FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination

FDA approves MenQuadfi^TM, the latest innovation in meningococcal (MenACWY) vaccination 

• Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.
• Safety and effectiveness studied in five double-blind, randomized clinical trials with nearly 5,000 individuals
• Helps protect an expanded age group and elicits a high immune response across multiple ages
• Under regulatory review in Europe and other countries to help support local immunization efforts

                   

PARIS – April 24, 2020 – The U.S. Food and Drug Administration (FDA) has approved a Biologics License Application for MenQuadfi^TM Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older.

“Meningococcal meningitis remains a major global health challenge because it can strike quickly and with devastating effect, taking a life in less than 24 hours. With the ability to help prevent this disease through vaccination, Sanofi believes one case is one too many,” said David Loew, Executive Vice President, Sanofi Pasteur. “Approval of this new vaccine in the U.S. represents an important milestone in the ongoing fight to help protect as many people as possible from meningococcal disease. It is our ambition to make this vaccine available to further expand protection to individuals worldwide.”

MenQuadfi is Sanofi’s Latest MenACWY Innovation

MenQuadfi was designed to elicit and 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 MenQuadfi as the only U.S. FDA-approved quadrivalent meningococcal vaccine indicated for persons 2 through 56 years of age and older.¹ MenQuadfi is the first and only quadrivalent meningococcal vaccine in the U.S. 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.