Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, insisted on Friday that she did not override a vaccine advisory committee by adding a proposal rejected by the panel to the CDC’s approval for Pfizer’s Covid Booster.
In an unusual move, Walensky broke out of the CDC’s Advisory Committee on Immunization Practices, which on Thursday voted 9 to 6 against approving vaccines for people in high-risk environments.
Walensky adopted the panel’s other recommendations to distribute the third vaccination to adults with pre-existing conditions and to anyone aged 65 and over. She said the final vote to release additional doses for teachers, health workers and other key employees was a “scientific scarcity”.
“I want to be very clear that I have not overridden an advisory committee,” said Walensky at a Covid briefing in the White House on Friday. “I have listened to all of the FDA advisory committee proceedings and listened carefully to this extraordinary group of scientists who spent hours publicly and very transparently about some of these very difficult questions and where the science was going.”
Dr. Rochelle Walensky, selected as director of the Centers for Disease Control and Prevention, speaks during an event at The Queen Theater in Wilmington, Del., Tuesday, December 8, 2020.
Susan Walsh | AP
Walensky’s policy aligns closely with the Food and Drug Administration’s decision on boosters on Wednesday. This agency similarly defied the advice of its Scientific Advisory Board by authorizing the recordings for a wider audience than was advocated by its Advisory Committee on Vaccines and Allied Biological Products.
“This was a scientific scarcity,” said Walensky, noting the lengthy two-day meeting and robust debate. “It was my call. If I had been in the room I would have voted yes.”
She tried to build public confidence by encouraging people to go back and listen to the committee’s deliberations. “We made it public, we made it transparent, and we did it with some of the best scientists in the country,” she added.
Dr. Paul Offit, an infectious disease doctor at Philadelphia Children’s Hospital and a voting member of the FDA’s advisory committee, turned down boosters for young people fearing they could cause myocarditis. Offit called Walensky’s expansion of the ACIP recommendation “a first,” adding that he felt Pfizer should have conducted more extensive booster studies before submitting its results to the FDA and CDC.
“As a healthy person under 30, I would wait and see how that goes,” Offit told CNBC. “Wait for a few million cans to get out of there.”
But with the US recording a seven-day average of 2,011 deaths per day on Thursday, 6% more than a week ago, according to a CNBC analysis of data from Johns Hopkins University, other doctors support Walensky’s decision.
Adjusting the panel’s guidelines was Walensky’s responsibility, even if it broke the precedent, said Dr. Arturo Casadevall, Chair of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health.
“These committees are advisory,” said Casadevall. “Ultimately, this is a matter of policy, and politics requires judgment.”
President Joe Biden said at a briefing Friday that the CDC’s recommendation had expanded booster vaccinations to about 60 million Americans, including educators, health workers and color supermarket clerks, Walensky said.
“I am also aware of the disproportionate impact of this pandemic on racial and ethnic minority communities,” Walensky said. “Many of our frontline workers, key workers, and those in meeting places come from communities that are already hardest hit.”
She said denying these groups access to boosters will only exacerbate inequalities in the pandemic, which have resulted in black and Hispanic Covid patients dying more often than whites.
More than 55% of the US is fully vaccinated, and more than 2.4 million Americans have received booster vaccinations since the agency approved it for people with compromised immune systems on Aug. 13, according to the CDC.
Walensky said the agency will work to quickly evaluate the booster data from Moderna and Johnson & Johnson in the coming weeks.
“We intend to have numerous advisory boards at the CDC to review many pending decisions, including Moderna, J&J, and pediatric vaccinations,” said Walensky.
