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

The company stated 60 cases of a severe however uncommon blood-clotting condition have been recognized, consisting of 9 deaths, out of about 18 million doses administered. The action comes about five 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. said that weighing the threats of Johnson & & Johnson’s vaccine against the benefits, it had chosen to restrict its use 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 individuals who experienced an extreme allergic reaction to the other two vaccines, the firm stated.

It said the vaccine might 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 project; federal officials have said the mRNA vaccines produced by those business are both more secure and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the adverse effects, not new data on the rate at which it happens. In a sign of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition understood as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities stopped briefly circulation of the vaccine for a security assessment. Regulators raised the pause 10 days later on but included an alerting to directions for its usage.

Then, in December, the C.D.C. suggested that adults looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower threats. Coupled with a host of making problems in the United States, some professionals said, the firm’s judgment illustrated that the federal government had actually all but 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 4 times as numerous as were reported when last year’s pause in circulation 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 increased.

The variety of deaths credited to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have been far less, if any, believed deaths due to adverse effects from the mRNA vaccines, federal health authorities have actually stated.

In its statement, the F.D.A. pointed out more than 6 cases and near one death credited to the blood-clotting condition for every two 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 dose, according to the C.D.C.’s information. 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 new limitations in a positive 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.”