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

The company stated 60 cases of a major but unusual blood-clotting condition have been determined, including nine deaths, out of about 18 million dosages administered. The action comes about five 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 versus the benefits, it had decided to limit its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be people who experienced a severe allergy to the other 2 vaccines, the company stated.

It said the vaccine might likewise be provided to adults 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 said the mRNA vaccines produced by those business are both safer and more reliable. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the adverse effects, not brand-new information on the rate at which it occurs. But in a sign of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition known as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency usage, federal authorities stopped briefly distribution of the vaccine for a safety evaluation. Regulators raised the pause 10 days later on however added an alerting to instructions for its use.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower threats. Paired with a host of making problems in the United States, some specialists said, the agency’s judgment showed that the federal government had all but 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 condition– or 4 times as many as were reported when last year’s pause in circulation was lifted. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has actually escalated.

The number of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health officials have actually said.

In its statement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting condition 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 dose, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight brand-new constraints 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.”