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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its usage to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The company said 60 cases of a serious however unusual blood-clotting disorder have actually been recognized, including nine deaths, out of about 18 million doses administered. The action happens 5 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 dangers of Johnson & & Johnson’s vaccine versus the benefits, it had chosen to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be people who experienced a severe allergic reaction to the other 2 vaccines, the agency stated.

It stated the vaccine could likewise be provided to adults 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 officials have said the mRNA vaccines produced by those business are both safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk of the adverse effects, not brand-new information on the rate at which it takes place. However in a sign of the firm’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to financiers.

Reports that the vaccine can activate a condition known as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators lifted the pause 10 days later on but included a warning to guidelines for its usage.

In December, the C.D.C. suggested that grownups seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower dangers. Paired with a host of making difficulties in the United States, some specialists stated, the firm’s judgment highlighted that the federal government had all but composed 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 lots of as were reported when last year’s time out in circulation was raised. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has actually skyrocketed.

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

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

Attempting to cast the tight brand-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.”