FDA Limits Authorized Use of Johnson & Johnson Vaccine

If they can, adults should get Moderna or Pfizer coronavirus shots, agency says
By Bob Cronin,  Newser Staff
Posted May 5, 2022 7:05 PM CDT
FDA Limits Authorized Use of Johnson & Johnson Vaccine
Vials of the Johnson & Johnson COVID-19 vaccine sit at a pharmacy in Denver last year.   (AP Photo/David Zalubowski, File)

Referring to new data on blood clots, the Food and Drug Administration announced limits Thursday on who should and should not be administered Johnson & Johnson's coronavirus vaccine. Only adults unable to receive other vaccines instead, either because the products are inaccessible or they're not clinically appropriate, are authorized to receive the Johnson & Johnson shot, the Washington Post reports. The agency has urged for months that people get Pfizer or Moderna shots instead, per the AP. The Centers for Disease Control and Prevention said the same thing in December.

"This is not a new safety signal—it is based on updated information showing that it is a persistent safety signal," said Peter Marks, the FDA's top vaccine official. The issue is the potentially fatal blood clotting and bleeding syndrome, thrombosis with thrombocytopenia syndrome. It's rare, but analysis of data through March 18 found 60 confirmed cases, nine of which were fatal. The syndrome can have long-term health consequences. It surfaces in the first two weeks after a person has had the shot, so Marks said "if you had the vaccine six months ago you can sleep soundly tonight knowing this isn't an issue."

The FDA also will strengthen the warning on the vaccine's "long-term and debilitating health consequences." Still, if unvaccinated people have no other options, Marks said, they should go ahead and get the J&J shot. "We've been careful to say that—compared to no vaccine—this is still a better option," he said. The manufacturer said that there's been no change "in the rate of cases observed" and that, for adults, the outlook for taking the J&J shot still appears favorable "when compared with no vaccine." (Read more Johnson & Johnson stories.)

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