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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 refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety concerns.

The firm said 60 cases of a rare however major blood-clotting condition have been identified, including nine deaths, out of about 18 million doses administered. The action happens five 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 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 suitable.” One example would be people who experienced an extreme allergic reaction to the other two vaccines, the company said.

It said the vaccine could also be provided 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 stated the mRNA vaccines produced by those business are both safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known danger of the side result, not brand-new data on the rate at which it takes place. But 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 set off a condition referred to 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 raised the pause 10 days later however included an alerting to directions for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower dangers. Coupled with a host of making problems in the United States, some professionals said, the agency’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 4 times as many as were reported when last year’s time out in distribution was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna recipients has actually skyrocketed.

The number of deaths attributed to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. However there have been far less, if any, thought deaths due to adverse effects from the mRNA vaccines, federal health officials have actually stated.

In its announcement, the F.D.A. cited more than six cases and close to one death credited to the blood-clotting disorder for each 2 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 dose, according to the C.D.C.’s information. By contrast, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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