FDA Approves New Vaccine to Protect Kids Against Meningitis

Jun 21, 2012 | Robyn Correll Carlyle | Research & Policy

Federal regulators approved a new vaccine that could prevent bacterial meningitis in young children.

Studies show that the combination vaccine, Menhibrix, protects children between six weeks and 18 months from pathogens that can cause bacterial meningitis in toddlers and infants: meningococcal bacteria Neisseria meningitidis groups C and Y, and Haemophilus influenzae type b (Hib).

“It is the first meningococcal vaccine that can be given starting as young as six weeks of age,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. The Food and Drug Administration approved the vaccine on June 14.

Meningitis is a serious condition where the protective membranes lining the brain and spinal cord (known as meninges) become inflamed. It can be caused by a variety of pathogens, such as bacteria, viruses, parasites and funguses, and other non-infectious causes like drugs and injury.

Bacterial meningitis is an often-severe form of meningitis caused by certain bacteria. N. meningitidis and Hib are among the most common causative agents of bacterial meningitis in children and infants. Others include Streptococcus pneumoniae and Escherichia coli.

It is important to note that while bacterial meningitis can be caused by meningococcus, having meningococcal disease does not necessarily lead to a meningitis diagnosis. It simply means that a person is infected with the specific bacterium N. meningitidis.

Antibiotics are available to treat bacterial meningitis if taken as soon as possible. But even with early diagnosis and access to antibiotic treatment, meningitis can have devastating consequences, such as learning disabilities, hearing loss and brain damage. Children under the age of two are particularly vulnerable.

Menhibrix is distributed in a four-dose series at two, four, six and 12 through 15 months of age, but can be given as early as six weeks or as late as 18 months.

Developed to adhere to the Centers for Disease Control and Prevention’s immunization schedule for children, Menhibrix provides protection against both Hib and meningococcus without adding an additional shot to the regimen. It can also be given at a younger age than currently available options – at six weeks versus two months – meaning earlier protection for small children.

Clinical trials of roughly 7,500 toddlers and infants over a period of seven years were conducted to evaluate its effectiveness and safety. These trials showed that Menhibrix produced sufficient antibodies against meningococcal groups C and Y to protect children against the bacteria for at least three years. Results also indicated that the protection produced against Hib was as effective as a currently available vaccine already approved by the FDA.

Side effects included pain at the injection site, drowsiness, loss of appetite and irritability.

Both N. meningitidis and Hib are spread from person-to-person through respiratory droplets and throat secretions of those who are infected. Close contact over a long period of time can facilitate transmission.

Twelve serotypes of N. meningitidis have been identified, and six (A, B, C, W135, X and Y) are known to cause epidemics. The Disease Daily reported on another meningococcal vaccine in January that could potentially protect against N. meningitidis group B, but it has yet to be approved by the FDA.

Menhibrix is manufactured by GlaxoSmithKline Biologicals.