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The dialogue centers on the FDA’s decision to limit access to COVID-19 boosters to people 65 and older or those at high risk, and the rationale behind that stance.
The first speaker notes surprise at the FDA announcement, which they interpret as restricting individual choice by narrowing booster eligibility. They ask for clarification on why the decision was made and why boosters might no longer be available to those who believe they would help.
The second speaker explains there has been no randomized controlled trial for four to five years, so the appropriate number of boosters for a healthy American is unknown. They pose questions: should booster frequency be like the two-dose pattern of the MMR vaccine, like the two or three doses for HPV or hepatitis B, or could it be as high as 80 boosters over a healthy person’s lifespan? They state that the theory of a repeated booster strategy for healthy individuals lacks supporting data. Their job, they say, is to require clinical trial data before approving a COVID vaccine for younger, healthy Americans, noting this population differs from five years ago due to ubiquitous population-based immunity, a different circulating virus, and a vaccine formulation that introduces a new protein in the body. They ask whether it makes sense to “blindly rubber stamp” a vaccine that creates a new protein every year for the rest of a person’s life, implying skepticism about perpetual annual vaccination for the next century. Consequently, they published a framework in The New England Journal of Medicine for “sensible COVID vaccine booster regulation in The United States” that uses an age-stratified approach and positions the U.S. as “catching up with the rest of the world.”
They claim part of the motivation is alignment with international practices: the UK recommends boosters for those 60, 75 and high risk, and France for 80 and high risk. They argue against pushing boosters on healthy six-year-old girls annually without evidence. They reference the framework’s reception from vaccine manufacturers, noting they issued positive statements because they like predictability.