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startups push for bigger role in vaccine making


“By giving all government procurement contracts to big companies, this blocks opportunities for any up-and-coming companies and [brings] no opportunity to create an innovation ecosystem,” he said.

“This is a major problem in Australia, whereas the US government mandates that a proportion of even the largest procurement contracts must flow to small- to medium-sized enterprises.”

Vaxine is planning its phase two and three trials of its COVAX-19 product and has been looking overseas for broad-scale manufacturing options given Australia would not have capacity to produce its doses onshore.

The company hopes it can work with the Australian government to deploy its vaccine locally if successful but has not yet been able to engage policymakers in that conversation.

A spokesman for Health Minister Greg Hunt said the government was working on a range of fronts to secure vaccine supply for Australians.

“Negotiations are well under way with COVID-19 vaccine developers on access and supply. The Australian government is considering advance purchasing options as well as local manufacturing options,” the spokesman said.

The government acknowledges that its key focus has been engaging biotechnology giant CSL in manufacturing.

“Our clear expectation and intention is to be able to provide manufacturing onshore through CSL either being a producer of Australian vaccines or producing under licence for an overseas vaccine supplier,” the spokesman said.

Contract manufacturers say CSL is best placed to produce a vaccine at scale in Australia but that the country should still be looking to invest in manufacturing options for different stages of the vaccine making process.

Melbourne firm Sypharma works with researchers on the “fill and finish” part of vaccine making, adding products to vials and ensuring they are safe for use in clinical trials.

The company has worked on both Vaxine’s candidate as well as clinical trial doses for the University of Queensland.

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Sypharma’s business strategy and innovation manager Ganesh Varnakulasingham said he hoped policymakers would think hard about future investment in the contract manufacturing sector. “One of the things that comes out of this pandemic for me is that lack of security that Australia has within its shores to be able to move quickly and be able to make 100 million doses of a vaccine,” he said.

While companies such as Sypharma tend to work on projects up only to about the phase two trial stage, Mr Varnakulasingham said more investment in firms of this size could attract more biotech business onto Australian shores.

“The exposure for us [from COVID products] has been great. We are finding a lot more people in that phase one stage reaching out and touching base.”

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Australian News

promising vaccine COVAX-19 could be ready in ‘three or four months’


Adelaide scientists have been working overtime on a new vaccine which has already shown promising results after clearing its first phase of human trials.

The drug named COVAX-19 was trialled on 40 volunteers earlier this month.

The vaccine is showing promising signs it “could actually save lives”, the developers of the vaccine said, who also predict it could safely be used in humans immediately.

In fact, vaccine developer Professor Nikolai Petrovsky claims there’s no reason it can’t be used in Victorian aged care homes now.

“We have something that we believe already has shown it can potentially save lives,” he told 3AW’s Neil Mitchell.

“The data suggests it’s highly effective, we just need to finish the clinical trial programs and then seek approval for it.

RELATED: Follow all the latest coronavirus news

Appearing on Sunrise, Professor Nikolai Petrovsky described the update as “very exciting”.

“Safety data from the clinical trials shows the vaccine isn’t showing any problems at all and is inducing the right type of immune response,” he said.

Dr Petrovsky said the vaccine had been shown to produce “very strong” antibodies which kill coronavirus in monkeys, ferrets and mice, and had been proven to induce an antibody response in humans.

While the Australian government “knocked back” Dr Petrovsky’s request for help funding the trial, he said he’s already negotiating with the Canadian and UK governments for funding.

RELATED: Russia claims vaccine approval on track for August


Phase two trials for COVAX-19 (with 400-500 volunteers) are scheduled to begin in September.

“Now we do much bigger clinical trials in a larger number of individuals to prove the vaccine is working,” Dr Petrovsky added.

The final trial (involving 50,000 volunteers) is the final stage before the vaccine would be made available to the public.

If all goes well, Dr Petrovsky says the drug could be available to everyone within “three or four months”.



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Johnson & Johnson gears up for collaboration on COVID vaccine supply


Pharmaceutical giant Johnson & Johnson is rapidly scaling up its manufacturing capabilities as it progresses development of its COVID vaccine and says it will be looking to work with governments to discuss fast-tracking supply if successful.

The vaccine hopeful is yet another option Australia will most likely have to negotiate to import if it wants supply, with the $US390 billion ($544 billion) biotech firm looking to the US and Europe for trials and broader manufacturing.

From AstraZeneca to Pfizer and Johnson & Johnson, the world's biotech giants are negotiating how to make a COVID vaccine at scale.

From AstraZeneca to Pfizer and Johnson & Johnson, the world’s biotech giants are negotiating how to make a COVID vaccine at scale. Credit:University of Oxford.

“We have expanded our manufacturing capacity, including establishing new US vaccine manufacturing capabilities and scaling up capacity in other countries,” a spokesperson for Johnson & Johnson’s pharmaceutical arm, Janssen Australia and New Zealand, told The Sydney Morning Herald and The Age.

“Johnson & Johnson has existing manufacturing capacity in Leiden, Netherlands. We have entered into agreements to expand our manufacturing capability, partnering with Emergent BioSolutions and Catalent Biologics.”



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Government confident CSL can produce enough vaccine for entire population


A spokeswoman for Pfizer in Australia said the company would work closely with the government and global vaccine initiatives on local supply. “Our goal is to ensure that rapid uptake and access is possible for patients who will need the vaccine by ensuring early allocation of doses needed,” she said.

Australia has its own coronavirus vaccine candidates in development, including at the University of Queensland, which has brokered a deal with CSL for local manufacturing if successful.

If a locally-made vaccine is not first to market, the country will have to broker deals with international developers to either import or licence the products for manufacturing if it wants early access.

“Our government is progressing conversations with leading COVID-19 vaccine developers, regarding access, supply, and onshore manufacturing options,” Mr Hunt’s spokesman told The Sydney Morning Herald and The Age.

Negotiations are underway with both CSL and international vaccine candidates, he said. “This includes the Minister for Health discussing international licensing arrangements for COVID-19 vaccines with the British Secretary of State for Health and Social Care this week to ensure access and supply for Australia to vaccines developed in the United Kingdom.”

Local vaccine researchers have warned Australia faces stiff competition when competing for doses and that local manufacturing approaches may not be adequate to ensure swift supply to the local population if a vaccine is successful.

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CSL told this masthead earlier in the week that its priority was working on production of the University of Queensland’s vaccine but that it was also keeping conversations open with other manufacturers.

Pfizer and BioNTech are working on four different options for their vaccine which use mRNA technology, a new approach that has not yet led to any successful vaccine. Early trial data has shown one of the products produces antibodies, however further testing is needed before the firms decide which prototype to take to more wide-scale testing.

A Pfizer spokeswoman said the company was focused on delivering supply of any successful product to at-risk populations, including the elderly and immuno-compromised individuals.



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AFL Indigenous players required to have pneumococcal vaccine before entering Queensland


Tensions between players and the AFL are rising as clubs prepare to move into a new hub in Queensland, with Indigenous players being made to have pneumonia vaccinations before arriving.

The Queensland Government says it was the AFL’s decision to tell Indigenous players and their families to get the injection by this weekend, before they travel to Queensland.

The ABC understands club doctors were informed that along with influenza vaccinations for all players, Indigenous players were requested by the Queensland Chief Medical Officer to also have a pneumococcal vaccination before travelling, due to a, “tightening of Queensland’s border controls”.

Research shows that Indigenous people are more likely to contract pneumonia. The vaccine is recommended for Indigenous people over 50 years of age.

Dr Jeannette Young speaks at a press conference at Parliament House in Brisbane.
The ABC understands that Indigenous players were requested to have a pneumococcal vaccination before travelling.(AAP: Darren England)

But some Indigenous players and their families are uncomfortable with the requirement to have the injection, saying it is an infringement on their human rights.

The family of one Indigenous player said they were concerned the AFL did not advocate for an exemption from the Queensland Government.

However, a spokesperson for Queensland Health said the vaccination was never a travel requirement.

“The decision for some players to have pneumococcal vaccinations was made by the relevant sporting code [the AFL],” the spokesperson said.

“People can apply for relevant exemptions directly with the sporting code.”

The CEO of the AFL players’ association, Paul Marsh, says he’s concerned about the issue.

“The fact that these vaccinations were not discussed with the AFLPA as part of the return-to-play protocols or otherwise, is a significant issue we have raised with the AFL.

“We are now working directly with players to ensure they understand their rights and options available to them regarding any requested vaccinations.”

The AFL are expected to release a statement shortly.



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Securing COVID-19 vaccine supply just as hard as the science


“It’s essential that everyone realises the government should be backing multiple local vaccines in the hope that one or more of them will work out.”

“It is simply not sensible or ethical for them to just ‘pick their best friend and sign up a single massive deal with them’,” he said.

Meanwhile, fund manager Platinum Asset Management’s healthcare portfolio lead, Dr Bianca Ogden, thinks there would likely be many iterations of a vaccine.

“I think this virus will be with us forever — we will get other generations of vaccination,” she said.
The Morrison government says it’s doing everything it can to secure early access to a successful vaccine, no matter where it originates.

“Australian researchers have shown that they are world leaders as the race continues for the development of a vaccine. To support them, the government has allocated $66 million from the Medical Research Future Fund for COVID-19 research, including $19 million for COVID-19 vaccine development,” a spokesman for health minister Greg Hunt said.

“In addition, the government is communicating regularly with researchers, developers and manufacturers of vaccine candidates in other nations.”

However, the work being carried out at the University of Queensland is being keenly watched, with CSL’s involvement keeping investors interested.

If the University of Queensland’s vaccine is successful, it would make Australia much less dependent on global supply chains. The partnership with CSL will see the $128 billion biotech giant produce the doses, which could add up to tens of millions by 2021, in theory supplying enough for the Australian population.

University of Queensland vice-chancellor Peter Hoj says it was an “incredible luxury” to have locally held intellectual property for the vaccine.

He is also quick to point out that no single product can eradicate the pandemic.

“One vaccine is not enough. I think what the governments across the world should do is see this as a global collaborative effort,” he said during an event with the Committee for Economic Development of Australia this week.

CSL is also urging caution about the commercialisation. “It’s important to note that vaccine development is a complex process and this stage of research development contains a high risk of failure. Right now it is not possible to say with any certainty whether the vaccine will be effective, however initial results are promising,” a CSL spokeswoman said.

COVID-19 research is a new frontier and the industry’s ability to manufacture and distribution at scale remains a mystery. Even projects gearing up for phase 3 clinical trials have not yet locked down the exact blueprint for wide-scale production.

US biotech Moderna, which has buoyed global sharemarkets in recent weeks with its vaccine trial results, is working on several international deals to ensure its stock can be produced and stored safely at scale.

Dr Ogden, whose fund has held shares in Moderna since its IPO, said that challenge is all the more difficult because teams are all working remotely.

“They all have to do this from their homes.”

Professor Petrovsky has also been hitting the phone in recent weeks, talking with international manufacturers to ensure Vaxine could deliver the doses if its work is successful. He’s wary some global firms working on treatments may end up over-promising and under-delivering on supply.

“When everyone wakes up to the fact in 6 months time that certain companies can’t produce 1 billion doses in 12 months, or even a tenth of this, then a lot of countries are going to find themselves in trouble with no vaccine supplies at all.”

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$330b wealth manager bets on coronavirus vaccine before year-end


One of Europe’s most-recognised fund managers is betting that a vaccine for the coronavirus will arrive this year, a key development that could presage a recovery for the global economy.

“Our central scenario today is that with 80 per cent probability there will be a vaccine by year-end by the likes of Pfizer or someone like that,” Cesar Perez Ruiz, Pictet Wealth Management’s chief investment officer, said on a conference call.

There are currently more than 130 vaccines under development globally, and first clinical trials have started.

There are currently more than 130 vaccines under development globally, and first clinical trials have started.Credit:AP

It will probably be made available to those who are most at risk of the virus, and then rolled out to everybody by the summer of next year, he added.

The company’s base case is for the global economy to bounce back nearly 6 per cent next year, after shrinking around 4 per cent this year.



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CSL vows to manufacture UQ COVID-19 vaccine if successful


The funding deal will see CSL and CEPI back the university’s research team through its phase one safety study, later clinical trials and the first phase of large-scale production should trials show the product is safe.

If the vaccine receives the green light, the first large-scale production runs will occur out of CSL’s Melbourne production facilities.

“CSL anticipates that the production technology can be scaled to produce up to one hundred million doses towards the end of 2021,” the company said.

The agreement would mean CSL would be able to subcontract to other vaccine manufacturers across the world to increase the number of doses being produced.

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A number of hurdles and unknowns need to be cleared ahead of commercialisation, including a plan for distributing doses.

If the development is successful, CEPI and CSL will each receive an allocation of vaccine doses depending on how much funding they end up contributing.

“We have to get across the finish line first, we’re not getting ready to take any orders,” Mr Perreault said.

Both CSL and CEPI are involved in a range of coronavirus research projects and say they are keen to continue to help other vaccine and treatment development efforts.

Mr Perreault said CSL was keeping its conversations with other organisations open in case it could also lend support if another project crosses the finish line first.

“We’ll go as fast as we can, we’re emphasising it is a high risk project,” CSL chief scientific officer Professor Andrew Cuthbertson said.

The University of Queensland’s vaccine candidate uses “molecular clamp” technology. The virus that causes COVID-19 is covered in proteins which attach to cells, uncoil and then infect them.

The molecular clamp technology locks those proteins in place before they uncoil. People who are vaccinated develop antibodies to the coiled shape of the proteins, meaning their immune system can recognise the virus and fend it off.

CSL has been working with researchers on the potential vaccine for months and will supply its MF59 adjuvant, which improves immune response, for use in its development.

The vaccine candidate must still clear a number of hurdles before it can be commercialised. It is hoped a phase one trial will begin in July.

CSL said it would use its allocation to supply Australians in the first instance and then look to its regional neighbours.

CSL shares dropped 3.9 per cent in early afternoon trade on Friday to sit at $282.70.

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As it happened: Novavax vaccine human trials begin in Melbourne; COVID-19 cases top 5.4 million worldwide; Australia death toll at 102



If you suspect you or a family member has coronavirus you should call (not visit) your GP or ring the national Coronavirus Health Information Hotline on 1800 020 080.



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Melburnians roll up their sleeves for coronavirus vaccine


“[Instead] we take blood tests from them and we test that in about half a dozen different ways, to show that this vaccine has hopefully provided the immune response that we need to protect people from COVID-19.”

American biotechnology company Novavax is behind the vaccine, which has been under development since January, and recently received a $US388-million ($590 million) boost from the Coalition for Epidemic Preparedness Innovations to support human trials.

Australian microbiologist Dr Paul Griffin is helping to trial a vaccine he believes could guard against coronavirus.

Australian microbiologist Dr Paul Griffin is helping to trial a vaccine he believes could guard against coronavirus.Credit:Justin McManus

The foundation’s Dr Rodney Pearce said new technology used to create the vaccine was exciting because, instead of using a live virus, proteins were created in the laboratory, in an attempt to trick the body into thinking it was dealing with coronavirus, triggering an immune response.

“So the beauty of that is that you don’t have to have this risk of saying, ‘Am I going to catch the virus from the vaccine?’” said Dr Pearce, who also cautioned that the vast majority of vaccines developed did not end up being effective.

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Novavax are yet to bring any vaccines to market but have advanced trials underway for vaccines for Ebola, influenza and respiratory syncytial virus, the most common cause of respiratory and breathing infections in children.

The Doherty Institute’s Professor Damian Purcell said one potential benefit of the nanoparticle technology used by Novavax was that it could be scaled up to make a large number of doses in a short time.

Dr Griffin said the company was so confident in the vaccine it already had plans for phase-two trials, which would likely involve more than 2000 people in Australian and the United States, while planning was also underway for a phase-three trial.

This testing would likely involve tens of thousands of people and would need to expand into countries where coronavirus was much more prevalent to measure its protective impact.

“Given the gravity of the situation, [Novavax] will hopefully have 100 million doses able to be produced by the end of the year, and then the target will be 1.5 billion-doses next year,” Dr Griffin said.

Nucleus Network will run human trials from its clinics in Melbourne and Brisbane. Strict requirements for healthy candidates aged between 18 and 59 meant researchers were still looking for people to participate.

It’s understood those involved receive small payments to cover the cost of their time.

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