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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 decline to get the Pfizer-BioNTech or Moderna vaccines, citing security issues.

The agency said 60 cases of a rare but serious blood-clotting disorder have been recognized, consisting of 9 deaths, out of about 18 million doses administered. The action happens five 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. stated that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be people who experienced a severe allergy to the other two vaccines, the company said.

It stated the vaccine might likewise be offered to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those companies are both more secure and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the side effect, not new data on the rate at which it happens. In an indication of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition known as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities paused circulation of the vaccine for a security assessment. Regulators raised 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, citing more benefits and lower threats. Combined with a host of producing difficulties in the United States, some experts said, the company’s judgment showed that the federal government had actually all however 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 disorder– or 4 times as lots of as were reported when last year’s time out in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has actually escalated.

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

In its statement, the F.D.A. pointed out more than six cases and near to one death credited 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 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 actually gotten at least 2 dosages 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 beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”