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The Johnson & Johnson vaccine has entered regulatory purgatory. This morning, the CDC and FDA jointly recommended, “out of an abundance of caution,” a nationwide halt to the single shot’s rollout. The two agencies are investigating a rare blood-clotting disorder: In the six cases reported so far, all in the United States, women ages 18 to 48 developed an unusual type of blood clot within about two weeks of receiving the company’s inoculation.
Experts haven’t yet conclusively determined whether J&J’s vaccine is directly causing these strange clots, or how frequently the condition might be occurring, because they’re relying largely on people reporting their health conditions to federal agencies. Roughly 7 million doses of the vaccine have been administered so far in the United States; among them were about 1 million women under the age of 50. “I think it’s reasonable to say it is a rare event, but I don’t think we should go into false precision in this kind of situation,” Saad Omer, a vaccine expert at Yale, told me. “Our numerators and denominators are still emerging.”
Though the pause isn’t mandatory, most states have decided to temporarily pull the J&J vaccine and replace it with shots made by Moderna and Pfizer-BioNTech—neither of which has been associated with clots—when possible. The announcement has, within a matter of hours, trapped past and future recipients of J&J’s jabs in an uneasy limbo.
Still, this particular in-between place has an exit, and the situation is in many respects more reassuring than not. I talked with 12 people today, including one who had recently received the J&J shot and several others who had originally intended to. They all struck a similar note: The pause is a reflection, they told me, of federal regulation in action—responding to even the tiniest hint of a safety issue, in case it blossoms into something serious. In similar situations, other vaccines have been subject to the same scrutiny; it’s not that uncommon for products to hit roadblocks after initial clearance.
“I’m somewhat concerned, but I’m not freaking out,” Omer said. With the right monitoring systems in place, investigations like this can and should happen, with transparency. “This is the system working as intended,” Natalie Dean, a biostatistician at the University of Florida who studies vaccine trials, told me. “We’re paying close attention to even these exceedingly rare outcomes.”
People who have already gotten the J&J vaccine absolutely shouldn’t panic, especially if more than a month has passed since they received their dose. So far, the incidents documented seem to be occurring with the first couple of weeks post-vaccination...
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