Pfizer/Valneva's Vaccine Study For Tick-Borne Infection Completes Primary Vaccination Series, Plans Approval In 2026

On Wednesday, Pfizer Inc PFE and Valneva SE VALN announced that the participants of the Phase 3 VALOR trial have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15.

Lyme disease is a bacterial infection that can be spread to humans by infected ticks.

Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.

"VLA15, the Lyme disease vaccine candidate we are co-developing with Valneva, is the one which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress," said Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer.

The Pfizer-sponsored VALOR trial is conducted at sites where Lyme disease is highly endemic across the U.S., Canada, and Europe.

The trial aims to evaluate the efficacy, safety, tolerability, immunogenicity, and lot consistency of VLA15, a 6-valent OspA-based Lyme disease vaccine candidate.

Trial participants aged five years and older were randomized 1:1 into two trial groups. They received four doses of either VLA15 or a saline placebo – one dose each at months 0, 2, 5-9 and a booster one year after the third dose, shortly before the peak of the next Lyme disease season.

Pfizer plans to submit marketing applications with the FDA and the European Medicines Agency in 2026.

VLA15 has shown a favorable safety profile in all clinical trials across all dose and age groups.

An independent Data Safety Monitoring Board (DSMB) has observed no safety concerns in any treatment group to date.

A second Phase 3 trial (C4601012) is ongoing, aiming to provide further evidence on the safety profile of VLA15 in the pediatric population between 5 and 17 years of age. The trial completed enrollment in June 2023.

Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.

Price Action: At last check Thursday, VALN stock was down 0.46% at $7.70, and PFE stock was up 0.50% at $30.18.

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