Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet

Saint-Herblain (France), June 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the Company’s pivotal Phase 3 data for its single-shot chikungunya vaccine candidate, VLA1553, have been published in The Lancet , the world’s leading peer-reviewed medical journal.

The article, titled “Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicenter, randomized, placebo-controlled phase 3 trial” provides a detailed analysis of the Phase 3 results showing that VLA1553 demonstrated a very high seroresponse rate of 98.9% in participants 28 days after receiving the single administration. This immunogenicity profile was similar in both younger and older adults, and 96% of participants maintained seroresponse six months after vaccination. VLA1553 was generally safe and equally well tolerated in younger and older adults. The Lancet Paper can be accessed via the following link: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)006 ....

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This publication in the Lancet underlines the strength of VLA1553’s scientific approach and is consistent with the quality of our pivotal Phase 3 study. We are pleased that more detailed results on our single-shot chikungunya vaccine candidate are now available to the scientific and broader public health communities.”

Valneva reported final pivotal Phase 3 data in March 2022¹, final lot-to-lot consistency results in May 2022² and positive twelve-month persistence data in December 2022³. A clinical study of VLA1553 in adolescents is ongoing in Brazil⁴, for which Valneva reported enrollment and vaccination completion in February 2023⁵.

VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. A Biologic License Application (BLA) is currently under priority review⁶ by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) review goal date at the end of August 2023, and a regulatory application has also been filed with Health Canada. If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.