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GEN News Highlights : Jun 15, 2012

FDA Approves GSK’s MenHibrix Meningitis Vaccine

Four-dose infant vaccine protects against Hib and Neisseria meningitidis serogroups C and Y.

FDA approved GlaxoSmithKline’s MenHibrix® (meningococcal groups C and Y and hemophilus b tetanus toxoid conjugate vaccine) for preventing disease caused by Neisseria meningitidis serogroups C and Y and Hemophilus influenzae type b in children aged six weeks to 18 months. The vaccine was developed as to comply with the Centers for Disease Control and Prevention’s recommended immunization schedule for Hib vaccination and to enable vaccination against meningococcal groups C and Y without the need for extra injections.

The MenHibrix vaccination regime involves administration of four doses given at 2, 4, 6, and 12–15 months of age, although the first dose can be given from six weeks of age and the last at up to 18 months of age. Approval of the vaccine was based on data from international clinical trials involving over 7,500 infants and toddlers.

Headquartered in Belgium, GSK Vaccines has over 30 approved pediatric and adult products and another 20 in development, both for therapeutic and prophylactic applications. The vaccines business reported turnover of £3.5 billion in 2011, representing 13% of total GSK turnover.