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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 adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, pointing out security concerns.

The company said 60 cases of a unusual but severe blood-clotting disorder have actually been recognized, including 9 deaths, out of about 18 million doses administered. The action happens 5 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 dangers of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to limit 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 could also be offered 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 project; federal authorities have said the mRNA vaccines produced by those business are both much safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the adverse effects, not new data on the rate at which it occurs. But in a sign of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.

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 situation use, federal authorities stopped briefly circulation of the vaccine for a security assessment. Regulators lifted the pause 10 days later on but included an alerting to instructions for its usage.

Then, in December, the C.D.C. suggested that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower threats. Combined with a host of making difficulties in the United States, some specialists stated, the company’s judgment highlighted 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 four times as lots of as were reported when in 2015’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has skyrocketed.

The variety of deaths associated to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have actually been far fewer, if any, presumed deaths due to adverse effects from the mRNA vaccines, federal health officials have actually said.

In its statement, the F.D.A. cited more than six cases and close 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 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 information. By contrast, more than 200 million Americans have gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

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