European Commission Approves Sanofi’s MenQuadfi: First Ready-to-Use Liquid Quadrivalent Meningococcal Vaccine for Individuals Aged 12 Months and Older

November 23, 2020 /Bio ValleyBIOON/ -- Sanofi recently announced that the European Commission (EC) has approved MenQuadfi, a meningococcal conjugate vaccine, for active immunization in individuals aged 12 months and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. In Europe, meningococcal disease is a rare but highly unpredictable and fatalBacteriasexually transmitted infection, but there are over 3,000 cases of infection annually.

It is worth mentioning that,MenQuadfi is the first quadrivalent meningococcal vaccine approved in Europe to be provided as a ready-to-use, fully liquid formulation.Eliminates the need for vaccine reconstitution by healthcare providers. Sanofi expects MenQuadfi to be launched in multiple European countries from 2021 onward, helping to protect individuals aged 12 months and older.

In terms of U.S. regulatory affairs, this April, MenQuadfi received FDA approval for the prevention of invasive meningococcal disease in individuals aged 2 years and older. Notably,MenQuadfi is a U.S.FDAThe only approved quadrivalent meningococcal vaccine indicated for individuals aged 2 to 56 years and older.This vaccine is also the first and only vaccine in the United States to use tetanus toxoid as a proteinCarrierquadrivalent meningococcal vaccine. The vaccine is provided as a ready-to-use liquid formulation, eliminating the need for reconstitution by healthcare providers.

MenQuadfi is the latest innovation in Sanofi’s meningococcal (MenACWY) immunization portfolio. This vaccine elicits robust immune responses against all four serogroups across multiple age groups and is well tolerated. It is designed to protect an expanded age range. Regulatory reviews for MenQuadfi are currently underway in other countries.

Neisseria meningitidis (Image source: britannica.com)

Invasive Meningococcal Disease (IMD) Remains a Significant Public Health Challenge, its epidemiology is highly unpredictable and varies significantly across different geographic locations over time. In Europe, with the increasing incidence of invasive meningococcal disease (IMD) caused by the highly pathogenic serogroup W, some countries have introduced MenACWY conjugate vaccines into their routine immunization programs. However, significant disparities remain among European countries, leaving unprotected and susceptible populations vulnerable to outbreaks.

In 2018, 3,233 people in Europe were infected with invasive meningococcal disease, and approximately one-tenth died; among all cases, 2,911 were reported as serogroups B, C, W, and Y, with nearly half (47%) being serogroups C, W, and Y. The incidence rate was highest in infants, followed by children under 5 years of age, with another peak observed in the 15–24-year-old age group.

Thomas Triomphe, Head of Sanofi Pasteur, stated, “Meningococcal meningitis remains a significant global health challenge; the disease can be fatal within as little as 24 hours and leave survivors with severe, permanent disabilities. In Europe, there were more than 3,000 cases of invasive meningococcal disease in 2018, half of which were caused by serogroups C, W, and Y. Our goal is to make this vaccine available worldwide, thereby expanding protection to as many people as possible. The European Commission’s approval of MenQuadfi brings us one step closer to achieving this goal.”

MenQuadfi benefits from Sanofi’s latest advances in formulation design, offering optimal stability while maintaining the convenience of a fully liquid vaccine. The vaccine is administered as a single dose and supports primary and booster vaccination across a broad age range, from toddlers aged 12 months to children, adolescents, adults, and older adults. It can also be co-administered with various routine pediatric and adolescent vaccines.

The European Union approved MenQuadfi based on the results of a robust and comprehensive international clinical program, including reliable data from seven pivotal Phase 2 and 3 randomized, active-controlled, multicenter studies. These studies evaluated the immunogenicity and safety of MenQuadfi vaccination, with 6,308 healthy subjects aged 12 months and older receiving a single dose of MenQuadfi. Across all age groups, MenQuadfi was compared with other licensed conjugate vaccines.

The results showed that across all studies and in all age groups, MenQuadfi demonstrated a favorable safety profile, induced high-level immune responses against all four serogroups (A, C, W, Y), and exhibited non-inferiority compared to the control vaccine. In toddlers aged 12–23 months, the most common adverse reactions were irritability and tenderness at the injection site. Among vaccinees aged ≥2 years, the most commonAdverse ReactionsMyalgia and injection site pain. Most of these reactions were mild or moderate in severity.

To better meet the global demand for lifelong prevention of meningococcal disease, Sanofi is currently conducting multiple Phase 3Clinical Trial, an investigation of MenQuadfi was conducted in infants and young children aged 6 weeks and older. (Bioon.com)

Original source: European Commissionapproves MenQuadfi®, the latest innovation in meningococcal (MenACWY) vaccination for individuals 12 months of age and older