Valneva announces the approval by the European Commission of an advance purchase agreement for a maximum of 60 million doses of the inactivated vaccine against COVID-19, VLA2001 – Zonebourse.com

Saint-Herblain (France), November 10 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a company specializing in vaccines, today announces that the European Commission (EC) has approved an agreement for the supply of up to 60 million doses of VLA2001, its vaccine candidate inactivated against COVID-19, for a period of two years, including approximately 27 million doses in 2022.

Under the current terms of the agreement, the EC has the option, during the year 2022, to increase its initial purchase to a total of 60 million doses to be supplied by the end of 2023. The agreement is expected to increase. be concluded after a final examination, relating in particular to the required volumes, by each of the Member States of the European Union. Today’s announcement follows the conclusion of advanced exploratory discussions with the European Commission that began in January 2021. Vaccine delivery is currently scheduled for April 2022, subject to regulatory approval following favorable advice from the European Commission. Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which is expected to begin the gradual review of data for VLA2001 soon.

Thomas lingelbach, Chairman of the Management Board from Valneva, said, “We are grateful to the European Commission for its support and look forward to contributing to the ongoing fight against the COVID-19 pandemic. We continue to receive messages from people around the world who are waiting for an inactivated vaccine. We are deeply committed to bringing an alternative vaccine solution to market as quickly as possible and we continue to work tirelessly to achieve this. Our Phase 3 results confirmed the benefits often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate could make an important contribution to the global fight against the COVID-19 pandemic. “

Franck Grimaud, Managing Director from Valneva, commented, “I would like to thank the respective teams of the European Commission and Valneva, who have worked diligently on this agreement. We look forward to concluding it and starting the gradual submission of the VLA2001 dossier to the EMA. Our recent Phase 3 data has enabled us to demonstrate the value of VLA2001 and we are confident that further supply agreements may follow on from it. “

Valneva published positive Phase 3 results for VLA2001 in October 2021¹. VLA2001 demonstrated superiority over AstraZeneca’s AZD1222 vaccine in terms of mean neutralizing antibody titers, as well as non-inferiority in terms of seroconversion rate and a better safety profile.

About VLA2001
VLA2001 is currently the only inactivated and adjuvanted COVID-19 vaccine candidate in clinical development in Europe. The indication targeted by VLA2001 is active immunization of populations at risk aimed at preventing virus transmission or symptomatic COVID-19 infection during the current pandemic, as well as potentially routine vaccination including against variants. VLA2001 could also be suitable for booster vaccinations since inactivated vaccines have been shown in the past to be particularly suitable for this type of vaccination. VLA2001 is developed on Valneva’s Vero cell-based platform and leverages Valneva’s Japanese encephalitis vaccine production technology, IXIARO^®. VLA2001 consists of inactivated particles of the SARS-COV-2 virus having a high density of protein S, conjugated to two adjuvants, alum and CpG 1018. In preclinical trials, this combination of adjuvants consistently induced levels of antibodies higher than the alum-based formulations alone and showed a shift in the immune response to Th1 cells. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the HEPLISAV-B vaccine^® approved by the US (FDA) and European (EMA) health authorities. This process, already implemented on an industrial scale, notably includes inactivation with β-propiolactone (BPL) in order to preserve the original structure of the S protein. VLA2001 should only require a standard cold chain (2 to 8 degrees Celsius). ).

About Valneva SE
Valneva is a company specializing in the development and marketing of prophylactic vaccines against infectious diseases generating significant medical needs. Valneva has a highly specialized and targeted approach and uses its expertise in the different modes of vaccination to develop prophylactic vaccines intended to fight against these diseases. The Group has used its expertise and infrastructure to successfully market two vaccines and to rapidly advance a wide range of vaccine candidates in clinical development, and in particular its candidate vaccines against Lyme disease, COVID-19 and the virus. of chikungunya.

Important information
This press release contains certain forward-looking statements relating to the business of Valneva, including with regard to the progress, timing and completion of research or development projects and clinical trials of product candidates, the ability to manufacture and market product candidates and their market acceptance, the ability to protect intellectual property and work without infringing the intellectual property rights of others, performance estimates and future estimates of anticipated operating losses, future income, capital requirements and other additional financing needs. Furthermore, even if the actual results or the development of Valneva are in accordance with the forward-looking statements contained in this press release, these results or developments of Valneva may not be representative of the future. In some cases, you may identify forward-looking statements by words such as “may”, “should”, “expects”, “anticipates”, “believes”, “intends”, “believes”, “aims”. “,” Target “or similar words. These forward-looking statements are based in large part 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 as well as other factors that could make actual results, actual performance or achievements differ materially from future results, future performance or achievements, 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 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, and the ability to obtain or maintain a patent or other intellectual property protection. In view of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will actually be realized. Valneva provides the information contained in this press release as of the date thereof and disclaims any intention or obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or for other reasons.

1 Valneva Announces Positive Phase 3 Results for Its Inactivated and Adjuvanted COVID-19 Vaccine Candidate, VLA2001

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