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

The company stated 60 cases of a serious however rare blood-clotting disorder have been recognized, including nine deaths, out of about 18 million dosages administered. The action happens 5 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 advantages, it had decided to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be people who experienced an extreme allergy to the other two vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both more secure and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the negative effects, not new data on the rate at which it occurs. However in an indication 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 trigger a condition called apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities paused circulation of the vaccine for a safety assessment. Regulators raised the time out 10 days later on however included a cautioning to directions for its usage.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower threats. Coupled with a host of producing troubles in the United States, some experts stated, the agency’s judgment illustrated that the federal government had all however 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 condition– or four times as many as were reported when last year’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has actually escalated.

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

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

Attempting to cast the tight new constraints 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 with no vaccine.”