The Food and Drug Administration put rigid limits on who can receive Johnson & Johnson’s one-dose COVID-19 vaccine on Thursday, saying the vaccine should only be given to people who cannot receive a different vaccine or those who specifically request it.
After the single-dose vaccine was authorized in February 2021, the FDA and Centers for Disease Control and Prevention temporarily paused administering the shot in April after reports of blood clots in a small number of people who received it. The pause was lifted 11 days later, with the health agencies determining the benefits of the J&J vaccine outweighed the risks.
But the FDA has reversed course, ruling the risks of the side effect, called thrombosis with thrombocytopenia syndrome, outweigh the benefits. The condition, also known as vaccine-induced thrombatic thrombocytopenia, is the combination of a blood clot with low platelet count. The blood clots form in unusual places, such as veins that drain blood from the brain.
Until late 2021, the U.S. had treated all three COVID-19 vaccines available to Americans – Pfizer, Moderna, and Johnson & Johnson – as an equal choice, since large studies found they all offered strong protection and early supplies were limited. But in December of last year, the CDC officially recommended the Pfizer and Moderna COVID vaccines over J&J’s.
Thursday’s decision goes one step further, formally limiting the vaccine’s use.
FDA vaccine chief Dr. Peter Marks said the agency made the decision after re-examining the data on the risks of life-threatening blood clots, concluding that they are limited to J&J’s vaccine.
“If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks said. “But we’ve been careful to say that — compared to no vaccine — this is still a better option.”
The problem occurs in the first two weeks after vaccination, he added: “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.”
Out of the about 17 million Americans who received the J&J shot, federal scientists had identified 60 cases of the side effect, including nine that were fatal, as of mid-March. That amounts to 3.23 blood clot cases per 1 million J&J shots. The problem is more common in women under 50, where the death rate was roughly 1 per million shots, according to Marks.
Following the FDA’s decision, the J&J vaccine will now carry the warning of potential “long-term and debilitating health consequences” of the side effect.
A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”
More than 200 million Americans have received Moderna’s and Pfizer’s two-dose shots, compared to J&J’s 17 million.
Contributing: Elizabeth Weise and Karen Weintraub, USA TODAY; The Associated Press