The first Lyme disease vaccine faces a delay

Pfizer and Valneva’s Lyme disease vaccine, which could be the first of its kind, is facing delays of about a year. The reason is problems at trial sites in the United States, which have forced the companies to drop half of the participants in an ongoing Phase III study.

The two companies are developing VLA15, which is currently the only vaccine candidate against Lyme disease in late-stage clinical development. In Phase II studies, the vaccine has proved to generate high levels of antibodies against six of the most common variants of Lyme disease in North America and Europe.

In August 2022, the companies initiated a Phase III study with the goal of recruiting 18,000 healthy participants living in tick-dense areas with endemic Lyme disease, including Sweden.

Earlier this year, however, it became clear that quality deficiencies were discovered at a number of trial sites in the United States run by the operator Care Access. As a result, about half of the participants in the study had to be screened out and replaced by new participants, which caused a delay in the programme.

According to the interim report published by Valneva on Thursday, an application for market authorisation in the United States and EU is now expected to be submitted only in 2026, which is one year later than previously stated.

According to Valneva, the costs of the increased recruitment will be borne by Pfizer.

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