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WASHINGTON– In yet another setback for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its use to adults who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The agency stated 60 cases of a unusual but severe blood-clotting disorder have actually been determined, including 9 deaths, out of about 18 million doses administered. The action comes about 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 risks of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to limit its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be people who experienced an extreme allergic response to the other two vaccines, the agency said.

It said the vaccine might likewise be offered to grownups who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both safer and more efficient. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not new information on the rate at which it occurs. In a sign of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to financiers.

Reports that the vaccine can trigger a condition referred to as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities paused circulation of the vaccine for a safety examination. Regulators lifted the time out 10 days later on however added an alerting to directions for its usage.

In December, the C.D.C. advised that adults looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Coupled with a host of manufacturing problems in the United States, some professionals said, the agency’s judgment illustrated that the federal government had all but crossed out Johnson & & Johnson’s vaccine.

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

The number of deaths associated to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. But there have actually been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health officials have actually said.

In its announcement, the F.D.A. mentioned more than 6 cases and near one death credited to the blood-clotting disorder for every two million shots of Johnson & & Johnson vaccine administered in the United States.

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

Attempting to cast the tight brand-new constraints in a positive light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”