FDA Advisors Reject COVID Booster Shot to General Public
The FDA advisory committee rejected a proposal intended to deliver Pfizer booster shots to the general public for COVID-19, however, the committee approved the proposal to provide a booster for those aged 65 and older or those who are immunocompromised.
Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital said, “It’s likely beneficial, in my opinion, for the elderly, and may be eventually indicated for the general population. I just don’t think we’re there yet in terms of the data.”
The decision is nonbinding and was made by the FDA’s Vaccines and Related Biological Products Advisory Committee at the same time as the Biden Administration said that they wanted to begin offering booster shots to the public in the next week, pending authorization from the FDA. The FDA does not always follow the advice of the committee, but, historically, they tend to. The CDC will now hold a meeting for two days to discuss what to do about a third shot.
“We are not bound at the FDA by your vote, just so you understand that. We can tweak this as need be,” stated Dr. Peter Marks, the agency’s top vaccine regulator. The panel voted 16–2 against distributing vaccines to Americans 16 years or older and unanimously agreed to give a booster to older and/or immunocompromised Americans. The committee also stated that they were in support of giving booster shots to healthcare and front-line workers, including teachers.
The booster is set to be able to be administered six months after the second dose was received. For the younger population, more data is needed to know if there is a benefit to a third dose.
Pfizer has collected an immense amount of data since it was released to the public over nine months ago, with extensive data coming from around the world which shows the vaccines strong protection in communities where vaccination levels are high, this data showed that the protection began to wane over time.
“These data, and the larger body of scientific evidence presented at the meeting, underscore our belief that boosters will be a critical tool in the ongoing effort to control the spread of this virus.” said Kathrin Jansen, senior vice president and head of vaccine research and development at Pfizer.
At the same time, many Americans have already received a third shot through doctors who were administering them “off-label”, it is now up to independent federal regulators to decide how vaccines will be labeled and administered.
The Biden Administration has also caused strain around this conversation. President Biden stated originally that they would wait on the decision of the FDA and CDC before vaccine rollout, but his announcement that a third dose would be available by September 20, which came earlier than the FDA and CDC’s decision.
References:
https://www.nytimes.com/2021/09/17/us/fda-pfizer-booster-covid.html
https://abcnews.go.com/Politics/fda-cusp-deciding-now-time-vaccine-boosters/story?id=80076547
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