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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 adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety concerns.

The firm said 60 cases of a severe but rare blood-clotting disorder have actually been determined, including nine deaths, out of about 18 million dosages administered. The action happens 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. said that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had actually 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 proper.” One example would be people who experienced a severe allergic reaction to the other 2 vaccines, the company said.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal authorities 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 reflected the already-known danger of the adverse effects, not new information on the rate at which it takes place. But in a sign of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.

Reports that the vaccine can trigger a condition known as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities stopped briefly distribution of the vaccine for a safety evaluation. Regulators raised the time out 10 days later on however added a cautioning to instructions for its use.

Then, in December, the C.D.C. advised that adults seeking a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower dangers. Coupled with a host of making problems in the United States, some experts stated, the firm’s judgment illustrated 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 disorder– or four times as numerous as were reported when in 2015’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

The variety of deaths credited to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have actually been far fewer, if any, suspected deaths due to side results from the mRNA vaccines, federal health officials have 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 each 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have now gotten one dosage of Johnson & & Johnson’s vaccine, and another 1.5 million have actually gotten a booster dosage, according to the C.D.C.’s data. By comparison, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

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