Single-Vial Presentation of Meningococcal Vaccine Menveo Gets FDA Approval

The Food and Drug Administration (FDA) has approved a new ready-to-use single dose vial presentation of Menveo (meningococcal [Groups A, C, Y, W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 10 through 55 years of age. 

The approval was based on immunogenicity data from an observer-blind randomized, multicenter controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT03433482) that compared the safety and immunogenicity of Menveo 1-vial presentation to the Menveo 2-vial presentation in individuals 10 to 40 years of age. The primary endpoint was the adjusted human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against Neisseria meningitidis serogroup A at day 29.

Results showed noninferiority of MenA serogroup hSBA GMTs at 28 days postvaccination for the Menveo 1-vial presentation group compared with the Menveo 2-vial presentation group. Additionally, comparable immune responses against N. meningitidis serogroups C, W-135 and Y as measured by hSBA GMTs were observed. An analysis of safety data showed no notable differences in the frequency or severity of solicited adverse reactions within 7 days after vaccination in individuals who received the 1-vial presentation vs those who received the 2-vial presentation.

Menveo 1-vial presentation will initially be available to US federal customers with broader availability expected in mid-2023. The new 1-vial presentations has a pink cap and does not require reconstitution before use. It is indicated for individuals 10 to 55 years of age.

Menveo is currently available in the 2-vial presentation which requires reconstitution before use. The 2-vial presentation is approved for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 2 months through 55 years of age.

This article originally appeared on MPR