To abandon vaccination targets is to abandon the mantle of leadership


Peter Gahan, The University of Melbourne and Jesse E. Olsen, The University of MelbourneThe Australian government has abandoned its ambitious targets to have the adult population vaccinated by the end of October. It has, in fact, abandoned having any target.

We all sometimes find ourselves in tough positions and just want to call it a day. But this decision is not what we should expect from the nation’s leaders when so much is at stake. It also goes against decades of research and evidence on the importance of goal-setting.

In January Prime Minister Scott Morrison said the plan was to have four million Australians vaccinated by the end of March, and the entire adult population by the end of October. At the start of April, however, the actual number was less than 842,000. (As of April 15 the number was just over 1.4 million doses.)

Then, on April 11, in a video posted to his Facebook page at 11:35pm, Morrison announced there would be no more targets. “We are just getting on with it,” he said.

But without any target, what is the “it” we should be “getting on with”?


Australia's vaccination score card as of April 4 2021.
Australia’s vaccination score card as of April 4 2021. Don’t expect to see any more of these.
Australian Government/Department of Health, CC BY-SA

Imagine if at your next work meeting the boss echoed the prime minister’s words that “one of the things about COVID is it writes its own rules” and said something like:

This quarter, rather than set targets that can get knocked about by every to and fro, we are just getting on with it.

Will these words inspire your team to succeed?

According to leadership research, good management necessarily entails influencing others to achieve goals or objectives. This is a point made even in introductory undergraduate management textbooks.

To abandon goals or targets is, by definition, to abandon the mantle of leadership.




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When goals work

Study after study has demonstrated why setting ambitious targets is important for virtually any activity — from turning a couch potato into a marathon runner, to putting an astronaut on the Moon, to building a driverless car.

Of course, just setting an ambitious goal is not enough. Done poorly, they can be discouraging and undermine performance, and even lead people to behave unethically. To work, people and organisations need to have the capabilities and resources to address unexpected twists and turns, as well as strategy to manage risks and overcome any barriers that crop up.

But so long as goals are set with these things in mind, they help achieve results, driving creativity, innovation and performance.

We already see evidence of this in COVID vaccinations overseas.

The US government’s Operation Warp Speed, the private-public partnership to develop and distribute multiple vaccines in record time, started with this goal:

to deliver tens of millions of doses of a SARS-CoV-2 vaccine — with demonstrated safety and efficacy, and approved or authorised by the US Food and Drug administration for use in the US population by the end of 2020, and to have as many as 300 million doses deployed by mid-2021.

The goal was both ambitious and specific, defining the “it” that everyone should “get on with”. It formed the basis for planning that has started paying dividends after a year of death and economic destruction.

Goal setting and effective leadership

The federal government’s decision to abandon goals goes against research the Commonwealth itself commissioned just a few years ago.

In 2015, the federal Department of Employment and Workplace Relations funded the University of Melbourne’s Centre for Workplace Leadership to survey more than 3,500 Australian workplaces about how the quality of management and leadership affects productivity and innovation.

The Study of Australian Leadership, which surveyed both private and public sector organisations, found very basic management practices to be among the most important drivers of organisational performance and innovation. These basic practices include setting clear and ambitious targets, communicating them, and regularly monitoring progress.

Scott Morrison communicates via a Facebook video on April 11 that the Australian government has abandoned vaccination uptake targets.
Scott Morrison communicates via a Facebook video on April 11 that the Australian government has abandoned vaccination uptake targets.
Facebook

Leading rapid implementation

Given the evidence, any government with claims to having competent leadership should be setting and communicating a clear and ambitious goal for its vaccination roll-out.

Successful roll-outs in other countries show this should be done in consultation with local and regional governments, health professionals and key players in the public and private sectors (who must also be involved in the design and implementation of strategies and processes).

Given the federal government’s own limited capacities at the local level (public hospitals, for example, are run by the state and territory governments), its engagement with other stakeholders must be meaningful — not just lip service. It must also resist the urge to control everything.

Let there be goals

When faced with complex problems, getting agreement on ambitious goals can be extremely powerful. Nor does it need to take forever, as is often claimed. Australia’s response to the pandemic in 2020 largely shows this.

There will be challenges with meeting targets. Vaccine supplies are limited. There will be hiccups. But abandoning any sense of ambition is not the answer.

Because COVID “writes its own rules”, as Morrison has rightly pointed out, the federal government should pursue multiple alternative paths to achieving its goals. In other words, it should not put all it eggs in one basket, as it did with its plan to rely on local GPs to deliver vaccines, rather than use “vaccination hubs” as other nations have done.




Read more:
Australian vaccine rollout needs all hands on deck after the latest AstraZeneca news, mass vaccination hubs included


Abandoning vaccination targets now undermines all that has been sacrificed to be in the relatively good position the nation is now in. The economic and social costs, as well as the potential further loss of life, will mount unless the Morrison government reconsiders its misguided decision.

It must put aside concerns about the political fallout of missing targets. We cannot “get on with it” without leadership that defines the “it” to be gotten on with.The Conversation

Peter Gahan, Professor of Management, Faculty of Business and Economics, The University of Melbourne and Jesse E. Olsen, Senior Lecturer, Dept of Management & Marketing, Faculty of Business & Economics, The University of Melbourne

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

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


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

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

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

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

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

How does the Novavax vaccine work?

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

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

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

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

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




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

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

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

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

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

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

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

What about protection against variants?

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

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




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

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




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The Conversation


Jamie Triccas, Professor of Medical Microbiology, University of Sydney

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

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


from www.shutterstock.com

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

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

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

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

Remind me again, what’s mRNA?

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

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

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

1. Flu vaccine

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

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

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

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

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

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




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2. Malaria vaccine

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

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

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

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

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




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3. Cancer vaccines

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

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

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

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

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

Yes, there are challenges ahead

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

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

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




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

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

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

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

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

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

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


KYDPL KYODO/AP

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

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

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

As the head of one nursing care centre put it,

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

A delayed start to Japan’s vaccine rollout

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

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

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

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

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




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

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

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

A history of vaccine scares

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

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




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


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

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

Political pressure on Suga

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

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

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

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

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

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

Playbook for a COVID-safe Olympics

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

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




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

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

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

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

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

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

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

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

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

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


Shutterstock

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

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

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

Previous problems

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

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

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

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

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

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

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

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

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

A need for accessible information

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

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

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

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

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

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

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

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

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

What protections are in place?

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

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

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




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

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

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

Gaps in our knowledge

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

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

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

They advised the data collected by HealthEngine:

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

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

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

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




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The Conversation


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

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

Is it the adenovirus vaccine technology, used by AstraZeneca and Johnson & Johnson, causing blood clots? There’s no evidence yet


Kylie Quinn, RMIT UniversityThis week, US health authorities recommended pausing the rollout of the one-shot Johnson & Johnson/Janssen COVID-19 vaccine while investigations into exceptionally rare blood clots take place.

Six women suffered blood clots out of nearly seven million doses administered.

The J&J vaccine uses broadly similar vaccine technology as the AstraZeneca vaccine, known as adenoviral vectors, which has led some experts to speculate there might be a link between this vaccine platform and the very rare blood clotting condition known as “vaccine-induced immune thrombotic thrombocytopenia” (VITT).




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So far, a link between adenovirus technology in general and blood clots is purely speculation — there’s no evidence yet — but it’s worthwhile for health authorities to assess the data and for researchers to try to understand:

  • can adenoviral vectors in general cause VITT?
  • is VITT specific to the AstraZeneca adenoviral vaccine?
  • are certain unlucky individuals pre-disposed to develop VITT?

So what’s an adenovirus, and how are they used in vaccines?

Adenoviruses are a large family of viruses found in humans and other animals. In humans, some of these viruses can cause the common cold.

Scientists can also use these viruses to make vaccines, by using them to make what’s called a “viral vector”. A vector is a virus shell that researchers can use to package up and deliver a target from another virus.

To make an adenoviral vector, scientists take an adenovirus and remove any genetic material that could either allow the virus to replicate and spread, or cause disease. Researchers then take the adenovirus shell and insert genetic instructions for how to make a target on the surface of another virus. For COVID-19, they use the instructions to make the “spike protein” on the surface of the SARS-CoV-2 virus.




Read more:
From adenoviruses to RNA: the pros and cons of different COVID vaccine technologies


To your immune system, an adenoviral vector looks like a serious virus, even though it can’t replicate or cause disease. As a result, your immune system mounts a serious response, which is why people have been reporting more noticeable side-effects like a fever, fatigue and sore arm in the couple of days after the vaccine.

Similar but different

Currently, four COVID-19 vaccines use adenoviral vectors: AstraZeneca, Janssen/Johnson&Johnson, CanSino Biologicals and Sputnik V.

There are many adenoviruses out there to use as a starting point to make different adenoviral vectors. While these vectors can share some characteristics, they can also be biologically pretty different.

Different adenoviruses use different access points, known as receptors, to get into our cells. This can result in a very different size and type of immune response. Also, the adenovirus used in the Sputnik V and CanSino vaccines, called “rAd5”, isn’t very good at setting off the alarms in our immune system, while other adenoviral vectors are better.

The different vaccines also deliver slightly different sets of instructions for the spike protein. The J&J vaccine, called “rAd26”, instructs our cells to make a spike protein that’s locked into a specific shape, to help our immune system recognise it, and it’s delivered to the surface of the cell. The AstraZeneca vaccine, called “chAdOx01” instructs the cell to make a spike protein that isn’t locked in place and it can be secreted from the cell.

Given these differences, if one adenoviral vaccine is linked with a particular effect in our bodies, for example blood clots, it doesn’t mean all vaccines in this family will have that same effect. But regulators should still investigate.

We need to understand more about these blood clots

A number of regulatory bodies have issued notifications of a plausible link between the AstraZeneca vaccine and VITT.

This risk is very, very low — around one in 200,000 people that receive the vaccine could develop the condition. But for the rare person that develops VITT, the consequences can be serious, with around one-quarter of those with the condition dying from it. So regulators are taking the situation seriously.

VITT isn’t like other clotting conditions. There are many different types of clotting conditions but it seems VITT is likely to be caused by an unusual immune response.

We don’t know exactly what triggers this immune response. There have been reports of clotting conditions with adenovirus infections or very high doses of adenoviral vectors. However, this occurred very quickly, while VITT is a delayed response, observed 4-20 days after vaccination. It seems more likely at this stage that, in certain very rare patients, some kind of unusual immune response may be triggered.




Read more:
How does the Johnson & Johnson vaccine compare to other coronavirus vaccines? 4 questions answered


While researchers try to understand VITT, many regulators are taking a cautious approach — advising their communities, giving guidelines for preferred vaccines with younger age groups and revisiting data for other vaccines to be vigilant.

In doing this, regulators must balance a very rare risk of VITT with the AstraZeneca vaccine, with a very real risk of death and disease that face people with COVID-19. For many people, particularly older people in regions with community transmission of the virus, it still makes clear sense for their health to receive whichever COVID-19 vaccine is available.

These are complex decisions resulting in nuanced information that is hard to communicate. But the fact regulators are engaging with them quickly and transparently has been reassuring to me and, I hope, others in our broader community.The Conversation

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

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

National cabinet to meet twice weekly in Morrison’s effort to get vaccination rollout ‘back on track’


Michelle Grattan, University of CanberraScott Morrison will hold twice-weekly meetings of the national cabinet for the “foreseeable future”, as the government battles to get its slow and problem-laden vaccine rollout back on course.

The Prime Minister says he has asked national cabinet and health ministers to “move back to an operational footing” to tackle the program’s challenges.

This comes as the rollout is being recalibrated following the medical advice restricting the use of the AstraZeneca vaccine to people over 50. Morrison has refused to set a target date for having all those eligible and willing vaccinated with at least one shot, after abandoning the government’s previous October target.

Morison’s action on the national cabinet and his comments are his bluntest admission so far of the program’s difficulties, which started from its beginning and have multiplied ever since.

“There are serious challenges we need to overcome caused by patchy international vaccine supplies, changing medical advice and a global environment of need caused by millions of COVID-19 cases and deaths,” he said in a statement.

“This is a complex task and there are problems with the programme that we need to solve to ensure more Australians can be vaccinated safely and more quickly.”

He said the federal government was trying to deal with its issues “and I have been upfront about those”.

But states and territories were also tackling their own issues, he said.

“Working together we are all going to be in a better position to find the best solutions.”

The federal government has taken the main responsibility for the rollout, but it does not have the states’ experience at service delivery and this has added to the problems.

The new regime for national cabinet meetings will start on Monday and continue “until we solve the problems and get the programme back on track”. It has been recently meeting only about monthly.

Meanwhile, a second person has suffered a blood clot after receiving the AstraZeneca vaccine.

A woman in her 40s is recovering in the Darwin Hospital after being transferred from a regional hospital in northern Western Australia.
The Western Australian Health Minister, Roger Cook, said the woman was in a stable condition in ICU.

Earlier a man in his 40s in Melbourne developed a clot after receiving the vaccine.

Last week Morrison announced the Australian Technical Advisory Group on Immunisation had advised against giving AstraZeneca vaccine to people aged under 50.

On Monday more than 56,000 doses of Pfizer and AstraZeneca vaccines were administered.The Conversation

Michelle Grattan, Professorial Fellow, University of Canberra

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

The best hope for fairly distributing COVID-19 vaccines globally is at risk of failing. Here’s how to save it


Deborah Gleeson, La Trobe UniversityCOVAX, the global initiative to coordinate the distribution of COVID-19 vaccines in an equitable way, is crucial for bringing the pandemic under control.

But COVAX’s aim of delivering 2 billion doses to participating countries by the end of 2021 — including 92 low-income countries that can’t afford to buy vaccines directly from manufacturers — is threatened by chronic under-investment, vaccine nationalism and export restrictions.

COVAX is not intended only for low-income countries: Canada has so far received 316,800 doses through the scheme. As such, it represents an important “insurance policy” for Australia, potentially enabling access to a wider portfolio of vaccines than we could secure through negotiations with suppliers.

The vulnerability of our vaccine procurement strategy has become clearer over the last few weeks, with supply blockages limiting vaccine imports from Europe and now the government’s warning about the AstraZeneca vaccine and its links to a rare blood-clotting disorder.

Saving COVAX will require more than donations (of both funds and vaccines), as well as the removal of export bans. Countries must collaborate to urgently remove the legal and technical barriers preventing more widespread vaccine manufacturing in order to increase the global supply of vaccines for COVAX to distribute.




Read more:
Yes, export bans on vaccines are a problem, but why is the supply of vaccines so limited in the first place?


How does COVAX work?

COVAX is led by the Coalition for Epidemic Preparedness Innovations (CEPI); Gavi, the Vaccine Alliance (a public-private partnership that aims to increase vaccination in low-income countries); and the World Health Organization.

It aims to deliver doses to all of the participating countries that have requested them in the first half of 2021, and 2 billion vaccines in total by the end of 2021.

COVAX is complex, but essentially it works by investing in a portfolio of promising vaccines and then distributing them according to a formula to both “self-financing countries” and “funded countries”.

Self-financing countries are those which have contributed funds to COVAX, such as Australia. They are able to buy the vaccines at cheaper prices negotiated by COVAX and will initially receive enough to vaccinate 20% of their populations. In the longer term, these countries may receive enough doses to vaccinate up to half of their populations, depending on how much they contribute.

Funded countries include 92 low-income countries that can’t afford to buy their own vaccines. They will also receive enough to vaccinate 20% of their populations, provided COVAX is able to meet its goals. This is nowhere near enough to achieve herd immunity, but will at least allow health workers and the most vulnerable groups to be vaccinated.

Australia has committed A$123.2 million to enable it to purchase 25 million vaccines for domestic use.

It has also committed A$80 million specifically earmarked for providing vaccines for low-income countries. This money will be drawn from existing aid funding, however, and won’t go very far in terms of assistance.

How is the program going so far?

COVAX made its first delivery of vaccines to Ghana on February 24. By April 11, it had shipped approximately 38.5 million doses to 106 countries and territories.

The first shipment of COVID-19 vaccines distributed by COVAX arriving in Ghana.
Francis Kokoroko/UNICEF/AP

While these figures might look promising at first glance, this is a long way behind COVAX’s aim to deliver 100 million doses by the end of March.

And they don’t stand up well in the context of global vaccine roll-outs. So far, only 0.2% of the 700 million vaccine doses administered globally have been given in low-income countries, whereas 87% have been received by people in high-income and upper middle-income countries.

Tedros Adhanom Ghebreyesus, director-general of the WHO, pointed out last week that only one in 500 people in low-income countries have so far received a vaccine — a situation he described as a “shocking imbalance”.




Read more:
Why ‘vaccine nationalism’ could doom plan for global access to a COVID-19 vaccine


Why is COVAX struggling to deliver?

COVAX needs more funding, to the tune of US$3.2 billion even to meet its modest goals for 2021. But the supply of vaccines is an even bigger problem.

Rich countries like Australia have undermined COVAX by negotiating deals for vaccines directly with pharmaceutical companies, rather than waiting for COVAX to allocate them fairly. By last November, high-income countries making up just 14% of the world’s population had negotiated pre-market agreements covering 51% of the global supply.

Adding to COVAX’s problems, the flow of vaccine deliveries has mostly dried up in the last week.

Some 90 million doses of the AstraZeneca vaccine manufactured in India that were to be delivered to 64 countries in March and April have been delayed as a surge in COVID-19 cases prompted the Indian government to restrict exports.

Boxes of AstraZeneca COVID-19 vaccines manufactured by the Serum Institute of India and provided through the COVAX global initiative arrive at the airport in Mogadishu, Somalia.
Farah Abdi Warsameh/AP

What needs to happen?

WHO has called on rich countries to immediately share 10 million doses to prop up COVAX in the first half of 2021.

But so far, no country has committed to do this. Donations that come after countries have fully vaccinated their own populations will be too late. And where bilateral donations have been made outside of the COVAX program (mainly by China and Russia), they have largely been driven by security, strategic or political considerations, rather than donated to the countries where they are most needed.




Read more:
New COVID variants have changed the game, and vaccines will not be enough. We need global ‘maximum suppression’


Removing export restrictions would help. But as long as demand exceeds supply and the countries where vaccines are manufactured face large outbreaks, we are likely to continue to see these types of barriers.

What is needed most are more sustainable approaches to dramatically boost the global supply of vaccines and ensure there’s enough to go around.

This first requires removing the intellectual property protections that allow vaccine developers to hold exclusive rights to control who can make and sell them.

India and South Africa have put forth a proposal at the World Trade Organization to waive intellectual property rights for COVID-19 medical products during the pandemic, which has been supported by more than 100 low- and middle-income countries. However, several high-income countries, including Australia, have blocked it.

Secondly, governments need to support mechanisms for sharing intellectual property, such as the WHO’s COVID-19 Technology Access Pool (C-TAP).

This was set up nearly a year ago, but no vaccine developer has contributed to it yet. Governments need to make sharing intellectual property and contributing to the pool a condition of public funding for the development of COVID-19 products.

Finally, governments need to help low- and middle-income countries to produce their own vaccines. This means investing money to build up manufacturing capacities in these countries and facilitating technology transfers from companies based in high-income countries.

For COVAX to supply enough vaccines for even 20% of the world’s population, rich countries will need to step up. And fast.The Conversation

Deborah Gleeson, Associate Professor in Public Health, La Trobe University

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

The ebb and flow of COVID-19 vaccine support: what social media tells us about Australians and the jab


Shutterstock

Bela Stantic, Griffith University; Rodney Stewart, Griffith University, and Sharyn Rundle-Thiele, Griffith UniversityAustralia’s COVID-19 vaccination rollout has hit yet another crossroads. Public confidence has wavered following the federal government’s announcement last week that the Pfizer vaccine was the preferred choice for people under age 50.

The advice was based on an extremely low risk of severe blood clots forming in younger recipients of the AstraZeneca vaccine. Many patients under 50 have since cancelled or been turned away from their vaccine appointments, according to reports.

Our Griffith University team is monitoring vaccine support levels among Australians. We’re doing this by analysing “big data” gleaned from social media platforms.

According to our analysis, the biggest drop in COVID-19 vaccine acceptance rates in Australia happened when blood clotting incidents were reported in some European countries, prompting rollouts to be stopped.

An evolving debate

Our team trawled through social media feeds for two months, collecting data on public attitudes towards the vaccine. We also watched these opinions change and evolve in response to important media announcements.

We found the Australian public cares about the vaccine’s effectiveness, side effects and roll-out process. Social media sentiment in particular is helping us identify misinformation in a way more traditional survey methods can’t.

Our findings, which have been provided to Queensland Health, are aiding decision makers in devising the best strategies to provide vaccine information to the public.




Read more:
Why telling stories could be a more powerful way of convincing some people to take a COVID vaccine than just the facts


Standard survey approaches

Carrying out surveys can be costly and time-consuming. It’s hard to get large samples because many people approached won’t participate. It’s also difficult to return to respondents later to understand how their beliefs may be changing over time.

Between October last year and February this year, the Gold Coast Public Health Unit ran a survey asking people if they intended to get the COVID-19 vaccine.

Almost 19,000 survey invitations were given to people who visited fever clinics at the Gold Coast University Hospital and Robina Health Precinct. From these, 2,706 responses came back.

Results showed just over 50% of respondents “definitely intended” to receive the COVID-19 vaccine. Around 15% said they “probably” or “definitely” wouldn’t receive the vaccine.

Results from the Gold Coast Public Health Unit’s survey of attitudes to COVID-19 vaccination.

Similarly, a study conducted by researchers at the Australian National University showed one in five (21.7%) respondents would “probably” not or “definitely” not receive a vaccine.

While such surveys provide a snapshot from one point in time, big data analytics can examine social media data (such as from Twitter) in real time and provide ongoing insight.

Nearly 100,000 posts from 42,000 accounts

We applied algorithms to social media content published between January 24 and March 24. In just two months, more than 97,000 Twitter posts from more than 42,000 Australian accounts (with 308,331 “likes”) were collected.

These posts attracted a further 49,642 comments from another 15,648 unique accounts. This sample size is much bigger than the surveys mentioned above. Notably, the data we collected showed us how vaccine hesitancy had changed during that time.

We used techniques called “sentiment polarity” calculations and “topic modelling analysis” and also looked at the number of likes received by posts for and against the vaccine.

During the two months, we were able to identify links between changes in sentiment and specific media announcements from trusted news sources. The announcements had an obvious impact on people’s opinions.

Negative reporting had a direct impact

Vaccine support started at around 80% in January. We then saw declining support as COVID cases in Australia dropped. But when the media showed people receiving the Pfizer vaccine in February, support grew again.

Pfizer vaccine in needle
The Pfizer vaccine is now the recommended one for people under age 50.
Joel Carrett/AAP

Negative stories started to appear mid-to-late February and support levels on social media feeds dropped. In late February, the media told us about a poorly trained doctor who gave higher than recommended vaccine doses to two elderly people.

We then received reports of multiple European Union countries banning the AstraZeneca COVID-19 vaccine, due to concerns of blood clotting as a potential side effect. This marked the biggest drop in support, from more than 80% to below 60%.

How Australian rates of vaccine acceptance changed over time, as measured by analysis of Twitter posts. Public confidence in the vaccine rollout shifted dramatically following key announcements in the media.

In late March, support bounced back when the same countries resumed rolling out the AstraZeneca vaccine, and news emerged that GP clinics in Australia were gearing up to do the same.

There are some limitations to our research method. For instance, the views of Twitter users don’t necessarily represent the general population. That said, our data pool does seem to reflect a fairly diverse group of users sharing opinions by posting, re-tweeting and liking posts.

All of these opinions are captured and incorporated into our analysis. Considering the large volume of data used, as well as insights from other correct predictions, we are confident in our ability to provide an accurate near real-time analysis.

Addressing what the public wants addressed

Big data analysis can deliver fast results that show not just the prevalence of vaccine hesitancy, but also help us understand the factors that drive it.

Further, by focusing on the regions or demographics which have the most doubts — whether this is certain age groups, or people with a given level of education — big data analysis can keep high-level decision makers informed about how the public feels.

This in turn assists them with pointing out key issues and vulnerable areas, to which they can direct targeted messaging. In this way, the news sources the public respects and trusts can (and must) be used to improve health outcomes for all.




Read more:
Just the facts, or more detail? To battle vaccine hesitancy, the messaging has to be just right


The Conversation


Bela Stantic, Professor, Director of Big data and smart analytics lab – IIIS, Griffith University; Rodney Stewart, Professor, Griffith School of Engineering, Griffith University, and Sharyn Rundle-Thiele, Professor and Director, Social Marketing @ Griffith, Griffith University

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

View from The Hill: Voters could wreak vengeance if Scott Morrison can’t get rollout back on track


Mick Tsikas/AAP

Michelle Grattan, University of CanberraLast week, people were falling over themselves to get vaccination appointments and had to be told, by their doctors and their government, to be patient.

Patience is still needed — indeed, more than ever — but now there’s rising vaccination hesitation and the message from the government is people should remain eager for the jab.

Conservative advice from the Australian Technical Advisory Group on Immunisation (ATAGI), recommending against the AstraZeneca vaccine for the under 50s (because of the very small danger of blood clots), has alarmed many people.

The danger is the advice has a knock-on effect, spooking people to whom it doesn’t apply.

Apart from younger frontline workers in health and aged care, those with underlying health conditions, and certain others, under 50s are not presently being vaccinated.

But with changing messages, some of the over 70s — the cohort now at the head of the vaccination queue — might start to have second thoughts, despite being told they shouldn’t.

They may or may not be reassured by Prime Minister Scott Morrison on Friday declaring his mother is lining up for her AstraZeneca shot soon. Or Commonwealth Chief Medical Officer Paul Kelly sharing the fact he’s urging his 86-year-old father to do so.

Thursday’s unwelcome medical advice was just the latest setback to the rollout and the Morrison government.

There have been the blocks and delays imposed on supplies from Europe and CSL production (of AstraZeneca) has been slower than anticipated.

The logistics haven’t all gone smoothly. Despite protestations to the contrary, the Commonwealth’s distribution has been sub-optimal.

Some doctors have complained of getting inadequate supplies; the arrangements for nursing homes have had glitches.

The whole program is running massively behind the original schedule. The government on Friday was celebrating passing one million doses administered, when we should have been well past four million.

We’re marching at a much slower pace than the United States or the United Kingdom. In the UK, incidentally, the authorities are being less conservative about AstraZeneca — it’s the under 30s who are being offered an alternative.

One can only imagine Morrison’s reaction when he was delivered the ATAGI advice, which of course he had to follow (even though some experts disagree with it). As he said, “You don’t get to choose the medical advice that’s provided by the medical experts”.

One guide to the prime ministerial mood is the fact he stresses it’s only advice to avoid AstraZeneca if you are under 50. The decision is up to you, and your doctor (though you will be signing a rigorous consent form if you ignore it).

But that line just contributes to the muddled messaging many people will feel they’re receiving.

With an already disorderly program thrown into further disarray by the medical advice, the government on Thursday night and Friday went into overdrive.

Another 20 million doses of the Pfizer vaccine — now the one for the under 50s — were instantly procured (this is on top of the 20 million already purchased). This is good news, if you are patient. They are not due to land until the last quarter of the year.

Health Minister Greg Hunt says Pfizer doses scheduled to arrive in coming days will ramp up, but details are sketchy.

The government is anxious to say the immediate stage of the vaccination schedule should not be much delayed.

The elderly who are being vaccinated now are good to get AstraZeneca.

As for the health and aged care workers? Determinedly looking on the bright side, Morrison noted many are over 50. Pfizer vaccines will have to be arranged for the younger ones, however, which could involve some scrambling.

But the rollout generally has to be recalibrated and delays are expected to hit in coming months when the program gets to the younger section of the general population.

For these people, vaccination is not as critical in health terms as it is for those older. But for the economy, vaccinating them as soon as can be done is vital.

At one level, Australia is being protected by our previous (and continued) success on the health front, which has left us with little or no community transmission. The rollout problems would be a disaster if we had COVID raging.

But we are riding on our luck. There are no guarantees against serious outbreaks.

Even without those, the longer the rollout drags on, the more we have the disruption of small lockdowns, and the slower the re-opening of Australia’s international border, with all the consequences that brings.

Morrison, who recently talked so confidently about everyone who was eligible and willing receiving one vaccine shot by October, now won’t commit to any date.

It would be a nightmare for him if the rollout wasn’t finished by year’s end, and the international border remained substantially shut.

He’d be only months from an election campaign, and Australians would probably be suffering a bad dose of cabin fever.

Politically, state and territory leaders have reaped rewards in elections from being seen to handle COVID well. A few months ago the pundits predicted Morrison would do the same.

But if they come to believe he has comprehensively mishandled the vaccine rollout, the voters could wreak vengeance.The Conversation

Michelle Grattan, Professorial Fellow, University of Canberra

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