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

The firm stated 60 cases of a serious however rare blood-clotting condition have actually been determined, consisting of 9 deaths, out of about 18 million dosages administered. The action comes about 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 dangers of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically proper.” One example would be people who experienced a severe allergic reaction to the other two vaccines, the agency said.

It said the vaccine might also be provided to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those companies are both safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk of the negative effects, not brand-new data on the rate at which it happens. In a sign of the firm’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition referred to as apoplexy 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 security assessment. Regulators raised the pause 10 days later however added a cautioning to instructions for its usage.

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 benefits and lower risks. Combined with a host of manufacturing difficulties in the United States, some specialists said, the company’s judgment illustrated that the federal government had all but crossed out 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 four times as numerous as were reported when last year’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

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. There have actually been far fewer, if any, presumed deaths due to side results from the mRNA vaccines, federal health authorities have stated.

In its statement, the F.D.A. mentioned more than six cases and near 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 dose, 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.

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