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

The firm stated 60 cases of a serious but rare blood-clotting condition have actually been recognized, consisting of 9 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 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 “medically proper.” One example would be individuals who experienced a severe allergic response to the other two vaccines, the firm said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal authorities 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 reflected the already-known risk of the negative effects, not new data on the rate at which it occurs. In an indication of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

Reports that the vaccine can trigger a condition referred to as thrombosis with thrombocytopenia syndrome have 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 examination. Regulators raised the pause 10 days later but included a warning to instructions for its usage.

Then, in December, the C.D.C. suggested that grownups seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower risks. Coupled with a host of making difficulties in the United States, some professionals said, the firm’s judgment showed that the federal government had all however 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 disorder– or 4 times as numerous as were reported when in 2015’s pause in distribution was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

The variety of deaths associated to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. However there have been far fewer, if any, suspected deaths due to side impacts from the mRNA vaccines, federal health officials have stated.

In its statement, the F.D.A. mentioned more than 6 cases and near 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 dose of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new restrictions 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.”