FDA clears Pfizer’s Covid booster injections for people 65 and older and other vulnerable Americans


Trung Nguyen, 13, receives his second dose of the coronavirus disease (COVID-19) vaccine at the Philadelphia Zoo in Philadelphia, Pennsylvania on September 7, 2021.

Rachel Wisniewski | Reuters

The Food and Drug Administration cleared Pfizer and BioNTech’s Covid-19 booster injections for people 65 and older and other vulnerable Americans six months after completing their first two doses, making many Americans eligible for get the injections now.

The FDA’s decision largely follows recommendations given on Friday by its main vaccine advisory committee during a more than 8-hour meeting of the agency. The Advisory Committee on Vaccines and Related Biologics voted 16-2 against distributing vaccines to Americans 16 and older, before unanimously adopting an alternative plan to give reminders to older Americans and to those who are at high risk of developing serious illness if they contract the virus.

Although Americans 65 and older make up about 17% of the U.S. population, they account for over 77% of all Covid deaths, according to the Centers for Disease Control and Prevention.

The FDA has granted emergency use authorization to administer the injections to older Americans, people between the ages of 18 and 64 with co-morbidities, frontline health workers, and other people in the most demanding jobs. exposing them to a greater risk of exposure. to the virus.

“The FDA has taken the committee’s comments into account and has conducted its own in-depth review of the data submitted to make today’s decision,” said Dr. Peter Marks, the leading vaccine regulator of the agency, in a press release. “We will continue to analyze the data submitted to the FDA regarding the use of COVID-19 vaccine booster doses and make further decisions, as appropriate, based on the data. ”

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The non-binding vaccine advisory committee decision was to be controversial, as the Biden administration said it wanted to start offering boosters to the general public as early as this week, pending clearance from U.S. health regulators.

Although the agency did not always follow the advice of its committee, it often does. Still, Marks reminded the panel after the votes that federal regulators do not have to accept his recommendation as written.

He asked the group for suggestions on other populations the FDA should consider for boosters, such as frontline health workers and other professions that are at higher risk for Covid. “We are not tied to the FDA by your vote, just so you understand. We can change that if necessary,” he said.

Some health experts have speculated that the agency may deviate at least a little from its committee’s opinion. Some scientists, including at least two from the FDA, said they were not fully convinced that every American who received the Pfizer vaccine needed additional doses at this time. However, the country’s leading health regulators, including CDC Director Dr Rochelle Walensky, FDA Acting Commissioner Dr Janet Woodcock and White House Chief Medical Advisor Dr Anthony Fauci, have already approved Biden’s recall plan in August.

The vote puts the committee in an “awkward position” as the administration has already announced it will begin handing out boosters this month, Northwell Health chief infectious disease officer Dr Bruce Farber said ahead of the recommendation. panel.

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Ahead of Friday’s two votes, which took place late in the afternoon, some committee members said they feared there wasn’t enough data to make a recommendation, while others argued that third shots should be limited to certain groups, such as people over 60. who are known to be at higher risk for serious illness. Some members have raised concerns about the risk of myocarditis in young people, saying more research is needed.

Phil Krause, an FDA vaccine regulator who is leaving the agency under pressure from the Biden administration to approve the injections, criticized the findings presented at the meeting, saying much of the data didn’t had not been reviewed by the federal agency or peer reviewed. . He said the models used were complex and scientists need to make sure they “give you the right results.”

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

Outlining plans last month to begin handing out boosters as early as this week, administration officials cited three CDC studies that showed vaccine protection against Covid declined over several months. Senior health officials said at the time that they feared protection against serious illness, hospitalizations and death “might” wane in the coming months, especially among those at higher risk or who were vaccinated during the early stages of the vaccination rollout.

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Pfizer said in documents released last week that an observational study in Israel showed that a third dose of the Covid vaccine six months after a second injection restores protection against infection to 95%. Data was collected from July 1 to August 30, when the fast-spreading delta variant was increasing across the country.

In a presentation Friday, Dr Sharon Elroy-Preiss of Israel’s Ministry of Health argued that had officials not started handing out boosters in late July, the country would likely have exceeded hospital capacity. Health officials have started to see a trend, she said, where people in their 40s and 50s who have been fully vaccinated are becoming seriously ill with Covid.

“We didn’t want to wait to see these results and we knew we needed to vaccinate more of the population in order to bring the numbers down quickly,” she told the committee. Israeli health officials expected severe cases to average 2,000 by the end of August, she said. “We were able to mitigate this effect and our severe cases are around 700 or less and have remained stable, although we still have days at 10,000 confirmed cases.”

The FDA’s OK is not the final green light. The CDC’s vaccine advisory committee held the first day of a two-day meeting on Wednesday to debate the third moves with a vote on the FDA proposal scheduled for Thursday afternoon. If they issue a recommendation and it is approved by the CDC, the booster shots could begin immediately.