When Lyme disease makes the news, it's typically not for positive reasons — but Pfizer is gearing up to seek regulatory approval for a new vaccine candidate, CNBC reported.
In April 2020, Pfizer and French vaccine company Valneva announced plans to jointly "develop and commercialize Valneva's Lyme disease vaccine candidate VLA15," which was in Phase 2 of development at the time (explained here by the Centers for Disease Control and Prevention).
The process of developing a vaccine is lengthy, and vaccine candidates are formulations that have demonstrated efficacy in early phase trials.
As CNBC noted, Pfizer's Lyme disease vaccine efforts hit a snag in a late-stage trial because "not enough people in the study contracted Lyme disease" during that key phase.
In 2023, the firms removed roughly half of the participants from ongoing research out of an abundance of caution over third-party testing protocols, according to BioPharma Dive.
Coupled with lower-than-anticipated infection rates, the setback reduced the trial's sample size, making the benchmark difficult to achieve.
Still, vector-borne and tick-borne infections like Lyme disease have been rising sharply in recent years, largely due to rising average temperatures, according to Boston University.
Consistently warmer weather doesn't just extend tick season and infection windows; it allows ticks to spread to new areas that were previously too cold.
As a result, disease vectors like ticks are transmitting illness in broader ranges and for longer periods each year, increasing the risk of a debilitating infection.
To combat this spread, on March 26, Pfizer and Valneva issued a joint press release announcing their decision to seek approval for the vaccine candidate PF-07307405 (LB6V), formerly dubbed VLA 15, citing high efficacy rates and a lack of preventive therapies.
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Save $1,000 this year 💸 Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer at Pfizer, explained why the impressive results of the Vaccine Against Lyme for Outdoor Recreationists (VALOR) study prompted the firms to move forward.
"Lyme disease can cause potentially serious consequences — where individuals and families face symptoms that can disrupt daily life, work, and long-term health — and there is currently no vaccine available," she began.
"The efficacy shown in the VALOR study of more than 70% is highly encouraging and creates confidence in the vaccine's potential to protect against this disease that can be debilitating."
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