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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 decline to get the Pfizer-BioNTech or Moderna vaccines, citing security issues.

The firm said 60 cases of a rare but major blood-clotting condition have actually 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 recommended Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the risks of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be individuals who experienced an extreme allergic response to the other two vaccines, the firm stated.

It said the vaccine might likewise be offered 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 campaign; federal officials have stated the mRNA vaccines produced by those companies are both safer and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the side impact, not brand-new data on the rate at which it occurs. In an indication 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 known as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities paused circulation of the vaccine for a safety assessment. Regulators lifted the time out 10 days later but included an alerting to instructions for its usage.

In December, the C.D.C. advised that grownups looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower dangers. Coupled with a host of manufacturing problems in the United States, some experts said, the firm’s judgment highlighted that the federal government had 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 4 times as lots of as were reported when in 2015’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna recipients has actually skyrocketed.

The variety of deaths credited to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have been far fewer, if any, presumed deaths due to adverse effects from the mRNA vaccines, federal health officials have actually said.

In its announcement, the F.D.A. pointed out more than 6 cases and close to one death credited 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 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 dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new constraints 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.”