Valneva is eyeing a 2027 launch for its Pfizer-partnered Lyme disease vaccine, CEO Thomas Lingelbach said Thursday during the company’s investor day.
Pfizer has sole commercial responsibility for the candidate, VLA15, which is currently in Phase 3. Pending those results, Lingelbach said a 2026 regulatory filing may be in reach, meaning vaccines could roll out as early as the fall of 2027. The CEO said the annual peak sales estimate is “certainly north of” $1 billion.
Thomas Lingelbach“We can start vaccinating people in the autumn of 2027 for the tick season 2028,” Lingelbach said. Tick season typically occurs between April and October in the Northern Hemisphere.
Lyme disease is on the rise in the US and Europe. The CDC estimates there are about 476,000 cases in the US each year. Pfizer put down $130 million upfront in 2020 to partner with Valneva on VLA15, which targets a surface protein on the bacteria that cause Lyme disease. The goal is to prevent the bacteria from leaving ticks and infecting humans.
Last month, the partners announced new Phase 2 results showing “strong immune responses” in patients who received a second booster dose of the vaccine, supporting the potential case for annual dosing.
Pfizer confirmed on Friday that recruitment in its Phase 3 VALOR trial is complete, and participants will be monitored until the end of Lyme season in 2025. That timeline is consistent with a delay Pfizer and Valneva announced in 2023 following quality standard issues at a contractor running some clinical sites. Pfizer declined to comment on those issues on Friday. Valneva did not respond to a request for comment.
When an analyst asked how VLA15’s potential market size compares to GSK’s Lymerix, which was discontinued in 2002 over insufficient demand, Lingelbach responded that “you cannot compare” the two markets.
“The number of confirmed Lyme cases was in a different ballpark,” he said, adding that the market opportunity will also depend on ACIP’s recommendations for use.