2023-03-16-世界卫生组织-2._A_H1N1_pdm09_-_Cell_culture-derived_-_Northern_Hemisphere_2023-2024_2页_198kb

报告摘要

Influenza A(H1N1)pdm09 Vaccine Candidate Development Summary

Overview: The World Health Organization (WHO) Collaborating Centres (CCs) within the WHO Global Influenza Surveillance and Response System (GISRS) isolate human influenza viruses using certified cell lines for developing vaccines targeting the 2023-2024 northern hemisphere influenza season. These efforts involve cell culture-derived candidate vaccine viruses (ccCVVs) or recombinant vaccine antigens.
Key Activities:
- Virus isolation is performed by WHO CCs using certified cell lines, such as MDCK 33016 and NIID-MDCK, derived from approved sources.
- Antigenic and genetic analysis are conducted; ccCVVs undergo two-way haemagglutination inhibition (HI) or virus neutralization (VN) tests against prototype viruses, with unspecified approval barriers.
- Testing for adventitious agents is not performed by WHO CCs.
- National or regional control authorities approve vaccine manufacturers, compositions, and formulations, requiring manufacturer consultation with local authorities.
Specific Viral Strains and Characteristics:
- Reference strains include A/Wisconsin/67/2022 (MDCK SIAT cell-derived), with accession number EPI_ISL_15928563.
- Listed strains: A/Georgia/12/2022 and A/West Virginia/30/2022, both cell-derived reassortants.
- Cell lines used: MDCK 33016 (approved by Novartis/Seqirus), and others from Japan's National Institute of Infectious Diseases.
- WHO recommends that recombinant vaccine antigens match the sequence of A/Wisconsin/67/2022 closely.
Resources and Contacts:
- Information on candidate vaccine viruses and orders is available via WHO links.
- Essential regulatory laboratories include CBER, MHRA, NIID, and TGA.
- Contact details provided for WHO CCs and regulatory bodies.
- Additional details and updated references can be found in specified WHO pages.