Valneva, Pfizer Plan 2027 Launch for Lyme Disease Vaccine

Valneva is planning for a 2027 launch of its Lyme disease vaccine, developed in partnership with Pfizer. During the company's investor day, CEO Thomas Lingelbach shared these details. The vaccine candidate, VLA15, is currently in Phase 3 trials, with Pfizer holding sole commercial responsibility. Lingelbach expressed optimism that regulatory filing could occur by 2026, potentially allowing vaccine distribution by the fall of 2027. He also noted that the estimated peak annual sales for the vaccine are expected to exceed $1 billion.

Lingelbach stated that vaccinations could begin in autumn 2027, in preparation for the 2028 tick season, which typically spans April to October in the Northern Hemisphere.

Lyme disease is becoming increasingly prevalent in the United States and Europe. According to the CDC, there are approximately 476,000 cases annually in the US. In 2020, Pfizer invested $130 million upfront to collaborate with Valneva on VLA15. The vaccine targets a surface protein on the bacteria that cause Lyme disease, aiming to prevent the bacteria from transferring from ticks to humans.

Recent Phase 2 results, announced last month by the partners, indicated that patients who received a second booster dose exhibited strong immune responses, suggesting the potential for annual dosing of the vaccine.

On Friday, Pfizer confirmed the completion of recruitment for its Phase 3 VALOR trial. Participants will be monitored until the end of the Lyme disease season in 2025. This timeline aligns with a delay announced in 2023 due to quality standard issues at a contractor overseeing some clinical sites. Although Pfizer declined to comment on these issues, Valneva did not respond to requests for comment.

During the investor day, an analyst inquired about how the potential market size for VLA15 compares to GSK’s Lymerix, a Lyme disease vaccine discontinued in 2002 due to insufficient demand. Lingelbach responded that the two markets are not comparable, citing the significantly higher number of confirmed Lyme disease cases today. He also noted that the market opportunity for VLA15 would depend on recommendations from the Advisory Committee on Immunization Practices (ACIP).

In summary, Valneva and Pfizer are making progress toward bringing their Lyme disease vaccine to market by 2027. With promising trial results and a substantial investment from Pfizer, the companies are poised to address the growing incidence of Lyme disease. The success of VLA15 will depend on regulatory approval, market demand, and recommendations from health authorities.