FDA Approves Meningococcal Vaccine for Infants, Toddlers

The FDA has approved the use of Sanofi Pasteur's quadrivalent meningococcal conjugate vaccine, which is marketed as Menactra, in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

The FDA said in an April 22 news release that the safety of quadrivalent meningococcal conjugate vaccine, or MCV4, was evaluated in four clinical studies in which more than 3,700 children received the vaccine. Children were given a two-dose series at ages 9 months and 12 months.

Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in the agency's news release that the highest rate of meningococcal disease occurs in children younger than 1 year of age.

It is not clear when the CDC's Advisory Committee on Immunization Practices will vote on a recommendation related to the vaccine's expanded approval. The committee's next scheduled meeting is June 22-23.

MCV4 already had been approved by FDA for use in people ages 2 through 55 years. A dose is recommended for children (1-page PDF; About PDFs) at age 11-12 years, with a booster dose at age 16 years. Previously unvaccinated teenagers also are recommended to receive one dose, with a booster dose recommended at age 16 through 18 years for those who received their first dose at age 13-15 years. The vaccine also is recommended for people ages 2-55 years in certain high-risk groups.