Valneva COVID-19 Vaccine (VLA2001) Description For 2022
Valneva SE's COVID-19 (VLA2001) vero cell-based, highly purified, whole-virus, inactivated vaccine is targeted against the SARS-CoV-2 beta coronavirus 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. VLA2001 is currently the only whole virus, inactivated, adjuvanted COVID-19 vaccine in clinical development in Europe.
Valneva SE's adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and has shifted 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 has already been upscaled to the final industrial scale and includes inactivation with BPL to preserve the native structure. CpG 1018 is a component of the US FDA-approved HEPLISAV-B® vaccine.
Valneva 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, particularly in vulnerable populations.
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 U.K. The trial met its co-primary endpoints: VLA2001 demonstrated superiority against AZD1222 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. Furthermore, 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.
On April 14, 2022, the U.K.'s Medicines and Healthcare products Regulatory Agency approved the Valneva COVID-19 vaccine after meeting the required safety, quality, and effectiveness standards. It is also the first whole-virus inactivated COVID-19 vaccine to gain regulatory approval in the U.K. On March 1, 2022, the National Health Regulatory Authority of the Kingdom of Bahrain granted authorization for VLA2001.
The Company announced on April 25, 2022, an update on the rolling review process with the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency (EMA), which accepted the Marketing Authorization Application filing on May 19, 2022. The CHMP concluded on June 23, 2022, that the benefits of COVID-19 Vaccine Valneva outweigh its risks and recommended granting a standard marketing authorization in the EU - EMEA/H/C/006019. The European Commission granted marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine on June 24, 2022.
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. The Company's vision is to contribute to a world where no one dies or suffers from preventable diseases through vaccination. Valneva also works with agencies outside the European Union for potential future approvals and additional purchase agreements.
Valneva COVID-19 Vaccine Omicron BA.x
On January 19, 2022, Valneva announced results from an initial laboratory study demonstrating that serum antibody induced by three doses of VLA2001 neutralizes the Omicron variant. All 30 samples (100%) presented neutralizing antibodies against the ancestral virus and Delta variant, and 26 samples (87%) showed neutralizing antibodies against the Omicron variant. The mean fold reduction of neutralization relative to the ancestral virus was 2.7-fold for Delta and 16.7-fold for Omicron. Previously, on December 16, 2021, the Company confirmed a phase 1/2 study evaluating sera from boosted participants for cross-neutralization against variants, including Omicron.
Valneva 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 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, that 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 U.K.'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 addition, 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 2020 to achieve the first regulatory approval in the second half of 2021, subject to the appropriate regulatory authority requirements.
Valneva 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). There are no data on immunocompromised people (people with weakened immune systems).
Valneva COVID-19 Vaccine For Children
As of June 24, 2022, COVID-19 Vaccine Valneva is not currently authorized in Europe for use in people below 18 years of age. EMA has agreed with the company on a plan to trial the vaccine in children at a later stage.
Valneva COVID-19 Vaccine For Women
Animal studies do not show any harmful effects in pregnancy; however, data on the use of COVID-19 Vaccine Valneva during pregnancy are limited and it is currently not known if the vaccine is present in human milk.
Valneva COVID-19 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 of 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 and 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 than those observed two weeks after primary immunization.
Valneva COVID-19 Vaccine Side Effects
As of June 24, 2022, The most common side effects of the COVID-19 Vaccine Valneva are mild and get better within a few days after vaccination. These include headache, muscle pain, tenderness and pain at the injection site, tiredness, and nausea (feeling sick) or vomiting. These may affect more than 1 in 10 people. Valneva reported positive Phase 1/2 data for its COVID-19 vaccine candidate in April 2021. In October 2021, the Company reported that VLA2001 was well tolerated, demonstrating a statistically significant better tolerability profile than the active comparator vaccine. In addition, Valneva has a substantial database on the safety of this inactivated virus approach from its J.E. vaccine, which is FDA/EMA/MHRA approved.
Valneva 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 to standard cold chain requirements (2 degrees to 8 degrees Celsius). 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.
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, and Valneva's manufacturing site in Livingston, Scotland.
Valneva Financial News For 2021 - 2022
June 15, 2022 - Valneva SE announced that it has entered into a settlement agreement with the Government of the United Kingdom in relation to the termination of the supply agreement for Valneva's COVID-19 vaccine.
June 10, 2022 - Thomas Lingelbach, CEO of Valneva, commented in a press release, "We hope that the E.C. and its member states will continue to evaluate the potential advantages of an inactivated vaccine. There is emerging evidence that hybrid immunity – from a combination of vaccination and natural infection – increases protection against the development of severe COVID-19 caused by different variants of concern, and our inactivated vaccine closely mimics natural infection by exposing vaccinees to the entire inactivated SARS-CoV-2 virus."
June 2, 2022 - The Company announced the availability of documentation for its Combined General Meeting and Special Meeting of holders of Convertible Preferred Shares.
May 16, 2022 - Valneva SE received a notice from the European Commission of intent to terminate the advance purchase agreement Valneva'sva's COVID-19 vaccine candidate VLA2001.
May 5, 2022 - The Company announced product sales, including the first COVID-19 vaccine sales, increased by 0.2% to €16.2 million in the first quarter of 2022 compared to €16.1 million in the first quarter of 2021.
April 26, 2022 - Valneva SE announced an agreement to increase the principal amount of its existing $60 million debt financing agreement - Up to an additional $40 million made available as part of the agreement.
March 24, 2022 - In a press release, Peter BühlValneva'sva's Chief Financial Officer, commented, "... With close to €350 million in cash, we entered 2022 in a strong position and will continue to focus on gaining regulatory approvals and preparing a market entry for our key late-stage progams."
February 21, 2022 - ValnSE'sSE's subsidiary Valneva Scotland was awarded research and development funding of up to £20 million by Scottish Enterprise. A grant of up to £12,500,000 will support R&D related to the manufacture of VLA2001. Discussions have included the potential supply of VLA2001 to Scotland, subject to regulatory approval, and an offer from Valneva to make up to 25,000 doses of VLA2001 available, free of charge, to NHS and frontline workers in Scotland.
February 3, 2022 - Valneva SE reported its revenue and cash balance for the full year 20Valneva'sva's total revenues were €348.1 million in 2021 compared to €110.3 million in 2020, increasing 216%. Product sales decreased by 4.5% to €63.0 million in 2021 compared to €65.9 million in 2020 as the travel industry continued to be impacted by the COVID-19 pandemic. On a constant exchange rate (CER) basis, product sales also decreased by 4.5% in 2021 as compared to 2020.
Valneva COVID-19 Vaccine News For 2020 - 2022
June 24, 2022 - Thomas Lingelbach, CEO of Valneva, commented in a press statement, “We are extremely pleased that the EC granted full marketing authorization for VLA2001, the only inactivated whole-virus COVID-19 vaccine available in Europe."
June 23, 2022 - Valneva SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended marketing authorization in Europe for Valneva's inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age. The CHMP concluded by consensus after a thorough evaluation that, "the data on the vaccine were robust and met the EU criteria for efficacy, safety, and quality."
May 19, 2022 - Valneva SE confirmed that the EMA accepted the filing of a marketing authorization application for VLA2001 and could receive a positive opinion in June 2022.
May 16, 2022 - Valneva SE announced that the United Arab Emirates granted emergency use authorization for Valneva's COVID-19 vaccine, VLA2001.
May 4, 2022 - Valneva SE announced the initiation of a heterologous booster trial. The VLA2001-307 clinical trial will be Company'sny's first clinical trial to provide booster data following primary vaccination with an mRNA vaccine or natural COVID-19 infection. The trial will be conducted in the Netherlands and topline results are expected in the third quarter of 2022.
April 25, 2022 - The Company remains focused on achieving a CMA for VLA2001 in Europe after being granted CMA in the U.K.
April 14, 2022 - The COVID-19 vaccine developed by Valneva has been given regulatory approval by UK's Medicines and Healthcare products Regulatory Agency. Valneva is currently discussing with the Scottish government to supply up to 25,000 doses to the National Health Service and frontline workers in Scotland.
March 24, 2022 - Valneva confirmed it expects to deliver the first VLA2001 shipments to Bahrain at the end of March 2022 as per the purchase agreement signed in December 2021.
March 11, 2022 - Valneva SE published an update on the regulatory review of VLA2001 by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
March 1, 2022 - Thomas Lingelbach, CEO of Valneva, commented, "We are extremely pleased with this first authorization and would like to thank the Kingdom of Bahrain for their trust and confidence. As the only dual-adjuvanted, inactivated COVID-19 vaccine approved in Bahrain, VLA2001 will provide a differentiated vaccine option to the Bahraini population and medical community."
January 25, 2022 - Valneva SE announced the start of booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare. This booster extension is intended to provide both homologous and first heterologous booster data to complement previous positive Phase 1/2 booster results. The data are not intended for the initial regulatory approval process, which the Company expects to finalize in the coming weeks. Valneva announced the first positive homologous booster results at the end of December 2021.
January 19, 2022 - The Company confirmed three doses of VLA2001 neutralized the SARS-COV-2 Omicron variant. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, "We are extremely pleased with these results, which confirm the potential for broad-spectrum protection of our vaccine and its ability to address currently circulating variants of concern. These results add to earlier findings from our Cov-Compare Phase 3 trial, in which two doses of VLA2001 given as a primary vaccination were shown to induce superior neutralizing antibody levels and broad T-cell responses."
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 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.'
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 a final review, including volumes required, by each of the European Union Member States.
September 23, 2021 - Valneva SE announced that it had commenced recruitment of adolescents in its pivotal Phase 3 Clinical Trial (VLA2001-3 "1, "Cov-Com" are") 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 13, 2021 - Valneva SE announced that it had received a termination notice from the U.K. 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 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.
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 of 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.
April 22, 2020 - Valneva announced developing VLA2001, an inactivated whole virus vaccine candidate against the novel coronavirus SARS-CoV-2. The Company collaborates with Dynavax to evaluate its CpG 1 adjuvant's potential use in the VLA2001 vaccine.
Valneva VLA2001 COVID-19 Vaccine Clinical Trial
VLA2001-307 is a multicenter, open-label, single-arm clinical study investigating the safety, tolerability, and immunogenicity of a VLA2001 booster vaccination in participants aged 18 years and older. Approximately 150 participants, either generally healthy or with a stable medical condition, will be enrolled in the trial. The VLA2001 booster will be given to adults 6 to 12 months after completion of primary vaccination with an mRNA COVID-19 vaccine or unvaccinated adults 6 to 12 months after PCR confirmation of natural SARS-CoV-2 infection.
Phase 3 clinical tr" al "Cov-Com" are" (VLA2001-301) compaValneva'sva's SARS-CoV-2 vaccine candidate, VLA2001, agaiAstraZeneca'sca'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 on 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 evaluVLA2001's01's booster performance for people in need of a booster. ClinicalTrial: NCT04956224 - Last Update Posted: October 28, 2021.