FDA Approves Glaxo's Rotarix Vaccine in Infants
Posted on: Friday, 4 April 2008, 06:00 CDT
GlaxoSmithKline has announced that the FDA has approved Rotarix vaccine for the prevention of rotavirus gastroenteritis in infants.
Rotarix (rotavirus vaccine, live, oral) will offer protection against the most commonly circulating rotavirus types in the US and allow infants to complete the vaccination series by four months of age. The US Centers for Disease Control and Prevention currently recommends that children complete the rotavirus immunization series by six months of age.
The FDA's approval of Rotarix was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants.
Barbara Howe, vice president and director of GlaxoSmithKline's North American vaccine development, said: "Among children less than five years of age in the US who are hospitalized due to rotavirus symptoms, approximately one in five is younger than six months of age. 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."
Source: Datamonitor
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