Major delay in Australian government’s Novavax deal, with 51m doses not expected until 2022

One of the federal government’s key vaccine deals has been hit with major delays, with 51 million doses of Novavax originally due to arrive in the second half of this year now not expected until 2022.

Since initially touting Novavax as one of three secured deals that could immunise the entire population as a “primary” vaccine by the end of this year, the federal government has quietly edged away from the commitment as it focuses instead on securing more Pfizer vaccines.

The Novavax that has been ordered will now serve as part of the government’s booster strategy when supplies mostly come on stream in 2022, with only a small portion of the 51m doses ordered now expected in the final quarter of this year.

The protein-based vaccine has shown promising results in clinical trials, but Novavax has yet to supply the Australian Therapeutic Goods Administration (TGA) with enough information for approval, and the vaccine has not yet been approved for use in any other country.

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The company, which has never brought a vaccine to market in its 34-year history, has reported supply problems – including the availability of plastic bags – as being a significant hurdle to global supply of its vaccine.

In a Covid committee hearing on Friday, John Skerritt from the TGA said that because of manufacturing issues facing the company, the regulator did not yet have sufficient data to assess its potential use in Australia.

“We still do not have complete information on the manufacturing. With a vaccine it’s not just the clinical trials, which I should add are quite promising with that vaccine, but making sure the product can be manufactured at scale and manufactured consistently,” he said.

“We do hope however, and we’re on the phone to them almost daily, that we will receive a complete set of information in September, but we really are at the mercy of the company for when they’ve sorted out the manufacturing issues.”

A spokesperson for the federal department of health told Guardian Australia on Monday the timeline for approval would “ultimately depend on when the complete data package is provided by Novavax to enable the required regulatory processes”.

The health department secretary, Brendan Murphy, told the committee he expected that “some millions of doses” would be delivered by the end of the year, but the government’s primary vaccination strategy no longer included Novavax.

“If they come, that will be valuable and could help accelerate. But our plan is not dependent on having Novavax this year.”

In February, a statement from the prime minister’s office said that the Novavax vaccines ordered would be arriving this year, with the supply “sufficient to vaccinate every Australian who chooses to be vaccinated in 2021”.

The health minister, Greg Hunt, had previously said the Novavax deal would serve as a back up “primary” vaccine for the whole population in the event that the backbone of Australia’s vaccination program – AstraZeneca – faced problems.

“Novavax … (is) there either as a primary vaccine option, pending any issues that may arise with regards to either the efficacy or the production of our current vaccines, or, as is more likely the case, it’s there as the potential for subsequent vaccination,” Hunt said in January, before problems emerged with the AstraZeneca jab.

The government continued to suggest the Novavax supplies would arrive in the third quarter of this year until the vaccine was dropped from the “horizon allocation” document released in June.

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On Monday, Hunt said the government had always considered Novavax as a “backup”, and the latest advice was that first doses would arrive in the final quarter this year.

“We’ve always thought of Novavax as the backup if there were an issue with the first three vaccines for this year, and as a foundation stone and platform of the booster program next year,” he said.

A company spokesman said the timing of approval was “still the subject of ongoing interactions with the regulatory authorities”, and it was working towards having final submissions “some time in Q3 2021”.

“Novavax are actively working to ensure NVX-CoV2373 is made available as quickly and safely as possible to Australians, ensuring that we fully address all safety, efficacy and quality elements required for regulatory submissions,” he said.

“Novavax were accepted by the TGA for provisional determination on 19 January, which initiated the rolling submission review process, and since then Novavax have been providing both clinical and non-clinical data to the TGA on an ongoing basis.”

The shift in the government’s language on the Novavax vaccine comes as the federal government faces accusations from the states of accumulating a national stockpile of Pfizer doses while states are crying out for more vaccines.

An extra 50,000 doses of Pfizer were directed to the NSW government on Saturday, which Hunt said had come from previously unallocated doses, which were in addition to a recent advance of Pfizer that had been distributed to the states on a per capita basis.

“We’ve been able to meet all of the commitments to states and territories and this is from the additional supplies that we’ve been able to secure,” Hunt said.

But the suggestion of an unallocated national stockpile drew criticism from other states, with the WA premier Mark McGowan saying its supposed existence was “news to us”.

“If there is a big warehouse sitting there full of Pfizer, my view is they should give it to the states and we’ll put it in people’s arms,” McGowan said on Monday.

“If you have spare Pfizer, please give it to us.”

The NT chief minister, Michael Gunner, said any available Pfizer needed to be “distributed immediately and we get it in arms, immediately,” he said.

“I hope that’s a very badly chosen set of words, I am worried that maybe it’s just code for the fact they took it out of other people’s allocations and didn’t want to say who or which state they took it from,” Gunner told the ABC.

Hunt said the federal government was not holding “large amounts of doses”, but did ensure it kept second doses reserved.

“There’s always a choice. If we were holding doses, people would say they should be out. If we aren’t holding doses, people are saying, why not? The simple answer is we make sure we have the second doses.

“We also make sure that everything that possibly can be distributed each week is distributed.”