Novavax，Fujifilm锁定了后期COVID-19疫苗试验的供应
马里兰生物技术Novavax
在本月特朗普政府的一次大输液中，在寻找COVID-19疫苗的过程中大获全胜。
现在，Novavax
正在使用其中的一些资金来帮助提供关键剂量的后期试验。
富士胶片薯yn生物技术
根据周四签署的一项制造协议，它将为诺瓦瓦克斯（Novavax）的COVID-19候选疫苗的第三阶段试验提供临床供应。
富士胶卷
两家公司在一份联合声明中表示，已经开始在北卡罗来纳州莫里斯维尔的工厂生产散装原料药。
给美国患者的疫苗。
这项安排将由特朗普政府的“扭曲速度”计划提供16亿美元的资助，
旨在迅速开发可分发的COVID-19疫苗并将其分发给美国患者。
Novavax计划
使用政府资金资助第三阶段，涉及多达30,000名患者
并迅速扩大制造规模，到2020年底将生产1亿剂。
富士胶片协定
是Novavax签署的第一个可以弥补特朗普政府首期付款的条件。
Novavax有望在几周内读出其疫苗的1期临床数据，并可能在此后立即进入2期测试。
激烈的制药
Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate
Gaithersburg, MD and Morrisville, NC,
July 23, 2020
Novavax, Inc. (NASDAQ: NVAX),
a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases,
and
FUJIFILM Diosynth Biotechnologies (FDB),
a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies,
announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate.
FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.
Operation Warp Speed (OWS)
This arrangement falls under Novavax’ recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS),
a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population.
The OWS funding
is being used by Novavax to complete late-stage clinical development, including
a pivotal Phase 3 clinical trial;
establish large-scale manufacturing;
and deliver 100 million doses of NVX CoV2373 beginning as early as late 2020.
NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and includes Novavax’ proprietary Matrix M™ adjuvant.
The batches
produced at the FDB site in North Carolina will be utilized in a future pivotal Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020
and which will determine the safety and efficacy of NVX-CoV2373.
Fujifilm Global