The US Food and Drug Administration (FDA) approved a combination meningitis vaccine for infants and children ages 6 weeks through 18 months, the agency announced today.
The agency said it is the first meningococcal vaccine that can be taken by children as young as 6 weeks of age.
The vaccine, called Menhibrix, is manufactured by GlaxoSmithKline Biologicals. Menhibrix combines already approved vaccines made by the company 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 less 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 7,500 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 between months 12 and 16. The last dose can be given as early as 6 weeks, and the last, as late as 18 months.
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