Now we’re getting somewhere

Even as COVID-19 cases, hospitalizations, and deaths have soared to record levels, there’s been an unmistakable ray of hope: the results from clinical trials of several candidate vaccines. Two of them, those produced by Pfizer/BioNTech and Moderna, have reported efficacy rates in the region of 95%, while Oxford/AstraZeneca’s reported positive findings have been mired in controversy.

Today the first of those vaccines, Pfizer/BioNTech’s, was reviewed by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). I had the opportunity to address the VRBPAC meeting; you can read my testimony here.

My first point was that, although the product demonstrated a striking degree of efficacy in preventing confirmed COVID-19, there was a notable rate of minor adverse events. These included injection site reactions, fatigue, and headache, all in over 50% of subjects, and chills in almost a third, all substantially elevated compared to rates in the placebo group. I do not believe that these events should stand between this product and authorization, but I do think the rates of these events are sufficiently elevated to merit open and even-handed discussion with patients to maintain trust in the vaccination effort. 

My second point addressed whether those in the placebo group in the trial need to receive the vaccine. I argued that no subject who has put their body on the line in a vaccine study should be at a disadvantage in terms of vaccine access as a result of their participation. I believe we can facilitate the collection of essential safety and effectiveness data while honoring the contributions of the tens of thousands of people whose altruistic efforts have brought us to where we are today.

Expect FDA to issue a so-called Emergency Use Authorization in a hurry (likely days from now) and vaccination to start shortly thereafter. But limitations in vaccine supply mean that it will be many months before everyone is vaccinated, starting with those at highest risk. In the meantime, wear your masks and keep your distance.