In February, 2002, SmithKline Beccham, the maker of the nation's only approved Lyme disease (LD) vaccine, Lymerix, discontinued its production, citing lack of demand as the reason for its action. The vaccine has been plagued by controversy based on charges by some patients that the vaccine made them ill and by debates over efficacy.
Use of Lymerix in children was no less controversial than its use in adults. Concerns included the need for three injections, questions about the neccesity for an additional booster dose, the expense, and the vaccine's relatively modest immunologic effect.
An FDA investigation failed to find evidence that the vaccine was dangerous, and the agency did not urge the manufacturer to remove the vaccine. Lymerix afforded protection against infection with the spirochete, Borrelia burgdorferi, which causes LD. It was recommended for individuals 15 to 70 years of ago who were at high risk for LD from significant exposure to tick habitats in endemic areas (northeast and north central United States) and for those who had been infected with LD.
February, 2003