Peter Marks, the FDA’s vaccines lead, told STAT the agency reached its decision after a recent review of the data on the vaccine revealed another person in this country had died after receiving it — the ninth such death — in the first quarter of the year.
With one death for every 2 million doses given in this country, the FDA decided that is a risk most people don’t need to take, Marks said.
A single-dose product is attractive to people who don’t like to be vaccinated, and cheaper to use for low- and middle-income countries.
But the level of protection the vaccine offered was not as high as that induced by the messenger RNA and in the U.S., people who received the J&J vaccine have since been urged to get mRNA boosters.
The company said it has updated its product sheet to reflect the FDA’s restrictions.
Marks stressed that people who received the J&J vaccine in the past do not need to worry.
He acknowledged the latest announcement won’t change much on the ground in the United States, where few vaccination sites stock the J&J vaccine at this point.