Public health experts want rigorous FDA review of Covid vaccine data

David Lim, Politico: August 7, 2020

Nearly 400 public health experts are calling on the Trump administration to allow the distribution of a future coronavirus vaccine only after the FDA is able to evaluate safety and effectiveness data from completed Phase 3 trials.

The Thursday letter to FDA Commissioner Stephen Hahn argues public meetings of the agency’s vaccine advisory committee are necessary to ensure public confidence in a vaccine.

“Some long-standing concerns about vaccine safety in general have no scientific foundation,” the letter states. “However, more than 60% of US voters prefer that a COVID-19 vaccine be thoroughly evaluated before it is made available, even if doing so delays its roll-out. A particular concern applies to communities of color, where historical medical inequities are also likely to reduce vaccine uptake.”

Signatories include Luciana Borio, former director for Medical and Biodefense Preparedness at the National Security Council; former Baltimore Health Commissioner Leana Wen; and National Center for Health Research President Diana Zuckerman.

Another expert who signed the letter, Paul Offit, told Zach that FDA’s advisory committee of outside experts on vaccines should be consulted on whether to give emergency authorization to or approve any coronavirus vaccines. The panel, which normally evaluates the data from late-stage vaccine trials, is rumored to be meeting in late October.

Offit, who directs the Vaccine Education Center at the Children’s Hospital of Philadelphia, expects that FDA will first give emergency authorization to any effective vaccine, rather than approval — “which is fine as long they’re vetted and have adequate data.”

A promising result from a late-stage trial of 30,000 people would be for just 5 people who received the vaccine to catch the virus, compared to 150-200 people in the placebo group, he said. Offit added that he doesn’t expect any coronavirus vaccines to be ready for widespread use early next year.

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