Informal consultation on regulatory preparedness for human pandemic influenza vaccines, 14-15 June 2007, Geneva, Switzerland
Summary and meeting documents
Welcome and purpose of the meeting - Dr Okwo-Bele
List of participants
Guidelines on regulatory preparedness for pandemic influenza vaccines
Summary and recommendations
Strategies to shorten the time between emergence of a pandemic influenza virus and the availability of a safe and effective vaccine are of the highest priority. One strategy is to promote international convergence on regulatory matters of quality, safety and efficacy of human pandemic influenza vaccines. Co-sponsored by the governments of Japan and Spain, the Department of Immunization, Vaccines and Biologicals at WHO convened a workshop on 14-15 June 2007, in Geneva, Switzerland.
Experts from 21 countries representing national regulatory authorities, national control laboratories, academia, public health institutions and industry reviewed draft WHO guidance that had been developed in two previous meetings and the meeting considered modifications in light of public comments received. Updates from regulatory authorities and industry perspectives on the state of the art in human pandemic influenza vaccine quality, safety, efficacy and post-marketing surveillance were also presented and discussed. Many outstanding issues were resolved and remaining and new ones were identified. Remaining unresolved issues of pandemic influenza vaccine regulation included the development of recommendations for WHO pre-qualification of pandemic influenza vaccines, and agreement on immunogenicity criteria to assess candidate pandemic vaccines.
The current regional/country regulatory capacity and preparedness to perform influenza vaccine batch release will be determined by a survey of National Control Laboratories to be conducted in the second half of 2007. The outcome of the survey may also help identify ways to streamline vaccine batch release procedures that build mutual confidence between regulatory authorities of different countries. A need for follow up workshops with National Regulatory Authorities to explain the guidelines aiming at wide adoption was also identified.
The outcome of this consultation on regulatory preparedness for human pandemic influenza vaccine goes beyond the preparation of guidelines. The process is creating a global network of key players engaged in pandemic influenza vaccine regulation. A revised version of the draft WHO document on regulatory preparedness for pandemic influenza vaccines will be available for review by the Expert Committee on Biological Standardization in October 2007.