I have no doubt that officials at the Food and Drug Administration and the Centers for Disease Control and Prevention agonized over the decision to halt administration of a highly effective and lifesaving vaccine. Still, I think it was the right choice. Medical professionals’ highest obligation is to avoid knowingly inflicting harm on patients. This pause is as much about maintaining public trust as it is about individual harm vs. potential benefit. Emerging data on the Johnson & Johnson vaccine was concerning enough to necessitate pausing and closer study.
So far, the data appears to indicate that six women have experienced “extremely rare” blood clots. While general concern is warranted about this vaccine, this pause should actually instill confidence among Americans that the safety monitoring process is working as it should. There is no drug for which all of the possible safety issues are known before authorization or approval. If a complication has an incidence of 1 in 1 million people, the complication may not become statistically detectable until several million people have received the therapy. Even then, it would become visible only if robust reporting and review systems are in place. That is exactly why the FDA reviews drug data for many years after initial approval. The covid-19 vaccine trials and approval process are working as they should, and now we have evidence that the monitoring process is functioning appropriately.
This is a moment to keep in mind that every medical treatment has risks as well as benefits. One can experience negative side effects from treatments as common as Tylenol (overdoses from which kill one to two people every day) or ibuprofen. With more than 6 million Americans having received the Johnson & Johnson vaccine so far, the risk of blood clots — if proved — appears to be less than 1 in 1 million. For perspective, the risk of blood clots from smoking is about 1 in 600; from birth control, it’s 1 in 1,000; and from covid-19, it’s 1 in 7 — all far greater. With further investigation, it might become clear that the women who developed the rare blood clots had a particular risk factor in common or that some other as-yet-unknown risk factor is present.
Here’s another thing to consider: More than 560,000 Americans have died of covid-19. That puts the risk of fatality from the virus around 1 in 600. You’re not worried about covid because you don’t consider yourself high-risk? The risk of dying from covid if you are younger than 40 is about 1 in 40,000 — still far greater than the potential 1-in-1-million chance of a blood clot.
Even if the Johnson & Johnson vaccine is proven to increase the risk of blood clots among some recipients, people should keep in mind that this vaccine has a different formulation than the Pfizer and Moderna vaccines. Those new types of mRNA vaccines have been given to exponentially more people, and no higher incidence of clots has been noted among recipients. Those worried that Tuesday’s “pause” signals something about all covid vaccines are wrong. We shouldn’t throw the baby out with the bath water: We still have two highly effective and safe vaccines to help us beat back covid, plus variants, and facilitate reopening.
As a practicing anesthesiologist, I regularly discuss consent with patients for surgery. I tell my patients that everything medical professionals do has the potential to harm them under certain circumstances but that the treatments we offer can also relieve suffering and perhaps save their lives. I explain the risks but also the benefits of proceeding. I also tell them what I’d choose or recommend if I or a loved one were making the choice.
I’m a scientist and a doctor. I followed the vaccine trials closely, and I decided to get vaccinated. If I had to choose again, I’d make the same decision. While we absolutely must review the data and find out whether certain people are at greater risk with the Johnson & Johnson vaccine, I’d still advise family members who weren’t already at increased risk for clots to take the Johnson & Johnson vaccine if it were the only one available to them.
Americans make many choices every day that carry a far greater risk. Among the greatest of those risks is the harm that comes from failing to protect ourselves from covid.