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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, pointing out safety concerns.

The firm stated 60 cases of a serious but uncommon blood-clotting disorder have actually been recognized, consisting of nine deaths, out of about 18 million doses administered. The action comes about 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. said that weighing the dangers of Johnson & & Johnson’s vaccine versus the advantages, 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 “clinically proper.” One example would be individuals who experienced an extreme allergic reaction to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal officials have said the mRNA vaccines produced by those business are both much safer and more reliable. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the negative effects, not brand-new data on the rate at which it occurs. However in a sign of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.

Reports that the vaccine can set off 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 paused circulation of the vaccine for a safety assessment. Regulators lifted the time out 10 days later on however added a cautioning to instructions for its use.

In December, the C.D.C. advised that adults looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower risks. Paired with a host of manufacturing troubles in the United States, some professionals said, the company’s judgment highlighted that the federal government had actually all but 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 numerous as were reported when last year’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna recipients has escalated.

The variety 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 actually been far fewer, if any, suspected deaths due to side results from the mRNA vaccines, federal health authorities have said.

In its announcement, the F.D.A. pointed out more than 6 cases and near to one death associated to the blood-clotting condition for every two 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 actually gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

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