Workshop on International Regulatory Capacity Enhancement for Influenza Vaccines (WIRCEIV)
June 8-10, 2011
Sao Paulo, Brazil
The World Health Organization (WHO), the U.S. Department of Health, and Human Services (HHS) and other like-minded organizations and governments are committed to assisting in the creation of regionally-based, independent and sustainable vaccine production capacity in developing and emerging economy countries through capacity building and technology transfer. As a means of initiating a coordinated discussion among the international community regarding this shared goal, WHO and HHS convened the Sustainable Influenza Vaccine Production Capacity Stakeholders’ Workshop in Washington D.C. in January 2010. A key theme that emerged during the workshop discussions was the fact that sustainable vaccine production capacity cannot be achieved in the absence of robust national regulatory systems. A robust regulatory system is one the exhibits the capability to perform their regulatory functions with consistency under a wide range of conditions. There is a need to increase the current investment by WHO in strengthening regulatory oversight in parallel with improving manufacturing facilities.
Building upon the Stakeholders’ Workshop, WHO and HHS hosted the Workshop on International Regulatory Capacity Enhancement for Influenza Vaccines (WIRCEIV). International regulatory capacity enhancement is defined as any efforts related to the development, utilization and enforcement of international scientific regulatory standards that help assure the efficacy, safety and quality of a regulated product. This follow-up workshop differed from the Stakeholders’ Workshop in that it focused on regulatory issues and expanded the scope beyond influenza vaccines. The workshop brought together regulatory experts and policy makers to identify current needs and gaps in vaccine regulatory oversight in developing countries; discuss the development of a coordinated approach to address needs and gaps; generate ideas for leveraging existing resources; discuss the roles and responsibilities of stakeholders; and delineate potential policy issues and options for the short, medium, and long-term.
The WIRCEIV informed the review and refinement of the implementation plan of the WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply (GAP), as part of the formulation of a GAP-2 in 2011. The new implementation plan will align a timeline to stakeholder roles and responsibilities in the creation of sustainable influenza vaccine production capacity worldwide.