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

The agency said 60 cases of a major however unusual blood-clotting disorder have actually been identified, consisting of 9 deaths, out of about 18 million dosages administered. The action happens 5 months after the Centers for Disease Control and Prevention suggested Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

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

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those companies are both more secure and more effective. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk 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 called apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency usage, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators lifted the pause 10 days later on however added an alerting to directions for its usage.

Then, in December, the C.D.C. suggested that grownups looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower risks. Paired with a host of manufacturing difficulties in the United States, some specialists stated, the agency’s judgment illustrated that the federal government had actually all however crossed out 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 4 times as numerous as were reported when last year’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

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

In its announcement, the F.D.A. cited more than 6 cases and near one death credited to the blood-clotting disorder for every 2 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 actually 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.

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