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

The firm stated 60 cases of a serious however unusual blood-clotting disorder have been identified, including nine 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. stated that weighing the threats of Johnson & & Johnson’s vaccine versus the advantages, it had chosen to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically suitable.” One example would be individuals who experienced a severe allergic response to the other 2 vaccines, the company said.

It stated the vaccine might also be provided 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 stated the mRNA vaccines produced by those business are both safer and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the adverse effects, not new data on the rate at which it takes place. But 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 called thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities stopped briefly circulation of the vaccine for a security evaluation. Regulators raised the pause 10 days later on however added an alerting to guidelines for its use.

Then, in December, the C.D.C. suggested that grownups looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower threats. Paired with a host of producing problems in the United States, some professionals stated, the agency’s judgment showed that the federal government had all but written off 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 lots of as were reported when last year’s pause in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety 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 increased much, if at all. But there have actually been far less, if any, thought deaths due to negative effects from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. cited more than 6 cases and close to one death attributed to the blood-clotting condition 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 dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

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