The European Medicines Agency (EMA) has validated Pfizer Inc. (NYSE: PFE) and Valneva SE’s (Nasdaq: VALN; Euronext Paris: VLA) Marketing Authorization Application for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate, and will proceed with reviewing the application.
The EMA will now begin its assessment of the application. This follows encouraging efficacy results of over 70% from the Phase 3 VALOR trial, which tested the vaccine in individuals aged five years and older. The vaccine was well-tolerated, with no safety concerns identified, marking a significant step toward addressing a growing public health need.
A Potential First for Lyme Disease Prevention
Currently, there are no approved human vaccines for Lyme disease. PF-07307405 is the most advanced candidate, with two completed Phase 3 trials. The vaccine targets the outer surface protein A (OspA) of the bacteria that causes Lyme disease, Borrelia burgdorferi. This mechanism of action has been established as effective in preventing the transmission of the bacteria from ticks to humans.
When vaccinated, the body produces antibodies against six Borrelia OspA serotypes. These antibodies are ingested by ticks during feeding, preventing the bacteria from leaving the tick and infecting the human host. This innovative approach addresses the root cause of transmission, offering a promising preventive measure.
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The VALOR trial, conducted across the U.S., Canada, and Europe, involved 9,437 participants who received either the vaccine or a placebo. The trial’s design included four doses administered at specific intervals to assess efficacy over multiple Lyme disease seasons, ensuring robust evaluation of the vaccine’s long-term effectiveness.
Addressing a Growing Need
Lyme disease is the most common vector-borne illness in the Northern Hemisphere, with an estimated 476,000 cases diagnosed annually in the U.S. and 132,000 in Europe. Early symptoms, such as erythema migrans (a gradually expanding rash) or nonspecific symptoms like fatigue and fever, are often overlooked or misinterpreted, leading to potential chronic complications affecting the skin, joints, heart, and nervous system. The disease’s expanding geographic footprint shows the urgent need for preventive measures.
The need for a vaccine is increasing as the disease spreads geographically. Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer at Pfizer, expressed pride in the progress and the potential to bring the first vaccine of its kind to Europe. She emphasized the vaccine’s role in enabling people to enjoy outdoor activities with greater confidence, reducing the risk of this debilitating disease.
“Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year,” Anderson said. “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.”
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Thomas Lingelbach, CEO of Valneva, highlighted the significance of the MAA acceptance, noting that over 200 million people in Europe live in Lyme disease risk areas. He thanked Pfizer for their collaboration and congratulated both teams on achieving this major milestone in the fight against Lyme disease.
The collaboration between Pfizer and Valneva began in April 2020, with Pfizer holding exclusive rights to manufacture and commercialize the vaccine upon regulatory approval. This partnership leverages Pfizer’s global resources and Valneva’s specialized expertise in vaccine development, creating a strong foundation for success.
The VALOR Trial: A Multicenter Effort
It involved 9,437 participants aged five years and older, randomized into two groups. Participants received four doses of either the vaccine or a saline placebo, administered at months 0, 2, 5-9, and a fourth dose one year later, shortly before the start of the following Lyme disease season. This design ensured full evaluation of the vaccine’s efficacy and safety across multiple seasons.
Pfizer and Valneva: A Collaborative Journey
It covers six prevalent OspA serotypes in North America and Europe, ensuring broad protection against the most common strains of the disease. This multivalent approach enhances the vaccine’s effectiveness across diverse geographic regions.
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