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WASHINGTON– In yet another obstacle 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, citing safety issues.

The company said 60 cases of a unusual but major blood-clotting condition have been determined, including nine deaths, out of about 18 million doses administered. The action happens five 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 restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically suitable.” One example would be people who experienced a severe allergy to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those companies are both more secure and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the side effect, not new data on the rate at which it takes place. In an indication of the company’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 understood as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities stopped briefly distribution of the vaccine for a safety examination. Regulators lifted the time out 10 days later on however added a cautioning to instructions for its usage.

Then, in December, the C.D.C. advised that grownups looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower risks. Coupled with a host of manufacturing troubles in the United States, some experts said, the agency’s judgment showed that the federal government had all however composed off 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 numerous as were reported when in 2015’s pause in distribution was lifted. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna recipients has actually increased.

The number of deaths credited to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far less, if any, thought deaths due to side results from the mRNA vaccines, federal health authorities have actually said.

In its announcement, the F.D.A. mentioned more than six cases and near to one death attributed to the blood-clotting condition for every single 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 dosage, according to the C.D.C.’s information. By contrast, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight 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 adults, when compared to no vaccine.”