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

The agency said 60 cases of a severe however rare blood-clotting disorder have been determined, consisting of nine 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. said that weighing the threats of Johnson & & Johnson’s vaccine against the benefits, it had chosen to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be people who experienced an extreme allergy to the other two vaccines, the company said.

It said the vaccine could also be provided to adults who “would otherwise not get 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 business are both safer and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the side result, not brand-new information on the rate at which it takes place. In a sign of the firm’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 understood as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities stopped briefly circulation of the vaccine for a safety examination. Regulators lifted the pause 10 days later on however added a cautioning to instructions for its usage.

Then, in December, the C.D.C. advised that adults seeking a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower threats. Paired with a host of producing difficulties in the United States, some professionals said, the agency’s judgment highlighted that the federal government had all however crossed out 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 4 times as many as were reported when in 2015’s pause in distribution 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 receivers has actually escalated.

The variety of deaths credited to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far less, if any, presumed deaths due to side impacts from the mRNA vaccines, federal health authorities have said.

In its statement, the F.D.A. mentioned more than six cases and close to one death attributed to the blood-clotting condition for every 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 information. By contrast, 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 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.”