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GlaxoSmithKline's pediatric MenHibrix vaccine gets "complete response"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

An approval for Glaxo's candidate meningococcal and Haemophilus influenza type b (Hib) combination vaccine MenHibrix (Hib-MenCY) on its June 11 action date might have changed the conversation at the June 23-24 meeting of CDC's Advisory Committee on Immunization Practices, which is engaged in an ongoing debate over whether a meningitis vaccine should eventually be recommended routinely for infants and toddlers (1"The Pink Sheet," Feb. 22, 2010). So far ACIP has had no approved vaccine to recommend. Two meningococcal vaccines are licensed in the U.S.: Sanofi-Pasteur's Menactra and Novartis' Menveo, but neither is approved for people younger than 11. GSK said it is working to address the questions the agency outlined and remains committed to bringing MenHibrix to market in the U.S. The proposed indication for the combination is immunization of infants and toddlers against meningococcal serogroups C & Y, and Hib diseases at two, four, six and 12-15 months of age. By combining the two vaccinations, GSK hopes to offer meningococcal protection without adding another shot to the number given in the first two years

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