EMA Begins Review of Pfizer-Valneva Lyme Disease Vaccine

Editor’s Take: There are currently no approved human vaccines for Lyme disease, but PF-07307405 is the current Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two pivotal Phase 3 trials completed.

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, Pfizer and Valneva’s 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate, and will begin its assessment of the application.

The application is based on encouraging efficacy of more than 70% observed in the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial (NCT05477524), which investigated whether the vaccine candidate, PF-07307405, prevented Lyme disease cases in individuals aged five years and older. The vaccine was well tolerated in the trial, with no safety concerns identified.

Developed in collaboration between Pfizer and Valneva, the Lyme disease vaccine has been evaluated for its efficacy, safety, tolerability, immunogenicity, and manufacturing lot consistency. The companies entered into a collaboration and license agreement in April 2020 for the co-development of PF-07307405 and for Pfizer to exclusively manufacture and commercialize PF-07307405, assuming regulatory success.

Comments from Leadership

“I’m proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe. I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer.

“We would like to thank and congratulate our partner Pfizer for the significant progress achieved towards delivering a potential vaccine solution in the fight against Lyme disease. MAA acceptance represents a major milestone, especially considering that more than 200 million people live in Lyme disease risk areas in Europe,” said Thomas Lingelbach, CEO and Board member of Valneva.