Dr. Marion Gruber, director of the FDA’s vaccines office, will quit at the end of October, and her deputy, Dr. Philip Krause, will leave in November because the White House has overstepped its mark by pressing ahead with what they deem to be an unscientific Covid-19 booster jab campaign.
The pair have accused the White House and CDC of pushing booster shots without supporting data, and are said to be frustrated that the CDC and their ACIP committee are involved in decisions that they think should be up to the Food and Drig Administration (FDA).
Marion Gruber is the director of the FDA’s Office of Vaccines Research & Review and has been with the agency for 32 years, whilst OVRR deputy director Phil Krause, has been at the FDA for more than a decade.
FDA’s former acting chief scientist Luciana Borio said on Twitter that the “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”
The Director of Centre for Biologics Evaluation and Research sent a letter to FDA staff confirming the resignations in which he wrote that “It is with mixed feelings that I have the news of two retirements… Our search for the next office director will begin imminently”.
When asked about the departures during a briefing, White House COVID Response Team Coordinator Jeff Zients did not directly answer whether he was concerned the departures could affect the level of trust in the FDA’s process.
Zients said the White House was “grateful for the tireless work of the senior team and the whole staff at FDA”.
A source familiar with the situation at the FDA told CNN there have been frustrations within the agency when it comes to vaccines.
According to the source, one issue centers around concerns that the CDC and its advisory committee have swerved into the FDA’s lane when it comes to vaccines.
However, the largest issue seems to be that by setting a goal for boosters, the “White House is getting ahead of where the science is and prejudging what the FDA would say.”
Members of the CDC’s ACIP during a meeting Monday also voiced frustration with the Biden administration’s plan to begin rolling out Covid-19 vaccine boosters next month, arguing the announcement got ahead of federal regulators and could exacerbate vaccine hesitancy.
A presentation by Dr. Sara Oliver suggested the panel may limit its initial endorsement of extra shots to vulnerable groups and healthcare workers.
“That kind of opened the door to a lot of confusion,” said Dr. Sandra Adamson Fryhofer of the American Medical Association during the panel’s discussion of booster doses.
“Many, many, many” hospitals across the South have already begun administering third doses to their healthcare workers amid an explosion of Covid-19 cases linked to the Delta variant, said Helen Keipp Talbot, an ACIP committee member and associate professor of medicine at Vanderbilt University.
“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,” Talbot said, adding that those providers have “now put themselves at risk” by immunising individuals outside FDA and CDC recommendations.
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