FDA Approves First Meningococcal Vaccine For Infants

Reuters (5/27, Sunny, Mahatole) reports the FDA has approved Sanofi’s meningococcal vaccine, MenQuadfi (MenACWY), for use in infants as young as six weeks. This marks the first approval of a meningococcal vaccine for this age group, as MenQuadfi is “already approved for individuals aged two years and older to protect against the four most common strains of meningococcal bacteria – A, C, W and Y.” The approval was based “on data from three late-stage studies involving more than 6,000 participants aged six weeks to 19 months, which showed that MenQuadfi was as effective” as GSK’s Menveo “when co-administered with other routine pediatric vaccines.”