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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 decline to get the Pfizer-BioNTech or Moderna vaccines, citing security concerns.

The agency said 60 cases of a rare however severe blood-clotting disorder have been determined, consisting of nine deaths, out of about 18 million doses administered. The action comes about 5 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 against the benefits, it had chosen to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically proper.” One example would be people who experienced a severe allergy to the other 2 vaccines, the agency stated.

It said the vaccine might also be offered to adults who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the negative effects, not new data on the rate at which it happens. But in an indication of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition referred to as apoplexy with thrombocytopenia syndrome have 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 assessment. Regulators lifted the pause 10 days later on but added an alerting to instructions for its use.

Then, in December, the C.D.C. advised that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower dangers. Combined with a host of manufacturing troubles in the United States, some experts said, the company’s judgment illustrated that the federal government had 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 many as were reported when last year’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has actually escalated.

The variety of deaths attributed to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. But there have actually been far less, if any, presumed deaths due to side results from the mRNA vaccines, federal health authorities have actually said.

In its statement, the F.D.A. pointed out more than 6 cases and near 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 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 data. By comparison, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new restrictions 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.”