Prasad, Makary, and An Evidence-Based Approach to Covid-19 Vaccination

When I joined Vinay Prasad,

John Mandrola

, Marty Makary, and Zubin Demania to launch Sensible Medicine as a shared Substack in the summer of 2022, I would not have guessed I’d eventually be writing about decisions two of those doctors would be making at the FDA.

As John and I wrote a couple of weeks ago, we are excited to see what Vinay will do as the Director of the Center for Biologics Evaluation and Research at the FDA. I am optimistic about what Vinay will accomplish the FDA given what I have seen from him over the 17 years I have known him. During the time we have collaborated, I have gotten a sense of his rigorous and knowledgable approach to data, on how hard he works, and what he is like personally — beyond his social media persona.

My optimism is tempered by many of the opinions and statements from RFK Jr. Jeffrey Flier did a perfect job of articulating my concerns about the HHS secretary in a November column in The Free Press.

With that background, I was happy to read Drs. Prasad and Makary’s article yesterday in the NEJM, An Evidence-Based Approach to Covid-19 Vaccination — please give it a read if you have not already. The article takes a sensible, transparent, and evidence based approach to future COVID vaccine policy. The plan sets a low bar for COVID vaccine approval for high risk patients and a high(er) one for low risk patients. The policy suggests better alignment with our European peers.

The article identifies our knowledge deficits and lays out the type of studies, including the primary and secondary endpoints, that are needed to answer important questions (and receive FDA approval) for COVID vaccines. It is also a quite “lenient” approach, with approval granted for patients with a wide range of risk factors (reading the article, it really seems like anyone who desperately wanted a shot could get one).

Because COVID policy with never be apolitical, the immediate criticisms of the article and policy are those to be expected. The New York Times article was titled F.D.A. Poised to Restrict Access to Covid Vaccines — a true statement but one with unnecessary negative connotations. The reaction that I have heard and read from many was echoed in the Times’ article by Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University: “This is overly restrictive and will deny many people who want to be vaccinated a vaccine.”

Medicine should offer care that people need, not care that people want. The release of the COVID vaccine in the fall of 2020, supported by robust clinical trial data, was one of the great successes of medicine I witnessed during my career. For the last few years, though, I have had a harder and harder time recommending the vaccine to my younger, healthier patients as I have little understanding of its benefit.

While I still have concerns about much of the messaging coming from HHS, this statement is one I celebrate.