2 FDA officials recuse themselves from COVID-19 vaccine approvals

Two FDA officials who were named as overseers of President Donald Trump's Operation Warp Speed will recuse themselves from the agency's considerations about approving COVID-19 vaccines, according to STAT.

Operation Warp Speed, the nation's endeavor to expedite development of COVID-19 treatments and vaccines, had Janet Woodcock, MD, and Peter Marks, MD, PhD, slated to head its efforts on therapeutics and vaccines. However, the involvement of two top FDA figures quickly elicited criticism from activists concerned about industry influence in the agency.

"It makes sense for FDA to work together with companies trying to develop a vaccine, to make sure the companies are gathering appropriate data for approval and to speed up the process as much as possible," Diana Zuckerman, PhD, president of the National Center for Health Research, told STAT. "But the FDA has repeatedly lowered its standards for getting tests and drugs on the market during the pandemic, and vaccines can do more harm than good if not tested adequately."

Dr. Woodcock and Dr. Marks recused themselves to reduce conflict-of-interest concerns, addressing dissenters arguing that the FDA's primary purpose is to critically assess drugs' safety and efficacy rather than advocate for their approval.

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