The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405.
With this validation, the agency will begin its formal assessment of the application.
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The submission is supported by efficacy and safety data from the Phase III VALOR clinical trial, which enrolled 9,437 participants aged five years and above across the US, Canada, and Europe.
In the study, PF-07307405 showed efficacy of more than 70% in preventing Lyme disease. The vaccine candidate was found to be well tolerated with no identified safety concerns, according to the companies.
Pfizer senior vice-president and chief vaccines officer Annaliesa Anderson 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.”
Pfizer and Valneva began collaborating on PF-07307405 in April 2020, with the former holding exclusive manufacturing and commercialisation rights if regulatory approval is achieved.
The vaccine is a 6-valent outer surface protein A (OspA)-based protein subunit, targeting six Borrelia OspA serotypes found in North America and Europe.
Currently, no approved human vaccines exist for Lyme disease.
In June 2026, Pfizer received approval from the US Food and Drug Administration for an expanded indication of Hympavzi (marstacimab-hncq) to treat haemophilia A or B.
