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

The firm stated 60 cases of a unusual but severe blood-clotting condition have actually been determined, consisting of nine deaths, out of about 18 million doses 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 risks of Johnson & & Johnson’s vaccine against the benefits, it had actually decided to limit its use to grownups 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 allergic response to the other two vaccines, the company stated.

It stated the vaccine could also be provided 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 authorities have said the mRNA vaccines produced by those companies are both much safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known danger of the adverse effects, not brand-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 supplying 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 authorized for emergency use, federal authorities paused distribution of the vaccine for a safety examination. Regulators raised the pause 10 days later on but included an alerting to guidelines for its use.

In December, the C.D.C. recommended that adults looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Coupled with a host of manufacturing troubles in the United States, some experts stated, the firm’s judgment showed that the federal government had all but crossed out 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 many as were reported when in 2015’s time out in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

The number of deaths associated to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health authorities have said.

In its statement, 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 dosage 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 gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Trying 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 adults, when compared to no vaccine.”