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

The company stated 60 cases of a unusual but major blood-clotting disorder have been identified, consisting of nine deaths, out of about 18 million doses administered. The action happens five months after the Centers for Disease Control and Prevention suggested 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 versus the benefits, it had actually chosen to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be people who experienced an extreme allergy to the other 2 vaccines, the company said.

It stated the vaccine might also be provided to adults who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both safer and more effective. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the adverse effects, not new information on the rate at which it takes place. However in an indication of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition called thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities stopped briefly distribution of the vaccine for a security assessment. Regulators lifted the time out 10 days later but added an alerting to directions for its usage.

Then, in December, the C.D.C. advised that grownups looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Combined with a host of producing troubles in the United States, some professionals stated, the firm’s judgment showed that the federal government had all but written 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 many as were reported when in 2015’s pause in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the number of Pfizer and Moderna receivers has escalated.

The variety of deaths attributed to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. There have been far less, if any, suspected deaths due to side results from the mRNA vaccines, federal health officials have actually stated.

In its statement, the F.D.A. mentioned more than 6 cases and close to one death attributed to the blood-clotting disorder for every single two million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually 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 information. By contrast, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

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