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Mar 23, 2026 12:01 PM

Valneva-Pfizer Lyme Shot Stumbles Yet Keeps Regulatory Path Alive

Valneva SE (NASDAQ:VALN) shares were falling on Monday following the announcement of topline results from the Phase 3 VALOR clinical trial for its Lyme disease vaccine candidate, which did not meet the primary endpoint criteria.

The investigational 6-valent OspA-based Lyme disease vaccine candidate, developed in collaboration with Pfizer Inc. (NYSE:PFE), aims to protect against Lyme disease, a tick-borne bacterial infection, which currently has no approved vaccine.

The Phase 3 VALOR trial results showed that fewer Lyme disease cases were accrued than anticipated, and the primary endpoint was not met in the first analysis.

Secondary Analysis For Valneva Drug

However, the second analysis indicated clinically meaningful efficacy, with Pfizer expressing confidence in the vaccine’s potential and planning