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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 refuse to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The firm said 60 cases of a unusual however severe blood-clotting condition have been identified, including nine deaths, out of about 18 million dosages 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. said that weighing the dangers of Johnson & & Johnson’s vaccine against the benefits, it had decided to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be individuals who experienced an extreme allergy to the other two vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those business are both more secure and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the side impact, not new information on the rate at which it takes place. But 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 activate a condition referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities stopped briefly distribution of the vaccine for a security assessment. Regulators lifted the pause 10 days later but added a cautioning to guidelines for its use.

Then, in December, the C.D.C. recommended that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower threats. Paired with a host of manufacturing problems in the United States, some specialists said, the agency’s judgment showed that the federal government had all however crossed out 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 pause in circulation 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 variety of deaths attributed 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 fewer, if any, presumed deaths due to side effects from the mRNA vaccines, federal health officials have stated.

In its statement, the F.D.A. mentioned more than six cases and near 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 now gotten one dose of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dosage, according to the C.D.C.’s data. 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 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 with no vaccine.”