EMA begins scientific assessment of Pfizer-Valneva’s 6-valent Lyme disease candidate
Lyme disease is transmitted primarily through the bites of infected ticks.
UK—The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) submitted by Pfizer and Valneva for their investigational Lyme disease vaccine candidate, PF-07307405.
The validation allows the EMA to begin its formal review of the application and assess whether the vaccine meets the requirements for approval in the European Union.
Phase III trial supports application
The companies supported their application with safety and efficacy data from the Phase III VALOR clinical trial, which enrolled 9,437 participants aged five years and older in Europe, the US and Canada.
In the trial, PF-07307405 demonstrated more than 70% efficacy in preventing Lyme disease.
Pfizer and Valneva also reported that participants generally tolerated the vaccine well and that the study identified no new safety concerns.
If approved, PF-07307405 could become the first human Lyme disease vaccine available in Europe.
Pfizer senior vice-president and chief vaccines officer Annaliesa Anderson said the company was encouraged by the vaccine’s progress and looked forward to working with the EMA throughout the regulatory review.
“Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year,” Anderson said.
She noted that untreated Lyme disease can cause serious and potentially long-lasting complications affecting the skin, joints, nervous system and heart.
Six-valent vaccine targets Borrelia
PF-07307405 is a six-valent, outer surface protein A (OspA)-based protein subunit vaccine.
It targets six OspA serotypes of Borrelia, the bacteria responsible for Lyme disease that are found in North America and Europe.
Lyme disease is transmitted primarily through the bites of infected ticks.
Although antibiotics can effectively treat the infection when diagnosed early, some untreated cases can progress to more serious complications.
Currently, no human Lyme disease vaccine has received regulatory approval.
Pfizer and Valneva began collaborating on PF-07307405 in April 2020.
Under their agreement, Pfizer holds exclusive manufacturing and commercialisation rights for the vaccine, subject to regulatory approval.
The companies are now awaiting the outcome of the EMA’s assessment, which will examine the vaccine’s quality, safety and efficacy before the agency recommends its potential authorisation.
Pfizer expands haemophilia portfolio
The development of PF-07307405 comes as Pfizer continues to expand its vaccine and specialty medicine portfolio.
In June 2026, the US Food and Drug Administration approved an expanded indication for Hympavzi (marstacimab-hncq), allowing its use in adults and children aged 12 years and older with haemophilia A or haemophilia B without inhibitors.
Pfizer and Valneva’s Lyme disease vaccine programme represents a separate effort focused on preventing a disease for which no approved human vaccine is currently available.
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