Vaccine Advisory Cmte. Will Expose Wide Audience To Uncertainties of Drug Development

 
• By Sarah Karlin-Smith

Meetings have long been touted as a tool to boost public confidence in COVID vaccines, but those looking for clean-cut answers may be unsettled to learn about the unknowns that come with all drug development, particularly that done at speed. Advisors are there to offer an ‘unvarnished’ view, committee member Paul Offit says in an interview with the Pink Sheet in advance of the the VBRAC’s 22 October meeting.

It’s not particularly unusual to spend eight-hours listening to a US Food and Drug Administration advisory committee poke hole after hole in a sponsor’s data, and then do a bit of a double-take when at the end of the day the majority of the committee votes in favor of the product’s risk-benefit profile.

At first glance it can be a little perplexing, but long-time FDA watchers know that in the world of drug...

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