Provisionally approved Novavax vaccine has ties to Gates, CEPI and the WHO

The head of the TGA, Professor John Skerritt (left) and health minister Greg Hunt announce provisional approval for the NUVAXOVID trial

Multibillion-dollar US vaccine maker Novavax has selected local Sydney biotech company, Biocelect to help plan its Australian rollout of the new NUVAXOVID vaccine.

Founded in 2014, Biocelect, which has only 22 staff, will assist Novavax with delivering data on the NUVAXOVID trials to the regulator.

Despite Novavax never bringing a vaccine to market in its 33-year history, a deal has been finalised with the company and the Australian government for 51 million doses of the NUVAXOVID vaccine, which is currently undergoing phase III trials in the United States and Mexico.

Australian experts stated the company could play a pivotal role in curbing the COVID-19 pandemic after the Therapeutic Goods Administration (TGA) last week granted provisional approval only, paving the way for the company to start the trial, and applying to register the product in Australia.

According to the TGA's website, NUVAXOVID is provisionally approved only for primary vaccination, with studies for use of NUVAXOVID as a booster dose and in paediatric patients ongoing with the vaccine not having regulatory approval for these purposes at this stage.

"The Novavax vaccine has received conditional marketing authorisation by the European Medicines Agency, and the World Health Organisation has issued an emergency use listing for the vaccine," the website states.

The NUVAXOVID vaccine will be the first protein-based COVID-19 shot and was recommended by the European Medicines Agency after the World Health Organisation (WHO) granted the vaccine 'emergency-use status'.

Novavax Inc. was the recipient of a $15,000,000 grant in July 2020 from the Bill and Melinda Gates Foundation, to "evaluate the safety, immunogenicity, and potential efficacy of a candidate vaccine to prevent COVID-19 infection and/or disease in the South African population".

In September, 2015, a further grant was awarded to Novavax from the Bill and Melinda Gates Foundation for $82,553,834 with another in October 2015, for $89 million Novavax was also granted $89 million from the Bill & Melinda Gates Foundation to conduct clinical trials of a vaccine for respiratory syncytial virus (RSV).

The Gates' Foundations latest donation was $150 million to the Coalition for Epidemic Preparedness Innovations (CEPI) to fund its COVID-19 pandemic response for future major health crises.

On the back of Gates' commitment, the UK government committed to raising $3.5 billion for CEPI who has announced a five-year strategy to expedite the development of vaccine to as little as 100 days.

"The unprecedented spread of the highly infectious Omicron variant around the world over the past two months exemplifies the ways in which we must be ready both in terms of speed and the scale of our response to future threats," CEPI Chief Executive Richard Hatchett told reporters in a briefing on Tuesday.

"We must endeavour to take pandemic threats off the table if we can," he said.

All three of the current vaccine classes – mRNA, viral vector and Novavax – are based on the immune systems response to a particular protein on the surface of the coronovirus – the so-called “spike” protein, which binds to receptors on the surface of target cells at the start of the process through which the virus makes its entrance.

For both the mRNA vaccines and the viral vector vaccines, the mechanisms of our cells are utilised to produce analogues of these spike proteins 'in situ'.

The Novavax vaccine differs in using the protein itself as the vaccine's active ingredient. It’s synthesised in bioreactors by using a genetically engineered insect virus, which is used to infect a culture of cells from a moth caterpillar.

The infected cells are harvested and the spike proteins collected and formulated.

Challenges however remain around the Novavax vaccine due to a lack of fundamental understanding regarding the in vivo behavior of nanoparticles, which can operate as either a delivery system to enhance antigen processing and/or as an immunostimulant adjuvant to activate or enhance immunity.

The Novavax trial is ongoing.