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WASHINGTON– In yet another setback 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 issues.

The company said 60 cases of a rare however severe blood-clotting condition have actually been identified, including 9 deaths, out of about 18 million doses administered. The action comes about 5 months after the Centers for Disease Control and Prevention advised 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 against the advantages, it had actually chosen to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be individuals who experienced a severe allergic response to the other 2 vaccines, the firm stated.

It stated the vaccine could likewise be provided to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier 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 statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the adverse effects, not brand-new information on the rate at which it happens. In a sign of the company’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 approved for emergency usage, federal authorities paused distribution of the vaccine for a security examination. Regulators lifted the pause 10 days later but included a cautioning to instructions for its use.

Then, in December, the C.D.C. suggested that adults looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower threats. Coupled with a host of manufacturing problems in the United States, some professionals said, the agency’s judgment highlighted that the federal government had actually all but composed 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 numerous as were reported when in 2015’s time out in circulation was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has skyrocketed.

The number of deaths associated to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health officials have actually stated.

In its announcement, the F.D.A. cited more than 6 cases and close to one death attributed to the blood-clotting condition for each 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 gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new limitations 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 with no vaccine.”