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WASHINGTON– In yet another obstacle 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, citing security issues.

The company said 60 cases of a major but unusual blood-clotting disorder have actually been recognized, including 9 deaths, out of about 18 million dosages administered. The action happens 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 threats of Johnson & & Johnson’s vaccine versus the benefits, it had actually chosen to restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be people who experienced a severe allergy to the other two vaccines, the agency said.

It said the vaccine might likewise be provided to grownups who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those business are both much safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the negative effects, not new data on the rate at which it occurs. But in an indication 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 trigger a condition known as thrombosis 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 lifted the pause 10 days later on but included a cautioning to directions for its usage.

Then, in December, the C.D.C. suggested that grownups looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower risks. Paired with a host of producing troubles in the United States, some professionals stated, the company’s judgment illustrated that the federal government had actually all however 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 lots of as were reported when in 2015’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has actually skyrocketed.

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 been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health authorities have said.

In its announcement, the F.D.A. mentioned more than six cases and near to one death credited to the blood-clotting disorder for each two 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 dose, according to the C.D.C.’s information. By comparison, 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 restrictions in a positive light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”