Novavax plans to trial combined flu and COVID super jab in Australia

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Novavax is yet to confirm when it expects to complete applications to get its coronavirus vaccine approved in Australia, but the biotech is already planning new local research into a combined influenza and COVID-19 shot.

The vaccine developer has again pushed out timelines for the approval of its vaccines in the US. It told investors on an earnings call overnight it now expects to file for emergency use approval with the Food and Drug Administration during the last three months of this year.

Australia has 51 million doses of Novavax’s COVID-19 vaccine on order.

The US biotech said it would seek emergency use approvals in India, Indonesia and the Philippines, while also continuing to prioritise approval from Britain’s medicines regulator, which is expected in September.

Submissions for approvals in Australia, New Zealand and Canada will happen “within weeks of the [UK] filing”, chief executive Stan Erck said, but no specific timelines have been outlined.

Australia still has more than 50 million doses of Novavax’s vaccine on order, though the product is shaping up to be a broader part of the country’s booster strategy, with the first doses only expected to flow at the end of this year at the earliest.

Novavax is now aiming to be a world-leader for booster shots across the globe. While it has not yet received approvals for its COVID-19 vaccine, it is already working on a new combined coronavirus and influenza shot that could be rolled out across the globe for annual use.

Novavax released details of pre-clinical studies for the vaccine back in May, which demonstrated in a study with hamsters that the vaccine produced an immune response for both SARS-CoV-2 and influenza.

In a statement on Friday morning, the company said it expects “to initiate [a] Phase 1 clinical trial in Australia later this year”.

Australia has already been key to Novavax’s development of its standalone COVID-19 vaccine, with an ongoing US-Australian study applying the initial two doses to local volunteers and then giving certain participants boosters.

Mr Erck told analysts that the company now expects to provide initial vaccinations to lower income countries outside the United States and hopes to become the “booster of choice” for higher income countries that have already received initial doses.

He said looking beyond 2022, Novavax’s product looks well positioned to “become the universal booster of choice and the preferred vaccine for annual re-vaccination”.

Novavax’s share price is up 41 per cent over the past 12 months but the company’s earnings update, which came after the US market closed on Thursday, may have spooked investors.

The stock finished 5.5 per cent higher on Thursday but dipped 9.8 per cent in after-hours trade to $US213.07.

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