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

The firm said 60 cases of a uncommon however major blood-clotting condition have been recognized, consisting of nine deaths, out of about 18 million doses administered. The action happens 5 months after the Centers for Disease Control and Prevention advised 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 versus the advantages, it had actually chosen to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be individuals who experienced a severe allergy to the other two vaccines, the agency said.

It said the vaccine might likewise be provided to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said 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 negative effects, not brand-new data on the rate at which it happens. In a sign 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 thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities paused distribution of the vaccine for a safety assessment. Regulators raised the pause 10 days later but included an alerting to guidelines for its usage.

Then, in December, the C.D.C. suggested that grownups looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower dangers. Combined with a host of manufacturing troubles in the United States, some specialists stated, the firm’s judgment showed that the federal government had actually all but written 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 last year’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has increased.

The number of deaths associated to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have actually been far less, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health authorities have actually stated.

In its statement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting disorder for every 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have now gotten one dose of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new limitations in a positive 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.”