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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 refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety concerns.

The company stated 60 cases of a serious but unusual blood-clotting condition have been recognized, including nine deaths, out of about 18 million doses administered. The action happens 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 risks of Johnson & & Johnson’s vaccine against 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 “clinically proper.” One example would be people who experienced an extreme allergy to the other 2 vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal authorities have said the mRNA vaccines produced by those companies are both more secure and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not brand-new information on the rate at which it takes place. But in a sign 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 known 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 paused distribution of the vaccine for a security evaluation. Regulators raised the pause 10 days later but added a warning to instructions for its usage.

In December, the C.D.C. advised that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Paired with a host of making difficulties in the United States, some experts said, the firm’s judgment showed that the federal government had actually all however written off Johnson & & Johnson’s vaccine.

According to the F.D.A. statement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or 4 times as lots of as were reported when last year’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna receivers has actually skyrocketed.

The number of deaths associated to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. But there have actually been far fewer, if any, believed deaths due to negative effects from the mRNA vaccines, federal health officials have stated.

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 actually now gotten one dose of Johnson & & Johnson’s vaccine, and another 1.5 million have 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 dosages of either Moderna’s or Pfizer’s vaccine.

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