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WASHINGTON– In yet another obstacle for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its usage to adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, citing security concerns.

The firm said 60 cases of a severe however rare blood-clotting disorder have actually been recognized, consisting of 9 deaths, out of about 18 million dosages administered. The action comes about 5 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 dangers of Johnson & & Johnson’s vaccine against the benefits, it had actually chosen to limit its usage to adults 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 allergic reaction to the other 2 vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those companies are both much safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the negative effects, not new data on the rate at which it happens. In a sign of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition referred to as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities stopped briefly distribution of the vaccine for a security examination. Regulators raised the pause 10 days later but included a warning to guidelines for its usage.

In December, the C.D.C. suggested that grownups looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Paired with a host of making difficulties in the United States, some experts stated, the company’s judgment showed that the federal government had actually all but 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 four times as numerous as were reported when last year’s pause in circulation 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 recipients has increased.

The variety of deaths associated to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have actually been far less, if any, suspected deaths due to adverse effects from the mRNA vaccines, federal health officials have actually 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 2 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 gotten a booster dosage, according to the C.D.C.’s data. By comparison, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Attempting 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 adults, when compared with no vaccine.”