Possible Lyme Disease Vaccine on the Horizon

Over the past several years, we have witnessed an increase in the incidence of Lyme disease, along with the debilitating impact this vector-borne disease has had on many of our patients, so any news about a potential vaccine for Lyme disease piques our interest.

On Aug. 8 of this year, Pfizer, the U.S.-based pharmaceutical and biotechnology firm, and Valneva, a French biotech company, announced the initiation of a Phase 3 clinical study named Vaccine Against Lyme for Outdoor Recreationists (VALOR). VALOR was set up to investigate the efficacy, safety, and immunogenicity of the company’s investigational Lyme disease vaccine candidate, VLA15. (Immunogenicity is a measure of a vaccine’s ability to stimulate an immune response in the body.)

Although we must wait for the final report on the effectiveness and safety of the vaccine, the research is promising. A safe, effective vaccine would be a welcome addition in the battle against Lyme disease. It could prove to be a valuable preventive measure for those who spend any amount of time outdoors in areas where tick-borne Lyme disease poses a significant health threat.

Important: Here at Restoration Healthcare, we are not big proponents of vaccines in general, nor are we antivaxxers. Our recommendation to receive a specific vaccine or not relies on several factors, including the vaccine’s risk/benefit profile, the individual’s likelihood of being infected, and the impact the disease is likely to have on the patient. We conduct a risk-benefit analysis for each patient, allowing them to decide what’s best for them and their family members on a case-by-case basis.

What Is Lyme Disease?

Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected ticks. It is considered the most common vector-borne illness in the Northern Hemisphere. (Vector-borne illnesses are those caused by parasites, viruses, and bacteria transmitted by an invertebrate, such as a mosquito or tick.)

While the true incidence of Lyme disease is unknown, it is estimated to affect approximately 476,000 people in the United States and 130,000 people in Europe every year.

Recognizing the Symptoms

Ticks infected with the bacteria that cause Lyme disease can be as small as a poppy seed, and their bite is painless, so a tick can be feeding on you for days or weeks before you notice it, if you ever do. (Fewer than 30 percent of patients in the U.S. who are treated for Lyme disease recall being bitten.)

You are more likely to notice the early symptoms of infection, such as the following (but you’re still unlikely to attribute these symptoms to a tick bite):

• Bull’s eye rash: the classic sign of early local infection with Lyme disease is a circular, outwardly expanding rash called erythema migrans (EM) rash, which may occur at the site of the tick bite within three to 30 days after the bite. Unfortunately, the EM rash is absent in more than 50 percent of Lyme disease cases, causing many people and their doctors to overlook the possibility of a tick bite.
• Fever
• Headache
• Fatigue
• Muscle and joint pain
• Numbness or tingling (in some cases)

Except for the rash, symptoms are often mistakenly attributed to the flu or other common illnesseses. In children, symptoms can be even more subtle — struggling at school, not feeling like playing, irritability, and difficulty concentrating. These symptoms are often dismissed as “growing pains” or misdiagnosed as an attention deficit disorder.

When the infection spreads past the skin, it can affect any system of the body, causing numerous and diverse symptoms including these:

• Anxiety, depression, irritability, psychosis, and other psychiatric symptoms
• Arthritis
• Fatigue
• Impaired thinking, memory, language, and math skills
• Headaches/confusion/brain fog
• Heart problems
• Muscle pain
• Nerve pain and weakness
• Numbness
• Vision and hearing problems
• Poor sleep

About the VLA15 Vaccine

VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This vaccine targets the outer surface protein A (OspA) of Borrelia burgdorferi — the bacteria that cause Lyme disease. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe.

According to Pfizer and Valneva, VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. Data from the Phase 2 studies continue to demonstrate strong immunogenicity in adults as well as in children, with acceptable safety and tolerability profiles in both study populations.

Further Studies Are Needed

A randomized, placebo-controlled, Phase 3 study is planned to enroll approximately 6,000 participants 5 years of age and older. The study is being conducted at up to 50 sites located in areas where Lyme disease is widespread, including the United States, Finland, Germany, the Netherlands, Poland, and Sweden. Participants in the study will receive three doses of VLA15 or a saline placebo as a primary vaccination series followed by one booster dose of VLA15 or the saline placebo.

Pending successful completion of the Phase 3 study, Pfizer may submit a Biologics License Application to the U.S. Food and Drug Administration and similar applications to the European Medicines Agency as early as 2025.

To find out more about Lyme disease and how we diagnose and treat it at Restoration Healthcare, see our previous Lyme Disease posts. If you know or suspect that you or a loved one has been bitten by a tick, early medical intervention can help speed recovery and improve your treatment outcome, so be sure to consult a doctor with experience in diagnosing and treating Lyme disease as soon as possible. If you’re in or near Irvine, California, contact us for an initial consultation. Our medical director, Dr. Sunny Raleigh, is widely recognized by patients and referring physicians from across the country as among the top Lyme doctors in the country.

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Disclaimer: The information in this blog post about a Lyme disease vaccine is provided for general informational purposes only and may not reflect current medical thinking or practices. No information contained in this post should be construed as medical advice from the medical staff at Restoration Healthcare, Inc., nor is this post intended to be a substitute for medical counsel on any subject matter. No reader of this post should act or refrain from acting on the basis of any information included in, or accessible through, this post without seeking the appropriate medical advice on the particular facts and circumstances at issue from a licensed medical professional in the recipient’s state, country or other appropriate licensing jurisdiction.