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

The company said 60 cases of a severe however rare blood-clotting condition have been identified, consisting of nine deaths, out of about 18 million doses administered. The action comes about five 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. said that weighing the risks of Johnson & & Johnson’s vaccine versus the benefits, it had decided to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically proper.” One example would be individuals who experienced a severe allergic reaction to the other 2 vaccines, the firm said.

It stated the vaccine might likewise be provided to grownups 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 much safer and more efficient. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known threat of the side effect, not brand-new data on the rate at which it happens. But in an indication 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 understood as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities stopped briefly distribution of the vaccine for a safety examination. Regulators raised the pause 10 days later on but added a warning to guidelines for its usage.

In December, the C.D.C. recommended that grownups seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower threats. Combined with a host of manufacturing problems in the United States, some professionals said, the agency’s judgment highlighted 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 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 slightly more than doubled, while the number of Pfizer and Moderna receivers has skyrocketed.

The variety of deaths attributed to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have been far fewer, if any, thought deaths due to negative effects from the mRNA vaccines, federal health authorities have said.

In its statement, the F.D.A. pointed out more than 6 cases and close to one death attributed to the blood-clotting disorder for each 2 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 gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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