Pfizer Inc. and Valneva SE have announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for PF-07307405, the companies’ 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 percent 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 5 years and older. The vaccine was well tolerated in the trial, with no safety concerns identified.

Annaliesa Anderson, PhD, Senior Vice President (SVP) and Chief Vaccines Officer, Pfizer, said, “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. Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart. We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence.”

Developed in collaboration between Pfizer and Valneva,1F,2F the investigational 6-valent OspA-based 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 commercialise PF-07307405, assuming regulatory success.

Thomas Lingelbach, CEO and Board member, Valneva, said, “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.”