2023-01-15-世界卫生组织-2._A_H1N1_pdm09_-_Cell_culture-derived_-_Southern_Hemisphere_2023_2页_187kb

Influenza A(H1N1)pdm09 Vaccine Development Summary for 2023 Southern Hemisphere Season

Core Content

This document outlines the selection and use of candidate vaccine viruses (ccCVVs) and recombinant vaccine antigens for the development and production of influenza vaccines intended for the 2023 southern hemisphere influenza season. It focuses on the A/Sydney/5/2021 strain, which is derived from MDCK cells and is recommended as a reference for vaccine development.

Main Points

• Candidate Vaccine Viruses (ccCVVs)

  • The ccCVVs are isolated using certified cell lines, specifically:
    • MDCK 33016 PF (approved by Novartis/Seqirus in compliance with Ph. Eur. 5.2.3)
    • NIID-MDCK (developed by the National Institute of Infectious Diseases, Japan)
  • These viruses have undergone antigenic and genetic analysis by WHO Collaborating Centres (CCs) within the WHO Global Influenza Surveillance and Response System (GISRS).
  • Unless otherwise specified, these ccCVVs have passed two-way haemagglutination inhibition (HI) or virus neutralization (VN) tests against prototype viruses matching WHO recommendations.
  • No additional testing, such as for adventitious agents, has been conducted by the WHO CCs on these viruses.

• Recombinant Vaccine Antigens

  • For recombinant vaccine antigens, it is recommended that the protein sequence closely matches that of the A/Sydney/5/2021 (MDCK-derived) strain.
  • This ensures antigenic similarity and effectiveness in vaccine production.

• Candidate Vaccine Viruses Overview

  • A/Sydney/5/2021 (Wild type virus):
    • Developed by VIDRL (Australia)
    • Isolated using MDCK 33016 PF
    • Passage level: P2-P3
    • Accession number: EPI ISL 8767089
  • A/Sydney/5/2021 CVR-115 (Cell reassortant):
    • Developed by Seqirus (Australia)
    • Isolated using MDCK 33016 PF
    • Passage level: P2-P3
    • Accession number: EPI ISL 8767089

• Reference Antigens

  • A freeze-dried reference antigen is available for the A/Sydney/5/2021 strain.
  • Ref Ag Lot number: H1-Ag-2209 (new reagents shown in blue)
  • Unitage (μg HA/ml): 72
  • Available from: CBER/FDA, USA

• Contact Information for Reagent Orders

  • VIDRL: whoflu@influenzacentre.org
  • WHO Essential Regulatory Laboratories:
    • CBER, FDA: CBERshippingrequests@fda.hhs.gov
    • NIBSC (MHRA): standards@nibsc.org or enquiries@nibsc.org
    • NIID (Japan): flu-vaccine@.nih.go.jp
    • TGA (Australia): influenza.reagents@health.gov.au

• Additional Resources

  • For other candidate vaccine viruses and potency testing reagents, visit:
    • https://www.who.int/teams/global-influenza-programme/vaccines/who-recommendations/candidate-vaccine-viruses
  • For general inquiries, contact:
    • GISRS WHO HQ: gisrs-whohq@who.int

Key Information

• The A/Sydney/5/2021 strain is the recommended reference for vaccine development.
• Cell culture-derived viruses are preferred over egg-derived ones for consistency and scalability.
• National or regional control authorities are responsible for approving vaccine composition and formulation.
• Manufacturers should consult these authorities before using ccCVVs for vaccine production.
• Recombinant antigens must closely match the sequence of the reference strain to ensure immunogenicity.
• Contact details for reagent orders are provided for key WHO laboratories and institutes.