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Issue Number 39            December 22, 1998

CONTENTS OF THIS ISSUE

1. Lyme disease vaccine license application approved by FDA

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(1)
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.