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WASHINGTON– In yet another problem 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 safety concerns.

The firm said 60 cases of a uncommon but major blood-clotting condition have actually been determined, including nine 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 against the advantages, it had decided to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be individuals who experienced a severe allergy to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal authorities have stated the mRNA vaccines produced by those business are both safer and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk of the adverse effects, not brand-new information on the rate at which it occurs. 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 trigger a condition known as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities paused distribution of the vaccine for a safety examination. Regulators lifted the time out 10 days later however added an alerting to instructions for its use.

In December, the C.D.C. recommended that grownups looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Paired with a host of producing problems in the United States, some specialists stated, the company’s judgment highlighted that the federal government had actually all however 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 4 times as many as were reported when last year’s time out in circulation was raised. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has actually skyrocketed.

The number of deaths credited to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far less, if any, presumed deaths due to side results from the mRNA vaccines, federal health authorities have 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 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 actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new limitations in a positive 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.”