Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.

Valneva's vaccine candidate is based on a proven approach and will leverage the Company's existing manufacturing platform being used for its US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Japanese encephalitis vaccine. VLA2001 entered Phase 1/2 clinical studies in December 2020[1] and Valneva expects to report initial safety and immunogenicity data in April 2021. Upon analysis of the data, Valneva will select the best dose and commence the second part of the Phase 1/2 clinical development. If clinical development is successful, an initial approval may be granted in the second half of 2021.

Thomas Lingelbach, Chief Executive Officer of Valneva, said, "Today's announcement helps to ensure that millions of Europeans potentially have access to a proven and well-established inactivated vaccine approach, upon approval of VLA2001. We are grateful to the European Commission for their support and eager to partner with them to address the ongoing pandemic. We are deeply committed to providing broad access to our inactivated SARS-CoV-2 vaccine candidate and, as we proceed with clinical development, we will simultaneously continue working with partners, including the European Commission and the UK Government, to help us reach that goal. We increasingly see wider recognition that our vaccine will be one that the world cannot do without."

In September 2020, Valneva announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its inactivated vaccine candidate, VLA2001[2]. Under the partnership agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021.

About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease

SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused approximately 2 million reported deaths globally. It has been declared a pandemic by the World Health Organization (WHO).

About VLA2001

VLA2001 is Valneva's vaccine candidate against the SARS-CoV-2 virus. 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 cellular immune response towards Th1. VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO?. The process, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. CpG 1018 is a component of the US FDA-approved HEPLISAV-B? vaccine.VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

About VLA2001-201

VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 150 healthy young adults aged 18 to 55 years will be recruited. The study includes an open-label dose-escalation phase and will be conducted as a randomized, double-blind, multicenter study. On January 8th 2021, a Data Safety Monitoring Board (DSMB) gave approval to progress into the study’s full randomization phase. VLA2001-201 is conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208). Following an evaluation of Part A data (i.e., data up to Day 36) from the present study, further clinical studies may be initiated.

About Valneva SE

Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO?/JESPECT? indicated for the prevention of Japanese encephalitis and DUKORAL? indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 500 employees.

1. Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine
2. Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Government