Beijing Sinovac Biotech Co Ltd. got official approval from the State Food and Drug Administration (SFDA) on April 2, 2008 to produce pandemic influenza vaccine, which laid a good foundation for the reserves of pandemic influenza vaccine before the holding of the Beijing 2008 Olympic Games.

To prevent the H5N1 bird flu transmission between humans and ensure public health and the successful holding of Beijing 2008 Olympic Games, SFDA has attached great importance to the development progress of pandemic influenza vaccine both at home and abroad, and approved the phase II clinical trial of pandemic influenza vaccine jointly developed by Sinovac Biotech Co Ltd. and Chinese Center for Disease Control and Prevention on April 2007. On March 28, 2008, SFDA initiated the special approval procedure for pandemic influenza vaccine and asked Sinovac Biotech Co Ltd. to make good preparation for the production work of pandemic influenza vaccine, organize production promptly after getting approval.

In view of the complexity in vaccine research and development and the urgency of the pandemic influenza prevention, SFDA implemented early intervention for vaccine R&D, and carried out the registration test of the vaccine simultaneously with the self-inspection of the enterprise. SFDA also initiated the special approval procedure for pandemic influenza vaccine. It is the first time to initiated special approval procedure since the issuing and implementation of SFDA's Special Procedures for Drug Approval.