The White House defended its COVID-19 vaccine booster shot campaign Tuesday after outside advisers complained of limited data on the need for third doses and senior Food and Drug Administration officials abruptly retired amid criticism of President Biden’s decision to trumpet the plan before regulators had signed off on it.
The booster decision “was made by and announced by the nation’s leading public health officials,” White House COVID-19 coordinator Jeff Zients said, rattling off a list that included leaders at the Centers for Disease Control and Prevention, the National Institutes of Health and acting Food and Drug Commissioner Janet Woodcock.
Mr. Biden wants to begin giving third doses of the Pfizer-BioNTech or Moderna vaccine to people who received their second dose eight months prior. He said the FDA and the CDC’s Advisory Committee on Immunization Practices (ACIP) must sign off on the plan but he announced a start date of Sept. 20, anyway, leading to charges he preempted experts.
ACIP members on Monday said data on the need for boosters is limited, signaling they might limit their blessing to a plan that protects health workers, older adults and people with preexisting conditions until they get data on the general population.
On Tuesday, FDA employees learned that Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, plans to retire on Oct. 31 after a 32-year career at the agency and Deputy Director Philip Krause will leave in November.
Peter Marks, chief of the FDA’s Center for Biologics Evaluation and Research, did not provide a reason for their departures in a letter to agency employees.
But a former senior FDA official told Endpoints News they were upset that CDC advisers were involved in decisions that are normally the FDA’s purview. The clincher, the official said, was the White House getting ahead of the FDA on booster shots.
Mr. Zients said the administration wanted to be upfront with people about signs of waning immunity in vaccinated people and fears it could lead to hospitalizations down the road, even if the shots are largely staving off severe illness for the vaccinated now.
“We announced our approach in order to stay ahead of the virus, give states and pharmacies time to plan, and to be transparent with the American people — as to the latest data and expert clinical judgments from the team — to give them time to do their own planning,” Mr. Zients said. “This is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation.”
Dr. Marks said the departure of Dr. Gruber, the OVRR director since 2011, is a “huge loss” and that Dr. Krause’s “keen insight and experience” will be sorely missed.
“We are confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines,” said FDA spokeswoman Stephanie Caccomo.
Still, the high-level departures come at a critical juncture in the COVID-19 fight, as the delta variant rips through poorly vaccinated areas and sparks fears of “breakthrough infections” in the fully vaccinated.
Mr. Biden, seven months into his presidency, hasn’t nominated a permanent FDA commissioner. The agency is now deciding whether to approve COVID-19 vaccines for children aged 5 to 11.
Critics say the booster plan, meanwhile, could distract from the main goal of getting all eligible people vaccinated — only 52% of the U.S. population had completed their vaccine course as of Tuesday.
The World Health Organization also panned richer countries for rolling out booster shot programs instead of sharing their doses with poor nations that need to start vaccinations.
CDC Director Rochelle Walensky defended the plan amid skepticism from her agency’s own panel of outside advisers.
She said the ACIP reviewed data that “looked at increased waning with regard to the vaccine effectiveness for infection and some suggestion there was increased waning vaccine effectiveness against hospitalization,” she said. “The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness warning against hospitalization, severe disease and death. They will be reviewing that as well.”
She said the complete package of data showed it was critical to “plan ahead to remain ahead of the virus.”
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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