EMA accepts submission of Marketing Authorization Application for Valneva’s inactivated COVID-19 vaccine candidate – PharmaLive

EMA accepts submission of Marketing Authorization Application for Valneva’s inactivated COVID-19 vaccine candidate

Holy Herblain (France), May 19, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a company specializing in vaccines, today confirmed that the European Medicines Agency (“EMA”) has accepted the filing of an application for authorization of Marketing Authorization (MA) for Valneva’s Inactivated Whole Virus COVID-19 Vaccine Candidate, VLA2001. Acceptance of the marketing authorization means that VLA2001 progresses from the rolling review process and enters the formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). If the CHMP accepts Valneva’s conditional marketing authorization application, the Company confirms that it will expect to receive a positive opinion from the CHMP in June 2022.

If a positive opinion is issued by the CHMP, the European Commission (EC) will review the recommendation and provide a final decision on MA. If granted by the EC, the centralized marketing authorization would be valid in all member states of the European Union as well as in Iceland, Liechtenstein and Norway.

Thomas LingelbachChief Executive Officer of Valneva, said: “EMA’s acceptance of the VLA2001 application is an important step towards product approval. We remain fully committed and determined to work together with regulators, European Member States and the European Commission to make more traditional and established COVID-19 vaccine technology available to Europeans.

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 (Nasdaq: DVAX), is a component of HEPLISAV-B approved by the US FDA and EMA.^® 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 and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be realised. significantly different. any future results, performance or achievement expressed or implied by such forward-looking statements. In particular, 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, competition in general, fluctuations currencies, the impact 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.