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Tags: robert whitley | dsmb | vaccine | candidates | gilead

Secret Board Will Decide on COVID-19 Vaccine

gilead sign outside hq building
Gilead Sciences headquarters sign is seen in Foster City, California on April 30, 2020. (Josh Edelson/Getty Images)

By    |   Thursday, 24 September 2020 11:02 AM EDT

A secret group of more than a dozen experts is in charge of vetting and approving a coronavirus vaccine — or vaccines — for the American public to use.

According to NBC News, the data and safety monitoring board, or DSMB, is led by pediatric infectious disease expert Dr. Richard Whitley, who was appointed by Dr. Anthony Fauci — the director of the National Institute of Allergy and Infectious Diseases, or NIAID.

The DSMB will review each vaccine candidate's safety and efficacy before deciding whether to allow it to enter the U.S. market. The group also is able to order a clinical trial of a drug vaccine or stop one. Experts told NBC the reason why the members' identities are kept secret is to prevent them from being lobbied by companies seeking approval for their drugs and vaccines.

The DSMB put together for the COVID-19 vaccine is made up of between 10 and 15 experts and is working under the guidance of the NIAID, which is under the larger umbrella of the National Institutes of Health.

NIH Director Francis Collins told reporters, "Until they are convinced that there's something there that looks promising, nothing is unblinded and sent to the FDA [Food and Drug Administration]. I doubt if there have been very many vaccine trials ever that have been subjected to this size of the trial and the rigor with which it's being evaluated."

There are concerns, however, about the impartiality of the group members. NBC reported that in 2019, Whitley earned about $430,000 as a board member at Gilead Sciences, which manufactures coronavirus treatment drug remdesivir. He also received nearly $8,000 that year from GlaxoSmithKline, which is working on a coronavirus vaccine.

"We want to know they're truly independent," Scripps Research Translational Institute Director Dr. Eric Topol told NBC. "The lack of transparency is exasperating."

Multiple clinical trials for coronavirus vaccine candidates are underway in the U.S., and President Donald Trump has predicted that a vaccine could be ready for use before the Nov. 3 election. Trump is emphasizing speed in the vaccine race, while some officials at the Centers for Disease Control and Prevention, the FDA, and elsewhere have tapped the brakes and have cautioned about rushing the development process.

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A secret group of more than a dozen experts is in charge of vetting and approving a coronavirus vaccine - or vaccines - for the American public to use. According to NBC News, the data and safety monitoring board, or DSMB, is led by pediatric infectious disease expert...
robert whitley, dsmb, vaccine, candidates, gilead
370
2020-02-24
Thursday, 24 September 2020 11:02 AM
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