Sanofi Pasteur's Meningococcal Vaccine is Prequalified by the World Health Organization

Sep 04, 2013
By PharmTech Editors

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Sanofi Pasteur, the vaccines division of Sanofi, announced in a press release that one of its quadrivalent vaccines to prevent invasive meningococcal disease has been prequalified by the World Health Organization (WHO). The prequalification procedure accepts Menomune vaccine for purchase by United Nations Agencies, such as UNICEF [The United Nations Children’s Fund].

The purpose of the United Nations prequalification assessment is to provide assurance that candidate vaccines meet WHO recommendations on quality, safety, and efficacy, including compliance with WHO’s recommended standards for GMP and good clinical practice (GCP). This Menomune vaccine prequalification was performed through a streamlined procedure in which WHO worked closely with FDA.

Menomune vaccine is designed for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 for use in persons 2 years of age and older. It is the first quadrivalent meningococcal vaccine prequalified by the WHO.

“The value of a quadrivalent meningococcal vaccine is becoming more and more realized as evidenced by the circulation of the W-135 strain in the western part of the African meningitis belt this past year,” explained Luc Kuykens, MD, MPH, Sanofi Pasteur’s Chief Medical Officer, in the press release. “Menomune is a proven vaccine with a 32-year track record of providing broad protection against this serious disease, so we try to keep a stockpile of the vaccine in case of any outbreaks.”