Australia Buys 40 Million Coronavirus Vaccine Doses
A Maryland based biotechnology company announced the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community.
Novavax, Inc.’s press statement issued on November 4, 2020, clarified 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.
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. This trial involved 131 Australians across trial sites in 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 USA.
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 Australian community most vulnerable to COVID-19, such as seniors and those with underlying medical conditions.
The vaccine regimen for this phase 3 study is expected to require two doses per individual, administered 21 days apart.
“This arrangement with the Australian Government reflects the importance of the ongoing clinical development of NVX-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.”
To date, Novavax has established various agreements for the supply of NVX-CoV2373 directly to the USA, the United Kingdom, Canada, and through partnerships, supply to Japan, South Korea, and India.
Previously, Novavax was awarded $1.6 billion by the US federal government as part of Operation Warp Speed.
NVX-2373 is a prefusion protein coronavirus vaccine candidate made using Novavax’s proprietary nanoparticle technology, Matrix-M, which is an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.
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