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

The firm said 60 cases of a serious but uncommon blood-clotting disorder have actually been recognized, including 9 deaths, out of about 18 million dosages 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 chosen to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically proper.” One example would be individuals who experienced a severe allergic response to the other two vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those companies are both much safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the adverse effects, not new data on the rate at which it happens. In an indication of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

Reports that the vaccine can trigger a condition referred to as thrombosis 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 examination. Regulators lifted the pause 10 days later but included an alerting to instructions for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower risks. Paired with a host of manufacturing problems in the United States, some professionals said, the firm’s judgment illustrated that the federal government had actually all but written off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or four times as lots of as were reported when last year’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna recipients has escalated.

The number of deaths associated to the condition triggered 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, thought deaths due to side effects from the mRNA vaccines, federal health officials have actually said.

In its announcement, the F.D.A. cited more than 6 cases and near one death attributed to the blood-clotting disorder for every two 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 gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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