• PublicHealthRising

Should I trust FDA on COVID vaccines?

After their handling of hydroxychloroquine, it’s a fair question. But they're on the right track.

Healthy skepticism and humility are key parts of science (and maybe would be good building blocks for regular life, too). Skepticism because good science depends on proof, and reproducibility of findings; and humility because most science is never “settled.” Although in some areas it seems pretty close (e.g. the earth orbits the sun, not the other way around), many scientific theories are ultimately superseded by new discoveries, new understanding, and new theories, resulting in reversals of medical and public health recommendations (e.g. remember when we used to recommend against peanuts for young children? That was the wrong idea).

Waiting for science to fully settle is not a good excuse for failing to take public health action when warranted. But it’s important to raise here since there is an entrenched dynamic in the U.S., especially when it comes to vaccines, where unhealthy skepticism may be countered by unhealthy over-confidence. Reasonable science acknowledges unknowns, accepts with humility that we can not fully predict the future, and asserts that with careful observation we can understand risks vs. benefits and implement sound, life-saving policies and practices. More to come on how that bears on our assessment of COVID vaccine safety, but for the moment let’s get ready for the FDA meetings that are coming up to review emergency use authorization (EUA) applications from Pfizer and Moderna for their new vaccines.

Skepticism of the FDA review process could be considered healthy. For example, the hydroxychloroquine debacle raises concerns. In brief: this drug, with no obvious clinical benefit for COVID but with known adverse effects, was granted an EUA until, months later, it was rescinded. There are other reasons to mistrust the FDA and other governmental public health agencies, and it’s more than the Tuskegee syphilis study. Distrust is reinforced by ongoing discrimination in our medical and public health systems, continuing today. Maternal mortality among black women is one example. Being black is not an intrinsic risk factor for dying in childbirth; it’s racism, not race that causes these disparities. And in the context of COVID, communities of color are carrying a greater burden of infection and death. There could be many reasons for this, but it certainly looks and feels like a pattern that has played out in medicine and public health in the United States over and over again.

This festering issue is going to require a lot of dedicated attention, and we’ll be circling back to this in future posts. For now, we would consider it a basic first step that the underlying science needs to be clear and reliable; if we aim to start restoring trust, we need to know that the information coming from our public health agencies is even worthy of starting this discussion. So, when it comes to the FDA and COVID vaccines: What is critically important is that the process looks very different from the steps used to grant an EUA for hydroxychloroquine (and please note, pharmaceuticals that receive FDA clearance -- a full license, not an EUA -- undergo much more thorough review. Don’t stop taking your FDA-cleared treatment for hepatitis C or anything like that). Take a look at the figure below, which provides a rough comparison of how the FDA approaches things like hydroxychloroquine, compared to the approach for COVID vaccine review. Vaccines: more steps, more transparency, more votes from independent commission members. And more post-EUA monitoring, which will be a key point we’ll return to in upcoming posts.

A better process means we’ll have enough information to ask the right questions, challenge assumptions, and determine if the risk vs. benefit calculations look reasonable. We’ll have to wait and see how the discussions and decisions land, but we’re confident that the information coming out of the FDA EUA review process will be good enough to discuss what we know, and what we don’t know, and to make the right call about getting immunized.

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