Second Rotavirus Vaccine Gets FDA Approval

April 4, 2008

The U.S. Food and Drug Administration has granted approval to Rotarix, manufactured by GlaxoSmithKline Biologicals of Rixensart, Belgium, making it the second oral vaccine against rotavirus on the market in the United States.

FRIDAY, April 4 (HealthDay News) -- The U.S. Food and Drug Administration has granted approval to Rotarix, manufactured by GlaxoSmithKline Biologicals of Rixensart, Belgium, making it the second oral vaccine against rotavirus on the market in the United States, along with Merck's RotaTeq.

The vaccine, administered in two oral doses to infants between 6 and 24 weeks of age, was approved on the basis of studies involving over 24,000 infants. The studies found that Rotarix effectively prevented severe and mild forms of rotavirus-associated gastroenteritis up to the age of 2 years. Adverse reactions included fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting. However, in a clinical trial involving over 63,000 infants, there was no increased risk of intussusception, a potentially life-threatening side-effect that caused an earlier rotavirus vaccine to be withdrawn from the market in 1999.

Unvaccinated children are likely to have at least one rotavirus infection by the age of 5, and the virus causes approximately 2.7 million cases of gastroenteritis every year, of which 55,000 to 70,000 will result in hospitalization and 20 to 60 of which will be fatal.

"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," Jesse L. Goodman, M.D., director of FDA's Center for Biologics Evaluation and Research, explained in a statement.

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