Pfizer, Valneva report positive phase 2 results for Lyme disease vax

Valneva and Pfizer have shared positive results from the phase 2 clinical trial of their Lyme disease vaccine candidate, VLA15.

The study, focused on booster administration, demonstrated that the vaccine significantly increased antibody levels in participants, reinforcing its potential to provide long-term protection against Lyme disease. The vaccine candidate is currently the only one in clinical development for Lyme disease.

The trial evaluated the immune response in adults and children one month after receiving a booster dose, following an initial three-dose primary series. The results revealed a strong antibody response across all age groups, with no significant safety concerns observed. These findings support the continued development of VLA15 as the companies move forward with phase 3 trials.

The growing incidence of Lyme disease, particularly in the U.S. and Europe, highlights the urgency for an effective vaccine. Lyme disease is caused by the Borrelia bacteria transmitted through tick bites, and it can lead to severe health complications if not treated early. The positive results from this phase 2 trial represent a significant step toward potentially addressing this public health issue.

Valneva and Pfizer plan to present detailed results from the phase 2 trial at upcoming scientific conferences, and they are already preparing for the phase 3 trials. 

Pfizer got its hands on the vaccine back in April 2020, when the drugmaker bought the rights to commercialize VLA15 from Valneva in co-development deal worth up to $308 million. The deal was signed when phase 2 clinical trials testing a two-dose series of the vaccine were already in progress.  

Despite plans to submit for regulatory approval in 2025, extended enrollment and trial adjustments pushed the timeline. Valneva reported that Pfizer would cover the additional costs, aiming for a 2026 submission pending positive trial outcomes.