Valneva switches focus to bilateral discussions to supply its inactivated, adjuvanted COVID-19 vaccine candidate VLA2001

ValnevaValneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced it is now focusing on bilateral discussions, on a country by country basis, to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).

This follows the recent announcement on April 6, 2021 of positive initial results from the Phase 1/2 clinical trial of VLA2001[1].

Valneva previously announced the advanced stage of its discussions, which started in the third quarter of 2020, with the EC on January 12, 2021[2]. In September 2020, Valneva announced a collaboration with the UK government to provide up to 190 million doses of VLA2001 through 2025[3], of which 100 million doses have already been ordered.

Thomas Lingelbach, Chief Executive Officer of Valneva, said, "We've committed significant time and effort to try to meet the needs of the central EC procurement process. Despite our recent clinical data, we have not made meaningful progress and have not yet secured a supply agreement. We are therefore now focusing our efforts on those European Union member states, and interested parties outside the EU, who would like to include our inactivated approach within their vaccination strategy. We are convinced that VLA2001 has an important role to play in the future, including boosters or potential modifications to the vaccine to address variants."

Valneva has the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe and is preparing a pivotal, comparative immunogenicity Phase 3 clinical trial expected to commence by the end of April 2021 with the aim of making regulatory licensure submissions in the autumn 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 millions of deaths globally[4]. It has been declared a pandemic by the World Health Organization (WHO).

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. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees 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. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our 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.

1. Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
2. Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19 Vaccine Candidate
3. Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Government
4. https://www.worldometers.info/coronavirus/

Most Popular Now

COVID-19 can trigger self-attacking antibodies

Infection with the virus that causes COVID-19 can trigger an immune response that lasts well beyond the initial infection and recovery - even among people who had mild sy...

Stopping dementia at the nose with combination of …

Dementia is thought to occur when proteins called amyloid-β, tau, and α-synuclein accumulate in the brain and form oligomers. A research group from the Department of Tran...

Treatments in weeks, not months: Scientists develo…

An international team of scientists has created a plan for an accelerated pipeline for developing drug cocktails to battle the COVID-19 pandemic. The pipeline could speed...

COVID-19 - Omicron: resistant to most monoclonal a…

The Omicron variant was detected for the first time in South Africa in November 2021 and has since spread to many countries. It is expected to become the dominant variant...

Scientists identify antibodies that can neutralize…

An international team of scientists have identified antibodies that neutralize omicron and other SARS-CoV-2 variants. These antibodies target areas of the virus spike pro...

Pfizer and BioNTech sign new global collaboration …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new research, development and commercialization collaboration to develop a potential first mRNA-based v...

Novartis and Molecular Partners report positive to…

Novartis and Molecular Partners announced that Part A of the EMPATHY clinical trial(1) that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic...

Bayer and Mammoth Biosciences to collaborate on no…

Bayer AG and Mammoth Biosciences, Inc., which is harnessing the diversity of nature to power the next-generation CRISPR products, today announced a strategic collaboratio...

Amgen and Arrakis Therapeutics announce multi-targ…

Amgen (NASDAQ:AMGN) and Arrakis Therapeutics today announced a research collaboration focused on the discovery and development of RNA degrader therapeutics against a rang...

Leiden University Medical Center and Intravacc to …

Intravacc, a global leader in translational research and development of therapeutic vaccines and vaccines against infectious diseases, today announced a partnership with ...

New Vaxzevria data further support its use as thir…

Positive results from a preliminary analysis of an ongoing safety and immunogenicity trial (D7220C00001) showed that Vaxzevria (ChAdOx1-S [Recombinant]), when given as a ...

AstraZeneca and Ionis close agreement to develop a…

AstraZeneca has closed a global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR-LRX. ...