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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 decline to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The agency said 60 cases of a rare but severe blood-clotting disorder have actually been identified, including 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 dangers of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to restrict its use to grownups 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 a severe allergic reaction to the other two vaccines, the company said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’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 stated the F.D.A.’s action showed the already-known danger of the negative effects, not brand-new data on the rate at which it takes place. But 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 trigger a condition referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities paused circulation of the vaccine for a security examination. Regulators raised the time out 10 days later on but included a warning to guidelines for its use.

In December, the C.D.C. suggested that adults looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower threats. Combined with a host of making problems in the United States, some specialists said, the agency’s judgment illustrated that the federal government had actually all however 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 disorder– or 4 times as numerous as were reported when in 2015’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna recipients has actually increased.

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

In its announcement, the F.D.A. mentioned more than six cases and near one death credited to the blood-clotting condition for every 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 gotten a booster dosage, according to the C.D.C.’s data. By comparison, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

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