Lyme disease is a tick-borne infection caused by Borrelia bacteria and transmitted by blacklegged ticks. Clinical manifestations can involve skin, joints, nervous system, and heart if untreated.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Pfizer and Valneva said their investigational Lyme disease vaccine candidate showed more than 70% efficacy in the phase 3 VALOR trial. Pfizer plans regulatory submissions after the study, which reported no safety concerns at the time of analysis.
Pfizer and Valneva said their investigational Lyme disease vaccine showed more than 70% efficacy in the Phase 3 VALOR trial with a favorable safety profile. The companies plan regulatory submissions despite the trial missing its primary statistical criterion due to fewer Lyme cases than expected.
The FDA agreed to review Moderna's mRNA flu vaccine application after initially rejecting it, reversing course within a week. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and above, with a decision expected by August 5.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07562087 |
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure |
RECRUITING | PHASE2 |
| NCT07561294 |
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age) |
RECRUITING | PHASE2 |
| NCT07500506 |
A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine |
RECRUITING | PHASE3 |
| NCT06045416 |
Borrelia B-cell Diagnostics |
RECRUITING | |
| NCT05634811 |
Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children |
COMPLETED | PHASE3 |
| NCT05477524 |
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) |
COMPLETED | PHASE3 |
| NCT05036707 |
Human Immune Response to Ixodes Scapularis Tick Bites |
RECRUITING | PHASE1/PHASE2 |
| NCT01143558 |
Searching for Persistence of Infection in Lyme Disease |
COMPLETED | EARLY_PHASE1 |
| NCT00001539 |
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations |
RECRUITING |
