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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 grownups who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The firm stated 60 cases of a major however rare blood-clotting condition 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 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 benefits, it had chosen to restrict its usage to adults 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 an extreme allergic reaction to the other two vaccines, the firm said.

It said the vaccine could likewise be given to adults who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal officials have said the mRNA vaccines produced by those companies are both more secure and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known threat of the adverse effects, not brand-new data 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 activate a condition referred to as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators raised the time out 10 days later on however added a cautioning to directions for its use.

Then, in December, the C.D.C. suggested that adults seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower dangers. Coupled with a host of making troubles in the United States, some professionals said, the company’s judgment highlighted that the federal government had actually all but written off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or 4 times as numerous as were reported when last year’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna recipients has actually escalated.

The number of deaths attributed to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. But there have been far less, if any, suspected deaths due to adverse effects from the mRNA vaccines, federal health authorities have said.

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

About 17 million Americans have 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 information. By contrast, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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