VLA2001 COVID-19 Vaccine Description
Valneva SE's VLA2001 (VLA2101) is a Vero-cell-based, highly purified, inactivated vaccine candidate against the novel beta 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 primarily 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 generate high titers of neutralizing antibodies. Thus, 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).
After positive Phase 1/2 results, VLA2001 progresses into a Phase 3 trial study on April 21, 2021. The Cov-Compare (VLA2001-301) study is a randomized, observer-blind, controlled, comparative immunogenicity trial in approximately 4,000 Adults. And, the new VLA2001-304 phase 3 study will be conducted in New Zealand and recruit approximately 150 participants aged 56 years and older (Cohort 1) to generate additional safety and immunogenicity data in this age group following vaccination with VLA2001 (two doses 28 days apart).
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, commented in a press release issued on August 11, 2021, "We have also been working on Variants of Concern as part of our continued efforts to stay ahead of the virus causing COVID-19, especially since we believe that our inactivated, whole-virus platform will be adaptable across variants. Hence we are extremely pleased to be able to invest in this very important additional clinical trial".
On August 23, 2021, Dr. Jaramillo said in a press release, "We are pleased to begin the regulatory review process for our COVID-19 vaccine with the MHRA. Valneva believes that everyone should have access to technology best suited to protect them against this virus. We are working hard to make our vaccine candidate available as soon as possible."
Saint-Herblain, France-based Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) 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 Cell Line
VLA2001 COVID-19 Vaccine uses the following cell lines: Design and Development of VLA2001: Vero Monkey cells; Production: Vero Monkey cells; Confirmatory Lab Tests: not disclosed.
VLA2001 COVID-19 Vaccine History
Valneva SE's VLA2001 is currently the only whole virus inactivated adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
The Company confirmed on September 13, 2021, Valneva is continuing its VLA2001 development plan. Testing for the Company's pivotal Phase 3 trial, Cov-Compare, is ongoing at Public Health England ("PHE"). In addition, Valneva recently announced that its Phase 3 results are expected to be available early in the fourth quarter and that these results will form part of its rolling submission for conditional approval of VLA2001 with the UK's Medicines and Healthcare products Regulatory Agency ("MHRA"). Subject to these data and MHRA approval, Valneva believes that initial approval for VLA2001 could be granted in late 2021.
The Company announced on April 22, 2020, and collaborates with Dynavax Technologies Corporation to evaluate the adjuvant CpG 1018, a U.S. FDA-approved HEPLISAV-B vaccine component. 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 that Dynavax would supply CpG 1018 to produce up to 100 million vaccine doses in 2021. And, Valneva has the option to purchase up to an additional 90 million doses through 2025.
In July 2020, Valneva agreed in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine manufactured 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," added 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 analyzing this data, including selecting the optimal dose currently expected in the early second quarter of 2021, additional trials are expected to commence immediately thereafter.
On January 28, 2021, the Company announced it had commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate parallel to the ongoing clinical studies. In a press release, Thomas Lingelbach, CEO of Valneva, stated, "We are extremely pleased to have achieved these two important milestones in such a short period of time. Our team in Scotland has done an amazing job of getting manufacturing started so quickly. In addition, 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."
On April 6, 2021, the UK's Health and Social Care Secretary, Matt Hancock, commented, "This vaccine will be made onshore in Livingston in Scotland, giving another boost to British life science, and if approved, will play an important role in protecting our communities. I look forward to seeing the results of the upcoming phase 3 trial."
Valneva announced it had enhanced its Biosafety Level 3 laboratory capabilities 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.
VLA2001 COVID-19 Vaccine Indication
Valneva SE's VLA2001 is a whole virus, inactivated, and adjuvanted vaccine 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 Side Effects
Valneva reported positive Phase 1/2 data for its COVID-19 vaccine candidate in April 2021. In addition, Valneva has a substantial database on the safety of this inactivated virus approach from its JE vaccine, which has been FDA/EMA/MHRA approved for over a decade.
VLA2001 COVID-19 Vaccine Production
Valneva's facility in Solna, France, dedicated to producing the Company's cholera vaccine, has expanded its capacity to provide full fill and finish operations for the VLA2001 vaccine. In addition, VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).
VLA2001 COVID-19 Vaccine News
September 23, 2021 - Valneva SE announced that it has commenced recruitment of adolescents in its pivotal Phase 3 Clinical Trial (VLA2001-301, "Cov-Compare") for its inactivated COVID-19 vaccine candidate VLA2001 in the United Kingdom. Topline results from the pivotal Cov-Compare trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults. The Company has also started to provide boosters to volunteers in its Phase 1/2 VLA2001-201 trial. This planned expansion of VLA2001 clinical trials will support future approval in further age groups, in addition to adults.
September 14, 2021 - Valneva SE announced that it had completed the recruitment of the initial cohort of elderly participants in Valneva's Phase 3 trial, VLA2001-304, of its inactivated COVID-19 vaccine candidate, VLA2001. About 300 volunteers aged 56 years and older have been recruited in New Zealand into the VLA2001-304 trial with the objective to generate further safety and immunogenicity data for this age group.
September 13, 2021 - Valneva SE announced that it had received a termination notice from the UK Government concerning the Supply Agreement for its COVID-19 vaccine candidate, VLA2001.
August 23, 2021 - Valneva SE confirmed a rolling submission for initial approval of its COVID-19 vaccine candidate, VLA2001, with the UK's Medicines and Healthcare products Regulatory Agency. VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe.
August 11, 2021 - Valneva SE announced the initiation of a further Phase 3 trial (VLA2001-304) for its inactivated, adjuvanted COVID-19 vaccine candidate. VLA2001-304 aims to generate data in the elderly and is also designed to enable variant-bridging through immune-comparability potentially. Data from this study are expected to complement ongoing clinical trials and support additional regulatory submissions.
August 10, 2021 - Valneva SE confirmed the recruitment was completed for the pivotal Phase 3 trial of inactivated, adjuvanted COVID-19 vaccine candidate VLA2001. Phase 3 topline data is now expected early in the fourth quarter of 2021.
July 5, 2021 - Valneva SE announced today it would host a virtual symposium titled, "Developing new vaccines to protect against infectious diseases at home and abroad" on July 9, 2021, at 14:15 CEST at the 31st European Congress of Clinical Microbiology & Infectious Diseases. Adam Finn, Principal investigator for Valneva's COVID-19 program, Professor of Paediatrics at the University of Bristol, and Consultant at the Bristol Royal Hospital for Children, will discuss Phase 1/2 data of VLA2001 whole-virus, inactivated adjuvanted COVID-19 vaccine candidate in clinical trials in Europe. To attend the digital conference and participate in Valneva's symposium, you can register at this link.
July 1, 2021 - Valneva SE indicated today it continues ongoing discussions with the European Commission regarding VLA2001, Valneva's inactivated, COVID-19 vaccine candidate.
June 23, 2021 - The company stated it expects to announce topline data of its inactivated COVID-19 vaccine candidate by September 2021.
June 3, 2021 - Valneva SE announced that it had recruited 4,000 volunteers for 26 sites in the UK for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate VLA2001. The Phase 3 trial "Cov-Compare" (VLA2001-301) compares Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria.
May 20, 2021 - Valneva Reported Q1 2021 Financial Results and Business Update. Thomas Lingelbach, Valneva's CEO, commented in a press statement, "Valneva continues to achieve significant R&D milestones thanks to the huge efforts of our team and our partners. Our recent successful Nasdaq listing marks a significant strategic step for Valneva as we look forward. I want to take this opportunity to thank our existing and new shareholders, partners, and employees for their support and contribution to our journey. We are now in a strong position to continue to execute our key programs and continue to build shareholder value."
May 19, 2021 - Valneva SE announced it would participate in a UK government-funded clinical trial looking at different COVID-19' booster' vaccines. As potential boosters, the Cov-Boost trial, led by University Hospital Southampton NHS Foundation Trust, will look at seven different COVID-19 vaccines, including Valneva's inactivated vaccine VLA2001. It will be the first trial in the world to provide vital data on how effective a booster of each vaccine is in protecting individuals from the SARS-CoV-2 coronavirus.
May 10, 2021 - Valneva SE announced today that the total number of Valneva's ordinary shares issued amounts to 8,145,176 ordinary shares bringing the gross proceeds of the Global Offering to approximately $107.6 million (€89.6 million).
April 29, 2021 - Valneva SE announced its intention to issue and sell, subject to market and other conditions, 7,082,762 of its ordinary shares in a global offering to specified categories of investors comprised of (i) an initial public offering of American Depositary Shares, each representing two ordinary shares, in the United States, and a concurrent private placement of ordinary shares in certain jurisdictions outside of the United States.
April 21, 2021 - Valneva SE announced it had initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. The Phase 3 trial "Cov-Compare" (VLA2001-301) will compare Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial.
April 20, 2021 - Valneva SE announced it is now focusing on bilateral discussions on a country-by-count basis to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, consequently deprioritizing the ongoing centralized discussions with the European Commission.
April 10, 2021 - Valneva SE (VALN) announced that it had filed a registration statement on Form F-1 with the U.S. SEC relating to a proposed initial public offering of its American Depositary Shares representing ordinary shares in the USA and a concurrent offering of its ordinary shares in certain jurisdictions outside of the United States.
April 6, 2021 - Valneva SE announced positive data for part A of their clinical study, VLA2001-201. VLA2001 was found well tolerated with no safety concerns identified. In the high dose group, IgG seroconversion rate of 100% and Neutralizing antibody titers at or above levels are generally seen in convalescent sera. The Company stated it has decided to advance the high dose into the Phase 3 clinical trial. Other trials, including booster trials, involving antigen sparing doses will also be evaluated. In a released press release, Thomas Lingelbach, CEO of Valneva, stated, "Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play. This includes potential modifications to the vaccine to address variants, using our existing manufacturing process."
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 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 will report initial results in April 2021.
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 to supply Dynavax's CpG 1018 adjuvant for Valneva's SARS-CoV-2 vaccine candidate VLA2001. Dynavax will supply CpG 1018 to produce up to 100 million doses of vaccine in 2021. In addition, 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 agreed in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate. The UK government is negotiating funding to expand Valneva's Scottish facility.
June 18, 2020 - Valneva SE and Bavarian Nordic A/S announced 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 collaborates with Dynavax to evaluate its CpG 1018 adjuvant's potential use as part of the VLA2001 vaccine.
VLA2001 COVID-19 Vaccine Clinical Trial
Phase 3 clinical trial "Cov-Compare" (VLA2001-301) will compare Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial. Last Update Posted: June 8, 2021.
Phase 3 clinical trial VLA2001-304 aims to generate data in the elderly and is also designed to enable variant-bridging through immune-comparability potentially. Data from this study are expected to complement ongoing clinical trials and support additional regulatory submissions. 300 volunteers aged 56 years and older have been recruited in New Zealand into the VLA2001-304 trial with the objective to generate further safety and immunogenicity data for this age group. The cohort size has been increased to 300, from 150, in consultation with the European Medicines Agency ("EMA"). Topline data from this cohort will read out in early 2022, and it is expected that the data will support additional regulatory submissions. Last Update Posted: August 19, 2021.