Saint-Herblain (France), November 23, 2021Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years. The agreement follows the announcement made earlier this month that the EC had approved the APA[1].

Under the terms of the agreement following final review of the volumes by each of the European Union (EU) Member States, Valneva expects to deliver 24.3 million doses during the second and third quarters of 2022, subject to approval of VLA2001 by the European Medicines Agency (EMA). The EC has the option to increase this initial firm purchase order up to a total of 60 million doses, the remainder of which would be delivered in 2023.

Thomas Lingelbach, Chief Executive Officer von Valneva , said, “We are extremely pleased that the European Commission and the Member States have completed this purchase agreement and are eager to help address the ongoing pandemic. We continue to receive messages from people across the world requesting access to an inactivated vaccine. Our Phase 3 results confirmed the advantages often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate can make an important contribution to the global fight against the COVID-19 pandemic.”

Franck Grimaud, Chief Business Officer of Valneva, commented, “I would like to express my thanks to the EC teams and the EU Member States who have placed VLA2001 orders. We are looking forward to getting the rolling review with EMA underway now that the rapporteurs have been appointed. The latest COVID-19 wave in Europe underlines the need for an alternative vaccine and we have some vaccine inventory ready to be used as soon as we receive EMA approval. Confirmation of the EC agreement will also allow us to optimize our manufacturing strategy for VLA2001.”

Valneva reported positive Phase 3 results for VLA2001 in October 2021[2]. VLA2001 demonstrated superiority in terms of neutralizing antibody titer levels against the active comparator vaccine, AstraZeneca’s AZD1222, as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile.

Über VLA2001

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials 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®, nutzt. VLA2001 besteht aus inaktivierten ganzen Viruspartikeln von SARS-CoV-2 mit hoher S-Protein-Dichte, in Kombination mit zwei Adjuvantien, Alum und CpG 1018. Diese Adjuvans-Kombination hat in präklinischen Experimenten konsistent höhere Antikörperspiegel induziert als reine Alum-Formulierungen und eine Verschiebung der Immunantwort in Richtung Th1 gezeigt. Das Adjuvans CpG 1018, bereitgestellt durch Dynavax Technologies Corporation (Nasdaq: DVAX), ist ein Bestandteil des von der US FDA und EMA zugelassenen Impfstoffs HEPLISAV-B® Der Herstellungsprozess für VLA2001, der bereits auf den endgültigen industriellen Maßstab hochskaliert wurde, beinhaltet eine chemische Inaktivierung, um die native Struktur des S-Proteins zu erhalten. Es wird erwartet, dass der Impfstoff VLA2001 Standard-Kühlkettenbedingungen (2 Grad bis 8 Grad Celsius) benötigt.

Über Valneva SE

Valneva ist ein Impfstoffunternehmen, das sich auf die Entwicklung und Vermarktung von prophylaktischen Impfstoffen gegen Infektionskrankheiten mit hohem ungedeckten medizinischen Bedarf spezialisiert hat. Das Unternehmen verfolgt bei der Impfstoffentwicklung einen hochspezialisierten und zielgerichteten Ansatz an und wendet sein tiefes Verständnis der Impfstoffwissenschaft an, um prophylaktische Impfstoffe gegen diese Krankheiten zu entwickeln. Durch Einsatz seines Fachwissens und seiner Fähigkeiten konnte das Unternehmen zwei Impfstoffe erfolgreich vermarkten und mehrere Impfstoffkandidaten schnell in und durch die klinische Entwicklung bringen, darunter Kandidaten gegen Borreliose, das Chikungunya-Virus und COVID-19.

Kontakte für Investoren und Medien

Laetitia Bachelot-Fontaine

VP, Global Communications and European Investor Relations

M +33 (0)6 4516 7099

investors@valneva.com

 

 

 

Teresa Pinzolits

Corporate Communications Specialist

T +43-1-206 20-1116

teresa.pinzolits@valneva.com

 

 

 

 

 

Zukunftsgerichtete Aussagen

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials and regulatory review processes for VLA2001. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based on the current expectations of Valneva 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 materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, including but not limited to the HMG Supply Agreement, and the impact of the COVID-19 pandemic, the occurrence of any of which could substantially harm Valneva’s business, financial condition, prospects and results of operations. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. 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 Announces European Commission Approval of Advance Purchase Agreement for up to 60 Million Doses of Inactivated COVID-19 Vaccine VLA2001

[2] Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001