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

The company said 60 cases of a rare but serious blood-clotting disorder have been recognized, including 9 deaths, out of about 18 million dosages 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 threats of Johnson & & Johnson’s vaccine against the benefits, it had chosen to restrict its usage 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 individuals who experienced a severe allergy to the other 2 vaccines, the firm stated.

It stated the vaccine could likewise be provided 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 authorities have stated the mRNA vaccines produced by those companies are both safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the negative effects, not brand-new data on the rate at which it happens. But 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 trigger a condition referred to as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities paused distribution of the vaccine for a security evaluation. Regulators raised the time out 10 days later but added a warning to instructions for its usage.

In December, the C.D.C. advised that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower dangers. Paired with a host of manufacturing troubles in the United States, some professionals stated, the firm’s judgment illustrated 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 disorder– or four times as numerous as were reported when last year’s time out in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has increased.

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

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

About 17 million Americans have actually now gotten one dose of Johnson & & Johnson’s vaccine, and another 1.5 million have actually gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new restrictions 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.”