Statement on the antigen composition of COVID-19 vaccines – World Health Organization
Key points:
The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) continues to meet regularly to assess the implications of SARS-CoV-2 evolution for COVID-19 vaccine antigen composition and advise WHO on whether changes are needed to the antigen composition of future COVID-19 vaccines. In May 2023, the TAG-CO-VAC recommended the use of a monovalent XBB.1 descendent lineage, such as XBB.1.5, as the vaccine antigen. Several manufacturers (using mRNA and protein-based and viral vector vaccine platforms) have updated COVID-19 vaccine antigen composition to monovalent XBB.1.5 formulations which have been approved for use by regulatory authorities.
The TAG-CO-VAC reconvened on 4-5 December 2023 to review the genetic and antigenic evolution of SARS-CoV-2, the performance of currently approved vaccines against circulating SARS-CoV-2 variants, and the implications for COVID-19 vaccine antigen composition. The twice-yearly evidence review by the TAG-CO-VAC is based on the need for continued monitoring of the evolution of SARS-CoV-2 and the kinetics of vaccine-derived immunity.
The published and unpublished evidence reviewed by the TAG-CO-VAC included: (1) SARS-CoV-2 evolution, including genetic and antigenic characteristics of earlier and current SARS-CoV-2 variants, and the impact of SARS-CoV-2 evolution on cross-neutralization and cross-protection following vaccination and/or infection; (2) Vaccine effectiveness (VE) of currently approved vaccines during periods of XBB descendent lineage circulation; (3) Antigenic cartography analyzing antigenic relationships of SARS-CoV-2 variants using nave animal sera and human sera following vaccination and/or infection; (4) Preliminary immunogenicity data on the performance of currently approved vaccines against circulating SARS-CoV-2 variants using animal and human sera; and (5) Cellular (T and B cell) immune responses following vaccination and/or infection. Further details on the publicly available data reviewed by the TAG-CO-VAC can be found in the accompanying data annex. Unpublished and/or confidential data reviewed by the TAG-CO-VAC are not shown.
The TAG-CO-VAC acknowledges several limitations of the available data:
Given the current SARS-CoV-2 evolution and the breadth in immune responses demonstrated by monovalent XBB.1.5 vaccines against circulating variants, the TAG-CO-VAC advises retaining the current COVID-19 vaccine antigen composition, i.e. a monovalent XBB.1.5 (e.g., hCoV-19/USA/RI-CDC-2-6647173/2022, GenBank: OQ054680.1, GISAID: EPI_ISL_16134259 or WHO Biohub: 2023-WHO-LS-01, GenBank: OQ983940, GISAID EPI_ISL_16760602) as the COVID-19 vaccine antigen.
Other formulations and/or platforms that achieve robust neutralizing antibody responses against currently circulating variants, including XBB- and BA.2.86 descendent lineages, can also be considered. In accordance with WHO SAGE policy, vaccination programmes can continue to use any of the WHO emergency-use listed or prequalified COVID-19 vaccines.
Given the limitations of the evidence upon which the recommendations above are derived and the anticipated continued evolution of the virus, the TAG-CO-VAC strongly encourages generation of the following data:
As previously stated, the TAG-CO-VAC continues to encourage the further development of vaccines that may improve protection against infection and reduce transmission of SARS-CoV-2.
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Statement on the antigen composition of COVID-19 vaccines - World Health Organization