- Pfizer and its partner Valneva, a France-based vaccine maker, have pushed back when they expect to submit an approval application for their experimental Lyme disease shot from 2025 to 2026, according to an earnings statement Thursday.
- The now-extended timeline is due to the recent disruption of a Phase 3 study testing the vaccine. Earlier this year, the companies removed half of the participants from the trial after uncovering study standards violations by Care Access, a contract research organization the companies had hired to run some sites.
- The Phase 3 study was initiated in August 2022 following positive Phase 2 trial results. After resolving the issues with Care Access, Valneva and Pfizer have continued to enroll new participants for their late-stage study.
Lyme disease is transmitted by the bite of an infected tick and is common across the U.S. and Europe. If not immediately treated, symptoms can last for days and can include rashes, headache, dizziness and, more seriously, inflammation of the brain and spinal cord.
Antibiotics are typically prescribed for treatment, but no vaccine is currently available.
Valneva and Pfizer’s candidate, known as VLA15, is a multivalent vaccine designed to target six serotypes of the bacteria Borrelia burgdorferi, which causes the disease.
The companies proceeded with their Phase 3 investigation after reporting encouraging data from an earlier, Phase 2 trial in adults and children. The larger study was set to recruit 6,000 participants aged five and older, and administer to each either a placebo or three doses of their experimental vaccine.
But in February, Valneva and Pfizer said almost half of the participants enrolled in the Phase 3 study were removed after “violations of Good Clinical Practice at certain clinical trial sites run by a third-party clinical trial site operator.” Good Clinical Practice is a code of ethical and scientific standards that clinical researchers must follow.
The third-party operator was later identified as Care Access, which subsequently let go a “significant number” of its staff.
Individuals currently in the study are eligible to receive their booster as planned in the second quarter of 2024. Primary vaccination will begin in the second quarter of 2023 for those additionally enrolled.