Holy Herblain (France), May 16, 2022 –Valneva SE VALNVLAa vaccine company, today announced that the United Arab Emirates (UAE) has granted emergency use authorization for Valneva’s adjuvanted inactivated COVID-19 vaccine, VLA2001.
Thomas LingelbachChief Executive Officer of Valnevacommented: “We are extremely satisfied with this new authorization and would like to thank the United Arab Emirates for their confidence. As the only inactivated, whole-virus, dual-adjuvanted COVID-19 vaccine approved by the UAE Ministry of Health and Prevention, VLA2001 could offer an alternative vaccine solution to people in the Emirates. This is our second approval in the Gulf countries, and we hope that further VLA2001 approvals will follow elsewhere.
This clearance follows conditional marketing clearance from the UK MHRA1which was granted last month, and Bahrain’s NHRA Emergency Use Authorization in March 20222.
VLA2001 is currently the only whole virus, inactivated and adjuvanted COVID-19 vaccine in clinical development in Europe. It is intended for active immunization of populations at risk to prevent carriage and symptomatic infection with COVID-19 during the pandemic and for routine vaccination, including against new variants. Additionally, VLA2001 could potentially be suitable for boosting, as repeated booster vaccinations have been shown to work well with inactivated whole-virus vaccines. 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 Adjuvant 1018, supplied by Dynavax Technologies Corporation DVAXis a component of HEPLISAV-B approved by the FDA and EMA in the United States® vaccine. 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).
About Valneva SE
Valneva is a vaccines company focused on the development, production and commercialization of prophylactic vaccines against infectious diseases with significant unmet medical needs. The Company takes a highly specialized and targeted approach to vaccine development, then applies its extensive knowledge of vaccine science to develop prophylactic vaccines against these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a wide range of candidate vaccines in and through the clinic, including candidates against Lyme disease, chikungunya and COVID-19.
This press release contains certain forward-looking statements with respect to Valneva’s business, including with respect to the progress, timing, design, reading of data, expected results and completion of clinical trials of VLA2001 and with respect to the eventual regulatory approval of VLA2001. Furthermore, even if the actual results or developments of Valneva are consistent with the forward-looking statements contained in this press release, such results or developments of Valneva may not be indicative of future results. In some instances, you can identify forward-looking statements by words such as “could”, “should”, “may”, “expect”, “anticipate”, “believe”, “intend”, “estimates”, “aims”, “targets” or similar words. These forward-looking statements are based on Valneva’s current expectations as of the date of this press release and are subject to a number of known risks and uncertainties and unknowns and other factors that may cause actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Valneva’s expectations could be affected by, among other things, uncertainties related to the development and manufacturing of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, general competition, currency fluctuations, impa ct of the global market and The credit crunch in Europe, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this presentation will actually materialize. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
1 Valneva receives conditional marketing authorization from the UK MHRA for its inactivated COVID-19 vaccine – Valneva
2 Valneva receives emergency use authorization from Bahrain for its VLA2001 inactivated COVID-19 vaccine – Valneva