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

The company stated 60 cases of a major however uncommon blood-clotting condition have been determined, including 9 deaths, out of about 18 million doses 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 dangers of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically proper.” One example would be people who experienced an extreme allergic reaction to the other two vaccines, the agency said.

It stated the vaccine could likewise be offered to grownups who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both more secure and more reliable. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the side impact, not brand-new data on the rate at which it happens. In a sign of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition understood as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities stopped briefly distribution of the vaccine for a security examination. Regulators lifted the pause 10 days later on but added a cautioning to guidelines for its use.

In December, the C.D.C. suggested that adults looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower threats. Paired with a host of manufacturing troubles in the United States, some specialists said, the firm’s judgment illustrated 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 condition– or 4 times as numerous as were reported when last year’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

The number of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. But there have actually been far fewer, if any, presumed 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 one death credited to the blood-clotting condition for every 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 actually gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least 2 dosages 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 grownups, when compared to no vaccine.”