Throughout the pandemic, the FDA has struggled to maintain a modicum of independence and respectability. It’s made mistakes—like issuing an Emergency Use Authorization for hydroxychloroquine. But it it’s also done the right thing in several situations—like revoking the Emergency Use Authorization for hydroxychloroquine.
With the first vaccine on the cusp of availability, the agency has worked especially hard to demonstrate its thoroughness and concern for public safety. In addition to performing an internal review, it has recruited a panel of outside experts and invited public comment. On Thursday, those experts voted to recommend approval of the vaccine from Pfizer for use with Americans above 16 years of age. The FDA itself has been going through the final steps to make that vaccine available, including preparing the instructions for those administering the vaccine and cautions for potential patients. The agency was expected to issue an EUA no later than Saturday or Sunday, making the vaccine available to healthcare workers next week.
How do you destroy this careful planning and wreck any impression that the agency isn’t moving too quickly? Well, last-minute pressure from the White House forcing the FDA to issue an EUA immediately just might do it.
As The Washington Post reports, White House chief of staff Mark Meadows delivered an outright threat to FDA Commissioner Stephen Hahn on Friday telling him to either produce an EUA right away, or hand over his resignation. At the same time, Trump tweeted a series of accusations at the FDA, including calling it a “a big, old, slow turtle” and demanding that Hahn “get the dam vaccines out now.” Presumably Trump means “damn.” Because it seems unlikely the FDA is involved with vaccines for reservoirs.
As a result of these threats, the FDA appears to be rushing to get the EUA out by the end of day on Friday, rather than waiting for Saturday or Sunday. Not only does this damage the impression that the agency was taking a carefully measured approach, it also means that safety information will be prepared before an analysis of two cases of severe allergic reaction from vaccine recipients in the U.K. will not be available to inform U.S. documentation.
And when all is said and done, threatening the FDA commissioner and blowing up the end of a well-orchestrated process will make the vaccine available … not one day sooner. It will still move out on and begin being administered to healthcare workers on Monday. It will just do so with an extra dash of bullying, and another slap to a desperately needed agency.