COVID-19：富士フイルム､ワクチン原薬製造受託：Novavax３万人分（動画）：
Novavax, Fujifilm lock up supply for late-stage COVID-19 vaccine trial：
Novavax，Fujifilm锁定了后期COVID-19疫苗试验的供应
COVID-19：
米政府より新型コロナウイルス感染症ワクチン候補の原薬製造を受託
米国テキサス拠点での生産を決定 |
FUJIFILM Diosynth Biotechnologies：
- 富士フイルムの完全子会社
- バイオ医薬品*1の開発・製造（CDMO）
FUJIFILM Diosynth Biotechnologies（FDB）が、新型コロナウイルス感染症ワクチン候補の原薬の製造受託を拡大します。
すでに、COVID-19ワクチン候補の原薬を製造している米国ノースカロライナ拠点に続き、
米国テキサス拠点でも同ワクチン候補の原薬製造を開始する計画です。
NVX-CoV2373：原薬製造受託
2020年7月、米国バイオ企業Novavax, Incから、原薬製造を受託。
2020年の秋、30,000人の第Ⅲ相試験に向けた、COVID-19ワクチン「NVX-CoV2373」の原薬製造受託です。
米国ノースカロライナ拠点にて「NVX-CoV2373」の原薬製造を開始しています。
富士フイルム [日本]
https://www.fujifilm.com/jp/ja/news/list/5252
Novavax, Fujifilm lock up supply for late-stage COVID-19 vaccine trial
Maryland biotech Novavax
scored a big leg up in its hunt for a COVID-19 vaccine with a major infusion from the Trump administration this month.
Now, Novavax
is using some of those funds to help supply doses of its shot for a pivotal late-stage trial down the road.
Fujifilm Diosynth Biotechnologies
will churn out clinical supply for a phase 3 trial of Novavax’s COVID-19 vaccine candidate expected to begin in the fall, according to a manufacturing pact signed Thursday.
Fujifilm
has already begun manufacturing bulk drug substance for the shot at its Morrisville, North Carolina, facility, the companies said in a joint release.
vaccines to U.S. patients.
The arrangement will be funded through a $1.6 billion grant from the Trump administration Warp Speed initiative,
which aims to rapidly develop and distribute workable COVID-19 vaccines to U.S. patients.
Novavax plans
to use the government funding to finance a phase 3 involving up to 30,000 patients
and rapidly scale manufacturing to produce 100 million doses of the shot by the end of 2020.
The Fujifilm pact
is the first Novavax has signed to make good on the Trump administration’s down payment.
Novavax is set to read out phase 1 clinical data for its vaccine within weeks and could roll into phase 2 testing immediately after that.
FiercePharma
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