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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 grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The firm stated 60 cases of a major however uncommon blood-clotting disorder have actually been determined, including 9 deaths, out of about 18 million doses administered. The action happens five months after the Centers for Disease Control and Prevention recommended 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 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 an extreme allergy to the other 2 vaccines, the company 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 earlier by Pfizer and Moderna in the country’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those business are both more secure and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the side result, not new data on the rate at which it takes place. In an indication of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

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 authorized for emergency situation use, federal authorities paused circulation of the vaccine for a safety assessment. Regulators raised the pause 10 days later but included a warning to instructions for its use.

In December, the C.D.C. recommended that grownups looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower threats. Paired with a host of making difficulties in the United States, some experts said, the firm’s judgment highlighted that the federal government had actually all but composed off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or four times as numerous as were reported when in 2015’s pause in circulation was lifted. 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 number of deaths credited to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have actually been far less, if any, thought deaths due to side impacts from the mRNA vaccines, federal health authorities have actually said.

In its statement, the F.D.A. pointed out more than six cases and close to one death associated to the blood-clotting disorder 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 data. By contrast, 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 new constraints in a positive light, Johnson & & Johnson stated: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”