Sanofi Pasteur Statement on the Discontinuation of Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined
Sanofi Pasteur is discontinuing the production of Menomune®, its quadrivalent A, C, Y and W-135 polysaccharide meningococcal vaccine. Sanofi Pasteur will withdraw the Menomune® vaccine license in the countries where the vaccine is commercialized, including the United States. Sanofi Pasteur has informed the US FDA (CBER) of its decision and is in the process of informing our partners and health authorities worldwide as discontinuation takes place. In the United States, we expect that remaining Menomune® supply will be available to customers until mid-2017. Other quadrivalent meningococcal vaccines available in the US are indicated for patients through 55 years of age who require a meningococcal vaccine.
Sanofi Pasteur’s decision to discontinue the production of Menomune® is not based on the vaccine’s safety, quality, or efficacy. This decision is based on evolving market dynamics leading to an increased interest in quadrivalent meningococcal conjugate vaccines, as well as on manufacturing challenges with maintaining Menomune® production at the highest quality and regulatory standards in the long term.
Sanofi Pasteur will focus its resources on quadrivalent meningococcal conjugate vaccines, including Menactra®, our current meningococcal conjugate vaccine available for persons 9 months through 55 years of age, and our future meningococcal conjugate vaccine, currently in Phase 3 clinical development.
This issue has no impact on Menactra production. Ample supply of Menactra is available to meet all needs and can more than cover any increase in demand from Menomune discontinuation (both in the U.S. and globally).
As a world leader in human vaccines, and the world’s main provider of meningococcal vaccines, Sanofi Pasteur is committed to working with the immunization community to minimize disruptions in current vaccination programs and is confident that current and future quadrivalent meningococcal conjugate vaccines will continue to address this public health need.