April 8, 2008 -- A new vaccine approved by the FDA promises to provide earlier protection against a leading cause of potentially deadly diarrhea in children. GlaxoSmithKline's Rotarix vaccine helps prevent rotavirusgastroenteritis, a common childhood condition responsible for as many as 70,000 hospitalizations each year in the United States.
The two-dose vaccine is a liquid taken by mouth and fully vaccinates infants by 4 months of age, 2 months earlier than the existing Rotateq vaccine, which is manufactured by Merck. The CDC recommends that rotavirus vaccination be completed by the time a child is 6 months old. However, one out of every five children admitted to the hospital with such infections is younger than 6 months.
Becoming protected against the disease at an earlier age could reduce the number of emergency room visits made by families. About 2.7 million children in the U.S. develop rotavirus disease every year. Rotavirus-related gastrointestinal illness typically strikes the southwestern U.S. during the late fall and early winter and the Northeast by spring.
"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, says in a news release.
The CDC, The American Academy of Pediatrics, and the American Academy of Family Physicians all recommend rotavirus immunization for infants. According to an FDA news release, "without vaccination, nearly every child in the U.S. would likely be infected at least once with rotavirus by age 5."
Studies involving 24, 000 infants showed that the Rotarix vaccine helped protect against both mild and severe rotavirus-associated gastroenteritis in children under age 2. The vaccine protects against the most commonly circulating strains of rotavirus.
Some children who receive the vaccine may experience side effects including fussiness, irritability, cough, runny nose, fever, lose of appetite, and vomiting.
An earlier rotavirus vaccine manufactured by Wyeth was pulled from the U.S. market after several children developed a potentially life-threatening intestinal condition called intussusception after being immunized. Researchers with GlaxoSmithKline evaluated more than 63,000 infants who received their vaccine and found no increased risk. However, the FDA has requested post-market testing to provide additional safety information.