Australia’s promised supplies of 51m doses of the Novavax vaccine, which failed to arrive in 2021 as planned, may be approved within months after the company finally completed its approval applications with the health department.
The protein-based vaccine, which was initially intended to be available as a primary vaccine for the entire Australian population last year, has earned the nickname “Never-vax” within the health department because of the ongoing setbacks.
After providing initial data to the Therapeutic Goods Administration in January 2021, the company provided the government with its “complete submission of data and responses” last week.
The Advisory Committee on Vaccines (ACV), which advises the TGA and the health minister, met to review the Novavax vaccine on Friday. The TGA is now preparing to review the committee’s final report.
“Once the ACV’s final report is received and reviewed by relevant parties, the TGA will be in a position to make a decision,” a spokesperson for the Department of Health said.
“The Novavax vaccine candidate will not be rolled out to the Australian public until the TGA has completed a full and thorough assessment. No part of this process has been rushed, and the TGA will not approve a vaccine unless it is found to be safe and effective.”
The department noted that the supply of Novavax vaccine after approval would still be dependent on products arriving in Australia and meeting laboratory batch release requirements, noting problems faced by the company last year.
“Throughout 2021, Novavax publicly indicated that there were delays in their regulatory submissions due to a series of vaccine manufacturing and supply issues,” the spokesperson said.
Speaking after Novavax sent its first shipment of its vaccine into the European market this week, the company’s chief executive, Stanley Erck, said the company had marked a significant milestone and was expecting Australian government approval within the next three months.
“There’s a lot of pent-up demand for our vaccine,” Erck told Bloomberg TV on Monday.
“We’re waiting for … approvals within the next 30, 60, 90 days from places like Australia, Canada, UK, and hopefully the US in that time period. So it’s a big transition for the company.”
In response to questions from Guardian Australia, Novavax said the TGA was now “actively evaluating” the data it had submitted in January, and said the company had made “remarkable progress” developing and securing approvals for its vaccine.
“Novavax are working closely with the TGA on the submission and are hopeful the regulatory evaluation will be completed shortly,” the spokesperson said.
“Once completed we will work with the TGA and federal government on the quantities and delivery schedule for the vaccine.”
When asked about the reasons for the delayed supply, the company said it believed “the important thing is to look forward and focus on how quickly we have got here”.
“We have spent the last year and a half conducting multiple late-stage trials with over 45,000 participants, creating our supply network, conducting tech transfer, and refining and validating our analytical methods and dealing, as all manufacturers have, with global raw materials shortages.”
The health minister, Greg Hunt, insisted repeatedly last year that the company was still on track to deliver on the contracted supplies for Australia in 2021, dismissing reports of ongoing delays as “incorrect”.
Unlike the Pfizer and Moderna vaccinations which use mRNA technology, the Novavax vaccine is a subunit protein vaccine, which uses a harmless part of the virus to trigger an immune response.
The head of the country’s vaccine taskforce, Lt Gen John Frewen, said that he believed there were a number of people who had been holding out for the Novavax vaccine.
“There is a group of people who are holding out for Novavax, so I think when Novavax eventually comes we will pick up maybe a couple of extra percentages there as well,” he said.
In November, Hunt agreed that some people were waiting for Novavax, promising Australia would be one of the first countries to start administering the drug.
“It may not be a full 2% exactly, but we do know that there are some people … who are waiting. Whilst we would advocate they don’t wait, I know that some will nevertheless make that decision, and I respect that,” Hunt said.
Latest government data from Operation Covid Shield shows Australia’s vaccination rate, for those over the age of 16, is sitting at 94.7% for first dose and 92.1% who are fully vaccinated.
Novavax was one of the three vaccines that the government prioritised in its initial vaccine procurement strategy, with the prime minister announcing in February last year that supplies would be “sufficient to vaccinate every Australian who chooses to be vaccinated in 2021”.
The government continued to suggest the Novavax supplies would arrive in the third quarter of last year until the vaccine was dropped from the “horizon allocation” vaccine rollout strategy when it was released in June.
