Pfizer announces it has begun Phase 3 clinical testing of its Lyme disease vaccine with French vaccine company Valneva SE, CNN reports.
Currently, approximately 6,000 participants are being recruited from Europe and the US where Lyme disease is endemic. Participants will receive three doses of the vaccine, called VLA15, or a placebo, followed by a booster.
VLA15 is the only Lyme disease vaccine in clinical trials, Pfizer says.
The vaccine targets the bacterium Borrelia burdorferi, the main cause of the tick-borne disease. In preclinical and clinical studies so far, the vaccine has “demonstrated a strong immune response and a satisfactory safety profile.”
According to Pfizer, if the study proves the vaccine is safe and effective, it could submit applications for approval to the US Food and Drug Administration and the European Medicines Agency in 2025.
Lyme disease is the most common vector-borne disease in the US, according to the US Centers for Disease Control and Prevention (CDC).
The only vaccine previously marketed in the US was discontinued in 2002.
Symptoms
Fever, chills, body aches, swollen lymph nodes, stiff neck, shortness of breath, headache, fatigue, and rashes are all typical symptoms of Lyme disease. Between 70% and 80% of people with Lyme disease develop a rash. Untreated, the infection can spread to the joints, heart and nervous system, according to the CDC. Which can lead to joint pain and swelling.
After several weeks to months, there may also be swelling of the membranes around the brain, temporary paralysis of part of the face and “brain fog”: confusion, loss of attention, loss of memory.
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