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Prasad has criticized COVID vaccine mandates, agency

leadership

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Biotech stocks fall, led by declines in Moderna ( MRNA ) shares

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Prasad to oversee regulation of biologic drugs, vaccines

(Adds details on Prasad's views in paragraphs 2, 4, comments

from analyst in paragraphs 5-6, physician comments in paragraph

11)

By Dan Levine and Julie Steenhuysen

May 6 (Reuters) - The U.S. Food and Drug Administration

has named Vinay Prasad, an oncologist who has previously

criticized FDA leadership and COVID-19 mandates, as the director

of its Center for Biologics Evaluation and Research, the agency

said on Tuesday.

In that role, Prasad, a frequent critic of the pharmaceutical

industry, will oversee the regulation of costly and complicated

biologic drugs, including 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.

Drug company stocks fell on the news, led by an 11% drop

in vaccine maker Moderna ( MRNA ) and a 20% fall in shares of

smaller gene therapy developers.

In a recent blog post on the Substack platform, Prasad said

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.

In another post, Prasad criticized media coverage of Marks'

departure and called him "one of the most dangerous, pro-pharma

regulators of the 21st century."

In a note to clients, RBC Capital Markets analyst Brian

Abrahams called Prasad an "anti-establishment physician" who has

been vocal on a broad range of matters, "including COVID-19,

oncology studies, and randomized clinical trial designs in

general."

Abrahams noted that Prasad has been particularly critical of

Marks' support of Sarepta Therapeutics' ( SRPT ) gene therapy

treatment for Duchenne muscular dystrophy.

Pfizer ( PFE ) shares fell 3%. Smaller gene therapy developers

such as Sarepta and Taysha Gene Therapies ( TSHA ) plunged about

20%.

A basket of biotech shares, the SPDR S&P biotech ETF,

fell 6%. It has fallen about 9% since Robert F. Kennedy Jr., a

vaccine critic, was confirmed as U.S. health secretary in

February.

Prasad is not without supporters, however.

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.

Walid Gellad, a physician from the University of Pittsburgh,

said Prasad is "a brilliant guy with remarkable experience

understanding evidence and data on drugs. He has a difficult

task ahead but an opportunity to bring those talents to

positively impact FDA and the American public."

Scott Steele 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.