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

The company said 60 cases of a uncommon however severe blood-clotting condition have actually been recognized, including nine deaths, out of about 18 million dosages administered. The action comes about 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. stated that weighing the threats of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to limit its use to grownups 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 a severe allergy to the other two vaccines, the firm stated.

It stated the vaccine might also be provided to adults 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 authorities have said the mRNA vaccines produced by those companies are both much safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the adverse effects, not brand-new data on the rate at which it takes place. In a sign of the firm’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 called thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities stopped briefly distribution of the vaccine for a security evaluation. Regulators lifted the time out 10 days later on however added a warning to instructions for its usage.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower dangers. Paired with a host of manufacturing problems in the United States, some professionals said, the company’s judgment showed that the federal government had actually all however composed off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or four times as lots of as were reported when last year’s time out in distribution was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has skyrocketed.

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. However there have been far fewer, if any, thought deaths due to negative effects from the mRNA vaccines, federal health officials have stated.

In its statement, the F.D.A. mentioned more than six cases and near 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 dose, according to the C.D.C.’s information. By contrast, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new limitations in a positive light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”