FDA Approves Combo Meningitis Vaccine for Infants

From FDA Approvals > Medscape Medical News

   Robert Lowes

June 14, 2012 — The US Food and Drug Administration (FDA) has approved a combination meningitis vaccine for infants and children aged 6 weeks through 18 months, the agency announced today.

The FDA said this is the first meningococcal vaccine that can be taken by children as young as 6 weeks of age.

The vaccine, called Menhibrix (GlaxoSmithKline Biologicals), immunizes against 2 types of bacteria: Neisseria meningitidis (serogroups C and Y) and Haemophilus influenzae type B (Hib). Each bacterium can infect the lining that surrounds the brain and spinal cord, according to the FDA.

Both meningococcal and Hib diseases can cause death or serious and permanent damage such as mental retardation and blindness. The diseases can progress rapidly, and their symptoms are hard to distinguish from those of other common childhood conditions, making them particularly dangerous for children younger than 2 years of age.

The FDA determined that Menhibrix is effective based on tests conducted with several hundred US infants and toddlers who received the vaccine. Their immune responses to the Hib component resembled those of infants and toddlers who received a vaccine against invasive Hib disease. Menhibrix also produced antibodies against the meningococcal component at levels, indicating that it would offer protection against meningococcal disease caused by serogroups C and Y of N meningitidis.

The vaccine’s safety was established by a study of roughly 7500 infants and toddlers in the United States, Mexico, and Australia. Pain, redness, and swelling at the injection site; irritability; and fever were common adverse reactions.

Menhibrix is administered in 4 doses at months 2, 4 and 6, with the fourth dose administered between months 12 and 16. The first dose can be given as early as 6 weeks, and the last as late as 18 months.