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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its usage to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning safety concerns.

The company said 60 cases of a serious however uncommon blood-clotting disorder have been determined, consisting of nine deaths, out of about 18 million dosages 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 threats of Johnson & & Johnson’s vaccine versus the advantages, it had decided to limit its usage 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 an extreme allergy to the other 2 vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the side result, not new information on the rate at which it occurs. In a sign of the company’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 known as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities stopped briefly distribution of the vaccine for a safety evaluation. Regulators lifted the pause 10 days later on but included a cautioning to guidelines for its usage.

Then, in December, the C.D.C. recommended that grownups looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower risks. Coupled with a host of making difficulties in the United States, some experts said, the agency’s judgment highlighted that the federal government had all but written off 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 numerous as were reported when in 2015’s pause in distribution was lifted. In the interim, the number of Johnson & & Johnson dosages administered has somewhat more than doubled, while the number of Pfizer and Moderna recipients has increased.

The variety of deaths credited to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far fewer, if any, thought deaths due to side impacts from the mRNA vaccines, federal health authorities have actually said.

In its statement, the F.D.A. pointed out more than 6 cases and close to one death attributed 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 dose of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new restrictions 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.”