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

The firm stated 60 cases of a major however unusual blood-clotting disorder have actually been recognized, consisting of nine 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 risks of Johnson & & Johnson’s vaccine versus the benefits, it had decided to restrict its usage 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 people who experienced a severe allergy to the other two vaccines, the firm said.

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

Johnson & & Johnson was eclipsed long ago 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 effective. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known threat of the side result, not new data on the rate at which it takes place. However in a sign 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 trigger a condition referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities paused circulation of the vaccine for a security assessment. Regulators raised the pause 10 days later however added an alerting to directions for its use.

Then, in December, the C.D.C. advised that grownups looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower risks. Combined with a host of making problems in the United States, some experts said, the firm’s judgment showed that the federal government had all but written 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 last year’s time out in circulation was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has actually skyrocketed.

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, presumed deaths due to side results from the mRNA vaccines, federal health authorities have actually stated.

In its statement, the F.D.A. cited more than six cases and near to one death associated to the blood-clotting condition for every 2 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.

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