Director Walensky Defends Overruling CDC Panel Over Pfizer COVID-19 Boosters

Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), on Friday defended overriding the CDC’s own advisory panel, which voted the previous day not to recommend a Pfizer COVID-19 booster shot for people at high risk of contracting the disease in the workplace.

“After those deliberations, I listened to the votes. I listened to the comments on the votes and this was a scientific close call,” Walensky said in a White House media briefing.

Rather than follow the panel’s advice, the CDC aligned with the FDA’s position and recommended boosters for people age 18 and older at high risk of disease in their place of work, including frontline healthcare workers and teachers.

Walensky balked at the suggestion that she had rejected the advice of the Advisory Committee on Immunization Practice (ACIP). “I want to be very clear that I did not overrule an advisory committee … [I] intently listened to this exceptional group of scientists that publicly and very transparently deliberated for hours over some of these very difficult questions,” she said (DID, Sept. 24).

In a separate White House briefing early Friday, President Biden said the CDC’s recommendations pave the way for 60 million Americans to receive a booster six months after receiving a second dose, and make 20 million U.S. citizens immediately eligible because they completed their two-dose inoculation more than six months ago.

The FDA’s Emergency Use Authorization (EUA) issued last week, which was aligned with its own advisory committee, covers those over age 65 and older, people 18 years and older with underlying health conditions who are at high risk of severe infection, as well as those age 18 and up at high risk of disease in their workplace. Like the FDA, the CDC may overrule its own advisory committee, but it is very rare and can raise concerns about the integrity of the agency review process (DID, Sept. 23).

One observer of the CDC expert panel’s proceedings, the American Academy of Pediatrics’ liaison to the advisory committee, Yvonne Maldonado, who is a pediatric infectious disease specialist at Stanford University, agreed with Walensky’s decision, telling FDAnews the committee  narrowly voted down the workplace recommendation.

But Walensky acknowledged the limitations of the available data on boosters, saying that “even with uncertainty, we must take actions that we anticipate will do the greatest good.”

President Biden also affirmed the independence of the FDA and CDC reviews, asserting that “the decision of which booster shot to give, when to start the shot and who will get them [was] left to the scientists and the doctors.”

Last month, the administration was accused of getting ahead of the FDA by rolling out a plan for booster shots before the agency authorized them for wide use (DID, Aug, 20).

In response to separate calls for boosters for those who received a Johnson & Johnson (J&J) or Moderna shots, administration officials reiterated Friday that they are working as fast as possible to review data supporting those booster authorizations.

“We will address, with the same sense of urgency, recommendations for the Moderna and J&J vaccines as soon as those data are available,” Walensky said. ― Jason Scott