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Whoever invents a coronavirus vaccine will control the patent – and, importantly, who gets to use it



LINEAR CLINICAL RESEARCH/PR handout

Natalie Stoianoff, University of Technology Sydney

With research laboratories around the world racing to develop a coronavirus vaccine, a unique challenge has emerged: how to balance intellectual property rights with serving the public good.

Questions of patent protection and access to those patents has prompted an international group of scientists and lawyers to establish the Open COVID Pledge.

This movement calls on organisations to freely make available their existing patents and copyrights associated with vaccine research to create an open patent pool to solve a global problem.

The EU is leading the charge to create such a pool by drafting a resolution at the World Health Organisation. The US, UK and a few others have been opposed to this idea.




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For now, however, there are very few pharmaceutical and biotechnology corporations participating in the pledge, raising questions over whether the initiative will work.

Instead, universities, publicly funded research institutes and pharmaceutical and biotechnology corporations are working on vaccine research through international consortia or public-private partnerships.

If one group does develop a viable vaccine, this raises other questions that will soon need to be addressed:

  • who is funding the research, and who has the rights to any patents coming out of it?

  • can governments compel the owners of those patents to license other manufacturers to make the vaccines or medicines?

What are patent rights and why are they important?

Patent rights are a form of intellectual property rights. They provide creators of new inventions, like novel vaccines and medicines, with a limited-term monopoly over those inventions in the marketplace to help recover the costs of research and development.

In other words, patents are an incentive to invent or innovate.

Patents are granted by individual nations, but don’t apply across borders. To gain global protection, an inventor needs to apply for patents in every country – something that could be critical when it comes to vaccines. The Patent Cooperation Treaty helps to streamline the process, but it is still expensive and time-consuming.




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Drug companies should drop their patents and collaborate to fight coronavirus


The limited-term monopoly on the market is balanced by the requirement that patent holders share information about their inventions in a register to make it available for anyone to use after the patent protection expires. The term of a standard patent is usually 20 years.

During the patent period, patent holders have exclusive rights to manufacture and sell their inventions. Or, they can choose to license the technology to others to manufacture and sell to the public.

Such licences include a specified time limit and geographical area to exploit the patent. In return, the patent holder receives royalties or licence fees, or both.

So, the race to develop a vaccine for COVID-19 is not just about saving lives during a pandemic, it’s also about owning the patent rights. This gives the owner control over the manufacturing and distribution of the vaccine in the countries where the patent rights are granted.

Who is currently researching a coronavirus vaccine?

The race currently includes universities, publicly funded research institutes and pharmaceutical and biotechnology companies, some working in partnership with government institutions.

The company that just announced early positive results on a vaccine is Moderna, a biotech company based in the US, which is working with the National Institutes of Health. A number of other developers are also doing human trials globally, including many in China.

When private companies and government institutions partner on developing a vaccine, it may result in joint ownership of a patent. This gives each owner the right to manufacture the vaccine, but only together they can license the manufacturing to third parties.

What about the rights of nations?

Even if patent ownership is in the hands of private companies, the state may still have the right to use them for its own purposes or in the case of emergencies. Many countries have specific laws to facilitate these arrangements.

In the US, the Bayh-Dole Act 1980 ensures the government retains sufficient rights to use patents resulting from federally supported research.

Under these rights, the government can be granted a free license to use the patent itself or the right to arrange for a third party to use the patent on its behalf.




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In cases where the patent holder of a publicly funded invention refuses to licence it to third parties, the Bayh-Dole Act gives the government “march-in” rights.

Under specific guidelines, this means a forced licence can be granted to a third party on reasonable terms. This includes in cases when the “action is necessary to alleviate health or safety needs” or to ensure the patented invention is actually manufactured within a reasonable time.

In the case of COVID-19 research, this means the US government could order a corporation or university that invents a vaccine with federal funding to license the patent to others to make it.

In Australia, the government can exploit the patented inventions of others under right of “crown use”. In these cases, the patent holder is entitled to financial compensation from the government.

Like most other members of the World Trade Organisation, Australia also has compulsory licensing rules in its patent law that force inventors to license their patents to third parties on reasonable terms in specific circumstances.

In reality, though, such compulsory licences are under-utilised in countries like Australia, New Zealand, the UK and Japan, and rarely granted, if at all.

Working together for the common good

This brings us to the Open COVID Pledge, which is designed to make the relevant intellectual property freely available under an open licence.

Such open-access licensing has been used in the publishing industry for years, for example with Creative Commons publications online, and in the technology industry through open-source licences.

If more of the public-private partnerships working on a coronavirus vaccine do sign up to the pledge, perhaps it will be one of the positives to come out of the pandemic. It could allow open-access licences for lifesaving technologies to become accepted practice.The Conversation

Natalie Stoianoff, Professor, Faculty of Law, University of Technology Sydney

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

The vaccine we’re testing in Australia is based on a flu shot. Here’s how it could work against coronavirus



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Kylie Quinn, RMIT University and Kirsty Wilson, RMIT University

A new trial has begun in Victoria this week to evaluate a potential vaccine against COVID-19.

The vaccine is called NVX-CoV2373 and is from a US biotech company, Novavax.

The trial will be carried out across Melbourne and Brisbane, and is the first human trial of a vaccine specifically for COVID-19 to take place in Australia.

This vaccine is actually based on a vaccine that was already in development for influenza. But how might it work against SARS-CoV-2, the coronavirus that causes COVID-19?




Read more:
Could BCG, a 100-year-old vaccine for tuberculosis, protect against coronavirus?


What’s in the mix?

Vaccines trigger an immune response by introducing the cells of our immune system to a virus in a safe way, without any exposure to the pathogen itself.

All vaccines have to do two things. The first is make our immune cells bind to and “eat up” the vaccine. The second is to activate these immune cells so they’re prepared to fight the current and any subsequent threats from the virus in question.

We often add molecules called adjuvants to vaccines to deliver a danger signal to the immune system, activate immune cells and trigger a strong immune response.




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The Novavax vaccine is what we call a “subunit” vaccine because, instead of delivering the whole virus, it delivers only part of it. The element of SARS-CoV-2 in this vaccine is the spike protein, which is found on the surface of the virus.

By targeting a particular protein, a subunit vaccine is a great way to focus the immune response.

However, protein by itself is not very good at binding to and activating the cells of our immune system. Proteins are generally soluble, which doesn’t appeal to immune cells. They like something they can chew on.

So instead of soluble protein, Novavax has assembled the SARS-CoV-2 spike protein into very small particles, called nanoparticles. To immune cells, these nanoparticles look like little viruses, so immune cells can bind to these pre-packaged chunks of protein, rapidly engulfing them and becoming activated.

The Novavax vaccine also contains an adjuvant called Matrix-M. While the nanoparticles deliver a modest danger signal, Matrix-M can be added to deliver a much stronger danger signal and really wake up the immune system.

The spike protein is formed into nanoparticles to attract immune cells, and Matrix-M is added as an adjuvant to further activate immune cells.
Author provided

Rethinking an influenza vaccine

The Novavax vaccine for SARS-CoV-2 is based on a vaccine the company was already developing for influenza, called NanoFlu.

The NanoFlu vaccine contains similar parts – nanoparticles with the Matrix-M adjuvant. But it uses a different protein in the nanoparticle (hemagglutinin, which is on the outside of the influenza virus).

In October last year, Novavax started testing NanoFlu in a phase III clinical trial, the last level of clinical testing before a vaccine can be licensed. This trial had 2,650 volunteers and researchers were comparing whether NanoFlu performed as well as Fluzone, a standard influenza vaccine.




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An important feature of this trial is participants were over the age of 65. Older people tend to have poorer responses to vaccines, because immune cells become more difficult to activate as we age.

This trial is ongoing, with volunteers to be followed until the end of the year. However, early results suggest NanoFlu can generate significantly higher levels of antibodies than Fluzone – even given the older people in the trial.

Antibodies are small proteins made by our immune cells which bind strongly to viruses and can stop them from infecting cells in the nose and lungs. So increased antibodies with NanoFlu should result in lower rates of infection with influenza.

These results were similar to those released after the phase I trial of NanoFlu, and suggest NanoFlu would be the superior vaccine for influenza.

So the big question is – will the same strategy work for SARS-CoV-2?

The Novavax vaccine is one of several potential COVID-19 vaccines being trialled around the world.
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The Australian clinical trial

The new phase I/II trial will enrol around 131 healthy volunteers aged between 18 and 59 to assess the vaccine’s safety and measure how it affects the body’s immune response.

Some volunteers will not receive the vaccine, as a placebo control. The rest will receive the vaccine, in a few different forms.

The trial will test two doses of protein nanoparticles – a low (5 microgram) or a high (25 microgram) dose. Both doses will be delivered with Matrix-M adjuvant but the higher dose will also be tested without Matrix-M.

All groups will receive two shots of the vaccine 21 days apart, except one group that will just get one shot.

This design enables researchers to ask four important questions:

  1. can the vaccine induce an immune response?

  2. if so, what dose of nanoparticle is best?

  3. do you need adjuvant or are nanoparticles enough?

  4. do you need two shots or is one enough?




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Coronavirus anti-vaxxers aren’t a huge threat yet. How do we keep it that way?


While it’s not yet clear how the vaccine will perform for SARS-CoV-2, Novavax has reported it generated strong immune responses in animals.

And we know NanoFlu performed well and had a good safety profile for influenza. NanoFlu also seemed to work well in older adults, which would be essential for a vaccine for COVID-19.

We eagerly await the first set of results, expected in a couple of months – an impressive turnaround time for a clinical trial. If this initial study is successful, the phase II portion of the trial will begin, with more participants.

The Novavax vaccine joins at least nine other vaccine candidates for SARS-CoV-2 currently in clinical testing around the world.The Conversation

Kylie Quinn, Vice-Chancellor’s Research Fellow, School of Health and Biomedical Sciences, RMIT University and Kirsty Wilson, Postdoctoral Research Fellow, RMIT University

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

Coronavirus anti-vaxxers aren’t a huge threat yet. How do we keep it that way?


Katie Attwell, University of Western Australia

The first I heard of the “Plandemic” video was when a friend shared it on her Facebook. “I’m pro-vaccine,” was her accompanying statement. “And I’m not a conspiracy theorist.”

For those who don’t know, Plandemic is a misinformation-driven viral video that’s garnered much attention in recent days.

It’s spreading numerous falsehoods about the COVID-19 pandemic, including that the virus is “activated” by face masks and hand-washing. And the major conspiracy, or the “plan”, as this article explains, is that:

… a secret society of billionaires around the world are plotting global domination, and they plan to control people through a vaccine.

Perhaps even more worrying is the level of traction such conspiracies receive. More than 100 people gathered in Melbourne last weekend, and some in Sydney, to protest lockdowns, tracking apps, vaccines and the public health philanthropy of billionaire Bill Gates. The protests were reportedly promoted on Facebook anti-vaxxing groups.

While Plandemic’s claims have been thoroughly debunked, my friend is exactly the kind of audience that should have policymakers worried.

Planting seeds of doubt

Conspiracy theorists – or “conspiracists” – generally take their place in the rich tapestry of life without causing too much trouble.

But with some governments caught off-guard by COVID-19 (making stuff up as they go), and public health experts wielding considerable power, conspiracists have fertile soil to plough. That soil is us.

The general public is uncertain, afraid, and experiencing cognitive impairment from the strain of it all. Governments overseas, most notably the US government, have failed dismally in responding efficiently to COVID-19. This has the potential to devastate citizens’ trust.

In this volatile cocktail, the distinction between what is “batshit crazy” and what is worryingly plausible starts to break down.

Reaping the harvest

Enter the organised anti-vaxxers, aligning with other conspiracists to spread misinformation and lead lockdown protests.

Underpinning their antics is the idea that COVID-19 is a highly organised operation, and also the accusation that governments will use lockdowns to forcibly medicate populations, perhaps with plans to incorporate a mind-controlling microchip in the vaccine.




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For those who reject these premises, it’s hard to understand how conspiracists sustain this alternative reality. But for those with long histories of rejecting government and expert authority, it’s completely conceivable.

Many of those who reject vaccines, or strenuously object to COVID-19 health measures, are influenced by interconnected social groups with clear identities. Standing atop a hill of self-ascribed expertise, they can gaze down on the “sheeple” eating from the trough.

Groups that set themselves apart from mainstream society, deliberately and with pride, develop strong in-group identification and take cues from people they perceive to be like them.

That may be why Australia is now seeing freedom-focused anti-lockdown protests you wouldn’t generally expect outside America.

Don’t fan the flames

Lockdown protesters remain small in number relative to the wider population. They also lack significant celebrity endorsement in Australia. Even the bizarre communications of disgraced My Kitchen Rules judge Pete Evans have not extended to lockdown resistance.

When it comes to lockdown protesters, it might be best to quietly ignore them, like a parent walking away from their child’s supermarket tantrum.

Ascribing great importance to conspiracists gives them unwarranted publicity, and risks cuing involvement from others who share their goals or opinions.

And lengthening the conversation unnecessarily could sway the minds of undecided onlookers.

Serious implications

That said, damage to public trust because of conspiracies is more complex.

It’s vital for governments to “keep the public’s ear” so they can maintain effective communication about what they are doing and why. This is crucial in retaining broad population support for the necessary health measures.

Western Australian Premier Mark McGowan’s sky-high approval ratings prove governments can bring people with them.

But they can’t bring everybody. And while dissent is not necessarily unhealthy, the burning question is where dissent leads us.

COVID-19 will likely divide people who have been lumped together by general society as “anti-vax”.

Researchers, myself included, have long argued for more nuanced understandings of vaccine refusers, especially because some remain open to changing their minds.

Some vaccine refusers are likely to find the COVID-19 vaccine is one they don’t want to skip. But for the diehard conspiracists, it’s the endgame.

These people know a large proportion of the population will need to receive it for normal life to resume. But if you believe vaccination to be unsafe, corrupt and toxic, the prospect of being pressured to receive one must be terrifying.




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Who is in danger here?

When (or if) a COVID-19 vaccine does come along, will the broader population be able to accept some people’s refusal to vaccinate? There are two answers.

The first is epidemiological. We don’t know how many of us will need to be vaccinated, but the figure for other diseases such as measles is as high as 95%.

Also, as some people can’t be vaccinated for medical reasons and governments may struggle to reach some disadvantaged populations, the remaining 5% leaves little wiggle room for vaccine refusal within the wider population. If there is room for refusal, there isn’t much.

This brings us to the second, political, answer.

If anti-vaccination propagandists achieve widespread community resistance to government power, there will be many more of them than our vaccine coverage goals can tolerate. This will likely result in more coercive policies from governments.

In Australia and California, populations and governments have previously supported crackdowns on vaccine refusers precisely because these activists behaved in reprehensible ways, or because they made it easy for the majority to construct them as a hated group in need of punishment.

Remember, when we walk away from a child having a tantrum in a supermarket, we are also saving them from themselves – even if they can’t appreciate it.The Conversation

Katie Attwell, Senior Lecturer, University of Western Australia

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

Could BCG, a 100-year-old vaccine for tuberculosis, protect against coronavirus?



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Kylie Quinn, RMIT University; Joanna Kirman, University of Otago; Katie Louise Flanagan, University of Tasmania, and Magdalena Plebanski, RMIT University

This week, the Bill and Melinda Gates Foundation announced it will donate A$10 million to help fund an Australian trial testing whether a very old vaccine, BCG, can be used against a new threat, COVID-19.

So what is the BCG vaccine and what might its place be in the fight against coronavirus?

The ABCs of BCG

The BCG vaccine has been used for nearly a century to protect against tuberculosis, a bacterial disease that affects the lungs. Tuberculosis is caused by a bacterium called Mycobacterium tuberculosis.

BCG is short for Bacillus Calmette-Guérin, as it was created by Léon Charles Albert Calmette and Jean-Marie Camille Guérin in the early 1900s.

To make the vaccine, they used Mycobacterium bovis, a bacterium found in cows and closely related to Mycobacterium tuberculosis. They grew it on a nutrient-rich jelly in the lab for nearly 13 years. The bacterium adapted to this comfortable lifestyle by losing elements in its DNA it no longer needed, including elements that cause disease.

This process is called attenuation and it results in a live but weakened microbe that can be given to humans as a vaccine.




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BCG is offered to infants in some parts of the world where there are still high rates of tuberculosis. It protects 86% of the time against some rarer forms of tuberculosis more common in children.

But it only protects about 50% of the time in adults.

Scientists and clinicians generally feel we need a better vaccine for tuberculosis. However, epidemiologists have noticed children who received BCG had significantly better overall health, with fewer respiratory infections and fewer deaths.

Immunologists suspect this is caused by a type of immune response called “trained immunity”.

Trained immunity is distinct from how we traditionally think of immunity, or “immune memory”, because it engages different types of immune cells.

Immune memory vs trained immunity

There are two main types of cells within our immune system: innate cells, which respond rapidly to microbes that cause disease, and adaptive cells, which initially respond quite slowly.

Adaptive cells include B cells, which make antibodies to block infection, and T cells, which can kill infected cells. Importantly, adaptive cells can remember particular microbes for years, or even decades, after we first encounter them.

This phenomenon is called “immune memory”.

When adaptive immune cells encounter the same microbe a second or subsequent time, they respond much more quickly, and the immune system can effectively clear an infection before it causes disease. Immune memory is why often we don’t get infected with a specific microbe, like chickenpox, more than once.

Most of our current vaccines exploit immune memory to protect us from infection.




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For decades, scientists believed innate cells lacked the ability to remember previous encounters with microbes. However, we’ve recently learnt some innate cells, such as monocytes, can be “trained” during an encounter with a microbe. Training can program innate cells to activate more quickly when they next encounter a microbe – any microbe.

Some live attenuated vaccines, such as BCG, can trigger trained immunity, which can enhance early control of other infections. This raises the tantalising possibility that BCG could train innate cells to improve early control of the SARS-CoV-2 virus, to reduce COVID-19 disease or even prevent infection.

And as a bonus, BCG could potentially protect us against other pathogens too.

The BCG vaccine targets trained immunity, whereas most other vaccines target immune memory.
Kylie Quinn, Author provided

Could BCG protect against COVID-19?

We don’t know yet whether BCG will reduce the severity of COVID-19, but the vaccine has some interesting features.

First, BCG is a potent stimulator of the immune system. Currently, it’s used alongside other therapies to treat bladder cancer and melanoma, because it can stimulate immune cells to attack the tumour.

BCG also seems to benefit lung immunity. As we mentioned, children who have had the vaccine appear to get fewer respiratory infections.

There’s a study underway in Melbourne looking at whether BCG can reduce symptoms of asthma in children.

And finally, BCG has been shown to limit viral infection. In one study, human volunteers were given BCG or a placebo one month before being infected with a virus. Volunteers who received BCG had a modest reduction in the amount of virus produced during infection compared to those who received the placebo.




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However, BCG can cause side-effects to be mindful of. It usually causes a small raised blister on the skin at the vaccine site and it can cause painful swelling in the surrounding lymph nodes.

Importantly, because it’s a live bacterium, it can spread from the vaccine site and cause disease, called disseminated BCG, in people who are immunodeficient, like people with HIV. This means BCG can’t be given to everyone.

Current clinical trials

The ultimate test of BCG as a preventative measure for COVID-19 is to run randomised clinical trials, which are now underway.

Researchers across Australia and the Netherlands are preparing to give BCG to the people who have arguably the highest risk of COVID-19: frontline health-care workers.

These phase III trials will collect data on whether workers vaccinated with BCG have fewer or less severe COVID-19 infections.

If BCG is shown to be effective, we’ll face other challenges. For example, supply of the vaccine is currently limited. Further, there are many different strains of BCG and they might not all provide the same protection against COVID-19.

Protection would likely start to wane relatively quickly. When trained immunity was tracked in humans after BCG, it started waning from three to 12 months after vaccination.

Protection would also not be as strong as what we see with many traditional vaccines, such as the MMR vaccine which protects against measles 94.1% of the time.




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So BCG would be most helpful for people at high risk of exposure, but it wouldn’t replace a traditional vaccine based on immune memory.

These studies are important to give us options. We need a complete toolkit for control of COVID-19, consisting of anti-viral and anti-inflammatory drugs and vaccines. But an effective COVID-19 vaccine is likely still many months, even years, away.

By repurposing an old, well-characterised vaccine, we could bridge this gap and provide some protection to our health-care workers as they confront COVID-19.The Conversation

Kylie Quinn, Vice-Chancellor’s Research Fellow, School of Health and Biomedical Sciences, RMIT University; Joanna Kirman, Associate Professor, University of Otago; Katie Louise Flanagan, Infectious Diseases Specialist and Clinical Professor, University of Tasmania, and Magdalena Plebanski, Professor of Immunology, RMIT University

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

While we wait for a coronavirus vaccine, eating well, exercising and managing stress can boost your immune system



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Julia J Rucklidge, University of Canterbury and Grant Schofield, Auckland University of Technology

Social distancing may remain necessary during the 18 months or more we’ll have to wait for a coronavirus vaccine.

This can feel like we have little control, but there are several evidence-based protective measures we can take in the interim to ensure we are as healthy as possible to fight off infection and prevent mental health problems that escalate with uncertainty and stress.




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Coronavirus and underlying medical conditions

There is recent evidence that some younger people suffer strokes after contracting the virus, but the majority of people who end up hospitalised, in intensive care or dying from COVID-19 have an underlying medical condition. One study showed 89% of those hospitalised in the US had at least one.

These underlying medical conditions include high blood pressure, high blood sugar (especially type 2 diabetes), excessive weight and lung conditions. An analysis of data from the UK National Health Service shows that of the first 2,204 COVID-19 patients admitted to intensive care units, 72.7% were either overweight or obese.

All of these health issues have been associated with our lifestyle including poor diet, lack of exercise, smoking, excessive alcohol and high stress.

It’s obvious we have created a society where being active, eating healthily, drinking less and keeping our stress under control is difficult. Perhaps it’s time to push back. This may be important for major conditions like heart disease and diabetes as well as the added threat we face from emerging infectious diseases.

One study shows only 12% of Americans are in optimal metabolic health, which means their blood pressure, blood glucose, weight and cholesterol are within a healthy range. This rate is likely similar in many Western countries.

There is now a body of evidence linking our unhealthy lifestyle with viral, especially respiratory diseases. High blood sugar reduces and impairs immune function. Excessive body fat is known to disrupt immune regulation and lead to chronic inflammation. Insulin resistance and pre-diabetes can delay and weaken the immune response to respiratory viruses.




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Regular exercise has long-term benefits for immunity – it’s important to stay active


Improving immunity through lifestyle choices

If we are going to restrict and change our lifestyles for 12 to 18 months while we wait for a vaccine, and if we want to protect ourselves better now and in the future, we could address these lifestyle factors. They not only affect our recovery from viruses and respiratory infections, but are also the biggest cost to the quality of life in most countries.

Optimising the health of the nation must be at the forefront. And this is long overdue. There has been a substantial under-investment by most developed countries in preventive medicine to reduce chronic diseases and improve both longevity and quality of life through healthy lifestyles.

Healthy organisms are naturally resistant to infections. This is true in plants, animals and people. Maintaining optimal health is our best defences against a pandemic until a vaccine is available.

We identify three modifiable risk factors:

1. Diet

Research shows better nourished people are less likely to develop both mental and physical problems. Certain nutrients, such as vitamins C and D and zinc have been identified as essential for improving immunity across the lifespan. A better diet is associated with a lower chance of developing mental health problems in both children and adults. Low levels of specific nutrients, such as vitamin D, have been recognised as risk factors for COVID-19. These nutrients are easy (and cheap) to replenish.

What does it mean to be better nourished? Eating real whole foods – fruits and vegetables, nuts, legumes, fish and healthy fats and reducing the intake of ultra-processed foods.

2. Exercise

Being physically fit adds years to your life – and quality of life. High cardiorespiratory (lung and heart) fitness is also associated with less respiratory illness, and better survival from such illnesses.

How do you get fit? Set aside time and prioritise walking at a minimum, and more vigorous activity if possible, every day. Ideally, you would get outside and be with important others. The more the better, as long as you are not overdoing it for your individual fitness level.

3. Stress

Stress impairs our immunity. It disrupts the regulation of the cortisol response which can suppress immune function. Chronic stress can decrease the body’s lymphocytes (white blood cells that help fight off infection). The lower your lymphocyte count, the more at risk you are of catching a virus.

How do we lower stress? Meditation, yoga, mindfulness, cognitive-behaviour therapy, optimising sleep and eating well can all help in mitigating the negative impact of stress on our lives. Taking additional nutrients, such as the B vitamins, and the full breadth of minerals like magnesium, iron and zinc, during times of stress has a positive impact on overall stress levels.




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Modifying lifestyle factors won’t eliminate COVID-19 but it can reduce the risk of death and help people to recover. And these factors can be in our control if we and our governments take the initiative.The Conversation

Julia J Rucklidge, Professor of Psychology, University of Canterbury and Grant Schofield, Professor of Public Health and Director of the Human Potential Centre, Auckland University of Technology

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

What if the vaccine or drugs don’t save us? Plan B for coronavirus means research on alternatives is urgently needed



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Tammy Hoffmann, Bond University and Paul Glasziou, Bond University

The curve of the COVID-19 epidemic has been flattened in many countries around the world, and it hasn’t been new antivirals or a vaccine that has done it. We are being saved by non-drug interventions such as quarantine, social distancing, handwashing, and – for health-care workers – masks and other protective equipment.

We are all hoping for a vaccine in 2021. But what do we do in the meantime? And more importantly, what if no vaccine emerges?

The world has bet most of its research funding on finding a vaccine and effective drugs. That effort is vital, but it must be accompanied by research on how to target and improve the non-drug interventions that are the only things that work so far.

Debates still rage over basic questions such as whether the public should use face masks; whether we should stand 1, 2 or 4 metres apart; and whether we should wash our hands with soap or sanitiser. We need the answers now.




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What about non-drug intervention research?

Across all health research, non-drug interventions are the subject of about 40% of clinical trials. Yet they receive far less attention than drug development and testing.

In the COVID-19 pandemic, millions of dollars have already been given to research groups around the world to develop vaccines and trial potential drug cures. Hundreds of clinical trials on drugs and vaccines are under way, but we could find only a handful of trials of non-drug interventions, and no trials on how to improve the adherence to them.

While holding our breath for the vaccine …

We all hope the massive global effort to develop a vaccine or drug treatment for COVID-19 is successful. But many experts, including Ian Frazer, who developed Australia’s HPV vaccine, think it will not be easy or quick.

If an effective vaccine or drug doesn’t materialise, we will need a Plan B that uses only non-drug interventions. That’s why we need high-quality research to find out which ones work and how to do them as effectively as possible.

Aren’t non-drug interventions straightforward?

You might think hand washing, masks and social distancing are simple things and don’t need research. In fact, non-drug interventions are often very complex.

It takes research to understand not only the “active components” of the intervention (washing your hands, for example), but also how much is needed, how to help people start and keep doing it, and how to communicate these messages to people. Developing and implementing an effective non-drug intervention is very different from developing a vaccine or a drug, but it can be just as complex.

To take one example, there has been a #Masks4All campaign to encourage everyone to wear face masks. But what type of mask, and what should it be made of? Who should wear masks – people who are ill, people who are caring for people who are ill, or everyone? And when and where? There is little agreement on these detailed questions.

Washing your hands also sounds simple. But how often? Twice a day, 10 times a day, or at specific trigger times? What’s the best way to teach people to wash their hands correctly? If people don’t have perfect technique, is hand sanitiser be better than soap and water? Is wearing masks and doing hand hygiene more effective than doing just either of them?

These are just are some of the things that we don’t know about non-drug interventions.

Existing research is lacking

We recently reviewed all the randomised controlled trials for physical interventions to interrupt the spread of respiratory viruses, including interventions such as masks, hand hygiene, eye protection, social distancing, quarantining, and any combination of these. We found a messy and varied bunch of trials, many of low quality or small sample size, and for some types of interventions, no randomised trials.

Other non-drug options to research include the built environment, such as heating, ventilation, air conditioning circulation, and surfaces (for example, the SARS-CoV-2 virus “dies” much more rapidly on copper than other hard surfaces).

Are some of the things we are doing now ineffective? Probably. The problem is we don’t know which ones. We need to know this urgently so we’re not wasting time, effort, and resources on things that don’t work.

At a time when we need to achieve rapid behaviour change on a massive scale, inconsistent and conflicting messages only creates confusion and makes achieving behaviour change much harder.

What about the next pandemic?

If a successful COVID-19 vaccine is developed, we’re out of the woods for now. But what happens when the next pandemic or epidemic arrives? Vaccines are virus-specific, so next time a new virus threatens us, we will again be in the same situation. However, what we learn now about non-drug interventions can be used to protect us against other viruses, while we wait again for another new vaccine or drug.

We have had opportunities to study non-drug interventions for respiratory viruses in the recent past, particularly during the Severe Acute Respiratory Syndrome (SARS) epidemic in 2003 and the H1N1 influenza pandemic in 2009. However, the chances for rigorous studies were largely wasted and we now find ourselves desperately scrambling for answers.




Read more:
Size does matter: why large-scale research is a must for public health


What about research for Plan B?

To prepare for the future and Plan B, the case where a vaccine doesn’t arrive, we need to conduct randomised trials into non-drug interventions to prevent the spread of respiratory viruses. The current pandemic is presenting us with a rare opportunity to rapidly conduct trials to answer many of the unknowns about this set of non-drug interventions.

Concentrating all our funding, efforts, and resources into vaccine and drug research may turn out to be a devastating and costly mistake in both healthcare and economic terms. The results will be felt not only in this pandemic, but also in future ones.The Conversation

Tammy Hoffmann, Professor of Clinical Epidemiology, Bond University and Paul Glasziou, Professor of Medicine, Bond University

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

The coronavirus lockdown might help limit this year’s flu season – but you should still get your flu jab anyway



Shutterstock

Lauren Bloomfield, University of Notre Dame Australia

Lockdown measures aimed at limiting the spread of COVID-19 should actually help cut the cases of flu this year. That’s because keeping people apart to reduce the spread of coronavirus will also help reduce the spread of flu.

That said, you really should receive a flu vaccine anyway.

In fact, getting your flu vaccination as soon as you can is a great way to help ease the strain on our health system, which is already expected to struggle to cope with the coronavirus outbreak.




Read more:
The ‘dreaded duo’: Australia will likely hit a peak in coronavirus cases around flu season


Flu cases skyrocketed last year

There were 313,079 cases of influenza reported in Australia in 2019, up from 58,862 in 2018. That’s much higher than average over the past 20 years.

Many states and territories saw a large and very early uptick in the number of influenza cases last year.

The most common influenza strain circulating at the time was influenza A/H3N2. It was reported that some circulating A/H3N2 viruses were “less well matched” to those in the vaccine, which could account at least in part for the higher number of cases in 2019.

The high, early and prolonged season was unusual. Some suggested different international travel patterns may have also contributed, but the truth is it’s not entirely clear the 2019 flu season was so unusual.

The WHO has recommended changes to three of the four strains in the vaccine most of us will be offered this year. There’s no guarantee of a good match, of course, but we’re certainly hoping for one.

With COVID-19 already likely to put our health-care systems under immense pressure, we cannot afford to burden the system with extra influenza cases requiring hospitalisation.

Social distancing: it works for coronavirus and for flu

Influenza and COVID-19 share some similar symptoms. They are also both spread via respiratory droplets: coughing, sneezing and touching.

Protecting ourselves from COVID-19 through good hygiene and social distancing also means protecting ourselves from flu. This is a small silver lining in an otherwise extremely disruptive time.

We will almost certainly see the impact of social distancing with a reduction in a range of infectious diseases in Australia, from influenza through to sexually transmitted infections and food-borne disease.

In fact, the coronavirus pandemic is as a good reminder of how lucky we are to live in an era where vaccines for many diseases are available. The unprecedented coronavirus measures highlight the lengths we need to go to in order to reduce risk when there’s no vaccine or natural immunity.

Doing your bit to ease the strain on our health system

If we had a roll of toilet paper for every time we’ve heard the term “flattening the curve” in the last few weeks, we’d probably be a lot happier. There are, notably, no mentions of “eliminating the curve”.

Flattening doesn’t mean people will not get COVID-19. These measures are not designed to get case numbers down to zero.

Flattening the curve is another way of saying slowing the spread. The epidemic is lengthened, but we reduce the number of severe cases presenting at the same time, causing less burden on public health systems. The Conversation/CC BY ND

In fact, until a vaccine is available, “flattening the curve” means the same number of people still get infected, but at a slower rate, so our health services can cope and we have as few deaths as possible.

If easing the burden on the health services is important to you, you can do your bit not just by following the coronavirus social distancing measures and washing hands frequently, but also getting your flu shot.




Read more:
Why the flu shot cannot give you the flu (and why you should get one now)


The 2020 flu vaccine is now starting to become available for those aged over six months, and people should speak to their health-care provider about booking to get one sooner rather than later.The Conversation

Lauren Bloomfield, Senior Lecturer, School of Medicine, University of Notre Dame Australia

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