Novavax’s Covid-19 vaccine could be a game changer for anti-vaxxers in Australia, across globe

Health Minister Greg Hunt has revealed when Australia will receive the world’s fifth Covid vaccine. What we know and why it could change everything for anti-vaxxers.

The long-awaited Novavax vaccine is expected to be available from the middle of next month as Australia’s drug regulator moves closer to giving it the green light.

Novavax’s Covid jab — which is a traditional protein-based vaccine compared to the Pfizer and Moderna mRNA vaccines — was approved by the European Union this week.

It’s understood the Therapeutic Goods Administration is still seeking extra data from Novavax but is making strong progress towards approving what would be the fifth vaccine for use in Australia.

Health Minister Greg Hunt said: “I’m hopeful that, subject to that data stacking up, that this will be available in January. It’s only worldwide, just going through these regulatory proposals”.

Mr Hunt urged Australians to “take any vaccine as early as possible”.

“We recognise that there are some who, for their own reasons, have said that they would be waiting for the protein vaccine. Don’t wait, but it is nevertheless coming,” he said.

Once Novavax is approved by the TGA, it would then also require the green light from Australia’s expert immunisation panel.

Novavax’s Covid vaccine could turn out to be a game changer for vaccine sceptics.

Nuvaxovid on Monday became the fifth jab to be approved by the EU for adults in the fight against Covid-19. It’s also the first protein-based vaccine enlisted by the Europeans.

Unlike the BioNTech-Pfizer and Moderna jabs that are created using mRNA technology, protein vaccines have been tried and tested for decades.

“Today’s Emergency Use Listing underscores the ongoing need and potential for Novavax to help significantly increase Covid-19 vaccine access across the globe through a protein-based option built on a well-understood platform,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.

“We thank the World Health Organisation for its thorough assessment and look forward to helping address major obstacles to controlling the pandemic, including practical barriers to access and vaccine hesitancy.”

This is what we know about Nuvaxovid:

HOW DOES IT WORK?

Novavax uses a traditional vaccine technology by using purified pieces of the actual SARS-CoV-2 coronavirus spike protein to spur the production of antibodies. Two 0.5ml doses are required 21 days apart.

If a person gets the jab, their immune system recognises the protein as foreign and produces natural defences. The vaccine can not replicate, nor can it cause Covid-19.

Glenda Daza and Emily Degli-Angeli work on samples collected in the Novavax phase 3 Covid-19 clinical vaccine trial in Seattle, Washington. Picture: Getty Images

HOW EFFECTIVE IS IT?

Two trials involving more than 45,000 people in the US, Mexico and the UK resulted in efficacy of about 90 per cent with only mild or moderate side effects.

Novavax said its vaccine was most effective against the original Covid strain, as well as the Alpha variant first detected in the UK.

The company has not conducted studies on the Delta strain.

“There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,” the EMA said.

A phase 3 paediatric trial in the US is also testing up to 3000 adolescents aged 12-17 years.

Novavax said it could start making variant-specific doses from January.

CAN IT CAUSE ADVERSE REACTIONS?

Novavax has said severe reactions are “infrequent and there were no safety concerns related to vaccination”.

The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and malaise.

HOW IS IT STORED?

Novavax’ Covid-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing 10 doses. The vaccine is stored at 2°- 8° Celsius, meaning the shots can be stored at normal refrigerator temperatures, averting the need for the freezers required for some other Covid-19 vaccines.

HOW MUCH IS EUROPE GETTING?

Novavax and the European Commission announced an advance purchase agreement for up to 200 million doses of Novavax’ Covid-19 vaccine in August 2021. Initial doses are expected to arrive in Europe in January. Novavax is working with the European Medicines Agency and its partners to expedite local release testing. Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, which will supply initial doses for the EU.

The vaccine has already received approval for use in Indonesia and the Philippines.

The Novavax vaccine uses a more conventional technology that the biotech firm hopes will reduce vaccine hesitancy. Picture: AFP

WHAT HAPPENS NOW?

Novavax will continue to collect and analyse real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

The company expects to submit its complete common pre-clinical, clinical and chemistry, manufacturing and controls (CMC) package to the US FDA by the end of the year. The brand name Nuvaxovid™ has not yet been authorised for use in the US by the FDA.

Originally published as Novavax’s Covid-19 vaccine could be a game changer for anti-vaxxers in Australia, across globe