|Maine Medicine Weekly Update
September 18, 2021
FDA Committee Votes to Authorize Pfizer Booster; Vote is Nonbinding; ACIP to Review
Late Friday, the US FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) unanimously voted to give Emergency Use Authorization for a Pfizer booster dose for:
Shortly after the vote, the VRBPAC informally polled members with the following question:
“Should health care workers or others at high risk for occupational exposure be included in this EUA?”
The poll showed unanimous support.
The F.D.A. is not obligated to follow the advice of the committee, but often does. The FDA said the final decision, expected next week, could be slightly different. The entire VRBPAC meeting can be viewed here and the FDA’s 23-page briefing document can be downloaded and read here.
IMPORTANT NOTE: The Maine Medical Association will continue to closely watch the process. Since boosters are not a medical emergency in the way that vaccinations were when first introduced, it may make sense to wait for ACIP to review all the data.
The US CDC Advisory Committee on Immunization Practices (ACIP) will further fine tune the specifics and recommendations. The ACIP is currently scheduled to meet next week, September 22, 2021, 10:00 a.m. – 5:00 p.m. and September 23, 2021, 11:00 a.m. – 2:00 p.m. ACIP meetings can be viewed by clicking here. No registration is required.
The VRBPAC rejected a proposal earlier in the meeting to allow a third Pfizer dose for people ages 16 and above six months after a second shot, citing a lack of sufficient data on the safety and efficacy of the measure. In recent weeks, the Biden administration had indicated a preference for approving booster shots to anyone 16 and older.
The FDA recently announced the resignations of two top officials in charge of approving vaccines in early September. It is believed the two resigned because of the Biden administration's mid-August announcement that third doses of COVID-19 vaccine would be offered to fully vaccinated Americans beginning Sept. 20, a decision made without official FDA review or approval. One of the officials, Philip R. Krause, MD, co-authored a paper published this month by The Lancet arguing that boosters were not needed in the general population.
Availability, and eligibility, for booster shots for those receiving Moderna or Johnson & Johnson vaccines was not/has not been discussed.Next Article >
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