By Dan Levine and Julie Steenhuysen
(Reuters) - The U.S. Food and Drug Administration has named Vinay Prasad, an oncologist who has previously criticized the FDA and was a fierce critic of COVID-19 vaccine and mask mandates, as the director of its Center for Biologics Evaluation and Research, an internal email seen by Reuters on Tuesday said.
In that role, Prasad will oversee the regulation of vaccines, gene therapies, and blood supply. He succeeds Peter Marks, who oversaw the approval of COVID-19 vaccines and was pushed out of the agency in March.
In a recent blog post on the Substack platform, Prasad said that the CDC "should ABSOLUTELY remove COVID-19 from the Childhood Immunization schedule. If it stays, it shows the United States is a corrupt country," citing the lack of randomized trial evidence for use of the vaccines in children.
The FDA’s commissioner, Marty Makary, announced Prasad’s appointment in an email to staff.
“He brings a great set of skills, energy, and competence to the FDA, and I know that he is eager to begin immersing himself in the important work of CBER and the agency as a whole,” Makary wrote.
Shares of vaccine-focused Moderna (NASDAQ:MRNA) fell about 10% after the appointment, while Pfizer (NYSE:PFE)’s shares fell 3%. Smaller gene therapy developers such as Sarepta Therapeutics (NASDAQ:SRPT) and Taysha Gene Therapies plunged about 20%.
Scott Steele, an FDA insider for the past five years, had been serving as acting head of CBER.
Prasad comes to the FDA from the University of California, San Francisco. He holds a medical degree from the University of Chicago, and has had stints at the National Cancer Institute and the National Institutes of Health.