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.
輝瑞公司（NYSE：PFE）和Valneva SE（NASDAQ：VALN）週三宣佈，第3階段VALOR試驗的參與者已經完成了萊姆病疫苗候選者VLA15的主要接種程序（三劑）。
Lyme disease is a bacterial infection that can be spread to humans by infected ticks.
萊姆病是一種細菌性感染病，可以通過感染蜱傳播給人類。
Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.
參與者將在2025年萊姆病季節結束前監測萊姆病病例的發生情況。
"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.
“我們與Valneva共同開發的萊姆病疫苗候選者VLA15是目前在臨床開發時間軸上取得最大進展的候選者，正在進行兩項第III期試驗，”輝瑞疫苗研究與開發高級副總裁兼負責人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.
輝瑞贊助的VALOR試驗在美國，加拿大和歐洲萊姆病高發地點進行。
The trial aims to evaluate the efficacy, safety, tolerability, immunogenicity, and lot consistency of VLA15, a 6-valent OspA-based Lyme disease vaccine candidate.
該試驗旨在評估6價OspA基礎的萊姆病疫苗候選者VLA15的療效，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.
試驗參與者年齡在5歲及以上，隨機分爲兩組進行試驗。他們在月份0、2、5-9的某個時候和第三劑劑量之後的一年內（在下一個萊姆病高發季節前不久）接受VLA15或生理鹽水安慰劑的四劑劑量。
Pfizer plans to submit marketing applications with the FDA and the European Medicines Agency in 2026.
輝瑞計劃在2026年向FDA和歐洲藥品管理局提交上市申請。
VLA15 has shown a favorable safety profile in all clinical trials across all dose and age groups.
在所有劑量和年齡組的所有臨床試驗中，VLA15展現出了良好的安全性環境。
An independent Data Safety Monitoring Board (DSMB) has observed no safety concerns in any treatment group to date.
獨立的數據安全監控委員會（DSMB）至今未觀察到任何治療組存在安全問題。
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.
第二個第III期試驗（C4601012）正在進行中，旨在爲5到17歲兒童人群的VLA15安全性證明提供進一步證據。該試驗已於2023年6月完成入組。
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.
輝瑞和Valneva於2020年4月簽署了一份合作協議，共同開發VLA15，並於2022年6月更新了該協議條款。
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.
股價走勢：本週四最新數據顯示，VALN股票下跌0.46％至7.70美元，PFE股票上漲0.50％至30.18美元。
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Image via Unsplash
圖片來源：Unsplash