Although my career has mostly been focused on informatics, I have always considered evidence-based medicine (EBM) to be a part of, or at least overlapping with, informatics. Even though I gave up seeing patients almost two decades ago, I still enjoy maintaining a connection to medical practice through my interest in EBM.
It therefore makes an imperative for me to volunteer to participate in a randomized controlled trial (RCT) for a SARS-Co-V-2 vaccine. If I advocate for more use of RCTs to discern what works in medicine, thus requiring others to participate in RCTs, I should put my own proverbial money where my mouth is. As such, I have entered my name into the US government registry of people volunteering for one of the three major COVID-19 vaccine RCTs for vaccine candidates from ModernaTX, AstraZeneca, and BioNTech SE and Pfizer. Although each of the three trials will enroll about 30,000 people, apparently the number of people who have entered their names into the registry is much larger, so not everyone will get called to participate.
Not only do I feel a call to duty to take part, but I am probably a good candidate for one of the trials. Although I am in relatively good health without any of the underlying conditions that increase risk of death and complications from COVID-19, I am in the age group where the risk starts to climb. I am also one who is eager to move on from this pandemic and return to normal life.
If I am called to participate in a trial, it will not be completely risk-free. The main risk, of course, is that I could be among the half of participants who end up in the placebo group. But even if I am given an actual vaccine, there are some other risks. One might be that the vaccine leads to adverse effects, such as Guillian-Barre Syndrome. Another is that vaccines can sometimes cause paradoxical effects, such as antibody-dependent enhancement, where viruses leverage antibodies to aid infection, or cell-based enhancement, which leads to allergic inflammation. And finally, I could end up in an RCT of a vaccine that turns out to be less efficacious than the others being tested.
There are other risks of participation related to the politics of COVID-19, which are being driven by a desire to have a vaccine approved by Election Day. This could be dangerous not only for those who participate in the trials, with both benefits and harms may not become fully apparent with a shortened trial, but also to society at large, in not knowing the true efficacy of the vaccines, and not being able to best compare the different candidates.
Although I am most disturbed by the politics, I am still willing to take the risks of participating if I am called. Bring on the informed consent form! I do hope this pandemic will end and the world can return to some semblance of normal soon.
This article post first appeared on The Informatics Professor. Dr. Hersh is a frequent contributing expert to HealthIT Answers.