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.
Novavax won a $US1.75 billion contract to develop its vaccine for the US market but its quarterly report revealed on Thursday the federal government may withhold funding until the company can resolve concerns about its processes.
“The US government has recently instructed the company to prioritise alignment with the US Food and Drug Administration on the company’s analytic methods before conducting additional US manufacturing and further indicated that the US government will not fund additional US manufacturing until such agreement has been made,” Novavax said.
The New York Times reported on Friday that four individuals familiar with the company claimed it had been unable to demonstrate its production processes met the standards of the regulator. The company said in a statement to the Times it did not expect any impact on funding arrangements.
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.