Vaccine efforts · Trials & data

The evidence,
in the open.

Three programs are working to prevent Lyme disease. Here is exactly where each one stands — the design, the numbers, and the timeline — with every figure traced to a public source at the foot of the page.

The pipeline at a glance

How far each has come.

PreclinicalPhase 1Phase 2Phase 3FDA filing
VLA15
Pfizer + Valneva
Moderna mRNA
mRNA-1975 / 1982
Lyme PrEP
Tonix (MassBiologics)

Progress reflects the furthest clinical stage each program has publicly reached. Only VLA15 has completed a Phase 3 efficacy trial.

The headline result

VLA15, in its Phase 3 trial.

In 9,437 people aged five and up, three doses plus a booster cut Lyme disease by more than seventy percent — with no safety concerns flagged at analysis.

Reduction in Lyme disease
>70%
Phase 3 VALOR · announced March 2026

Program by program

The three, in full.

VLA15

>70% efficacy in Phase 3

Pfizer + Valneva

Approach
Protein-subunit vaccine targeting OspA, the outer-surface protein on the tick’s gut — covering the six most common Borrelia serotypes in the U.S. and Europe.
Trial
Phase 3 “VALOR” — Vaccine Against Lyme for Outdoor Recreationists. Randomized, placebo-controlled.
Participants
9,437 people, age 5 and older, across endemic regions of the U.S. and Europe.
Regimen
Three-dose primary series plus one booster.
Result
More than 70% efficacy in preventing Lyme disease, with no safety concerns identified at analysis (announced March 23, 2026).
Timeline
Primary series completed July 2024 · boosters July 2025 · FDA (BLA) and EMA (MAA) submissions planned for 2026.
Status
Awaiting regulatory submission — the only candidate near approval.

Moderna mRNA

Early human trials

Moderna

Approach
mRNA vaccine (candidates mRNA-1975 and mRNA-1982) — the same platform as modern COVID vaccines, instructing cells to display Lyme antigens and raise immunity.
Trial
Phase 1/2, randomized and placebo-controlled, in healthy adults aged 18–70.
Stage
Testing safety and immune response (immunogenicity) before any efficacy trial.
Timeline
Study completion estimated later this decade (~2028).
Status
Early clinical — years behind VLA15, but a fast-iterating technology.

Lyme PrEP

A shot, not a vaccine

MassBiologics → Tonix Pharmaceuticals

Approach
Pre-exposure prophylaxis: a single injection of a ready-made human monoclonal antibody that protects for a season — without waiting for your own immune system to build a response.
Trial
First-in-human Phase 1 safety and pharmacology study, 66 volunteers.
Origin
Developed at UMass Chan / MassBiologics; licensed to Tonix Pharmaceuticals in 2025 for further development.
Why it’s different
Works immediately and suits people who won’t complete a multi-dose vaccine course — conceptually the closest cousin to post-exposure prophylaxis.
Status
Phase 1.

One line of history

There was a Lyme vaccine once.

LYMErix was approved in 1998 and pulled from the market in 2002 — not because it failed, but amid sagging sales and unproven safety fears that later reviews did not bear out. The candidates above are the field’s first serious return since. It’s worth being both hopeful and precise about them.

Sources

Every figure, traced.

The primary and authoritative sources behind the numbers on this page.

  1. 01Pfizer & Valneva — Phase 3 VALOR efficacy announcement. Press release, March 23, 2026. VLA15 demonstrated >70% efficacy against Lyme disease. Read the source →
  2. 02Pfizer — VALOR primary series & booster completion. Phase 3 VALOR trial design, enrollment (9,437) and dosing schedule. Read the source →
  3. 03IDSA — Tick-borne disease vaccines: what clinicians should know in 2026. Infectious Diseases Society of America, Science Speaks, 2026. Read the source →
  4. 04Current and Future State of Vaccines for Lyme Disease. Clinical Infectious Diseases (Oxford Academic), review of the OspA and pipeline landscape. Read the source →
  5. 05Moderna — mRNA Lyme disease programs. Overview of mRNA-1975 / mRNA-1982 clinical development. Read the source →
  6. 06Lyme PrEP — monoclonal antibody enters human trials. MassBiologics / UMass Chan program, licensed to Tonix Pharmaceuticals (2025). Read the source →
  7. 07CDC — Lyme Disease Vaccine. History of LYMErix (approved 1998, withdrawn 2002) and current guidance. Read the source →

Current to the Phase 3 VALOR efficacy readout of March 2026. Trial timelines and regulatory dates change; this page reflects publicly reported data at the time of writing and is educational — it is not a recommendation for or against any specific product.

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