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

The firm said 60 cases of a major however unusual blood-clotting condition have actually been determined, including 9 deaths, out of about 18 million dosages administered. The action comes about five 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. stated that weighing the threats of Johnson & & Johnson’s vaccine against the benefits, 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 “clinically suitable.” One example would be individuals who experienced an extreme allergic reaction to the other 2 vaccines, the company said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal authorities have stated the mRNA vaccines produced by those companies are both safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known risk of the side result, not brand-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 offering sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition known as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities paused circulation of the vaccine for a safety examination. Regulators raised the pause 10 days later on however included a cautioning to guidelines for its use.

In December, the C.D.C. recommended that grownups looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower dangers. Coupled with a host of producing troubles in the United States, some professionals said, the agency’s judgment highlighted that the federal government had actually all but 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 4 times as numerous as were reported when last year’s pause in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna recipients has skyrocketed.

The variety of deaths attributed to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far less, if any, thought deaths due to side results from the mRNA vaccines, federal health officials have said.

In its statement, the F.D.A. pointed out more than six cases and near one death attributed to the blood-clotting disorder for each 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have now gotten one dosage of Johnson & & Johnson’s vaccine, and another 1.5 million have actually gotten a booster dose, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

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