The voluntary withdrawal of the LYMErix vaccine in the US also led to its removal from Canada and left Europe without a Lyme disease vaccine as it was still undergoing testing prior to approval for many European countries. The LYMErix vaccine itself could not be used in Europe as the different strains of Lyme disease bacteria there would have rendered it effectively useless. Instead, GlaxoSmithKline were working on a combination Lyme disease vaccine which produced antibodies to the OspA variants found in Borrelia burgdorferi sensu stricto, Borrelia garinii, and Borrelia afzelii.
In a presentation given in 2002 at the Belgian Society of Infectious Diseases and Clinical Microbiology, GSK cited prevention rates of 75-100% using the European Lyme disease vaccine which covered the three Borrelia pathogenic species present in Europe. The tick-challenges on which the results were based involved ticks collected in Germany, Sweden, Finland, Switzerland, Austria, France, and Belgium. Withdrawal of the LYMErix vaccine led to a hiatus on the research into a European Lyme disease vaccine and no company has since developed or introduced a viable alternative.
Lyme Vaccine in Canada
In Canada, the LYMErix vaccine was voluntarily withdrawn at the same time as in the US (2002) although there was another vaccine in development at the same time as LYMErix which was thought to share similar success rates. ImuLyme from Pasteur Merieux Connaught was not licenced in Canada or the US however, despite reports of it having a higher rate of prevention (92%) compared to LYMErix and fewer reports of adverse side-effects. ImuLyme was rigorously tested by Dr. Leonard Sigal, Director of the Lyme Disease Center at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, in a three year study but the ImuLyme trademark has now been abandoned by the company developing the Lyme disease vaccine.
ImuLyme differed from LYMErix in that it did not use alum as an adjuvant, seen as a possible advantage by many in the medical community. The reasons given for not pursuing licencing of ImuLyme were technical issues in the phase III clinical trials, issues of royalties regarding patents with GSK, and an assessment of the potential market for the Lyme disease vaccine. Withdrawal was not met with much surprise considering the poor response to LYMErix.
European Lyme Vaccine Development
The increasing prevalence and recognition of Lyme disease in many European countries, including the UK, is likely to make many manufacturers reconsider developing a Lyme disease vaccine in the future. The US remains the major market for such a vaccine but as the zoonosis appears to be spreading due to animal migration and, possibly, climate change, the market may expand considerably over the coming years. Improved knowledge regarding the molecular mimicry hypothesis proposed as an explanation of the adverse effects of LYMErix, and detailed reviews of the policy failures, public relations issues, and patient concerns surrounding the Lyme disease vaccine will hopefully allow such problems to be avoided in the future. Offering a Lyme disease vaccine to protect people worldwide is just one aspect of Lyme disease prevention however, with tick awareness remaining the top priority.
Haake, D.A., Spirochaetal lipoproteins and pathogenesis, Microbiology. 2000 July; 146(Pt 7): 1491–1504.
Johnson, B.J., Sviat SL, Happ CM, Dunn JJ, Frantz JC, Mayer LW, Piesman J. Incomplete protection of hamsters vaccinated with unlipidated OspA from Borrelia burgdorferi infection is associated with low levels of antibody to an epitope defined by mAb LA-2. Vaccine.1995;13:1086–1094
Poland, G.A., Vaccines against Lyme Disease: What Happened and What Lessons Can We Learn? Clin Infect Dis. (2011) 52 (suppl 3): s253-s258.