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

The firm stated 60 cases of a uncommon but severe blood-clotting condition have actually been recognized, including nine deaths, out of about 18 million doses administered. The action comes about 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 threats of Johnson & & Johnson’s vaccine against the benefits, it had actually chosen to limit its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be individuals who experienced an extreme allergy to the other two vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those business are both more secure and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the negative effects, not new information on the rate at which it occurs. 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 activate 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 use, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators raised the pause 10 days later on but included a cautioning to directions for its usage.

In December, the C.D.C. recommended that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower threats. Coupled with a host of making problems in the United States, some experts stated, the company’s judgment highlighted that the federal government had actually all but crossed out 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 many as were reported when in 2015’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 number of deaths attributed to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have been far fewer, if any, believed deaths due to side results from the mRNA vaccines, federal health authorities have said.

In its announcement, the F.D.A. mentioned more than six cases and near one death attributed to the blood-clotting condition for every single 2 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 gotten a booster dose, according to the C.D.C.’s data. By comparison, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

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