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

The company said 60 cases of a major but unusual blood-clotting disorder have been identified, consisting of 9 deaths, out of about 18 million dosages administered. The action happens 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. said that weighing the dangers of Johnson & & Johnson’s vaccine versus the advantages, it had actually decided to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically proper.” One example would be people who experienced a severe allergy to the other two vaccines, the agency said.

It said the vaccine could 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 nation’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those companies are both much safer and more reliable. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the side result, not brand-new data on the rate at which it happens. But 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 called thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities paused distribution of the vaccine for a security evaluation. Regulators lifted the time out 10 days later but added a cautioning to instructions for its use.

In December, the C.D.C. advised that grownups looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower dangers. Paired with a host of making problems in the United States, some experts stated, the firm’s judgment highlighted that the federal government had actually all but composed 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 four times as numerous as were reported when last year’s time out in circulation was raised. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna recipients has increased.

The variety of deaths credited to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have actually 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. mentioned more than six cases and near one death associated to the blood-clotting disorder for every 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 actually gotten a booster dose, according to the C.D.C.’s data. By contrast, 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 restrictions in a favorable 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.”