In a move that links the quadrivalent meningococcal vaccine (MenQuadfi, Sanofi) throughout people’s lifetimes, the FDA has approved the expanded indication for the immunization for children aged 6 weeks to 23 months. The vaccine had previously been approved for people aged 2 years and older.
MenQuadfi becomes the only MenACWY vaccine that can help protect for individuals 6 weeks of age and older, with no upper age limit.
“Invasive meningococcal disease (IMD) remains a major global health challenge because it can strike quickly and with devastating effects, potentially taking a life in less than 24 hours. As infants continue to have the highest risk of IMD, Sanofi considers it an important milestone that the US Food and Drug Administration (FDA) has expanded the indication for MenQuadfi,” a Sanofi spokeperson said in a statement. “With this expanded indication, healthcare professionals can now offer MenQuadfi to infants as young as 6 weeks of age to help protect them against IMD caused by N meningitidis serogroups A, C, W, and Y. Previously, MenQuadfi was approved for use in individuals 2 years of age and older. Now, MenQuadfi becomes the only MenACWY vaccine that can help protect for individuals 6 weeks of age and older, with no upper age limit.”
In terms of dosing, for infants aged from 6 weeks, a 4-dose series at 2, 4, 6 and between 12 and 18 months of age. The first dose may be given as early as 6 weeks. For infants 6 months through 23 months, this is a 2-dose series with the second dose administered in the second year of life and at least 3 months after the first dose. For everyone aged 2 years or older, it is 1 vaccine.
MenQuadfi is available as a fully liquid solution that does not require reconstitution and is supplied in a single-dose vial. FDA approval of MenQuadfi for use across a broad age range was based on a robust clinical research program, which demonstrated safety and efficacy of the vaccine from infancy to adulthood, explained Sanofi.
Since introduction of the first MenACWY conjugate vaccine in 2005, IMD caused by serogroups C, W, and Y has declined by approximately 90% among adolescents and young adults, according to the company.
Trial Data
Immunogenicity results demonstrate non-inferior immune responses, administered with routine pediatric vaccines, compared to currently licensed MenACWY conjugate vaccines. No unexpected safety concerns were found in infants and toddlers (from 6 weeks to 23 months) compared to the safety profile in individuals ≥2 years and other licensed MenACWY conjugate vaccines.
No relevant safety profile differences were observed based on sex or race. The safety profile of 237 infants with a history of preterm birth (31-36 weeks gestational age)** was comparable to infants who had been born full-term, with no new safety concerns or AEs leading to study discontinuation.
Previous FDA Approval
The vaccine was previously FDA approved in April 2020 for people aged 2 years and older. The approval is based upon clinical data from 5 double-blind, randomized, multicenter phase 2 and 3 trials. These studies assessed safety and immune responses following vaccination, with nearly 5000 individuals 2 years of age and older.
In the studies, the vaccine achieved non-inferiority compared with licensed quadrivalent meningococcal vaccines. Four of the studies evaluated the vaccine in individuals without history of a meningitis vaccine; the other study enrolled individuals who were previously immunized with a quadrivalent meningococcal vaccine.
Against each of the 4 meningococcal serogroups, 55.4%—97.2% of meningococcal-naïve individuals had a vaccine-induced immune response 30 days following vaccination with MenQuadfi. Among previously immunized individuals, 92.2%–98.2% demonstrated an immune response against each serogroup.
In clinical studies, the most common side effects following a first dose of MenQuadfi included injection site pain (25.5%—45.2%), muscle ache (20.1%–35.6%), headache (12.5%–30.2%), and tiredness (14.5%–26.0%). According to Sanofi, similar rates of these reactions were observed in both adolescent and adults.
