The US Food and Drug Administration has approved
a biologic license application for MenQuadfi meningococcal (Groups A, C, Y, W) conjugate vaccine. The approval was granted to Sanofi for the prevention of invasive meningococcal disease in persons 2 years and older.
MenQuadfi is the only FDA approved quadrivalent meningococcal vaccine that is indicated for individuals 2 through 56 years of age and older.
The vaccine is the first and only quadrivalent meningococcal vaccine in the United States that uses tetanus toxoid as a protein carrier. It will be made available to health care providers in a ready-to-use liquid formulation.
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.
There are phase 3 trials currently in progress that are assessing MenQuadfi in infants, as young as 6 weeks of age.
Approval of this new vaccine in the US represents an important milestone in the ongoing fight to help protect as many people as possible from meningococcal disease,” said David Loew, executive vice president, Sanofi Pasteur, in a press release. “It is our ambition to make this vaccine available to further expand protection to individuals worldwide.”
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