The US 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.
The vaccine which was designed to elicit the immune response 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 the vaccine as the only US FDA-approved quadrivalent meningococcal vaccine indicated for persons 2 through 56 years of age and older.
It is the first and only quadrivalent meningococcal vaccine in the US 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, Sanofi said.
The ongoing phase 3 trials are investigating its use in infants as young as 6 weeks of age to better address the worldwide needs for meningococcal disease prevention throughout life.