Lyme disease vaccines: a second chance for the US market

Lyme disease is caused primarily by Borrelia burgdorferi, transmitted through the bite of infected Ixodes ticks, and is the most common vector-borne disease in the United States [1]. CDC reports more than 80,000 Lyme disease cases a year [2]. Separately, an insurance-claims analysis estimated that about 476,000 people were diagnosed and treated each year in the United States during 2010–2018 [3]. Lyme cases are concentrated in the Northeast, mid-Atlantic and upper Midwest: during 2008–2015, 14 high-incidence states accounted for 95.2% of reported cases, and reported cases peaked among children aged 5–9 years and adults aged about 50–55 years [4]. The VacZine Analytics’ 2026 model estimates a US target population of 10–15 million people under its defined Lyme-risk criteria.

Erythema migrans, an expanding skin rash, is a common early sign of infection for Lyme disease. Patients treated promptly for early Lyme disease usually recover fully; recommended oral treatments include doxycycline, amoxicillin and cefuroxime axetil [1,5]. Importantly, delayed diagnosis of Lyme disease can allow the infection to spread to the joints, heart and nervous system, causing arthritis, carditis, facial palsy and meningitis [1]. Also, a minority of treated patients report fatigue, pain and cognitive symptoms that can persist for months [6]. A CDC-supported study estimated that diagnosed Lyme disease costs US society about $345–968 million a year, in 2016 US dollars [7].

SmithKline Beecham, now part of GSK, previously developed the Lyme disease vaccine LYMErix. The OspA vaccine showed 76% efficacy in the second study year after three doses in a US trial [8]. In 1999, ACIP advised that vaccination should be considered for people aged 15–70 years with frequent or prolonged exposure to tick-infested habitat in areas of high or moderate Lyme disease risk [9]. Unfortunately, SmithKline Beecham withdrew LYMErix in 2002, citing poor sales, amid public safety concerns and declining confidence [10].

Currently, the most advanced Lyme disease vaccine is Pfizer and Valneva’s LB6V (PF-07307405, formerly VLA15). LB6V (PF-07307405) is an investigational six-valent OspA vaccine. According to the developers, it targets the six most prevalent OspA serotypes associated with Lyme disease in North America and Europe [11]. For LB6V, the Phase 3 VALOR trial enrolled about 9,400 participants aged five years and older in North America and Europe [12]. Pfizer and Valneva reported efficacy of 73.2% from 28 days after the fourth dose, during the second Lyme season (95% CI 15.8–93.5%); the lower bound fell short of the prespecified success criterion of 20% [13]. The European Medicines Agency validated the marketing-authorisation application in August 2026 [12]. On Pfizer’s 3 November 2026 results call, management said it had also filed in Canada, that FDA discussions were continuing and that an update was expected in Q4 2026 [14]. Press reports also cited analyst expectations that a US filing could follow by year-end [15].

Many commercial questions remain for LB6V. For example, in a trial extension with no further vaccination, efficacy in the following season was 18.6%, with a wide confidence interval [16], and a fifth-dose study is under way [17] which would suggest a frequent need for boosting and therefore higher cost. Also, the US ACIP, the main vaccine recommending committee was reconstituted in 2025 [18], and CDC lists all three scheduled 2026 meetings as cancelled because of ongoing litigation [19]. This makes the timing of any Lyme vaccine recommendation, and therefore payer coverage, harder to predict. Other preventive approaches are also in development: Moderna is evaluating its mRNA-1982 vaccine in Phase 2 [20], and Tonix is developing TNX-4800, a long-acting monoclonal antibody rather than a vaccine [21].

In Q4 2026, VacZine Analytics is launching MarketVIEW: Lyme disease vaccines (VAMV024). The analysis provides forecasts for the United States and Canada to 2045, with sub-state analysis of the US market. This is because, Lyme risk is local, and neighbouring counties can differ sharply in incidence. The model estimates the at-risk population and evaluates four recommendation scenarios, each with distinct uptake assumptions and sensitivity to price and payer mix.

In the new model, a switchable overlay models vaccine demand if a different kind of preventive and competitive reaches the market. Annual doses and net revenue are forecast to 2045, with US outputs by state, season and risk zone and Canadian outputs by province. The MS-Excel model is fully interactive: users can change schedules, boosters, uptake and pricing, and the forecast recalculates throughout. The model comes with an Executive Presentation covering disease, epidemiology, surveillance, economic burden, vaccine history, the pipeline and the value case.

Why buy, and how

For developers, investors and partners, VAMV024 gives an independent, transparent view of a potential new US Lyme disease prevention market as regulatory decisions approach. The analysis is available to order now. For pricing and licence options, contact [email protected] or visit www.vaczine-analytics.com.

VacZine Analytics, established in the UK since 2007, provides disease and commercial analysis for the vaccine and gene therapy sectors.

VacZine Analytics is a trading division of Assay Advantage (VacZine Analytics) Ltd, UK Company No. 5807728.

References:

1. Steere AC, et al. Lyme borreliosis. Nat Rev Dis Primers. 2016;2:16090. doi:10.1038/nrdp.2016.90
2. Centers for Disease Control and Prevention. Lyme disease surveillance and data. Updated 9 September 2026. https://www.cdc.gov/lyme/data-research/facts-stats/index.html
3. Kugeler KJ, 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
4. Schwartz AM, et al. Surveillance for Lyme disease — United States, 2008–2015. MMWR Surveill Summ. 2017;66(22):1-12. doi:10.15585/mmwr.ss6622a1
5. Lantos PM, et al. IDSA/AAN/ACR 2020 guidelines for the prevention, diagnosis and treatment of Lyme disease. Clin Infect Dis. 2021;72(1):e1-e48. doi:10.1093/cid/ciaa1215
6. Aucott JN, et al. Post-treatment Lyme disease syndrome symptomatology and the impact on life functioning: is there something here? Qual Life Res. 2013;22(1):75-84. doi:10.1007/s11136-012-0126-6
7. Hook SA, et al. Economic burden of reported Lyme disease in high-incidence areas, United States, 2014–2016. Emerg Infect Dis. 2022;28(6):1170-1179. doi:10.3201/eid2806.211335
8. Steere AC, et al. Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. N Engl J Med. 1998;339(4):209-215. doi:10.1056/NEJM199807233390401
9. Centers for Disease Control and Prevention. Recommendations for the use of Lyme disease vaccine: recommendations of the ACIP. MMWR Recomm Rep. 1999;48(RR-7):1-17, 21-25.
10. Nigrovic LE, Thompson KM. The Lyme vaccine: a cautionary tale. Epidemiol Infect. 2007;135(1):1-8. doi:10.1017/S0950268806007096
11. Valneva. Lyme disease: LB6V (VLA15). Developer web page. Accessed November 2026. https://valneva.com/research-development/lyme-disease/
12. Pfizer and Valneva. Pfizer and Valneva’s Lyme disease vaccine candidate marketing authorization application validated by European Medicines Agency. Press release, 14 August 2026. https://valneva.com/press-release/pfizer-and-valnevas-lyme-disease-vaccine-candidate-marketing-authorization-application-validated-by-european-medicines-agency/
13. Pfizer and Valneva. Pfizer and Valneva announce Lyme disease vaccine candidate demonstrates strong efficacy in Phase 3 VALOR trial. Press release, 23 March 2026. https://valneva.com/press-release/pfizer-and-valneva-announce-lyme-disease-vaccine-candidate-demonstrates-strong-efficacy-in-phase-3-valor-trial/
14. Pfizer. Third-quarter 2026 earnings conference call (webcast and transcript), 3 November 2026. https://investors.pfizer.com/Investors/news-events/default.aspx
15. Armstrong A. Pfizer eyes Europe first for Lyme vaccine as prevalence rises in US. BioSpace, 4 November 2026. https://www.biospace.com/business/pfizer-eyes-europe-first-for-lyme-vaccine-as-prevalence-rises-in-us
16. Hovius JW, Auwaerter PG, et al. Efficacy and safety of the LB6V Lyme disease vaccine candidate: results from a Phase 3 study in participants ≥5 years of age. IDWeek 2026, Washington DC, 21–24 October 2026. Conference presentation.
17. ClinicalTrials.gov. NCT07500506: Safety, tolerability and immunogenicity of a fifth dose of 6-valent OspA-based Lyme disease vaccine, VLA15. https://clinicaltrials.gov/study/NCT07500506
18. US Department of Health and Human Services. HHS takes bold step to restore public trust in vaccines by reconstituting ACIP. Press release, 9 June 2025. https://www.hhs.gov/press-room/hhs-restore-public-trust-vaccines-acip.html
19. Centers for Disease Control and Prevention. ACIP meeting information. Updated 9 October 2026. https://www.cdc.gov/acip/meetings/index.html
20. ClinicalTrials.gov. NCT07561294: Dose-finding study of the safety, reactogenicity and immunogenicity of mRNA-1982, an mRNA vaccine to prevent Lyme disease, in healthy adults 18 to 70 years. https://clinicaltrials.gov/study/NCT07561294
21. Tonix Pharmaceuticals. Tonix Pharmaceuticals announces presentation of Phase 1 data and outlines planned adaptive Phase 2 field study of TNX-4800 for the prevention of Lyme disease at the World Vaccine Congress Washington 2026. Press release, 31 March 2026. https://www.sec.gov/Archives/edgar/data/1430306/000199937126007254/ex99-01.htm