Photo: Joseph Prezioso/AFP via Getty Images On Tuesday, the FDA and CDC recommended pausing the administration of the Johnson & Johnson COVID vaccine while the agencies investigate an extremely rare possible side effect. Six women in the U.S. who received the J&J vaccine — all between the ages of 18 and 28 — experienced a blood- clotting disorder called cerebral venous sinus thrombosis in the days after getting their shots, and one has died.
James Hamblin, a doctor and journalist who is a colleague of Wu’s, said in a tweet on Tuesday, “Pausing vaccination to look into a possible one in a million side effect may scare people. It could just as easily be seen as reassuring, proof that close attention is being paid to, and extremely high priority put on, vaccine safety.”
He added that the regulators’ decision to pause the J&J vaccine “should drastically improve our faith in the public health institutions tasked with protecting us. With how they had been politicized and over-ruled by the previous admin, this is critical. And that’s exactly why I think today’s decision was the right one.”
Johns Hopkins’s Tinglong Dai, who has been studying management-and-operations issues during the COVID-vaccine rollout, made a similar point in a Twitter thread, noting that because the U.S. is in an “enviable supply position” and J&J’s vaccine made up only a tiny fraction of the doses being administered and is now experiencing manufacturing disruptions, “it’s an okay timing [for the FDA] to pause and look into what’s going on.
COVID-19 vaccines confer massive protection from hospitalization and death from COVID-19, not to mention protection from persistent symptoms that have dogged upwards of a third of people afflicted with COVID-19. These benefits come at the cost of common side effects like sore arm, low-grade fevers, achy muscles and fatigue, as well as extremely rare toxicities like blood clots arising from the auto-immune generation of antibodies that activate platelets.Scientific transparency is similar.
But epidemiologist Caitlin Rivers added that the numbers may look different in the end: “One in a million will not be the final estimate for the unconfirmed J&J events, and I think we should be cautious in citing it.”
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