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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its use to adults who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The firm stated 60 cases of a rare but serious blood-clotting condition have actually been identified, including nine deaths, out of about 18 million doses administered. The action comes about 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 risks of Johnson & & Johnson’s vaccine versus the advantages, it had actually chosen to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically proper.” One example would be people who experienced a severe allergic reaction to the other two vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal authorities have said 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 negative effects, not brand-new data on the rate at which it occurs. 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 set off a condition called apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency usage, federal authorities paused circulation of the vaccine for a safety assessment. Regulators raised the pause 10 days later on but included an alerting to instructions for its use.

In December, the C.D.C. advised that adults looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower dangers. Combined with a host of producing troubles in the United States, some professionals said, the company’s judgment illustrated that the federal government had all however crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. statement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or four times as many as were reported when in 2015’s time out in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has escalated.

The variety of deaths attributed to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have been far less, if any, thought deaths due to negative effects from the mRNA vaccines, federal health authorities have said.

In its announcement, the F.D.A. mentioned more than 6 cases and near to one death associated 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 information. By comparison, 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 limitations in a favorable light, Johnson & & Johnson stated: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared to no vaccine.”