Valneva Receives Marketing Authorization in Europe for Inactivated Whole Virus COVID-19 Vaccine… | New

VLA2001 becomes the first COVID-19 vaccine to receive standard marketing authorization in Europe

Saint Herblain (France), June 24, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a company specializing in vaccines, today announces that the European Commission (EC) has granted marketing authorization market in Europe for Valneva’s inactivated whole virus COVID-19 vaccine, VLA2001, for use as a primary series in people aged 18 to 50.

With this approval, VLA2001 becomes the first COVID-19 vaccine to receive standard marketing authorization in Europe. The marketing authorization will cover the 28 Member States of the European Union as well as Iceland, Liechtenstein and Norway.

Thomas Lingelbach, Chief Executive Officer of Valneva, said: “We are extremely pleased that the EC has granted full marketing authorization for VLA2001, the only inactivated whole virus COVID-19 vaccine available in Europe. Once again, we have shown that Valneva has the expertise to take a vaccine from the test bench to the market. Since we started working on VLA2001, we have continued to receive messages from Europeans who are waiting for more traditional vaccine technology. Now that we have received this full marketing authorization, we hope that the EC and its Member States will place orders that reflect this request. 15% of Europeans over the age of 18 are not yet vaccinated1, and we believe that the availability of our inactivated vaccine could increase vaccination coverage and have a significant impact on public health.

The EC approval follows yesterday’s recommendations from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to grant marketing authorisation. This new marketing authorization in Europe follows a conditional marketing authorization in the United Kingdom, which was granted in April 20222, and an emergency use authorization granted in the United Arab Emirates and in Bahrain in May 2022 and March 2022, respectively.

About VLA2001

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 (Nasdaq: DVAX), is a component of the HEPLISAV-B® vaccine approved by the US FDA and EMA. 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 relating to Valneva’s business, including with respect to the potential 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.

1EMA press briefing of May 5, 2022:https://www.youtube.com/watch?v=C5DL66-Fb0Q

2Valneva receives conditional marketing authorization from the UK MHRA for its inactivated COVID-19 vaccine – Valneva

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