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

The firm stated 60 cases of a rare but major blood-clotting condition have been recognized, including 9 deaths, out of about 18 million dosages administered. The action comes about 5 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 decided to limit its usage 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 individuals who experienced a severe allergy to the other two vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have said the mRNA vaccines produced by those business are both more secure and more effective. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the adverse effects, not brand-new information on the rate at which it occurs. However in an indication 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 referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities paused distribution of the vaccine for a safety examination. Regulators lifted the pause 10 days later but added an alerting to directions for its use.

In December, the C.D.C. suggested that adults looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower threats. Paired with a host of producing difficulties in the United States, some experts 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. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– 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 slightly more than doubled, while the number of Pfizer and Moderna recipients has escalated.

The variety of deaths attributed to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have actually been far less, if any, presumed deaths due to side results from the mRNA vaccines, federal health authorities have actually said.

In its statement, the F.D.A. cited more than six cases and close to one death associated 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 doses of either Moderna’s or Pfizer’s vaccine.

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