Valneva SE confirmed that the World Health Organization (WHO) has issued recommendations for use of the Company’s inactivated COVID-19 vaccine. WHO’s interim recommendations for use of the Valneva VLA2001 vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) on its August 11, 2022 extraordinary meeting and published in its background document. WHO’s interim recommendations also include a recommendation for a booster dose of VLA2001 four to six months after completion of the primary series and note that a booster dose of VLA2001 following primary vaccination with ChAdOx1-S (AstraZeneca) can be considered.
WHO may further update its interim recommendations to include additional uses of Valneva’s COVID-19 vaccine as new data are made available. VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine which has received marketing authorization in Europe for use as primary vaccination in people from 18 to 50 years of age. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®.
VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation, is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine.
VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius). VLA2001 is the first COVID-19 vaccine to receive a standard marketing authorization in Europe.
The vaccine was also granted conditional marketing authorization in the United Kingdom and emergency use authorization in the United Arab Emirates and Kingdom of Bahrain.
