Sanofi Receives the US FDA’s Approval for its MenQuadfi Meningococcal (MenACWY) Conjugate Vaccine

Shots:

• The US FDA’s approval is based on five P-II & P-III studies assessing MenQuadfi vs licensed quadrivalent meningococcal in ~5000 people aged ≥2yrs. Four studies evaluated MenQuadfi in meningococcal-naïve person and the other study evaluated MenQuadfi in persons prior to immunized with a quadrivalent meningococcal vaccine
• Meningococcal-naïve person showed 55.4%–97.2% vaccine induced response 30 days following vaccination with MenQuadfi while prior vaccinated group demonstrated 92.2%–98.2% immune response against each serogroup. The company is investigating the vaccine in ongoing P-III study in infants as young as 6wks. of age
• The approval marks MenQuadfi as the only US FDA approved quadrivalent meningococcal vaccine indicated for person 2-56yrs. of age and older and is the only vaccine that uses tetanus toxoid as a protein carrier

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Trax Retail