LYMErix, the first and last Lyme disease vaccine that was licensed and approved by the Food and Drug Administration (FDA), was pulled off the market in 2002.
Since then, research and studies on the disease and potential vaccines have continued, but there hasn't been another Lyme disease vaccine made commercially available to the public.
Here are some key points about the Lyme disease vaccine. More detail and supporting information is in the main article.
- Lyme disease is spread by the tick, Borrelia burgdorferi
- LYMErix is the only vaccine to have been approved for Lyme disease
- Scientists are still approaching the vaccine problem from a number of angles
What is Lyme disease?
Borrelia burgdorferi transfers Lyme disease to humans.
Lyme disease is contracted through the bite of a black-legged tick infected with the Borrelia burgdorferi bacterium.
Also called Lyme Borreliosis, Lyme disease is the most common vector-borne, or tick-borne, disease in the United States.
According to the U.S. Centers for Disease Control and Prevention (CDC), over 30,000 cases are reported each year. This figure doesn't reflect the full scope of the illness as some cases go unreported.
The CDC suggests that the number of people diagnosed with Lyme disease every year is approximately 300,000.
Early symptoms of Lyme include fever, chills, fatigue, and other flu-like symptoms. Later, symptoms can progress to severe headaches, arthritis, facial palsy (loss of muscle control to part of the face), irregular heart rhythms, inflammation of the brain and spinal cord, and memory problems.
Taking steps to avoid being bitten by ticks can help prevent Lyme disease, and, it is treatable with antibiotics. However, the disease can lead to serious complications if it is not caught early or is left untreated.
Lyme disease vaccine
In the 1990s, GlaxoSmithKline, known as SmithKline Beecham (SKB) at that time, developed a vaccine based on the outer surface protein A (OspA), a protein found on the cell surface of the B. burgdorferi bacterium. The vaccine boosts production of antibodies against OspA; it targets the bacterium within the tick rather than the human.
When a tick bites a vaccinated person, blood full of antibodies enters the tick and kills the bacterium before it can be transmitted to the person.
SKB's vaccine, called LYMErix, went through phase 3 clinical trials and was eventually approved by the FDA in 1998. LYMErix was given to people in three doses and was found to be about 80 percent effective in preventing Lyme disease.
Not long after its release, the vaccine was met with a public backlash when reports of adverse reactions surfaced. SKB received a class action lawsuit by a Philadelphia law firm that represented over a hundred people who claimed they had experienced adverse reactions to the vaccine. Citing low demand and decreasing sales as the reason, SKB eventually pulled LYMErix off the market in 2002.
Though LYMErix was the first and last Lyme disease vaccine approved by the FDA, it was not the only one being developed.
Around the same time SKB created LYMErix, Pasteur Merieux Connaught also manufactured its own vaccine based on OspA. The vaccine, ImuLyme, also went through phase 3 clinical trials, but the company decided not to apply for regulatory approval without revealing the reasons.
Following the withdrawal of LYMErix from the market, Erol Fikrig, one of the physicians who helped develop the vaccine, tried a different approach.
He focused on the tick's saliva and found a way to block transmission of the B. burgdorferi bacterium and potentially other bacteria, too. In 2009, Fikrig and his research team published the findings of their studies on mice in Cell Host & Microbe.
In 2013, researchers from Stony Brook University, Brookhaven National Laboratory, NY, and Baxter International Inc., IL, published the results of their trials into another vaccine based on OspA.
Researchers are using multiple approaches to solve the Lyme disease vaccine puzzle.
The group conducted trials in Germany and Austria and gave the vaccine to 300 participants. There were only a few mild adverse reactions and no serious adverse events related to the vaccine.
The researchers have yet to conduct efficacy studies of the vaccine.
In 2015, MassBiologics, a non-profit vaccine manufacturer at University of Massachusetts Medical School, presented their research on pre-exposure prophylaxis.
Their vaccine has the potential to prevent Lyme disease infection and protect the vaccinated person for about 6 months, just long enough to ride out the risk period of infection. The lab is looking to do more research and further tests, including human trials.
Another notable project investigating potential Lyme disease vaccines is headed up by Dr. Richard Marconi of Virginia Commonwealth University School of Medicine.
Dr. Marconi's team is developing a vaccine based on OspC, another surface protein, similar to OspA. This vaccine will not require the regular boosters that the OspA vaccine relies upon to stay active. So far, the vaccine has been trialed in dogs and provided promising results.
Though doctors and scientists continue their research into methods of combatting Lyme disease, there is no news of any vaccine prototype that seems close to becoming approved.