Novavax protein-based COVID-19 vaccine receives TGA approval

Melbourne, Australia, Thursday 20th January, Novavax’s NUVAXOVID, one of the most anticipated COVID-19 vaccines under development, has now received approval for use in Australia by the Therapeutic Goods Administration (TGA). This is the first protein COVID-19 vaccine to receive regulatory approval in Australia.

This protein vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent COVID-19 in individuals 18 years of age and older. It is recommended that the vaccine is given in 2 doses administered 3 weeks apart.

This comes as the rollout of the COVID-19 vaccines continues throughout the country to combat the Delta and Omicron strains of the virus, with many people expected to receive their third (booster) dose.

Novavax has already received approval from the World Health Organization (WHO) and the European Medicines Agency (EMA) has started distributing doses of their vaccine in several countries, including the Philippines and Indonesia, and is one of the four key vaccines ordered by the Australian Government. Novavax and the Australian government announced an advance purchase agreement for 51 million doses of Novavax's COVID-19 vaccine in January 2021. The first shipment to Australia of the Novavax vaccine is expected in the coming month.

Australians can be confident that the TGA's review process of NUVAXOVID was rigorous. The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.

Australian contribution

In May 2020, Australia’s largest Phase 1 Clinical trials specialist, Nucleus Network, commenced dosing the first human participants for the Phase 1/2 trial of NVX‑CoV2373, the SARS-CoV-2 Recombinant Spike Protein Nanoparticle vaccine, at its Melbourne and Brisbane clinics.

“Approximately 200 healthy participants, aged 18 to 59 years of age, in Melbourne and Brisbane put their hands up to take part in of the Novavax trial,” says Cameron Johnson, CEO of Nucleus Network. “Those participants were an important part of the process in ensuring the vaccine was both safe and effective. They can be justifiably proud of their participation, and we are very thankful for their contributions,” he adds.

“The fact that Australia was selected to host the first-in-human trial also reflects well on the quality and reliability of the medical research sector in our country, as well as the support that has been provided by the Federal and State Governments throughout this process.”

Novavax has been equally appreciative of the role that participants and clinical trial administrators have played in helping this vaccine gain approval.

"We thank the Australian clinical trial participants and trial sites, as well as the regulatory and vaccine experts, for their assistance and contribution to this vaccine program." Said Stanley C. Erck, President and Chief Executive Officer, Novavax.

Australia has played a pivotal role in the Phase 1 and Phase 2 clinical trials supporting the development of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant.

“Nucleus Network has played a pivotal role in development of COVID-related vaccine and treatment trials, having conducted more than ten COVID-related trials in the past two years at our Brisbane, Melbourne and Minneapolis sites.”

A traditional vaccine

“A key difference with this vaccine in comparison to other available options is that it is a protein-based option,” says Nucleus Network Principal Investigator, infectious diseases physician and clinical microbiologist, Associate Professor Paul Griffin “It’s an older type of vaccine technology, but the way these types of vaccines work is very well understood from decades of study and research.”

Associate Professor Griffin also suggests there may be the potential for this vaccine to address the hesitation of some people to receive the vaccine.

“While the data strongly supports that all of the vaccines available in Australia are well understood, safe to use and effective in combating COVID-19 and the known variants, the fact that this vaccine is made using a more traditional method may be comforting to many people,” says Griffin.

“While I, myself was happy to have the Astra-Zeneca vaccine, and many of my co-workers have had the Pfizer or Moderna vaccines and boosters, I believe that this addition will help us as a nation push our vaccination rate even higher and help us protect the most vulnerable and high-risk groups from this disease.”

Delta, Omicron and emerging variants

As with many respiratory viruses, COVID-19 is mutating into variants at an unpredictable rate. While the severity and transmissibility of each variant requires time to understand, early data suggests the Novavax vaccine will continue to provide protection to those who receive the full schedule of vaccine doses.

"In the midst of an evolving pandemic, NVX-CoV2373 showed strong immune responses against Omicron and other circulating variants,” said Gregory M. Glenn, President of Research and Development, Novavax. “We are encouraged that boosted responses against all variants were comparable to those associated with high vaccine efficacy in our Phase 3 clinical trials, suggesting that NVX-CoV2373 can play an important role in the ongoing fight against new variants. Given the continued evolution of the coronavirus, the development of an Omicron vaccine could be necessary. Novavax has cloned, expressed and characterized the Omicron spike protein vaccine and will soon enter the GMP-phase of production. We expect to begin clinical studies in the first quarter of 2022."

Additional booster trials and a Phase 1/2 trial for a combination vaccine using Novavax' seasonal influenza and COVID-19 vaccine are also underway in Australia, investigating the suitability of combining Novavax’s vaccine with the yearly flu shot.