My Blog

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

The firm said 60 cases of a uncommon but major blood-clotting disorder have actually been recognized, consisting of 9 deaths, out of about 18 million dosages administered. The action comes about five 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 risks of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be people who experienced an extreme allergic reaction to the other 2 vaccines, the company said.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those business are both more secure and more reliable. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the adverse effects, not brand-new information on the rate at which it happens. In an indication of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.

Reports that the vaccine can set off 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 usage, federal authorities paused circulation of the vaccine for a security examination. Regulators lifted the time out 10 days later but included an alerting to instructions for its use.

Then, in December, the C.D.C. recommended that grownups looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower threats. Coupled with a host of producing troubles in the United States, some specialists stated, the company’s judgment showed 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 condition– or four times as many as were reported when last year’s pause in distribution was raised. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna recipients has escalated.

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

In its statement, the F.D.A. mentioned more than six cases and close to one death credited 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 dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

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