Should FDA run or walk to J&J COVID-19 booster decision?

An FDA advisory committee’s recommendations and the agency’s decisions about authorization of a booster dose of J&J’s COVID-19 vaccine will hinge on their views about the purpose of vaccines, as well as their comfort with data that FDA has not independently reviewed.

Two questions are embedded in the briefing document FDA prepared for the Oct. 15 meeting of its Vaccines and Related Biological Products advisory committee. Should COVID-19 vaccines be expected to prevent infection or is their primary purpose preventing severe disease? Is the COVID-19 situation so urgent in the U.S. that decisions should be made in the absence of FDA’s independent review of the data?...