The National Institutes of Health is attempting to revive an anti-diarrhea vaccine that was pulled off the market five years ago after a life-threatening side effect struck some babies.
At issue is rotavirus, an intestinal infection that kills 600,000 children worldwide each year. In the United States, 3 million children get rotavirus annually, but good medical care ensures only about 40 of them die. In developing countries, however, about one child in every 250 dies of rotavirus.
The first vaccine, called RotaShield, was pulled off the market by its manufacturer in 1999 after 20 U.S. infants, of the almost 1 million vaccinated, suffered a life-threatening bowel obstruction.
Health authorities deemed the rare side effect too risky for Americans because rotavirus is seldom lethal here. Some developing countries, though, complained that the vaccine could have saved at least 100 of their children’s lives for every case of the bowel problem.
New vaccines tested
NIH scientists, who created RotaShield, announced Tuesday they have licensed it to another manufacturer — BIOVIRx of Minneapolis — that will attempt to sell it again.
First use probably will be abroad, said NIH’s Michael Mowatt. But company president Leonard Ruiz said he planned to meet simultaneously with the U.S. Food and Drug Administration and foreign drug regulators, in hopes of marketing globally.
Here, a comeback may be tough: Scientists have been testing new rotavirus vaccine candidates designed to avoid the bowel side effect, but have found parents and pediatricians somewhat reluctant to try them.
There is scientific disagreement about the side effect. The Centers for Disease Control and Prevention has estimated the risk of the bowel obstruction, called intussusception, at one in 10,000 vaccine recipients. The NIH said Tuesday that recent studies suggest it’s more rare, and Ruiz contended there’s no risk when the vaccine is used at the appropriate age.