Pfizer and its partner Valneva announced that their Lyme disease vaccine did not meet the target in a clinical trial, although the companies are still seeking its approval.
According to the companies, the “fact that the 95% confidence interval lower bound was above 20 in the second pre-specified analysis” gave Pfizer confidence in the inoculation.
“Lyme disease can cause potentially serious consequences – where individuals and families face symptoms that can disrupt daily life, work, and long-term health – and there is currently no vaccine available,” said Annaliesa Anderson, Pfizer’s Senior Vice President and Chief Vaccines Officer. “The efficacy shown in the VALOR study of more than 70% is highly encouraging and creates confidence in the vaccine’s potential to protect against this disease that can be debilitating.”
Thomas Lingelbach, CEO and Board member of Valneva, said the results “bring us a step closer to our goal of delivering a much-needed vaccine to help protect against Lyme disease. We are grateful to our partner Pfizer for their strong commitment which we both share in developing this vaccine as quickly as possible.”
In 2022, Pfizer tested its Lyme disease vaccine on children. The VLA15 vaccine is a multivalent protein subunit vaccine,” targeting “the outer surface protein A (OspA) of Borrelia,” the bacteria which causes Lyme disease, Pfizer said. Its Phase 2 study included adult subjects and children 5 to 17 years old. Overall, 600 healthy participants were enrolled in the study.
“VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies,” Pfizer said.
