Doctors do not face a greater legal risk if they give AstraZeneca to younger Australians — here’s why


Simon Santi/AAP

Cameron Stewart, University of SydneyLast week, the federal government changed its recommendation for COVID-19 vaccines. The Pfizer vaccine is now the “preferred” jab for adults under 50.

Amid the political fallout and worries about what it means for Australia’s COVID recovery, doctors have expressed concern about their liability. Some said they would even stop giving the AstraZeneca jab until they were more certain of their position.




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Are they at greater legal risk if they give AstraZeneca to younger Australians? The government insists they are not. This is correct — here’s why.

Proving fault

In Australia, medical liability is, for the most part, fault-based. This means patients who are injured by medicines, medical devices and medical interventions must prove the doctors who used them were to blame for any injury they suffered before any compensation will be paid.

Australian liability laws are state-based, but generally speaking, fault can only be proven when the doctor has acted outside of the professional standard of care in a way that is not supported widely in Australia by professional peers.

What is the standard of care?

The standard of care for diagnosis and treatment is effectively set by the medical profession. In cases — such as COVID vaccines — where the treatment is new and knowledge about the treatment is emerging, the standard of care is also developing.

Importantly, doctors are judged by measuring their behaviour against the standard of care at the time the treatment was given. This means that if, in 2020 a doctor administers a COVID vaccine in a way that was supported by their peers at that time, they will not be found to have breached the standard of care if, years later, other side effects become known.

Prime Minister Scott Morrison inspecting AstraZeneca production.
Last week the Morrison government changed its advice around the AstraZeneca vaccine.
David Caird/AAP

We should also be careful not to automatically equate the government’s advice concerning the AstraZeneca vaccine with what the standard of care should be at the individual level.

The government’s advice is concerned with the big picture and with risks across a population. Doctors have the task of treating individuals. So, the government’s advice should be considered by doctors when working out which vaccines to offer to patients, but there may well be situations where the AstraZeneca is the best option for individual adult patients under 50.

Giving advice and accepting risks

Doctors also have a duty to inform individual patients about material risks of the treatments they provide. Every intervention comes with a set of risks but only the material ones need to be disclosed.

Material risks include those the profession would usually notify patients of (objective material risks), as well as risks the individual patient may have a particular concern about (subjective material risks).

The classic example of this is the 1993 case of Rogers v Whitaker where a woman who was blind in one eye was considering cosmetic surgery on that eye. She was concerned about any risk (no matter how remote) of going blind in her “good eye”. Later, she became blind from a complication of her treatment, which was known but very rare. The doctor’s failure to inform her was considered a breach of the duty to inform — even though it was not a risk normally disclosed — because the risk was subjectively material to her.

Again, the doctor will always be judged by what the profession knew at the time regarding these risks. If a patient is told about the material risks of the treatment and decides to go ahead with the treatment, the doctor has satisfied their legal duty to advise and cannot be held liable for subsequent injuries.

What now for GPs and AstraZeneca?

As long as doctors consider the government advice, keep up with professional news about best practice and communicate material risks to patients, they face no greater liability for providing COVID vaccines than they do for any other treatment.

The reality is the risks of people being injured by vaccines, and of doctors being sued for vaccine-related injury, is incredibly low.

At the weekend, the Australian Medical Association also said if a patient makes an informed decision to receive the AstraZeneca vaccine, GPs are protected under professional indemnity insurance.

Of course, the reality of low risk may not match the fear practitioners experience. So, are there things we can do to reduce the anxiety practitioners feel regarding liability?




Read more:
Bad reactions to the COVID vaccine will be rare, but Australians deserve a proper compensation scheme


One obvious measure is to move to no-fault systems of compensation. Many countries including the United States and New Zealand have no-fault compensation schemes for vaccine-related injury. Putting such a scheme in place may very well help doctors get over the fear of being sued. It might also give patients confidence knowing that in an extremely rare case of injury, they will be covered.

This could be done either with a one-off scheme or by expanding the National Injury Insurance Scheme, which covers personal injuries from motor vehicle accidents.

Without such schemes, Australian patients will only have access to compensation for vaccine-related injury if they can prove it was caused by a failure to act according to medical standards of care or a failure to properly inform the patient of material risks.The Conversation

Cameron Stewart, Professor at Sydney Law School, University of Sydney

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

As India’s COVID crisis worsens, leaders play the blame game while the poor suffer once again


Sujeet Kumar, Jawaharlal Nehru University India is witnessing a sharp spike in COVID-19 cases after months of declining numbers had given the country hope it had made it through the worst of the pandemic relatively unscathed.

On March 1, India recorded just 12,286 new cases, but since early April this figure has skyrocketed to over 100,000 every day. Earlier this week, it hit a record of 168,912 cases in a day — the highest in the world.

As the health crisis escalates, the poor are once again fearing a return to lockdown and economic hardship. Migrants have started fleeing from cities to their home villages in order to avoid the pain and trauma they went through a year ago when Prime Minister Narendra Modi enacted a nationwide lockdown. Many cities, including Mumbai and Delhi, have already announced nightly curfews.




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For now, the Indian government has just asked the states to focus on “stringent containment and public health measures”, including testing, tracing and inoculations. Modi has also appealed to people to get vaccinated during a four-day “Tika Utsav” (special vaccination drive), which began on Sunday.

However, the situation remains grim. Even though India is one of the world’s biggest coronavirus vaccine manufacturers, some states are experiencing vaccine shortages. At the same time, experts fear a lack of social distancing and new variants of the virus are causing infections to potentially spiral out of control.

How the poor suffered during last year’s lockdown

When COVID-19 first appeared in India last year, the Modi government was quick to bring the country together.

In a speech to the nation last March, he announced a 21-day nationwide lockdown of 1.3 billion people with only four hours’ notice. All means of transportation were suspended. The rich and affluent started hoarding food and medicines, while the poor worried about their livelihoods.

A mass migration ensued as hundreds of millions of migrant workers headed from the major cities back to their home villages on foot. This was the most visible face of the humanitarian crisis. Others, however, suffered out of the public eye, such as the street vendors, waste pickers, domestic maids and shopkeepers in slums, who were all forced to stop working.

Migrant laborers wait for buses during last year's lockdown.
Migrant laborers wait for buses to transport them to their hometowns following last year’s lockdown.
AP

As part of a study last year, I helped conduct a series of six rounds of telephone surveys in 20 diverse slums in the city of Patna, the capital of the northeastern Bihar state from July to November.

Nearly all slum residents we spoke with — except the rare few with protected formal sector jobs — were cut off suddenly from their sources of income after the lockdown was announced. And more than 80% of slum households in Patna lost their entire primary source of income.




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‘How will we eat’? India’s coronavirus lockdown threatens millions with severe hardship


Economic recovery since the lockdown has also been slow. By mid-November, one-third of respondents had still not fully recovered their pre-pandemic incomes. Many had been hired back at their old jobs on a part-time basis or at a fraction of their former pay. Many jobs simply disappeared.

The poor survived by cutting back on their food, borrowing money and helping each other.

Given these struggles, there is now a sense of anxiety in these slum communities and a mistrust of the government, especially Modi. Says Ajay, 35, a street vendor who lives in the Kankarbagh slum,

The government finds it is easy to lock us down but not to provide financial and livelihood support. PM is busy campaigning for an election where thousands of people come without masks and are violating social distancing norms.

The government’s failed leadership

Undoubtedly, Modi still remains popular among most ordinary people. When he says something, India listens carefully. It worked well last year, and his appeal compelled people to wear masks and maintain social distancing, helping to flatten the curve and limit the loss of lives.

However, making public speeches will not be enough during this second wave. The prime minister needs to be seen adhering to these practices in his own daily life, but this is not happening on the ground.

In the ongoing elections in West Bengal, Assam, Kerala and Tamil Nadu, as well as the election in Bihar last year, Modi and other party leaders have addressed several rallies without paying much attention to COVID restrictions. Modi himself has addressed more than 20 rallies attended by thousands of unmasked people.

When leaders are seen addressing mass gathering without masks and social distancing, the public will not only assume everything is normal, they will lose their fear of COVID.

Modi has also insisted he would not politicise the pandemic, but he has done exactly that. In states like Maharashtra, Punjab and Chhattisgarh, which are facing a spike in cases, Modi’s party is pointing the finger at the state leaders, who come from opposing parties. The states, meanwhile, are blaming Modi’s government for failed leadership.




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Another concern is the Modi government’s decision to allow a major festival, Kumbh Mela, to take place in Uttrakhand state, which is ruled by his party, the BJP. Several million people gathered at the Ganges River for an auspicious bathing day this week, flouting social distancing practices.

Uttrakhand’s chief minister said the “faith of devotees will overcome the fear of COVID-19”, at a time when infections are skyrocketing.

Millions take part in Hindu festival.
Devotees take holy dips in the Ganges during the Hindu festival, Kumbh Mela.
DIVYAKANT SOLANKI/EPA

Who will help the poor?

As the numbers of COVID-19 cases are rising every day, the fear of a return to lockdown is ever-present, haunting the poor. Many have yet to recover from their previous debts, and COVID-19 is now threatening their livelihoods again.

Last year, several not-for-profit, grassroots organisations came forward to help the migrants and urban poor dwellers, but this is going to be more challenging this year.

Not only have their funds been depleted, but recent changes brought by the government have stopped the flow of foreign aid money to many organisations. Amnesty International announced in September it would halt its operations in India after its bank accounts had been frozen.

One NGO volunteer, Prabhakar, who works with slum dwellers in Patna, told us,

if the government is going to announce the complete lockdown like last year, many people will run out of food, as parent NGOs have stopped sponsoring the small organisations which work with the slum dwellers.

This is the time for Modi to show decisive leadership in not only controlling the surge of the virus, but also providing financial assistance to millions of urban poor and helping them reach their home villages with their dignity intact. This is what is needed to instill trust in the prime minister again.


Binod Kumar, a senior project officer in the Entrepreneurship Development Institute of India, contributed to this article.The Conversation

Sujeet Kumar, Senior Research Fellow, Centre for the Study of Law and Governance, Jawaharlal Nehru University

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

What is Novavax, Australia’s third COVID vaccine option? And when will we get it?


Jamie Triccas, University of SydneyAs AstraZeneca is no longer the preferred vaccine for Australian adults under 50, attention is turning to what other COVID-19 vaccine options are in our arsenal.

The federal government has ordered 40 million doses of the Pfizer vaccine, which will become the mainstay of the rollout, while AstraZeneca will continue to be administered for people over 50 in the current phase 1B.

The federal government also this week ruled out using Johnson & Johnson’s one-shot vaccine.

But Australia does have a deal for a third vaccine, by US biotech company Novavax. The government has ordered 51 million doses of this vaccine, though it’s yet to be approved by Australia’s drug regulator, the Therapeutic Goods Administration (TGA), which is expected to make a decision in the third quarter of the year.

At this stage, Novavax would be made offshore and imported, although Melbourne-based biotech CSL can make the vaccine if requested by the federal government.

How does the Novavax vaccine work?

The Novavax vaccine is given as two doses, similar to the Pfizer and AstraZeneca shots already being used in Australia.

It can be stored for up to three months at fridge temperature, which differs from the Pfizer mRNA vaccine which needs to be kept at ultra-low temperatures. In saying that, the TGA said last week the Pfizer vaccine can be stored at normal freezer temperatures for two weeks during transport, and at fridge temperatures for five days — though must still be kept ultra-cold after transport and in the long-term.

A graphic comparing Australia's three vaccine options
Comparing Australia’s three COVID-19 vaccine options.
Jamie Triccas, made with BioRender, CC BY-ND

The vaccine also uses a different technology to the Pfizer and AstraZeneca vaccines. It’s a “protein subunit” vaccine; these are vaccines that introduce a part of the virus to the immune system, but don’t contain any live components of the virus.

The protein part of the vaccine is the coronavirus’ “spike protein”. This is part of the other COVID-19 vaccines in use but in a different form.




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The Novavax vaccine uses a version of the spike protein made in the lab. The spike proteins are assembled into tiny particles called “nanoparticles” which aim to resemble the structure of the coronavirus, however they cannot replicate once injected and the vaccine cannot cause you to get COVID-19.

In order for these subunit vaccines to generate strong protective responses, they need to include molecules that boost your immune system, called “adjuvants”. The goal of these adjuvants is to mimic the way the real virus would activate the immune system, to generate maximum protective immunity.

Novavax includes an adjuvant based on a natural product known as saponin, an extract from the bark of the Chilean soapbark tree.

How effective is the vaccine compared to those already in use in Australia?

The interim data from phase 3 testing, released in March, was very encouraging. When tested in the UK in a clinical trial including more that 15,000 people, the vaccine was 96% effective at preventing COVID-19 disease for those infected with the original strain of the coronavirus.

This compares well to the Pfizer vaccine, with an efficacy of 95%, and recent data from AstraZeneca demonstrating 76% efficacy against COVID-19.

The Novavax vaccine is also safe. In early clinical testing the vaccine caused mainly mild adverse events such as pain and tenderness at the injection site, and no serious adverse reactions were recorded. In the larger trials, adverse events occurred at low levels and were similar between the vaccine and placebo groups.

What about protection against variants?

In the UK trial, the vaccine maintained strong protection against disease in people infected with the B.1.1.7 “UK variant”, demonstrating 86% efficacy.

This is good news because the B.1.1.7 variant is now dominant in many European countries, is more transmissible and deadly than the original SARS-CoV-2 virus, and is responsible for most of the cases that have arisen recently in Australia.




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Less encouraging is protection against the B.1.351 variant first identified in South Africa, which can evade immunity that developed in response to earlier versions of the virus. The efficacy of Novavax’s shot dropped to 55% in protecting against COVID-19 symptoms from this variant. Protection against severe disease however was 100%, indicating the vaccine will still be important in reducing hospitalisation and death due to this variant.

Novavax, along with the other major vaccine companies, are developing booster vaccines to target the B.1.351 variant. Novavax are planning to test a “bivalent” vaccine, which targets two different strains, using the spike protein from both the original Wuhan strain and the B.1.351 variant.




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The Conversation


Jamie Triccas, Professor of Medical Microbiology, University of Sydney

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

Double trouble: floods and COVID-19 have merged to pose great danger for Timor-Leste


Antonio Dasiparu/EPA

Mark Quigley, The University of Melbourne; Andrew King, The University of Melbourne; Brendan Duffy, The University of Melbourne; Claire Vincent, The University of Melbourne; Ian Rutherfurd, The University of Melbourne; Januka Attanayake, The University of Melbourne, and Lisa Palmer, The University of MelbourneTimor-Leste is reeling after heavy rain caused severe floods and landslides over the Easter weekend, killing at least 42 people. Rates of COVID-19 in Timor-Leste are also on the rise. Together, these hazards threaten to interact with deadly consequences.

Our research has assessed the likelihood of natural hazards coinciding with, and influencing, the COVID-19 pandemic. Unsurprisingly, we found temporary relaxations of COVID-19 restrictions during natural disasters are likely to cause large spikes in infection rates.

In Timor-Leste’s capital Dili, the floods and the pandemic have combined to form a dangerous dynamic. Flood damage prompted authorities to temporarily lift COVID-19 restrictions. Evacuees are gathered in group shelters where social distancing may be challenging. Flooding cut power to some COVID treatment centres and put extra pressure on Timor-Leste’s health system.

The situation offers lessons for other populated, flood-prone cites battling the COVID-19 pandemic. Natural hazards will, of course, persist throughout the pandemic. Better understanding the complex interactions between double disasters will help societies and systems become more resilient.

A boy undergoes a COVID test
A boy undergoes a COVID test in Timor-Leste, where the pandemic response has been complicated by flooding.
Antonio Dasiparu/EPA

Dili: a recipe for disaster

On April 3 and 4, more than 400mm of rain was recorded in Dili. Floodwater and debris washed into populated areas. Recent reports indicate at least 42 people died and 13,554 were displaced. Nearby Indonesian islands were also hit and at least 130 deaths were reported.

Several natural and human factors combine to make Timor Leste vulnerable to flooding.

The country’s mountainous topography (see image below) encourages rainfall and creates steep stream systems that rapidly transfer floodwater into adjacent populated areas. Weak rocks and steep catchments are highly susceptible to landslides.




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Flowing water interacts with the mountains, causing sediment to accumulate in the shape of a fan or cone. This directs flood waters and sediment into central Dili. Also, rampant deforestation and development has increased soil erosion and stream discharge during heavy rain.

Rapid and largely uncoordinated population growth, particularly in Dili, has concentrated vulnerable populations into flood plains and low-elevation coastal areas highly exposed to flooding.

Other factors increasing the flood risk in Dili include:

  • concrete structures that don’t allow water to sink into the ground
  • multi-pylon concrete bridges that trap flood debris
  • urban drainage channels choked with sediment and urban waste.

More broadly in the region, three climate features combined to create ideal conditions for the recent high rainfall and tropical storms: the West Pacific Monsoon, the Madden Julian Oscillation and a La Niña

The top image shows modelled rainfall from April 1 to 5 across Timor-Leste. Inset images show the total daily rain (top left) and maximum hourly rain over a 24-hour period (bottom right) recorded at Dili. The bottom image shows the topography of northern Timor-Leste, where high-elevation catchments exit into low-elevation populations centres of Dili and Laclo.

The COVID combination

Dili is frequently hit by large floods – most recently in March 2020. But this time, the disaster coincided with an escalation in Timor Leste’s COVID-19 infection rate.

In late March this year, the number of new daily cases in Timor-Leste was rising quickly. On April 10, there were 70 new daily cases, bringing the total confirmed cases to more than 1,000.

Even without these twin disasters, many in Timor-Leste already lacked access to medical services and lived below the poverty line. COVID-19 restrictions exacerbated food shortages and poverty.




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Then the floods hit. They left thousands homeless with severely restricted access to food and clean water. Roads and bridges collapsed. Crops were destroyed and firewood collection – essential for cooking – has been difficult in some areas.

The floods disrupted a COVID-19 lockdown in Dili, and forced people into crammed refuge centres. Flooding of a national medical storage facility damaged supplies. The national laboratory also flooded and a COVID-19 isolation facility was temporarily evacuated.

During floods, the risks of waterborne and vector-borne disease outbreaks increases. Should this occur, Timor-Leste’s fragile health system would be under even greater pressure.

The first batch of COVID-19 vaccines arrived in Timor Leste on April 5 and the vaccination program has managed to operate despite the flood-related challenges.

A road collapsed after floods
Floods in Timor-Leste caused roads to collapse.
Antonio Dasiparu/EPA

A global problem

Many global cities are vulnerable to multiple interacting hazards like those now faced by Timor-Leste. Our analysis suggests 16 of the world’s 20 most populous cities, comprising 5% of the world’s population, have similar geology, population density and/or land use to Dili and could face similar multiple disasters. These cities include Jakarta, Tokyo and Manila.

In emergency situations, the need for disaster response and recovery may justify temporarily lifting COVID-19 restrictions. But pandemic measures must be reinstated as soon as possible. Our modelling, pictured below, suggests when COVID restrictions are lifted in response to a disaster, infection rates ascend rapidly.

Blue line shows confirmed daily COVID-19 infections, which have increased since mid-March. The red and green lines are modelled forecasts for daily infection rates assuming relaxation of COVID-19 restrictions for two weeks (green) and three weeks (red). Testing delays may produce a time-lag between our forecast scenarios and the real-world data.

What can be done?

Potential solutions are more likely to be effective when they involve multiple groups working together. This includes international and local experts, diverse support agencies and affected communities.

Our research identifies ways to improve disaster preparedness and response in a COVID-19 world. They include:

  • developing scenarios and forecasts to deal with the interaction of multiple hazards, including COVID-19
  • using centrally operating disaster coordination platforms to assist and empower local disaster responders
  • evacuation centres that allow for social distancing
  • storing supplies of personal protective gear and medical equipment in areas less exposed to natural hazards
  • mobile teams of humanitarian workers, volunteers and medical staff that can respond to natural disasters in COVID-affected regions.
Dili residents clean up after flooding
Widespread change is needed to protect vulnerable Dili residents from future disasters.
Antonio Dasiparu/EPA

Finally, measures must be taken to reduce the risks posed by future disasters. This must be done in culturally informed ways and includes:

  • improving land and water management
  • land-use planning that considers disaster risk
  • urban clean-up after events such as floods.

Such actions are crucial in developing nations such as Timor-Leste, where urban development can amplify natural hazards with tragic results.

Oktoviano Tilman de Jesus, Demetrio Amaral Carvalho and Josh Trindade contributed invaluable expertise to this work.


This article is part of Conversation series on the nexus between disaster, disadvantage and resilience. Read the rest of the stories here.The Conversation

Mark Quigley, Associate Professor of Earthquake Science, The University of Melbourne; Andrew King, ARC DECRA fellow, The University of Melbourne; Brendan Duffy, Fellow in Structural Geology and Tectonics, The University of Melbourne; Claire Vincent, Lecturer in Atmospheric Science, The University of Melbourne; Ian Rutherfurd, Professor in Geography, The University of Melbourne; Januka Attanayake, Research Fellow, The University of Melbourne, and Lisa Palmer, Associate Professor, School of Geography, The University of Melbourne

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

3 mRNA vaccines researchers are working on (that aren’t COVID)


from www.shutterstock.com

Archa Fox, The University of Western Australia and Damian Purcell, The Peter Doherty Institute for Infection and ImmunityThe world’s first mRNA vaccines — the COVID-19 vaccines from Pfizer/BioNTech and Moderna — have made it in record time from the laboratory, through successful clinical trials, regulatory approval and into people’s arms.

The high efficiency of protection against severe disease, the safety seen in clinical trials and the speed with which the vaccines were designed are set to transform how we develop vaccines in the future.

Once researchers have set up the mRNA manufacturing technology, they can potentially produce mRNA against any target. Manufacturing mRNA vaccines also does not need living cells, making them easier to produce than some other vaccines.

So mRNA vaccines could potentially be used to prevent a range of diseases, not just COVID-19.

Remind me again, what’s mRNA?

Messenger ribonucleic acid (or mRNA for short) is a type of genetic material that tells your body how to make proteins. The two mRNA vaccines for SARS-CoV-2, the coronavirus that causes COVID-19, deliver fragments of this mRNA into your cells.

Once inside, your body uses instructions in the mRNA to make SARS-CoV-2 spike proteins. So when you encounter the virus’ spike proteins again, your body’s immune system will already have a head start in how to handle it.

So after COVID-19, which mRNA vaccines are researchers working on next? Here are three worth knowing about.

1. Flu vaccine

Currently, we need to formulate new versions of the flu vaccine each year to protect us from the strains the World Health Organization (WHO) predicts will be circulating in flu season. This is a constant race to monitor how the virus evolves and how it spreads in real time.

Moderna is already turning its attention to an mRNA vaccine against seasonal influenza. This would target the four seasonal strains of the virus the WHO predicts will be circulating.

But the holy grail is a universal flu vaccine. This would protect against all strains of the virus (not just what the WHO predicts) and so wouldn’t need to be updated each year. The same researchers who pioneered mRNA vaccines are also working on a universal flu vaccine.

The researchers used the vast amounts of data on the influenza genome to find the mRNA code for the most “highly conserved” structures of the virus. This is the mRNA least likely to mutate and lead to structural or functional changes in viral proteins.

They then prepared a mixture of mRNAs to express four different viral proteins. These included one on the stalk-like structure on the outside of the flu virus, two on the surface, and one hidden inside the virus particle.

Studies in mice show this experimental vaccine is remarkably potent against diverse and difficult-to-target strains of influenza. This is a strong contender as a universal flu vaccine.




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2. Malaria vaccine

Malaria arises through infection with the single-celled parasite Plasmodium falciparum, delivered when mosquitoes bite. There is no vaccine for it.

However, US researchers working with pharmaceutical company GSK have filed a patent for an mRNA vaccine against malaria.

The mRNA in the vaccine codes for a parasite protein called PMIF. By teaching our bodies to target this protein, the aim is to train the immune system to eradicate the parasite.

There have been promising results of the experimental vaccine in mice and early-stage human trials are being planned in the UK.

This malaria mRNA vaccine is an example of a self-amplifying mRNA vaccine. This means very small amounts of mRNA need to be made, packaged and delivered, as the mRNA will make more copies of itself once inside our cells. This is the next generation of mRNA vaccines after the “standard” mRNA vaccines seen so far against COVID-19.




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COVID-19 isn’t the only infectious disease scientists are trying to find a vaccine for. Here are 3 others


3. Cancer vaccines

We already have vaccines that prevent infection with viruses that cause cancer. For example, hepatitis B vaccine prevents some types of liver cancer and the human papillomavirus (HPV) vaccine prevents cervical cancer.

But the flexibility of mRNA vaccines lets us think more broadly about tackling cancers not caused by viruses.

Some types of tumours have antigens or proteins not found in normal cells. If we could train our immune systems to identify these tumour-associated antigens then our immune cells could kill the cancer.

Cancer vaccines can be targeted to specific combinations of these antigens. BioNTech is developing one such mRNA vaccine that shows promise for people with advanced melanoma. CureVac has developed one for a specific type of lung cancer, with results from early clinical trials.

Then there’s the promise of personalised anti-cancer mRNA vaccines. If we could design an individualised vaccine specific to each patient’s tumour then we could train their immune system to fight their own individual cancer. Several research groups and companies are working on this.

Yes, there are challenges ahead

However, there are several hurdles to overcome before mRNA vaccines against other medical conditions are used more widely.

Current mRNA vaccines need to be kept frozen, limiting their use in developing countries or in remote areas. But Moderna is working on developing an mRNA vaccine that can be kept in a fridge.

Researchers also need to look at how these vaccines are delivered into the body. While injecting into the muscle works for mRNA COVID-19 vaccines, delivery into a vein may be better for cancer vaccines.




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The vaccines need to be shown to be safe and effective in large-scale human clinical trials, ahead of regulatory approval. However, as regulatory bodies around the world have already approved mRNA COVID-19 vaccines, there are far fewer regulatory hurdles than a year ago.

The high cost of personalised mRNA cancer vaccines may also be an issue.

Finally, not all countries have the facilities to make mRNA vaccines on a large scale, including Australia.

Regardless of these hurdles, mRNA vaccine technology has been described as disruptive and revolutionary. If we can overcome these challenges, we can potentially change how we make vaccines now and into the future.The Conversation

Archa Fox, Associate Professor and ARC Future Fellow, The University of Western Australia and Damian Purcell, Professor of virology and theme leader for viral infectious diseases, The Peter Doherty Institute for Infection and Immunity

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

Japan is facing a fourth COVID wave and sluggish vaccine rollout. Will it be ready for the Olympics?


KYDPL KYODO/AP

Craig Mark, Kyoritsu Women’s UniversityAs a fourth wave of the coronavirus pandemic worsens in Japan, Prime Minister Yoshihide Suga faces a formidable challenge to successfully host the increasingly beleaguered Tokyo Olympic and Paralympic Games, with less than 100 days left to go.

More contagious variants of COVID-19 are spreading from Japan’s second-largest city Osaka. Cases are already rising again in Tokyo, requiring a so-called “quasi state of emergency” to be reimposed in Japan’s major cities.

Anxieties are also rising over the country’s sluggish vaccine rollout, which is far behind many other countries, including Singapore, South Korea and Indonesia. Opinion polls show up to 70% of Japanese feel the vaccine rollout has been too slow.

As the head of one nursing care centre put it,

the government doesn’t seem to understand the urgency of the matter.

A delayed start to Japan’s vaccine rollout

Taro Kono, the minister in charge of the rollout, has said 100 million doses should be stockpiled by June to cover the country’s elderly population (36 million people), health care workers and those with pre-existing conditions. This means, however, less than half the population is likely to be vaccinated when the Olympics start on July 23.

The main cause of the slow rollout stems from the initial decision by the government to go through a delayed approval process for the Pfizer-BioNTech vaccine.

Japan only began vaccinating those over 65 years old this week.
Kyodo News/AP

Even though Phase 3 trials were concluded last November and the vaccine was approved by the World Health Organisation on December 31, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) took another six weeks to conclude its own trials before granting approval. The rollout has been further impeded by strains on Pfizer’s production capacity and export controls imposed by the European Union.

At least four Japanese pharmaceutical companies have been conducting their own vaccine trials, but these have been stymied by a lack of investment and the slow pace of bureaucratic approval by the PMDA.




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Japan also has orders for 120 million doses of the AstraZeneca vaccine and 50 million doses of Moderna’s vaccine, with hopes they will be approved for distribution and domestic production by May. Local trials have also begun for the Novavax vaccine, with hopes of being able to produce it domestically by the end of 2021.

Though achingly slow to be delivered, this means Japan has secured the rights for 564 million doses — more than enough for its population of 120 million people.

Osaka’s torch relay was held in a park without any crowds due to COVID concerns.
Hiro Komae/AP

A history of vaccine scares

But vaccine supply isn’t the only issue the country is facing. There are also concerns over the relatively high rate of vaccine reluctance among the Japanese public. Less than 25% strongly agree vaccines are effective, important and safe, according to a survey by The Lancet.

This is the legacy of vaccine safety scares in past decades. A small number of infants died from whooping cough vaccinations in the 1970s, followed by some adverse reactions to a combined measles, mumps and rubella (MMR) vaccine in the 1980s.




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For now, the Tokyo Olympics will go ahead. But at what cost?


Unfounded safety fears even led to the government withdrawing a national vaccination program for the human papillomavirus (HPV) in 2013, with fewer than 1% of Japanese girls now vaccinated for HPV.

Two recent surveys, however, show more than 60% of Japanese people are willing to get a COVID vaccine. The groups with more hesitancy included women and younger generations, with just over half indicating they wanted to get vaccinated.

Political pressure on Suga

For over a year, Japan’s pandemic strategy has largely relied on requests for businesses and the public to take voluntary precautions, such as closing bars and restaurants by 8pm, rather than enforce strict lockdowns. The government’s goal was to minimise the impact on the economy.

The Suga government and that of his predecessor, Shinzo Abe, however, have been under constant criticism for what many perceive as a reactive approach to the crisis. There have been a number of missteps along the way, too.

Prime Minister Yoshihide Suga has seen his popularity drop significantly since the start of his term last year.
Kaname Yoneyama/AP

This has worsened the approval ratings for the governing conservative Liberal Democratic Party (LDP), which has to face a national election for the lower house of the Diet (Japan’s parliament) by October. Numerous corruption scandals implicating LDP Diet members, senior bureaucrats and even Suga himself have also undermined public support for the government, which could ultimately threaten Suga’s leadership.

Relations have also worsened between Suga and leaders of Japan’s prefectural governments, especially the governors of Osaka and Tokyo. They have been insisting a “quasi state of emergency” be reimposed for at least a month, following the premature lifting of the previous state of emergency on March 21.

Osaka’s governor has also called off the Olympic torch relay through the streets of his city.

Playbook for a COVID-safe Olympics

The Tokyo Olympics, themselves, however, are still proceeding as planned. The Suga and Tokyo governments and the International Olympic Committee believe there is simply too much at stake in terms of corporate sponsorships, broadcasting rights and political prestige — despite the vast majority of Japanese people believing the games should be cancelled or postponed.

Suga is even expected to invite US President Joe Biden to the Olympics during his official visit to the US this week.




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Foreign spectators have now been barred from attending, but organisers are still hopeful to have a domestic audience for the games, particularly since
socially-distanced sporting events have resumed in Japan, such as baseball, soccer and sumo wrestling.

However, there is so far no requirement that local spectators be vaccinated. And the IOC is only encouraging — not requiring — that athletes be vaccinated, according to IOC Vice President John Coates.

All athletes, coaches and support staff, as well as the foreign media, will instead have to show negative COVID-19 test results before entering Japan. They will also be required to follow a COVID-safe “Playbook”, which will strictly control their activities during the games and require testing every four days.

How the government handles the games may just determine its fate in the October elections.

Scandals and negative publicity have swirled around the event for months, putting enormous pressure on the government and organisers.

Last week, a report that priority vaccinations were being considered for the Japanese Olympic team ahead of the public sparked a social media backlash and prompted a denial by the government.

With less than 100 days to go until the opening ceremonies, the Suga government needs to take a stronger approach towards the pandemic and dramatically speed up its vaccine rollout. The success of the games — and the survival of Suga’s government — depend on it.The Conversation

Craig Mark, Professor, Faculty of International Studies, Kyoritsu Women’s University

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

How safe are your data when you book a COVID vaccine?


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Joan Henderson, University of Sydney and Kerin Robinson, La Trobe UniversityThe Australian government has appointed the commercial company HealthEngine to establish a national booking system for COVID-19 vaccinations.

Selected through a Department of Health limited select tender process, the platform is being used by vaccine providers who don’t have their own booking system.

However, HealthEngine has a track record of mishandling confidential patient information.

Previous problems

In 2019 the Australian Competition and Consumer Commission took HealthEngine to court for allegedly skewing reviews and ratings of medical practices on its platform and selling more than 135,000 patients’ details to private health insurance brokers.

The Federal Court fined HealthEngine A$2.9 million in August 2020, just eight months ago.

Department of Health associate secretary Caroline Edwards told a Senate hearing the issues were “historical in nature, weren’t intentional and did not involve the sharing of clinical or medical related information”.

How might the alleged misconduct, which earned HealthEngine A$1.8 million, be considered “historical in nature” and “not intentional”?

Edwards added that HealthEngine had strengthened its privacy and security processes, following recommendations in the ACCC’s digital platforms inquiry report. Regarding the new contract, she said:

[…] the data available to HealthEngine through what it’s been contracted to do does not include any clinical information or any personal information over what’s required for people to book.

That’s somewhat reassuring, considering the larger amount of information usually requested from patients booking an appointment (as per HealthEngine’s current Privacy Policy).

The list of personal information HealthEngine may collect from patients booking an appointment with a health professional.
Screenshot

Importantly, HealthEngine then owns this information. This raises an important question: why is so much personal information requested just to book an ordinary appointment?

A need for accessible information

While using HealthEngine to book a vaccination is not mandatory, individual practices will determine whether patients can make appointments over the phone, are directed to use HealthEngine’s platform, or another existing platform.

Personal details currently requested through HealthEngine’s vaccination booking system are:

HealthEngine’s Privacy Policy for COVID-19 vaccination bookings.
screenshot

This list is substantially shorter than the one concerning non-COVID related bookings. That said, there’s still more information being gathered than would be required for the sole purpose of arranging a patient’s vaccination.

What is the justification for this system to collect data about patients’ non-COVID medical and health services, or the pages they visit?

A representative from the Department of Health told The Conversation that all patient data collected through the COVID vaccination booking system was owned by the department, not HealthEngine. But what need would the department have to collect web analytics data about what sites a patient visits?

An underlying administrative principle of any medical appointment platform is that it should collect the minimum amount of data needed to fulfil its purpose.

Also, HealthEngine’s website reveals the company has, appropriately, created an additional privacy policy for its COVID-19 vaccination booking platform. However, this is currently embedded within its pre-existing policy. Therefore it’s unlikely many people will find, let alone read it.

For transparency, the policy should be easy to find, clearly labelled and presented as distinct from HealthEngine’s regular policies. A standalone page would be feasible, given the value of the contract is more than A$3.8 million.

What protections are in place?

Since the pandemic began, concerns have been raised regarding the lack of clear information and data privacy protection afforded to patients by commercial organisations.

Luckily, there are safeguards in place to regulate how patient data are handled. The privacy of data generated through health-care provision (such as in general practices, hospitals, community health centres and pharmacies) is protected under state and territory or Commonwealth laws.

Data reported (on a compulsory basis) by vaccinating clinicians to the Australian Immunisation Register fall within the confines of the Australian Immunisation Register Act 2015 and its February 2021 amendment.




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Also, data collected through the Department of Health’s vaccination registration system are legally protected under the Privacy Act 1988, as are data collected via HealthEngine’s government-approved COVID-19 vaccination booking system.

But there’s still a lack of clarity regarding what patients are being asked to consent to, the amount of information collected and how it’s handled. It’s a critical legal and ethical requirement patients have the right to consent to the use of their personal information.

If the privacy policy of a booking system is unclear, this presents risk for patients who have challenges with the English language, literacy, or are potentially distracted by pain or anxiety while making an appointment.
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Gaps in our knowledge

As health information managers, we had further questions regarding the government’s decision to appoint HealthEngine as a national COVID-19 vaccination booking provider. The Conversation put these questions to HealthEngine, which forwarded them to the Department of Health. They were as follows.

  1. Is there justification for the rushed outsourcing of the national appointment platform, given the number of vaccine recipients whose data will be collected?
  2. How did the department’s “limited select tender” process ensure equity?
  3. Who will own data collected via HealthEngine’s optional national booking system?
  4. What rights will the “owner” of the data have to give third-party access via the sharing or selling of data?
  5. What information will vaccine recipients be given on their right to not use HealthEngine’s COVID-19 vaccination booking system (or any appointment booking system) if they’re uncomfortable providing personal information to a commercial entity?
  6. How will these individuals be reassured they may still receive a vaccine, should they not wish to use the system?

In response, a department representative provided information already available online here, here, here and here. They gave no clarification about how patients might be guided if they’re directed to the HealthEngine platform but don’t want to use it.

They advised the data collected by HealthEngine:

can not be used for secondary purposes, and can only be disclosed to third-party entities as described in HealthEngine’s tailored Privacy Policy and Collection Notice, as well as the department’s Privacy Notice.

But according to HealthEngine’s privacy policy, this means patient data could still be provided to other health professionals a patient selects, and de-identified information given to the Department of Health. The policy states HealthEngine may also disclose patients’ personal information to:

  • third-party IT and software providers such as Adobe Analytics
  • professional advisers such as lawyers and auditors, for the purpose of providing goods or services to HealthEngine
  • courts, tribunals and law enforcement, as required by law or to defend HealthEngine’s legal rights and
  • others parties, as consented to by the patient, or as required by law.

Ideally, the answers to our questions would have helped shed light on the extent to which patient privacy was considered in the government’s decision. But inconsistencies between what is presented in the privacy policies and the Department of Health’s response have not clarified this.




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The Conversation


Joan Henderson, Senior Research Fellow (Hon). Editor, Health Information Management Journal (HIMJ), University of Sydney and Kerin Robinson, Adjunct Associate Professor, La Trobe University

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