Pfizer, Valneva Initiate Phase 3 Study of Lyme Disease Vaccine VLA15

By Denny Jacob

Drug giant Pfizer Inc. and specialty vaccine company Valneva SE said Monday they initiated a Phase 3 clinical study for VLA15, a Lyme disease vaccine candidate.

The study will enroll about 6,000 participants ages five and up who will receive three doses of VLA15 or a placebo as a primary vaccine series followed by one booster dose of either the vaccine or the placebo, the companies said. The study will be conducted at up to 50 sites in areas where Lyme disease, an infection caused by bacteria passed to humans by infected ticks, is highly endemic including Finland, Germany and the U.S., among others.

Pfizer said it could potentially submit a biologics license application to the U.S. Food and Drug Administration and marketing authorization application to the European Medicines Agency in 2025 pending a successfully completed Phase 3 study.

As part of its collaboration agreement, Pfizer said it will make a $25 million milestone payment to Valneva upon initiation of the study.

Write to Denny Jacob at [e-mail]

(END) Dow Jones Newswires

August 08, 2022 17:21 ET (21:21 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.