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

The company said 60 cases of a uncommon but major blood-clotting condition have been determined, including nine 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 risks of Johnson & & Johnson’s vaccine versus the benefits, it had 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 suitable.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those companies are both more secure and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the negative effects, not brand-new information on the rate at which it happens. In a sign of the firm’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition known as apoplexy with thrombocytopenia syndrome have 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 safety assessment. Regulators raised the time out 10 days later on however included a warning to guidelines for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower threats. Combined with a host of manufacturing problems in the United States, some specialists said, the firm’s judgment illustrated that the federal government had all however written 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 4 times as lots of as were reported when last year’s time out in circulation was lifted. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

The number of deaths attributed to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far fewer, if any, presumed deaths due to side impacts from the mRNA vaccines, federal health officials have said.

In its statement, the F.D.A. pointed out more than six cases and close to one death credited to the blood-clotting disorder for each two 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 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.

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