FDA Approves a Single Vaccine Against Meningococcal Groups A, B, C, W, and Y

The USFDA has approved a vaccine to prevent invasive meningococcal diseases caused by the five most common meningococcal serogroups, namely A, B, C, W, and Y, for individuals of 10 through 25 years of age. This pentavalent vaccine combines the components from two meningococcal vaccines, namely meningococcal group B vaccine (MenB) and meningococcal groups A, C, W-135, and Y conjugate vaccine (MenACWY-conjugate). Phase 3 trial (NCT04440163) data A randomized, active-controlled, and observer-blinded trial demonstrated the safety, tolerability, and immunogenicity of this pentavalent vaccine.

The seroresponse rates to serogroups A, C, W, and Y following two doses of the pentavalent vaccine were found to be non-inferior to that generated after a single dose of MenACWY-conjugate and after two doses of MenB vaccine. Administration Intramuscular use only Two doses (approximately 0.5 ml each) to…