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WASHINGTON– In yet another setback 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, pointing out safety concerns.

The firm stated 60 cases of a uncommon but major blood-clotting disorder have been identified, including nine deaths, out of about 18 million doses administered. The action happens 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. said that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be individuals who experienced a severe allergy to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those companies are both much safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the negative effects, not brand-new data on the rate at which it takes place. In a sign of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

Reports that the vaccine can activate 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 situation use, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators lifted the pause 10 days later on however included a warning to instructions for its usage.

In December, the C.D.C. suggested that adults seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower dangers. Coupled with a host of making troubles in the United States, some professionals said, the firm’s judgment highlighted that the federal government had all however 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 many as were reported when last year’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has increased.

The variety of deaths attributed to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. But there have actually been far less, if any, presumed deaths due to adverse effects from the mRNA vaccines, federal health authorities have actually stated.

In its statement, the F.D.A. pointed out more than 6 cases and near to one death attributed to the blood-clotting disorder for every single 2 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 gotten a booster dosage, according to the C.D.C.’s data. By comparison, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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