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

The company stated 60 cases of a serious however unusual blood-clotting condition have actually been recognized, including 9 deaths, out of about 18 million doses 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. said that weighing the risks of Johnson & & Johnson’s vaccine versus the benefits, it had decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the company said.

It stated the vaccine might also be offered to adults who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have said 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 showed the already-known threat of the negative effects, not brand-new data on the rate at which it happens. In a sign of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition called apoplexy with thrombocytopenia syndrome have 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 evaluation. Regulators raised the time out 10 days later on however added a warning to guidelines for its use.

In December, the C.D.C. suggested that adults seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower risks. Combined with a host of producing difficulties in the United States, some professionals said, the firm’s judgment highlighted that the federal government had actually all but written off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or four times as lots of as were reported when in 2015’s time out in circulation was lifted. In the interim, the variety 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 attributed to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have been far less, if any, thought deaths due to adverse effects from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. pointed out more than 6 cases and close to one death credited to the blood-clotting disorder for every 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 gotten a booster dosage, according to the C.D.C.’s information. 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 limitations in a positive light, Johnson & & Johnson said: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”