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WASHINGTON– In yet another obstacle for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its use to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety concerns.

The agency stated 60 cases of a severe but uncommon blood-clotting condition have been recognized, including 9 deaths, out of about 18 million doses administered. The action happens 5 months after the Centers for Disease Control and Prevention advised Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the dangers of Johnson & & Johnson’s vaccine against the benefits, it had actually chosen to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically proper.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the firm said.

It stated the vaccine could also be offered to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those business are both safer and more efficient. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk of the adverse effects, not brand-new information on the rate at which it takes place. In a sign of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.

Reports that the vaccine can set off a condition referred to as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities stopped briefly circulation of the vaccine for a security assessment. Regulators raised the time out 10 days later but included an alerting to instructions for its use.

In December, the C.D.C. suggested that adults seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower threats. Paired with a host of producing troubles in the United States, some experts stated, the agency’s judgment highlighted that the federal government had all however composed off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or four times as numerous as were reported when last year’s pause in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has escalated.

The variety of deaths credited to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far fewer, if any, presumed deaths due to side results from the mRNA vaccines, federal health officials have actually said.

In its announcement, the F.D.A. cited more than six cases and near one death associated to the blood-clotting condition for every 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have now gotten one dose of Johnson & & Johnson’s vaccine, and another 1.5 million have actually gotten a booster dose, according to the C.D.C.’s information. By contrast, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new restrictions in a positive light, Johnson & & Johnson said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”