Novavax and Australian Government announce COVID-19 vaccine agreement

Biotech News: Novavax, a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced the signing of 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.

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 two trial sites (Melbourne and Brisbane).

Dr Paul Griffin, Director of Infectious Diseases at Mater Health Services, Associate Professor at University of Queensland School of Medicine and Mater Research Institute, was the Australian lead clinical trial investigator.

“The agreement with Novavax represents another very important vaccine option selected by the Federal Government to protect Australians in the future. What’s critical is to have a number of different options which will allow Australia to remain on the front foot in the battle against COVID-19.

“We must also acknowledge the significant role Australians have played in Phase 1 and 2 clinical trials of the Novavax vaccine together with the clinical trial teams. I look forward to seeing the results of the Phase 3 studies in early 2021. Today we should be feeling more hopeful and positive about our future here in Australia,” he said.

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.

“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.”

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.

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.

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising
antibodies.

Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

Novavax is progressing large-scale manufacturing of NVX-CoV2373 across multiple locations around the world. Delivery of initial doses of the vaccine
is expected as early as the end of this year, with the goal to expand the production to enable delivery of over 2 billion doses annually, once all
production is online.