CDC Director Overrules Agency’s Own Vaccine Safety Committee, Sides With FDA to Approve Boosters for ‘High-Risk’ Workers
In an “unusual move,” the director of the Centers for Disease and Control and Prevention (CDC) on Thursday overruled a recommendation by the agency’s vaccine advisory committee to limit Pfizer’s COVID booster shot for people 65 and older, long-term care facility residents and certain people with underlying conditions.
Instead, CDC Director Dr. Rochelle Walensky aligned with the U.S. Food and Drug Administration’s (FDA) authorization of a third dose of Pfizer’s vaccine for a broader population, including healthcare workers, teachers and others whose jobs put them at “high risk” of infections, plus residents of prisons and homeless shelters.
President Biden today acted on the news, announcing his administration will begin to deliver booster shots this week, Politico reported.
The CDC’s Advisory Committee on Immunization Practices (ACIP) on Thursday voted unanimously to approve Pfizer’s booster shot for people 65 and older, long-term care facility residents and certain people with underlying conditions, with the third shot to be administered at least six months after the second dose.
But the ACIP panel voted against recommending a booster dose for people whose jobs or situations put them at high risk of vaccine breakthrough infection.
In a similar scenario, the FDA on Wednesday granted Pfizer extended Emergency Use Authorization for boosters for people 65 and older and those at higher risk of severe disease and death, as well as frontline workers at higher risk of breakthrough infections — even though last week, the agency’s safety panel had rejected, in a 16 – 2 vote, Pfizer’s application for boosters for the general population.
In opposing Pfizer’s application, the FDA’s Vaccines and Related Biological Products Advisory Committee cited a lack of long-term data and said the vaccine’s risks did not outweigh the benefits for the broader population.
Critics slammed the decision, calling it “unjustified and unethical” and a “consolation prize” for Pfizer, which wanted approval for everyone in the general population, over age 16.
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The broad nature of the FDA’s authorization of Pfizer’s third shot did not sit well with several members of the CDC’s ACIP. According to Reuters, the ACIP gave the thumbs down for new additional doses for groups — including healthcare workers, teachers and residents of homeless shelters and prisons — in part because of the difficulty of implementing such a proposal.
ACIP member Lynn Bahta, a nurse who works with the Minnesota Department of Health, voted against that measure. Bahta said the data does not support boosters in that group yet.
Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, said he believed the CDC advisers were worried recommending boosters based on employment would allow overly broad use, especially in younger people for whom the health benefits of a booster shot are still unclear.
“That was a hole that you could drive a truck through, that essentially what we were doing was basically what the (Biden) administration initially asked — to just have a vaccine for the general population, because obviously the pharmacists aren’t going to figure out whether you’re working in a grocery store or hospital,” Offit said.
The CDC now says people 65 years and older and residents in long-term care settings should get a booster and so should people 50 to 64 years old who have an underlying medical condition.
Those 18 to 49 with underlying medical conditions, and those 18 to 64 who are at an increased risk because of an occupational or institutional setting “may” get a shot, the CDC said.
Last month, President Biden and top health officials, including Walensky, Surgeon General Vivek Murthy and acting FDA Commissioner Dr. Janet Woodcock, publicly announced a booster shot program would begin the week of Sept. 20, well before the FDA and CDC examined the evidence.
At the time, numerous scientists expressed skepticism over the need for COVID boosters, including two FDA officials who resigned over the issue.
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