Pfizer, Valneva begin final study phace for Lyme disease vaccine

A new vaccine candidate by Pfizer and Valneva for Lyme disease has entered Phase 3 of a clinical trial, bringing new hope to limit the disease in the future.

The trial, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), is investigating the efficacy, safety and immunogenicity of the vaccine candidate, VLA15. The Phase 3 trial enrolled 6,000 participants aged 5 and older, and it is a randomized, placebo-controlled study taking place at up to 50 local sites in areas where Lyme disease is highly endemic, such as Finland, Germany, the Netherlands, Poland, Sweden and the United States. 

The development is an exciting one for Lyme disease, which is transmitted to humans through the bite of infected blackleg ticks and is the most common vector-borne disease in the United States, according to the Centers for Disease Control and Prevention (CDC). The disease is characterized by  fever, headache, fatigue, and a characteristic skin rash called erythema migrans, and, if left untreated, the infection can spread to joints, the heart and the nervous system. In the U.S. alone, approximately 476,000 people may get Lyme disease each year, according to recent estimates from the CDC. 

“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,” Annaliesa Anderson, PhD, senior vice president and head of vaccine research & development at Pfizer, said in a statement. “We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial."