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FDA Approves Menhibrix for Bacterial Meningitis

vaccine, childhood immunizations, child health and safety, bacterial meningitis

Meningitis is a bacterial infection that is extremely serious and potentially deadly. The US Food and Drug Administration (FDA) has approved a new vaccine that can be given to young children to reduce the risk of their developing the dangerous disease.

Meningitis is inflammation of the lining that surrounds the brain and spinal cord, collectively known as the meninges. Many viruses and bacteria can cause infection, however bacterial infection is the most serious because they often develop rapidly and can cause death from sepsis (blood infection) or serious, life-long damage such as blindness, mental retardation, or amputations.

"These bacteria can quickly cause significant damage to the developing infant brain very quickly despite the infant's having received excellent medical care," says Morven S. Edwards, M.D., professor of Pediatrics at Baylor College of Medicine. "This is a potentially devastating illness and we still have a large percentage of infants who have poor outcomes after the infection."

Menhibrix, manufactured by GlaxoSmithKline Biologicals in Belgium, combines the Haemophilus influenza type b (Hib) vaccine with a product that prevents invasive disease caused by Neisseria meningitidis serogroups C and Y. The Hib vaccine is already approved and given to infants and toddlers in four total doses at 2 months, 4 months, 6 months and one year. Children who receive this have long-term protection against the illnesses caused by the Hib bacteria, which includes meningitis, pneumonia and infections of the blood, bones and joints.

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The new vaccine provides additional protection without adding another shot to the currently recommended immunization schedule for children. Neisseria meningitidis is another bacterium that can cause meningitis and a major cause of morbidity and mortality during childhood with approximately 2500 to 3500 cases occurring each year in the US. Children under the age of 5 are at greatest risk. Of the twelve serotypes of the bacteria, C and Y strains are among those known to cause epidemics since the bug can be transmitted in the exchange of saliva and other respiratory secretions.

Although Menhibrix will be given at the same intervals as the previous meningitis-prevention vaccine beginning at 2 months, it can be given earlier – at 6 weeks.

Menhibrix was tested in 7,500 babies in the US, Mexico and Australia. The Hib component was shown to be as effective as another already FDA-approved vaccine for invasive Hib disease. The N. meningitidis product was shown to produce antibodies in sufficient quantity to protect against invasive disease for at least 3 years after vaccination.

Another vaccine that has recently been approved by the FDA for meningitis is Menctra, which also protects against inflammation caused by Neisseria meningitides.

US Food and Drug Administration
KA Bryant, GS Marshall. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50.
R. Libster, K. M. Edwards, F. Levent, M. S. Edwards, M. A. Rench, L. A. Castagnini, T. Cooper, R. C. Sparks, C. J. Baker, P. E. Shah. Long-term Outcomes of Group B Streptococcal Meningitis. PEDIATRICS, 2012; DOI:10.1542/peds.2011-3453

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