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

The agency stated 60 cases of a uncommon but major blood-clotting disorder have been determined, consisting of 9 deaths, out of about 18 million doses administered. The action comes about five 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 risks of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be people who experienced a severe allergic reaction to the other two vaccines, the firm said.

It stated the vaccine might also be provided to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those companies are both safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the adverse effects, not brand-new data on the rate at which it occurs. However in a sign of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition understood as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities stopped briefly distribution of the vaccine for a security examination. Regulators raised the pause 10 days later on however added a cautioning to directions for its usage.

In December, the C.D.C. suggested that adults seeking a booster shot pick 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 said, the agency’s judgment showed 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 condition– or 4 times as lots of as were reported when in 2015’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna recipients has actually skyrocketed.

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

In its statement, the F.D.A. pointed out more than 6 cases and close to one death credited to the blood-clotting condition for each 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 actually 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.

Trying 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 with no vaccine.”