The vaccine will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age.
The company believes that the vaccine could help prevent many of the 55,000-70,000 hospitalizations by young children that result from rotavirus in the U.S. each year.
Merck already markets Rotateq, a similar product, which is usually given in three doses over the course of six months. Rotateq was Merck's second-best selling vaccine last year with revenue of $525 million.
"With only two doses, Rotarix allows infants to complete the vaccination series against rotavirus earlier than ever before, which may prevent many of the emergency department visits and hospitalizations that are a burden on families and the healthcare system," said Barbara Howe, a company vice president.
The FDA's approval of the vaccine was based on data from nearly 75,000 infants
