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WASHINGTON– In yet another setback 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, pointing out safety issues.

The agency said 60 cases of a rare however major blood-clotting disorder have been identified, including nine deaths, out of about 18 million doses 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 risks of Johnson & & Johnson’s vaccine versus the benefits, it had chosen to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically suitable.” One example would be individuals who experienced an extreme allergy to the other two vaccines, the firm said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the adverse effects, not brand-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 providing sales outlooks for the shot to financiers.

Reports that the vaccine can activate a condition called 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 distribution of the vaccine for a security assessment. Regulators lifted the pause 10 days later on however added a cautioning to guidelines for its usage.

Then, in December, the C.D.C. advised that grownups seeking a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower dangers. Combined with a host of manufacturing difficulties in the United States, some experts stated, the firm’s judgment showed 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 many as were reported when last year’s pause in distribution 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 actually escalated.

The variety of deaths associated to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. There have been far less, if any, believed 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 six cases and near one death credited to the blood-clotting disorder for every 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 actually gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new constraints 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.”