FDA authorizes booster shots for older adults and people at high risk
After the FDA authorized booster doses of the Pfizer-BioNTech vaccine for people at high risk for severe COVID-19, a CDC advisory committee made specific recommendations on who should be eligible for a third shot.
Under an expanded emergency use authorization (EUA), the FDA said booster doses of the vaccine can be administered at least 6 months after completion of the initial two-dose series in people aged 65 years or older, people who are at high risk from severe COVID-19 and people who face a high risk for serious complications based on “frequent institutional or occupational exposure to SARS-CoV-2.”
That third group, acting FDA Commissioner Janet Woodcock, MD, explained in a statement, includes “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” but the CDC committee elected not to recommend that these groups be eligible for boosters.
At the end of a second straight daylong meeting, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously, 15-0, to recommend a booster dose of the Pfizer-BioNTech vaccine for people aged 65 years or older and residents of long-term care facilities, to be given at least 6 months after the second dose, supporting the FDA decision.
Three other votes were not as close, however, and one vote ended with the ACIP recommending against boosters for younger populations with no underlying medical conditions.
The committee voted 13-2 to recommend a booster dose for people aged 50 to 64 years who have an underlying medical condition, and 9-6 in favor of recommending a third dose for people aged 18 to 49 years with underlying conditions, “based on individual benefit and risk” — both also at least 6 months after the primary series.
The language in the latter vote reflects previous ACIP guidance suggesting the use of “shared clinical decision-making” between clinicians and patients to determine the best course of action.
In a fourth vote, the committee elected in a 9-6 decision not to recommend booster doses in people aged 18 to 49 years without an underlying condition “who are in an occupational or institutional setting where the burden of COVID-19 infection and risk of transmission are high.”
ACIP member Lynn Bahta, RN, MPH, CPH, who advises the Minnesota Department of Heath on immunizations, voted no on each of the last two questions, saying she felt the committee was being drawn into an “emotional situation” and that it needed to focus on the science, which she said has not supported the use of boosters in younger age groups.
Instead, Bahta said, voting yes on those two questions could put doubt in the minds of people that the vaccine is effective.
“We know that isn’t true, but that’s how that message will be conveyed to the broader public,” she said.
Voting members noted that vaccine safety is the committee’s highest priority, and that once more data is available, they will reconvene and reassess if changes need to be made to specific recommendations.
For example, if myocarditis is more prevalent among younger people following the administration of booster doses, members would assess the recommendation and makes changes, if necessary.
The ACIP votes came nearly a week after a unanimous vote by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) last Friday supported the use of boosters for high-risk Americans. The FDA official FDA authorization, which aligned with that vote, was issued Wednesday night.
The VRBPAC voted against recommending a booster shot for everyone fully vaccinated with the Pfizer-BioNTech vaccine based on evidence suggesting they may not be needed — a setback for the Biden administration’s plan to offer booster doses of both the Pfizer-BioNTech and Moderna’s messenger RNA COVID-19 vaccines to any fully vaccinated American.
The FDA authorization “demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” Woodcock said.
“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” Woodcock said. “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.”
The FDA had already authorized booster doses of the Pfizer-BioNTech and Moderna vaccines for certain immunocompromised patients.
The FDA fully approved the Pfizer-BioNTech vaccine last month. Moderna has also applied for full approval and for authorization of a booster dose.
Perspective
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The FDA, by ratifying the decision of its advisory group, followed the science of where the need for boosters actually exist. In general, healthy populations, we have not seen erosion of protection against serious disease, hospitalization, or death — what really matters. When it comes to those who are above the age of 65 years, and at high risk for severe disease, the analysis is different as reflected by the FDA authorization. As decisions about booster vaccination doses are made, it is critical that it is a clinically driven, scientific, evidence-based, transparent process.
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