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WASHINGTON– In yet another setback for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its usage to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning safety issues.

The firm stated 60 cases of a serious but rare blood-clotting condition have actually been recognized, consisting of nine deaths, out of about 18 million dosages administered. The action happens five 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 risks of Johnson & & Johnson’s vaccine versus 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 “scientifically appropriate.” One example would be individuals who experienced a severe allergy to the other 2 vaccines, the agency 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 officials have stated 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 risk of the negative effects, 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 providing sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities stopped briefly distribution of the vaccine for a security assessment. Regulators raised the time out 10 days later but included a warning to directions for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower risks. Paired with a host of manufacturing difficulties in the United States, some experts said, the firm’s judgment showed 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 four 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 a little more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

The number of deaths credited to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. However there have been far less, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. pointed out more than 6 cases and near to one death credited to the blood-clotting condition for every 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 actually gotten a booster dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new constraints in a favorable 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.”