Valneva Provides Update on European Whole Virus Inactivated Vaccine Program Against COVID-19 VLA2001
Saint Herbwool (France), June10, 2022 – ValnevaSE (Nasdaq: VALN; Euronext Paris: VLA), a vaccines company, today provides an update on its European inactivated whole virus COVID-19 vaccine candidate VLA2001.
Following receipt of the Notice of Intent from the European Commission (EC) to terminate the Advance Purchase Agreement (APA)1Valneva has proposed a remediation plan, which is now the subject of further discussion within the EC and among participating member states.
Some Member States have confirmed their interest in having an adjuvanted inactivated whole virus vaccine solution in their portfolio. However, the preliminary and unofficial volume indications received from the EC would not be sufficient to ensure the sustainability of Valneva’s COVID-19 vaccine program. It would also hamper future development of the program beyond the current product profile.
If these indications are confirmed, Valneva will not be able to conclude an amendment to the APA which would allow a reduced order, and the EC is therefore likely to terminate the agreement. As a result, Europeans would not have access to Valneva’s VLA2001 inactivated vaccine.
Thomas Lingelbach, CEO of Valneva, commented: “We hope that the EC and its Member States will continue to assess the potential benefits of an inactivated vaccine. There is emerging evidence that hybrid immunity – derived from a combination of vaccination and natural infection – increases protection against the development of severe COVID-19 caused by different variants of concern, and our inactivated vaccine closely mimics that. natural infection by exposing vaccinees to the whole of inactivated SARS. CoV-2 virus. Additionally, market research in six European countries has indicated material interest in an inactivated COVID-19 vaccine for primary or booster vaccination. We continue to receive messages from people looking for more traditional vaccine technology and we hope to receive a significant order to further support public health in Europe.”
In parallel, the regulatory process with the European Medicines Agency (EMA) is continuing as planned. The EMA accepted the filing of the marketing authorization application on May 19, 20222 and the Committee for Medicinal Products for Human Use (CHMP) is expected to take a final vote during the week of June 21, 2022. Valneva also continues to work with agencies outside the European Union for potential future approvals and agreements additional purchases.
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 at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination, including control of 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.
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This press release contains certain forward-looking statements relating to Valneva’s business, including with respect to potential purchase agreements and 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.
1Valneva Receives Notification of European Commission’s Intent to Terminate COVID-19 Vaccine Purchase Agreement – Valneva
2EMA accepts submission of Marketing Authorization Application for Valneva’s inactivated COVID-19 vaccine candidate – Valneva