New Lyme Disease Vaccine Linked to Arthritis


Last year when the newly approved Lyme disease vaccine went on the market, HealthFacts reported some wary reactions from researchers. And for good reason, animal studies had already indicated a possible link between the vaccine and the induction of Lyme-arthritis. Now the worst fears might have been realized for humans.

There were 298 reports of adverse reactions last year, about 10% of which involved symptoms of chronic arthritis, according to Newsday. The Long Island newspaper made a Freedom of Information Act request for reports to the Food and Drug Administration. The FDA's Vaccine Adverse Events Reporting System is voluntary so it's safe to assume that the 30 or so reports of arthritis symptoms are not a true reflection of the scope of the problem. In 1999, an estimated 600,000 people were given the vaccine, which is sold under the brand name LYMErix and made by SmithKline Beecham Pharmaceuticals, Inc., in Philadelphia.

The vaccine is a recombinant lipoprotein, called OspA, which stimulates the immune system to produce antibodies to the protein found on the outer surface of the bacterium B. burgdorfi, the cause of Lyme disease. In some people, the vaccine could produce a "cross-reaction." This means that the immune system could attack the human protein, causing a treatment-resistant form of arthritis similar to rheumatoid arthritis.

SmithKline Beecham maintains that arthritis did not show up in the FDA-required trials involving 20,000 participants. Yet Newsday found that at least four lawsuits were filed against the company by people who had participated in its clinical trials--two involve debilitating arthritis. Such lawsuits are unusual for clinical trials because all participants sign extensive consent forms.

As with any new drug, a new vaccine must be on the market for years and given to hundreds of thousands of people before rare side effects become evident.

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