EMA Validates Marketing Authorization Application for Pfizer/Valneva's Lyme Disease Vaccine Candidate

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, Pfizer and Valneva's six-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate, and will now begin its formal assessment.¹ There are currently no approved human vaccines for Lyme disease anywhere in the world, and PF-07307405 is the candidate furthest along in clinical development, with two completed pivotal phase 3 trials.¹ Validation confirms the submitted dossier is administratively complete rather than representing any judgment on the underlying data.² The program holds PRIME designation from the EMA and Fast Track designation from the FDA, and Valneva has said it expects regulatory decisions in both Europe and the US within roughly 12 months.²

What data supports the application?

The MAA is based on the Phase III VALOR ("Vaccine Against Lyme for Outdoor Recreationists") trial (NCT05477524), a multicenter, placebo-controlled, randomized, observer-blinded study conducted at sites in areas of high Lyme disease incidence across the US, Canada, and Europe.¹ The trial randomized 9,437 participants ages five and older 1:1 to receive four doses of either PF-07307405 or saline placebo, with doses given at months 0, 2, and 5-9, followed by a fourth dose one year later, timed shortly before the start of the following Lyme disease season.¹ The vaccine demonstrated efficacy of more than 70% and was well tolerated, with no safety concerns identified.¹ Worth noting for context: VALOR's second pre-specified analysis missed its predetermined statistical significance criterion, which Pfizer and Valneva have attributed to fewer Lyme disease infections occurring during the study than anticipated; the companies proceeded with regulatory submissions because the 95% confidence interval's lower bound remained above the threshold needed to support filing.³

How does the vaccine work?

PF-07307405 is a multivalent protein subunit vaccine that targets outer surface protein A (OspA) on Borrelia burgdorferi, the bacteria that cause Lyme disease.¹ When a vaccinated person is bitten by a tick, vaccine-induced antibodies against OspA are ingested by the tick as part of its blood meal; those antibodies then bind to OspA on the bacteria while they remain inside the tick, inhibiting the bacterium's ability to leave the tick and blocking transmission to the human host before an infection can take hold.¹ The vaccine covers the six most prevalent OspA serotypes expressed by Borrelia burgdorferi sensu lato species across North America and Europe, a broader design than LYMErix, the only Lyme disease vaccine previously licensed for human use in the US, which targeted a single OspA serotype before its 2002 withdrawal.⁴

What did company leadership say?

Annaliesa Anderson, PhD, senior vice president and chief vaccines officer at Pfizer, 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."¹ Thomas Lingelbach, chief executive officer and board member of Valneva, said, "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."¹

How significant is Lyme disease as a public health burden?

The US Centers for Disease Control and Prevention estimates that approximately 476,000 people in the US are diagnosed and treated for Lyme disease each year, while roughly 132,000 cases are reported annually across European countries with surveillance systems in place.¹ Early symptoms, including a gradually expanding rash called erythema migrans, fatigue, fever, headache, and joint pain, are often overlooked or misinterpreted, and untreated infections can disseminate to cause arthritis, carditis, or neurological complications.¹ Pfizer and Valneva entered into a collaboration and license agreement in April 2020 for the co-development of PF-07307405, with Pfizer holding exclusive rights to manufacture and commercialize the vaccine upon regulatory approval.¹

References

1. Pfizer and Valneva's Lyme disease vaccine candidate Marketing Authorization Application validated by European Medicines Agency. News release. Valneva SE; August 14, 2026. Accessed August 14, 2026.
2. EMA takes Pfizer and Valneva Lyme disease vaccine into review. The Pharma Letter. August 14, 2026. Accessed August 14, 2026.
3. Pfizer, Valneva Lyme vaccine starts review in Europe. pharmaphorum. August 14, 2026. Accessed August 14, 2026.
4. Marconi RT, et al. A broadly conserved protective epitope on the Lyme disease vaccine antigen, OspA. bioRxiv. Preprint posted online December 25, 2025. doi:10.64898/2025.12.24.696337