My Blog

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

The firm said 60 cases of a severe but rare blood-clotting condition have been identified, including 9 deaths, out of about 18 million dosages administered. The action comes about 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. said that weighing the dangers of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be people who experienced a severe allergy to the other two vaccines, the agency said.

It said the vaccine could likewise be provided to adults who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal officials have said the mRNA vaccines produced by those business are both safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the negative effects, not new data on the rate at which it occurs. 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 trigger a condition referred to as apoplexy with thrombocytopenia syndrome have actually 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 assessment. Regulators raised the pause 10 days later on but added a cautioning to instructions for its usage.

In December, the C.D.C. recommended that adults looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower dangers. Coupled with a host of making problems in the United States, some experts 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. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or 4 times as numerous as were reported when last year’s time out in distribution was raised. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has increased.

The variety of deaths associated to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have actually been far less, if any, presumed deaths due to side impacts from the mRNA vaccines, federal health authorities have stated.

In its statement, the F.D.A. cited more than six cases and near to one death associated to the blood-clotting disorder for each 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually now gotten one dose 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 comparison, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

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