Pfizer Inc. and Valneva SE announced that the European Medicines Agency has formally accepted for review the Marketing Authorization Application for their jointly developed Lyme disease vaccine candidate, PF-07307405 (formerly known as VLA15). The validation confirms the submitted dossier is complete and clears the way for EMA’s scientific assessment to begin.
The vaccine targets six variants of the outer surface protein A found on the Borrelia bacteria responsible for Lyme disease, the most widespread tick-borne illness across Europe and North America. Its mechanism works within the tick itself: antibodies generated by vaccination attack the bacteria inside a feeding tick’s gut, cutting off transmission before infection can take hold in the human bloodstream.
Backing the submission is data from the Phase 3 VALOR study, which enrolled participants aged five and older and recorded efficacy exceeding 70% against symptomatic Lyme disease. Researchers also reported a favorable tolerability profile, with no significant safety signals emerging during the trial.
Pfizer’s chief vaccines officer, Annaliesa Anderson, noted that Lyme disease affects over 100,000 people annually in Europe, with untreated cases sometimes progressing to lasting joint, nerve, skin, or cardiac complications. She framed the vaccine as a potential added safeguard for people who spend time outdoors.
If ultimately approved, PF-07307405 would represent the first vaccine against Lyme disease authorized for human use in more than twenty years. The companies had earlier submitted supporting data to the U.S. FDA, with Phase 3 results first disclosed in March 2026. EMA’s review timeline has not yet been specified.
Written By: Sayan Das
Graphics by: Pramit Hazra
