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

The agency stated 60 cases of a uncommon but major blood-clotting disorder have actually been determined, including 9 deaths, out of about 18 million doses administered. The action comes about 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. stated that weighing the threats of Johnson & & Johnson’s vaccine versus the advantages, it had decided to restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the firm stated.

It said the vaccine might likewise be offered to grownups who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination campaign; federal officials have said the mRNA vaccines produced by those business are both much safer 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 new information on the rate at which it takes place. In an indication of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

Reports that the vaccine can set off a condition understood as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators lifted the time out 10 days later on but included an alerting to guidelines for its usage.

In December, the C.D.C. recommended that adults seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower dangers. Paired with a host of producing difficulties in the United States, some specialists stated, the firm’s judgment showed that the federal government had all however composed off 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 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 slightly more than doubled, while the variety of Pfizer and Moderna receivers has 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. There have actually been far fewer, if any, presumed deaths due to side results from the mRNA vaccines, federal health officials 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 every single 2 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 information. By comparison, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

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