The FDA amended the emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine, BNT162b2 (Comirnaty), to authorize a single booster dose for persons age 65 or older and high risk individuals.
With the amended EUA, the FDA announced that boosters can be administered beginning 6 months after completion of the primary immunization series in:
- “Individuals 65 years of age and older.
- “Individuals 18-64 years of age at high risk of severe Covid-19.
- “Individuals 18-64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19 including severe Covid-19.”
The agency stressed that this authorization only applies to the Pfizer-BioNTech vaccine.
“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech Covid-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, MD, in a statement. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
This decision leaves the CDC’s Advisory Committee on Immunization Practices (ACIP) open to vote on recommendations for the Covid-19 booster shots and determine who should get these booster shots, and when. ACIP’s two-day meeting started on Wednesday, and a vote is expected Thursday afternoon.
The EUA amendment follows on the heels of a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) at which a panel of vaccine experts overwhelmingly dismissed authorizing the booster shot for all individuals age 16 years and older, voting instead to restrict booster dosing to older individuals, high-risk patients, and health care workers.
As previously reported by BreakingMED, the VRBPAC panel raised concerns about the lack of data on booster vaccine safety among younger adults and adolescents, particularly given the observed increased risk of myocarditis among younger recipients of the mRNA-based Covid-19 vaccines.
The FDA’s choice represents a blow to the Biden administration’s initial plan to start rolling out booster shots to all Americans who previously received a complete series of mRNA-based Covid vaccines starting by the end of this month, a plan that was first announced in August in the face of reports of waning immunity and increasing rates of breakthrough infections as the Covid-19 pandemic rages on.
The administration’s plan met with mixed support—in a commentary published in The Lancet, experts outlined the reasons behind their opposition of the move, writing that, “The message that boosting might soon be needed, if not justified by robust data and analysis, could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination. Public health authorities should also carefully consider the consequences for primary vaccination campaigns of endorsing boosters only for selected vaccines.”
FDA director of the Office of Vaccines Research and Review Marion F. Gruber, PhD, and deputy director Philip Krause, MD, both among the commentary authors, announced in late August that they will be leaving the FDA, in part due to concerns over the administrations booster plans.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 31
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