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

The firm said 60 cases of a serious however uncommon blood-clotting condition have been identified, including 9 deaths, out of about 18 million doses administered. The action comes about 5 months after the Centers for Disease Control and Prevention recommended 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 versus the advantages, 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 “scientifically appropriate.” One example would be individuals who experienced a severe allergy to the other two vaccines, the agency stated.

It said the vaccine might also be provided 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 campaign; federal officials have stated the mRNA vaccines produced by those business are both much safer and more efficient. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the adverse effects, not brand-new information on the rate at which it happens. However in a sign of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition referred to as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities paused circulation of the vaccine for a security evaluation. Regulators lifted the pause 10 days later on but added a warning to directions for its use.

In December, the C.D.C. advised that adults looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower threats. Combined with a host of manufacturing problems in the United States, some experts stated, the agency’s judgment highlighted that the federal government had actually 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 4 times as lots of as were reported when last year’s time out in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna recipients has increased.

The variety of deaths associated to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have actually been far fewer, if any, believed deaths due to negative effects from the mRNA vaccines, federal health authorities have actually said.

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

About 17 million Americans have now gotten one dosage 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 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 constraints in a favorable light, Johnson & & Johnson said: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”