“Speculation about the FDA approving a vaccine under political pressure “only undermines confidence in the public health system,” Caputo said in a statement. “I’ve never met one FDA regulator who wouldn’t resign over improper pressure, and that’s how America knows their seal of approval is the gold standard.”
“In a letter sent to agency staff and obtained by BioPharma Dive, Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said both plan to step down from the FDA within the next two months. Gruber, an FDA veteran for three decades and the head of its vaccine review office, will retire on Oct. 31. Krause, the vaccine team’s deputy director, will leave the agency in November, Marks said.”
Aftermath featured in Politico:
“Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.
The tension within the administration plus open skepticism from outside experts has fueled finger-pointing and divisions among health agencies. Career scientists in particular have been confused and surprised by the process…”