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

The company said 60 cases of a uncommon but severe blood-clotting condition have been determined, including nine deaths, out of about 18 million dosages administered. The action comes about 5 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 chosen to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically proper.” One example would be people who experienced a severe allergy to the other two vaccines, the agency said.

It stated the vaccine might also be provided to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both much safer and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known threat of the negative 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 investors.

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

Then, in December, the C.D.C. suggested that grownups looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower risks. Combined with a host of manufacturing difficulties in the United States, some specialists said, the company’s judgment showed that the federal government had actually 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 many as were reported when last year’s pause 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 actually increased.

The number of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have actually been far fewer, if any, believed deaths due to adverse effects from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. pointed out more than six cases and near 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 dose, 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 restrictions 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 to no vaccine.”