Bringing Novavax to Australia’s COVID-19 vaccine rollout

Sydney-based sister companies Biointelect and Biocelect have been a driving force in the rollout of the Novavax COVID-19 vaccine in Australia. Here’s more on their contribution.

NSW’s high-quality research, clinical trial infrastructure, and skilled workforce in the pharmaceutical industry have made it a strong player in bringing Novavax to Australian shores, with NSW Health’s Office for Health and Medical Research connecting companies and helping them navigate the state’s health ecosystem.

In a pandemic, time is of the essence. In just two years, Australia has approved 4 COVID-19 vaccines, with Novavax being the latest addition to the rollout. In February 2022, the first batch of Novavax’s protein-based vaccine landed in general practices, community pharmacies, and state-run workplaces and vaccination clinics.

The Novavax COVID-19 vaccine, or Nuvaxovid^TM, was provisionally approved by the Therapeutic Goods Administration (TGA) in January 2022 for use in people aged 18 years and over, making it the first protein-based COVID-19 vaccine to receive regulatory approval in Australia. By early March, the Australian Technical Advisory Group on Immunisation (ATAGI) permitted Nuvaxovid to be used as a booster for Australians aged 18 years and over where no other vaccine is suitable. Adding a protein-based vaccine option to Australia’s COVID-19 vaccine portfolio offers more choices to those who may not be immunised or boosted.

“The ability to get a vaccine approved in just under 2 years is a really tremendous achievement,” says Karl Herz, who heads Sydney-based Biocelect, sponsor for Novavax’s COVID-19 vaccine in Australia and New Zealand. “The level of collaboration across industry and government has been equally unprecedented.”

Biocelect and sister company Biointelect were well positioned to bring Novavax’s COVID-19 vaccine to Australia. Run by husband-and-wife team Jenny and Karl Herz, the 2 companies have been supporting Novavax since 2014. “They know us well and what our capabilities are,” says Jenny Herz.

Before the COVID-19 pandemic gripped the world, Novavax had already built a strong track record in developing vaccines for other respiratory diseases, such as influenza, respiratory syncytial virus (RSV), and Middle East respiratory syndrome (MERS). These earlier efforts created a solid foundation for developing a COVID-19 vaccine quickly, says Jenny. “Importantly, they already knew how to make a coronavirus vaccine,” she says. “They had a platform technology that could be adapted.”

Biocelect offers services for companies without a presence in Australia and supported Novavax as the company brought the vaccine out of the lab and into arms every step of the way. In May 2020, ATAGI were notified that Novavax had a candidate COVID-19 vaccine that was undergoing clinical trials in Australia. This prompted negotiations between Novavax and the Australian Government for an advance purchase agreement. Six months later, the Australian Government committed to purchasing doses of Nuvaxovid once the vaccine had been shown to be safe and effective in clinical trials that were underway.

By January 2021, Biocelect commenced the local registration process, which involved sharing clinical trial data with the TGA at a rapid pace. “What’s been different about pandemic products is that there is a rolling submission process,” says Jenny. “Instead of waiting until you’ve got all of the data in one big file, you send tranches of data as they ‘come off the press’.” Biocelect also collects and reports safety data on Novavax to regulatory authorities.

Making Novavax a part of the vaccine rollout has been a collaborative effort. For instance, Biocelect worked with logistics company DHL to set up systems and processes to ship the vaccine safely. It has also collaborated with other small- and medium-sized enterprises in Australia, including government relations consultancy Nexus APEC and health and communications consultancy Cube (both based in Sydney), and Melbourne’s 360biolabs and Nucleus Network, to get Novavax into clinics.

Since the beginning of the pandemic, Australia has played an important role in the development of Nuvaxovid with several Phase 1 and Phase 2 clinical trials that have included nearly 1500 participants across the country. Of the 16 sites for Novavax clinical trials in Australia, 8 are in NSW, run by research institutes such as UNSW Sydney’s Scientia Clinical Research (SCR) in Randwick and Paratus Clinical in Blacktown. NSW’s high-quality research, clinical trial infrastructure, and skilled workforce in the pharmaceutical industry have made it a strong player in bringing Novavax to Australian shores, with NSW Health’s Office for Health and Medical Research connecting companies and helping them navigate the state’s health ecosystem, says Jenny.

With the duration of the pandemic remaining uncertain, Biointelect and Biocelect hope to establish a long-term presence for Novavax in Australia and New Zealand. Clinical trials are already underway across the country to further explore Novavax’s potential as a booster, along with another trial on a combination seasonal influenza and COVID-19 vaccine. “It all comes down to teamwork, collaboration, and communication,” says Jenny.