Lyme disease is the most common vector-borne disease in the United States, infecting thousands of people annually. Yet there’s currently no vaccine on the market that can protect humans from contracting this disease — a solution that would be in high demand in high-risk areas, such as Maine.
The new report Protective Immunity and New Vaccines for Lyme Disease, published by the Oxford University Press for the Infectious Diseases Society of America, sheds some light on the situation.
The report was developed following a series of meetings at Cold Spring Harbor Laboratory Banbury Center in New York, during which participants from the pharmaceutical industry, academia and government agencies discussed recent efforts to develop a Lyme vaccine for the general public.
“There was no intent to take a vote, or consensus, during the meeting; rather there was a discussion of research findings that support the best pathways forward,” the report states. “What emerged was a recognition among all participants that an effective vaccine is an important individual and public health tool to use in the United States and Europe.”
Much of the report is saturated with scientific terminology, which makes it a challenge for lay readers. However, it does make clear that efforts are being made to develop a variety of Lyme vaccines. And it mentions an interesting bit of history: there used to be a Lyme vaccine that was approved by the Food and Drug Administration, then it disappeared.
The first Lyme vaccine failed
Lyme disease is a bacterial disease transmitted through the bite of infected deer ticks, also known as black-legged ticks. Each year, approximately 30,000 cases of Lyme disease diagnosed in humans are reported to the U.S. Centers for Disease Control and Prevention, with the majority of those cases in the Northeast and north central U.S., where infected deer ticks live in abundance.
To combat this problem, a Lyme vaccine for humans called LYMErix was manufactured by SmithKline Beecham Biologicals, a pharmaceutical company in Belgium, and underwent clinical trials before being licensed by the FDA in 1998. Trials showed that the vaccine reduced Lyme infections in vaccinated adults by nearly 80 percent. However, just three years later, the manufacturer voluntarily withdrew it from the market.
A detailed story about the short-lived vaccine is told in the 2007 article “ The Lyme vaccine: a cautionary tale,” published in the peer-reviewed medical journal Epidemiology and Infection.
The article states that within a year of the release of LYMErix, patients started reporting a variety of side-effects, including arthritis. In 1999, a Philadelphia law firm filed a class-action lawsuit against the vaccine’s manufacturer, representing 121 people who claimed they experienced significant adverse reactions to the vaccine.
Media coverage of the lawsuit raised public concern about the vaccine and pushed the FDA to investigate.
“The FDA found no suggestion that the Lyme vaccine caused harm to its recipients,” the article states.
Nevertheless, the vaccine’s manufacturer chose to withdraw the product from the market in 2002 due to declining sales and ongoing litigation. In 2003, they settled the lawsuit. The final agreement included more than $1 million in legal fees for prosecuting lawyers but no financial compensation to those who claimed side-effects from the vaccine. The voluntary removal of LYMErix from the market accomplished the main goal of the suit.
Moving forward with Lyme vaccines
For years, researchers in the U.S. and Europe have been working to better understand Lyme disease. Leading the way, an Austrian biotech company named Valneva has developed a Lyme vaccine called VLA15 and is now conducting clinical trials. But it’s unclear when or if that vaccine will make it to market in the U.S.
“I know that they’re developing vaccines right now in Europe, which are going to be tested first to see if there are any issues with them,” said Chuck Lubelczyk, a field biologist for Maine Medical Center Research Institute. “I don’t think you’ll see [Lyme vaccines] widespread within the next five years.”
“I think companies are really wary about investing a bunch of resources into something that isn’t going to pan out,” he said.
The public’s negative reaction to LYMErix in the late 1990s may scare some companies away from investing in Lyme vaccines for humans, but it hasn’t stopped companies from releasing Lyme vaccines for dogs.
“There are actually two vaccines for dogs, not just one,” Lubelczyk said. “Interestingly, one is very similar to the human vaccine that came out in the ‘90s. But [companies] generally don’t get sued if a dog gets sick from a vaccine. Also, dogs get different symptoms than we do.”
Yet, according to the new report for the Infectious Diseases Society of America, there is a push to offer a Lyme vaccine to people once again. Perhaps it’s because the incidence of Lyme disease in the U.S. has approximately doubled since 1991.
“When [LYMErix] came out in the ‘90s, Lyme was a problem … but it’s gotten a lot worse,” Lubelczyk said. “The need for [a vaccine] is much greater now.”
A portion of the recent meetings in New York — and the resulting report — was devoted to discussing public perceptions of vaccination. Since Lyme disease is not contagious, any future vaccination would be completely voluntary — in contrast to mandated vaccines to protect populations against highly contagious diseases.
“Lyme disease vaccination is an individual’s personal choice,” the report states. “Advisable to people at risk. A decision to be vaccinated should be based on scientific evidence such as risk of exposure in areas where the infected vector is present and the disease is endemic.”
In a place like Maine, one of the worst states for Lyme disease in the nation, this is a decision residents will need to make — if and when the vaccine comes.
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