A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A FIFTH DOSE OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY PARTICIPANTS ≥7 YEARS OF AGE

The purpose of this study is to learn about the safety effects of the Lyme disease vaccine (called VLA15), and its ability to protect people from Lyme disease after a 5th dose of the vaccine.
This study is seeking participants who:
* are generally healthy and 7 years of age and older,
* have already been vaccinated with 4 doses of VLA15 (from the VALOR study), and have blood sample taken post dose 4.
* are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners.
* 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 1 dose through a shot in the upper arm, either VLA15 or saline shot (saltwater).
The study will compare the experiences of people receiving the study vaccine or saltwater shot.
Participants will take part in this study for about 12 months. During this time, they will have 4 planned clinic visits. The clinic visits may include having a health check, giving a small amount of blood and getting the study vaccine or saltwater as a shot at the first visit.

Start Date08 Apr 2026

Sponsor / Collaborator

Pfizer Inc.

NCT07226882

/ Active, not recruitingPhase 3

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.

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.

120

News (Medical) associated with VLA15

18 Aug 2026

·www.biospace.com

Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency

Submission based on favorable efficacy and safety results from Phase 3 VALOR trial NEW YORK & LYON, France, August, 14, 2026 Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, the companies’ 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application. The application is based on encouraging efficacy of more than 70% observed in the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial ( NCT05477524 ), which investigated whether the vaccine candidate, PF-07307405, prevented Lyme disease cases in individuals aged five years and older. The vaccine was well tolerated in the trial, with no safety concerns identified.0F 1 “I’m proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe. I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart. We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence.” “We would like to thank and congratulate our partner Pfizer for the significant progress achieved towards delivering a potential vaccine solution in the fight against Lyme disease. MAA acceptance represents a major milestone, especially considering that more than 200 million people live in Lyme disease risk areas in Europe,” said Thomas Lingelbach, CEO and Board member of Valneva. Developed in collaboration between Pfizer and Valneva,1F 2 , 2F 3 the investigational 6-valent OspA-based Lyme disease vaccine has been evaluated for its efficacy, safety, tolerability, immunogenicity, and manufacturing lot consistency. 4 The companies entered into a collaboration and license agreement in April 2020 for the co-development of PF-07307405 and for Pfizer to exclusively manufacture and commercialize PF-07307405, assuming regulatory success. 2 , 3 About Lyme disease vaccine candidate, PF-07307405 There are currently no approved human vaccines for Lyme disease. PF-07307405 is the current Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two pivotal Phase 3 trials completed. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi , the bacteria that cause Lyme disease. When a person is immunized with PF-07307405, their body creates antibodies against six Borrelia OspA serotypes. As the tick feeds on the vaccinated person, these antibodies are ingested by the tick as part of its blood meal. Binding of vaccine-induced antibodies to OspA on Borrelia inside the tick inhibits the bacterium’s ability to leave the tick, preventing it from being transmitted to the human host. The vaccine candidate covers the six most prevalent OspA serotypes expressed by the Borrelia burgdorferi sensu lato species in North America and Europe. About VALOR The VALOR trial was a multicenter, placebo-controlled, randomized, observer-blinded trial conducted at sites in areas of high incidence of Lyme disease across the U.S., Canada, and Europe.3F 4 9,437 trial participants aged 5 years and older were randomized 1:1 into two trial groups and received four doses of either PF-07307405 or a saline placebo – one dose administered at months 0, 2, and 5-9, followed by a fourth dose one year later, shortly before the start of the following Lyme disease season (season 2). 4 About Lyme Disease Lyme disease is a systemic infection caused by Borrelia burgdorferi sensu lato bacteria that are transmitted to humans by the bite of infected Ixodes ticks.4F 5 It is considered the most common vector-borne illness in the Northern Hemisphere.5F 6 , 6F 7 The U.S. Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated each year and 132,000 cases are reported annually in Europe from countries with surveillance systems.7F 8 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called erythema migrans or other nonspecific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint pains) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis), or the nervous system. 7 , 8F 9 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.9F 10 About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For over 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer . 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 . Pfizer Disclosure Notice The information contained in this release is as of August 14, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about an investigational Lyme disease vaccine candidate, PF-07307405, and a collaboration between Pfizer and Valneva for PF-07307405, including their potential benefits, the results of the Phase 3 VALOR clinical trial and a Marketing Authorization Application (MAA) for PF-07307405 pending with the European Medicines Agency , that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data, as well as uncertainties regarding the future of the Lyme disease vaccine program; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications may be filed in any other jurisdictions for PF-07307405; whether and when the MAA or any such other applications that may be filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether PF-07307405 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PF-07307405; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S. or elsewhere; challenges related to public vaccine confidence or awareness; whether our collaboration with Valneva will be successful; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Valneva Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the initiation, progress, results, and timing of regulatory review of vaccine candidates. 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. Pfizer Media Contacts: PfizerMediaRelations@Pfizer.com Pfizer Investor Relations: IR@pfizer.com Valneva Media Contacts: +33 (0)6 4516 7099 Communications@valneva.com Valneva Investor Relations: +1 917 815 4520 investors@valneva.com # # # 1 Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates Strong Efficacy in Phase 3 VALOR Trial. Pfizer. March 23, 2026. Accessed July 2026. Available from: . 2 Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15. April 2020. Accessed July 2026. Available from: . 3 Valneva and Pfizer Enter into Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15. June 20, 2022. Accessed July 2026. Available at: . 4 ClinicalTrials.gov. An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR). Last Updated June 2026. Accessed August 2026. Available from: . 5 Stanek G, Wormser GP, Gray J, Strle F. Lyme borreliosis. Lancet . 2012;379(9814):461-473. doi:10.1016/S0140-6736(11)60103-7. 6 Burn L, Tran TMP, Pilz A, et al. Incidence of Lyme borreliosis in Europe from national surveillance systems (2005–2020). Vector Borne Zoonotic Dis. 2023;23(4):156‑171. doi:10.1089/vbz.2022.0071 7 Kugeler KJ, Schwartz AM, Delorey MJ, et al. Estimating the frequency of Lyme disease diagnoses, United States, 2010-2018. Emerg Infect Dis . 2021;27(2):616-619. doi:10.3201/eid2702.202731 8 Centers for Disease Control and Prevention. Signs and Symptoms of Untreated Lyme Disease. Updated May 15, 2024. Accessed July 2026. Available from: . 9 Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nat Rev Dis Primers . 2016;2:16090. doi:10.1038/nrdp.2016.90. 10 Centers for Disease Control and Prevention. Press Kit: Understanding Lyme and Other Tickborne Diseases. Updated June 26, 2024. Accessed July 2026. Available from . Attachment FINAL Lyme EMA Technical Validation Press Release_8.13.26_EN

Phase 3Clinical ResultVaccineLicense out/in

18 Aug 2026

·pmlive.com

Pfizer and Valneva’s application for Lyme disease vaccine candidate validated by EMA

Pfizer and Valneva have announced that the Marketing Authorisation Application (MAA) for their Lyme disease vaccine candidate has been validated by the European Medicines Agency (EMA). The MAA is for PF-07307405, the companies’ 6-valent outer surface protein A (OspA)-based vaccine candidate. The application is based on encouraging efficacy of more than 70% observed in the phase 3 VALOR clinical trial, which investigated whether the vaccine candidate, PF-07307405, prevented Lyme disease cases in individuals aged five years and older. The VALOR trial was conducted at sites in areas of high incidence of Lyme disease across the US, Canada and Europe and included 9,437 trial participants aged five years and older. The vaccine was well tolerated in the trial, with no safety concerns identified. Thomas Lingelbach, CEO and Board member of Valneva, said: “MAA acceptance represents a major milestone, especially considering that more than 200 million people live in Lyme disease risk areas in Europe.” Lyme disease is a systemic infection caused by bacteria that are transmitted to humans by the bite of infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere. The Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the US are diagnosed and treated each year and 132,000 cases are reported annually in Europe from countries with surveillance systems. Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called erythema migrans or other nonspecific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint pains) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system. The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens. There are currently no approved human vaccines for Lyme disease. PF-07307405 is the current Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two pivotal phase 3 trials completed. Annaliesa Anderson, Senior Vice President and Chief Vaccines Officer at Pfizer, said: “Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart. We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence.”

Phase 3Clinical ResultVaccine

17 Aug 2026

·www.pharmaceutical-technology.com

EMA validates Pfizer and Valneva’s Lyme disease vaccine

In the VALOR clinical trial, PF-07307405 showed efficacy of over 70% in preventing Lyme disease. Credit: MrWinn / Shutterstock.com. The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405. With this validation, the agency will begin its formal assessment of the application. The submission is supported by efficacy and safety data from the Phase III VALOR clinical trial, which enrolled 9,437 participants aged five years and above across the US, Canada, and Europe. In the study, PF-07307405 showed efficacy of more than 70% in preventing Lyme disease. The vaccine candidate was found to be well tolerated with no identified safety concerns, according to the companies. Pfizer senior vice-president and chief vaccines officer Annaliesa Anderson said: “I’m proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe. I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle.” “Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart. “We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence.” Pfizer and Valneva began collaborating on PF-07307405 in April 2020, with the former holding exclusive manufacturing and commercialisation rights if regulatory approval is achieved. The vaccine is a 6-valent outer surface protein A (OspA)-based protein subunit, targeting six Borrelia OspA serotypes found in North America and Europe. Currently, no approved human vaccines exist for Lyme disease. In June 2026, Pfizer received approval from the US Food and Drug Administration for an expanded indication of Hympavzi (marstacimab-hncq) to treat haemophilia A or B.

Clinical ResultVaccinePhase 3Phase 1

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	NDA/BLA	European Union	Valneva SE	14 Aug 2026
Lyme Disease	NDA/BLA	European Union	Pfizer Inc.	14 Aug 2026
Lyme Neuroborreliosis	Phase 1	United States	Pfizer Inc.	31 Jan 2017
Lyme Neuroborreliosis	Phase 1	United States	VALNEVA Austria GmbH	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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05634811 (CTgov)	Phase 3	Lyme Disease	3,547	VLA15 (VLA15: 5 to 11 Years)	zoymxdsniv = fybcumpqww nocxmbhvzr (ejkfphxykd, hszagnaovi - ugthprulwh) View more	-	07 May 2026
				Placebo (Placebo: 5 to 11 Years)	zoymxdsniv = pzlfrekogl nocxmbhvzr (ejkfphxykd, xfsdvxsxyp - ftybggqgby) View more
NCT05477524 (VALOR, Corporate Publications) Manual	Phase 3	Lyme Disease	-	PF-07307405	mmdqhdjyek(ieioetbamq) = ixmxvldpsv nuqizkgnmm (jkkyofksnz )	Positive	23 Mar 2026
NCT04801420 (VLA15-221, GlobeNewswire) Manual	Phase 2	Lyme Disease	560	VLA15 (month 0-2-6)	iwzxkadxvo(skfbngnvzz) = yekaygcxvw inwrayeqsl (rqevuoupqi ) View more	Positive	26 Nov 2025
				VLA15 (month 0-6)	iwzxkadxvo(skfbngnvzz) = kdcfznbxub inwrayeqsl (rqevuoupqi ) View more
NEWS Manual	Phase 2	Lyme Disease	560	VLA15	chkenaobcy(bvviuibpem) = Seroconversion rates hit 100% for all outer surface protein A serotypes in all age groups nouvucnxhb (purmulnhgx ) View more	Positive	03 Sep 2025
				placebo
NCT04801420 (VLA15-221, NEWS) Manual	Phase 2	Lyme Disease	-	VLA15	omkufnecay(noqmlcljxp) = 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. xoztdmbcxl (kmyhjhucbf ) View more	Positive	06 Sep 2024
				Placebo
NCT04801420 (VLA15-221, GlobeNewswire) Manual	Phase 2	Lyme Disease	560	VLA15 second booster dose	ccguklvxes(vdudernkcq) = jmjmbtymwc xjlclemzch (xgaopcnzdp )	Positive	03 Sep 2024
				Placebo	-
NCT04801420 (VLA15-221, CTgov)	Phase 2	Lyme Disease	625	VLA15 (Group 1: VLA15)	sbbonxyqbp = defqqkrsxg vzwsrskpoe (ipbytmvxei, taulmdesjs - iohdkngdvp) View more	-	07 Jun 2023
				Placebo+VLA15 (Group 2: VLA15 + Placebo)	sbbonxyqbp = aptvkpexqg vzwsrskpoe (ipbytmvxei, xqaqmofckw - cuotfxiouf) View more
NCT03970733 (CTgov)	Phase 2	Lyme Disease	246	VLA15 (VLA15 With Alum Lower Dose)	uejilugqha(lklbnocfpp) = cguzlykdsk gocoyvzneo (ckvoyfgjct, euzprwkcoz - qujcqjizxt) View more	-	08 Jul 2021
				VLA15 (VLA15 With Alum Higher Dose)	uejilugqha(lklbnocfpp) = gnsdbgkrbj gocoyvzneo (ckvoyfgjct, ozfbnhmhnp - mombcatvpo) View more
NCT03769194 (CTgov)	Phase 2	Lyme Disease	572	VLA15 (VLA15 Low Dose)	dtkicicpaw(bsmvaiqsry) = aomzzftwlo wqjznbakek (woxknpghiq, kvbbdmyoas - flcyzbpddj) View more	-	30 Jun 2021
				VLA15 (VLA15 Medium Dose)	dtkicicpaw(bsmvaiqsry) = zvfdqjlonw wqjznbakek (woxknpghiq, welbuocvhu - rzrdvmlqce) View more

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