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FDA sharply limits use of Johnson & Johnson shot due to rare blood clots

Regulators say the concerns are not new — but are persistent — and that other coronavirus vaccines are safer

The Food and Drug Administration limited use of the Johnson & Johnson coronavirus vaccine to people who are not able to take other vaccines because of a rare, life-threatening side effect. (Ethan Miller/Getty Images)
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The Food and Drug Administration imposed new restrictions Thursday on the Johnson & Johnson coronavirus vaccine, saying the risk of a rare and life-threatening blood clot syndrome outweighed the benefits of the vaccine for people who are 18 or older and can get another shot, unless they would otherwise remain unvaccinated.

The FDA said only people who are unable to receive other vaccines because they are not accessible or clinically appropriate, or because individuals refused to get a different vaccine, should receive the Johnson & Johnson shot.

The Johnson & Johnson vaccine has been associated with a rare but potentially deadly blood clotting and bleeding syndrome called thrombosis with thrombocytopenia syndrome, or TTS. The condition usually occurs within one to two weeks of vaccination, and a commonly used treatment to address clotting, heparin, can cause additional harm.

“This is not a new safety signal — it is based on updated information showing that it is a persistent safety signal,” Peter Marks, the FDA’s top vaccine official, said in an interview. He said other, safer vaccines that can be used to inoculate people against the coronavirus.

Centers for Disease Control and Prevention officials in December already recommended that other vaccines should be used instead of the Johnson & Johnson shot, but an additional analysis persuaded the FDA to make major changes to the vaccine’s emergency use authorization, which stipulates how the shot can be used.

About 18.7 million doses of the Johnson & Johnson vaccine have been administered in the United States, compared with 340.6 million of the Pfizer-BioNTech shots and 217.5 million Moderna shots.

The Johnson & Johnson vaccine was authorized in February 2021, a one-shot vaccine that proponents hoped would ease the logistics of vaccination campaigns globally. The vaccine was somewhat less effective in its clinical trial than the messenger RNA vaccines authorized in 2020, and instantly became the butt of jokes and memes portraying it as a lesser vaccine.

Public health officials attempted to convey the message that the vaccines were all valuable and touted the benefits of a one-shot regimen. But Johnson & Johnson shots were paused in April 2021 as federal health officials investigated reports of the rare but concerning blood clotting syndrome. The vaccine campaign was restarted, but manufacturing and supply problems also slowed the rollout.

An updated analysis of safety data through March 18 found that there have been 60 confirmed cases of the blood-clotting syndrome, including nine that resulted in death. Even with quick treatment, vaccine recipients can rapidly worsen, with long-term health consequences.

The FDA said there were 3.23 cases of the clotting syndrome per million doses of vaccine administered and 0.48 deaths per million doses of vaccine administered.

“That is not what we expect from our prophylactic vaccines in the United States,” said Marks, director of the FDA’s Center for Biologics Evaluation and Research.

In a statement, Johnson & Johnson emphasized that this was not a new risk “and does not reflect a change in the rate of cases observed.” It added that “data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”

Marks said regulators had hoped they could find a “mitigation strategy” — a way to determine who was most likely to have the rare blood clots after the vaccine, and to avoid giving them the shot. “But that has not happened,” Marks said. The only pattern that has been found is that the complication seems much less likely to occur in people 65 and older, he said.

Marks added that the FDA’s action should not be a source of concern for people who previously received the vaccine.

“This is a complication that occurs within a week or two, at most three weeks,” Marks said.

People who could still consider the shot include those who have an anaphylactic reaction to messenger RNA vaccines, or people who would otherwise not be vaccinated.

As part of its action, the FDA updated its fact sheets for health-care providers and for vaccine recipients and caregivers.

The agency said in its fact sheet for health-care providers that about 15 percent of the blood clot cases have been fatal.

“Cases of TTS following administration of the [Johnson & Johnson] COVID-19 Vaccine have been reported in males and females, in a wide age range of individuals 18 years and older, with the highest reporting rate (approximately 8 cases per 1,000,000 doses administered) in females ages 30-49 years,” the FDA said.

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