Valneva Receives Notice of European Commission’s Intent to Terminate COVID-19 Vaccine Purchase Agreement
Valneva SE, a specialty vaccine company, today announced that it has received a notice from the European Commission (“EC”) of intent to terminate the advance purchase agreement (“APA”) for Valneva’s inactivated whole-virus COVID-19 vaccine candidate VLA2001.
The APA provides the EC with a right to terminate the APA if VLA2001 had not received a 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 a marketing authorization or propose an acceptable remediation plan.
The Company will work with the EC and the participating EC member states to agree to a remediation plan and to make VLA2001 available to those member states who still wish to receive it.
Thomas Lingelbach, Chief Executive Officer 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 started a dialogue with member states who are 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, 2022 that it received a further List of Questions (“LoQ”) from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA. 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 would expect to receive a positive CHMP opinion at the latest in June 2022.
VLA2001 received a Conditional Marketing Authorization from the Medicines and Healthcare products Regulatory Agency in the United Kingdom on April 14, 2022 and Emergency Use Authorizations from the Ministry of Health & Prevention of the United Arab Emirates and from the National Health Regulatory Authority in Bahrain on May 13, 2022 and on February 28, 2022, respectively.
If the EC ultimately terminates the APA, Valneva will not be required to return the down payments received since Valneva has committed the full amount of those down payments and the APA does not require reimbursement of such payments under these circumstances.
Based on the outcome of the discussions with the EC and the relevant member states, Valneva will reconsider its full-year 2022 financial guidance.
The Company will hold an analyst call at 3:00pm CEST or 9:00am EDT.
About VLA2001
VLA2001 is currently the only whole virus, inactivated, 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 addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
Media & Investor Contacts
Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com