Children may need to be vaccinated against COVID-19 too. Here’s what we need to consider



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Ketaki Sharma, University of Sydney; Kristine Macartney, University of Sydney, and Nicholas Wood, University of Sydney

An ideal COVID-19 vaccine would not only protect people from becoming ill, it would also stop the virus spreading through the population. The best way to do this is to vaccinate as many people as possible.

If the best available vaccine is only moderately protective — for example, if it only prevents 50% of infections — we might need to vaccinate children as well as adults to interrupt the spread.

There is no COVID-19 vaccine being developed specifically for children. So if children are to be vaccinated, they will likely receive the same vaccine as adults. They might require a different dosing schedule, but that is not yet clear.

So what are the issues with developing a safe and effective COVID-19 vaccine for children? And where are we up to with clinical trials including them?

Why children?

Children don’t appear to be “super-spreaders” of COVID-19, although they can still be infected. And if infected, they have a lower risk of severe illness or death than adults.

However, some children may have a higher risk of severe illness, such as those with existing medical problems. We are also learning more about a rare but serious inflammatory condition reported in some children after COVID-19 infection.

There is also a broader issue at stake. Delaying children’s access to vaccines could delay our recovery from COVID-19. This would prolong the pandemic’s considerable impact on children’s education, health and emotional well-being.




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Rare multisystem inflammatory syndrome in children linked to coronavirus


Would children react differently to a vaccine?

The way a child’s immune system reacts to pathogens or vaccines can be different to adults. Age can determine the number of required doses. For example, infants sometimes require more doses of a vaccine than older children.

Age can also influence the side-effect profile of a vaccine. For example, mild fever following vaccination can be common in babies and young children.

So vaccine developers need to include children in their clinical trials so they can gather age-specific information on the immune response, the effectiveness of the vaccine in preventing disease, and any side-effects.

Are COVID-19 vaccines already being tested in children?

Vaccine trials are usually done in stages. They typically start with healthy, young and middle-aged adults.

Once a vaccine is confirmed to be safe in these earlier trials, developers then test the vaccine in older and younger age groups.

Children playing outside under a colourful parachute
Some vaccine developers have already announced plans to test their COVID-19 vaccines in children.
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Several COVID-19 vaccine developers already have plans to include children in their clinical trials.

University of Oxford researchers will recruit children aged 5-12 into a phase 2/3 trial of its vaccine. This is one of the vaccines for which the Australian government has a supply agreement, should clinical trials prove successful.




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Pfizer will enrol children aged 12 and older in a phase 2/3 trial of its vaccine. Multiple developers in China and in India are also including children in COVID-19 vaccine trials, some as young as six.

All of these trials are ongoing and have not released results.




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How could we get more children included in trials?

We need more children included in clinical trials, an issue recognised globally. For instance, the US Food and Drug Administration announced it will work as quickly as possible with vaccine developers to set up trials for COVID-19 vaccines in children.

The US National Institutes of Health is developing a protocol for researchers to include children in vaccine trials in a safe but timely way.

Having a universal protocol, which we don’t yet have for COVID-19 vaccine trials, would make it easier for researchers to include children in future trials, and to compare different vaccines.

There are no protocols yet including children in COVID-19 vaccine trials run in Australia. Any Australian studies would only likely examine the immune response and safety in children (phase 1 and 2 trials). They would probably not examine effectiveness (phase 3 trials) because of the low rates of COVID-19 here.




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Before any child is enrolled in a trial their parent or guardian will be asked to read an information sheet that explains the risks and benefits of taking part. Safety data from earlier trials in adults would need to be included in child-specific information sheets, so parents are aware of the known risks before they decide to enrol their child.

In Australia, it may be a challenge to enrol children in COVID-19 vaccine trials, as the disease burden is low compared with other countries, so parents may not want their child to take part.

However, it is important we learn as much as we can about how COVID-19 vaccines perform in children, and participating in such research helps us gather this valuable information.

How is vaccine safety assessed?

Vaccine trials are closely supervised by an independent data and safety monitoring board, who follow strict protocols and have the authority to pause a trial if there are safety issues.

Australia also has strict guidelines for the registration of vaccines. A vaccine will only be licensed if its safety has been demonstrated in large studies, usually including many thousands of people. Usually, vaccines are registered according to the age groups in which trials have been done.

Even after a vaccine is licensed in Australia, its safety continues to be monitored. A doctor, patient or parent can report side-effects to the authorities.




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Alternatively, researchers can more actively engage with the public to monitor side-effects, such as with the AusVaxSafety system.

In this system, when a GP gives someone a vaccine, that person receives a text message three days later to ask about side-effects and to complete a survey on their smart phone or computer. This is “real time”, important safety data.

We already use this system to monitor the safety of each year’s flu vaccines and will potentially use it when COVID-19 vaccines are rolled out into the community.

In a nutshell

Although there has been extraordinary progress in COVID-19 vaccine trials, only some vaccine developers have taken steps to recruit children so far. That needs to change if we are to protect children and the wider community. So we need protocols that make it easier for researchers to recruit children into COVID-19 vaccine trials.

As early data in adults accumulates, providing information to parents — and where age-appropriate, their children — to consent to their child participating in trials has a lot of benefits. It will also ultimately help us in the race to end this pandemic.The Conversation

Ketaki Sharma, PhD student, University of Sydney; Kristine Macartney, Professor, Discipline of Paediatrics and Child Health, University of Sydney, and Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of Sydney

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

Curious Kids: how do vaccines kill viruses?



Palak Mehta, Author provided

Kylie Quinn, RMIT University and Palak Mehta, RMIT University

How are vaccines made to kill a virus? Layla, aged 7

Thanks Layla. This is a very important question, especially now, as scientists all around the world are working hard to develop a vaccine to protect us against the coronavirus. Actually, scientists are trying to find vaccines for many different diseases.

To understand how vaccines are made, we first need to understand how viruses make us sick, and how special cells in our bodies defend us against infections.




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Viruses are pretty sneaky

Viruses make us sick when they invade our cells. The way this works is kind of complicated — us scientists have to study for many years to fully understand it. But you can think of it like this.

Viruses can get inside our cells by using a special key that fits into a lock on the outside of our cells. Once inside, the virus hijacks the cell, forcing it to make more virus by turning cells into tiny virus factories.

Viruses use a special key to get inside our cells and start to make us sick.
Palak Mehta, Author provided

This is stressful for our cells, which can make us start to feel sick. The virus made in the virus factories can spread the infection through our body, to make us even sicker.

It can also spread from our body to infect other people, and make them sick too.

Your immune system is your defence force

Your immune system is made up of immune cells — very special cells that live all throughout your body. Their job is to look out for any signs of an infection and defend all the other cells in your body when there is a threat.

There are many types of immune cells that work as a team to stop and even kill the virus. Two very important immune cells are B cells and T cells.

Our immune cells — T cells and B cells — can defend us against viruses.
Palak Mehta, Author provided

B cells make a secret weapon called antibodies. Antibodies are tiny Y-shaped particles that are incredibly sticky — they stick all over the key on the virus so it no longer fits into the lock on our cells. This stops the virus from getting in and causing an infection.

If a virus does sneak past the B cells and get into our cells, T cells can deal with it — they are the ninjas of our immune system! They kill any cells that get infected to stop the virus from spreading within our body.

Our body comes across viruses — like the common cold, for example — every day, and they don’t always make us sick because our immune cells can protect us. But our immune cells are much better at their job if the virus is one they’ve seen before.

If we come across a new virus — like the coronavirus, for example — our immune cells can’t recognise it straight away. This gives the virus a chance to infect our cells and it can start to make us sick.




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Vaccines teach our immune cells about the virus

All vaccines contain a little piece of the virus, which our immune cells pick up and start to show to each other. Our B cells and T cells can then recognise that little piece of virus and remember it, sometimes for years.

Vaccines protect against viruses by teaching our immune cells what the virus looks like.
Palak Mehta, Author provided

The next time we see that virus, our immune cells recognise it straight away and kick into action.

If our immune cells can act quickly enough, we won’t get sick, and our bodies won’t make more virus that could make other people sick.

So, we hope that answers your question Layla. Your immune system is a powerful defence force — it protects you every day from infections. But sometimes it needs a little help from a vaccine, especially with a new virus it hasn’t seen before.


Hello, curious kids! Have you got a question you’d like an expert to answer? Ask an adult to send your question to curiouskids@theconversation.edu.auThe Conversation


Kylie Quinn, Vice-Chancellor’s Research Fellow, School of Health and Biomedical Sciences, RMIT University and Palak Mehta, PhD student, RMIT University

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

Who pays compensation if a COVID-19 vaccine has rare side-effects? Here’s the little we know about Australia’s new deal



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Nicholas Wood, University of Sydney

In last week’s federal budget the Australian government announced it had given the suppliers of two COVID-19 vaccines indemnity against liability for rare side-effects.

Although details are unclear, it appears the government would foot the bill for compensation if a member of the public wins legal action against the drug company.

This is in contrast to 25 other countries with no-fault compensation schemes for rare vaccine side-effects.

Here’s the little we know about Australia’s latest indemnity deal and what we could be doing better.

What do we know about Australia’s new deal?

The deal relates to two vaccines the government had previously announced it would supply, should clinical trials prove successful.

These are the University of Oxford vaccine, from AstraZeneca, and the University of Queensland vaccine, from Seqirus (part of CSL).

However, it is not entirely clear what this indemnity deal means in practice. The budget papers say the government will cover:

certain liabilities that could result from the use of the vaccine.

The government considers further details “commercial in confidence”.

For instance, we don’t know how serious or disabling a side-effect would have to be to qualify or whether there is any cap on the amount of compensation.

We also don’t know what would happen if there were errors involved, or contaminants introduced, while manufacturing the vaccine. These would still be the company’s liability, but it may be hard to determine where boundaries lie.




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How unusual is this?

This deal is not entirely new or unexpected. The government has provided some indemnity to pharmaceutical companies that make vaccines against smallpox and influenza.

The governments of many other countries have also agreed to indemnify COVID-19 vaccine manufacturers, including governments in the UK, US and the European Union.

The manufacturers believe that as the use of their vaccine is for the benefit of society, they should not be held financially accountable for any consequences from a vaccine reaction.




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So what does this mean for the public?

If a person in Australia believes they have been injured by a vaccine, including future COVID-19 vaccines, they will need to pursue compensation through the legal system.

Under the latest agreement, it would appear the government, rather than the drug company, would pay that compensation, should the person win their case.

However this is not ideal. The person still has to engage with the legal system, which is both costly and complex, and there’s no guarantee of success.

Woman consulting professional looking woman in office
Under the latest indemnity deal, it seems that people would still need to go through the legal system, with no guarantee of success.
www.shutterstock.com

Compensation may not even be possible via our legal system. That’s because in most cases, it will be difficult to show in court a serious side-effect was due to a fault in the vaccine composition or negligence in the way it was administered.

So in Australia, people with a vaccine injury, either COVID-19 or other vaccine, will likely bear the costs of their injury by themselves, and seek treatment by our publicly-funded or private health systems.

The National Disability Insurance Scheme helps fund therapies for people with a permanent and significant disability but does not cover temporary vaccine-related injuries.

Participants in COVID-19 vaccine clinical trials can be compensated for temporary and permanent vaccine injuries.




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What’s happening overseas?

In the US, people with a rare but serious reaction to a COVID-19 vaccine will be able to access a special compensation scheme. This is designed to provide compensation for the use of COVID-19 pandemic medications and vaccines.

However, applicants only have one year from the date they had the vaccine or medicine to request benefits.

The US already has a vaccine compensation scheme for vaccines other than COVID-19. This is an example of a no-fault compensation scheme. These compensate for specific vaccine reactions, without having to go to court to prove the vaccine manufacturer is liable.

Australia, in contrast to 25 countries including the US, UK and New Zealand, does not have a no-fault vaccine compensation scheme, and does not have the equivalent of the US COVID-19 vaccine compensation scheme.

How would a no-fault system work?

There are numerous benefits to a no-fault vaccine compensation system. These include simplified access to compensation, and avoiding a lengthy, costly and complex encounter with the legal system, with no guarantee of success.

Most are government funded. The US government funds it by a flat rate of US$0.75 for each disease prevented for each vaccine dose.

Finland and Sweden fund their programs via insurance payments from pharmaceutical companies marketing their products there.

The New Zealand scheme includes compensation for vaccine-related injuries, as well as for accidents and treatment injuries. This is funded through a combination of general taxation, and levies collected from employee earnings, businesses, vehicle licensing and fuel.

However, compensation awarded via such no-fault schemes is usually lower than you would receive after a successful liability lawsuit.




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Where to next?

To encourage people to receive COVID-19 vaccines for the benefit of the entire community, we need compensation schemes to be in place if there is a rare but serious side-effect.

Should options to increase vaccine uptake include mandates or penalties — such as employment or travel restrictions if not vaccinated — this would make a no-fault vaccine compensation scheme even more essential.

Although it is important manufacturers receive indemnity for “certain liabilities”, we still need to look after our community. That means a compensation system the public can easily access and which provides appropriate support.The Conversation

Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of Sydney

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

Infecting volunteers with coronavirus may be one way to test potential vaccines. But there are risks



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Euzebiusz Jamrozik, Monash University; Kanta Subbarao, The Peter Doherty Institute for Infection and Immunity, and Michael Selgelid, Monash University

Researchers are considering using “human challenge studies” to accelerate COVID-19 vaccine research and development. This would involve giving an experimental vaccine to healthy volunteers, then deliberately exposing them to the virus to see whether they’re protected from infection.

Challenge studies can also allow scientists to monitor the progress of infectious diseases from the moment they begin, and to study infection and immunity more closely than other types of research.

These studies can answer scientific questions in a short time. They recruit small numbers of participants — up to around 100 volunteers per study — usually young, healthy adults.

However, deliberate infection with SARS-CoV-2, the virus that causes COVID-19, involves risks to volunteers.

How do these studies differ from standard, larger studies?

Standard “field” trials for some COVID-19 vaccine candidates have already begun. Each aims to recruit at least 10,000 people. Usually, half or two-thirds receive the experimental vaccine and the rest might receive a placebo or a vaccine against another disease.

Participants then go about their daily lives. Scientists observe whether those who received the COVID-19 vaccine are less frequently infected with the virus than the other group, allowing them to determine how effective the vaccine is.

Two scientists in a lab look at a syringe.
Human challenge studies involve fewer participants than standard field trials.
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In large epidemics, field trials can quickly reveal whether a vaccine works. But proof may be delayed when there’s less community transmission, for example due to local public health measures.

If current field trials identify a highly effective vaccine, there might be less need for human challenge trials. However, if the first vaccines fail, or turn out to be only moderately effective, challenge studies could be used to select the next most promising candidates for future field trials.




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Challenge studies need extra preparation

First, scientists need to prepare a strain of SARS-CoV-2 in the laboratory to administer to volunteers. The strain needs to be similar to the virus circulating in the community.

There’s also a need for special research facilities with health-care support and capacity to isolate participants.

Volunteers may have to remain in these facilities for 2–3 weeks to be closely monitored, and so they are not released into the community while they may be infectious.




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Past experience and recent developments

While COVID-19 challenge trials are now making news, scientists have previously conducted these kinds of experiments with many different types of microorganisms.

Such studies have been used to develop vaccines against malaria, typhoid and cholera. They have also provided unique insights into immunity to influenza and “common cold” coronaviruses.

One research centre in London has announced a plan to conduct challenge studies with SARS-CoV-2. Another centre in the United States is also preparing a strain of the virus.

Ethical and scientific questions

The World Health Organisation (WHO) convened two advisory groups, in which we were involved, to consider COVID-19 human challenge studies. One focused on ethics, the other on scientific and technical aspects.

The ethics group identified eight criteria proposed challenge studies would need to meet before going ahead.

These included the need for researchers to consult and engage with the general public before, during, and after the trials. There would also need to be careful independent expert review, and demonstration that expected benefits are likely to outweigh risks.

Relevant risks might be especially hard to predict for SARS-CoV-2, partly because it’s a new pathogen.

While young, healthy people generally fare better with COVID-19 than older adults with pre-existing conditions, there are exceptions. For example, a multisystem inflammatory syndrome has been reported in rare cases among previously healthy adults after they contracted COVID-19.




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Members of WHO’s science group agreed on a number of technical requirements for COVID-19 challenge studies to maximise volunteers’ safety and prevent wider spread of infection.

These included recruiting only healthy young adults, conducting the studies under strict biosafety procedures (for example, isolating participants), giving the virus via the nose to mimic natural infection, and carefully increasing the dose of the virus.

Group of young adult students outside looking at books and papers, studying
Only young adults without underlying health conditions could volunteer for these studies.
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However, the experts were split on other issues, such as whether:

  • challenge studies would actually accelerate vaccine approval

  • results in young healthy adults would demonstrate whether or not a vaccine works for older people

  • challenge trials should begin before a proven and highly effective treatment for COVID-19 becomes available.

What next?

To design an ethically acceptable challenge study, it’s important to minimise the risks to study volunteers, research staff, and the wider community.

In the future, there may be additional ways scientists can reduce the risks. They may be able to better identify those at lowest risk of severe infection, develop a weakened strain of the virus, or have a highly effective treatment on hand to use if needed.

In the meantime, scientists could obtain results relevant to COVID-19 by conducting less risky challenge studies with other viruses.

For example, challenge studies with “common cold” coronaviruses, which are being considered in Australia, could teach us about the types of immune responses that protect us against coronavirus diseases.




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Research eventuating in safe and effective vaccines for COVID-19 could save many lives. However, whether the benefits of challenge studies in the current pandemic outweigh the risks depends on many factors.

We must carefully consider proposals for these studies in light of the current state of science and vaccine development, and update our evaluations as new data emerge.The Conversation

Euzebiusz Jamrozik, Infectious Disease Ethics Fellow, Ethox & Wellcome Centre for Ethics and Humanities, Univeristy of Oxford. Adjunct, Monash University; Kanta Subbarao, Professor, The Peter Doherty Institute for Infection and Immunity, and Michael Selgelid, Professor of Bioethics, Monash Bioethics Centre, Monash University, Monash University

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

The budget assumes a COVID-19 vaccine becomes available next year. Is this feasible?


Holly Seale, UNSW

The Australian federal budget, unveiled on Tuesday, bases several assumptions on Australians having access to a COVID-19 vaccine in 2021.

This timeline is possible, according to researchers on the frontline of vaccine development. A survey published in early October asked 28 US and Canadian experts when they thought a COVID-19 vaccine would be available.

They weren’t optimistic a vaccine would be available before mid-2021, but on average thought September or October 2021 was achievable. However, several thought it could take until July 2022.

They also thought a vaccine could be available by March or April 2021 to people with a high risk of either contracting the disease or having serious consequences, such as health-care workers.

But in this scenario, it’s likely healthy adults will have to wait a while longer.

Even if we do get a successful vaccine, it won’t necessarily mark the immediate end of COVID-19. It might only be 60-70% effective, which means it won’t stop transmission completely, and spot fires of infection will continue to crop up.

Unfortunately, this means we have to accept the fact public health measures aren’t going away soon. Social distancing, mask-wearing, contact tracing, and limits on gatherings and workplaces will remain part of our lives for some time to come.

Governments and the media need to start communicating this to the public, rather than relying on the idea of a vaccine as a silver bullet.

The political will is unprecedented

Traditionally, vaccines can take five to ten years from the lab to your arm. One of the fastest vaccines ever developed was for a viral infection called mumps, which took less than five years. A vaccine for ebola was also created in about five years. On face value, these may dampen expectations for our ability to make a successful COVID-19 vaccine in just one or two years.

However, unprecedented resources are being poured into the development of a COVID-19 vaccine. The funding available, the number of candidates, and the amount of researchers involved in development are greater than any vaccine previously. The World Health Organisation is tracking more than 190 candidate vaccines in varying stages of development.

There were vaccine candidates in the pipeline for other coronaviruses including SARS and MERS, but the dwindling nature of those outbreaks meant there wasn’t overwhelming political will to see those completed. But COVID-19 is still at pandemic status, meaning a vaccine is seen as vital.




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An approved vaccine is only one step

There are many things we still don’t know about potential COVID-19 vaccines. Successful candidates might require two or more doses, separated by an as yet unknown interval.

Manufacturing is another issue. Many of us might think once a vaccine is approved, the pandemic is over. But there needs to be enough produced to vaccinate everyone in Australia, which takes time.

What’s more, to reduce the risk of importing the virus, or if we want to travel overseas again, there may be a need to ensure robust COVID-19 vaccine programs have been implemented globally. If we’re looking at a two-shot vaccine, global coverage would require almost 16 billion doses, and probably more when accounting for loss of stock, logistical problems and so on. It will also take time to consistently test new batches and conduct safety monitoring of those who’ve received a shot.

Australians may need to rein in their love of travel for a few years yet. We should think about travelling locally and supporting local businesses, rather than jetting off to another continent.




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Getting everyone vaccinated is another challenge

Once we have an approved vaccine, and have made enough of it, there are still hurdles to overcome.

We have a great system of childhood immunisation in Australia, but it’s a very different thing to get healthy adults vaccinated en masse. We don’t necessary have the same strong culture of immunisation towards healthy adults in this country. Public health officials are still battling to increase uptake of yearly flu vaccines.

Although vaccine coverage has surged this year, historically Australia has recorded less than optimal uptake for influenza vaccination for adults who are medically at-risk. And, our vaccine coverage for other recommend vaccines including for shingles, pneumococcal and whooping cough also needs improving.

In a study I led (yet to be peer-reviewed), my colleagues and I found 80% of the Australian residents surveyed agreed “getting myself vaccinated for COVID-19 would be a good way to protect myself against infection”. Another challenge, therefore, is there may be some people who have misgivings about receiving a vaccine.

To support future uptake to the required levels, we may need to focus on the factors that motivate people to get vaccinated. It may be necessary to highlight that getting immunised isn’t just to protect ourselves, but to protect our family, friends, colleagues, and community at large. This is particularly crucial given evidence COVID-19 can spread asymptomatically.




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Beyond ensuring we promote acceptance of a vaccine to the public, we also need to minimise practical barriers. To improve access, we may need to offer the vaccine at multiple locations and times. For example, we could convert existing drive-through testing centres into drive-through immunisation clinics. We could also look to deliver people the vaccine via pharmacies, workplaces or community centres, or in other environments that make sense to them, like their local church, mosque, synagogue or temple.

Ultimately, the federal government’s belief that a vaccine will be available next year is plausible. But it’s not the full picture. The hurdles that exist in ending the pandemic go beyond the approval of a vaccine candidate.




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The Conversation


Holly Seale, Senior Lecturer, UNSW

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

Vaccine refusers are health literate and believe they’re pro-science. But this just reinforces their view


Tomas Rozbroj, Monash University

Australians belonging to the vaccine refusal movement consider themselves a science advocacy group, according to a study published today.

My colleagues and I found this group believes it lobbies for unbiased research against increasing industry interference. We also found vaccine refusers construct their identities around developing health literacy, engaging with science and being informed when making decisions about their health.

Other research shows people who refuse vaccines seek to take control of their health decisions. And conversely, they think people who follow public health advice to vaccinate lose out by not educating themselves.

It may be tempting to dismiss these self-perceptions. But that would be to miss the point.

The vaccine refusal movement is a loosely connected community that organises to resist vaccination programs. Not all Australians who refuse vaccines are part of the movement. There is great diversity in the extent to which people refuse vaccines, and in their reasons for doing so.

On average, Australians who refuse vaccines know more about vaccination than do those who fully vaccinate, perhaps because their scepticism prompts them to seek out information. They access both mainstream and alternative vaccine information. People who refuse vaccines are often more likely to have higher health literacy.

Refusing vaccines is risky, and it can be linked to problematic health beliefs and behaviours. But people who refuse vaccines also embody many traits we desire among modern patients, including seeking to be informed, engaged and empowered in their health decision-making.

Is more health information better?

Health literacy means having the knowledge and skills to find, understand and use health information.

The public and policy makers often treat health literacy as an antidote to health conspiracy movements like the vaccine-refusal movement.

Pro-vaccine Australians generally think vaccine misinformation is only accepted by people who are too foolish or too health illiterate to know better.

The president of the Australian Medical Association, in response to growing vaccine refusal, called in May for educational resources to help Australians “differentiate the good from the bad and the downright deadly”.




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Some researchers have called for improving health literacy to fight vaccine refusal, and many vaccine promotion strategies rely on improving knowledge and understanding.

After all, it makes a lot of sense. Increased public health literacy often leads to improved health. Evidence suggests it can correct some beliefs in health misinformation. It’s easy to assume that all Australians would be pro-vaccine, if only they had adequate health literacy and critical thinking

Higher health literacy is unlikely to counter refusers’ beliefs

As far as we know, people who refuse vaccines use their health literacy skills to dive deeper into vaccine information, develop more sophisticated views and greater confidence in those views.

But health literacy doesn’t appear to make pro-vaccine evidence look more convincing to refusers. In fact, when people who distrust vaccination also have higher health literacy, they are even more likely to choose information that matches their biases, and to think that information supports their beliefs. Indeed high health literacy seems to help reinforce anti-vaccination beliefs among people who refuse vaccines.




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Vaccine refusers’ “pro-science, health literate” identity is not benign. In their eyes, it makes them highly credible, which helps them resist public health messages. It also makes them look more credible to others, who may in turn be persuaded to question vaccines.

We need to understand the limitations of health literacy

People who refuse vaccines sometimes hold different health beliefs compared with people who accept vaccination, and lean towards conspiracies (though sometimes they don’t).

But their views are built on mainstream trends. These include trends towards consumer-driven health care, exposure to alternative health paradigms, distrust in “big pharma” and in government.

If people who refuse vaccines can go down health misinformation “rabbit holes” despite having high health literacy, it’s feasible any of us could also be misled by health misinformation.




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We undoubtedly need higher public health literacy in Australia. It has clear and well established benefits. But the vaccine-refusal movement shows we may be placing too much faith in health literacy as a solution for health misinformation. It also shows we need to understand its potential to lead some people to internalise harmful health beliefs.

This understanding is sorely needed amid the COVID-19 “infodemic”, where we are confronted with an overwhelming amount of health information. It’s particularly crucial given the public needs to understand and accept credible information to follow public health directives to slow the spread of the virus.The Conversation

Tomas Rozbroj, Post-doctoral fellow, Monash University

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

A COVID-19 vaccine may come without a needle, the latest vaccine to protect without jabbing



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Vasso Apostolopoulos, Victoria University; Maja Husaric, Victoria University, and Maximilian de Courten, Victoria University

Vaccines are traditionally administered with a needle, but this isn’t the only way. For example, certain vaccines can be delivered orally, as a drop on the tongue, or via a jet-like device.

Vaccines that appear particularly suitable to needle-free technology are DNA-based ones, including a COVID-19 vaccine being developed in Australia.

Needle-free vaccines are attractive as they cause less pain and stress to people with needle phobias. But they have other benefits.




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Fear of needles could be a hurdle to COVID-19 vaccination, but here are ways to overcome it


Jet injectors and beyond

The earliest needle-free injection systems date back to 1866 and used jet injectors. These hand-held devices used pressure to penetrate the skin and deliver medicine.

They became increasingly popular around the middle of the 20th century, and were used to deliver vaccines against typhus, polio and smallpox.

A hepatitis B outbreak linked to their use meant they were discontinued in the 1980s. However, research picked up again in the 1990s. Variations included a spring-loaded jet injector (a spring is released to deliver the drug), a battery-powered jet injector, and a gas-powered jet injector.

Jet injection has also been used in dental care to deliver local anaesthetic.




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Beyond jet injection, oral vaccines including rotavirus, cholera, polio and typhoid have been around for several decades, and are still used today in various parts of the world. They can come as a liquid or tablet.

More recently, researchers and biotechnology companies have developed vaccines you inhale, such as nasal sprays, as well as skin patches. These are mostly still in clinical testing.

A health worker drops an oral polio vaccine into a child's mouth.
Oral vaccines have been around for many years.
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DNA-based vaccines and the gene gun

DNA vaccines were a chance discovery as a result of early gene therapy experiments in the 1990s, where injecting DNA into the muscle unexpectedly generated an immune response.

With a DNA vaccine, a small section of the genetic material of the virus is delivered into cells under the skin. These cells then express the DNA as viral proteins. The body recognises these as foreign and stimulates an immune response.

DNA vaccines are simple and cheap to produce in large quantities, and they’re relatively safe as they don’t contain any infective agents, such as live virus.




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Scientists have explored a number of ways to deliver DNA vaccines, either with a needle or needle free. The needle-free methods include ultrasound (sound waves) and electroporation (electrical pulses) that disrupt cell membranes, allowing DNA into the cells.

The gene gun or “biojector 2000”, a form of jet injector, seems to be the most effective method. This uses pressure to inject DNA into deep layers of the skin. Because it improves the distribution of the vaccine deeper into the injection site, this method uses far less DNA than injection with a needle to generate the same immune response.

But no DNA vaccine has been licensed for use in humans yet. Although needle-free DNA vaccines have shown success in pre-clinical and early clinical trials, DNA vaccines in general are also not as effective in generating immune responses against diseases such as HIV and cancer.

Needle-free COVID-19 contenders

The University of Sydney recently received federal government funding to commence human trials using a “liquid jet” injector to deliver its DNA-vaccine.

Liquid jet injectors use small volumes of liquid forced through a tiny opening (smaller than a human hair). This ultra-fine high pressure stream penetrates the skin where cells then take up the vaccine and stimulate immune cells.

This method was effective in several clinical trials against HIV and is currently used to deliver some influenza vaccines.

A child receives a vaccination with a needle.
Needle-free vaccine technologies may be appealing to many people who dislike needles, including children.
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Other needle-free COVID-19 vaccines in development include a bandaid-like patch made up of 400 tiny needles, a nasal vaccine, an oral vaccine as a tablet, and a needle-free device that delivers an mRNA vaccine.

Vaccines based on mRNA work in similar ways to DNA vaccines.

Advantages and disadvantages

The advantages of needle-free vaccine technology, specifically jet injectors, include:

  • they may be significantly more acceptable for people afraid of needles, including children

  • there’s no risk of being accidentally injured with a needle

  • they eliminate needle disposal (up to 500 million needles are thrown in landfill every year after vaccinations, and 75 million of these could be infected with blood-borne diseases)

  • they improve vaccine delivery into the skin and use a lower vaccine volume.

Disadvantages include:

  • start-up costs for those using the device, including buying gun devices, and access to gas/air systems to power them

  • staff who administer the vaccine will need special training, and may not feel confident using the technology

  • the equipment needs regular maintenance.




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The Conversation


Vasso Apostolopoulos, Professor of Immunology and Pro Vice-Chancellor, Research Partnerships, Victoria University; Maja Husaric, Lecturer; MD, Victoria University, and Maximilian de Courten, Health Policy Lead and Professor in Global Public Health at the Mitchell Institute, Victoria University

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

Australia’s just signed up for a shot at 9 COVID-19 vaccines. Here’s what to expect



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Adam Taylor, Griffith University

Australia’s A$123 million contribution to a global vaccine initiative, announced earlier this week, means the country would have access to a wider pool of COVID-19 vaccines, should they pass clinical trials.

The agreement with the World Health Organisation-backed COVAX initiative currently covers nine vaccines, with another nine being considered. These are to be shared with other member countries, rich and poor, by the end of 2021.

However, the agreement may only cover up to half the doses Australia needs, if each person needs two doses. So countries are still free to negotiate their own vaccine deals with individual manufacturers, as Australia has done.

Here’s what you need to know about the nine vaccines COVAX is currently backing, which are at various stages of development. These include pre-clinical animal testing and human clinical trials, which move through three phases. During the pandemic, some of these phases have been combined.




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1. INO-4800 comes with a zap

INO-4800 is a DNA vaccine being developed by US company Inovio.

After the vaccine is injected, a hand-held device delivers a short electrical pulse. This pulse opens small pores in your cells to allow the vaccine to enter.

Once inside your cells, instructions in the vaccine’s DNA are used to make copies of the full spike protein of SARS-CoV-2, the virus that causes COVID-19. Your body mounts an immune response against this, ready to protect you the next time you encounter the virus.

Phase 2/3 trials are expected to begin soon. No serious side effects were reported from clinical trials so far.

2. Moderna’s mRNA-1273 is in phase 3

The mRNA-1273 vaccine is developed by US company Moderna with the US National Institutes of Allergy and Infectious Diseases. The genetic material in this RNA-based vaccine also codes for the full spike protein.

There have been promising results from trials so far. The vaccine is in phase 3 clinical trials.

3. Germany’s CVnCoV may have one or two doses

CVnCoV is another RNA-based vaccine and is made by German company CureVac. It also codes for the virus’ spike protein.

The vaccine has entered phase 2 trials, which is testing one and two doses.

4. TMV-083 uses a version of the measles vaccine

TMV-083 is being developed by Institut Pasteur and American company Merck. It is in phase I trials.

The vaccine uses a live-attenuated (weakened) measles vaccine to deliver and express the SARS-CoV-2 spike protein. The virus is still viable (live) but cannot cause disease.




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5. AZD1222, the Oxford vaccine

AZD1222 is being developed by AstraZeneca with the University of Oxford. It uses
a modified chimpanzee adenovirus to express the SARS-CoV-2 spike protein.

There have been good antibody responses against SARS-CoV-2 and no severe side effects in early clinical trials.

Phase 3 trials have started in multiple countries. However, these were suspended recently after a study participant developed an immune complication. The trials have since resumed.

Australia has already entered an agreement to supply this vaccine should phase 3 trials prove successful. This deal is independent of the COVAX agreement.




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6. Modified flu vaccine delivered up the nose

Hong Kong University has developed a flu-based vaccine, which was recently approved for human clinical trials with Chinese company Beijing Wantai.

It will be the first nasal spray COVID-19 vaccine to be tested in humans.

The weakened flu virus delivers a part of the SARS-CoV-2 spike protein, which elicits a highly targeted immune response.

7. NVX-CoV2373 was tested in Australia

NVX-CoV2373 is a protein subunit vaccine developed by US company Novavax. It is made from purified pieces of the virus (full-length SARS-CoV-2 spike protein). It also contains an adjuvant — an extra molecule that boosts the immune response.

The vaccine was safe and stimulated a strong immune response in early clinical trials in Queensland and Victoria. Phase 3 trials are expected to start soon.




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8. SCB-2019 is another protein subunit vaccine

SCB-2019 is another protein subunit vaccine, this time developed by Chinese company Clover Biopharmaceuticals. It is also based on the spike protein of SARS-CoV-2, purified in the lab, and also uses an adjuvant to stimulate the immune system.

Phase 1 trials have started in partnership with GlaxoSmithKline and Dynavax Technologies.




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9. University of Queensland’s ‘molecular clamp’ vaccine

This vaccine is another protein subunit vaccine. It uses a “molecular clamp” to stabilise the SARS-CoV-2 spike protein in the configuration thought to elicit the best protective immune response.

A phase 1 trial, in partnership with CSL, started in July.

The Australian government has already entered into a deal to supply this vaccine should it progress through phase 3 trials. This deal is independent of the COVAX agreement.




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The Conversation


Adam Taylor, Early Career Research Leader, Emerging Viruses, Inflammation and Therapeutics Group, Menzies Health Institute Queensland, Griffith University

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

Eyeing local development: a look at the 3 Australian COVID vaccine candidates to receive a government boost



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Harry Al-Wassiti, Monash University

On Sunday, the Australian government announced it would put A$6 million towards the research and development of three local COVID-19 vaccine candidates, via the Medical Research Future Fund.

The three candidates to share this funding are:

  • a targeted subunit protein vaccine, developed by the Doherty Institute

  • an mRNA vaccine, developed by the Monash Institute of Pharmaceutical Sciences (MIPS)

  • a needle-free DNA vaccine, developed by the University of Sydney.

Let’s take a look at these different approaches.




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Targeting the tip

I’m part of the Monash team working with scientists at the Doherty Institute on both the protein vaccine and the mRNA vaccine. Although we initially developed these vaccine candidates separately, they target a similar part of the virus — so we’ve now joined forces to further develop the two together.

Until now, vaccine candidates, such as those developed by the University of Queensland and the University of Oxford, have generally used the entire spike protein as a target. The spike is a large protein found on the surface of SARS-CoV-2, the virus that causes COVID-19.

A region at the tip of the spike called the “receptor-binding domain” enables the virus to establish itself by binding to our cells and causing infection.

Instead of vaccinating against the “whole” spike protein, our approach is unique in that it uses the receptor-binding domain tip.

The subunit protein vaccine contains the receptor-binding domain from SARS-CoV-2 as the antigen, or target. Exposing our immune system to this protein is intended to create antibodies that generate immunity against this part of the virus, protecting us if we encounter SARS-CoV-2 in the future.

For the mRNA vaccine, rather than injecting the protein itself, a short piece of the genetic material from the virus (mRNA) provides a blueprint to make the receptor-binding domain. So this vaccine also targets the receptor-binding domain to induce an immune response, although the process is different.

The subunit protein vaccine and the mRNA vaccine both target the receptor-binding domain, a region at the tip of the spike protein.
Created with BioRender.com, Author provided

We’re exploring the two vaccine options simultaneously. One may prevail as the most promising candidate. It’s also possible one candidate might be the primary vaccine and the other could serve as a booster — it’s still early to tell.

The funding we’ve received will support the development and manufacturing of the two candidates with the intention to enter phase 1 human trials next year if the vaccines prove promising in mice and monkeys. Early results are encouraging.

Notably, both of these vaccines can be produced and manufactured rapidly. For example, within three weeks of receiving the genetic sequence of SARS-CoV-2, we were able to produce three mRNA vaccine candidates.

This flexibility of the Doherty/MIPS approach will be particularly important if COVID-19 mutates into a new strain, and could also be useful for vaccine development in future pandemics.




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A needle-free DNA vaccine

The third COVID-19 vaccine candidate uses DNA technology. A DNA-based vaccine works in a similar way to an mRNA vaccine. By producing the viral antigen inside us, mRNA and DNA vaccines teach our immune system to recognise the antigen should the virus invade in the future.

DNA vaccines have been under development for roughly the past 20 years. While they’re safe, their effectiveness remains in question. So the University of Sydney scientists are rethinking the way they’re delivered.

The previous DNA vaccines relied on a standard needle and syringe delivery, but the University of Sydney’s innovative approach uses a needle-free device. This method will deliver the vaccine using a “liquid jet” to penetrate our skin.

Needle-free delivery improves the distribution of the DNA vaccine deeper into the injected site, which can improve the vaccine’s effectiveness.

Needle-free technology can facilitate a better distribution of vaccines once injected.
Created with BioRender.com, Author provided

The University of Sydney group will aim to recruit 150 volunteers for a phase 1 clinical trial using the needle-free jet system.

The technology is already used to deliver some influenza vaccines. The technology may later be taken up for other COVID-19 vaccine candidates — including mRNA and proteins — if the needle-free system proves safe and effective.

Naturally, another key advantage of this approach is the absence of needles. This may improve vaccine acceptance in some groups, including children.

Further, DNA vaccines can be produced relatively easily in large quantities.

The importance of local vaccine development

Investing in vaccine technologies will be essential for Australian public health, biosecurity and economic independence.

First, it’s unclear whether the current COVID-19 vaccines in phase 3 clinical trials will provide adequate protection. If they do, it’s similarly unclear how long that protection will last. Continued investments in a variety of vaccines at different stages of the development pipeline will ensure we have the best collection of vaccine technologies at our disposal.

Second, some of the development efforts could later yield a significant return on investment if they prove successful. Australia has an evolving biomanufacturing and biotechnology sector, and investment into these areas will benefit the next chapter of our country’s economic recovery.




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Correction: this article previously stated it’s possible the scientists would combine both the mRNA and subunit protein vaccines into a one-shot product. This is not something the team at Monash University and/or the Doherty Institute are investigating as part of their forthcoming trial, so this has been removed.The Conversation

Harry Al-Wassiti, Bioengineer and Research Fellow, Monash University

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