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

The company said 60 cases of a major but uncommon blood-clotting disorder have actually been identified, including 9 deaths, out of about 18 million doses administered. The action comes about 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 threats of Johnson & & Johnson’s vaccine versus the benefits, 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 “scientifically appropriate.” One example would be people who experienced a severe allergic response to the other two vaccines, the firm said.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those business are both safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the adverse effects, not new information on the rate at which it takes place. In a sign of the firm’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 called apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators raised the pause 10 days later but included an alerting to directions for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower dangers. Paired with a host of producing problems in the United States, some specialists stated, the company’s judgment showed that the federal government had actually all however written off 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 numerous as were reported when last year’s pause in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna recipients has increased.

The number of deaths credited to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have actually been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health officials have actually stated.

In its statement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting disorder 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 gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

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