What Does the Retirement of Two Senior FDA Officials Mean for COVID-19 Vaccine Regulations?
Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.
In the fall of 2021, two of FDA’s vaccine regulators will be leaving, which may potentially impact COVID-19 vaccine regulations—including vaccine recommendations for children under the age of 12 and booster shots recommendations—according to an Aug. 31, 2021, article in The New York Times. In a Tuesday email to the staff cited in the same article, it was revealed that Marion Gruber, the director of FDA’s vaccines office, will retire in October. Philip Krause, Gruber’s deputy, will leave in November.
As stated in The New York Times article, their departure could have been in part due to the Biden administration encouraging adults to get a booster vaccine eight months after receiving their second shot. According to anonymous individuals close to the situation referenced in the article, Gruber and Krause believed there was not enough data to justify offering booster shots yet.
According to an Aug. 31, 2021 memo shared with The Washington Post, Peter Marks, director of the Center for Biologics Evaluation and Research, FDA, will be the acting head of the vaccine office while FDA searches for a replacement.
Sources: The New York Times, The Washington Post
Guidance on Quality Culture Standards
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