The regulator has approved Sanofi’s biologics licence application (BLA) for MenQuadfi meningococcal (Groups A, C, Y, W) conjugate vaccine to prevent invasive meningococcal disease in persons aged two and older.
Sanofi Pasteur executive vice president David Loew said: “Meningococcal meningitis remains a major global health challenge because it can strike quickly and with devastating effect, taking a life in less than 24 hours. With the ability to help prevent this disease through vaccination, Sanofi believes one case is one too many.”
MenQuadfi is claimed to be the only FDA-approved quadrivalent meningococcal vaccine to treat persons from two to 56 years old. It is also said to be the first and only quadrivalent meningococcal vaccine in the US that applies tetanus toxoid as a protein carrier.
The approval was based on clinical results from five double-blind, randomised, multicentre phase 2 and 3 trials, which evaluated the safety and immune responses following vaccination with around 5,000 persons two years of age and older.
Four studies assessed MenQuadfi in meningococcal-naïve persons, while the other study evaluated MenQuadfi in persons earlier immunised with a quadrivalent meningococcal vaccine.
According to the company, the majority of meningococcal-naïve trial participants had a vaccine-induced immune response 30 days following vaccination with MenQuadfi, against each of the four meningococcal serogroup.
The MenQuadfi will be provided in a ready-to-use liquid formulation to help healthcare providers eliminate vaccine reconstitution.
The ongoing phase 3 trials are evaluating use in infants as young as six weeks of age to meet the worldwide requirements for meningococcal disease prevention across life.
Sanofi plans to make the MenQuadfi vaccine available for the providers and pharmacies across the in 2021.
Sanofi Pasteur scientific and medical affairs senior director Dr Corey Robertson said: “MenQuadfi’s pivotal clinical trials demonstrated a high immune response across all four serogroups and provides a new vaccine option to help protect an expanded age group.”
Recently, British drugmaker GlaxoSmithKline has joined forces with Sanofi for the development of an adjuvanted vaccine for COVID-19 disease.