Sanofi announced that its quadrivalent vaccination for meningococcal disease had been approved by the US Food and Drug Administration (FDA) for persons two years of age and older.
The vaccine, known as MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine), will be made available in ready-to-use liquid formulation, allowing medical professionals to administer directly to patients rather than it being necessary to reconstitute the vaccine.
According to the company, the vaccine is the only quadrivalent meningococcal vaccine that uses tetanus toxoid as a protein carrier in the US.
The approval was based on late-stage trials that showed 55.4%-97.2% of patients administered with the vaccine who had not previously received vaccination showed a vaccine-induced immune response after receiving MenQuadfi.
Of those patients who had already received a quadrivalent vaccine, 92.2%-98.2% demonstrated an immune response against each serogroup.
The US guidance is for people to receive a vaccination against meningococcal disease at 11-12 years of age and then a second dose at 16 years of age. According to Sanofi, approximately half of teenagers do not receive the additional second dose.
Sanofi is also conducting Phase III trials in infants as young as six weeks to determine whether it is possible to lower the age requirements.
The company’s application in Europe, among other regions, is still under review.