The Food and Drug Administration (FDA) has approved MenQuadfiTM Meningococcal (Groups A, C, Y, W; Sanofi Pasteur) Conjugate Vaccine for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in patients aged ≥2 years.
MenQuadfi is a sterile liquid vaccine administered by intramuscular injection that contains Neisseria meningitidis serogroup A, C, W, and Y capsular polysaccharide antigens that are individually conjugated to tetanus toxoid protein. It is the first quadrivalent meningococcal vaccine in the US that uses tetanus toxoid as a protein carrier, however it is not a substitute for routine tetanus immunization.
The approval was based on data from 5 double-blind, randomized, multicenter phase 2 and 3 trials that assessed the safety and immune responses of MenQuadfi in approximately 5000 patients 2 years of age and older. MenQuadfi was evaluated in meningococcal-naïve patients as well as those previously immunized with a quadrivalent meningococcal vaccine.
Results showed that MenQuadfi achieved non-inferior immune responses compared with licensed quadrivalent meningococcal vaccines. Among the majority of meningococcal-naïve patients, MenQuadfi was associated with a vaccine-induced immune response 30 days after administration against each of the 4 meningococcal serogroups (55.4%-97.2%). Among adolescents and adults previously vaccinated, 92.2%–98.2% demonstrated an immune response against each serogroup.
With regard to safety, the most common adverse reactions following a primary dose included injection site pain, myalgia, headache, and malaise. In adolescents and adults, rates of adverse reactions following a booster dose were comparable to those observed following primary vaccination.
MenQuadfi is expected to be available in 2021. The product will be supplied as 0.5mL single-dose, ready-to-use vials in packages of 5.
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