Novavax says it can’t confirm how many of Australia’s 51 million contracted doses will arrive in the country this year due to delays in the manufacturing process.
The company’s vaccine is meant to play a role in Australia’s plan to use booster shots to battle COVID variants.
The news of its delay came as Health Minister Greg Hunt urged Australians to get vaccinated with the current stock of vaccines as soon as possible, warning older people “if you catch COVID, you could die”.
The federal government had previously anticipated several million Novavax doses would arrive in Australia by October.
But it is now unclear when we will see the first shipments of the promising vaccine, or even when the company will apply for Australian regulatory approval.
“Given the number of variables, we’re not providing specific estimates on the number of doses that will be delivered by the end of 2021,” a Novavax spokesperson told The New Daily.
What is Novavax?
Novavax, a biotech company based in the US state of Maryland, has been tipped by many public health experts as having among the most promising COVID vaccines on the market.
Clinical trial results from the United Kingdom in March found it had a 96 per cent efficacy rate against the original coronavirus strain, comparable to Moderna or Pfizer.
It also scored 86 per cent against the UK strain and 55 per cent against the South African variant, which is higher than many other vaccines.
Novavax’s is a two-dose ‘protein-based’ vaccine, known as NVX-CoV2373.
It is thought Novavax may be especially well suited as a booster shot, after someone has received two doses of another vaccine, such as Pfizer or AstraZeneca.
Just two weeks ago, Mr Hunt said Moderna and Novavax would be Australia’s “two main options” for the government’s booster and variant strategy in 2022, but manufacturing issues overseas have seen Novavax play down expectations of when the first doses may arrive in Australia.
The company recently told investors it was “delayed from where we thought we’d be”, citing shortages of raw materials and production issues, but it further dampened expectations in comments to TND.
When will Australia get Novavax?
Novavax is undergoing a ‘rolling review’ by Australia’s Therapeutic Goods Administration but has not been officially approved.
The company spokesperson said they were unable to say when official paperwork would even be lodged for consideration.
“Timing of approval is still the subject of discussions with the regulatory authorities,” they said.
The company said it couldn’t provide “specific estimates” on delivery but was optimistic doses would arrive in Australia in 2021.
“We are confident that we are well positioned to meet our global manufacturing targets for the second half of this year and to complete our global regulatory submissions in the third quarter,” the Novavax spokesperson said.
They wouldn’t comment on when the first doses may be shipped, but said Novavax hoped to produce 100 million global doses per month by October and 150 million per month by the end of 2021.
On Sunday Mr Hunt said he still expected Novavax would be available “subject to supply, later in the year”.
On May 13, Mr Hunt said the government had “very conservative expectations” on Novavax’s arrival.
“We’re always planning for contingencies,” he said.
“We’ve prepared … Novavax as a contingency in case something were to happen with Pfizer or Moderna.”
Australia also has contracts for 100 million doses of Pfizer, AstraZeneca and Moderna to arrive in 2021.
Another 15 million Moderna doses are expected in 2022.
AstraZeneca confidence urged in Australia
On Sunday, Mr Hunt said he was buoyed by accelerating vaccination figures in Australia, with more than 500,000 jabs last week taking the country’s overall total to 3.6 million.
“Please come forward. If you are not vaccinated, and you catch COVID, you could die, it’s as simple as that,” he said.
“We do not want anybody to wait. Do not wait to be vaccinated if you are eligible … If you do wait, you put yourself and your family at risk.”
Last week, real-world data showed AstraZeneca has huge benefits in reducing death and illness, and blood clot issues arose in just one in every 100,000 vaccinations.
Novavax is expanding new production sites in South Korea, but potential on-shore manufacturing in Australia is still some way off.
Melbourne’s CSL, which is currently making AstraZeneca, says it can’t produce both vaccines at the same time.
And although Novavax’s boss John Trizzino told the Nine newspapers he would “love to have a manufacturing facility in Australia”, a company spokesperson told TND it would “focus on producing doses in the sites that are already in place” for the time being.