- Valneva SE (NASDAQ:VALN) and Pfizer Inc (NYSE:PFE) have reported Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
- In pediatric participants (5-17 years old) who received VLA15 in either the two-dose schedule (N=93) or three-dose schedule (N=97), VLA15 was found to be more immunogenic than in adults with both vaccination schedules tested.
- These data build on the strong immunogenicity profile reported for adult participants (18-65 years old) in February 2022.
- Like in adults, the immunogenicity and safety data support a three-dose primary vaccination schedule in pediatric participants in the Phase 3 study.
- The safety and tolerability profile observed in the 5- to 17-year age group was similar to the previously reported profile in adult participants.
- No vaccine-related serious adverse events (SAEs) were observed.
- Valneva and Pfizer plan to proceed with including pediatric participants in their planned Phase 3 trial.
- The trial will evaluate VLA15 in adults and pediatric subjects 5 years and above. It is expected to be initiated in Q3 of 2022.
- Price Action: VALN shares are down 6.27% at $26.62, and PFE stock is up 0.28% at $49.69 during the market session on the last check Tuesday.
