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

The firm said 60 cases of a uncommon but severe blood-clotting condition have been identified, consisting of nine deaths, out of about 18 million doses administered. The action comes about 5 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. said that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to limit its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be people who experienced a severe allergic response to the other two vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those companies are both safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the adverse effects, not new information on the rate at which it happens. In an indication 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 known 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 stopped briefly circulation of the vaccine for a safety assessment. Regulators raised the time out 10 days later on however added a warning to instructions for its use.

Then, in December, the C.D.C. advised that grownups looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower dangers. Combined with a host of making troubles in the United States, some professionals said, the agency’s judgment illustrated that the federal government had actually all but 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 four times as lots of as were reported when in 2015’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the variety of Pfizer and Moderna recipients has skyrocketed.

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

In its statement, the F.D.A. pointed out more than six cases and close to one death attributed to the blood-clotting condition for every single 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 gotten a booster dosage, according to the C.D.C.’s information. By contrast, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

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