Pfizer and Valneva initiate phase III study of Lyme disease vaccine candidate VLA 15.

“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “We hope that the data generated from the Phase III study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial."

The randomized, placebo-controlled, Phase III VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older. The study is being conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States. Participants will receive three doses of VLA 15 180 µg or saline placebo as a primary vaccination series followed by one booster dose of VLA 15 or saline placebo (1:1 ratio). Data from the Phase II studies continue to demonstrate strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles in both study populations. Pending successful completion of the Phase III study, Pfizer could potentially submit a Biologics License Application (BLA) to the FDA and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.

As per the terms of the collaboration agreement between Pfizer and Valneva, Pfizer will make a $25 million milestone payment to Valneva upon initiation of the Phase III study.