FDA approves MenQuadfi, the latest innovation in meningococcal (MenACWY) vaccination .- Sanofi
The FDA has approved a Biologics License Application for MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older.
“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,” said David Loew, Executive Vice President, Sanofi Pasteur. “Approval of this new vaccine in the U.S. represents an important milestone in the ongoing fight to help protect as many people as possible from meningococcal disease. It is our ambition to make this vaccine available to further expand protection to individuals worldwide.”
MenQuadfi was designed to elicit and demonstrated a high immune response across all four serogroups for multiple ages and was well tolerated. MenQuadfi is intended to protect an expanded age group. Licensure marks MenQuadfi as the only U.S. FDA-approved quadrivalent meningococcal vaccine indicated for persons 2 through 56 years of age and older. MenQuadfi is the first and only quadrivalent meningococcal vaccine in the U.S. that uses tetanus toxoid as a protein carrier. It will be available in a ready-to-use liquid formulation allowing healthcare providers to avoid vaccine reconstitution.
The ongoing Phase III trials are investigating use in infants as young as 6 weeks of age to better address the worldwide needs for meningococcal disease prevention throughout life.
The FDA approval is based on clinical data from five double-blind, randomized, multicenter Phase II and III trials that assessed safety and immune responses following vaccination, with nearly 5,000 persons 2 years of age and older. Based on study objectives, immune responses elicited by MenQuadfi achieved non-inferiority compared to those induced by licensed quadrivalent meningococcal vaccines. Four studies evaluated MenQuadfi in meningococcal-naïve persons; the other study evaluated MenQuadfi in persons previously immunized with a quadrivalent meningococcal vaccine. Against each of the four meningococcal serogroups (A, C, W, Y), the majority (55.4%–97.2%) of meningococcal-naïve trial participants had a vaccine-induced immune response 30 days following vaccination with MenQuadfi. Among adolescents and adults previously vaccinated, 92.2%–98.2% demonstrated an immune response against each serogroup.
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%). In adolescents and adults receiving a MenQuadfi booster, similar rates of these reactions were observed..
