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January 12, 2000

Lyme Disease Vaccine

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorMargaret A.WinkerMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Fishbein FellowIndividualAuthor

JAMA. 2000;283(2):199-200. doi:10-1001/pubs.JAMA-ISSN-0098-7484-283-2-jbk0112

To the Editor: In the Medical News & Perspectives article by Dr Jefferson,1 several statements about the Lyme disease vaccine, require clarification to avoid misrepresenting the efficacy and safety of the vaccine.

Jefferson noted that " . . . vaccine is not the first-line prevention for Lyme disease; prevention of tick bites is much more important." While personal protective measures have been advocated as the cornerstone of Lyme disease prevention, the incidence of Lyme disease continues to increase. Hayes et al2 suggest that either this intervention is not effective or that too few individuals are engaged consistently enough for the intervention to be effective. Several studies have failed to show that personal protective measures (eg, tucking pants into socks, checking for ticks) have a statistically significant effect in preventing Lyme disease.2-4 Vaccination with the Lyme disease vaccine is the only method proven clinically and statistically to prevent Lyme disease in a large, double-blind, randomized, placebo-controlled trial.5

We acknowledge that varicella and Lyme disease present different clinical concerns and therefore different issues regarding the corresponding vaccines. Regarding the efficacy of the Lyme disease vaccine, following completion of the primary 3-dose series, the vaccine was shown to be 78% effective against laboratory-confirmed disease and 100% effective against asymptomatic infection, which may be a significant factor in the cause of late Lyme disease. As the stated efficacy of the varicella vaccine (ie, 70%-90%) is considered by the author to be acceptable, it seems inconsistent that the efficacy of Lyme disease vaccine, with a similar efficacy rate, would be characterized as "not great."

Jefferson noted that a small number of vaccinated persons developed autoimmune arthritis. As would be expected in a large efficacy study (N = 10,936) evaluating individuals with a mean age of 46 years (range, 15-70 years), with almost 2 years of follow-up, adverse events of arthritis were observed.5 However, in the trial there was no statistical difference in the incidence of arthritis between the vaccine and placebo groups. Also, the incidence of inflammatory arthropathy was specifically addressed in a post hoc analysis by the data safety monitoring board, an outside independent panel of experts. They did not detect a statistical difference between the vaccine group and the placebo group. A double-blind, placebo-controlled trial to assess the safety and immunogenicity of the vaccine in 4000 subjects as young as 4 years of age is currently under way.

Jefferson  T Pediatricians alerted to five new vaccines.  JAMA. 1999;281:1973-1975.Google Scholar
Hayes  EBMaupin  GOMount  GAPiesman  J Assessing the prevention effectiveness of local Lyme disease control.  J Public Health Manage Pract. 1999;5:84-92.Google Scholar
Smith  PFBenach  JLWhite  DJStroup  DFMorse  DL Occupational risk of Lyme disease in endemic areas of New York state.  Ann N Y Acad Sci. 1988;539:289-301.Google Scholar
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Steere  ACSikand  VKMeurice  F  et al.  Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant.  N Engl J Med. 1998;339:209-215.Google Scholar