The FDA Did the Right Thing in Pausing the J&J Vaccine


Covid Army Medic

Army medics fill syringes with the Johnson & Johnson Covid-19 vaccine at a vaccination site in Orlando, Fla. (Paul Hennessy / SOPA Images/Sipa USA)

After more than a year of Covid, everyone on Twitter is an epidemiologist now. Ever since the news broke early Tuesday that the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended that states “pause” their Johnson and Johnson vaccine efforts because of evidence that six women between the ages of 18 and 48 had experienced rare blood clots after being vaccinated (one died and another is in critical condition), social media has been swarmed by folks with no medical background who are nonetheless convinced the federal agencies are making a horrible public health mistake. Admittedly, six clotting episodes out of more than 6 million doses delivered looks like a literal one in a million risk. And that made it easy for some would-be experts to proclaim that the regulators are wrong.

As he tends to do, data journalist Nate Silver cannonballed into the deep end of the pool, with no doubt there to muffle his big splash:

Silver had a lot of company, though not everyone’s reply was as one-dimensional. Ezra Klein of The New York Times at least nodded to the very real dilemma that regulators faced: If they got the J&J decision wrong, “trust could collapse in all the vaccines, and in future vaccines.” But Klein still concluded that the decision to pause vaccinations was the bigger risk, and suggested that the agencies might have considered alternatives like “since the clots were all in women, use J&J for men, and Pfizer/Moderna for women.” It’s not a crazy idea; it might be the plan going forward.

But all the Twitter epidemiologists are substituting their own (comparatively uninformed) opinions for those of the scientists and policy-makers in charge of making these decisions. Vaccine hesitancy is a very real obstacle to a full social recovery from Covid. Perhaps, as a woman, I have more innate concern and curiosity about what the clotting might mean, especially in younger women, mostly of child-bearing age, at comparatively lower risk for Covid in the first place. The type of blood clots reported to date are rare, dangerous, and actually worsened when treated the way more common clots are. Researchers need time to sort through the medical evidence and publicize the right response. (This is an excellent thread by a doctor.)

We don’t know anything about the race, ethnicity or health status of the women who’ve been afflicted; those data points could be important. Given the history of medical research ignoring differences between men and women’s bodies, as well as racial differences—not to mention actively experimenting on Black patients to their own detriment—it’s important to get this right. Get the data right, and get the messaging right as well.



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