Three Takeaways From Major FDA Advisory Meeting On Covid-19 Vaccines

Yesterday a panel of outside experts — formally known as the Vaccines and Related Biological Products Advisory Committee — and laypeople convened to advise the U.S. Food and Drug Administration (FDA) on how to make the approval process for Covid-19 vaccines safer, more robust, and deserving of public trust. One thing became clear over the course of the seven-hour meeting — that a hastily expedited vaccine might benefit some people, but fail those who need protection most.

The primary objective of the ongoing late-stage vaccine trials, which have involved hundreds of thousands around the world, is to prevent the onset of Covid-19 symptoms in half of everyone vaccinated. What we really need from a vaccine, however, isn’t a broad reduction in mild cases, but mitigation of serious illness and death. The probing of the advisory committee, as well as presentations that featured insights and concerns from everyday folks, raised issues with the current regulatory framework that are threefold: efficacy, safety, and access.

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Originally published on Forbes (October 23, 2020)

© William A. Haseltine, PhD. All Rights Reserved.