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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 security issues.

The company said 60 cases of a unusual but major blood-clotting disorder have actually been recognized, including 9 deaths, out of about 18 million doses administered. The action happens 5 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 threats of Johnson & & Johnson’s vaccine against the advantages, it had chosen to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be people who experienced an extreme allergic reaction to the other two vaccines, the company said.

It stated the vaccine could likewise be offered to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those business are both much safer and more effective. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger 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 offering sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition called thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities stopped briefly distribution of the vaccine for a security examination. Regulators raised the pause 10 days later on however added a cautioning to directions for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower dangers. Paired with a host of making problems in the United States, some experts stated, the agency’s judgment highlighted that the federal government had 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 condition– or 4 times as lots of as were reported when last year’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has increased.

The variety of deaths credited to the disorder 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, believed deaths due to negative effects from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. cited more than six cases and close to one death associated to the blood-clotting condition for every two million shots of Johnson & & Johnson vaccine administered in the United States.

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

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