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WASHINGTON– In yet another problem 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, pointing out security concerns.

The firm stated 60 cases of a uncommon but major blood-clotting disorder have actually been recognized, including 9 deaths, out of about 18 million doses administered. The action happens five months after the Centers for Disease Control and Prevention suggested 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 advantages, it had decided to limit its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically proper.” One example would be individuals who experienced an extreme allergic response to the other 2 vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have said the mRNA vaccines produced by those business are both more secure and more effective. In a declaration, 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. 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 set off a condition called thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities paused distribution of the vaccine for a safety evaluation. Regulators lifted the time out 10 days later on however included a warning to directions for its usage.

Then, in December, the C.D.C. advised that adults seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower threats. Coupled with a host of making difficulties in the United States, some experts said, the firm’s judgment showed that the federal government had actually all however composed off 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 many as were reported when last year’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna receivers has actually escalated.

The number 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 been far less, if any, suspected deaths due to side effects from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. cited more than 6 cases and near to one death attributed to the blood-clotting condition for each 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 gotten a booster dosage, according to the C.D.C.’s information. 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 positive 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.”