“I do feel it’s a shame that we have a safe and effective [Lyme disease] vaccine and people cannot get it.”
Dr. Allen Steere, who helped discover Lyme disease in 1977, said in a recent interview with CTV that he and his team may have inadvertently fostered the panic around the LYMErix vaccine that resulted in it being pulled from the market by its manufacturers. Speaking from his office at Massachusetts General Hospital, in Boston, he bewailed the fact that Lyme disease is “really the only infectious disease […] for which there is a safe and effective vaccine and it is not available [for] who wants it.” So what happened with LYMErix and why is there still no Lyme disease vaccine available for humans, despite dogs and horses having access to such Lyme disease prevention methods?
Juvenile Arthritis or Lyme Disease?
The Lyme disease outbreak that occurred in Old Lyme in Connecticut in the late 1970s led to the discovery of the Lyme disease bacteria, Borrelia burgdorferi, and the establishment of a set of guidelines for diagnosing and treating the infection. Allen Steere was a rheumatologist who was called in to investigate a cluster of cases in local school children which he at first diagnosed as juvenile arthritis before changing his assessment after soldiers at a nearby military base also suffered from the arthritis-like symptoms. Steere and coleagues recognized a likely zoonosis and over time the bacteria, the ticks as vector, and the Lyme disease rash and other symptoms were elucidated.
Steere and the Lyme Disease Conspiracy
Steere continued to work in Lyme disease research and has published many papers over the years informing the current Lyme disease guidelines issued by the Centers for Disease Control (CDC). This researcher is considered by a number of Lyme disease activists to be part of the Lyme disease conspiracy that denies the existence of Chronic Lyme disease and ignores evidence about persistence after antibiotic treatment. Steere himself said in this latest interview that it may have been a finding by his own team that sparked fears about LYMErix, leading to its downfall.
How Lyme Disease Vaccine Worked
LYMErix was devised as a new kind of vaccine, unusual in that it worked to immunize the culprit transmitting the disease (the tick) rather than the bacteria itself. In those vaccinated with LYMErix and bitten by a tick carrying Borrelia burgdorferi the vaccine worked by entering the tick and preventing the bacteria from adhering to the tick’s gut wall, thus leading it to be flushed from the tick insted of being transmitted to the human host (or other mammalian host).
Booster Shots for Lyme Disease Immunity
The usual transmission time for Lyme disease after a tick bite is thought to be around a day, which means that many people simply brush off ticks before the bacteria have a chance to invade their system. The fact that the LYMErix vaccine did not create immunity in the person themselves meant that questions were raised over how long it would remain effective and Steere was hoping to gather enough evidence after vaccinations took place to ascertain the need, if any, for booster shots. Unfortunately, the vaccine was quickly embroiled in a controversy over its potential to acually trigger Lyme disease symptoms in patients.
How Effective is LYMErix?
The Lyme disease vaccine was based on a protein found in the bacteria itself in order to trigger a response in the tick which then neutralized the bacteria prior to transmission. There was some concern during the early stages of testing of the vaccine that some patients could be sensitive to this protein and have an autoimmune reaction and arthritis as consequences of vaccination. Despite the vaccine being effective in around 78% of patients after three doses, there were still nagging doubts in Steere, and colleagues, about the potential for this autoimmune reaction.
Autoimmune Arthritis and LYMErix
LYMErix sold fast, despite being expensive and new, and between 1998 and 2001 there were more than 1.4million doses distributed in the US. Of those vaccinated there were 905 reported reactions, most mild in nature but with seven serious reactions. However, a handful of patients came forward to claim that the vaccine had produced strange side-effects including arthritis development shortly after vaccination. Media outlets picked up these stories and the fact that Steere was investigating the potential for this type of reaction added weight to the fears of these patients.
LYMErix Safe, According to CDC and FDA
A review by the CDC and FDA (Food and Drug Administration) in 2001 concluded that there was no evidence showing the LYMErix vaccine had caused serious reactions or problems at a rate higher than any other vaccine currently approved and used in the US. LYMErix was exonerated by the FDA and CDC and allowed to continue to be sold but fears remained and patients began forming action groups and talking about suing the manufacturer. Steere embarked on a Phase III study to determine if autoimmunity and arthritis could be triggered by the LYMErix vaccine but found no evidence of such a reaction occurring. Later studies, according to Steere, also found no evidence that arthritis occurred at a higher rate in vaccine recipients than in other patients taking placebos or those in the general population.
Lawuits Bring Down GSK
GlaxoSmithKline decided in February 2002 to withdraw the vaccine from the market as the Lyme disease counterculture had damaged its reputation and sales had declined to the point that defending themselves against lawsuits would not be economical. This short run for the Lyme disease vaccine meant that researchers like Steere could not gather sufficient data from post-market testing to answer questions about the need for booster shots or the maintenance of the effectiveness of the vaccine. LYMErix is the only vaccine ever to be withdrawn from sale voluntarily due to low public demand even when rates of disease continued to rise and approval was maintained by the FDA.
Lyme Disease – A Growing Problem
Steere noted that “Even if the manufacturer had launched some kind of campaign to dispel myths, it wouldn’t have much of a difference. They tried but they were just overwhelmed by the threat of class action lawsuits.” Without the vaccine Lyme disease continues to spread and cause suffering in an ever increasing number of people. Climate change is also allowing ticks to populate areas previously uninhabitable, creating Lyme endemic areas previously free of the infection. Other vectors, such as bedbugs, are also being considered as possible causes of the spread of infection and no new vaccine has been created to fill the gap LYMErix left.
Big Pharma and Lyme Disease
Manufacturers are, understandably, wary of investing in developing and marketing a vaccine when considering the backlash against a seemingly effective and safe vaccine that gained approval and may still be helpful in combating Lyme disease. Another manufacturer, Pasteur Mérieux Connaught, had created and tested its own Lyme disease vaccine around the same time as LYMErix was launched but decided to shelve their plans to apply for a licence after seeing the barrage of abuse launched at GlaxoSmithKline. Baxter Bioscience in Vienna are, reportedly, working on a vaccine but the European strains of Borrelia differ from US strains and so it may be that a European Lyme disease vaccine is ineffective in the US.
New Generation Lyme Disease Vaccine
Lyme disease continues to spread in the US and as case numbers swell the call for a new Lyme disease vaccine grows louder. Recent research into dendritic cells and cross-presentation could lead to development of a whole new generation of vaccines, including one for Lyme disease that works differently to LYMErix. The question now is whether patient groups will give any new vaccine a fair trial and whether researchers have developed a more refined media strategy to cope with any initial problems until Lyme disease vaccine safety data becomes available.