Manufacturer discontinues only Lyme disease vaccine

FDA Consumer, May-June, 2002

The world's only vaccine to prevent Lyme disease is being discontinued because of poor demand, according to the product's manufacturer, GlaxoSmithKline, Research Triangle Park, N.C.

The FDA licensed LYMErix in December 1998 to prevent Lyme disease, a bacterial infection transmitted by ticks. Initially, hundreds of thousands of people received the vaccine. However, sales plummeted after highly publicized reports that some users suffered arthritis-like symptoms, muscle pain and other ailments following vaccination.

GlaxoSmithKline says that it is not discontinuing the product because of safety issues. The manufacturer maintains that the scientific record remains clear that the vaccine is safe and effective. The Centers for Disease Control and Prevention (CDC) confirmed that it found no unexpected safety problems with LYMErix after reviewing the data.

Lyme disease is caused by the bacterium Borrelia burgdorferi. These bacteria are transmitted to humans by the bite of infected deer ticks and cause more than 16,000 infections in the United States each year. Symptoms include a characteristic "bull's-eye" rash accompanied by nonspecific symptoms, such as fever, malaise, fatigue, headache, muscle aches, and joint aches. The incubation period from infection to onset of the rash typically is seven to 14 days but may be as short as three days or as long as 30 days.

The FDA continues to caution people who live or work in tick-infested areas to be vigilant for symptoms of Lyme disease, especially in the spring and summer months when they are likely to spend more time outdoors.

For more information on preventing Lyme disease, see "New Vaccine Targets Lyme Disease," May-June 1999 FDA Consumer, www.fda.gov/fdac/ features/1999/3 99_lyme.html.