This background document was prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 vaccines to inform the discussions of SAGE for Valneva vaccine (VLA2001) at its meeting on 11 August 2022, which resulted in the issuance of the interim recommendations (1) and evidence to recommendation tables (annexes) (2). These are available on the SAGE COVID-19 webpage: https://www.who.int/groups/strategic-advisory-group-of-experts-onimmunization/covid-19-materials.
Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries of the reported interests can be found on the SAGE meeting webpage and SAGE Covid-19 Working Group webpage.
This document refers to the COVID-19 Valneva vaccine (VLA2001) developed by Valneva. It is based on the Valneva core nonclinical and clinical data for regulatory evaluation.
The COVID-19 Valneva (VLA2001) vaccine is a highly purified, inactivated, and adjuvanted whole virus SARS-CoV-2 vaccine. The whole-virion inactivated vaccine is adsorbed to alum with a toll-like receptor 9 agonist (cytosine phosphor-guanine: CpG 1018) adjuvant (3, 4). The two adjuvants increase the magnitude of vaccine-mediated cellular immune response without compromising safety. Following administration, the spike protein of SARS-CoV-2, and other viral surface antigens, stimulate both neutralizing and other functional binding antibodies, as well as cellular immune responses (Th1) directed against the spike and other surface proteins, all of which are thought to contribute to protection against COVID-19. Inactivated vaccines cannot replicate, therefore cannot infect individuals (5).
The vaccine is developed by Valneva’s research and development teams in France and Austria with the marketing authorization holder, Valneva Austria GmbH. As of 11 August 2022, the vaccine has received conditional marketing authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom of Great Britain and Northern Ireland (the United Kingdom) for use in adults aged 18–50 years; standard marketing authorization from the European Medicines Agency for use in adults aged 18–50 years; emergency use authorization from the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain, and that of the United Arab Emirates. The vaccine dossier is currently being reviewed by the national regulatory agency of Malaysia; submissions have been initiated for emergency use listing (EUL) by WHO as well as with the regulatory authorities of Argentina and Thailand (from data on file). In the subsequent text, the vaccine will be referred to as VLA2001.
Source: World Health Organization