Valneva, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, is the eighth pharmaceutical group with which the Commission has negotiated in relation to COVID-19 vaccine procurement.
The EU officials have already signed contracts with six companies, securing nearly 2.3bn doses, and have also held exploratory talks with Novavax.
Valneva said its vaccine candidate is based on tried and tested technology. VLA2001 is currently the only inactivated vaccine candidate approach against COVID-19 in the EU. Most of the influenza vaccines and many childhood vaccines use this approach.
Valneva will leverage its existing manufacturing platform that is 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; the pharma firm expects to report initial safety and immunogenicity data in April 2021.
Upon analysis of the data, the Saint-Herblain headquartered company said it will select the best dose and commence the second part of the Phase 1/2 clinical development.
Thomas Lingelbach, CEO, 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 VLA2001. Under that deal, if vaccine development is successful, the company said it would provide the UK government with 60 million doses in the second half of the year.
The low down on Valneva’s technology
Inactivated vaccines like VLA2001 use technology that has been around for decades. They contain viruses treated with heat, chemicals or radiation, so they cannot replicate, but can still trigger an immune response.
Valneva says inactivated vaccines could also prove to help people with weakened immune systems who are at greatest risk: population groups that newer vaccines do not yet have much data on. This includes pregnant women, the elderly and certain immunocompromised patients.
“Inactivated vaccine approaches are historically among the safest and most effective vaccine development strategies, with billions having been vaccinated with this technology over the past century,” a Valneva spokesperson told this publication previously.
"These include those with weakened immune systems who are at the greatest risk of COVID-19 infection. We believe having an inactivated vaccine that can be used widely and in those at the greatest risk of COVID-19 makes this approach most appropriate. Additionally, having an inactivated vaccine that has a longer shelf life that does not require special shipping or storing requirements is also optimal to reach all those in need of protection.”
The company outlined how 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, it maintains.
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°- 8°C) added Valneva.
Clinical trial work
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 8, 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 from the present study, further clinical studies may be initiated, said the company.
