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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 grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security concerns.

The company stated 60 cases of a major but unusual blood-clotting disorder have been determined, including nine deaths, out of about 18 million dosages administered. The action happens 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. stated that weighing the risks of Johnson & & Johnson’s vaccine versus the benefits, it had chosen to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be people who experienced an extreme allergy to the other 2 vaccines, the company said.

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

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

Reports that the vaccine can activate a condition called thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities paused distribution of the vaccine for a safety evaluation. Regulators lifted the time out 10 days later however added a warning to directions for its use.

In December, the C.D.C. recommended that adults seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Combined with a host of producing troubles in the United States, some professionals said, the company’s judgment showed that the federal government had actually 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 variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna recipients has increased.

The number of deaths associated to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. However there have been far less, if any, presumed deaths due to side results from the mRNA vaccines, federal health officials have actually said.

In its announcement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting disorder for every two million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually 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 actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new restrictions in a favorable light, Johnson & & Johnson said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared to no vaccine.”