After the Biden administration had pushed ahead with a plan to recommend booster shots of the coronavirus vaccine for Americans, two major officials at the Food and Drug Administration have decided to resign. It’s not clear whether they were stepping down because of Biden’s push, but according to Politico, one former FDA official believes the decision was out of anger for the booster planning process.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, who has served at the FDA for 32 years, will leave at the end of October; OVRR deputy director Phil Krause, who served at the FDA for over ten years, will step down in November.
On August 18, U.S. Surgeon General Vivek Murthy stated:
Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan is now. We are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization and death. That is why today we are announcing our plan to stay ahead of this virus by being prepared to offer COVID-19 booster shots to fully vaccinated adults eighteen years and older. They would be eligible for their booster shot eight months after receiving their second dose of the Pfizer or Moderna MRNA vaccines.
“While third doses are still only authorized for immunocompromised people, including organ-transplant patients, others who don’t fit into that category have plunged ahead with additional vaccinations under the mistaken notion that FDA has already given the green light,” Politico explained.
Politico reported that a former official of the FDA said of Gruber and Krause’s decision that it was motivated by anger over the FDA’s lack of autonomy in the decision-making process. “A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA’s top vaccine official Peter Marks,” Politico wrote, adding:
Woodcock and Marks were instrumental in crafting an Aug. 18 statement from HHS officials on the Sept. 20 booster timeline, said one senior official. That person said that the timeline was informed in part by Woodcock and Marks’ estimation of when they would get key data from vaccine makers, but also could shift based on new data, echoing the joint statement.
An FDA spokesperson informed Politico, “FDA has and will continue to make regulatory decisions. And the [Centers for Disease Control and Prevention’s vaccine advisory committee] will continue to make clinical recommendations.” Politico noted, “While third doses are still only authorized for immunocompromised people, including organ-transplant patients, others who don’t fit into that category have plunged ahead with additional vaccinations under the mistaken notion that FDA has already given the green light.”
Acting FDA Commissioner Janet Woodcock told vaccine regulators on Tuesday, “The issues are complex and the days are long, but please know the work you all have done to date and will continue to do in the days, weeks and months ahead, will hopefully one day allow us to fully put Covid-19 behind us and better prepare us for future challenges.”
Meanwhile, Paul Offit, a member of FDA’s vaccine advisory committee, stated of the booster plan that it was “the administration’s booster plan; it wasn’t the FDA’s booster plan. The administration has kind of backed themselves up against the wall a little bit here.”
On Tuesday, a CNBC reporter asked Jeff Zients, White House Covid-19 response coordinator:
I’m hoping you can comments on these reports we’ve seen today confirming that two of the top regulator in the vaccine unit there are retiring in October and November, Marion Gruber and Phil Krause. A number of organizations are reporting in part that they are resigning because the FDA hasn’t been as involved in the booster discussion, that CDC in some ways is front-running them and in some ways the White House is front-running it. … Are you concerned, in general, about these resignations affecting trust in the FDA and the vaccine process and also about the ability for the FDA to quickly review vaccines for kids, especially as the review for kids is coming up around that time?”
Zients answered:
“As the president said last week, FDA is the gold standard and we are all grateful for the tireless work of the senior team and the whole staff at FDA, especially during the pandemic,” Zients replied, then defended Woodcock and Marks, saying, “The FDA has strong leadership in Dr. Woodcock and Dr. Peter Marks at the Center for Biologics Evaluation and Research and their critical work continues as we work to get safe and effective vaccines to the American people. The booster decision, which you reference, as we’ve talked about, that decision was made by and announced by the nation’s leading public health officials, including Dr. Walensky, Dr. Fauci, Surgeon General Vivek Murthy, Dr. Janet Woodcock —the acting FDA commissioner —Dr. Francis Collins, Dr. Kessler and others. And as our medical experts laid out, having reviewed all the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.
He added, “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 the latest data and expert clinical judgments from the team to give them time to make their own planning. We have been also very clear throughout that this is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommendation.”