Lyme disease is a systemic infection transmitted to humans by infected ticks, caused by the Borrelia burgdorferi bacteria. It is the most common vector-borne illness in the Northern Hemisphere. According to the CDC, state health departments report 30,000 cases each year. However, recent estimates suggest that it infects closer to 476,000 people annually in the US.  

Lyme disease often goes untreated due to misinterpretation of early symptoms. It then causes serious complications to the joints, the heart, or the nervous system. 

“The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.” 

Pfizer’s response was to initiate a collaborative approach with Valneva. VLA15 is currently the only Lyme disease candidate in clinical development. It is an “investigational multivalent protein subunit vaccine”. Targeting the outer surface protein of the disease-causing bacteria, the vaccine is expected to inhibit the bacterium’s ability to “leave the tick and infect humans”. The vaccine addresses the most common OspA serotypes prevalent in North America and Europe.  

In studies to date, VLA5 “demonstrated a strong immune response and satisfactory safety profile”. This next phase of development requires up to 6,000 participants above the age of 5. The trial takes place across 50 sites in areas where the disease is “highly endemic”

“Pending successful completion of the Phase III study, Pfizer could potentially submit a Biologics License Applications (BLA) to the FDA and Marketing Authorisation Application (MAA) to the EMA in 2025.” 

Valneva and Pfizer started this collaboration in April 2020. The agreement states that Pfizer makes a $25 million “milestone payment” to Valneva at the start of the Phase III study. 

Dr Juan Carlos Jaramillo, CMO of Valneva, suggested that Lyme disease comprises a “high unmet medical need”. Dr Annaliesa Anderson of Pfizer agrees that “providing a new option for people to help protect themselves” is “more important than ever”. She hopes that progressing the vaccine to Phase III will provide “positive evidence” in support of the candidate.

To hear from Dr Anderson and representatives from Valneva at the World Vaccine Congress in Europe 2022 click here to get tickets.