Taken directly from the niaid.nih.gov website, the National Institute for Allergy and Infectious Diseases:
Double-blind, randomized, placebo-controlled clinical trials—the most rigorous type of clinical trial used today— have been completed for each of two Borrelia burgdorferi vaccines manufactured by GlaxoSmithKline [(GSK), formerly SmithKline Beecham (SKB)], and Pasteur Merieux Connaught. Each study involved more than 10,000 volunteers from areas of the United States where Lyme disease is common.
The SKB vaccine was ultimately licensed as LYMErix and approved by the Food and Drug Administration (FDA) in December 1998.
Why must thousands of Americans be denied an effective vaccine because the patent holders of LYMErix refuse to manufacture or licence the manufacture of the vaccine?