VLA2001 COVID-19 Vaccine Description
VLA2001 is a Vero-cell-based, highly purified inactivated vaccine candidate against the novel coronavirus SARS-CoV-2 that causes COVID-19 in humans. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018.
Valneva SE's adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and has 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 the final industrial scale, includes inactivation with BPL to preserve the native structure. CpG 1018 is a component of the US FDA-approved HEPLISAV-B® vaccine.
Valneva has designed a process that largely uses this platform regarding upstream- and downstream process steps as plug-and-play with moderate adjustments. The process includes inactivation with BPL to preserve the native structure of the S protein.
The combination with CpG 1018 is expected to induce a strong immune response and has the potential to generate high titers of neutralizing antibodies.
An inactivated SARS-CoV-2 vaccine would be suitable for wide deployment including, particularly vulnerable populations. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees centigrade).
VLA2001 COVID-19 Vaccine History
VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.
The Company announced on April 22, 2020, and it is collaborating with Dynavax Technologies Corporation to evaluate the adjuvant CpG 1018, a component of the U.S. FDA-approved HEPLISAV-B vaccine. The combination with CpG 1018 adjuvant is expected to induce a strong immune response and has the potential to generate high titers of neutralizing antibodies.
On September 14, 2020, Valneva announced Dynavax would supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. And, Valneva has the option to purchase up to an additional 90 million doses through 2025.
In July 2020, Valneva reached an agreement in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine to be manufactured at its facilities in Livingston, Scotland. And a further 30 million to 90 million doses, in aggregate, across 2023 to 2025.
The VLA2001 vaccine candidate is expected to enter clinical studies by the end of 2020 and to reach regulatory approval in the second half of 2021 potentially, said the company.
The VLA2001-201 study announced on December 16, 2020, is a randomized, double-blind trial evaluating the safety and immunogenicity for three dose levels in approximately 150 healthy adults in the UK. Adam Finn, the Chief investigator for the VLA 2001-201 program, Professor of Paediatrics at the University of Bristol, and Consultant at the Bristol Royal Hospital for Children said, “I’m very pleased and proud to be leading the clinical trials effort to bring this vaccine forward in the UK working alongside a solid team across several National Institute for Health Research NHS sites."
"We expect this inactivated vaccine containing two adjuvants could generate a broader immune response," add Finn.
The study will be conducted in study sites across the United Kingdom and is supported by the National Institute for Health Research (NIHR). Last Update Posted: December 30, 2020. Estimated Primary Completion Date: February 15, 2021.
The primary endpoint read-out will be two weeks after completing the two-dose primary immunization (day 0, 21). Subject to the analysis of this data, including selecting the optimal dose currently expected in the early second quarter of 2021, additional trials are expected to commence immediately thereafter.
Thomas Lingelbach, CEO of Valneva, said on January 12, 2021, “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."
On January 28, 2021, the Company announced it had commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate in parallel to the ongoing clinical studies. Thomas Lingelbach, CEO of Valneva, stated in a press release, “We are extremely pleased to have achieved these two important milestones in such a short period of time. Our team in Scotland have done an amazing job to get manufacturing started so quickly. I want to thank the UK Vaccines Taskforce and the National Institute for Health Research, who have played vital roles in the rapid recruitment and enrollment of the volunteers for the clinical study."
The Interim Chair of the UK government’s Vaccines Taskforce Clive Dix said on February 1, 2021, “Valneva’s manufacturing site in Scotland is already up and running, ready to supply their promising vaccine as soon as it has proven to be safe and effective and is approved. To best ensure we have enough successful candidates to ensure maximum coverage of the UK population, the Vaccines Taskforce has invested in seven of the most promising vaccines."
"The further 40 million doses secured through today’s deal significantly bolsters our portfolio and gives us future flexibility should we need to revaccinate any of the UK population. I want to thank everyone involved in the development of this vaccine for the hard work that has helped us reach this point and also to pay tribute to those UK citizens who have volunteered to take part in the important clinical trials of this vaccine.”
Valneva announced it had enhanced its Biosafety Level 3 laboratory capabilities at its sites in Nantes, Vienna, and Livingston, NJ. Assuming that preclinical activities are successful and the requisite financing is in place, Valneva plans to commence clinical studies by the end of 2020 to achieve the first regulatory approval in the second half of 2021, subject to the appropriate regulatory authority requirements.
Saint-Herblain, France-based Valneva SE is a vaccine company specializing in preventing diseases in generating significant or unmet medical needs. Their vision is to contribute to a world where no one dies or suffers from preventable diseases through vaccination.
VLA2001 COVID-19 Vaccine Indication
VLA2001 is indicated to prevent SARS-Cov-2 infection, which causes COVID-19 disease.
Valneva’s inactivated vaccine candidate is expected to have a 2-dose regimen (day 0, 21).
VLA2001 COVID-19 Vaccine News
February 1, 2021 - Valneva SE announced that the UK Government had exercised its option to order 40 million doses of its inactivated, adjuvanted COVID-19 vaccine candidate for supply in 2022. This brings the total volume of the Valneva vaccine ordered by the UK Government to 100 million doses. The UK Government retains options over a further 90 million doses for supply between 2023 and 2025. Furthermore, the Phase 1/2 clinical study is now fully enrolled and is expected to read out within the next three months.
January 28, 2021 - France-based Valneva SE announced it had commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate in parallel to the ongoing clinical studies to optimize the timeline for potential deliveries of the vaccine. The Phase 1/2 clinical study is now fully enrolled and is expected to report initial results in April 2021. A total of 150 healthy adults aged 18 to 55 years have been recruited for the Phase 1/2 study commenced mid-December 2020.
January 12, 2021 - Valneva SE announced it is in advanced discussions with the European Commission to supply up to 60 million doses of its COVID-19 vaccine, VLA2001, the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.
December 16, 2020 - Valneva SE announced a Phase 1/2 clinical study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. The VLA2001-201 study is a randomized, double-blind trial evaluating the safety and immunogenicity for three dose levels in approximately 150 healthy adults. The study will be conducted in study sites across the United Kingdom and is supported by the National Institute for Health Research (NIHR).
September 14, 2020 - Valneva SE announced a vaccine partnership with the UK government for its inactivated COVID-19 vaccine, VLA2001. Under the agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. UK Government then has options for over 40 million doses in 2022 and a further 30 million to 90 million doses, in aggregate, across 2023 to 2025.
September 14, 2020 – Valneva and Dynavax Technologies Corporation announced a commercial partnership for the supply of Dynavax’s CpG 1018 adjuvant for use in Valneva’s SARS-CoV-2 vaccine candidate, VLA2001. Dynavax will supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. Valneva has the option to purchase up to an additional 90 million doses through 2025.
August 5, 2020 - A manufacturing facility in Livingston, West Lothian, United Kingdom, will be at the heart of efforts to produce a new coronavirus vaccine - VLA2001 - thanks to a multi-million-pound joint investment as part of an agreement in principle by the UK government to secure early access to 60 million doses of Valneva’s promising vaccine candidate.
July 20, 2020 - Valneva has reached an agreement in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate. The UK government is expected to contribute to UK clinical studies costs and is negotiating funding to expand Valneva’s Scottish facility.
June 18, 2020 - Valneva SE and Bavarian Nordic A/S announced that they had signed a binding term sheet to establish a partnership for their commercial products' marketing and distribution. Valneva will commercialize Bavarian Nordic’s marketed vaccines under the agreed terms, leveraging its commercial infrastructure in Canada, UK, France, and Austria.
April 22, 2020 - Valneva announced developing VLA2001, an inactivated whole virus vaccine candidate against the novel coronavirus SARS-CoV-2. VLA2001 leverages Valneva’s well-established platform for IXIARO®, its vaccine approved for active immunization to prevent Japanese encephalitis. The Company is also collaborating with Dynavax to evaluate its CpG 1018 adjuvant's potential use as part of the VLA2001 vaccine. This vaccine is expected to enter clinical studies by the end of 2020 and potentially reach regulatory approval in the second half of 2021.
VLA2001 COVID-19 Vaccine Clinical Trial
ClinicalTrials.gov Identifier: NCT04671017 Dose-Finding Study to Evaluate Safety, Tolerability, and Immunogenicity of an Inactivated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults. Last Update Posted: December 30, 2020. Estimated Primary Completion Date: February 15, 2021.
VLA2001-201 is the first-in-human Phase 1/2 study that will evaluate 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 will be recruited. The study will start with an open-label dose-escalation phase.
Following a review of safety data by an independent Data Safety Monitoring Board, the study will be conducted as a randomized, double-blind, multicenter study. VLA2001-201 is conducted in 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.