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

The agency said 60 cases of a serious but rare blood-clotting disorder have actually been recognized, consisting of nine 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. said that weighing the threats of Johnson & & Johnson’s vaccine versus the benefits, it had chosen 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 people who experienced an extreme allergic reaction to the other 2 vaccines, the agency said.

It stated the vaccine could likewise be provided 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 companies are both safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the adverse effects, not brand-new information on the rate at which it occurs. In a sign of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to financiers.

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

Then, in December, the C.D.C. suggested that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower dangers. Combined with a host of producing troubles in the United States, some experts said, the firm’s judgment showed 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 condition– or four times as lots of as were reported when in 2015’s pause in circulation was raised. In the interim, the number of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna receivers has escalated.

The variety of deaths credited to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. There have actually been far fewer, if any, presumed deaths due to side results from the mRNA vaccines, federal health authorities have stated.

In its statement, the F.D.A. mentioned more than 6 cases and close to one death associated to the blood-clotting disorder for every two 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 dosage, according to the C.D.C.’s data. 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 brand-new constraints in a favorable light, Johnson & & Johnson said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”