Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15 9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic Trial conclusion expected by year-end 2025Pfizer aims to submit regulatory filings in the U.S.

辉瑞公司和Valneva完成了莱姆病候选疫苗3期VALOR试验的招募，VLA15 9437*参加者参加了美国，欧洲和加拿大莱姆病流行地区的试验。结论预计到2025Pfizer年底，美国将提交监管文件。

and Europe in 2026 New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15.

2026年12月4日，纽约州纽约市和法国圣赫布拉因-辉瑞公司（纽约州：辉瑞公司）和Valneva SE（纳斯达克股票代码：VALN；Euronext巴黎：VLA）今天宣布他们已经完成招募用于莱姆病候选疫苗VLA15的户外娱乐（VALOR）（NCT05477524）针对莱姆病的3期试验疫苗。

The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15. “We are pleased that the Phase 3 trial recruitment is complete. Lyme disease is the most prevalent vector-borne infectious disease in the United States and Europe, can sometimes even lead to long lasting consequences,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer.

该试验建立在以前的阳性1期和2期试验结果的基础上，包括成人和儿科参与者，目的是确认VLA15的有效性，安全性，批次一致性和免疫原性。“我们很高兴第三阶段的试验招募已经完成，莱姆病是美国和欧洲最普遍的媒介传播传染病，有时甚至会导致长期的后果，”辉瑞公司高级副总裁兼疫苗研发主管Annaliesa Anderson博士说。

“If approved, a vaccine could prevent the disease and ease the burden of acute, severe and sometimes persistent consequences in both adults and children. We look forward to progressing the trial with the goal of submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive data.” Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said: “The completion of enrollment is indeed an important milestone in the development of a potential vaccine for Ly.

“如果获得批准，疫苗可以预防这种疾病，减轻成人和儿童急性，严重和有时持续后果的负担。我们期待着向美国提交生物制剂许可证申请（BLA）的试验进展。食品和药物管理局（FDA）和欧洲药品管理局（EMA）的上市许可申请（MAA）在2026年，获得了积极的数据。”Valneva首席医疗官Juan Carlos Jaramillo M.D.表示：“入学完成确实是开发Ly潜在疫苗的重要里程碑。

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