Valneva receives conditional marketing authorization from the UK MHRA for its inactivated COVID-19 vaccine

Holy Herblain (France), April 14, 2022 –Valneva SE VALNVLAa vaccine company, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization (CMA) for its COVID vaccine candidate -19 inactivated whole virus, VLA2001, for primary vaccination in adults 18 to 50 years of age.

The MHRA has found that VLA2001 meets the required safety, quality and efficiency standards.

Thomas LingelbachChief Executive Officer of Valnevacommented: “We are extremely pleased with this new clearance and would like to thank the MHRA for their confidence. VLA2001 is the only inactivated whole virus COVID-19 vaccine approved in the UK and this clearance could pave the way for the availability of an alternative vaccine solution for the UK population. We continue to receive messages every day from people who are looking for a more traditional vaccine approach. We believe this new approval may also lead to additional marketing authorizations in other regions of the world. I would like to personally thank everyone who has supported us in this endeavor as well as our internal teams for their hard work.”

This new Marketing Authorization is in addition to the Emergency Use Authorization that was granted by the Bahrain NHRA in March 2022¹. A continuous review process is still ongoing with the European Medicines Agency (EMA). In the UK, following the termination of the supply contract with the UK government in September 2021²Valneva is currently in discussions with the Scottish Government to provide up to 25,000 doses to the National Health Service and frontline workers in Scotland³⁴.

About VLA2001
VLA2001 is currently the only whole virus, inactivated and adjuvanted vaccine candidate in clinical trials against COVID-19 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. VLA2001 may also 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 and commercialization of prophylactic vaccines for 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.

Forward-looking statements
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 emergency use authorization from Bahrain for its VLA2001 inactivated COVID-19 vaccine – Valneva
2 Valneva Receives Notice of Termination of COVID-19 Vaccine Supply Agreement by UK Government – ​​Valneva
3 Valneva and Scottish Enterprise in advanced discussions for a major grant for the completion of the Livingston site – Valneva
4 Valneva receives up to £20m from Scottish company to advance vaccine development – ​​Valneva

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