Meningitis Vaccine for Infants Wins FDA Approval

Meningitis Vaccine Gets FDA Approval

The meningitis vaccine, Menctra, will now be available to children and infants as young as 9 months of age, according to an announcement made by the FDA late Friday. Meningitis is a life-threatening disease caused by the meningococcus bacteria that most often affects children under the age of 1.

Menctra Expands Its Age Availability

Menctra was originally approved by the FDA in 2005 for meningococcus bacteria prevention in people between the ages of 2 and 55. However, since younger children and infants are most susceptible to this disease, the new age expansion is expected to significantly reduce the overall incidence of meningitis in the United States.

The safety and effectiveness of Menctra was established through four different clinical trials including 3,700 participants. No adverse effects were reported. The most common side effect was injection site tenderness and redness and some children developed mild fevers.

Meningitis and Children

Meningitis is a disease in which the protective barrier to the spinal cord and brain, known as the meninges, becomes inflamed. In young children and infants this inflammation is most often caused by Neisseria meningitidis, also known as the meningococcus bacteria. Early signs of the disease include flu-like symptoms such as fever, headache, stiff neck, nausea, vomiting, and sensitivity to light. Infants, however, may only present with lethargy, irritability, vomiting, loss of reflexes or poor feeding.

In the United States the overall incidence of meningitis is rare, occurring in approximately 2,600 individuals per year. However, if contracted, it progresses quickly and can result in death within hours. Even with prompt intensive antibiotic treatment there is a 15 percent mortality rate and another 20 percent are left with debilitating effects including brain damage, hearing loss, or loss of a limb.


Infants and children are especially susceptible to this disease due to their immature immune systems. Adults with weakened immune systems such as the elderly or those undergoing immunosuppresive treatments along with those living in close community housing such as college dorms are also considered groups at a high risk for meningitis contraction.

Vaccinating Your Child Against Meningitis

Manctra is a two-dose series, the first of which can be administered as early as 9 months of age followed by a second dose three months later. Once the two doses are administered the child will develop a sufficient amount of antibodies to protect against the meningococcus bacteria.

The Center for Disease Control and Prevention (CDC) and American Academy of Pediatrics (AAP) have not yet changed their current recommendations for the meningococcus bacteria immunization schedule. Guidelines state that children should receive their first dose of the vaccine at age 11 to 12. However, it is likely that these guidelines will be updated soon to incorporate the new FDA approval.

This announcement couldn’t have come at a better time as April 23 marks the first day of “National Infant Immunization Week”. The CDC along with the AAP both support this campaign's effort to raise national awareness about the importance of vaccination children against preventable diseases. Recent concerns about the safety of vaccines in children has caused a decline in the number of parents choosing to vaccinate their children – a trend which has now caused an increase in vaccine-preventable disease cases, such as measles. However, extensive studies have proven that these concerns are unfounded. Therefore the CDC and AAP continue to recommend routine vaccinations according to the published Immunization Schedule.

Manctra is manufactured by Sanofi Pasteur Inc.

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