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WASHINGTON– In yet another problem 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, mentioning safety concerns.

The company stated 60 cases of a major however unusual blood-clotting condition have actually been determined, including nine deaths, out of about 18 million doses administered. The action happens 5 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 threats of Johnson & & Johnson’s vaccine against the advantages, it had decided to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be individuals who experienced an extreme allergic reaction to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both safer and more reliable. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the side impact, not brand-new data on the rate at which it takes place. But in a sign of the company’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 referred to as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities paused distribution of the vaccine for a safety examination. Regulators raised the time out 10 days later on but included a cautioning to directions for its use.

Then, in December, the C.D.C. recommended that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower risks. Combined with a host of producing difficulties in the United States, some experts said, the agency’s judgment showed that the federal government had all but composed off 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 lots of as were reported when last year’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has actually escalated.

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

In its statement, the F.D.A. cited more than 6 cases and close to one death credited to the blood-clotting condition for every single 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 gotten a booster dosage, 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.

Trying to cast the tight new constraints in a positive 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.”