Valneva Chikungunya Vaccine (VLA1553) May 2023
Valneva SE's VLA1553 is a monovalent, single-dose, live-attenuated chikungunya vaccine candidate. The VLA1553 vaccine is based on an infectious clone (CHIKV LR2006-OPY1) attenuated by deleting a significant gene encoding the non-structural replicase complex protein nsP3 protection against various Chikungunya virus (CHIKV) phylogroups and strains. Valneva's VLA1553 vaccine candidate is designed for prophylactic, active, single-dose immunization against Chikungunya in humans over 1-year-old. VLA1553 is currently the only chikungunya vaccine candidate worldwide for which a regulatory review process is underway, and if approved, it could become the first licensed chikungunya vaccine. In addition, VLA1553 has shown sustained titers one year after a single vaccination.
In 2020, VLA1553's complete Phase 1 data were published in the peer-reviewed medical journal The Lancet Infectious Diseases. And on October 16, 2020, Valneva announced the European Medicines Agency (EMA) granted PRIority MEdicines (PRIME) designation. In addition, an analysis announced on March 8, 2022, confirmed the very high level of seroprotection, with 98.9% of participants achieving protective levels of CHIKV-neutralizing antibodies one month after receiving a single vaccination (263 of 266 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 96.7-99.8). In addition, the immunogenicity profile was maintained over time, with 96.3% of participants showing protective CHIKV-neutralizing antibody titers six months after receiving a single vaccination (233 of 242 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 93.1-98.3). VLA1553 was also highly immunogenic in elderly study participants (65 years or older), who achieved equally high seroprotection rates and neutralized antibody titers over time as younger adults. In addition, on December 5, 2022, Valneva reported positive antibody persistence data 12 months after vaccination with a single dose of VLA15. No safety concern was identified during follow-up, confirming the safety profile observed in earlier studies.
On May 5, 2022, Valneva confirmed that the Coalition for Epidemic Preparedness Innovations (CEPI) funded a phase 3 study. In addition, the Company reported positive topline lot-to-lot manufacturing consistency trial results for VLA1553. Valneva confirmed on August 18, 2022, that it initiated a rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drugs Administration (FDA). The program previously received FDA Fast Track (2018) and Breakthrough Therapy designations in 2021. The FDA completed a filing review of Valneva's BLA on February 20, 203, and determined that the application was sufficiently complete to permit a substantive review with Priority Classification. As a result, VLA1553 was assigned a Prescription Drug User Fee Act review goal date of August 2023.
Saint-Herblain, France-based Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) is a specialty vaccine company providing prevention against diseases with significant unmet medical needs. If approved, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations. In addition, market research indicates that the global vaccine market against Chikungunya will exceed $500 million annually by 2032.
VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. Valneva SE announced on May 30, 2023, the filing of a regulatory application with Health Canada for marketing approval of the Company's single-shot chikungunya vaccine candidate, VLA1553, in adults aged 18 years and above. The Company intends to make additional regulatory submissions in 2023. A BLA is currently under priority review by the U.S. FDA, with a PDUFA review goal date at the end of August 2023.
To make VLA1553 also accessible to Low and Middle-Income Countries, Valneva and the Butantan Institute in Brazil signed a binding term sheet in May 2020 to develop, manufacture, and market VLA1553. The collaboration is within the $23.4 million funding framework Valneva received from the CEPI in July 2019.
VLA1553 U.S. CDC Review
The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) on February 23, 2023, included presentations: Introduction by Dr. Beth Bell; Global epidemiology of Chikungunya; Dr. Susan Hills; Chikungunya in U.S. travelers, Ms. Nicole Lindsey; Persistent arthralgia following Chikungunya, Ms. Nicole Lindsey; Workgroup considerations, Ms. Nicole Lindsey. During the ACIP meeting on October 19, 2022, Katrin Dubischar, VP, Program Director Chikungunya Vaccine, delivered VLA1553 Chikungunya Vaccine Candidate Introduction, Evidence Supporting the Serological Endpoint, and Clinical Study Overview.
VLA1553 is currently the most clinically advanced chikungunya vaccine candidate worldwide. In addition, it targets long-term protection following vaccination with a single dose.
VLA1553 is administered intramuscularly. At clinical trial centers in Illinois and Alabama, U.S., healthy volunteers aged 18–45 years were randomly assigned (1:1:2) to one of three escalating groups (low dose 3·2 × 10^3 per 0·1 mL; medium dose 3·2 × 10^4 per 1 mL; or high dose 3·2 × 10^5 50% tissue culture infection dose per 1 mL) and received a single-shot immunization on day 0. Individuals in all groups were revaccinated with the highest dose on either months 6 or 12 and followed for 28 days after revaccination.
Chikungunya Outbreaks 2023
Countries in Europe and the Americas confirmed chikungunya virus outbreaks as of May 2023. In addition, the U.S. CDC reissued a travel alert in April 203 regarding Paraguay's chikungunya outbreak. In 2022, the Pan American Health Organization / World Health Organization (PAHO/WHO) reported the number of cases and deaths due to Chikungunya in the Region of the Americas was above the numbers reported in previous years. And the first weeks of 2023 have seen this trend continuing.
Valneva SE Financial News - (Euronext Paris: VLA)
May 31, 2023 - Valneva SE announced that its senior management will attend the Jefferies Healthcare Conference (June 7-9 in New York), Goldman Sachs Annual Global Healthcare Conference (June 12-15 in Dana Point, California), and the Stifel European Healthcare Conference (June 28-30 in Bordeaux, France).
March 23, 2023 - The Company announced 2023 financial guidance - Expected total revenues and other income between €220 million and €260 million.
November 10, 2022 - Product sales of €74.4 million (vs. €45.5 million in the first nine months of 2021) driven by a continued recovery of travel vaccine sales and by COVID-19 vaccine sales in Europe.
VLA1553 Vaccine News For 2018 - 2023
May 30, 2023 - Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, "No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to bring VLA1553 to different territories as soon as possible."
April 5, 2023 - Susanne Eder-Lingelbach, Vice President, Clinical Development at Valneva, will review the clinical results of the Company's single-shot chikungunya vaccine candidate.
February 14, 2023 - Valneva SE announced that it completed enrollment and vaccination of its Chikungunya vaccine candidate for a Phase 3 clinical trial in adolescents, VLA1553-321. The first results of the trial are expected in mid-2023.
January 18, 2023 - The peer-review journal Nature Biotechnology published an article: Chikungunya and Lyme vaccines make headway.
December 23, 2022 - Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, "The completion of our BLA submission (to the FDA) is essential as it takes us a step closer to potentially bringing a preventative solution to fight this debilitating disease. If the FDA approves the submission, our goal is to provide a tool to help curtail this growing, unmet medical need."
December 5, 2022 - Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said in a press release, "We are excited about these twelve-month data, which are in line with what we saw from our previous readout at month six, and strengthen the possibilities of inducing a long-lasting antibody response with our chikungunya vaccine candidate."
October 19, 2022 - The U.S. CDC vaccine committee reviews various presentations, such as OVERVIEW OF CHIKUNGUNYA AND CHIKUNGUNYA VACCINES by Susan Hills, MBBS, MTH CDC Lead, Chikungunya Vaccines Work Group.
October 10, 2022 - Valneva announced that it would present updates on its single-shot chikungunya vaccine candidate at several leading scientific conferences during the fourth quarter of 2022.
August 18, 2022 - Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, "... we are very proud to be the first Company worldwide that has begun submission of a BLA (with U.S. FDA) for a chikungunya vaccine candidate.
May 25, 2022 - Valneva SE announced the successful completion of the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. With a 96.0% seroprotection rate at Day 180, the immunogenicity profile from study VLA1553-301 was also confirmed.
December 21, 2021 - Valneva SE announced positive topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination.
August 5, 2021 - Valneva SE announced positive topline results from the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553.
July 7, 2021 - Valneva SE announced that it had been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the U.S. FDA.
June 10, 2021 - Valneva SE announced that it had completed recruitment for the clinical lot-to-lot consistency Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553.
February 22, 2021 - Valneva SE announced that it had initiated the clinical lot-to-lot consistency Phase 3 study for its single-shot chikungunya vaccine candidate, VLA1553.
January 25, 2021 - Valneva SE and Instituto Butantan announced the signing of definitive agreements for developing, manufacturing, and marketing Valneva's single-shot chikungunya vaccine, VLA1553, in Low and Middle-Income Countries (LMICs).
November 3, 2020 - To make VLA1553 accessible to Low and Middle-Income Countries, Valneva and the Butantan Institute in Brazil signed a binding term sheet in May 2020 to develop, manufacture, and market VLA1553.
October 16, 2020 - Valneva SE announced that the European Medicines Agency had granted PRIority MEdicines designation for its single-shot Phase 3 chikungunya vaccine candidate VLA1553.
September 30, 2020 - Health officials in Chad have reported an outbreak of Chikungunya. The Abéché health district (Ouaddaï Region) is reporting the most cases; the health districts of Biltine (Wadi Fira Region) and Abdi (Ouaddaï Region) are also reporting cases.
September 8, 2020 - Valneva SE announced initiating a pivotal Phase 3 clinical trial for its differentiated, single-shot chikungunya vaccine candidate VLA1553, the first chikungunya vaccine Biologics License Application to be approved in the U.S. would be eligible to receive a Priority Review Voucher.
June 1, 2020 - A new study published in The Lancet found that the live-attenuated CHIKV vaccine was well tolerated and highly immunogenic in adults. It could be an effective intervention for preventing chikungunya disease worldwide.
March 25, 2020 – Valneva SE announced that it completed an End-of-Phase 2 meeting with the U.S. FDA and agreed on the clinical development plan toward licensure for its unique, single-shot chikungunya vaccine VLA1553.
November 18, 2019 - Final Phase, one results up to Month 13, confirm the excellent immunogenicity and safety profile for VLA1553, its single-shot vaccine candidate. After a single vaccination, the final results showed an excellent immunogenicity profile in all vaccinated dose groups. In addition, a 100 percent seroconversion was achieved on Day 14 after a single vaccination in all dose groups, and titers were sustained at 100 percent at Month 12.
December 21, 2018: VLA1553 was granted Fast Track designation by the US Food and Drug Administration.
VLA-1553 Clinical Trials
Valneva continues to test the VLA1553 Chikungunya Vaccine in various clinical trials.
On December 5, 2022, the Company announced the antibody persistence trial enrolled 363 healthy adult participants and followed them from month six after vaccination to month twelve. 99% of participants retained neutralizing antibody titers above the seroresponse threshold of 150 12 months after the single-dose vaccination. These antibody levels confirm the antibody persistence profile observed in an earlier study. In addition, the antibody persistence was similar in older adults aged ≥65 years, who retained neutralizing antibody titers comparable to younger adults throughout the follow-up. These results follow the completion of the pivotal study VLA1553-301, for which a seroresponse rate of 96% six months after vaccination was reported.
VLA1553-301 Phase 3 trial was initiated in September 2020. It is a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 trial evaluating 4,115 participants aged 18 years or above. Lyophilized VLA1553 or placebo was administered as a single intramuscular immunization. The trial's primary objective was to assess the immunogenicity and safety of VLA1553 at one month following a single vaccination.
Conducted in Brazil by Instituto Butantan, VLA1553-321 is a double-blinded, multicenter, randomized, and placebo-controlled Phase 3 trial. Seven hundred fifty0 adolescents aged 12 to 1s will be randomized at a 2:1 ratio to receive either VLA1553 or a placebo. The trial's primary objective is to evaluate safety and immunogenicity following a single vaccination with VLA1553. Participants will be assessed after 28 days and followed up to twelve months. The study will also provide safety and immunogenicity data in participants previously exposed to Chikungunya.