Regulators in the USA have asked GlaxoSmithKline more information about the company’s investigational vaccine MenHibrix.
The company says it has received a complete response letter from the US Food and Drug Administration for the Biologics License Application for the meningococcal and Hib combination vaccine, MenHibrix. The proposed indication is the immunisation of infants and toddlers against meningococcal serogroups C & Y, and Haemophilus influenzae type b diseases at two, four, six and 12-15 months of age.
GSK noted that the submission included data from studies involving more than 9,000 infants and the vaccine demonstrated immunogenicity “with a safety profile comparable to other US-licensed Hib vaccines”. Meningococcal disease most commonly presents as meningitis and the company noted that 1,000-3,000 cases are reported every year in the USA across all age groups; 300 cases are reported annually in infants and toddlers under two years of age.
GSK said it will “work to respond to the questions posed by the FDA” and “remains committed to making this vaccine available in the USA”.
