FDA seeks additional GlaxoSmithKline meningitis vaccine data

Officials with GlaxoSmithKline have announced that the U.S. Food and Drug Administration has requested more information about the company’s experimental meningitis vaccine, MenHibrix, before deciding if they will approve it.

The combination vaccine is meant to provide immunization for infants and toddlers against meningococcal serogroups C & Y, and Haemophilus influenzae type b (Hib) diseases at two, four, six and 12 to 15 months of age.

Both meningococcal and Hib diseases are caused by potentially deadly bacteria that can lead to meningitis and other very serious complications.

GlaxoSmithKline's original submission to the FDA included data from random multicenter studies conducted in five countries with more than 9,000 infants. The vaccine demonstrated immunogenicity with a safety profile comparable to other US-licensed Hib vaccines in infants and toddlers when administered at two, four, six and 12 to 15 months of age, GlaxoSmithKline officials told

Company officials added that they “will work to respond to the questions posed by FDA” and “remain committed to making this vaccine available in the United States.”

Company officials said the combination vaccine, if approved, will be administered in accordance with the existing CDC-recommended Hib vaccination schedule without increasing the number of shots given in the first two years of life.