The Second Covid Booster and the FDA’s ‘Emergency’

What level of vaccination provides adequate protection? 

Letter to WSJ.

"In “FDA Shuts Out Its Own Experts in Authorizing Another Booster” (op-ed, April 4), Marty Makary focuses on the wrong question. He chastises the Food and Drug Administration for not holding an advisory committee on this emergency-use authorization, but there was no need to hold one.

There’s no value in convening an expert panel when the facts are clear: A second booster safely increases Covid-19 antibody count in higher-risk cohorts (age 50+, immunocompromised, some pre-existing conditions). No need for outside advice when the data speaks so plainly.

The more important question is: What are sufficient antibody levels? We don’t know. More antibodies are better than fewer, but that’s not an answer. A second booster is a new tool in our pandemic arsenal, but we lack the knowledge to use it with finesse.

The FDA’s emergency-use authorization also raises the question: What’s the emergency? With both infection and hospitalization rates low, should we be scaring people into a second booster when we don’t know what “adequately protected” means?

Peter J. Pitts

New York

Mr. Pitts is president of the Center for Medicine in the Public Interest. A former FDA associate commissioner, he led the FDA’s Office for Advisory Committee Oversight."