Contract Pharma Staff11.05.20
Novavax Inc., a late stage Biotechnology company developing next-generation vaccines for serious Infectious Diseases , has signed a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the Company’s COVID-19 Vaccine candidate, NVX-CoV2373, for the Australian community.
“This arrangement with the Australian Government reflects the importance of the ongoing clinical development of NVAX-CoV2373, and will ensure that the citizens of Australia will have access to its supply,” said Stanley C. Erck, president and chief executive officer of Novavax. “We are pleased with the progress of our ongoing Phase 3 clinical trial in the UK, and are pressing forward to deliver Efficacy data for NVX-CoV2373, with interim data in this event-driven trial expected as soon as early first quarter 2021.”
The Heads of Terms provides for the delivery of NVX-CoV2373 to Australia starting as early as the first half of 2021, subject to the successful completion of Phase 3 clinical development and approval of the vaccine by Australia’s Therapeutic Goods Administration ( TGA ). The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
To date, Novavax has established various agreements for the supply of NVX-CoV2373 directly to the United States and the United Kingdom, Canada and now Australia, and through partnerships, supply to Japan, South Korea and India.
Australia’s Contribution
Australia has played a pivotal role in the clinical development program for NVX‑CoV2373. Australian clinical researchers led the global Phase 1 clinical trial in August, which involved 131 Australians across two trial sites (Melbourne and Brisbane). In addition, approximately 690 Australians have participated in the Phase 2 arm of the clinical trial, which has been conducted across up to 40 sites in Australia and the U.S.
The planned global Phase 3 clinical programs evaluating NVX-CoV2373 will assess immunity, safety and COVID‑19 disease prevention. The trials seek to recruit members of the community most vulnerable to COVID-19 – the elderly, those with underlying medical conditions as well as diverse racial and ethnic representation.
“This arrangement with the Australian Government reflects the importance of the ongoing clinical development of NVAX-CoV2373, and will ensure that the citizens of Australia will have access to its supply,” said Stanley C. Erck, president and chief executive officer of Novavax. “We are pleased with the progress of our ongoing Phase 3 clinical trial in the UK, and are pressing forward to deliver Efficacy data for NVX-CoV2373, with interim data in this event-driven trial expected as soon as early first quarter 2021.”
The Heads of Terms provides for the delivery of NVX-CoV2373 to Australia starting as early as the first half of 2021, subject to the successful completion of Phase 3 clinical development and approval of the vaccine by Australia’s Therapeutic Goods Administration ( TGA ). The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
To date, Novavax has established various agreements for the supply of NVX-CoV2373 directly to the United States and the United Kingdom, Canada and now Australia, and through partnerships, supply to Japan, South Korea and India.
Australia’s Contribution
Australia has played a pivotal role in the clinical development program for NVX‑CoV2373. Australian clinical researchers led the global Phase 1 clinical trial in August, which involved 131 Australians across two trial sites (Melbourne and Brisbane). In addition, approximately 690 Australians have participated in the Phase 2 arm of the clinical trial, which has been conducted across up to 40 sites in Australia and the U.S.
The planned global Phase 3 clinical programs evaluating NVX-CoV2373 will assess immunity, safety and COVID‑19 disease prevention. The trials seek to recruit members of the community most vulnerable to COVID-19 – the elderly, those with underlying medical conditions as well as diverse racial and ethnic representation.
