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Significant delay in Australian Government Novavax contract, 51 million doses not expected until 2022 | Australian politics

One of the federal government’s major vaccine trades has been hit by a significant delay, with 51 million Novabax, originally scheduled to arrive later this year, not scheduled until 2022.

The federal government has decided to ensure more security since it first advertised Novabax as one of three safe trades that could immunize the entire population as a “primary” vaccine by the end of this year. Because of the focus, we are quietly moving away from our commitment. Pfizer vaccination.

The ordered Novavax will serve as part of the government’s booster strategy if supply is nearly available in 2022 and only a small portion of the 51 million doses ordered in the final quarter of this year are planned. To do.

Protein-based vaccines have shown promising results in clinical trials, but Novavax has not yet provided the Australian Therapeutic Goods Authority (TGA) with sufficient information for approval, and vaccines are used in other countries. Has not been approved yet.

Company to own I have never brought a vaccine Introduced to the market in 34 years of history, supply issues, including availability of plastic bags A serious hurdle For the worldwide supply of that vaccine.

At a hearing on Friday’s Covid Commission, TGA’s John Skerritt said regulators still have enough data to assess potential use in Australia due to manufacturing issues facing the company. I said I didn’t.

“We don’t have complete manufacturing information yet. In the case of vaccines, it’s not just clinical trials that need to be added, but the vaccine is very promising, but we know that the product can be manufactured on a large scale and consistently. I’ll confirm, “he said.

“But we want to get the full information over the phone almost every day in September, but when we sort out the manufacturing issues, we’re really at the mercy of the company.”

A federal health ministry spokesperson told Guardian Australia on Monday that the approval timeline “finally depends on when Novavax will provide the complete data package to enable the required regulatory process.” rice field.

Health Department secretary Brendan Murphy told the commission that he expects “millions of doses” to take place by the end of the year, but Novabax is no longer the government’s main vaccination strategy. It was not included.

“If they come, it’s worth it and will help accelerate, but our plans don’t rely on the introduction of Novavax this year.”

In February, a statement from the Prime Minister’s residence said the ordered Novavax vaccine will arrive this year with a supply “enough to vaccinate all Australians who chose to vaccinate in 2021.”

Health Minister Greg Hunt had previously stated that the NovaBucks contract would serve as a backup “primary” vaccine for the entire population in the event of problems with AstraZeneca, the backbone of Australia’s vaccination program.

“Novavax … (is) present as a major vaccine option, or more likely, until a potential problem arises with respect to the efficacy or production of the current vaccine. It’s there, Hunt said in January, before the AstraZeneca jab had problems.

The government continued to propose that Novavax’s supply arrive in the third quarter of this year until the vaccine was removed from the “Horizon Allocation” document released in June.

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

“We’ve always considered Novavax as a backup in case of problems with the first three vaccines of the year, and as the foundation and platform for next year’s booster program,” he said.

A spokesman for a company said the timing of approval was “still subject to ongoing interaction with regulators” and is working on a final submission “sometime in the third quarter of 2021”. Said.

“Novavax is committed to making NVX-CoV2373 available to Australians as quickly and safely as possible, with all the safety, effectiveness and quality factors required for regulatory filing. We are fully prepared for this, “he said.

“Novavax was approved by TGA for a tentative decision on January 19, and the rolling submission review process began. Since then, Novavax has been continuously providing both clinical and non-clinical data to TGA. increase.”

The change in government language regarding the Novavax vaccine is due to state criticism that the federal government is accumulating a national stockpile of Pfizer doses while the state is seeking more vaccines.

An additional 50,000 dose of Pfizer was directed to the Government of New South Wales on Saturday. Hunt said this came from previously unallocated doses, in addition to recent advances in Pfizer distributed to the state on a per capita basis.

“We were able to fulfill all our promises to the states and territories, and this is from the additional supplies we were able to secure,” Hunt said.

However, the unallocated country’s stockpile proposal has sparked criticism from other states, and WA Prime Minister Mark Magawan said its supposed presence is “news for us.”

“If there’s a big warehouse full of Pfizer, I think they should give it to the state and we should put it in people’s arms,” ​​McGowan said on Monday. Said.

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

Northern Territory Prime Minister Michael Gunner said the available Pfizer needs to be “distributed immediately and put into weapons immediately.”

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

Hunt said the federal government did not hold a “high dose” but confirmed that it had a second dose.

“There is always a choice. If we were taking it, people would say they should go out. If we don’t hold the dose, people are saying, why? The simple answer is to make sure you have a second dose.

“We also ensure that everything that could be distributed weekly is distributed.”

Significant delay in Australian Government Novavax contract, 51 million doses not expected until 2022 | Australian politics

Source link Significant delay in Australian Government Novavax contract, 51 million doses not expected until 2022 | Australian politics

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