Therapy Areas: Vaccines
Pfizer and Valneva launch Phase 3 trial of Lyme disease vaccine
9 August 2022 -

US biopharmaceutical company Pfizer Inc (NYSE:PFE) and vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) announced on Tuesday the start of a Phase 3 clinical study of a potential new vaccine for Lyme disease.

The randomized, placebo-controlled study will investigate the efficacy, safety and immunogenicity of Pfizer and Valneva's investigational Lyme disease vaccine candidate, VLA15.

Approximately 6,000 participants aged five years and older are expected to take part in the trial, which is being conducted 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 VLA15 180 µg or saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo (1:1 ratio).

Pending successful completion of the Phase 3 study, Pfizer could potentially submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.

Under the terms of the collaboration agreement between Pfizer and Valneva, Pfizer will make a USD25m milestone payment to Valneva upon initiation of the Phase 3 study.