My Blog

WASHINGTON– In yet another setback 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, mentioning security concerns.

The firm stated 60 cases of a unusual however serious blood-clotting condition have actually been identified, including 9 deaths, out of about 18 million doses administered. The action happens five 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 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 “medically suitable.” One example would be people who experienced a severe allergy to the other 2 vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both much safer and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the negative effects, not new information on the rate at which it occurs. In an indication of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to financiers.

Reports that the vaccine can activate a condition known as thrombosis 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 safety examination. Regulators raised the time out 10 days later but included a cautioning to instructions for its usage.

In December, the C.D.C. advised that adults seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower risks. Combined with a host of manufacturing difficulties in the United States, some specialists said, the company’s judgment showed that the federal government had all but composed off 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 many as were reported when last year’s time out in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has actually increased.

The number of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. There have actually been far less, if any, believed deaths due to side impacts from the mRNA vaccines, federal health authorities have actually stated.

In its announcement, the F.D.A. mentioned more than six cases and near one death associated to the blood-clotting condition for every 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually now gotten one dose 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 contrast, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight brand-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 with no vaccine.”