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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its usage to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning safety concerns.

The agency stated 60 cases of a rare however serious 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 advised Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the dangers of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to restrict its use to grownups 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 allergy to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those companies are both safer and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not new information on the rate at which it takes place. But in an indication of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

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 approved for emergency situation usage, federal authorities stopped briefly distribution of the vaccine for a security evaluation. Regulators lifted the pause 10 days later however added a cautioning to guidelines for its use.

Then, in December, the C.D.C. advised that grownups seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower dangers. Paired with a host of making difficulties in the United States, some professionals said, the agency’s judgment illustrated 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 condition– or 4 times as lots of as were reported when last year’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna receivers has actually escalated.

The variety of deaths credited to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. There have actually been far less, if any, thought deaths due to side impacts from the mRNA vaccines, federal health officials have actually said.

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

About 17 million Americans have 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 gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

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