LDA/Columbia 2011
Scientific Conference

Hyatt Penns Landing

Philadelphia, PA

October 1-2, 2011

Category:  Lyme Transmission and Prevention

How safe is the Lyme vaccine?

The simplest answer to this question is that we do not know for certain. When the LymeRix vaccine produce by Glaxo Smith/Kline was first considered for approval by the FDA, there was considerable concern about the safety of the vaccine among patients who carry the HLA-DR4 genetic marker because past research had indicated that patients who carry this marker are at increased risk of developing a chronic treatment-refractory arthritis after infection with Borrelia burgdorferi. The fear was that the vaccine itself could cause symptoms in a genetically vulnerable population. Since approval in 1998, the FDA has received reports of cases of patients who developed arthritis after the vaccine. According to the FDA, the frequency of this occurrence has not been greater than one would expect for the development of arthritis in the community at large. Nevertheless, because of the increasing concern generated by these cases, the FDA convened a special committee hearing in Jan 2001. The conclusion of this committee reportedly was that the data did not yet indicate that the vaccine caused an increased risk of arthritis, however concern was great enough to warrant recommendation of a change in the package insert and the aggressive pursuit of more safety data from a larger sample of patients. It was not clear at that time what the long-term safety of the vaccine would be, given that patients would need to be re-vaccinated on an ongoing basis in order to keep the protective antibody levels elevated. The Lyme vaccine was withdrawn from the U.S. market in 2002; the exact reason for withdrawal remains unclear.

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