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Valneva and Pfizer report Lyme disease antibody data

Children and adults have been treated using the Lyme disease antibody candidate VLA15

Pfizer has reported antibody persistence data six months after the completion of a two to three-dose vaccination schedule. It involves the company’s Lyme disease vaccine candidate, VLA15, and is being tested on both children and adults.

This is the first occasion in which antibody persistence data has been reported across paediatric populations for this particular vaccine candidate.

It follows positive safety data and immunogenicity during a phase 2 study last year, Valneva and Pfizer evaluated the persistence of antibodies six months after the original vaccination VLA15 schedule in healthy adults (96) and paediatric participants (81) from five to 65 years of age.

As in previous clinical studies, antibody levels declined over time in all study groups but remained above baseline, confirming their persistence six months after completion of both vaccination schedules. Furthermore, antibody levels remained higher with the three-dose vaccination schedule compared to the lower two-dose schedule.

These results further validate the use of the three-dose vaccination schedule, which is included in the phase 3 protocols across all participants.

Annaliesa Anderson, chief scientific officer of vaccine research and development at Pfizer, explained: “Rates of Lyme disease continue to increase globally, underscoring the importance of a vaccine that may help protect both adults and children. These six-month antibody persistence data are encouraging, and we hope that the data generated from the phase 3 studies will further support the positive evidence for VLA15 to date.”

Juan Carlos Jaramillo, chief medical officer at Valneva, commented: “We are pleased with these antibody persistence data that further validate the use of the three-dose vaccination schedule in our ongoing phase 3 study and the acceptable safety and tolerability profiles of our vaccine candidate.”

“Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere, and each new report of positive data takes us a step closer to potentially bringing this vaccine to both adults and children who could benefit from it,” he added.

Once the phase 3 study has reached its conclusion, Pfizer could potentially submit a biologics licence application to the US Food and Drug Administration and a marketing authorisation application to the European Medicines Agency in 2025.