The US Food and Drug Administration (FDA) announced on Thursday that it has approved the combination vaccine Menhibrix against two potentially life-threatening bacteria that cause meningitis in children after reviewing how effective the vaccine was in hundreds of infants and toddlers.
Menhibrix, manufactured by GlaxoSmithKline Biologicals, based in Rixensart, Belgium, is indicated for infants and toddlers aged 6 weeks through 18 months, to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y, and Haemophilus influenzae type b.
"Menhibrix gives healthcare providers the option of combining Hib immunization with meningococcal C and Y immunization without increasing the number of shots for infants and toddlers, said GSK Vaccines, North America vaccine development, clinical and medical affairs head, vice president, Leonard Friedland.
These bacteria can cause sepsis in the bloodstream ("blood poisoning") and meningitis, especially in young children. Meningitis is inflammation of the lining that surrounds the brain and spinal cord.
Meningococcal and Hib diseases are dangerous because they often develop rapidly and can cause death or serious, life-long damage such as blindness, mental retardation, or amputations.
Karen Midthun, director of the Center for Biologics Evaluation and Research at the FDA, told the press that Menhibrix is:
"… a combination vaccine that can be used to prevent potentially life-threatening Hib disease and two types of meningococcal disease in children. It is the first meningococcal vaccine that can be given starting as young as six weeks of age."
Without vaccination, babies and toddlers under two years of age can be particularly at risk from these illnesses, the early symptoms of which are often difficult to distinguish from other common childhood illnesses, says the FDA.
The vaccine is indicated as four doses starting at 2 months of age, then at 4 and 6 months, with the final dose between 12 and 15 months of age. The first dose can also be given as early as 6 weeks of age, and the last dose as late as 18 months.
The vaccine's effectiveness was tested on several hundred US babies. For the Hib component it was shown to be as effective as another FDA-approved vaccine for invasive Hib disease. The meningococcal component produced antiobodies in sufficient quantity to protect against invasive meningococcal disease caused by serogroups C and Y, said the FDA.
The vaccine's safety was tested in 7,500 babies in the US, Mexico and Australia. The most common side-effects were irritability and fever, and pain, swelling and redness at the injection site.