Pharmaceutical companies Pfizer and Valneva are collaborating to create a vaccine designed to protect against tick-borne Lyme disease. The two companies are entering a late-stage clinical trial where they plan to test the vaccine on 6,000 participants.
“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” said Annaliesa Anderson, Pfizer’s head of vaccine research and development, in a statement.
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The companies plan to test the vaccine, known as VLA15, in 50 sites where Lyme disease is “highly endemic”, including Finland, Germany, the Netherlands, Poland, Sweden, and the U.S. Ages of participants will range from five years old and up.
Participants in the trial will receive three doses of either the vaccine or a placebo, plus one booster consisting of a vaccine or placebo.
“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,” Pfizer said.
The vaccine works by blocking a protein, known as OspA, in the bacteria that causes Lyme disease. By blocking OspA, the bacterium is unable to leave the tick and infect humans.
Pfizer and Valneva entered into their collaboration in April 2020. If the clinical trials prove successful, Pfizer said it believes it could seek approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to release the vaccine in the U.S. and Europe by 2025. Considering the FDA’s close partnership with Health Canada, it’s likely the vaccine would be approved in Canada the same year.
This wouldn’t be the first time the FDA has approved a Lyme disease vaccine. In 1998, GlaxoSmithKline released LYMErix, which reduced new infections in vaccinated adults by nearly 80 per cent. But the drug was pulled after three years due to low sales.
Since the 2000s, the number of people affected by Lyme disease has grown. In 2009, Health Canada reported 144 cases of Lyme disease. Case numbers have progressively gotten higher, peaking at 2,851 in 2021. In the U.S., the Centers for Disease Control and Prevention (CDC) estimates that as many as 476,000 Americans are infected with Lyme disease each year.
Lyme disease is spread through the bite of an infected black-legged tick, typically found in areas with high grass or brush. The ticks attach themselves as people pass by, usually migrating to hard-to-see areas, such as the groin, armpits, and scalp. The tick must be attached for 36 to 48 hours for the disease to transfer.
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Signs of infection include fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes. If caught early, Lyme disease can be treated with antibiotics. But if the disease isn’t treated, it could result in facial palsy, arthritis, inflammation of the brain and spinal cord, and heart palpitations known as Lyme carditis.
A number of Canadian celebrities have spoken publicly about their battles with Lyme disease, including singers Justin Bieber and Avril Lavigne.
“Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere,” said Juan Carlos Jaramillo, Valneva’s chief medical officer, in a statement. “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.”