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WASHINGTON– In yet another obstacle for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its usage to grownups who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The agency stated 60 cases of a uncommon but serious blood-clotting disorder have actually been recognized, consisting of nine deaths, out of about 18 million dosages administered. The action happens five 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. said that weighing the threats of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically suitable.” One example would be people who experienced a severe allergy to the other two vaccines, the firm said.

It said the vaccine could also be given to grownups who “would otherwise not receive a Covid-19 vaccine.”

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

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 use, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators raised the time out 10 days later but included a warning to directions for its use.

Then, in December, the C.D.C. suggested that grownups looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Combined with a host of producing troubles in the United States, some experts said, the agency’s judgment highlighted that the federal government had actually all but 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 four times as many as were reported when last year’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has actually escalated.

The number of deaths attributed to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have 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. mentioned more than six cases and near one death attributed to the blood-clotting disorder for every single 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 actually gotten a booster dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least two doses 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 beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”