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FDA Advisory Panel Rejects COVID Booster Shot for Most Americans

Emergency Room Physician Steven Roumpf MD receives the Pfizer-BioNTech coronavirus vaccine at Indiana University Health, Methodist Hospital in Indianapolis, Ind., December 16, 2020. (Bryan Woolston/Reuters)

An advisory panel to the Food and Drug Administration on Friday recommended against approving a booster shot of the Pfizer COVID-19 vaccine to most Americans. 

The scientific advisory committee voted 16-to-3 against recommending the additional shots, thwarting the Biden administration’s hopes that the FDA would approve the third shot in time to begin rolling out the extra dose for Pfizer recipients next week.

However, the panel voted 18-0 in favor of recommending a booster shot for anyone over 65 or anyone who is at high risk of severe disease from COVID-19.

The vote followed a daylong debate in which a number of the panel’s independent experts questioned whether the data justified a broad rollout of an additional shot to most Americans while the vaccines still appear to offer strong protection against severe COVID-19 disease and hospitalization. 

“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.

The CDC’s Dr. Sara Oliver presented data showing that vaccines continue to offer robust protection against severe forms of COVID-19 in the U.S., even in people 75 and older.

Jonathan Sterne, a professor of medical statistics and epidemiology in the U.K., said his analysis of 76 different studies on the vaccines’ real world effectiveness found that a number of factors can skew the results, including how many unvaccinated people in a study have natural immunity from earlier COVID-19 disease. He cautioned against drawing conclusions from short-term results from booster shots, such as data from Israel which shows that a booster can strengthen protection for a few weeks in older adults.

The decision comes after President Biden announced last month that he planned to make booster shots available to most adults who had received a second Pfizer or Moderna vaccine at least eight months ago beginning the week of September 20.

“Just remember, as a simple rule — rule: Eight months after your second shot, get a booster shot,” Biden said on August 18.

The president had touted the booster shots as a tool to fight the highly-transmissible delta variant.

Dr. Anthony Fauci had also spoken in favor of the booster campaign, telling reporters earlier this month that it is likely Americans will need to receive a third dose of the mRNA vaccines to be considered fully vaccinated against COVID-19.

“From my own experience as an immunologist, I would not at all be surprised that the adequate, full regimen for vaccination will likely be three doses,” he said.

While the FDA is not required to follow the committee’s recommendations, it typically does. The agency is expected to make a decision regarding the Pfizer booster shots by early next week.

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