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Lyme Vaccine Candidate: Valneva Announces Phase 2 Study Results

Vaccine Candidate Valneva announced that the vaccine candidate against Lyme disease, VLA15-201, showed positive initial results meeting its endpoints in the Phase 2 study. They stated in the July 22, 2020 press release that “compared to Phase 1, the higher doses used in this trial elicited higher antibody responses across all serotypes.”  Of particular note was the the immunological response found in older adults (50-65 years), one of the main target groups for a Lyme vaccine. The vaccine candidate is described as “generally safe across all dose and age groups tested”, finding no Serious Adverse Events (SAEs) associated with VLA15. This is an important finding given the history of vaccines and serious concerns that have been generated regarding patient safety and vaccines in the Lyme community.
 
VLA15 is the only active Lyme disease vaccine candidate in clinical development today, covering six serotypes of Lyme disease prevalent in North America and Europe.  It was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017.   In a few months, Valneva expects to report top-line results for the second Phase 2 study, VLA15-202.  Valneva and Pfizer are collaborating for development and commercialization of VLA15. 
 
Read full July 22, 2020 press release here
 
Read Valneva vaccine history and Lyme Disease Association’s concerns here:

https://lymediseaseassociation.org/news/lyme-disease-vaccine-collaboration-announced/

https://lymediseaseassociation.org/about-lyme/controversy/vaccine/new-vaccine-in-the-news/