The Food and Drug Administration approved Pfizer and BioNTech’s Covid-19 booster syringes for people 65+ and other at-risk Americans six months after completing their first two doses, which means many Americans are now eligible to receive the syringes.
The FDA’s decision on Wednesday, which has yet to be reviewed by the Centers for Disease Control and Prevention, largely follows the recommendations its key vaccine advisory committee made on Friday at a more than eight-hour meeting of the agency.
The CDC’s Vaccine Advisory Committee is expected to vote on the FDA’s proposal on Thursday afternoon. If she recommends approval and the CDC approves it, the booster shots could start right away.
Last week, the FDA Advisory Committee on Vaccines and Related Biological Products voted 16-2 against distributing the vaccines to Americans 16 and older, before unanimously adopting an alternative plan to older Americans and those at high risk of developing serious illnesses to get sick to give a booster if they get the virus.
Although Americans 65 and older make up about 17% of the US population, they are most at risk of dying from Covid and account for more than 77% of all Covid deaths, according to the CDC.
The FDA has issued emergency clearance to administer Pfizer shots to elderly Americans and people ages 18 to 64 with conditions that put them at serious risk of disease. The agency also added a broad definition of anyone between the ages of 18 and 64 “whose frequent institutional or professional exposure” to the virus puts them at high risk of developing serious complications from Covid. That leaves enough room for the CDC to potentially release third doses for people in nursing homes, prisons, frontline health workers, and other key workers who were among the first Americans to receive their first syringes in December.
“The FDA took into account the committee’s input and conducted its own thorough review of the submitted data in order to make today’s decision,” said Dr. Peter Marks, the agency’s lead vaccines agency, in a statement. “We will continue to analyze the data submitted to the FDA regarding the use of booster doses of COVID-19 vaccines and, if necessary, make further decisions based on the data.”
The vaccine advisory board’s non-binding decision was expected to be controversial as the Biden administration announced it would offer booster shots to the public as early as this week pending approval from U.S. health officials.
Although the agency has not always followed the advice of its committee, it often does. Still, Marks reminded the panel on Friday that federal regulators did not have to accept their written recommendation.
“We’re not tied to your vote at the FDA just for you to understand. We can adjust this as needed, ”he said.
In releasing the vaccinations, which will only apply to people who received the original Pfizer vaccine, the FDA cited a small study by the company of around 300 people who received the booster, data from the UK, as well as more comprehensive but less stringent data , from the Israeli health authorities.
Some scientists, including at least two from the FDA, said they weren’t entirely convinced that every American who got the Pfizer vaccine would need extra doses at this point. The country’s leading health authorities, including CDC director Dr. Rochelle Walensky, Acting FDA Commissioner Dr. Janet Woodcock and White House Senior Medical Advisor Dr. Anthony Fauci, however, already approved Biden’s booster plan in August.
Friday’s vote put the FDA panel in an “uncomfortable position” as the government had already announced that it would begin distributing boosters to the general public this month, said Dr. Bruce Farber, Head of Infectious Diseases at healthcare provider Northwell Health, before the panel’s recommendation.
Some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued that the third vaccination should be limited to certain groups, e.g. Some members raised concerns about the risk of myocarditis in younger people and said more research was needed.
Dr. Phil Krause, an FDA vaccine regulator who is leaving the agency under pressure from the Biden administration to approve the shots, criticized the results presented at the meeting, saying that much of the data has not been verified by the federal agency or a peer-reviewed . He said the models used are complex and scientists need to make sure they are “getting the right results.”
“That’s part of the difficulty of looking at this type of data without a way for the FDA to review it,” he said.
In last month’s plans to start distributing boosters as early as this week, administration officials cited three CDC studies that showed vaccines protection against Covid had waned over several months. Senior health officials said at the time they feared protection from serious illness, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.
Pfizer said in documents released last week that an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second vaccination. The data was collected from July 1 to August 30 when the rapidly expanding delta variant emerged across the country.
In a presentation on Friday, Dr. Sharon Elroy-Price of the Israeli Ministry of Health said that if officials there had not started distributing boosters in late July, the country would likely have exceeded its hospital capacity. She said health officials had seen a trend in fully vaccinated people in their 40s and 50s who became seriously ill with Covid.
“We didn’t want to wait to see these results, and we knew we had to vaccinate a larger section of the population to get the numbers down quickly,” she told the committee. Israeli health officials expected an average of 2,000 serious cases by the end of August, she said. “We have been able to dampen this effect and our severe cases are around 700 or less and have remained stable even though we still have days with 10,000 confirmed cases.”
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