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FDA APPROVES ROTARIX(R) [Rotavirus Vaccine, live, oral], THE FIRST VACCINE LICENSED TO COMPLETE THE ROTAVIRUS IMMUNIZATION SERIES BY FOUR MONTHS OF AGE
Date:4/3/2008

Vaccine Offers Early Protection with Only Two Doses Against the Most

Commonly Circulating Rotavirus Types in the U.S.

PHILADELPHIA, April 3, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved ROTARIX(R) [Rotavirus Vaccine, live, oral] for the prevention of rotavirus gastroenteritis in infants. ROTARIX 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. Since rotavirus disproportionately affects young children -- severe rotavirus diarrhea and dehydration can occur as young as three months of age -- ROTARIX could help prevent many of the 55,000-70,000 hospitalizations by young children that result from rotavirus in the U.S. each year.

"Among children less than five years of age in the U.S. who are hospitalized due to rotavirus symptoms, approximately one in five is younger than 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 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."

Not only does ROTARIX confer protection at an early age, but clinical trials have shown that protection is broad and sustained. ROTARIX is indicated for the prevention of rotavirus gastroenteritis caus
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SOURCE GlaxoSmithKline
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