FDA Mulls Merck & Co., Inc. Rotavirus Vaccine For Infants

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Dec. 14, 2005--Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously that the data from the Phase III clinical trials with 70,000 infants support the efficacy and safety of ROTATEQ(R) (rotavirus vaccine, live, oral, pentavalent), the Company’s investigational vaccine developed to prevent rotavirus gastroenteritis. Rotavirus gastroenteritis is the most common cause of severe dehydrating diarrhea in infants and young children, causing an estimated 250,000 emergency department visits and 500,000 visits to physicians offices each year in the United States.

MORE ON THIS TOPIC