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"Among children less than five years of age in the U.S. who arehospitalized due to rotavirus symptoms, approximately one in five is youngerthan six months of age," said Barbara Howe, M.D., Vice President and Director,North American Vaccine Development, GlaxoSmithKline. "With only two doses,ROTARIX allows infants to complete the vaccination series against rotavirusearlier than ever before, which may prevent many of the emergency departmentvisits and hospitalizations that are a burden on families and the healthcaresystem."
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Not only does ROTARIX confer protection at an early age, but clinicaltrials have shown that protection is broad and sustained. ROTARIX isindicated for the prevention of rotavirus gastroenteritis caused by G1 andnon-G1 types (G3, G4, and G9) when administered as a two-dose series ininfants and children. Clinical data published on the two-dose series ofROTARIX show that protection was sustained through the first two years of lifeand was highly efficacious against rotavirus hospitalizations (96%) and severerotavirus gastroenteritis (90%). In addition, ROTARIX was effective againstrotavirus gastroenteritis of any severity (79%). Specifically, significantprotection was demonstrated against severe rotavirus gastroenteritis duringtwo rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%),and G9 (85%), the most commonly circulating rotavirus types in the U.S.
"Studies have shown that naturally occurring rotavirus infection protectsagainst subsequent moderate to severe rotavirus gastroenteritis regardless ofthe infecting serotype," David I. Bernstein, M.D., M.A., Director, InfectiousDiseases; Gamble Program at Cincinnati Children's Hospital Medical Center."ROTARIX was developed to mimic natural infection and to protect againstrotavirus gastroenteritis without regard to serotype."
The FDA's approval of ROTARIX was based on one of the largest clinicaldevelopment plans undertaken by a vaccine manufacturer and includes data fromnearly 75,000 infants. These clinical trials were conducted in the Americas,Europe, Asia and Africa and reflect an ethnically diverse population.
The CDC Advisory Committee on Immunization Practices, the American Academyof Pediatrics, and the American Academy of Family Physicians recommend thatinfants receive routine rotavirus vaccination in order to prevent rotavirusgastroenteritis. ROTARIX will be commercially available in the U.S. in thesecond half of 2008.
About ROTARIX(R)
ROTARIX is an oral live-attenuated human rotavirus vaccine licensed inmore than 100 countries around the world. More than 25 million doses ofROTARIX have been distributed worldwide. The vaccine was developed for theprevention of rotavirus gastroenteritis by mimicking the protective effects ofnatural human rotavirus infection. Naturally occurring human rotavirusinfection provides significant protection against subsequent moderate tosevere rotavirus gastroenteritis regardless of the infecting serotype(s).Five phase III clinical trials were conducted worldw
