Dr. Marion Gruber , director of the FDA’s Office of Vaccines Research and Review, plans to resign
Two of the U.S. Food and Drug Administration’s top vaccine regulators plan to leave the agency in the next several months amid a reported power struggle with the White House over COVID-19 booster shots.
Dr. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, plans to step down on October 31 and her top deputy Dr. Philip Krause also plans to leave the FDA in November, according to a department memo seen by EndPoints News.
Gruber played a key role in approving COVID-19 vaccines for the public, but her departure comes amid reports that FDA officials are frustrated with the White House for announcing booster shots before regulators formally approved them.
President Joe Biden has vowed to begin offering booster shots to the general public on September 20, a move that many health experts view as politicized and premature in coming before the FDA issues a formal recommendation.
In the US, the first courses of COVID vaccines from Johnson & Johnson and Moderna have emergency use authorization from the FDA, while the Pfizer vaccine’s two-dose initial course has full approval. But the FDA has yet to rule on widespread booster doses.
Biden has vowed to begin offering COVID booster shots to the general public on September 20, but some regulators are frustrated the announcement came before FDA approval
In a joint statement last month, Biden’s top health advisors called for a booster course of an additional Pfizer or Moderna shot for anyone who had received any of the three vaccines now in use, starting eight months after the initial dose.
‘We have developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness,’ the statement said.
The joint statement released by the FDA was signed by Dr. Anthony Fauci, CDC Director Dr. Rochelle Walensky, and FDA Acting Commissioner Dr. Janet Woodcock, among others — but it was merely a press release, and did not amount to an official FDA authorization.
While the White House booster strategy is contingent on securing approval from regulators, the public announcement irked mid-level officials at the FDA and Centers for Disease Control and Prevention, some of whom have spoken out publicly.
Biden getting ahead of the FDA on booster shots was the final straw for Gruber and Krause, according to trade publication Endpoints News, citing a former senior FDA leader.
The source also said that Gruber and Krause were frustrated with the CDC’s vaccine advisory committee for getting involved in decisions that they felt should be left up to the FDA.
The source did not suggest that there was any disagreement between Gruber and her superiors over the safety and efficacy of COVID vaccines, but rather that she was frustrated with inter-agency turf struggles.
Biden’s COVID czar Dr. Jeff Zients (above) defended the booster announcement and argued that FDA Acting Commissioner Dr. Francis Collins supported the booster shots
Gruber had been with the FDA for 32 years. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research will serve as the acting director of the vaccines group while the FDA searches for its next director. The search process will begin immediately.
The FDA did not immediately respond to an inquiry from DailyMail.com on Wednesday.
A spokesperson for the agency told Reuters that the FDA is ‘confident in the expertise and ability of our staff to continue our critical public health work, including evaluating COVID-19 vaccines’ following the resignations.
At a briefing on Tuesday, Biden’s COVID czar Dr. Jeff Zients was asked about the rumors of frustration within the FDA over the boosters, and argued that FDA Acting Commissioner Dr. Francis Collins supported the booster shots.
‘As our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,’ said Zients.
‘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,’ he said.
‘We have been — also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation,’ said Zients.
On Tuesday, several members of the CDC’s independent vaccine advisory panel voiced frustration Monday with the Biden administration’s plan to begin doling out Covid-19 boosters next month.
‘I think since it was given with a date, many assumed that it was given a blessing by the White House and this was the next step,’ said Helen Keipp Talbot, a committee member and associate professor of medicine at Vanderbilt University, during a panel meeting reported by Politico.
‘Many, many, many’ hospitals across the South have already begun administering third doses to their health care workers as the highly infectious Delta variant drives a surge in cases, Talbot noted.
While regulators have authorized booster shots for immunocompromised individuals, their need for the general public has not yet been recommended by the FDA.
The CDC on Monday said it may be difficult to determine at this point whether immunity from prior vaccination is waning over time or if the vaccines are just less able to prevent infection by the highly-transmissible Delta variant.