Pfizer Completes Enrollment for Phase 3 of Lyme Vaccine

Industry Dive (Alvarado, D.) 12.05.2023, published “Pfizer, after delay, completes enrollment in Lyme vaccine trial.” Pfizer and Valneva completed enrollment for a Phase 3 trial of their Lyme disease vaccine, ending a delay sparked by concerns about trial misconduct. The FDA found no wrongdoing, but the study’s completion is pushed back to 2025.

The vaccine, VLA15, targets protection against six strains of Lyme disease and holds the potential to be the first preventive shot for the disease in over two decades. Despite disagreements over participant removal, the FDA’s clearance of Care Access in October marked a turning point in the trial, which has since enrolled over 9,400 volunteers across the U.S., Europe, and Canada.

This vaccine, as the sole one in clinical development, aims to address the rising need for Lyme disease prevention. Currently, there are no approved vaccines for Lyme disease, although past options like GSK’s Lymerix faced withdrawal due to low demand in 2002. The increasing prevalence of Lyme disease underscores the necessity for effective preventive measures, according to the Centers for Disease Control and Prevention.

For more information:

Read the full article on Industry Dive’s website here.

Read LDA President’s Blog discussing the August 2023 Bloomberg vaccine article.

Read Why Lyme Vaccine Candidates Were Pulled Out of Study.

Read more about the VLA15 Lyme disease vaccine.

Read additional articles on the Lyme Vaccine on LDA’s website.