Pfizer Inc. (PFE) and Valneva SE (VALN) reported promising results on Tuesday from their VLA15-221 Phase 2 study, showcasing positive immunogenicity and safety data for a second booster dose of their Lyme disease vaccine candidate, VLA15. This booster was administered one year following the initial booster dose.Pfizer plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration and a Marketing Authorization Application with the European Medicines Agency by 2026, contingent on favorable Phase 3 outcomes.According to the companies’ statement, the immune response and safety profile one month post-second booster dose were consistent with the findings after the first booster dose. This aligns with the expected benefits of a booster vaccination prior to each Lyme disease season.Lyme disease, a systemic infection caused by Borrelia burgdorferi bacteria, is transmitted to humans through the bites of infected Ixodes ticks. Without treatment, the disease can spread, leading to severe chronic symptoms affecting the skin, joints, heart, or nervous system. Currently, there are no approved human vaccines for Lyme disease.The Centers for Disease Control and Prevention (CDC) estimate that around 476,000 people are diagnosed and treated for Lyme disease annually in the U.S., with approximately 129,000 cases reported each year in Europe.VLA15, an investigational multivalent protein subunit vaccine, operates using an established mechanism targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria responsible for Lyme disease.The companies emphasized that VLA15 has progressed the most in the clinical development timeline compared to other Lyme disease vaccine candidates, with two Phase 3 trials currently in progress.In August 2022, Pfizer and Valneva launched the ongoing Phase 3 clinical trial, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to assess the efficacy, safety, and immunogenicity of VLA15 in participants aged five and older in regions highly endemic to Lyme disease in the U.S. and Europe.Favorable safety profiles for VLA15 have been observed across all age groups and vaccinations. The primary vaccination series for all participants concluded in July 2024. Additionally, a second Phase 3 study (VLA15-1012) is underway to further evaluate the safety profile of VLA15 in pediatric populations.The material has been provided by InstaForex Company – www.instaforex.com
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