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

The company stated 60 cases of a major but uncommon blood-clotting disorder have actually been determined, including nine deaths, out of about 18 million doses administered. The action happens 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 versus the benefits, 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 an extreme allergic reaction to the other 2 vaccines, the firm said.

It stated the vaccine might likewise be provided to grownups 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 officials have stated the mRNA vaccines produced by those companies are both much safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the adverse effects, not new information on the rate at which it occurs. In an indication of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to financiers.

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 usage, federal authorities paused circulation of the vaccine for a security examination. Regulators lifted the pause 10 days later but included an alerting to guidelines for its usage.

In December, the C.D.C. suggested that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower dangers. Combined with a host of producing problems in the United States, some professionals said, the agency’s judgment showed that the federal government had actually 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 4 times as lots of as were reported when in 2015’s pause in distribution was lifted. In the interim, the number of Johnson & & Johnson doses 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 actually increased much, if at all. However there have actually been far fewer, if any, thought deaths due to adverse effects from the mRNA vaccines, federal health officials have actually said.

In its statement, the F.D.A. cited more than 6 cases and close to one death credited to the blood-clotting disorder for every single 2 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 comparison, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

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