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WASHINGTON– In yet another setback for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its use to adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, pointing out security concerns.

The agency said 60 cases of a rare however serious blood-clotting disorder have actually been determined, consisting of 9 deaths, out of about 18 million doses administered. The action happens 5 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 decided to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be individuals who experienced a severe allergy to the other 2 vaccines, the agency said.

It said the vaccine could 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 country’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those companies are both much safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the side impact, not brand-new data on the rate at which it occurs. In a sign of the firm’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 called thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities paused circulation of the vaccine for a security assessment. Regulators raised the pause 10 days later but included a warning to guidelines for its use.

In December, the C.D.C. suggested that adults seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower dangers. Paired with a host of producing difficulties in the United States, some specialists stated, the agency’s judgment showed that the federal government had actually all but 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 disorder– or four times as many as were reported when in 2015’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has actually increased.

The number of deaths attributed to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have actually been far less, if any, believed deaths due to negative effects from the mRNA vaccines, federal health officials have stated.

In its statement, the F.D.A. pointed out more than six cases and near one death credited 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 gotten a booster dose, according to the C.D.C.’s data. By comparison, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Attempting 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.”