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

The company said 60 cases of a rare however major blood-clotting condition have been recognized, including nine deaths, out of about 18 million doses administered. The action happens five months after the Centers for Disease Control and Prevention recommended 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 chosen to limit its use to adults 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 a severe allergy to the other two vaccines, the firm said.

It stated the vaccine could likewise be offered 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 project; federal authorities have said the mRNA vaccines produced by those business are both safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the negative effects, not new data on the rate at which it takes place. But in a sign of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can activate 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 situation usage, federal authorities stopped briefly distribution of the vaccine for a security evaluation. Regulators raised the time out 10 days later however included a cautioning to guidelines for its use.

In December, the C.D.C. advised that adults looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower dangers. Combined with a host of manufacturing difficulties in the United States, some specialists said, the firm’s judgment illustrated that the federal government had actually all but crossed out 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 four times as numerous as were reported when last year’s time out in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna recipients has increased.

The number of deaths credited to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far fewer, if any, believed deaths due to side results 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 condition for each 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 actually 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 doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new limitations in a favorable light, Johnson & & Johnson said: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”