Pfizer and Valneva have cleared a key regulatory hurdle for their Lyme disease vaccine candidate in Europe, with the European Medicines Agency validating the companies’ Marketing Authorization Application.

 

The application covers PF-07307405, a six-valent vaccine candidate targeting outer surface protein A (OspA) of the bacteria that cause Lyme disease. The EMA will now begin its formal assessment of the application.

 

The filing is backed by results from the Phase 3 VALOR clinical trial, which found the vaccine candidate demonstrated more than 70% efficacy in preventing Lyme disease in people aged five and older. The vaccine was also well tolerated, with no safety concerns identified.

 

“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, Senior Vice President and Chief Vaccines Officer, Pfizer. 

 

“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.”

 

The companies said the milestone could be significant for Europe, where more than 200 million people live in areas considered at risk for Lyme disease.

 

“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.

 

Pfizer and Valneva began collaborating on the vaccine in 2020 under a co-development and licensing agreement. Pfizer has exclusive rights to manufacture and commercialize PF-07307405 if it wins regulatory approval.

 

There are currently no approved human vaccines for Lyme disease. PF-07307405 has completed two pivotal Phase 3 trials and is the most advanced Lyme disease vaccine candidate in clinical development, according to the companies.

 

The vaccine is designed to target six OspA serotypes found in Borrelia burgdorferi sensu lato, the group of bacteria responsible for Lyme disease in North America and Europe.