Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) have made the difficult decision to discontinue the participation of a significant portion of participants enrolled in the U.S. in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. This decision was prompted by violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator, and not due to any safety concerns with the investigational vaccine or any participant-reported adverse events. Despite this setback, the study is still ongoing to assess the efficacy, safety and immunogenicity of the investigational Lyme disease vaccine candidate, VLA15.
When Pfizer discovered potential violations of the Good Clinical Practice (GCP) – the international ethical and scientific quality standard for clinical trials – it conducted a thorough review of the operations and data collection at the clinical trial sites run by the third party, ensuring the highest possible level of protection for trial participants and scientific integrity. Following standard operating safeguards, Pfizer took the necessary steps to address the situation and ensure compliance with GCP.
Pfizer is continuing to enroll new participants in the ongoing clinical trial at sites not operated by the third party. With successful completion of the Phase 3 studies, the companies anticipate submitting a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorisation Application to the European Medicines Agency by 2025. The agreement of these regulatory agencies to any proposed modifications to the trial plan are essential for the fulfillment of this ambition.
Pfizer has informed the FDA, other regulatory agencies, as well as the independent Institutional Review Board, that participants in the study have been notified. This exciting development marks a major milestone in the progress of the study!
The integrity of data collected in clinical trials is paramount in providing evidence and confidence in the safety and efficacy of potential vaccines and medications, such as VLA15. Pfizer and Valneva have been very encouraged by the data from the Phase 2 clinical studies, which demonstrated strong immunogenicity and acceptable safety and tolerability profiles.2-4 With robust data collection and analysis, VLA15 could have the potential to be submitted for regulatory approval.
VLA15 is the only Lyme disease vaccine candidate that has made it to clinical development and is showing promise! This vaccine is based on an established mechanism of action, using outer surface protein A (OspA) of Borrelia burgdorferi to block the bacterium’s ability to leave the tick and infect humans. The vaccine is multivalent, covering the six most common OspA serotypes from the Borrelia burgdorferisensulato species that are prevalent in North America and Europe. In clinical and pre-clinical studies, VLA15 has demonstrated a strong immune response and satisfactory safety profile, and the U.S. FDA has granted it Fast Track designation. Valneva and Pfizer have entered into an agreement to co-develop VLA15, and updated the terms of the agreement in June 2022. This vaccine is giving hope for Lyme disease sufferers around the world!
About Lyme Disease
Lyme disease is a systemic infection caused by the Borrelia burgdorferi bacteria, which is transmitted to humans by infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere and is estimated to affect approximately 476,000 people in the United States and 130,000 people in Europe each year. Unfortunately, the early symptoms of Lyme disease are often overlooked or misinterpreted, leading to a much more serious condition if left untreated. This can include joint pain, heart problems, and even damage to the nervous system. With the rising prevalence of this disease, the need for a vaccine is becoming increasingly urgent.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we are dedicated to providing therapies that significantly improve the lives of people around the world. We are committed to delivering top-notch quality, safety and value in the development and manufacture of health care products, such as medicines and vaccines. Our team is working hard to prevent and treat some of the most feared diseases of our time, and to make sure everyone has access to reliable, affordable health care. We are proud to have been making a difference for over 170 years, and will continue to strive for excellence in all that we do.