Valneva SE (NASDAQ:VALN) and Pfizer Inc (NYSE:PFE) released pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster. 

Lyme disease is a bacterial infection that can be spread to humans by infected ticks.

The study showed a robust anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent participants (12 to 17 years of age), as well as in adults, one month after administration of a booster dose (month 19).

Depending on the primary schedule they received, participants seroconverted after the booster dose, yielding seroconversion rates (SCRs) of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, respectively. 

Additionally, OspA antibody titers were significantly higher one month after the booster dose compared to one month after the primary schedule, with 3.3- to 3.7-fold increases in adults, 2.0- to 2.7-fold increases in adolescents, and 2.3- to 2.5-fold increases in children for all serotypes.  

The safety and tolerability profile of VLA15 after a booster dose was consistent with previous studies, as the vaccine candidate was well-tolerated in all age groups regardless of the primary vaccination schedule. 

An independent Data Safety Monitoring Board observed no vaccine-related serious adverse events and no safety concerns.

These results follow six-month antibody persistence data in children and adults reported for the VLA15-221 study in December 2021 and immunogenicity and safety data reported in April 2022.

A second Phase 3 study (VLA15-1012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population, is also ongoing.

Pfizer aims to submit a Biologics License Application to the FDA and a Marketing Authorisation Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.

Price Action: VALN shares closed at $13.69 on Wednesday.