Pfizer, Valneva Report Further Positive Phase 2 Booster Results For Lyme Disease Vaccine Candidate

(RTTNews) - Drug makers Pfizer Inc. (PFE) and Valneva SE (VALN) announced Tuesday positive 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.

Pfizer aims to submit a Biologics License Application or BLA to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.

In a statement, the companies noted that the immune response and safety profile of VLA15 one month after receiving the second booster dose were similar to those reported after receiving the first booster dose. It showed compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season.

Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of infected Ixodes ticks. If left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints, heart or nervous system. There are currently no approved human vaccines for Lyme disease.

Around 476,000 people are diagnosed and treated for Lyme disease each year in the U.S., according to the Centers for Disease Control and Prevention, while around 129,000 cases are reported annually in Europe.

VLA15, an investigational multivalent protein subunit vaccine, uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.

The companies noted that VLA15, the Lyme disease vaccine candidate, has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.

In August 2022, Pfizer and Valneva initiated the currently ongoing Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), 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 companies noted that favorable safety profile of VLA15 was observed in all age groups and for all vaccinations.

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.

For More Such Health News, visit rttnews.com