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

The agency stated 60 cases of a serious but uncommon blood-clotting disorder have actually been recognized, including 9 deaths, out of about 18 million dosages 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 dangers of Johnson & & Johnson’s vaccine against the advantages, it had actually 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 people who experienced an extreme allergy to the other two vaccines, the company said.

It said the vaccine could also be offered to adults 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 officials have said the mRNA vaccines produced by those business are both safer and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known danger of the adverse effects, not new data on the rate at which it happens. However in an indication of the firm’s own flagging interest in its vaccine, it has stopped supplying 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 use, federal authorities paused circulation of the vaccine for a security examination. Regulators lifted the time out 10 days later however added a cautioning to guidelines for its use.

Then, in December, the C.D.C. advised that adults seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Coupled with a host of manufacturing problems in the United States, some specialists said, the agency’s judgment showed that the federal government had actually all however written off 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 circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

The variety of deaths credited to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. However there have actually been far fewer, if any, presumed deaths due to adverse effects from the mRNA vaccines, federal health officials have actually stated.

In its statement, the F.D.A. pointed out more than 6 cases and near to one death credited to the blood-clotting disorder for every single 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 gotten a booster dosage, according to the C.D.C.’s information. By contrast, more than 200 million Americans have gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Attempting 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 adults, when compared to no vaccine.”