FRIDAY, April 4 (HealthDay News) -- The U.S. Food and Drug Administration has approved a second oral vaccine for the prevention of rotavirus, an infection that causes vomiting and diarrhea in infants and children.
The Rotarix vaccine is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.
Rotavirus causes an estimated 2.7 million cases of gastroenteritis in U.S. children each year -- and about 55,000 to 70,000 of those children require hospitalization. Between 20 and 60 deaths are attributed to the infection. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5, the FDA said in its late-Thursday announcement.
There are many strains of rotavirus; the new vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains, the agency said.
"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," Dr. Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research, said in a prepared statement released Thursday night.
In studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of gastroenteritis caused by rotavirus during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting, the FDA said.
Rotarix is manufactured by GlaxoSmithKline Biologicals, of Rixensart, Belgium.
In 1999, a different rotavirus vaccine from another manufacturer was voluntarily withdrawn from the U.S. market because of an association with an increased risk of intussusception, or intestinal folding, which can lead to potentially life-threatening intestinal blockage. Intussusception can occur in children who haven't been vaccinated, but to help ensure that Rotarix doesn't increase the risk of intussusception, GlaxoSmithKline Biologicals conducted a study of more than 63,000 infants.
