Pfizer and Valneva report results for Lyme disease vaccine VLA15 that complicate regulatory path. In the phase 3 VALOR study, half of the participants had to be excluded due to good clinical practice violations at some of the US sites managed by Care Access. The original target of recruiting 6000 people for the primary efficacy data has shifted, with a total plan of 18,000 healthy people from endemic areas with a higher risk of tick bites. Participants receive VLA15 or placebo in a three-dose schedule, with annual boosters before tick season. Submission for FDA and EMA approval is delayed to 2026, a year later than planned. Phase 2 showed a strong anamnestic immune response and a favorable safety profile six months after the third booster dose in all age groups. Antibody levels remained above baseline for all six serotypes. No safety concerns were noted by an independent monitoring committee.[1][2][3][5]