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

The agency said 60 cases of a major however unusual blood-clotting condition have been recognized, consisting of nine deaths, out of about 18 million dosages administered. The action comes about 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 threats of Johnson & & Johnson’s vaccine versus the benefits, it had chosen to restrict its usage 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 a severe allergy to the other two vaccines, the firm said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those business are both much safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the side impact, not new data on the rate at which it occurs. In an indication of the company’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 usage, federal authorities stopped briefly circulation of the vaccine for a security assessment. Regulators lifted the pause 10 days later on but added a cautioning to instructions for its use.

In December, the C.D.C. suggested that grownups seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower risks. Coupled with a host of producing difficulties in the United States, some professionals said, the firm’s judgment illustrated that the federal government had actually all however crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or four times as numerous as were reported when last year’s pause in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has actually escalated.

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 less, if any, suspected deaths due to side results from the mRNA vaccines, federal health authorities have stated.

In its announcement, the F.D.A. mentioned more than six cases and near to one death credited to the blood-clotting condition for every single 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 data. By contrast, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Attempting 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 grownups, when compared with no vaccine.”