Valneva - Pfizer Choose Three-Dose Schedule For Lyme Vaccine Candidate Moving Forward

Valneva SE VALN and Pfizer Inc PFE have reported further Phase 2 data for their Lyme disease vaccine candidate, VLA15. 

• The Phase 2 trial, VLA15-221, compared the immunogenicity of VLA15 after administration of two or three primary series doses. 
• In the sub-analysis of adult participants (18-65 years old), VLA15 was immunogenic with both vaccination schedules tested. 
• These data are consistent with the strong immunogenicity profile observed for this age group in previous Phase 2 studies. 
• Related: Valneva, Pfizer's Phase 2 Data Suggests Booster Strategy For Lyme Disease Vaccine Candidate.
• However, the induction of anti-OspA IgG (anti-outer surface protein A immunoglobulin G) antibody titers was higher in participants who received the three-dose primary series compared to the two-dose primary series.
• Valneva and Pfizer plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 trial based on these new results. 
• The trial will evaluate VLA15 in adults and pediatric subjects five years of age and above and is expected to be initiated in 2022.
• The VLA15-221 trial is ongoing to assess the safety and immunogenicity of VLA15 in 5-17-year-olds. Initial pediatric data are expected in 1H of 2022.
• The analysis was also consistent with the acceptable safety and tolerability profile observed in previous studies of VLA15. 
• No vaccine-related serious adverse events were observed.
• Price Action: VALN shares closed at $33.56 on Thursday, while PFE stock is down 0.17% at $53.29 during the premarket session on the last check Friday.