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

The agency stated 60 cases of a serious but uncommon blood-clotting disorder have actually been recognized, 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 risks of Johnson & & Johnson’s vaccine versus the advantages, it had actually chosen to limit its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal authorities have stated the mRNA vaccines produced by those companies are both safer and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known threat of the adverse effects, not brand-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 providing 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 usage, federal authorities paused circulation of the vaccine for a safety evaluation. Regulators lifted the time out 10 days later however added a cautioning to instructions for its usage.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower risks. Combined with a host of producing problems in the United States, some professionals said, 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 numerous 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 escalated.

The variety of deaths attributed to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. However there have actually been far fewer, if any, thought deaths due to negative effects from the mRNA vaccines, federal health authorities have actually said.

In its announcement, the F.D.A. cited more than six cases and close to one death associated 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 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 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 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 to no vaccine.”