A PHASE 3, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF DIFFERENT VACCINATION SCHEDULES OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY ADULT PARTICIPANTS

The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points.
This study is seeking participants who:
* are generally healthy and between 18 and 44 years of age,
* have never had a vaccine for Lyme disease before,
* are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners, and
* are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine.
All participants in this study will receive a total of 5 doses through a shot in the upper arm. Four doses will be the study vaccine (VLA15), and 1 dose will be saltwater.
The study will compare the experiences of people receiving the study vaccine at different time points. This will help see if the study vaccine is safe and will help understand its effect on the body.
Participants will take part in this study for about 2 years. During this time, the participants will have 11 planned visits - 8 will be at the study clinic and 3 will be done over the phone. The clinic visits may include having a health check, giving a small amount of blood (about 20 mL or 4 teaspoons), and getting the study vaccine or saltwater as a shot.

Start Date19 Nov 2025

Sponsor / Collaborator

Pfizer Inc.

NCT05634811

/ CompletedPhase 3

A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE

This study is to understand if the study vaccine (called VLA15) is safe in healthy children.
We are looking for children who:
* are healthy
* are age 5 through 17
* have not been diagnosed with any form of Lyme disease in the past
* have not received any vaccines for Lyme disease in the past
Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.
Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.
Everyone participating in this study will:
* get the shots in a clinic or in a hospital office
* receive a total of 4 shots
* receive the first 3 shots within 6 months
* receive the last shot about 1 year afterwards
* need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

Start Date12 Dec 2022

Sponsor / Collaborator

Pfizer Inc.

NCT05477524

/ Active, not recruitingPhase 3

A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence.
Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months after end of primary vaccination series. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. A subset of participants will be followed for a third Lyme disease season.
Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective.
If enrolled, participants will need to visit the research site at least 7 times during the study, and for a subset of participants up to 9 times. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.

Start Date04 Aug 2022

Sponsor / Collaborator

Pfizer Inc.

[+1]

100 Clinical Results associated with VLA15

100 Translational Medicine associated with VLA15

100 Patents (Medical) associated with VLA15

Literatures (Medical) associated with VLA15

01 Mar 2026·VACCINE

Protective properties of a candidate C-terminal domain OspA vaccine for prevention of Lyme disease

Article

Author: Baranova, Danielle ; Li, Yan ; Embers, Monica E ; Simon, Raphael ; Seidel, Stefan ; Park, Jeong-Jin ; Hochreiter, Romana ; Timofeyeva, Yekaterina ; Anderson, Annaliesa S ; Hasenkampf, Nicole R ; Esadze, Alexandre ; Kanevsky, Isis ; Wellnitz, Sabine ; Gribenko, Alexey ; Gaylord, Michelle ; Tran, Sirena ; Tardo, Amanda C ; Singh, Guy ; Dane, Jill ; Meinke, Andreas ; Sun, Jun ; Giordano-Schmidt, Donna ; Bartuschka, Ursula ; Lundberg, Urban ; Kalina, Warren ; Jost, Sandra ; Fritzer, Andrea

Lyme disease is a growing public health concern that is geographically focused in regions where ticks that carry the causative bacteria, Borrelia burgdorferi sensu lato (s.l.), are endemic. Outer surface protein A (OspA) is expressed by B. burgdorferi s.l. spirochetes during the tick phase and OspA antibodies introduced during tick feeding can block transmission and prevent B. burgdorferi infection. Candidate Lyme disease vaccine VLA15 is comprised of the C-terminal domains of the six B. burgdorferi s.l. OspA serotypes (ST) prevalent in North America and Europe. We report herein that non-human primates immunized with VLA15 were protected against challenge with Ixodes scapularis ticks bearing B. burgdorferi sensu stricto (s.s.) (OspA ST1). Levels of residual B. burgdorferi s.s. tick colonization were reduced in ticks that fed on VLA15-immunized primates compared to those immunized with full length-OspA ST1 (FL-OspA) at a point when OspA-binding IgG levels were similar. Furthermore, monoclonal antibodies targeting the C-terminal half of OspA, elicited by FL-OspA immunization in primates, were more effective at complement-mediated bactericidal killing in vitro and clearance of spirochetes in ticks versus those directed against other parts of the protein.

01 Mar 2026·LANCET INFECTIOUS DISEASES

Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial

Article

Author: Bézay, Nicole ; Maguire, Jason D ; Hochreiter, Romana ; Obersriebnig, Michaela ; Murphy, Timothy ; Kadlecek, Vera ; Messier, Marc ; Eder-Lingelbach, Susanne ; Hegele, Lisa ; Larcher-Senn, Julian ; Wagner, Laura ; Jaramillo, Juan Carlos ; Derhaschnig, Ulla

BACKGROUND:

Lyme borreliosis is the most common tick-borne disease in temperate climates of the northern hemisphere. Although in some cases Lyme borreliosis progresses to serious outcomes, no human vaccines are available for its prevention. A previous report showed positive immunogenicity and safety of VLA15, an investigational Lyme borreliosis vaccine based on Borrelia burgdorferi outer surface protein A (OspA), when administered as a 0-2-6-month or 0-6-month primary series to children, adolescents, and adults. Here, we report data from the same trial after receipt of an initial booster dose at month 18.

METHODS:

This ongoing, randomised, observer-blind, placebo-controlled, phase 2 trial is taking place at 14 clinical study centres in Lyme borreliosis-endemic areas in the USA. Healthy, eligible participants aged 5-65 years were enrolled. Participants were randomly assigned within each age cohort (18-65 years, 12-17 years, and 5-11 years) in a 1:1:1 ratio to receive intramuscular injections of VLA15 at months 0, 2, and 6; VLA15 at months 0 and 6 and placebo at month 2; or placebo at months 0, 2, and 6. In this phase of the trial, a month 18 VLA15 booster vaccination was administered to participants in both VLA15 groups (termed VLA15 M0-2-6-18 and VLA15 M0-6-18, respectively); the placebo group received placebo at month 18. Data up to month 12, including the primary endpoints, have been reported previously; this report includes data up to month 19. Secondary endpoints related to the month 18 booster vaccination included OspA serotype-specific IgG geometric mean titres (GMTs; evaluated in the per-protocol analysis set) and solicited and unsolicited adverse events (evaluated in the safety analysis set [ie, all participants who received one or more vaccinations]) from month 18 to month 19. This trial is registered at ClinicalTrials.gov, NCT04801420, and is closed for recruitment.

FINDINGS:

Between March 15, 2021, and Feb, 24, 2022, 625 participants were randomly assigned and received the first vaccination. 532 (85%) of 625 participants were White, 68 (11%) were Black or African American, 13 (2%) were Asian, one (<1%) was an American Indian or Alaska Native, and 11 (2%) had their race recorded as other. 321 (51%) of 625 participants were female and 304 (49%) were male. The month 18 booster vaccination was administered to 449 participants at 13 of the trial sites (148 participants in the VLA15 M0-2-6-18 group; 143 participants in the VLA15 M0-6-18 group; 12 other VLA15 recipients; and 146 participants in the placebo group) between Sept 21, 2022, and Jan 24, 2023. The 12 other VLA15 booster recipients, of whom 11 received VLA15 and one received placebo for the month 18 booster, received at least one primary or booster VLA15 dose but could not be evaluated within a designated VLA15 group for safety because of missed or incorrect vaccinations, and were excluded from post-booster immunogenicity analyses. Of the 513 participants included in the per-protocol analysis set, 398 received the booster and 394 completed the month 19 visit. OspA-specific IgG GMTs in both VLA15 groups declined after the primary series up to month 18. At 1 month after the month 18 booster vaccination, GMTs in both VLA15 groups rose to levels that exceeded those after the primary series, ranging in the overall population from 1057·0 U/mL (95% CI 843·1-1325·1; serotype 1) to 1807·9 U/mL (1486·2-2199·3; serotype 2) in the M0-2-6-18 group and from 830·0 U/mL (621·3-1108·9; serotype 1) to 1603·1 U/mL (1239·7-2073·0; serotype 2) in the M0-6-18 group. GMTs at month 19 were higher in the paediatric cohorts compared with adults, consistent with observations after the primary vaccination series. The tolerability profile of the month 18 booster was similar to that of the primary doses and generally similar across age cohorts. Related unsolicited adverse events were reported by four (1%) of 302 VLA15 booster vaccination recipients and three (2%) of 147 placebo booster recipients within 1 month after the month 18 booster; all of these events resolved without sequelae. Unsolicited adverse events leading to trial withdrawal, unsolicited serious adverse events, and adverse events of special interest that were reported up to month 19 were all considered unrelated to trial vaccination and occurred before the month 18 booster. No deaths were reported up to month 19 of the trial.

INTERPRETATION:

The safety and robust anamnestic immune responses associated with VLA15 boosting support its use as a strategy to increase anti-OspA antibody levels before tick season among children, adolescents, and adults. Forthcoming data after administration of subsequent annual boosters will provide further information about VLA15 antibody persistence and boostability.

FUNDING:

Valneva and Pfizer.

01 Oct 2025·Therapeutic advances in vaccines and immunotherapy

Exploring the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk population: a systematic review and meta-analysis of randomized controlled trials

Review

Background::

Lyme disease, the most common vector-borne illness in the Northern Hemisphere, is caused by Borrelia burgdorferi and transmitted via tick bites. With rising global incidence and no approved human vaccine, VLA15, a novel recombinant vaccine targeting six OspA serotypes, shows promise as an effective preventive strategy.

Objective::

This study aims to assess the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk populations.

Design::

We conducted a systematic review and meta-analysis of three randomized controlled trials.

Methods::

This systematic review and meta-analysis, registered in PROSPERO (CRD420251058818), was conducted following PRISMA guidelines. A thorough search of PubMed, EMBASE, Cochrane Library, Scopus, ScienceDirect, and ClinicalTrials.gov was performed up to May 2025. Data extraction and quality assessment (using Cochrane ROB 2) were performed independently by reviewers. Risk ratios (RR) with 95% confidence intervals (CI) were calculated using random-effects models.

Results::

Three RCTs, including 5907 participants (4500 VLA15; 1407 placebo), met inclusion criteria. VLA15 recipients showed a significantly higher risk of adverse events: fever (RR 2.65, 95% CI: 1.77–3.96), headache (RR 1.40, 95% CI: 1.21–1.62), fatigue (RR 1.33, 95% CI: 1.15–1.55), and arthralgia (RR 2.50, 95% CI: 1.67–3.76), all with p < 0.0001. Subgroup analysis revealed a dose-response trend for arthralgia, particularly at 135 μg and 180 μg doses. However, nausea (RR = 1.34, p = 0.10) and severe unsolicited AEs (RR = 1.22, p = 0.42) were not statistically significant, suggesting no meaningful increase in these risks. Immunogenicity outcomes consistently favored VLA15, showing elevated IgG levels, GMTs, and seroconversion rates.

Conclusion::

VLA15 exhibits strong immunogenicity and acceptable safety, despite an increased risk of mild-to-moderate adverse events. Continued research and monitoring are warranted to support its use in Lyme disease prevention.

101

News (Medical) associated with VLA15

19 Feb 2026

·www.biospace.com

Valneva Reports Preliminary Unaudited 2025 Revenue and Cash and Provides 2026 Outlook

Total Revenues of €174.7 million in line with guidance, including €157.9 million in product sales Strong year-end cash position of €109.7 million, with enhanced financial flexibility following successful debt refinancing 2026 to be a potentially transformational year with Phase 3 Lyme disease data expected in the first half of the year Chief Executive Officer’s contract renewed for a further three-year term, ensuring continuity in leadership Lyon (France), February 19, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its preliminary unaudited full-year 2025 revenue and cash results 1 and provided a first outlook for 2026. 2025 full-year revenue and cash results (unaudited): Total revenues of €174.7 million in 2025 compared to €169.6 million in 2024 including recognition of variable consideration relating to the research collaboration and licensing agreement for the Lyme disease program Product sales of €157.9 million compared to €163.3 million in 2024, as third-party sales decreased by 42.3% to €19.2 million (€33.2 million in 2024), as expected Product sales increased by 9% at constant exchange rate (CER) 2) and excluding third-party sales Cash and cash equivalents of €109.7 million as of December 31, 2025, compared to €168.3 million as of December 31, 2024 2026 Outlook and Financial Guidance: First Phase 3 data readout for Lyme disease vaccine candidate anticipated in the first half of 2026, with regulatory submissions expected to follow as planned by Pfizer, subject to positive results If successful, VLA15 will be the fourth vaccine developed by Valneva and its successful commercialization by Pfizer would enable Valneva to further expand and accelerate a pipeline of innovative vaccines in line with its strategic vision First Phase 2 data for tetravalent shigella vaccine candidate S4V2 A decision on subsequent development steps is anticipated in the second half of 2026 Progress in enhancing the R&D pipeline with differentiated vaccine candidates addressing areas of high unmet medical need Total revenues for 2026 are expected in the range of €155-170 million, including product sales between €145-160 million Lower product sales guidance in 2026 compared to 2025 reflects continued growth of established commercial brands, offset by the wind-down of third-party sales as previously guided. Disciplined cash management to continue with operating cash burn expected to decline further in 2026 while sustaining strategic R&D investments Peter Bühler, Valneva’s Chief Financial Officer , commented, “2025 challenged our resilience while reaffirming the strength of our team’s disciplined execution. We remained committed to growing our commercial brands and made strong progress across our key R&D programs, despite headwinds around IXCHIQ ® and the broader geopolitical pressures. As we enter 2026, we look forward to the potentially transformative Phase 3 data readout for our Lyme disease vaccine candidate, while remaining focused on prudent capital allocation, to support shaping and growing our business in line with our strategic vision.” Valneva also announced today that its Board of Directors has renewed Thomas Lingelbach’s mandate as Chief Executive Officer for a further three-year term and confirmed his continued role as a Board member, subject to approval at the Company’s 2026 Annual General Meeting. Anne-Marie Graffin, Chairperson of Valneva’s Board of Directors, commented, “As a co-founder of the Company, Thomas has been a driving force behind our growth, culture, and sustained success over the past 13 years. The Board firmly believes that his continued leadership is critical as we enter the next era of the Company’s development, and we have full confidence in his ability to drive the Company’s future and deliver value for all our stakeholders.” Non-IFRS Financial Measures - Product sales (excluding third-party sales) at constant exchange rates: References to changes in net sales at constant exchange rates (CER) indicate that the impact of currency fluctuations has been removed. This is done by recalculating net sales for the period in question using the exchange rates applied in the prior period. € in million Twelve months ended December 31 (unaudited results, consolidated per IFRS) 2025 2024 Year-over-year growth % Product sales 157.9 163.3 - 3.3% Third-party product sales 19.2 33.2 - 42.3% Product sales excluding third-party sales 138.7 130.1 + 6.7% Effect of exchange rates (excluding third-party sales) 3.1 Product sales (excluding third-party sales) at constant exchange rates (CER) 141.8 + 9.0% About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at . Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products, and financial guidance including projected product sales, total revenue and total R&D investments. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 The financial figures presented in this release are preliminary and unaudited. The final audited financial results, which remain subject to approval by the Board of Directors, are expected to be published in March. 2 Changes in product sales are presented at constant exchange rate (CER), where indicated. The definition of CER is provided in this press release Attachment 2026_02_19_FY2025_RevCash_PR_EN_Final

Financial StatementVaccineExecutive ChangePhase 3

19 Feb 2026

·www.pharmaceutical-technology.com

Valneva’s Lyme disease vaccine offers beacon of hope amid 2025 sales dip

Valneva’s commercial portfolio is made up of three travel vaccines. Credit: mundissima/Shutterstock.com Valneva reported a drop in product sales in 2025 amid market restrictions for chikungunya vaccine Ixchiq, with the travel vaccine specialist betting on upcoming readouts to turn the business’ growth around. As per preliminary results, Valneva’s product sales reached €157.9m ($186.1m) in 2025, a 3.3% drop from €163.3m in 2024. The company’s commercial products include Japanese encephalitis vaccine Ixiaro and cholera vaccine Dukoral, but its lead brand is Ixchiq. Ixchiq has endured a difficult regulatory spell over the past year. In August 2025, the US Food and Drug Administration (FDA) suspended Ixchiq’s license due to “serious safety concerns”. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) followed suit in February 2026 for the same reasons. The vaccine had been temporarily suspended in people over 65 years of age in the UK in June 2025. While Valneva did not reveal Ixchiq’s sales numbers for 2025, the company said the total product sales downturn was “expected”. The segment that dragged growth was third-party sales, which decreased 42.3% – though this contributed €19.2m to the €157.9m. Despite its products not tracking well, Valneva’s total revenue increased to €174.7m in 2025, up from €169.6m in 2024. The company added that this was buoyed by the ongoing research collaboration and licensing agreement for the Lyme disease programme with Pfizer. In April 2020, Pfizer began working with Valneva to help develop the latter’s Lyme disease vaccine candidate, which was in Phase II trials at the time. Valneva expects the first Phase III (NCT05477524) data readout for the candidate, dubbed VLA15, in the first half of 2026. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence VLA15 could represent an avenue back to more positive financial results for Valneva. There is currently no approved vaccine available for the disease that is caused by a bacterial infection transmitted by infected tick bites. Recent estimates by the US Centers for Disease Control and Prevention (CDC) suggest that approximately 476,000 people may be diagnosed and treated for Lyme disease each year in the US. “VLA15’s successful commercialisation by Pfizer would enable Valneva to further expand and accelerate a pipeline of innovative vaccines in line with its strategic vision,” Valneva said in a statement. Valneva also plans to report the first Phase II data for tetravalent shigella vaccine candidate S4V2 in 2026. In-licensed from LimmaTech Biologics AG, Valneva will make a decision on the next steps of development for the jab in the second half of 2026. While shareholders prepare for pipeline updates this year, they could be set for another financially lukewarm year for Valneva. The company said it expects 2026 total revenues of between €155-170m – the higher end of this forecast would still represent a near $5m drop from 2025’s figure. Peter Bühler, Valneva’s chief financial officer, commented: “2025 challenged our resilience while reaffirming the strength of our team’s disciplined execution. We remained committed to growing our commercial brands and made strong progress across our key R&D programmes, despite headwinds around Ixchiq and the broader geopolitical pressures. As we enter 2026, we look forward to the potentially transformative Phase III data readout for our Lyme disease vaccine candidate, while remaining focused on prudent capital allocation, to support shaping and growing our business in line with our strategic vision.” Valneva is not the only company to struggle with sales growth amid a US vaccine landscape that has undergone volatility in the past year. Moderna also reported declining vaccine sales in its Q3 results, leading to a trim in its 2025 guidance. Health Secretary Robert F Kennedy (RFK) Jr has implemented policies to reduce reliance on vaccines for respiratory diseases, though there has been a knock on effect to the travel vaccine sector.

VaccinePhase 2License out/inPhase 3

20 Jan 2026

·www.fiercepharma.com

Valneva withdraws chikungunya vaccine Ixchiq from US amid new FDA investigation

Valneva's withdrawal of Ixchiq leaves Bavarian Nordic’s Vimkunya the only available chikungunya vaccine in the U.S. Following an FDA marketing suspension, Valneva has decided to voluntarily withdraw its chikungunya vaccine Ixchiq in the U.S.The French company announced the decision Monday, noting that the FDA has also opened an investigation into a newly reported serious adverse event.The FDA suspended Ixchiq’s approval in August after raising serious safety concerns related to the vaccine. At that time, the agency said it had received reports of one death from encephalitis “directly attributable” to the vaccine and more than 20 serious adverse events—hospitalizations and deaths—that were “consistent with chikungunya-like illness.”According to Valneva, the agency recently placed a clinical hold on Ixchiq’s development program to investigate a new case reported outside the U.S. The event involved a younger adult who received three vaccines together, including Ixchiq. Valneva described the case as “plausibly related to Ixchiq vaccination" but caveated that "causality has not been determined.”With an FDA accelerated approval in November 2023, Ixchiq became the world’s first shot for chikungunya. Its retreat leaves Bavarian Nordic’s Vimkunya the only available chikungunya vaccine in the U.S. To confirm Ixchiq’s efficacy and safety profile, Valneva has planned to start a post-marketing phase 4 program, including a randomized controlled efficacy and safety study for adults in endemic countries and an observational effectiveness study in Brazil. In its Jan. 19 release, the company said it “intends to move forward” with the post-marketing activities “subject to further discussions with relevant regulatory authorities.”With the withdrawal, it appears that Valneva does not wish to bring Ixchiq back to the U.S., even upon completing the post-marketing study.“This is a permanent decision,” a Valneva spokesperson told Fierce Pharma.“The withdrawal of our Ixchiq BLA in the U.S. does not have any impact on Valneva’s workforce,” the spokesperson added.As the vaccine was in its early launch phase and had been suspended since August, Valneva didn’t factor any U.S. Ixchiq sales into its projections for 2025 and beyond.Despite the safety issues and U.S. withdrawal, Valneva said it continues to engage with other health regulators in Europe, Canada, the U.K. and Brazil, where Ixchiq is licensed. While the vaccine’s various marketing authorizations target travelers, Valneva argues that “Ixchiq’s benefit-risk profile also remains favorable for people living in the endemic and outbreak settings.” RELATED Vaccine-focused Valneva consolidates R&D footprint by shuttering site, eliminating 30 rolesMeanwhile, Valneva investors’ focus remains on a potentially imminent phase 3 readout from VLA15, a Lyme disease vaccine partnered with Pfizer. There are about 476,000 annual cases of Lyme disease in the U.S. and 87 million people living in endemic regions in the country, with no vaccine currently available, according to Valneva.VLA15 uses a primary series of three doses, followed by a booster dose before the second tick season. That’s different from the two-plus-one regimens by LYMErix and ImuLyme, both of which were withdrawn from the market in the early 2000s amid poor market performance. VLA15’s efficacy will be evaluated after that second season in the phase 3 trial.

Phase 3VaccineDrug ApprovalAccelerated Approval

100 Deals associated with VLA15

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lyme Disease	Phase 3	United States	Valneva Sweden AB	30 Jan 2022
Lyme Neuroborreliosis	Phase 1	United States	VALNEVA Austria GmbH	31 Jan 2017
Lyme Neuroborreliosis	Phase 1	United States	Pfizer Inc.	31 Jan 2017
Lyme Neuroborreliosis	Phase 1	Belgium	VALNEVA Austria GmbH	31 Jan 2017
Lyme Neuroborreliosis	Phase 1	Belgium	Pfizer Inc.	31 Jan 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04801420 (VLA15-221, GlobeNewswire) Manual	Phase 2	Lyme Disease	560	VLA15 (month 0-2-6)	abgibshfxj(idltkapixp) = knvprrgjsu tzrvcvjtak (obdexfiodh ) View more	Positive	26 Nov 2025
				VLA15 (month 0-6)	abgibshfxj(idltkapixp) = acaqfakskq tzrvcvjtak (obdexfiodh ) View more
NEWS Manual	Phase 2	Lyme Disease	560	VLA15	myskvctovx(hxbcecmxsv) = Seroconversion rates hit 100% for all outer surface protein A serotypes in all age groups njwojtrrhh (gewgnzjgff ) View more	Positive	03 Sep 2025
				placebo
NCT04801420 (VLA15-221, NEWS) Manual	Phase 2	Lyme Disease	-	VLA15	mrizseqqnl(tifvhnettf) = New results from the study demonstrated a significant anamnestic antibody response across all six serotypes covered by the vaccine in paediatric, adolescent, adult and older adult participants, measured one month after administration of the second booster dose. jwbpjsgpbx (uenmgoduah ) View more	Positive	06 Sep 2024
				Placebo
NCT04801420 (VLA15-221, GlobeNewswire) Manual	Phase 2	Lyme Disease	560	VLA15 second booster dose	uxrngxcvwq(cgbkqqvryh) = vrvhdstczp efxiooufcc (ruxdmjiaui )	Positive	03 Sep 2024
				Placebo	-
NCT04801420 (VLA15-221, CTgov)	Phase 2	Lyme Disease	625	VLA15 (Group 1: VLA15)	kxrapvsnvf = obrnffqvup qyzracumtj (zdzjsxomxp, nukoombakd - affhhrwcns) View more	-	07 Jun 2023
				Placebo+VLA15 (Group 2: VLA15 + Placebo)	kxrapvsnvf = dtvjzkvstt qyzracumtj (zdzjsxomxp, eygisquurs - rtmyukrkxo) View more
NCT03970733 (CTgov)	Phase 2	Lyme Disease	246	VLA15 (VLA15 With Alum Lower Dose)	jhsxkplzqp(ylvwyyalqn) = jrrkgurczi oimvjdqtnx (iqvattxpex, jjcyahsdzx - msmyuskrkk) View more	-	08 Jul 2021
				VLA15 (VLA15 With Alum Higher Dose)	jhsxkplzqp(ylvwyyalqn) = mlnfzyzaap oimvjdqtnx (iqvattxpex, ukjlwpessp - yieuqqzhza) View more
NCT03769194 (CTgov)	Phase 2	Lyme Disease	572	VLA15 (VLA15 Low Dose)	balgavonuc(vyaljsbczp) = aorlolqzfc hvfjqkbgjf (hfukghwqvt, mxcbmtrayx - qhtizefkyp) View more	-	30 Jun 2021
				VLA15 (VLA15 Medium Dose)	balgavonuc(vyaljsbczp) = lbkbmlvvym hvfjqkbgjf (hfukghwqvt, iqnxphtktg - isovteaxyw) View more

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