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

Valneva and Pfizer have reported encouraging results from their phase 2 clinical trial for their Lyme disease vaccine candidate, VLA15. The study, which focused on the administration of a booster dose, showed a significant increase in antibody levels among participants, suggesting the vaccine's potential for long-term protection against Lyme disease. This vaccine candidate remains unique as it is currently the only one in clinical development for Lyme disease.

The trial examined the immune response in both adults and children one month after receiving a booster dose, following an initial series of three doses. The results indicated a strong antibody response across all age groups, with no major safety issues recorded. These positive findings support the further development of VLA15 as Valneva and Pfizer progress to phase 3 trials.

The increasing prevalence of Lyme disease, particularly in the United States and Europe, underscores the need for an effective vaccine. Lyme disease, caused by Borrelia bacteria transmitted through tick bites, can result in serious health problems if not treated promptly. The successful outcomes from this phase 2 trial represent a significant step towards potentially mitigating this public health challenge.

Valneva and Pfizer plan to present detailed phase 2 trial results at forthcoming scientific conferences and are already gearing up for phase 3 trials. 

Pfizer acquired the rights to commercialize VLA15 in April 2020 through a co-development agreement with Valneva, valued at up to $308 million. This deal was made when phase 2 clinical trials, which initially tested a two-dose series of the vaccine, were already underway.

Although there were initial plans to seek regulatory approval in 2025, changes in enrollment and trial adjustments have extended this timeline. Valneva announced that Pfizer would bear the additional costs, now aiming for a regulatory submission in 2026, assuming positive trial results.

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