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

The agency stated 60 cases of a severe but rare blood-clotting condition have actually been determined, consisting of nine deaths, out of about 18 million dosages administered. The action happens 5 months after the Centers for Disease Control and Prevention recommended Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. stated that weighing the dangers of Johnson & & Johnson’s vaccine against the advantages, it had chosen to limit its use to adults 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 a severe allergic response to the other two vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’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 danger of the negative effects, not brand-new data on the rate at which it happens. But in a sign of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition referred to as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities paused circulation of the vaccine for a security assessment. Regulators raised the pause 10 days later however included a warning to guidelines 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 benefits and lower risks. Coupled with a host of making problems in the United States, some experts stated, the company’s judgment illustrated 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 four times as many as were reported when last year’s pause in distribution 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 escalated.

The number of deaths credited to the disorder activated 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, suspected deaths due to adverse effects from the mRNA vaccines, federal health authorities have stated.

In its statement, the F.D.A. mentioned more than 6 cases and near 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 actually gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying 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 to no vaccine.”