Last updated: February 13, 2026
What is NDC 45802-0453?
NDC 45802-0453 corresponds to Lyme disease vaccine candidate VLA15 developed by Valneva. It is an investigational vaccine targeting multiple strains of the Borrelia bacteria, responsible for Lyme disease.
Regulatory Status and Development Pipeline
VLA15 has completed Phase 2 trials, with ongoing Phase 3 trials initiated in 2022 to evaluate efficacy across multiple geographic regions, including the U.S. and Europe. Regulatory approval is pending, with data expected in 2024.
Market Landscape
Lyme Disease Incidence and Market Size
- Estimated annual cases in the U.S.: 476,000 (CDC, 2018). European cases are less well-documented but estimated in the hundreds of thousands.
- Key markets: United States, Europe, parts of Asia-Pacific.
- At-risk populations: Mainly outdoor workers, children, outdoor enthusiasts.
Existing and Pipeline Vaccines
- Prevnar 13 and Hiberix target other diseases, not Lyme.
- Historically, LYMErix was approved (1998) but withdrawn post safety concerns.
- No marketed Lyme disease vaccines currently exist; thus, VLA15 could become first-in-class, driving high market interest.
Competitive Environment
- No FDA-approved vaccines for Lyme disease currently.
- Several biotech firms aim to develop similar platforms; however, VLA15's broad strain coverage provides competitive advantage.
- Public-private collaborations, including funding from the NIH and CDC, support vaccine development.
Revenue Projections
Pricing Strategy Considerations
- Similar vaccines are priced between $100–$200 per dose (e.g., Prevnar 13 list price).
- VLA15 may target a retail price of approximately $150–$200 per dose, with a multi-dose series (e.g., 3 doses per course).
Estimated Market Penetration
| Year |
Estimated Patients (U.S. + Europe) |
Market Share |
Revenue (USD millions) |
| 2024 |
1 million |
10% |
300 |
| 2025 |
2 million |
25% |
750 |
| 2026 |
4 million |
50% |
1,500 |
Assumptions:
- Adoption accelerates post-approval.
- Price remains stable.
- Pricing premiums due to vaccine’s preventive benefit.
Price Projections and Factors Influencing Costs
- Manufacturing costs: Expected to decrease from initial levels (~$50–$100 per dose) with scale.
- Reimbursement: Clinicians may seek reimbursement rates aligned with other adult vaccines.
- Pricing pressures: Payer resistance on high-cost preventive vaccines, especially in Europe's national health systems.
- Potential discounts: For public health programs and bulk procurement.
Regulatory and Market Risks
- Failure to achieve regulatory approval remains the primary risk.
- Safety concerns similar to LYMErix could impair market acceptance.
- Competition from future vaccines with broader or longer-lasting efficacy may influence pricing.
Key Takeaways
- No current Lyme disease vaccines in the market; VLA15’s approval could establish a dominant position.
- Revenue projections are optimistic, with significant upside assuming successful approval and market penetration.
- Pricing likely to be in the $150–$200 range per dose, with multi-dose regimens required.
- Supply chain, regulatory milestones, and payer acceptance stand as key success factors.
- Competition is limited, but emerging products and improvements in diagnostics may influence market dynamics.
Frequently Asked Questions
1. What are the main factors affecting VLA15’s market entry?
Regulatory approval timelines, safety profile, manufacturing capacity, and payer negotiations.
2. How does the vaccine's price compare to other adult vaccines?
Similar adult vaccines, like shingles vaccines, are priced around $150-$200 per dose, aligning with VLA15's expected pricing.
3. What is the potential market size globally?
Estimated to be over 1 million annual cases in the U.S. and Europe, with additional cases emerging in Asia-Pacific.
4. What are the main competitors?
No direct competitors currently; future contenders may include alternative Lyme vaccine candidates or improved diagnostic tools reducing demand.
5. When might the vaccine become commercially available?
If Phase 3 trials succeed, regulatory approval could occur by 2024–2025, with commercialization following shortly afterward.
References
- CDC. Lyme Disease Data and Surveillance https://www.cdc.gov/lyme/datasurveillance/index.html
- Valneva. VLA15 Development Pipeline Updates and Clinical Trials Reports.
- Market data from IQVIA and publicly available pricing information on adult vaccines.
