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FDA taps senior official as acting vaccine director

By Brian Buntz | September 28, 2021

FDAAfter two senior FDA officials announced their intent to retire, CBER director Dr. Peter Marks will take the reins of the agency’s Office of Vaccines Research and Review.

Marks assumed the role of acting director of the office on Monday.

The departing officials, director of the FDA’s Office of Vaccines Research and Review Dr. Marion Gruber and deputy director Dr. Phil Krause, plan on leaving in October and November, respectively.

In an internal memo dated September 27 obtained by Endpoints News, Marks wrote that he would be “assuming responsibilities as the Acting Office Director, and Marion [Gruber] will transition oversight and management of the activities of the office to me.” The move  “will allow Marion and Phil time to transfer their activities and take care of close-out activities prior to departing and help to assure a smooth transition.”

Peter Marks

Dr. Peter Marks

The two officials had questioned the federal government’s plan to endorse COVID-19 booster shots for the broader public with what they perceived as insufficient evidence. In addition, Gruber and Krause had co-written a Lancet article questioning the immediate need for boosters for most people.

Gruber was the signatory authority for an amendment to the emergency use authorization for the Pfizer-BioNTech vaccine that allowed its use as a booster in some individuals.

FDA is currently gearing up to decide whether to make the Pfizer-BioNTech vaccine available to children between the ages of five and 11.

Marks was involved in establishing Operation Warp Speed, the Trump-era program designed to accelerate the development of COVID-19 vaccines and therapeutics. He, however, left the program in May 2020.


Filed Under: Infectious Disease
Tagged With: FDA, Marion Gruber, Peter Marks, Phil Krause
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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