Novavax prepares for COVID-19 vaccine launch
The technology behind Novavax’s coronavirus vaccine is different from other products that Australia has ordered. The protein-based candidate contains one element of the virus, a version of the “spike protein” in SARS-CoV-2, and the vaccine delivers this to the body to prompt an immune response.
Unlike mRNA vaccines like Pfizer’s, which must be stored at very low temperatures, Novavax’s product is designed to be more easily stored with standard refrigeration methods.
Novavax’s vaccine is in phase 3 testing in the US and Mexico and the company’s executive vice-president, chief commercial officer and chief business officer John Trizzino says it was preparing to deliver trial data to Australia’s Therapeutic Goods Administration (TGA) as soon as it becomes available.
“We would expect packets of information and rolling submissions to take place in advance of that final data-set in order to accelerate that approval as quickly as possible,” he says.
The company won’t disclose the value of the Australian deal, but Trizzino says Novavax would keep dose pricing consistent across the globe. “We believe that what we do with pricing is going to be fair,” he says.
The health department says it hopes Novavax doses will “be available in Australia as early as the first half of 2021”, though there are several hurdles to jump before this happens.
Meanwhile the TGA, which is working around the clock to secure the first approvals of COVID-19 vaccines, has so far only given ”provisional determinations” to Pfizer, AstraZeneca and Johnson & Johnson.
When asked whether it had received documentation yet from Novavax about its vaccine, a spokesperson said: “Due to the commercial-in-confidence nature of applications for registration of therapeutic goods, the TGA can neither confirm nor deny whether it has received an application for provisional determination from Novavax. If such an application is received and approved, details will be published on the TGA website”.
Griffith University virologist Dr Adam Taylor says because Novavax has only recently launched its 30,000-strong US phase 3 trial, results could be expected from the middle of this year.
According to the government’s national immunisation road map, vaccine rollout will begin with the Pfizer vaccine, followed by AstraZeneca. Dr Taylor says having additional options like Novavax coming through later this year was positive.
“It’s going to be useful to have another string to our bow in the way we manage and treat COVID-19,” he says.
“As we move into this mass vaccination process, we’re going to need a number of candidates to rely on.”
Valued at $US8 ($A10.3) billion, Novavax is a minnow compared to the likes of Pfizer and AstraZeneca. However, US stock analysts have been considering how far the company can go from here.
J.P. Morgan biotechnology analyst Eric Joseph believes Novavax’s vaccine design puts it in a unique position.
“We continue to view NVX-CoV2373 [the vaccine] as well-differentiated in the overall COVID-19 vaccine space, both clinically and logistically, and believe current levels under-reflect its long-term commercial potential.”
It’s a welcome assessment for a company that almost went belly up in 2019, facing the prospect of being delisted from the stock exchange because its share price had been trading below the $US1 mark for too long.
Then COVID-19 hit and amid the chaos of the global pandemic Novavax had better news to share with investors. In March 2020, it announced a late-stage trial for a new kind of flu vaccine had been successful, paving the way for approval.
Its research team was also working on its COVID-19 vaccine, and by July 2020 Novavax had announced it had $US1.6 billion from the US government’s vaccine project Operation Warp Speed to develop the project.
Investors started to take notice. Over the past 12 months, Novavax shares are up 2894 per cent to $US128.18, making it one of the biggest beneficiaries of the vaccine “sugar rush” which has propelled global markets.
Trizzino calls the company’s path to this moment a “fascinating story”, arguing that the company’s previous failures prepared it well for the unpredictability of COVID-19 and the development of a vaccine.
“We know that we learned a tremendous amount 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) sent the Novavax’s share price plummeting 84 per cent to $US1.29.
“But I believe that made us very well prepared for what we encountered in the beginning of 2020,” he says.
Trizzino added “biotech is not for the faint of heart” but that Novavax has shown persistence pays off.
“You pursue your goals, you don’t let your setbacks cause you to stop believing. Where we are with COVID is a perfect example of that.”
Emma reports on healthcare companies for The Age and Sydney Morning Herald. She is based in Melbourne.