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Valneva SE confirms World Health Organization recommendations for its inactivated COVID-19 vaccine

Valneva SE has confirmed that the World Health Organization (WHO) has issued recommendations for the use of the Company’s inactivated COVID-19 vaccine. WHO’s interim recommendations for the use of the Valneva VLA2001 vaccine were developed based on advice from the Strategic Advisory Group of Experts on Immunization (SAGE) at its extraordinary meeting on August 11, 2022 and published in its reference document. The WHO interim recommendations also include a recommendation for a booster dose of VLA2001 four to six months after the end of the primary series and note that a booster dose of VLA2001 after primary vaccination with ChAdOx1-S (AstraZeneca) may be considered.

WHO may update its interim recommendations to include additional uses of Valneva’s COVID-19 vaccine as new data becomes available. VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine that has received marketing authorization in Europe for use as a primary vaccination course in people aged 18-50 years. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging Valneva’s licensed Japanese encephalitis vaccine manufacturing technology, IXIARO®.

VLA2001 consists of inactivated SARS-CoV-2 whole virus particles with high protein S density, in combination with two adjuvants, alum and CpG 1018. This combination of adjuvants consistently induced higher antibody levels in preclinical experiments than alum-only formulations and showed a shift in immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation, is a component of the HEPLISAV-B® vaccine approved by the FDA and EMA in the United States.

The manufacturing process for VLA2001, which has already been scaled up to final industrial scale, includes chemical inactivation to preserve the native protein S structure. VLA2001 is expected to meet standard cold chain requirements (2 to 8 degrees Celsius). VLA2001 is the first COVID-19 vaccine to receive standard marketing authorization in Europe.

The vaccine has also been granted conditional marketing authorization in the United Kingdom and emergency use authorization in the United Arab Emirates and the Kingdom of Bahrain.