2023-09-28-世界卫生组织-3._A_H3N2_-_Egg-derived_-_Southern_Hemisphere_2024_2页_188kb

Influenza Vaccine Summary for 2024 Southern Hemisphere Season

Overview

The development and production of vaccines for the 2024 southern hemisphere influenza season involve Influenza A(H3N2) lineage cells, specifically cell culture-derived candidate vaccine viruses (ccCVVs) or recombinant vaccine antigens.

WHO Involvement and Testing

• WHO Collaborating Centers (CCs) within the Global Influenza Surveillance and Response System (GISRS) isolate viruses using certified cell lines (e.g., MDCK 33016 PF, NIID-MDCK).
• ccCVVs undergo antigenic and genetic analysis, passing hemagglutination inhibition (HI) or virus neutralization (VN) tests against prototype viruses.
• No testing for adventitious agents is conducted by WHO CCs.

Regulatory Approval

• National or regional control authorities approve vaccine composition, formulation, and manufacture in each country.
• Manufacturers must consult authorities on using ccCVVs for production.

Key Antigens and Reference Materials

• The recommended ccCVV is antigenically like A/Massachusetts/18/2022 (MDCK SIAT cell-derived), with GISAID accession number EPI_ISL_16968012.
• Reference antigens are available; for recombinant antigens, the protein sequence must align closely with A/Massachusetts/18/2022.
• Listed ccCVVs include A/California/123/2022, cultured from MDCK 33016 PF cells, available from CDC.

Access and Contacts

• For ordering candidate vaccine viruses or reagents, contact institutes like CDC, CBER, MHRA, NIID, or TGA via provided emails or websites.
• WHO Essential Regulatory Laboratories coordinate reagent orders.

References

• WHO recommendations and candidate vaccine virus listings available on WHO websites.