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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 safety concerns.

The agency said 60 cases of a major however uncommon blood-clotting condition have actually been identified, consisting of nine deaths, out of about 18 million doses administered. The action comes about 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 against the benefits, it had decided to restrict its usage to adults 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 an extreme allergic response to the other 2 vaccines, the agency said.

It said the vaccine could likewise be offered 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 side result, 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 providing sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition called thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities paused distribution of the vaccine for a security assessment. Regulators raised the pause 10 days later on but added an alerting to instructions for its usage.

In December, the C.D.C. recommended that adults looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower dangers. Paired with a host of making difficulties in the United States, some professionals stated, the agency’s judgment illustrated 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 pause in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has actually increased.

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

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 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 dosage, according to the C.D.C.’s information. By contrast, more than 200 million Americans have gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new restrictions in a favorable light, Johnson & & Johnson stated: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”