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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 adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety issues.

The company said 60 cases of a unusual but severe blood-clotting condition have actually been identified, including nine deaths, out of about 18 million dosages administered. The action comes about 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 dangers of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to restrict its use 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 individuals who experienced a severe allergy to the other two vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both much safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not brand-new data on the rate at which it takes place. In a sign of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition called apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities paused circulation of the vaccine for a security assessment. Regulators lifted the pause 10 days later on however included a cautioning to instructions for its usage.

In December, the C.D.C. suggested that grownups looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower risks. Combined with a host of manufacturing problems in the United States, some professionals stated, the agency’s judgment illustrated that the federal government had all however 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 lots of as were reported when last year’s time out in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

The variety of deaths associated to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have actually been far fewer, if any, thought deaths due to negative effects from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. pointed out more than 6 cases and near one death associated to the blood-clotting condition for each 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 information. By comparison, 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 said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”