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Lyme vaccine enters US Phase 3 clinical trials

By Evan Taylor Aug 15, 2022 | 11:18 AM

John Tann / CC

A Lyme disease vaccine is being developed by Pfizer in partnership with Valneva SC and is making progress in the United States as it’s now set to begin Phase 3 clinical trials.

The vaccine known as VLA15 will now be put into trials designed to test its efficacy, safety, and immunogenicity.

“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, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “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.”

At this point, Pfizer has not publicized any plans for testing in Canada.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are extremely pleased to reach this important milestone in the development of VLA15. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere. 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.”

Phase 3 US testing will see 6,000 participants aged 5 and up trial the vaccine, they will be selected from regions across the world that have a high prevalence of Lyme, including; Finland, Germany, the Netherlands, Poland, Sweden and the United States.

Phase 2 trials produced results that showed strong immunogenicity in adults as well as in children, with acceptable side effects.

Pfizer has said that should Phase 3 trials prove successful they could submit the vaccine for approval by the US FDA by 2025.



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