July 8–15, 1999
cover story
A Valuable Vaccine?
So what do we do to ward off this varmint of doom? The vaccine LYMErix, manufactured by SmithKline Beecham, whose U.S. headquarters are in Philadelphia, hit the market in January with shaky FDA approval. Developed from a recombinant protein, OspA, which was pioneered at Yale, the vaccine was tested over four years involving 11,000 patients, 10 states and 31 researchers. But like everything else about this disease, LYMErix is not without controversy.
FDA apprehension includes the vaccine’s safety for children under 15, people who have had Lyme, have chronic Lyme or for those with a family history of rheumatoid arthritis until further research has been completed.
Even after three doses, the vaccine is only 78 percent effective and may require subsequent boosters. LYMErix works by generating antibodies that kill the Borrelia burgdorferi spirochete inside the gut of the tick itself as it ingests its host’s blood; there is concern about how much bacteria will manage to evade the antibodies and slip into the host’s blood system, at which point the vaccine is ineffective.
Once a person has had the vaccine, antibody tests will no longer be effective, creating an even larger diagnostic nightmare. It also doesn’t protect against all strains of the disease or other tick-borne diseases such as babesiosis, ehrlichiosis or Rocky Mountain spotted fever. On the other hand, if you work outside in an endemic area, some protection is better than none.
The Lyme Disease Foundation is taking a cautious approach but has generally encouraged vaccination.
French pharmaceutical company Pasteur Mérieux Connaught is also developing an OspA vaccine, and although it has not received FDA approval, Connaught actually holds the OspA patent and is suing SmithKline Beecham for patent infringement. SmithKline Beecham had no comment.
Any forthcoming patent on LYMErix will belong to Yale, and either way, the institution will be receiving royalties (a portion of which will go to the OspA researchers) determined by the quantity of the vaccine sold. They’ve already received payments for successful trial phases and the FDA approval of LYMErix.
Aside from apprehensions about the vaccine’s safety and efficacy, patients and doctors are worried that research for a cure, or at least better treatment, will fall by the wayside in light of the vaccine.
"Nobody is looking for better treatment right now except maybe some of the clinicians struggling with the patients who have chronic illness," Liegner says. "There should be a major, major effort on the part of everybody — the government, pharmaceutical companies, basic researchers — on designing better treatment."
Regardless of the vaccine, everyone should seek a medical evaluation for an embedded deer tick. Whether to treat all bites prophylactically with antibiotics is another scorching debate, despite the fact that much of the medical community does agree that by the time definitive tests and symptoms occur, the spirochete has had a chance to disseminate throughout the body, increasing the risk for chronic problems. In a society where acne elicits unquestioned antibiotic treatment, shouldn’t a potentially debilitating disease get the same consideration?
