Pfizer/Valneva report promising Lyme disease vaccine results

Pfizer and Valneva have recently announced promising results from a phase 2 study of their Lyme disease vaccine candidate, VLA15. This mid-stage clinical trial, known as VLA15-221, involved randomizing healthy individuals to receive either the VLA15 vaccine or a placebo. The study followed a structured vaccination schedule consisting of an initial series of doses, a booster at 18 months, and a second booster at 30 months.

Currently, there are no approved vaccines for Lyme disease, a bacterial infection transmitted through the bite of an infected tick. This disease is the most common vector-borne illness in the Northern Hemisphere and can lead to severe complications if left untreated. These complications may affect the skin, joints, heart, and nervous system.

The new study results revealed a significant anamnestic antibody response across all six serotypes targeted by the vaccine. This response was observed in various demographics, including children, adolescents, adults, and older adults, one month after the second booster dose. The safety and tolerability of the second booster were consistent with those seen after the first booster, with no safety issues reported in any age group or treatment category.

Annaliesa Anderson, Senior Vice President and Head of Vaccine Research and Development at Pfizer, emphasized the importance of preventive behaviors as the only current strategy to protect against Lyme disease. She highlighted that the data from the VLA15-221 study marks a crucial step towards developing a vaccine that could mitigate the acute, severe, and sometimes long-lasting effects of the disease.

VLA15-221 is now being assessed in a phase 3 study involving participants aged five and older in regions of the US and Europe where Lyme disease is highly prevalent. Another phase 3 trial aims to gather more data on the vaccine's safety profile, particularly in pediatric participants. Pfizer plans to submit regulatory applications to the US Food and Drug Administration and the European Medicines Agency in 2026, contingent on favorable phase 3 outcomes.

Valneva's Chief Medical Officer, Juan Carlos Jaramillo, also commented on the study results, underscoring the growing prevalence of Lyme disease and its significant unmet medical need. He noted that each positive data set brings them closer to potentially offering a vaccine for both adults and children in Lyme disease-endemic areas. 

These developments represent a critical advancement in the fight against Lyme disease, bringing hope for a future where effective vaccination can prevent the illness and its severe consequences.

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