Novavax prepares for COVID-19 vaccine launch


The know-how behind Novavax’s coronavirus vaccine is completely different from different merchandise that Australia has ordered. The protein-based candidate comprises one component of the virus, a model of the “spike protein” in SARS-CoV-2, and the vaccine delivers this to the physique to immediate an immune response.

In contrast to mRNA vaccines like Pfizer’s, which should be saved at very low temperatures, Novavax’s product is designed to be extra simply saved with commonplace refrigeration strategies.

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Novavax’s vaccine is in part three testing within the US and Mexico and the corporate’s govt vice-president, chief business officer and chief enterprise officer John Trizzino says it was getting ready to ship trial information to Australia’s Therapeutic Items Administration (TGA) as quickly because it turns into obtainable.

“We’d anticipate packets of data and rolling submissions to happen prematurely of that remaining data-set with a view to speed up that approval as shortly as doable,” he says.

The corporate will not disclose the worth of the Australian deal, however Trizzino says Novavax would hold dose pricing constant throughout the globe. “We imagine that what we do with pricing goes to be honest,” he says.

The well being division says it hopes Novavax doses will “be obtainable in Australia as early as the primary half of 2021”, although there are a number of hurdles to leap earlier than this occurs.

In the meantime the TGA, which is working across the clock to safe the primary approvals of COVID-19 vaccines, has to this point solely given ”provisional determinations” to Pfizer, AstraZeneca and Johnson & Johnson.

When requested whether or not it had acquired documentation but from Novavax about its vaccine, a spokesperson mentioned: “As a result of commercial-in-confidence nature of functions for registration of therapeutic items, the TGA can neither affirm nor deny whether or not it has acquired an software for provisional dedication from Novavax. If such an software is acquired and accepted, particulars might be printed on the TGA web site”.

Griffith College virologist Dr Adam Taylor says as a result of Novavax has solely not too long ago launched its 30,000-strong US part three trial, outcomes could possibly be anticipated from the center of this 12 months.

Secretary of the Department of Health Professor Brendan Murphy, Health Minister Greg Hunt and Chief Medical Officer Professor Paul Kelly  during a press conference on the COVID-19 vaccine road map on Thursday.

Secretary of the Division of Well being Professor Brendan Murphy, Well being Minister Greg Hunt and Chief Medical Officer Professor Paul Kelly throughout a press convention on the COVID-19 vaccine highway map on Thursday. Credit score:Alex Ellinghausen

In line with the federal government’s nationwide immunisation highway map, vaccine rollout will start with the Pfizer vaccine, adopted by AstraZeneca. Dr Taylor says having extra choices like Novavax coming by later this 12 months was constructive.

“It’s going to be helpful to have one other string to our bow in the best way we handle and deal with COVID-19,” he says.

“As we transfer into this mass vaccination course of, we’re going to want a variety of candidates to depend on.”

Valued at $US8 ($A10.three) billion, Novavax is a minnow in comparison with the likes of Pfizer and AstraZeneca. Nonetheless, US inventory analysts have been contemplating how far the corporate can go from right here.

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J.P. Morgan biotechnology analyst Eric Joseph believes Novavax’s vaccine design places it in a novel place.

“We proceed to view NVX-CoV2373 [the vaccine] as well-differentiated within the total COVID-19 vaccine house, each clinically and logistically, and imagine present ranges under-reflect its long-term business potential.”

It is a welcome evaluation for an organization that nearly went stomach up in 2019, dealing with the prospect of being delisted from the inventory alternate as a result of its share worth had been buying and selling under the $US1 mark for too lengthy.

Then COVID-19 hit and amid the chaos of the worldwide pandemic Novavax had higher information to share with traders. In March 2020, it introduced a late-stage trial for a brand new sort of flu vaccine had been profitable, paving the best way for approval.

Its analysis staff was additionally engaged on its COVID-19 vaccine, and by July 2020 Novavax had introduced it had $US1.6 billion from the US authorities’s vaccine mission Operation Warp Pace to develop the mission.

Traders began to take discover. Over the previous 12 months, Novavax shares are up 2894 per cent to $US128.18, making it one of many greatest beneficiaries of the vaccine “sugar rush” which has propelled world markets.

Trizzino calls the corporate’s path to this second a “fascinating story”, arguing that the corporate’s earlier failures ready it effectively for the unpredictability of COVID-19 and the event of a vaccine.

“We all know that we realized an amazing quantity from our failures and we weathered the storm with our RSV vaccine,” he says. In 2016, the failure of a late-stage trial for a vaccine for respiratory syncytial virus (RSV) despatched the Novavax’s share worth plummeting 84 per cent to $US1.29.

“However I imagine that made us very effectively ready for what we encountered to start with of 2020,” he says.

Trizzino added “biotech is just not for the faint of coronary heart” however that Novavax has proven persistence pays off.

“You pursue your targets, you don’t let your setbacks trigger you to cease believing. The place we’re with COVID is an ideal instance of that.”

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