FDA releases COVID-19 vaccine guidelines despite White House opposition



Statement of CSPI president Dr. Peter G. Lurie

It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors. These appear to be similar to the guidelines that the White House wanted to keep under wraps so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.

The document released by FDA today isincluded in materials provided in advance of an October 22 meeting of the agency’s Vaccine and Related Biological Products Advisory Committee. Importantly, the guidelinesrequire manufacturers to collect a median of two months of data after the last injection in order to assess the safety of the candidate vaccine.

Even the pharmaceutical industry has beenclamoring for the release of these guidelines.We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later. But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.

Assuring that even a vaccine released under an Emergency Use Authorization has been adequately evaluated for safety is critical to build public and provider confidence in the product. FDA’s career employees are to be complimented for sticking with strong scientific standards despite overt political pressure.

Right now the administration has its hands full handling the White House outbreak that has resulted from its own negligence. For the sake of our health, I hope it stays miles away from the FDA’s vaccine review and leaves the science to the experts. The stakes are too high and its track record too poor.

Contact Info:  Contact Jeff Cronin (jcronin[at]cspinet.org) or Richard Adcock (radcock[at]cspinet.org).