Saint Herbwool (France), May16, 2022 – Valneva SEa vaccine company, today announced that it has received notice from the European Commission (“EC”) of intent to terminate the Advance Purchase Agreement (“APA”) for the inactivated whole virus vaccine candidate against Valneva VLA2001 COVID-19.
The APA gives the EC the right to terminate the APA if VLA2001 has not received marketing authorization from the European Medicines Agency (“EMA”) by April 30, 2022. Based on the terms of the APA, Valneva has 30 days from May 13/2022 to obtain marketing authorization or propose an acceptable remediation plan.
The Company will work with the EC and participating EC Member States to agree on a remediation plan and make VLA2001 available to those Member States that still wish to receive it.
Thomas Lingelbach, CEO of Valneva, commented, “The EC decision is regrettable, especially as we continue to receive messages from Europeans who are looking for a more traditional vaccine solution. We have entered into a dialogue with Member States interested in our inactivated approach. Valneva continues to believe that its vaccine candidate VLA2001 can make an important contribution to the fight against COVID-19 and complement existing vaccines with an inactivated whole virus approach.”
The Company announced on April 25, 20221 that it has received a new list of questions (“LoQ”) from the EMA’s Committee for Medicinal Products for Human Use (“CHMP”). Valneva submitted its responses on May 2, 2022 and believes that they adequately address the remaining questions. If the CHMP accepts Valneva’s responses, the Company will expect to receive a positive opinion from the CHMP no later than June 2022.
VLA2001 received conditional marketing authorization from the Medicines and Healthcare products Regulatory Agency in the UK on April 14, 20222 and emergency use authorizations from the United Arab Emirates Ministry of Health and Prevention and the National Health Regulatory Authority of Bahrain on May 13, 2022 and February 28, 20223respectively.
If the EC ultimately terminates the APP, Valneva will not be required to return any installments received since Valneva has committed the full amount of such installments and the APA does not require repayment of such installments in these circumstances.
Based on the results of the discussions with the EC and the Member States concerned, Valneva will reconsider its financial forecast for the year 2022.
The company will host a conference call with analysts and a webcast at 3:00 p.m. CEST or 9:00 a.m. EDT. Details of the webcast will be available on the Company’s website.
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.
|Media and investor contacts
Vice President of Global Communications and European Investor Relations
M +33 (0)6 4516 7099
Joshua Drumm, Ph.D.
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.
1 Valneva provides regulatory update on its inactivated COVID-19 vaccine candidate
2Valneva receives conditional marketing authorization from the UK MHRA for its inactivated COVID-19 vaccine – Valneva
3 Valneva receives emergency use authorization from Bahrain for its VLA2001 inactivated COVID-19 vaccine – Valneva