Why the FDA’s COVID Vaccine Guidelines are Controversial

Ever since Vinay Prasad and Marty Makary published their intentions regarding COVID vaccine approvals in NEJM in May, I’ve thought quite a bit about the decision.¹ I’ve kept returning to their article because it raises so many important issues. I’ve also read, with great interest, comments from those who have spoken out in favor of the guidelines, those who lined up against it, and those who seemed to struggle with the recommendations. I’ve kept my mouth shut because I’m not an expert and don’t have terribly strong opinions on the issue.²

This week, as vaccine season approaches, the FDA’s decisions resurfaced in the news, and RFK Jr. reiterated VP and MM’s article in a tweet:

There were, predictably, hundreds of replies, but one by Jake Scott, an ID doctor at Stanford, did a nice job of summarizing the most common objections:

Let’s analyze these tweets and figure out the root of the disagreements.