Europe’s medicines regulator has taken the first formal step toward what could be the first approved human vaccine against Lyme disease in decades.
The European Medicines Agency (EMA) has validated the marketing authorisation application for the Lyme disease vaccine candidate developed by Pfizer and Valneva — a procedural milestone that begins the formal review. Pfizer holds exclusive rights to manufacture and commercialise the vaccine.
How it works
The vaccine is a six-valent protein subunit based on outer surface protein A (OspA), targeting six Borrelia OspA serotypes found across North America and Europe. OspA-based vaccines are designed to interrupt the bacterium before it can establish infection.
The trial data
The application is backed by the Phase 3 VALOR trial, which enrolled 9,437 participants aged 5 and older across the US, Canada and Europe. The vaccine showed more than 70% efficacy in preventing Lyme disease and was well tolerated, with no new safety concerns identified.
Why it matters
There is no approved human Lyme vaccine today, even as the tick-borne illness affects over 100,000 people a year in Europe and remains common in parts of North America. “I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle,” Pfizer’s chief vaccines officer said. A validation is the start of review, not an approval — the outcome and timing remain to be decided.