Geneva, Switzerland, 1/24/2006 - Dr. Harvey E. Bale Jr., Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), today made a statement to the Executive Board of the World Health Organization (WHO), setting out the industry’s considerable efforts to prepare to combat pandemic influenza, and requesting that its unique expertise be included in pandemic planning and decision making processes.

The statement read: “Speaking for the industry which researches and develops vaccines and drugs for pandemic influenza, the IFPMA shares the global concern about a possible pandemic influenza and set up the IFPMA Influenza Vaccine Supply International Task Force in February 2002, to address many of the challenges we face today. The research-based pharmaceutical and vaccine manufacturers that comprise the IVS Task Force continue to work around the clock, doing everything they can to develop and test prototype vaccines, to prepare for rapid approval and high-volume production of pandemic vaccines.”

“I would like to inform the WHO and its Member States that there are currently at least 28 prototype vaccines under development around the world by 13 different manufacturers in our IVS task force. Although the H5N1 strain is the current concern, there is no certainty that this will form the basis for the next pandemic strain. Therefore, these prototypes focus on 6 main viral strains (H2N2, H5N1, H5N3, H7N1, H7N7 & H9N2), using a range of vaccine types (inactivated subunit, inactivated surface antigen, inactivated split virus, inactivated whole virion, live attenuated, whole virion & virosomal). While many prototype vaccines use egg production techniques, others use cell culture, which could offer the prospect of much quicker scale-up of production.”

“Many different dosing regimens are being tested, along with three different types of adjuvant. Some early clinical trials have been completed and results published, while many more trials are underway. In certain cases, mock-up files have already been submitted to regulatory authorities, in order to speed up the regulatory process for approval of actual pandemic vaccines.”

“Our industry’s efforts go beyond prototype and smart vaccines. Pharmaceutical companies are also scaling up production of the new-generation antiviral medicines, which are needed to buy time while the pandemic strain is identified and tailored vaccines are prepared.”

“Industry and the international community must work together, participating as full partners in key planning and decision-making processes. This is essential for Industry to bring its unique expertise in research and development, manufacturing, safety, regulatory and logistics to bear to the current and future pandemic threats. Thank you, Mr. Chairman.”