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GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix(R) (Rotavirus Vaccine, Live, Oral)
Date:2/20/2008

If Approved, Rotarix Would be the Only Vaccine Indicated to Prevent Rotavirus Caused by the Five Most Commonly Circulating Types, Offering Completion of the Vaccination by Four Months of Age, with Only Two Doses

GAITHERSBURG, Md. and PHILADELPHIA, Feb. 20 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) provided a favorable recommendation for the Company's oral rotavirus candidate vaccine, ROTARIX(R) [rotavirus vaccine, live, oral], to prevent rotavirus gastroenteritis in infants. The Committee voted unanimously (12-0) in favor of GSK's data being adequate to support the efficacy of the candidate vaccine. The Committee voted 11-1 in favor of GSK's data being adequate to support the safety of the candidate vaccine.

If approved by the FDA, GSK's candidate vaccine would allow for completion of the rotavirus vaccination series by four months of age and could be integrated into the current vaccine schedule at the two and four month immunization visits. Severe rotavirus diarrhea and dehydration can occur as young as three months of age. Of children under five years of age in the U.S. hospitalized with rotavirus, approximately one in five are younger than six months of age. Rotavirus infects virtually every child in the U.S. by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide.

The candidate vaccine contains a live, weakened form of human rotavirus derived from the most common human rotavirus strain. "If approved, we believe ROTARIX, which was developed to mimic the protective effects of natural infection, would offer an important op
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SOURCE GlaxoSmithKline
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