IAC Home page
Issue Number 39
December 22, 1998
CONTENTS OF THIS ISSUE
- Lyme disease vaccine license
application approved by FDA
Back to Top
December 21, 1998
LYME DISEASE VACCINE LICENSE APPLICATION APPROVED BY FDA
A license application for a Lyme disease vaccine was approved by the Food and Drug
Administration (FDA) on December 21, 1998.
LYMErix, the trade name of the FDA-approved vaccine against Lyme disease, is manufactured
by SmithKline Beecham Biologicals, Rixensart, Belgium, and is distributed by SmithKline
Beecham Pharmaceuticals, Philadelphia, PA.
LYMErix is indicated for active immunization against Lyme disease in individuals 15 - 70
years of age. Primary immunization against Lyme disease consists of a 30mcg/0.5mL dose of
LYMErix given at 0, 1, and 12 months. Individuals most at risk for Lyme disease may be
those who live or work in grassy or wooded areas that are infested with Borrelia
burgdorferi infected ticks.
Lyme disease is the most common reported vector-borne illness in the United States. Since
1982, over 99,000 cases have been reported to CDC by 47 state health departments. Cases
occur primarily in three distinct regions: the Northeast (from Massachusetts to Maryland),
the Midwest (Minnesota and Wisconsin), and in the West (California and Oregon). [Source:
MN Dept. of Health, "Lyme Disease: Guidelines for Minnesota Clinicians,"
1998, p. 3.]
For additional information about this vaccine, see the package insert. For information
about Lyme disease, go to CDC's website at http://www.cdc.gov/ncidod/diseases/lyme/lyme.htm
Within the next few days the Lyme Disease Foundation is expected to place more information
about Lyme disease vaccine on its website at http://www.lyme.org.