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

The firm stated 60 cases of a unusual however severe blood-clotting condition have been identified, consisting of nine deaths, out of about 18 million dosages administered. The action happens 5 months after the Centers for Disease Control and Prevention advised Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the threats of Johnson & & Johnson’s vaccine against the benefits, it had 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 people who experienced a severe allergic reaction to the other two vaccines, the company said.

It said the vaccine might also be offered 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 authorities have said the mRNA vaccines produced by those business are both much safer and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk of the side result, not brand-new data on the rate at which it takes place. In an indication of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

Reports that the vaccine can activate 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 situation use, federal authorities paused circulation of the vaccine for a security evaluation. Regulators raised the pause 10 days later but added a warning to instructions for its use.

In December, the C.D.C. advised that grownups seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower dangers. Coupled with a host of producing troubles in the United States, some experts stated, the firm’s judgment illustrated that the federal government had actually all however 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 four times as lots of as were reported when last year’s pause in distribution was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has actually increased.

The variety of deaths attributed to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have been far fewer, if any, believed deaths due to side impacts from the mRNA vaccines, federal health authorities have actually stated.

In its announcement, the F.D.A. pointed out more than 6 cases and near one death credited to the blood-clotting disorder for each 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 information. By contrast, more than 200 million Americans have gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-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 with no vaccine.”