Vaccines against Lyme disease: What happened and what lessons can we learn?

Clin Infect Dis. 2011 Feb;52 Suppl 3:s253-8. doi: 10.1093/cid/ciq116.

Abstract

This article reviews events that led to the withdrawal of the only vaccine to prevent Lyme disease licensed in the United States. The primary issues that led to the vaccine's withdrawal appear to be a combination of vaccine safety concerns, sparked by a molecular mimicry hypothesis that suggested that the vaccine antigen, outer surface protein A, serves as an autoantigen and hence was arthritogenic; concerns raised by anti-vaccine groups regarding vaccine safety; vaccine cost; a difficult vaccination schedule and the potential need for boosters; class action lawsuits; uncertainty regarding risk of disease; and low public demand. This article reviews lessons learned from these events and proposes that future candidate Lyme disease vaccines are unlikely to be developed, tested, and used within the United States in the near future, thus leaving at-risk populations unprotected.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Attitude to Health
  • Borrelia burgdorferi / immunology
  • Clinical Trials as Topic
  • Drug Approval
  • Health Priorities
  • Humans
  • Immunization Schedule
  • Lyme Disease / immunology
  • Lyme Disease / prevention & control*
  • Lyme Disease Vaccines / adverse effects*
  • Lyme Disease Vaccines / immunology
  • Molecular Mimicry
  • Product Recalls and Withdrawals*
  • United States / epidemiology
  • United States Food and Drug Administration

Substances

  • Lyme Disease Vaccines