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Phil B.FontanarosaMD, Deputy EditorIndividualAuthorMargaret A.WinkerMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Fishbein FellowIndividualAuthor
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
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.
Schofield DH, Parenti D. Lyme Disease Vaccine. JAMA. 2000;283(2):199–200. doi:10-1001/pubs.JAMA-ISSN-0098-7484-283-2-jbk0112
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