Pfizer/Valneva's Vaccine Study For Tick-Borne Infection Completes Primary Vaccination Series, Plans Approval In 2026
Pfizer/Valneva's Vaccine Study For Tick-Borne Infection Completes Primary Vaccination Series, Plans Approval In 2026
On Wednesday, Pfizer Inc (NYSE:PFE) and Valneva SE (NASDAQ:VALN) announced that the participants of the Phase 3 VALOR trial have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15.
辉瑞公司（NYSE：PFE）和Valneva SE（NASDAQ：VALN）周三宣布，第3阶段VALOR试验的参与者已经完成了莱姆病疫苗候选者VLA15的主要接种程序（三剂）。
Lyme disease is a bacterial infection that can be spread to humans by infected ticks.
莱姆病是一种细菌性感染病，可以通过感染蜱传播给人类。
Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.
参与者将在2025年莱姆病季节结束前监测莱姆病病例的发生情况。
"VLA15, the Lyme disease vaccine candidate we are co-developing with Valneva, is the one which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress," said Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer.
“我们与Valneva共同开发的莱姆病疫苗候选者VLA15是目前在临床开发时间轴上取得最大进展的候选者，正在进行两项第III期试验，”辉瑞疫苗研究与开发高级副总裁兼负责人Annaliesa Anderson博士表示。
The Pfizer-sponsored VALOR trial is conducted at sites where Lyme disease is highly endemic across the U.S., Canada, and Europe.
辉瑞赞助的VALOR试验在美国，加拿大和欧洲莱姆病高发地点进行。
The trial aims to evaluate the efficacy, safety, tolerability, immunogenicity, and lot consistency of VLA15, a 6-valent OspA-based Lyme disease vaccine candidate.
该试验旨在评估6价OspA基础的莱姆病疫苗候选者VLA15的疗效，安全性，耐受性，免疫原性和批次一致性。
Trial participants aged five years and older were randomized 1:1 into two trial groups. They received four doses of either VLA15 or a saline placebo – one dose each at months 0, 2, 5-9 and a booster one year after the third dose, shortly before the peak of the next Lyme disease season.
试验参与者年龄在5岁及以上，随机分为两组进行试验。他们在月份0、2、5-9的某个时候和第三剂剂量之后的一年内（在下一个莱姆病高发季节前不久）接受VLA15或生理盐水安慰剂的四剂剂量。
Pfizer plans to submit marketing applications with the FDA and the European Medicines Agency in 2026.
辉瑞计划在2026年向FDA和欧洲药品管理局提交上市申请。
VLA15 has shown a favorable safety profile in all clinical trials across all dose and age groups.
在所有剂量和年龄组的所有临床试验中，VLA15展现出了良好的安全性环境。
An independent Data Safety Monitoring Board (DSMB) has observed no safety concerns in any treatment group to date.
独立的数据安全监控委员会（DSMB）至今未观察到任何治疗组存在安全问题。
A second Phase 3 trial (C4601012) is ongoing, aiming to provide further evidence on the safety profile of VLA15 in the pediatric population between 5 and 17 years of age. The trial completed enrollment in June 2023.
第二个第III期试验（C4601012）正在进行中，旨在为5到17岁儿童人群的VLA15安全性证明提供进一步证据。该试验已于2023年6月完成入组。
Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.
辉瑞和Valneva于2020年4月签署了一份合作协议，共同开发VLA15，并于2022年6月更新了该协议条款。
Price Action: At last check Thursday, VALN stock was down 0.46% at $7.70, and PFE stock was up 0.50% at $30.18.
股价走势：本周四最新数据显示，VALN股票下跌0.46％至7.70美元，PFE股票上涨0.50％至30.18美元。
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Image via Unsplash
图片来源：Unsplash