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

The company stated 60 cases of a severe but uncommon blood-clotting disorder have been identified, including 9 deaths, out of about 18 million dosages administered. The action happens 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 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 suitable.” One example would be individuals who experienced an extreme allergic reaction to the other two vaccines, the company said.

It stated the vaccine might also be given to adults who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination project; federal officials have stated the mRNA vaccines produced by those business are both safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the side result, not new information on the rate at which it takes place. However in a sign of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition called apoplexy with thrombocytopenia syndrome have actually 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 safety examination. Regulators lifted the time out 10 days later but added a warning to directions for its use.

In December, the C.D.C. advised that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Paired with a host of manufacturing difficulties in the United States, some specialists stated, the company’s judgment illustrated that the federal government had all but 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 disorder– or four times as numerous as were reported when last year’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson dosages administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has increased.

The variety of deaths attributed to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. There have actually been far fewer, if any, suspected deaths due to side results from the mRNA vaccines, federal health authorities have actually said.

In its announcement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting condition for every single 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have now gotten one dose 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 contrast, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new restrictions in a positive light, Johnson & & Johnson stated: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”