Valneva VLA2001 COVID-19 Vaccine Description
Valneva SE's VLA2001 (VLA2101) is a Vero cell-based, highly purified, inactivated vaccine candidate against the SARS-CoV-2 betacoronavirus 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 steps upstream and downstream as plug-and-play with moderate adjustments. The method includes inactivation with BPL to preserve the native structure of the S protein. The combination with CpG 1018 is expected to induce a robust immune response and generate high neutralizing antibody titers. Thus, an inactivated SARS-CoV-2 vaccine would be suitable for broad deployment, including particularly vulnerable populations.
As of October 17, 2021, the Company is preparing to commence rolling submission for conditional approval with the European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency. A final assay validation required by the MHRA to verify the integrity of the VLA2001-301 data remains ongoing.
The Cov-Compare (VLA2001-301) study results announced on October 18, 2021, were based on 4,012 participants aged 18 years and older across 26 trial sites in the UK. The trial met its co-primary endpoints: VLA2001 demonstrated superiority against AZD1222 (ChAdOx1-S), in terms of geometric mean titer for neutralization antibodies (GMT ratio=1.39, p<0.0001), (AZD1222(ChAdOx1-S) GMT 576.6, as well as non-inferiority in terms of seroconversion rates (SCR above 95% in both treatment groups) at two weeks after the second vaccination (i.e., Day 43) in adults aged 30 years and older. T-cell responses analyzed in a sub-set of participants showed that VLA2001 induced broad antigen-specific IFN-gamma producing T-cells reactive against the S- (74.3%), N- (45.9%), and M- (20.3%) protein. In addition, the tolerability profile of VLA2001 was significantly more favorable compared to the active comparator vaccine.
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.
Valneva VLA2001 COVID-19 Vaccine Variant Effectiveness
Valneva believes that VLA2001 can potentially play a role in protecting against the new SARS-Cov-2 virus variant known as Omicron. In contrast to other vaccines that target only the spike protein of the SARS-COV-2 virus, VLA2001 is developed using the entire SARS-CoV-2 virus envelope. Preserving the whole virus envelope is expected to elicit a broad immune response. Together with the CpG1018 adjuvant, may provide an improved immunological profile by boosting T-cell responses against additional SARS-CoV-2 proteins.
On December 16, 2021, the Company confirmed a phase 1/2 study evaluating sera from boosted participants for cross-neutralization against Variants of Concern, including Omicron.
Valneva 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.
Valneva 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. In addition, testing for the Company's pivotal Phase 3 trial, Cov-Compare, is ongoing at Public Health England ("PHE"). Subject to these data and MHRA approval, Valneva believes that initial approval for VLA2001 could be granted in late 2021.
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 UK's Medicines and Healthcare products Regulatory Agency (MHRA)" The MHRA requires a final assay validation to verify the integrity of the VLA2001-301 data remains ongoing. It is a prerequisite for the final submission of the clinical study report.
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. 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.
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.
Valneva 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).
Valneva VLA2001 COVID-19 Vaccine Booster Effectiveness
The Company announced Phase 1/2 study's initial results on December 16, 2021, confirming that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination; 77 of the 153 original participants, aged 18-55 years, received a booster dose seven to eight months after completion of their primary immunization with either a low, medium or high dose of VLA2001. All participants received a single booster vaccination with VLA2001 at the same (high) dose level used in the pivotal Phase 3 "Cov-Compare" trial. IgG antibody titers (spike protein-based) were measured at the time of the booster as well as two weeks after the booster dose; 45 of the 77 boosted participants were included in the final analysis. The third dose of VLA2001 elicited an excellent anamnestic response, with similar antibody levels observed whether participants were initially vaccinated with a low, medium, or high dose (GMT 9699.3 (95%CI: 8497.76, 11070.71)). This represents a strong boosting effect, increasing levels of antibodies against the Wuhan virus 42- to 106-fold, depending on the pre-boosting levels of antibodies. Antibody levels measured two weeks after the booster dose was approximately four-fold higher compared to those observed two weeks after primary immunization.
Valneva VLA2001 COVID-19 Vaccine Side Effects
Valneva reported positive Phase 1/2 data for its COVID-19 vaccine candidate in April 2021. In October 2021, the Company reported VLA2001 was well tolerated, demonstrating a statistically significant better tolerability profile compared to the active comparator vaccine. 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.
Valneva 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).
On November 29, 2021, Valneva SE and IDT Biologika announced their collaboration for the production of VLA2001. IDT Biologika will produce VLA2001's drug substance at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, in addition to Valneva's manufacturing site in Livingston, Scotland.
Valneva has commenced manufacturing for the European Commission supply contract and has some inventory ready for labeling and deployment upon regulatory approval. Valneva expects to have the capacity to produce over a hundred million doses of vaccine per annum through a combination of in-house production and CMO capacity.
Valneva Financial News (Nasdaq: VALN; Euronext Paris: VLA)
December 23, 2021 - Valneva SE announced that it is in advanced discussions, with Scottish Enterprise, for a multi-million-pound grant which will enable it to fully complete its strategic manufacturing site in Livingston, Scotland.
December 8, 2021 - Valneva SE signed an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the VLA2001 vaccine.
November 23, 2021 - Valneva SE announced that it has signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years. The Company expects to deliver 24.3 million doses during the second and third quarters of 2022, subject to the approval of VLA2001 by the European Medicines Agency. The purchase order can be increased up to a total of 60 million doses, the remainder of which would be delivered in 2023.
November 18, 2021 - The Company confirmed Total revenue (excluding COVID) of €69.8 million in the first nine months of 2021 compared to €58.8 million in the first nine months of 2020.
November 3, 2021 - Valneva SE announced today the closing, which occurred on November 2, 2021, of its previously announced global offering to specified categories of investors. After the entire exercise of the option and before deducting underwriting commissions and estimated expenses payable by the Company, they were approximately $102.0 million (€88.0 million).
October 29, 2021 - Valneva SE announced today the pricing of 4,500,000 ordinary shares in a global offering to specified categories of investors comprised of a public offering. The aggregate gross proceeds are expected to be approximately $88.7 million, equivalent to about €76.5 million, before deducting underwriting commissions and estimated expenses payable by the Company.
October 26, 2021 - Valneva SE announced its intention to issue and sell, subject to market conditions, 5,500,000 of its ordinary shares in a global offering. Approximately $100 million would further develop its COVID-19 VLA2001 vaccine candidate through conditional licensure and commercial launch, including capital expenditure into production facilities.
Valneva VLA2001 COVID-19 Vaccine News
January 6, 2022 - Valneva SE confirmed the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Valneva expects regulatory approvals in the first quarter of 2022.
December 16, 2021 - Valneva SE announced the initial results show an excellent immune response after the third dose of VLA2001 administered 7 to 8 months after the second dose of primary vaccination; Antibody titers increased 42- to 106-fold two weeks after booster dose vs pre-booster levels; Antibody titers four-fold higher compared to two weeks after primary immunization; and Evaluating sera from boosted participants for cross-neutralization against Variants of Concern, including Omicron.
December 3, 2021 - The Company responded to data published from the COV-Boost COVID-19 vaccine trial. It believes it likely that the short interval between the second shot and booster shot could have adversely impacted the results for VLA2001, given that a longer interval is generally required for inactivated vaccines. 'Interpretation should avoid focusing on the headline spike IgG levels or antibody boost ratios because the relationship between antibody levels at day 28 and long-term protection and immunological memory is unknown.'
December 2, 2021 - The EMA's human medicines committee confirmed it has started a rolling review of VLA2001 developed by Valneva.
November 29, 2021 - Dr. Jürgen Betzing, CEO of IDT Biologika, stated in a press release, "This assignment shows the importance of the role played by IDT in the fight against COVID-19. It is a great achievement and demonstrates the trust that Valneva has placed in us and our employees."
November 10, 2021 - Valneva SE announced that the European Commission had approved an agreement pursuant to which Valneva would supply up to 60 million doses of VLA2001 over two years including approximately 27 million doses in 2022. The agreement will be completed following final review, including volumes required, by each of the European Union Member States.
October 18, 2021 - Valneva SE announced positive topline results from the Phase 3 pivotal trial Cov-Compare of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001: Superior neutralizing antibody titer levels compared to active comparator vaccine, AstraZeneca's AZD1222 (ChAdOx1-S); Neutralizing antibody seroconversion rate above 95%; VLA2001 induced broad T-cell responses with antigen-specific IFN-gamma-producing T-cells against the S, M and N proteins. In addition, the complete absence of any severe COVID-19 cases may suggest that both vaccines used in the study prevented severe COVID-19 caused by the circulating variant(s) (predominantly Delta).
September 23, 2021 - Valneva SE announced that it had 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. In addition, 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 different 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 to generate additional 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.
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 other 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 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 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.
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.
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.
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.
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.
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, the 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.
Valneva VLA2001 COVID-19 Vaccine Clinical Trial
Phase 3 clinical trial "Cov-Compare" (VLA2001-301) compared Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial. Reported on October 18, 2021. Last Update Posted: October 29, 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. Last Update Posted: October 28, 2021.
The Company is preparing for trials in children (5-12 years of age) and a Valneva sponsored booster trial to evaluate VLA2001's booster performance for people in need of a booster. ClinicalTrial: NCT04956224 - Last Update Posted: October 28, 2021.