EMA Validates Pfizer and Valneva’s Marketing Authorization Application for Lyme Disease Vaccine Candidate
Pfizer Inc.and Valneva SE have announced an important regulatory milestone for their investigational Lyme disease vaccine candidate, PF-07307405, after the European Medicines Agency (EMA) validated the companies’ Marketing Authorization Application (MAA). The validation means the application has been accepted for formal assessment by the European regulatory authority, beginning the next stage of the review process for the potential vaccine.
PF-07307405 is an investigational six-valent outer surface protein A (OspA)-based vaccine designed to help protect against Lyme disease. The vaccine candidate is being developed by Pfizer and Valneva as a potential preventive option for Lyme disease, an increasingly important public health concern in Europe and other regions where the disease is transmitted by ticks.
The MAA submission is supported by encouraging efficacy results from the Phase 3 VALOR (Vaccine Against Lyme for Outdoor Recreationists) clinical trial, which evaluated the ability of PF-07307405 to prevent Lyme disease in individuals aged five years and older. According to the companies, the vaccine demonstrated more than 70% efficacy in the study and was well tolerated, with no safety concerns identified during the trial.
The EMA validation represents an important step toward potentially making the vaccine available in Europe. However, validation of the application does not constitute an approval. The EMA will now conduct a detailed assessment of the available clinical, manufacturing and other supporting data before reaching a regulatory conclusion.
Potential New Prevention Option for Lyme Disease
Lyme disease is a bacterial infection primarily transmitted through the bites of infected ticks. The disease is caused by bacteria belonging to the Borrelia group and can affect multiple systems in the body if it is not diagnosed and treated appropriately.
Early symptoms can include fever, fatigue, headache and characteristic skin changes. In some patients, untreated infection can progress and cause more serious complications involving the joints, nervous system or heart. Because symptoms can vary and may overlap with those of other conditions, timely diagnosis and treatment remain important.
Pfizer estimates that Lyme disease affects more than 100,000 people each year in Europe, making it the most common vector-borne illness in the region. The potential burden is also substantial because large populations live in areas where Lyme disease transmission occurs.
An effective vaccine could therefore provide an additional layer of protection, particularly for individuals who regularly spend time outdoors in areas where infected ticks are present.
Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer at Pfizer, highlighted the significance of the regulatory milestone.
“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,” Anderson said. She added that Pfizer looks forward to working with the EMA as the candidate moves through the regulatory review process.
Anderson also emphasized the potential impact of Lyme disease on people who participate in outdoor activities and the importance of developing preventive strategies against the infection.
Phase 3 VALOR Trial Provides Clinical Support
The EMA application is supported by data from the Phase 3 VALOR study, which was designed to evaluate the vaccine candidate in people aged five years and older.
The study, identified as NCT05477524, investigated whether vaccination with PF-07307405 could reduce the occurrence of Lyme disease cases. The trial also assessed safety, tolerability and immune responses generated by vaccination.
According to Pfizer and Valneva, the candidate demonstrated more than 70% efficacy in preventing Lyme disease.
The companies also reported that PF-07307405 was well tolerated during the study and that no safety concerns were identified.
Clinical trials for preventive vaccines typically evaluate multiple factors beyond efficacy. Researchers assess how effectively the vaccine generates an immune response, how consistently it performs across different participants and vaccine lots, and whether adverse events present an acceptable safety profile.
The VALOR program therefore represents a significant stage in the development of PF-07307405, providing the clinical evidence supporting the companies’ European regulatory application.
Six-Valent OspA-Based Vaccine Approach
PF-07307405 is based on outer surface protein A, or OspA, a protein associated with the bacteria responsible for Lyme disease.
The candidate is designed as a six-valent vaccine, meaning it targets six different OspA variants. The objective of this multivalent approach is to provide broad coverage against different strains or variants associated with Lyme disease.
The diversity of Lyme disease-causing bacteria and their geographic distribution presents a challenge for vaccine development. A multivalent strategy may help address this biological diversity by generating immune responses against multiple OspA targets.
Pfizer and Valneva have been studying the candidate across several development parameters, including efficacy, safety, tolerability, immunogenicity and manufacturing lot consistency.
Immunogenicity is particularly important for vaccines because it measures the body’s immune response to vaccination. Demonstrating that a candidate can consistently generate an appropriate immune response is a critical part of establishing its potential effectiveness.
Manufacturing consistency is also an important consideration as vaccine candidates progress toward commercialization. Regulators require manufacturers to demonstrate that different production lots can be made consistently and meet established quality specifications.
Importance of Prevention in High-Risk Areas
The potential availability of a Lyme disease vaccine could be particularly significant for individuals living in or traveling to regions where Lyme disease is prevalent.
Ticks can be encountered in forests, grasslands, gardens and other outdoor environments. People who participate in hiking, camping, hunting, gardening and other outdoor activities may have increased opportunities for tick exposure.
While measures such as using insect repellents, wearing protective clothing and checking for ticks can reduce exposure risk, these approaches do not completely eliminate the possibility of infection.
Vaccination, if approved, could provide another layer of protection alongside existing preventive measures.
Pfizer noted that more than 200 million people live in areas of Europe where Lyme disease poses a risk, underscoring the potential public health relevance of an effective preventive vaccine.
Valneva CEO and Board member Thomas Lingelbach described the EMA validation as an important milestone for the collaboration.
“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,” Lingelbach said.
He emphasized the scale of the population living in Lyme disease risk areas in Europe and described the acceptance of the MAA as a major step in the development program.
Pfizer and Valneva Collaboration
PF-07307405 is being developed through a collaboration between Pfizer and Valneva.
The companies entered into a collaboration and license agreement in April 2020 covering the co-development of the Lyme disease vaccine candidate. Under the agreement, Pfizer has exclusive responsibility for manufacturing and commercializing PF-07307405 if the vaccine successfully receives regulatory approval.
The collaboration combines Valneva’s vaccine development expertise with Pfizer’s global clinical development, regulatory, manufacturing and commercial capabilities.
The partnership has progressed the candidate through clinical development and into the regulatory review stage in Europe.
The MAA validation is therefore an important milestone not only for the vaccine candidate but also for the long-term collaboration between the two companies.
EMA Review Begins
Following validation of the MAA, the EMA will now assess the application and supporting evidence. The review will involve detailed evaluation of the vaccine’s clinical efficacy, safety profile, manufacturing processes, quality and overall benefit-risk profile.
The agency’s assessment will ultimately determine whether PF-07307405 meets the requirements for authorization in the European Union.
The current milestone should therefore be viewed as the beginning of the formal regulatory evaluation rather than a final approval decision.
If the candidate is ultimately approved, it could potentially become an important new tool for Lyme disease prevention in Europe.
For Pfizer and Valneva, the regulatory milestone also demonstrates the progress of their vaccine development strategy. The companies have spent several years evaluating PF-07307405, including its ability to provide protection against Lyme disease and its safety and immunogenicity characteristics.
Addressing an Unmet Preventive Need
Lyme disease prevention remains an important public health priority, particularly as people continue to engage in outdoor activities in regions where tick populations are established.
Although Lyme disease can often be treated effectively with antibiotics when diagnosed early, prevention remains valuable because delayed diagnosis or untreated infection can result in more serious complications.
A preventive vaccine could potentially reduce the number of infections and the associated burden on patients and healthcare systems.
The development of PF-07307405 also reflects broader efforts within the vaccine industry to create products that address diseases for which preventive options remain limited. A multivalent OspA-based strategy could offer a differentiated approach by targeting multiple bacterial variants.
The companies will now focus on supporting the EMA review and responding to regulatory questions as the assessment progresses.
The validation of the Marketing Authorization Application marks a significant transition for Pfizer and Valneva’s Lyme disease vaccine program, moving PF-07307405 from late-stage clinical development into formal European regulatory assessment.
The Phase 3 VALOR trial provided encouraging evidence, with reported efficacy of more than 70% and no safety concerns identified. The vaccine’s six-valent OspA design is intended to provide broad immune coverage, while the companies have also evaluated immunogenicity, tolerability and manufacturing consistency as part of the development program.
If regulatory review ultimately results in authorization, PF-07307405 could provide a new preventive option for people at risk of Lyme disease across Europe.
For now, the EMA validation represents an important step forward, while the final regulatory decision will depend on the agency’s complete assessment of the application and supporting evidence. Pfizer and Valneva remain focused on advancing the candidate through the review process with the goal of potentially delivering a new vaccine-based approach to Lyme disease prevention.
About Lyme disease vaccine candidate, PF-07307405
There are currently no approved human vaccines for Lyme disease. PF-07307405 is the current Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two pivotal Phase 3 trials completed. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.
When a person is immunized with PF-07307405, their body creates antibodies against six Borrelia OspA serotypes. As the tick feeds on the vaccinated person, these antibodies are ingested by the tick as part of its blood meal. Binding of vaccine-induced antibodies to OspA on Borrelia inside the tick inhibits the bacterium’s ability to leave the tick, preventing it from being transmitted to the human host. The vaccine candidate covers the six most prevalent OspA serotypes expressed by the Borrelia burgdorferi sensu lato species in North America and Europe.
About VALOR
The VALOR trial was a multicenter, placebo-controlled, randomized, observer-blinded trial conducted at sites in areas of high incidence of Lyme disease across the U.S., Canada, and Europe.4 9,437 trial participants aged 5 years and older were randomized 1:1 into two trial groups and received four doses of either PF-07307405 or a saline placebo – one dose administered at months 0, 2 and 5-9 followed by a fourth dose one year later, shortly before the start of the following Lyme disease season (season 2).4
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi sensu lato bacteria that are transmitted to humans by the bite of infected Ixodes ticks.5 It is considered the most common vector-borne illness in the Northern Hemisphere.6,7
The Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated each year and 132,000 cases are reported annually in Europe from countries with surveillance systems.8 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called erythema migrans or other nonspecific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint pains) are often overlooked or misinterpreted.
Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system.7,9 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.10
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines.
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About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com.