Lyme disease is caused by a bacterium that is transmitted via infected blacklegged ticks. This new vaccine in development has arrived 20 years after the vaccine was discontinued. This brings new hope to those who have been diagnosed with it as experts say that this is ‘a long time coming.’
A vaccine that’s being studies has been designed to protect those as young as 5 years of age from Lyme disease. The group behind it is now recruiting participants for its third and final clinical trial. This was according to an announcement made by Pfizer and the French pharmaceutical company named Valneva, the developers of the said vaccine.
The trial, Vaccine Against Lyme for Outdoor Recreationists (VALOR) will look into the efficacy, safety, and immunogenicity of the investigational candidate for Lyme disease vaccine, VLA15. “We are extremely pleased to reach this important milestone in the development of VLA15. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere,” Juan Carlos Jaramillo, MD, chief medical officer of Valneva, spoke in a recent release. “We look forward to further investigating the VLA15 candidate in phase 3, which will take us a step closer to potentially bringing this vaccine to both adults and children who would benefit from it.”
“I think it’s great that we’re getting a new vaccine for Lyme disease — I think it’s important that we have one, especially in environments where there are lots of opportunities to get a tick bite that can transmit the disease,” said Mark Soloski, PhD. He is a professor (emeritus) of molecular microbiology and immunology at the Johns Hopkins School of Medicine in Baltimore. He has done a research on Lyme disease. “The data from the phase 1 and 2 trials is promising,” he also shared.
The Lyme Disease Vaccine Has Been ‘A Long Time Coming’
Right now, they’re in the third phase of the trial. If the vaccine is found to be effective and successful, and if the vaccine will be approved, this will be the first and only Lyme disease vaccine available for people living in the U.S. However, this isn’t going to happen overnight. The process will beed more years, according to the companies. In fact, they will only begin to get authorization in 2025, which is three years from now.
This new Lyme disease vaccine “has been a while coming,” according to Dr. Soloski. “We did have a vaccine back in the 1990s that was taken off the market. That vaccine, called LYMERix, was withdrawn 20 years ago due to some adverse reactions that were reported, including arthritis, which some believed was caused by specific segments of the vaccine protein,” as per the National Institute of Allergy and Infectious Diseases.
The U.S. Food and Drug Administration also analyzed the previous vaccine. However, they didn’t find proof that supports the previous reports. Still, the sales figures of the vaccine spiraled down. This was when the manufacturer discontinued it. The reports scared potential customers from availing the vaccine that could have been helpful.
The New Vaccine is Designed to Lower These Potential Side Effects
This new vaccine comes with the same kind of mechanism of action that came with the discontinued one. This was designed to target the OspA, which is the outer surface protein of the Borrelia bacteria that brings about Lyme disease. The vaccine inhibits the bacterium’s ability to leave the tick, which in turn, infects the people it bites.
Still, this new one has been engineered in a different manner, stated Soloski. “The part of the protein that was thought to be drive significant side effects like promoting arthritis or other kinds of musculoskeletal illnesses has been taken out,” he explained.
Lyme Disease Patients Have Almost Doubled Over the Past 30 Years
Lyme disease is the most common vector-borne illness happening in the U.S. alone. The disease has affected around 476,000 people. This was according to the Centers for Disease Control and Prevention (CDC). As for Europe, around 130,000 have been hit as findings of a research revealed. So, Lyme disease reports have almost doubled in the last three decades, This trend has been connected to climate change, according to the U.S. Environmental Protection Agency (EPA).
The perpetrator behind this disease, as stated earlier, is the bacteria Borrelia burgdorferi and, rarely, Borrelia mayonii. This can be transmitted to people through the infected blacklegged tick bites, according to the experts from CDC.
Once the person is infected, symptoms come in the form of the following health issues: fever, headache, fatigue, and a characteristic skin rash that is erythema migrans. The person is diagnosed with Lyme disease based on the symptoms, physical findings, and whether or not the person has been exposed to ticks. Lab testing will be required and used to validate it.
If Lyme disease is diagnosed in its early stages, then this can easily be treated. The person is just required to take antibiotics for a few weeks. On the other hand, the infection can spread to the joints, heart, and even nervous system if treatment isn’t sought immediately.
Around 6,000 Are Expected to Enroll in the Trial
Around 6,000 participants will be part of the randomized, placebo-controlled, phase 3 trial and they are aged 5 or older. The study will be found in 50 different sites, particularly in places where prevalent Lyme disease cases happen. This includes Finland, Germany, the Netherlands, Poland, Sweden, and some states in the U.S.
The participants will be given three doses of the vaccine or a saline placebo. This is what they call the primary vaccination series. After this comes one booster dose of VLA15 or saline placebo. Investigators will monitor them to make sure that the new vaccine is able to stimulates immunity safely, especially when there are natural occurrences of Lyme disease.
“If approved, the vaccine will be voluntary — it will be someone’s personal choice,” said Soloski. Those who will be vaccinated might be those who reside in New England and in states such as Maryland. They may also include those who spend a lot of time working outdoors for construction, gardening, farming, hiking, and camping. The CDC provides further information about this in case you want to see if you’re also at risk.
Around 10 to 15 Percent of Those With Lyme Disease Continue to Experience Symptoms Even After Treatment
Some patients who have been diagnosed with Lyme disease regain full health. Then, there are those who experience persistent symptoms even long after, stated Soloski. “It can be really debilitating; this vaccine will really benefit those folks,” he said.
An estimated 10 to 15 percent of those who have Lyme disease have “post-treatment Lyme disease (PTLD),’ as per John Hopkins Medicine. “These individuals can have cognitive issues, sleep issues, vision issues, brain fog, pain and fatigue. If we can stop the infection from occurring at all, that would be a really good thing — then you won’t be one of these individuals,” added Soloski.
Part of the Plans Include Other Potential Vaccines and Prevention Tools
Aside from the Pfizer-Valneva vaccine, there are also other prospective therapies and vaccines. These are all in the pipeline as added protection, assured Soloski. “There’s a company, MassBiologics, which has developed a monoclonal antibody that can prevent a tick bite from transmitting the bacteria that causes Lyme disease,” he said. That vaccine may be sold in the market as early as 2024, according to a UMass Chan Medical School release.
Another one in the pipeline that’s still early on in the experimental phase is a vaccine that has the ability to immunize people against any type of tick bites. They’re going beyond the blacklegged ticks, said Soloski. “That’s important because that vaccine would not only protect against Lyme disease but many other tickborne diseases as well,” he also said.
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