A second concern about a new candidate Lyme
disease vaccine relates to the necessity for the
vaccine to be approved for use in the highest-risk groups. As mentioned above, one of the limitations of LYMErix was that, at the time of licensing, it had not yet been approved for use in children <15 years of age. Consequently, the vaccine was not available for one of the groups at highest risk for contracting Lyme disease, children 5–14 years of age.