What’s Australia’s first local Pfizer-style COVID vaccine? And when might it be in our arms? An mRNA expert explains


Penny Stephens/AAP

Archa Fox, The University of Western AustraliaAustralia has struggled to get enough Pfizer doses to meet Australians’ growing demand for COVID-19 vaccinations.

Australia has been producing doses of AstraZeneca since March, but this vaccine is no longer recommended for those aged under 60 because of the small but serious risk of clotting.

Now a research team at Monash University, led by Professor of Pharmaceutical Biology Colin Pouton, hopes to develop a new mRNA vaccine, which works by the same principles as the Pfizer vaccine, and could be manufactured locally.

So how would the vaccine work? What hurdles do the researchers need to overcome to make it a reality? And when could it become available?

It’s based on existing technology

Before COVID, the researchers were developing mRNA vaccines against a variety of viruses and diseases, and testing the technology in mice. After the pandemic hit, they pivoted their skills and technology and started work on an mRNA vaccine against COVID-19.

The vaccine is an mRNA vaccine, like the ones by Pfizer and Moderna. These vaccines prompt your body to produce the virus’ spike protein, to which your immune system makes antibodies against.

But the Monash mRNA vaccine is a little bit different, as it directs our cells to only make a small part of the spike protein, the “receptor binding domain”, which is the most important part allowing the virus to enter our cells.

The receptor binding domain, or tip of the spike protein, is also the part that’s quickly mutating to form the different variants of concern. Directly targeting this part makes sense to get the most variant-specific response.

How do mRNA vaccines work again?

MRNA vaccines work as instructions, telling our cells to make certain proteins. If these proteins are foreign to our bodies, our immune system will recognise them and mount an immune response. Over time, immune memory is developed, meaning when we encounter the virus, our immune system will clear it.

The researchers began modelling the vaccine off the original strain of the virus, first discovered in Wuhan. But they’ve since adjusted their sequence to model the shot off the Beta variant, first discovered in South Africa. This adjustment was made partly because the neutralising antibodies from patients infected with the Wuhan strain are least effective against the Beta variant.

Our current crop of approved COVID vaccines protect well against the Alpha variant, first found in the United Kingdom, and the Delta variant, first discovered in India. But because the Beta variant is good at evading immunity from vaccines, it’s more likely than most other variants to surge when vaccine protection begins to wane.

For these reasons, there’s a stronger clinical need for Beta variant vaccines.

This quick adjustment of the sequence demonstrates how flexible the mRNA technology is. It’s easy to change the sequence of the vaccine to adapt to new variants of the virus that have emerged, and might emerge in future. This ability to quickly change the sequence is similar for DNA vaccines like AstraZeneca, but harder for traditional and protein-based vaccines.

As with all other mRNA vaccines, the RNA will be broken down in the body over the course of a day or so. The vaccine doesn’t stay in your body over the long term. You gain immunity as your immune system learns how to respond to the short burst of proteins your body makes. When you get the second dose of mRNA vaccine, the immune memory is reinforced.

The group has tested this vaccine in mice, and says its results are really promising.

Based on these pre-clinical results, the Victorian government has given the project A$5 million. The money has come out of a A$50 million research fund earmarked to support local mRNA vaccine development.

The A$5 million will help pay for a manufacturer in Europe to make a sufficient amount of the mRNA for the phase 1 trials. This material will then be shipped via ultra-cold storage to Australia, and a local company is going to package the RNA into “lipid nanoparticles” which allows the mRNA to get into human cells.

What are the next steps?

Phase 1 trials to check the vaccine is safe in humans will begin in October or November this year, and will initially include 150 volunteers.

If the vaccine passes this trial, it will move to phase 2 and 3 trials which require tens of thousands of participants. The primary aim of these later stage trials will be to see if the vaccine can reduce the severity of COVID-19 disease, while also checking it’s still safe.

These later stage trials are quicker to complete if conducted in areas with (unfortunately) high community transmission. One reason we saw Pfizer and Moderna’s vaccines approved so quickly was because trials took place in countries where the virus was rampant. If and when this vaccine goes to phase 2 and 3 trials, Australia will hopefully not be in a situation with widespread transmission. So the team may need to involve international partners and recruit participants overseas.




Read more:
What if I can’t get in for my second Pfizer dose and the gap is longer than 3 weeks?


However, there may also be alternative metrics to measure how well a vaccine is working. Researchers can look at study volunteers’ blood to see how many, and the type of, antibodies they’re producing. This could work as a proxy for measuring efficacy. But it’s not clear if Australia’s drug regulator, the Therapeutic Goods Administration, would approve the vaccine without the traditional exposure model.

The team will also compare their mRNA vaccine directly with Pfizer, in a side-by-side comparison, to see how stable it is and how well it elicits antibodies against the virus.

So when can we get it into our arms? It’s uncertain how long the full suite of trials will take, but probably not for a couple of years. It’s possible the vaccine will not make it past phase 1 or 2 trials, although with the similarity in methodology to the Pfizer and Moderna vaccines, both of which are safe, this is less likely.

Why we need Australian-made vaccines

This is an important step in developing Australia’s sovereign capacity for mRNA vaccine production, and for the newly developing Australian RNA biotechnology sector as a whole. It’s likely we’ll need booster shots for some years to come, so we need to develop local manufacturing capability.

I sincerely hope it’s successful, but even if it’s not, it’s creating a pipeline for onshore mRNA vaccine development.

What’s more, mRNA vaccines are the new gold standard and the next generation vaccine technology. It’s likely we’ll see more pandemics and novel viruses in future, so that adds to the argument for having local mRNA vaccine capacity.

We don’t know how much the federal government paid for the Pfizer and Moderna vaccines, but it’s likely to have been much more costly than making it here. If we can make it ourselves more cheaply, we’re at a real advantage.The Conversation

Archa Fox, Associate Professor and ARC Future Fellow, The University of Western Australia

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Healing the urban-rural divide: Why a ‘locals-first’ approach doesn’t work in a pandemic



DARREN ENGLAND/AAP

Timothy Baker, Deakin University; Emma Tumilty, Deakin University, and Kristy Hess, Deakin University

Toilet paper and ventilators may be unlikely bedfellows, but they serve as powerful symbols of the growing tensions between urban and rural regions in Australia and elsewhere amid the COVID-19 pandemic.

Last month, the media reported dozens of frenetic “supermarket swoops” across the nation. Busloads of city residents converged on rural grocery stores to fill their trolleys with supplies, leaving the shelves bare for local shoppers.

As a result, supermarket managers and security guards stepped in to be custodians of the local, refusing access to those who did not look familiar.

It is important to note that “local” is a powerful cultural idea. Local shoppers don’t legally have a right to toilet paper in this instance, but there is a moral perception they should have first dibs based on their need for essential services and in the interests of social order.

No ‘locals only’ option for hospitals

The toilet paper fiasco serves as an analogy for a much graver issue as the pandemic spreads around the world.

What happens if overwhelmed city hospitals hoard the staff and resources needed to manage COVID-19, leaving rural areas to fend for themselves? Rural areas of the United States are already confronting this reality.

To compound the problem, many people have been eager to escape crowded cities like Sydney, London, New York and San Francisco for the imagined safety of the countryside. This places strain on rural healthcare providers, making it difficult to prepare for and utilise already stretched resources.

Small town health services cannot plaster “locals only” posters on their doors or allow only “familiar faces” access to lifesaving equipment.

As rural professionals in medicine, ethics and media/cultural studies, we bring an interdisciplinary perspective to the issue of local resourcing and implications for the urban-rural divide.

We understand that in a pandemic, urban health care workers would also feel a need to protect and ensure supplies at their local hospitals first. But the equity of urban-rural resourcing during the COVID-19 crisis warrants more attention.




Read more:
COVID-19 may hit rural residents hard, and that spells trouble because of lack of rural health care


Big media focus on urban problems

Urban areas in Australia already have almost three times as many hospital specialists per capita as outer regional areas and many times more critical care specialists.

Our regional health systems are struggling. Many hospitals rely on fly-in-fly-out emergency, anaesthetic and intensive care doctors. These doctors (often from city hospitals on short-term contracts to fill gaps in the local roster) are now limited by quarantine restrictions. They also want to stay near their metropolitan hospitals in case they are needed.




Read more:
Geographical narcissism: when city folk just assume they’re better


There’s a concern that a capital city’s rush for resources could also leave patients in rural hospitals without medical necessities, similar to the panic buying of supermarket goods that has left some remote Indigenous communities without basic food and hygiene necessities.

Yet, these issues have not been discussed enough. Big media tends to focus on the impact of this health crisis on major metropolitan areas where more people live.

How we can more equitably share resources

We need a better strategy for rural-urban resource allocation during the crisis.

Nobel Prize-winning economist Amartya Sen suggests solutions may have to be tailored to specific contexts (like rural and urban settings) to be effective and ensure everyone’s health is of equal value. Drawing on his “capability approach”, we need to allocate resources in a way that is community-centred, equity-focused and puts an emphasis on deliberative democratic processes.

To hash out solutions, stakeholders in rural and urban hospitals should gather around a “virtual” table to discuss their differing needs. Government organisations and medical colleges have already begun this process.




Read more:
‘Coronavirus holidays’ stoke rural fury


Effective resource allocation could impact who gets critical care treatment. Centralising resources is a proven lifesaver in normal times when transport is secure, but pandemics threaten to overwhelm our ability to move rural patients to hospitals in big cities. Transport could be delayed by days or even cease for a time.

Accessibility of life-saving equipment becomes key. We need to increase the capacity of transport services to get rural patients to cities when need be and ensure there is enough staff and equipment in regional areas to treat as many patients as possible locally.

The long-term benefits of better urban-rural cooperation

An unexpected upside to COVID-19 may be an increased sharing of knowledge and ideas between rural and urban communities.

Regional Australia has many general practitioners with anaesthetic skills, for instance. They are experienced in short-term ventilation for operations. These doctors can become “accidental intensivists”, meaning they could take care of critically ill patients, with preparatory online courses and real-time video support from urban specialists (who get to remain in their urban communities).

Urban doctors may also benefit from interacting with rural doctors who are already experts in making do with fewer resources. This kind of digital interaction could be useful long after the crisis has abated, too.

Civil wars have been fought over access to resources many times in the past. There is no reason to broaden the urban-rural divide in a war against a virus that has no borders.The Conversation

Timothy Baker, Associate Professor and Director, Centre for Rural Emergency Medicine, Deakin University; Emma Tumilty, Lecturer, Deakin University, and Kristy Hess, Associate Professor (Communication), Deakin University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

First locally-transmitted COVID-19 cases in Australia, as Attorney-General warns drastic legal powers could be used



Twitter

Michelle Grattan, University of Canberra

The coronavirus has moved to a new stage in Australia, with the first two cases of local transmission of the disease.

The NSW government announced a 53-year-old Sydney health worker – who had not recently travelled abroad – had been diagnosed. The other case is the 41-year-old sister of an Iranian man who had arrived in Australia on Saturday. The woman had not travelled to Iran.

Other cases in Australia – now more than 30 – have been people who have come from abroad. These include the third new case announced in NSW on Monday, a man in his 30s, who had recently travelled from Iran.

There has been one death in Australia, a 78-year-old man who had been evacuated from the Diamond Princess cruise ship.

Health authorities have anticipated the spread of the virus locally, with plans being ramped up to deal with that.

Efforts were being made on Monday to track down passengers who sat near travellers from Iran who have been diagnosed with the virus. There is now a ban on the entry of foreigners coming from Iran.

News of the local transmission comes amid the expectation the Reserve Bank will cut interest rates on Tuesday as the virus scare hits the economy, and panic buying of items such as toilet paper.

Hand sanitisers have been a runaway sales item. The share price of Zoono, a company that makes them, has jumped 70% in under a week.

On Friday the futures market rated the probably of a Tuesday rate cut at just 18%. On Monday it was rating the probability at 100%, with some economists even speculating about the possibility of the cut being double the usual 0.25%.

The Australian share market fell by 0.77%, after a 10% fall in what was the worst week since the global financial financial crisis.

NSW Health Minister Brad Hazzard said it was time for people to “give each other a pat on the back” rather than shaking hands. He also suggested a degree of caution when kissing.

In parliament, the government took a series of questions on the virus and its fallout. Attorney-General Christian Porter said it was important for Australians to understand the use of certain powers may become necessary in the months ahead.

Notably among these were changes made in 2015 to the Biosecurity Act, which replaced the Quarantine Act.

COVID-19 had been listed as a human disease for the purposes of this act in January.

“That has a number of very important consequences for Australia and Australians in what will no doubt be challenging months going ahead,” Porter said.

“There are two broad ranges of powers that people may well experience for the first time.

“There is the ability of the government to impose – always based on medical advice, but nevertheless impose – a human biosecurity control order on person or persons who have been exposed to the disease.

“It could require any Australian to give information about people that they’ve contacted or had contact with so that we can trace transmission pathways. It will also mean that Australians could be directed to remain at a particular place or indeed undergo decontamination.”

“Secondly, a very important power that may be experienced for the first time—and that we will be monitoring very carefully—is the declaration of a human health response zone, ” he said.

This was done with the Diamond Princess.

“But it’s very important to understand, going forward, that that is a power that can be used for either localised disease outbreaks in Australia or indeed to restrict individuals from attending places where a large number of people may otherwise choose to gather, such as shopping centres, schools or work.

“These are challenging times going forward, and these will be some of the first times that these important powers may be used,” Porter said.The Conversation

Michelle Grattan, Professorial Fellow, University of Canberra

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Australian Politics: 21 July 2013


The new hardline regime concerning asylum seekers has been implemented with the first boat arriving since the announcement of the changes by Kevin Rudd and Labor. The Coalition is supporting some of the changes, which for Labor should be an alarm bell, meaning it has gone too far to the right.

For more visit:
http://www.theaustralian.com.au/national-affairs/first-asylum-boat-arrives-under-rudds-hardline-png-solution/story-fn59niix-1226682406568



The link below is to an article that looks at some of the divergent interest parties contesting this year’s federal election.

For more visit:
http://www.easternriverinachronicle.com.au/story/1650949/something-for-everyone-how-niche-parties-are-taking-over-australias-political-landscape/

Australia: The First Family


The link below is to an article that takes a look at the Rudd family.

For more visit:
http://www.smh.com.au/national/meet-the-rudds-where-politics-is-a-family-affair-20130719-2q9uo.html

Article: First ‘Gay’ Bible Released


The link below is to an article reporting on the release of the first ‘gay’ Bible – I guess it was bound to happen sooner or later in this age of Bibles for everything and every occasion.

For more visit:
http://www.christianpost.com/news/recently-released-queen-james-purports-to-be-first-ever-gay-bible-86627/

Article: The Voice Australia – Latest News


Keen to know what is happening with the three runners-up from the first season of The Voice Australia? The link below is to an article that reports on the news for Darren Percival, Sarah De Bono and Rachael Leahcar.

For more visit:
http://www.dailytelegraph.com.au/entertainment/insider/the-voice-runners-up-darren-percival-sarah-de-bono-and-rachel-leahcar-will-also-have-record-deals/story-e6frewt9-1226406377829

Video: Rachael Leahcar’s First Appearance on The Voice (Australia)


Rachael Leahcar Sings ‘La Vie En Rose’

Sadly I couldn’t embed this video here, which is disappointing. Click on the link and really enjoy a great performance that tugs at the heart.

http://www.dailymotion.com/embed/video/xq94c8
The Voice Australia: Rachael Leahcar sings La…

Pastor, Church Official Shot Dead in Nigeria


Muslim militants of Boko Haram blamed for killings in Borno state.

JOS, Nigeria, June 10 (CDN) — Muslim extremists from the Boko Haram sect on Tuesday (June 7) shot and killed a Church of Christ in Nigeria (COCIN) pastor and his church secretary in Maiduguri, in northeastern Nigeria’s Borno state.

The Rev. David Usman, 45, and church secretary Hamman Andrew were the latest casualties in an upsurge of Islamic militancy that has engulfed northern Nigeria this year, resulting in the destruction of church buildings and the killing and maiming of Christians.

The Rev. Titus Dama Pona, pastor with the Evangelical Church Winning All (ECWA) in Maiduguri, told Compass that Pastor Usman was shot and killed by the members of the Boko Haram near an area of Maiduguri called the Railway Quarters, where the slain pastor’s church is located.

Pona said Christians in Maiduguri have become full of dread over the violence of Boko Haram, which seeks to impose sharia (Islamic law) on northern Nigeria.

“Christians have become the targets of these Muslim militants – we no longer feel free moving around the city, and most churches no longer carry out worship service for fear of becoming targets of these unprovoked attacks,” Pona said.

Officials at COCIN’s national headquarters in Jos, Plateau state, confirmed the killing of Pastor Usman. The Rev. Logan Gongchi of a COCIN congregation in Kerang, Jos, told Compass that area Christians were shocked at the news.

Gongchi said he attended Gindiri Theological College with Pastor Usman beginning in August 2003, and that both of them were ordained into pastoral ministry on Nov. 27, 2009.

“We knew him to be very gentle, an introvert, who was always silent in the class and only spoke while answering questions from our teachers,” Gongchi said. “He had a simple lifestyle and was easygoing with other students. He was very accommodating and ready at all times to withstand life’s pressures – this is in addition to being very jovial.”

Gongchi described Usman as “a pastor to the core because of his humility. I remember he once told me that he was not used to working with peasant farmers’ working tools, like the hoe. But with time he adapted to the reality of working with these tools on the farm in the school.”

Pastor Usman was excellent at counseling Christians and others while they were at the COCIN theological college, Gongchi said, adding that the pastor greatly encouraged him when he was suffering a long illness from 2005 to 2007.

“His encouraging words kept my faith alive, and the Lord saw me overcoming my ill health,” he said. “So when I heard the news about his murder, I cried.”

 

Motives

The late pastor had once complained about the activities of Boko Haram, saying that unless the Nigerian government faced up to the challenge of its attacks, the extremist group would consume the lives of innocent persons, according to Gongchi.

“Pastor Usman once commented on the activities of the Boko Haram, which he said has undermined the church not only in Maiduguri, but in Borno state,” Gongchi said. “At the time, he urged us to pray for them, as they did not know how the problem will end.”

Gongchi advised the Nigerian government to find a lasting solution to Boko Haram’s violence, which has also claimed the lives of moderate Muslim leaders and police.

The Railway Quarters area in Maiduguri housed the seat of Boko Haram until 2009, when Nigerian security agencies and the military demolished its headquarters and captured and killed the sect’s leader, Mohammed Yusuf, and some of his followers.

The killing of Pastor Usman marked the second attack on his church premises by the Muslim militants. The first attack came on July 29, 2009, when Boko Haram militants burned the church building and killed some members of his congregation.

On Monday (June 6), the militants had bombed the St. Patrick’s Catholic Church, along with other areas in Maiduguri, killing three people. In all, 14 people were killed in three explosions at the church and police stations, and authorities have arrested 14 people.

The Boko Haram name is interpreted figuratively as “against Western education,” but some say it can also refer to the forbidding of the Judeo-Christian faith. They say the word “Boko” is a corruption in Hausa language for the English word “Book,” referring to the Islamic scripture’s description of Jews and Christians as “people of the Book,” while “Haram” is a Hausa word derived from Arabic meaning, “forbidding.”

Boko Haram leaders have openly declared that they want to establish an Islamic theocratic state in Nigeria, and they reject democratic institutions, which they associate with Christianity. Their bombings and suspected involvement in April’s post-election violence in Nigeria were aimed at stifling democracy, which they see as a system of government built on the foundation of Christian scripture.

Christians as well as Muslims suffered many casualties after supporters of Muslim presidential candidate Muhammudu Buhari lost the April 16 federal election to Goodluck Jonathan, a Christian. Primarily Muslim rioters claimed vote fraud, although international observers praised the polls as the fairest since 1999.

Nigeria’s population of more than 158.2 million is almost evenly divided between Christians, who make up 51.3 percent of the population and live mainly in the south, and Muslims, who account for 45 percent of the population and live mainly in the north. The percentages may be less, however, as those practicing indigenous religions may be as high as 10 percent of the total population, according to Operation World.

Report From Compass Direct News
http://www.compassdirect.org/