Informal consultation on technical specifications for a (WHO) international H5N1 vaccine stockpile, 17-18 October 2007, Geneva, Switzerland
Summary and meeting documents
This consultation was held to discuss technical specifications for a WHO international H5N1 vaccine stockpile. The objectives of the meeting were to develop consensus on vaccine quality, safety and efficacy specifications; regulatory pathways; and logistical specifications for the proposed stockpile. The need for additional studies and guiding principles for access to the stockpile were also discussed. This was not a decision making meeting but rather a meeting to develop options for consideration by WHO.
Representatives from Ministries of Health, National Regulatory Authorities, National Control Laboratories, Influenza Reference and Collaborating Centres, industry, academia, non-governmental organizations, WHO, and members of the Global Action Plan (GAP) to increase pandemic influenza vaccine supply attended the meeting. The meeting Chairperson was Dr. Gary Grohmann from the Therapeutic Goods Administration, Australia and the Rapporteur was Ms. Stephanie Hardy, seconded staff from the Biologics and Genetic Therapies Directorate, Health Canada to WHO.
It was stressed that stockpiled vaccines would not be intended for mass immunization programs but rather for vaccination of a small proportion of a population. Furthermore, it was highlighted that decisions on vaccine use from the WHO stockpile rested with the WHO Department of Immunization, Vaccines and Biologicals (IVB)'s Strategic Advisory Group of Experts (SAGE).
Nevertheless, recommendations for the establishment, maintenance, operation, and governance of a WHO international H5N1 human influenza vaccine stockpile were provided. Considerations for further studies, country preparedness to receive stockpiled vaccines, and ethical issues were discussed. The conclusions of this meeting were presented to GAP on 19 October 2007 and to SAGE on 6-8 November 2007 for decision-making. A detailed final report with recommendations can be accessed at this site.