Sanofi Pasteur, the vaccines division of Sanofi, announced that its quadrivalent vaccines which is used 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.

The UNICEF supply division has been notified of Menomune vaccine’s acceptance by the WHO.

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 good manufacturing practice (GMP) and good clinical practice (GCP). This Menomune vaccine prequalification was performed through a streamlined procedure in which the WHO worked closely with the United States Food and Drug Administration (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 two years of age and older. It is the first quadrivalent meningococcal vaccine pre-qualified by the WHO. The WHO notification to UNICEF states that following the evaluation of consistency of final product characteristics, GMP and quality system audits of the manufacturing facilities, and follow-up of implementation of recommendations made by WHO reviewers during the evaluation, Menomune vaccine has been found acceptable.  It is manufactured in Pennsylvania, USA.

“Sanofi Pasteur’s commitment to help protect against meningococcal disease began almost 40 years ago with the introduction of a monovalent vaccine that offered protection against serogroup A and a bivalent vaccine that offered protection against serogroups A and C,” said Olivier Charmeil, president and chief executive officer, Sanofi Pasteur. “Our commitment to remaining at the forefront of advancing the prevention of meningococcal disease, worldwide, continues today.”

Menomune – A/C/Y/W-135 vaccine was first licensed by the US FDA in 1981. It is now licensed in 17 countries with more than 22 million doses shipped worldwide since it first became available.

“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. “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.”

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.