Kids Don't Need This Shot, That's Why We Resigned From FDA

Dr. Marion Gruber &  Dr. Philip Krause at the FDA resigned are about to go public,  

"kids don't need this shot, that's why we resigned" 

The two top virologists at the FDA that just resigned are about to go public, reports are they have said
"kids don't need this shot, that's why we resigned." Whoa!!

— Darla Shine (@DarlaShine) September 2, 2021

Top Food and Drug Administration officials resigned Tuesday over the Biden administration's announced plans to roll out COVID-19 booster shots before the agency had approved the inoculations. 

Dr. Marion Gruber, director of the FDA's Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, plan to leave the FDA within the next three months, BioCentury first reported. 

The FDA announced the resignations Tuesday.

An @US_FDA spokesperson confirms departure of @FDACBER's Dr. Marion Gruber and Dr. Phil Krause

Email from Dr. Peter Marks announcing the "two retirements" calls Dr. Gruber's departure "a huge loss" and thanks Dr. Krause for "incredible contributions to public health" https://t.co/Ko5KzfhZzc pic.twitter.com/e5aolUwQ6v

— Alexander Tin (@Alexander_Tin) August 31, 2021

Two top vaccine regulators have resigned from the Food and Drug Administration, revealing anger, frustration, and turmoil at the federal agency as it faces intensifying pressure to authorize COVID-19 vaccine booster shots and doses for children under the age of 12. 

The two regulators leaving are Marion Gruber, director of the FDA’s Office of Vaccines Research and Review (OVRR), and OVRR Deputy Director Phil Krause. Gruber has been with the FDA for more than 30 years, and Krause has been at the agency for more than a decade.

Their resignations, first reported by pharmaceutical trade publication BioCentury, were apparently sparked by frustration that the Biden administration had overstepped the FDA in announcing plans to offer COVID-19 booster shots beginning on September 20. The pair also clashed with higher-up Peter Marks, who reportedly went along with the administration's plans. Marks is the director of the FDA's Center for Biologics Evaluation and Research (CBER), which includes the OVRR.

Marks announced the two resignations in a letter sent to FDA staff. Gruber's planned departure on October 31 is a "huge loss" for the agency, Marks wrote. Krause, who will depart in November, played a "key role in our interactions to address critical vaccine-related issues," he added. The letter was published in full by biopharmaceutical outlet Endpoints News.

Regulatory rebellion

As news spread of the high-profile resignations, current and former FDA regulators were quick to reveal growing tensions coming from some in the agency who see the Biden administration's booster plan as premature, unnecessary, and out of step with regulators' opinions. Politico, which spoke with 11 former and current health officials, described the situation at the FDA as a "potential mutiny" among agency staff and outside vaccine experts.

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