Pfizer and Valneva’s Lyme disease vaccine candidate has moved a step closer to potential European approval after the EMA validated the marketing authorisation application for PF-07307405.
The investigational six-valent outer surface protein A (OspA)-based vaccine candidate was developed to prevent Lyme disease in individuals aged five years and older. The application was supported by efficacy and safety findings from the phase 3 VALOR trial, in which the vaccine candidate demonstrated more than 70% efficacy.
“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,” said Annaliesa Anderson, Senior Vice President and Chief Vaccines Officer, Pfizer.
The EMA validation means the application can now enter the agency’s assessment process. PF-07307405 remains investigational and has not yet received marketing authorisation.
VALOR was a multicentre, placebo-controlled, randomised and observer-blinded phase 3 trial conducted across sites in the US, Canada and Europe. The study enrolled 9,437 participants aged five years and older who were randomised to receive either PF-07307405 or saline placebo.
Participants received four doses, administered at months 0, 2 and 5–9, followed by a fourth dose one year later before the subsequent Lyme disease season.
The vaccine candidate targets OspA, a protein expressed by the bacteria responsible for Lyme disease. Following vaccination, antibodies targeting six OspA serotypes are generated. During a tick blood meal, these antibodies are ingested by the tick and are intended to inhibit the bacterium’s ability to leave the tick and reach the human host.
The candidate covers six of the most prevalent OspA serotypes expressed by the bacteria in North America and Europe.
The companies reported that PF-07307405 was well tolerated in the VALOR trial, with no safety concerns identified. The candidate has now completed two pivotal phase 3 trials and is described as the most advanced Lyme disease vaccine candidate in clinical development.
Lyme disease remains a significant public health concern in Europe, where the companies stated that more than 100,000 people are affected each year. More than 200 million people also live in areas of Europe considered at risk of Lyme disease.
For the pharmaceutical sector, the EMA validation represents an important regulatory milestone for a vaccine candidate addressing an area of unmet preventive need.
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