Pfizer And Valneva Partnered Lyme Disease Vaccine Shows Effectiveness As Booster Shot In Mid-Stage Study

Tuesday, Valneva SE VALN and Pfizer Inc. PFE released immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose.

One month after receiving the second booster dose, the immune response and safety profile of VLA15 were similar to those reported after receiving the first booster dose, showing compatibility with the anticipated benefit of a booster vaccination before each Lyme season.

Also Read: Pfizer/Valneva’s Vaccine Study For Tick-Borne Infection Completes Primary Vaccination Series, Plans Approval In 2026.

A high proportion of participants seroconverted after the second booster dose, yielding seroconversion rates (SCRs) above 90% for all outer surface protein A (OspA) serotypes in all age groups, in line with SCRs after the first booster.

Seroconversion is the process by which the body develops antibodies in the blood serum in response to an infection or immunization.

Geometric Mean Titers were comparably high at one month post first and second booster (i.e. month 19 vs. month 31).

In August 2022, Pfizer and Valneva initiated the currently ongoing Phase 3 VALOR study to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the U.S. and Europe.

The primary vaccination series for all participants was completed in July 2024.

A second Phase 3 study (VLA15-1012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population, is also ongoing.

Pfizer aims to submit marketing applications to the FDA and the European Medicines Agency in 2026, subject to positive Phase 3 data.

There are currently no approved human vaccines for Lyme disease, and the company says VLA15 is the vaccine candidate that has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.

The Centers for Disease Control and Prevention has estimated that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease each year, and 129,000 cases are reported annually in Europe.

Price Action: VALN stock is down 0.27% at $7.30, and PFE stock is down 2.13% at $28.40 at the last check on Tuesday.

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