This article is part of the Arthritis Archives.
Editor note: In February 2002 the maker of LYMErix (the Lyme disease vaccine) announced they would stop producing the vaccine due to "insufficient consumer demand" The CDC reports, the protection provided by this vaccine does diminish over time. Therefore, if you received this Lyme disease vaccine before 2002, you are probably no longer protected against Lyme disease.
Dateline: December 18, 1999
Lyme Disease Vaccine Class Action Lawsuit
Reporting on the latest medical news is becoming increasingly frustrating. It seems that a relatively short time after a favorable safety profile is reported with regard to a new medication or treatment, another report follows offering information which is contrary. Such was the case recently with the COX-2 selective inhibitors and now, once again, a negative report about the safety of the Lyme vaccine has followed what initially were positive reports.
On December 14, 1999, a class action lawsuit was filed in Chester County, Pennsylvania, claiming that LYMErix, the vaccine manufactured by SmithKline Beecham, which was developed to prevent Lyme disease, can cause an incurable form of autoimmune arthritis and possibly produce symptoms worse than those of the illness.
The lawsuit claims that SmithKline Beecham neglected to alert doctors and the public that about 30 percent of the population has a predisposition to a degenerative autoimmune syndrome which can be triggered by contents of the vaccine. The assertion is that SmithKline Beecham used high concentrations of OspA (Outer Surface Protein A of Borrelia burgdorferi) as the foundation of the vaccine. The amount of OspA entering the bloodstream at any phase of the three-dose LYMErix vaccine places patients who are HLA-DR4+ at risk of developing "treatment resistant Lyme arthritis".
Treatment Resistant Lyme Arthritis
The lawsuit further alleges that although the connection between OspA and "treatment resistant Lyme arthritis" is well-documented, SmithKline Beecham did not include the information in promotional materials and maintained that LYMErix was safe and generally well-tolerated. HLA-DR4+ is detectable by a blood test, yet allegations suggest that SmithKline Beecham did not recommend that doctors screen for the presence of the trait prior to administering the vaccine.
The complaint also suggests that patients already infected with the Lyme bacteria (either asymptomatic or in the early stages of infection) when they receive LYMErix could suffer symptoms more severe than had they not received the vaccine. Negligence is also mentioned in regard to lack of information about the necessity of booster shots beyond the initial three vaccination schedule to maintain immunity.
A significant resource from January, 1999, The Lyme Disease Vaccine Discussion And Position Paper" <http://www2.lymenet.org/domino/file.nsf/UID/VaccinePosition/> details the development of the vaccine and points to some of the same issues of safety which are the focus of the lawsuit.
Sources: Mealey Publications: SmithKline Sued Over Lyme Vaccine; The Lyme Disease Vaccine Discussion And Position Paper, The LymeNet Editors, January 1999
First published: 12/18/1999