration, is critical of the findings presented at the conference, and much of the data is also reviewed by federal agencies. He said it had not been peer reviewed. He said the model used was complex and scientists had to make sure it “gives you the right results.”

“This is part of the difficulty of seeing this kind of data without the FDA having the opportunity to review it,” he said.

Overview of plans to start last month Distribute boosters as early as this week, Government officials cited three CDC studies that showed that vaccine protection against Covid was reduced over the course of several months. Senior health officials said they were concerned that protection against severe illness, hospitalization and death could diminish in the coming months.

Pfizer said in a document released last week that an observational study in Israel showed a third dose of the Covid vaccine six months after the second injection restored protection from infection to 95%. Data were collected from July 1st to August 30th, when the rapidly prevailing delta variants were booming across the country.

In a presentation on Friday, Dr. Sharon Elroy Price of the Israeli Ministry of Health claimed that the country would have exceeded the capacity of the hospital if it had not started distributing boosters at the end of July. Health officials have begun to see individuals in their 40s and 50s who are fully vaccinated tend to become seriously ill with Covid, she said.

“We didn’t want to wait to see those results, and we knew we needed to vaccinate more parts of the population to quickly reduce numbers,” she said. Told the committee. Israeli health officials expect an average of 2,000 serious cases by late August, she said. “We were able to mitigate that effect, and our severe cases are around 700 or less, and 10,000 confirmed cases still have days, but remain stable.”

FDAOK is not final approval. The CDC’s Vaccine Advisory Board held the first day of the two-day meeting on Wednesday, voting on the FDA’s proposal scheduled for Thursday afternoon to discuss the third shot. If they issue a recommendation and it is approved by the CDC, booster shots may start immediately.

FDA approves Pfizer’s Covid booster shots for people over the age of 65 and other vulnerable Americans

Source link FDA approves Pfizer’s Covid booster shots for people over the age of 65 and other vulnerable Americans

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