2022-09-22-世界卫生组织-8._Influenza_B_Victoria_Lineage_-_Cell_culture-derived_-_Southern_Hemisphere_2023_2页_180kb

This report outlines the development and production guidelines for influenza vaccines for the 2023 Southern Hemisphere season, focusing on Influenza B Victoria lineage strains. Vaccines are based on cell culture-derived candidate vaccine viruses (ccCVVs) or recombinant vaccine antigens, with the reference virus B/Austria/1359417/2021.

WHO Collaborating Centres isolate and perform antigenic and genetic analysis on these viruses, using certified cell lines like MDCK 33016 PF. The ccCVVs have passed compatibility tests but no additional testing, such as for adventitious agents, is done. National or regional control authorities must approve vaccine manufacture, composition, and formulation.

Key antigens and reference materials are listed, including specific strains and their passage levels, with availability from institutes like CDC and VIDRL. Recombinant antigens must closely match the referenced B/Austria/2021-like sequence.

For vaccine production, manufacturers should consult relevant authorities and are directed to order reagents from WHO Essential Regulatory Laboratories, with detailed contact information provided. Additional resources are available via WHO links.

Overall, this defines the standardized process for vaccine development to ensure strain suitability and regulatory compliance for the 2023 Southern Hemisphere influenza vaccination efforts.