2022-07-27-世界卫生组织-4._A_H3N2_-_Cell_culture-derived_-_Northern_Hemisphere_2022-2023_2页_185kb

Summary of Influenza A(H3N2) Vaccine Development for 2022-2023 Northern Hemisphere Season

Key Points

• WHO recommends the use of cell culture-derived candidate vaccine viruses (ccCVVs) or recombinant antigens for developing influenza vaccines targeting the Influenza A(H3N2) lineage during the 2022-2023 northern hemisphere flu season.
• WHO Collaborating Centres (CCs) within the Global Influenza Surveillance and Response System (GISRS) isolate and analyze influenza viruses using certified cell lines, such as MDCK 33016 PFa or NIID-MDCK, ensuring adherence to standards like those approved by Novartis/Seqirus or the National Institute of Infectious Diseases (NIID).
• These ccCVVs undergo antigenic and genetic analysis, passing two-way haemagglutination inhibition (HI) or virus neutralization (VN) tests against recommended prototype viruses; however, no comprehensive testing for adventitious agents is performed.
• National or regional control authorities approve the manufacture, composition, and formulation of vaccines in each country; manufacturers should consult these authorities regarding the suitability of ccCVVs or recombinant antigens.
• Specific viral strains used include A/Darwin/6/2021 (accession EPI_ISL_3534319) and A/Darwin/11/2021; recombinant antigen sequences must closely match A/Darwin/6/2021 derived from MDCK-SIAT.
• Contact details for WHO-approved laboratories (e.g., VIDRL, CBER/FDA, NIBSC, NIID, TGA) are provided for vaccine and reagent orders, including specific institutes and email addresses.
• Additional information and reference reagents are available through WHO links, such as for potency testing and general inquiries.