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

The agency said 60 cases of a rare however major blood-clotting condition have been identified, consisting of 9 deaths, out of about 18 million doses 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. said that weighing the dangers of Johnson & & Johnson’s vaccine against the benefits, it had actually decided to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be individuals who experienced an extreme allergic reaction to the other two vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination campaign; federal officials have said the mRNA vaccines produced by those companies are both much safer and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the side result, 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 providing 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 authorized for emergency use, federal authorities stopped briefly distribution of the vaccine for a safety assessment. Regulators raised the pause 10 days later however added an alerting to directions for its usage.

Then, in December, the C.D.C. suggested that grownups seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower threats. Combined with a host of producing troubles in the United States, some specialists said, the firm’s judgment showed that the federal government had all however crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or 4 times as many as were reported when last year’s pause in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has skyrocketed.

The number of deaths credited to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. But there have been far fewer, if any, thought deaths due to side impacts from the mRNA vaccines, federal health officials have said.

In its statement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting disorder for every single 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 contrast, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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