COVID-19：ノババックス､英国でＰ３開始：Euro Filing（動画）：
COVID-19: Novavax launches P3 in the UK: in Pursuit of Euro Filing：
COVID-19：Novavax在英国推出P3：追求欧元申报
ノババックスのＰ３：
- 健康成人に限定せず、１８～８４歳を最大１万例を登録する。
- ２１日間隔で２回、筋肉内注射する。
- 主要評価項目は他社と同様に陽性率。
基準とする陽性例数の６７％が報告された時点で、中間解析を行う。
一部の症例では、季節性インフルエンザのワクチンも接種する。
試験結果を見て欧州域内で承認申請する方針。
ノババックスのワクチン：
原薬を、インド血清研究所や富士フイルムの米子会社が、受託製造する。
アジュバント（免疫増強剤）を、ＡＧＣ米子会社が、受託製造する。
来年中ごろ、最大で年２０億回分を生産できるようにする。
日本向けは武田薬品工業が供給する予定。
化学工業日報
https://www.chemicaldaily.co.jp/
Novavax Taps into the $1.6b in U.S. Fed Award to Fund Phase 3 Clinical Trial in the UK in Pursuit of Euro Filing
Novavax Inc.
has progressed their investigational vaccine product for COVID-19 called NVX-CoV2373 to Phase 3 to evaluate the efficacy, safety and immunogenicity of this candidate.
Much of Novavax research occurs outside of the United States.For example,
their Phase 1 trial occurred only in Australia. However, they expanded that study (NCT04368988)to include locations in the United States as well.Their other Phase 2 study (NCT04533399) is managed in South Africa.
Now a Phase 3 study is being conducted in the United Kingdom (UK) in partnership with the UK Government Vaccines Taskforce and
is expected to enroll up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.
Big U.S. Federal Grant with Ties to Vaccine Release in 2020
Novavax made it from small biotech to big time in early July
when the company announced that the U.S. federal government via Operation Warp Speed awarded it $1.6 billion award to support completion of late-stage clinical development, including this Phase 3 clinical trial.The funds
also go toward the establishment of major manufacturing capability and include the delivery of 100 million doses of their experimental vaccine candidate early as late 2020.The UK Study
Gregory M. Glenn, MD, President, Research and Development for the company
suggests that the UK is a good place for rapid completion because of the “…[H]igh level of SARS-CoV-2 transmission observed and expected to continue in the UK,we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy.”
Dr. Glen further elaborated that data generated from this specific trial will be used to support a regulatory filing for ultimate approval and license in the UK, EU and other countries.