US biopharmaceutical company Pfizer Inc (NYSE:PFE) and French vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) on Monday reported positive topline results from the Phase 3 VALOR trial of their Lyme disease vaccine candidate PF-07307405 (LB6V).

The investigational vaccine demonstrated efficacy above 70% in preventing Lyme disease among individuals aged five and older. It was well tolerated with no identified safety concerns.

In pre-specified analyses, efficacy reached 73.2% at 28 days post-dose four and 74.8% at one day post-dose four compared to placebo. While the primary endpoint statistical threshold was not met due to fewer-than-expected cases, the companies highlighted clinically meaningful efficacy and expressed confidence in the candidate's potential.

Pfizer plans to submit the vaccine for regulatory approval, following its co-development with Valneva under a 2020 collaboration agreement granting Pfizer exclusive manufacturing and commercialisation rights.

The vaccine, targeting six serotypes of Borrelia burgdorferi, is among the most advanced candidates in development, addressing a market with no currently approved human vaccines for Lyme disease.