Alt-Health: Where’s a Lyme Vaccine?

Since the ’70s, when it was first discovered in Lyme, Connecticut, Lyme Disease has become one of the fastest growing infectious diseases in our country. It is a debilitating infection that, if not caught in its earliest stages, can become a lifelong, crippling illness. The CDC estimates that 300,000 people every year are diagnosed. In 2005 in Rhode Island, there were only 3.6 Lyme diagnoses for every 100,000 residents. By 2014, our rate of infection was 15 times higher, with 54 diagnosed cases per 100,000. This was by far the largest increase in the country. Today, Lyme disease is more common in Rhode Island than in all but three other US states.

Unfortunately, at this point in time, our only recourse is to shield ourselves with clothing or repellents and avoid the wooded areas where ticks cluster and dwell. Wouldn’t it be great if someone discovered a vaccine? Well, somebody already did – the problem is, you can’t get it anymore if you are human. You must be canine to qualify. It may behoove us to ask why.

The first and only licensed vaccine against Lyme disease, called LYMERix, was developed by SmithKline Beecham (now GlaxoSmithKline) and approved by the The Food and Drug Administration in 1998. The vaccine had an unusual method of action – it stimulated antibodies that attacked the Lyme bacteria while it was still in the tick’s gut as it fed on the human host. This neat trick killed off the bacteria before it was able to enter the body, and showed great promise in bringing the spreading Lyme epidemic to a halt.

Admittedly, the vaccine had certain drawbacks. It only protected against the North American strain of Lyme and could not be given to children under 15. The shots cost $50 each (rather expensive at the time) and were not always covered by insurance. But did it work? Yes. Results from the efficacy trial showed that it was 78% effective in preventing Lyme disease after all three doses were given. It was also shown to be 100% effective at preventing asymptomatic cases, those in which an individual would get the disease and develop antibodies against it, but never develop any symptoms. So, what happened?

Media-induced hysteria seems to be what happened. In 1998, a study (which was later proven to have been falsified) was published in The Lancet, a weekly peer-reviewed general medical journal. The article claimed that there was a link between certain vaccines and autism. Since The Lancet was recognized as one of the oldest and most prestigious general medical journals in the world, this study was given a great deal of weight and spawned a movement that declared war on seemingly ALL vaccination. The drama set the stage for the demise of LYMERix. Here’s how.

As a safety measure, post-licensure monitoring is conducted on all vaccines, including analysis of reports to the Vaccine Adverse Events Reporting System (VAERS). VAERS is an open system that accepts reports about adverse events from anyone, including healthcare providers, vaccine recipients and their relatives, vaccine manufacturers and lawyers. The data should never be used without careful analysis – sometimes symptoms are reported that are purely coincidental and have nothing to do with the vaccine itself. Information needs to be cross referenced against the rate of similar symptoms that appeared in persons who did not receive the vaccine.

Between December 28, 1998, and July 31, 2000, 905 adverse reports came in after patients were given the Lyme disease vaccine. However, closer examination of the data showed that the events occurred at the same rate in the general population. The matter would have been dropped there, but as research was reviewed, the media began to cover the topic heavily. Their goal was to create exciting news that people would watch; to that end, they hyped the potential dangers. By the time the truth came out, nobody cared. By 2002, SmithKline Beecham had withdrawn LYMERix from the market, despite the fact that it demonstrated its efficacy in a Phase III clinical trial. Why? Sponsors of the vaccine dropped out due to lawsuits alleging potential, though unproven, damage.

Today there are no vaccines available to prevent Lyme disease in humans, and it is not likely that there will be any licensed in the near future.

Your dog, however, has access to several vaccines that can help prevent disease caused by Borrelia burgdorferi, the Lyme disease organism. For pets, an initial vaccination is followed by a booster vaccine 2 to 4 weeks later (in accordance with label recommendations) and annual boosters as long as the risk for disease exposure remains. Veterinarians have found the vaccine to be remarkably effective. As to the potential for humans? We may never know.