COVID-19：Novavax在英国推出P3：追求欧元申报
新星雄鹿P3：
不仅限于健康的成年人，将登记多达10,000个年龄在18至84岁之间的病例。
每隔21天进行两次肌肉注射。
主要终点是阳性率，类似于其他公司。
当报告67％的参考阳性病例时，将进行中期分析。
在某些情况下，还会提供季节性流感疫苗。
该政策是根据测试结果在欧洲内部申请批准。
新星雄鹿疫苗：
原料药是由印度血清研究所和Fujifilm的美国子公司按合同制造的。
AGC美国子公司以合同形式生产佐剂（免疫增强剂）。
到明年年中，将有可能每年生产20亿次。
武田制药有限公司将向日本供货。
化工日报
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.