Over 700 health experts are calling for urgent action to expand global production of COVID vaccines


Anupam Nath/AP

Deborah Gleeson, La Trobe University and Michael Toole, Burnet InstituteToday, we are joining over 700 health professionals and academics in sending an open letter to Prime Minister Scott Morrison urging him to take a leadership role in expanding the global production of COVID-19 vaccines and other medical tools to fight the pandemic.

The letter, signed by 207 doctors, 177 academics and 111 public health professionals, asks the government to help remove legal and technical barriers to increasing the production of COVID-19 vaccines, diagnostic tests, treatments and other equipment.

We argue there is more Australia — and other wealthy nations — can and should be doing to end the pandemic.

The need to act urgently

The COVID-19 pandemic is escalating sharply in the developing world. In addition to India’s spiralling infections, cases are surging across the globe in countries like Argentina, Uruguay, Sweden, France, Turkey, Mongolia, and Costa Rica.

The roll-out of vaccines must rapidly accelerate. Uncontained transmission will inevitably lead to the emergence of new variants that may be more infectious and resistant to vaccines.




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As of today, more than 1.06 billion vaccine doses have been administered worldwide. However, 37% of these doses have been given in the world’s 27 wealthiest countries. Those countries represent just 10.5% of the global population.

Meanwhile, countries making up the least wealthy 11% have received just 1.6% of the vaccine doses so far. At this pace, most of the world’s population will remain unprotected at least until 2023.

Vaccine shortage in India.
Vaccine shortages have been a frequent occurrence in India in recent weeks.
Rafiq Maqbool/AP

Monopolisation of vaccines

Two of the chief obstacles to vaccinating the world are the monopolisation of vaccines and the means of producing them. The world is relying on the pharmaceutical industry and market forces to solve the problems of inadequate supply and inequitable distribution — and this won’t work.

Rich countries have monopolised the world’s supply of vaccines by pre-purchasing doses in bulk. By November 2020, 7.5 billion doses had been reserved, half of these by rich countries making up only 14% of the global population.

Canada has more vaccines than it needs on order.
Countries like Canada have far more vaccines than they need on order.
Paul Chiasson/AP

Rich countries have also under-invested in COVAX, the global program for equitably distributing vaccines. COVAX needs an additional US$3.2 billion just to meet its target of vaccinating 20% of populations of participating countries.

Added to this, countries faced with large outbreaks have erected export restrictions to bolster their own supply of vaccines, excluding others.

This includes the European Union’s refusal to release 3.1 million doses to Australia this year. India has also restricted vaccine exports, resulting in delays in delivering 90 million doses to low-income countries.

The US, too, has been stockpiling its supplies, though the Biden administration announced this week it will now allow the export of raw materials needed to manufacture vaccines in India.

Monopolies on the means of producing vaccines

While the hoarding of vaccines is a concern, the monopolies on the rights to produce them is an even bigger problem.

The exclusive rights to manufacture COVID-19 vaccines are currently held by a small number of companies. These intellectual property rights are enshrined in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, otherwise known as TRIPS.

Under TRIPS, WTO members must allow patents of at least 20 years for new pharmaceutical products, along with other types of intellectual property protection.




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TRIPS allows nations to invoke compulsory licensing of pharmaceutical products, which enables patented inventions to be produced without the consent of the patent owner in an emergency.

But compulsory licensing can only be applied on a product-by-product basis, and it only applies to patents, not the other types of knowledge and data needed to manufacture vaccines.

Countries also tend to face diplomatic and trade pressure not to enact such licenses. To our knowledge, no country has yet issued a compulsory licence for a COVID-19 vaccine.

Reliance on the pharmaceutical industry and market forces

So far, the world has placed its trust in the pharmaceutical industry and market forces to solve the problem, hoping vaccine makers would voluntarily enter into licensing arrangements with other manufacturers to increase supply.

But voluntary licensing has been little used to date. When it has been used, it has been done in an ad hoc and opaque way, with restrictive conditions.

AstraZeneca, Gamaleya/Sputnik V and Sinopharm are so far the only companies to implement voluntary licensing for COVID-19 vaccines. AstraZeneca, for instance, has licensed SK Bio in South Korea, the Serum Institute of India and CSL in Australia to manufacture the vaccine.




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Other companies’ reluctance to enter into these arrangements means available manufacturing capacity in Asia, Africa, and Latin America is not being used.

The pharmaceutical industry is heavily invested in the status quo. Pfizer and Moderna expect to generate US$15 billion and US$18.4 billion in revenue respectively in 2021, just based on existing supply agreements.

The People’s Vaccine Alliance estimates Pfizer, Johnson & Johnson and AstraZeneca have distributed US$26 billion to their shareholders in the form of dividends and stock buybacks in the past 12 months – enough to cover the cost of vaccinating 1.3 billion people.

A BioNTech production site in Germany
Pfizer/BioNTech’s goal is to produce 2.5 billion doses globally by the end of the year.
Michael Probst/AP

What Australia has done to help so far

Australia has been generous to date, providing AU$80 million to COVAX (specifically for low-income countries).

It has also pledged $523 million to the Regional Vaccine Access and Health Security Initiative, which provides health system support for vaccinations and $100 million to the Quad initiative by India, Japan, Australia and the US, which aims to distribute 1 billion doses in the Indo-Pacific region by 2022.

Australia has also provided 8,840 doses of AstraZeneca vaccine to PNG for frontline health workers and negotiated with the EU to free up 1 million of its own doses on order for PNG. Canberra has also pledged doses to Timor-Leste, Solomon Islands and Vanuatu.

These contributions are important stop-gaps to help address immediate needs. But they won’t go far enough on their own.

Further steps Australia needs to take

Increasing the global supply of vaccines will require governments to remove legal and technical barriers to their production.

To help remove legal barriers, the Australian government should support a proposal by India and South Africa in October 2020 to waive certain intellectual property rights for COVID-19 medical products.

This proposal, known as the “TRIPS Waiver”, is now supported by more than 100 of the WTO’s 164 member states. However, it has been blocked or stalled by the US, EU, Japan, Canada, and Australia.

Australia will have another chance to support it when it’s discussed at a TRIPS council meeting later this week.

To remove technical barriers, Australia must use its leverage to persuade pharmaceutical companies to share their knowledge and transfer technology to low and middle-income countries.

Australia should also endorse the COVID-19 Technology Access Pool (C-TAP), which was established last May by the World Health Organization but has so far been unused.

C-TAP relies on voluntary commitments by pharmaceutical companies. For it to work, governments need to provide incentives or require pharmaceutical companies to share their IP, data and know-how as a condition of public funding for research and development.

Over 700 health professionals and academics see the government’s leadership in these areas as a critical part of our pandemic response.

It’s time for Australia to act, and to encourage regional allies such as New Zealand, Japan, South Korea, and Singapore to do the same.The Conversation

Deborah Gleeson, Associate Professor in Public Health, La Trobe University and Michael Toole, Professor of International Health, Burnet Institute

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

The world is hungry for mRNA COVID vaccines like Pfizer’s. But we’re short of vital components


Archa Fox, The University of Western Australia and Pall Thordarson, UNSWGiven the AstraZeneca COVID-19 vaccine is no longer recommended for under-50s following news of very rare blood clots, Australia is looking to other vaccines to plug the gap.

Pfizer’s mRNA vaccine will become the mainstay of the rollout, with 40 million doses expected to arrive before year’s end.

But Australia isn’t the only country eager to get its hand on this vaccine.

Skyrocketing demand coupled with shortages of vital components is leading to bottlenecks in the supply chain of this and other mRNA vaccines, delaying vaccine supplies.

The Victorian government also announced last week it would provide A$50 million to set up local manufacturing of mRNA vaccines in Australia. It’s feasible supply chain issues could also impact local manufacturing of mRNA vaccines.

So what are the missing supplies for making mRNA vaccines?




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The shortages slowing mRNA vaccine production

1. mRNA manufacturing and capping

Manufacturing mRNA vaccines is kind of like making a car, with an assembly line and many steps. Each step needs to lead to the next and flow smoothly to make the final product.

COVID mRNA vaccine manufacturing starts with making the “messenger RNA”, the instructions that tell our cells to make the coronavirus’ spike proteins. The mRNA is produced in reactor vessels, where protein enzymes track along a DNA template and copy that DNA sequence into RNA form.

The first shortage is in sterile, single-use plastic bags which sit inside the metal reactor vessels used for making the mRNA, almost like a bin liner. Several suppliers of these plastic liners are ramping up production so it’s anticipated this shortage won’t last too long.

The second main shortage relates to “capping” the mRNA at one end. Capping involves adding a chemical molecule to the mRNA which stops the mRNA breaking down too quickly and helps our cells use the mRNA to make protein. Early on during the worldwide upscaling of mRNA manufacturing, rumours abounded that the enzymes and raw materials to make the mRNA cap were running short, given related enzymes used for COVID tests were also in short supply.

However, while only a few players dominate the field, this doesn’t seem to be a bottleneck now. But it does still remain one of the most costly parts of the mRNA production process.

2. Lipids in nanoparticles

The main bottleneck right now is the supply of some of the lipids making the nanoparticles that protect the mRNA and deliver it into our cells.

One lipid in particular, a so-called “cationic lipid”, wraps around the mRNA and then releases it inside the cell. Several chemical synthesis steps are required to make these cationic lipids, and prior to COVID only a handful of manufacturers worldwide were making these, and only on a fairly small scale.

Upscaling this production of cationic lipids has been even harder than setting up the mRNA production. Currently, four companies — Croda/Avanti, CordenPharma, Evonik and Merck — are the main manufacturers of these lipids.

As an indication of how serious this shortfall in lipids is, in December 2020 former US President Donald Trump invoked the Defense Production Act to assist Pfizer in accessing more lipids.

Why do we have these shortages?

The reasons for these shortages are complex. In most cases, demand has outstripped supply. In some cases, some countries or companies have been stockpiling some of these components. “Operation Warp Speed”, initiated by the Trump administration to speed up COVID vaccine development, used its financial clout throughout 2020 to buy up and secure many vaccine components including vials and lipids. This has put the vaccine manufacturers based in the United States in a good position, including Moderna and several Pfizer sites.

For some materials, the reason for the shortfall is simply that they’re hard to make. The bespoke cationic lipids are chemically synthesised in ten steps that all have to performed under strict quality control. Even if the equipment is ready, setting up such a manufacturing process takes months.

How could these shortages impact future mRNA manufacturing in Australia?

When Victoria’s new mRNA manufacturing facility comes online, hopefully in the next 12-24 months, some of these global shortages may still be plaguing the worldwide supply chains. This shouldn’t stop our efforts on that front as raw material supplies are rapidly increasing.

Australia should also do more manufacturing of small molecule active pharmaceutical ingredients, that is, the biologically active component in each drug, including lipids and other building blocks of mRNA. Australia imports over 90% of its drugs from overseas. Making active pharmaceutical ingredients is important, not just for COVID vaccines but more generally.

Australia nearly ran out of some essential drugs, like ventolin, in the early days of the COVID-19 crisis. This was due to both Australians’ panic buying, as well as COVID-hit Chinese factories slowing down their manufacturing, leading to a lack of access to these ingredients for our most commonly used drugs. The added benefits of locally based manufacturing of active pharmaceutical ingredients is we’d be part of the solution when components are in short supply in future.

Australia also has a very strong research community in mRNA and nanomedicine. There are several world-leading groups working on creating better lipid nanoparticles for the delivery of mRNA and other medical products.

Having access to local manufacturing capability of active pharmaceutical ingredients would therefore transform the ability of Australian researchers to lead the way in developing the next blockbuster medical technology based on mRNA or nanoparticle delivery.




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The Conversation


Archa Fox, Associate Professor and ARC Future Fellow, The University of Western Australia and Pall Thordarson, Professor, Chemistry, UNSW

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

Here are 9 ways we can make it easier for Australians to get the COVID-19 vaccine


Carissa Bonner, University of Sydney and Rachael Dodd, University of SydneyBetween vaccine supply issues, confusion about the role of GPs, and changed advice for AstraZeneca, the Australian COVID-19 vaccine rollout is well behind schedule.

How can we make it easier for the majority of Australians who want to be vaccinated? Especially given all Australians over 50 years of age are eligible to be vaccinated from May 3 next week.

There are tangible things we can do now to help people understand the benefits and possible risks of COVID-19 vaccination, and get the vaccine quickly as soon as they’re eligible.

Improve understanding

We know communication about COVID-19 hasn’t met the needs of people with low health literacy or those who speak different languages. These groups are also more susceptible to misinformation so it’s vital we communicate well to them.

Here are some practical things we can do:

  1. use standard terms: governments need to develop a national glossary for COVID-19 vaccination terms. This would standardise and simplify information for diverse communities. For example, the Department of Health provides a glossary for mental health terms, which can ensure patient information and translations for words like “care plan” are consistent
  2. write for year 8 reading level: one study of COVID-19 information found government information in Australia, the US and UK was too complex for many people to understand; and it was worst for Australia. Online “readability” calculators can be used to check health information is at the recommended year 8 reading level. Real-time editing tools help writers avoid acronyms and uncommon words, and use shorter, simpler sentences
  3. use supporting images: we can make sure text is supported by helpful images such as the vaccination timeline, rather than negative images like pictures of needles that may scare people.



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Improve access

We know vaccine supply is a challenge but we can still make sure every available vaccine dose is used as soon as possible.

Strategies to do this could include:

  1. local vaccination: our COVID-19 testing model has been successful including pop up clinics in places where there have been localised outbreaks. But our vaccine distribution logistics are falling behind. The US has used community clinics, pharmacies and mobile field officers to vaccinate millions of people a day. While some testing clinics now offer vaccinations, we could be doing more to provide vaccines for free as locally as possible
  2. national registry: registries can keep track of vaccine doses and notify people as soon as they’re eligible. This is done in childhood vaccination, and notification systems are used effectively for cancer screening programs. We could use the existing Australian Immunisation Register to track and promote COVID-19 vaccination
  3. automated appointments: people could sign up for “opt out” appointments with their local GP or vaccination clinic. This means they would be automatically booked into an appointment as soon as they’re eligible and supply is available, or moved to an earlier appointment if there’s a cancellation. This pre-registration approach will reduce wasted vaccine doses when several doses must be used from the same vial in the same day.



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Improve motivation

Our research, published as a pre-print in February, shows motivation is a particular challenge for Australia. Many people perceive their individual risk of contracting COVID-19 to be lower given case numbers are so low, and many people therefore haven’t been as strict with distancing behaviours.

Even before the new risk of serious clots was identified with the AstraZeneca vaccine, the top barriers for getting the vaccine in 2020 were safety concerns and side effects, which may outweigh the individual risk of COVID-19 for some people.

But most Australians have high intentions to get vaccinated, and there are things we can do to maintain motivation:

  1. explain benefits AND risks: rather than focusing on single cases of serious side effects, we need to balance information in the media. We can use simple graphics to help people consider how the rare risk of serious side effects weighs up against the serious complications of COVID-19 for their age group during a local outbreak — which could still happen any time
  2. emphasise community benefits: since COVID-19 is well controlled in Australia, we can focus on emphasising the benefits to the community of getting vaccinated. This might help people understand why they should get vaccinated even though their individual risk might be low. Our research in 2020 found the top motivators were “to protect myself and others” and “belief in vaccination and science”. Even if a 25-year-old views their individual risk of COVID-19 complications as low, protecting family, friends, and wider society may be important to them
  3. provide incentives: getting vaccinated as soon as someone’s eligible could be linked to financial incentives. This has been used for childhood vaccination where access to childcare rebates is easier with up-to-date vaccination, and health professionals are incentivised to address vaccination gaps. However, this needs to be done carefully to avoid the concerns of coercive policies.

More coercive options include: mandatory vaccination, such as for certain jobs; financial sanctions like fines; and movement restrictions, including requiring a “vaccine passport” for travel.

These may increase vaccination uptake, but there are ethical concerns because such approaches could undermine trust and increase inequalities.

Australian vaccination communication experts have argued against a mandatory approach, in response to a suggestion Prime Minister Scott Morrison made in August last year that a COVID-19 vaccine would be “as mandatory as you can possibly make it”, which he later retracted.




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We could be doing much more to improve understanding, access and motivation among Australians right now. We need to ensure everyone has the information they need to get a COVID-19 vaccine as soon as they’re eligible.The Conversation


Department of Health/The Conversation, CC BY-ND

Carissa Bonner, Research Fellow, University of Sydney and Rachael Dodd, Research Fellow, University of Sydney

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

Vaccinating the highest-risk groups first was the plan. But people with disability are being left behind


Shutterstock

Helen Dickinson, UNSW and Anne Kavanagh, The University of MelbourneWith Australia’s COVID vaccination campaign set to open up to over 50s on May 3, many at-risk Australians eligible under phase 1A are still waiting.

Last week we learned only 6.5% of residents in disability care homes had received the vaccine.

Aged care is faring slightly better, with roughly 30% of aged-care facilities having received both vaccine doses. But that’s still some way to go.

Also worrying, an estimated 15% of aged-care workers and only 1% of disability-care workers have so far been vaccinated.

Federal health department officials have conceded the vaccine rollout in the disability sector is progressing more slowly than they would have liked.

But critics like shadow minister for the National Disability Insurance Scheme (NDIS) Bill Shorten have described the situation as reflecting a “pathology of dangerous incompetence” in the government’s treatment of vulnerable Australians.

After failing to address the needs of people with disability at the height of the pandemic last year, the poorly executed rollout in disability care does little to reassure this group the government has their best interests at heart.




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A high-risk group

Australians with disability are at heightened risk during the COVID pandemic because many have other health conditions (for example, respiratory problems, heart disease, and diabetes). This makes them more likely to get sicker or die if they become infected.

People with disability are also more likely to be poorer, unemployed and socially isolated, making them more likely to experience poor health outcomes.

Many people with disability, particularly those with complex needs, require personal support, which puts them in close contact with other people. Different workers will come through residential disability-care settings, sometimes moving between multiple homes and services, just as in aged care.

Should there be an outbreak of COVID-19 in residential disability care, there’s high potential for it to spread because some residents may have difficulties with physical distancing, personal hygiene, and other public health recommendations.

In Victoria’s second wave we saw outbreaks linked to at least 50 residential disability settings among workers and residents.

Two people with Down Syndrome cooking in the kitchen.
People with disability are at higher risk during the pandemic.
Shutterstock

In other countries we’ve seen people with disability die from COVID-19 at higher rates than their non-disabled peers. In England, nearly six out of every ten people who died with COVID in 2020 were disabled, and this risk increases with level of disability.

While Australia has not seen these levels of deaths, the longer this group goes without being vaccinated, the longer they’re contending with this risk. Discussions about reopening international borders only serve to heighten fears.

Given the unique risks this group faces, the disability community fought hard to ensure disabled people living in residential care and their support workers were included in phase 1A of the vaccine rollout.




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Repeating previous mistakes

Last year the disability royal commission was presented with extensive evidence to show the Australian government had not developed policies addressing the needs of people with disability in their initial emergency response plans.

For example, while others on welfare payments received the COVID supplement, people with disability and their carers were denied this.

Many schools didn’t make appropriate adjustments so children with disability could engage with remote learning. And families with a child with disability struggled to secure the basics.

Advocates did significant work before governments started to consider people with disability in their COVID response plans. But this was often made more challenging because no data were collected about disability in the case numbers, reflecting an endemic problem of lack of recognition of people with disability in the health system.

We’re seeing this again in the vaccine rollout, where daily updates on vaccination numbers group aged and disability care together, rather than breaking these figures down across the sectors.

Without this sort of data, we can’t effectively plan for people with disability.

Meanwhile, the government’s announcement that the Pfizer vaccine is recommended for under 50s because of the very rare but serious side effect of low platelet count (thrombocytopenia) and blood clots (thrombosis) will see further pressure on Australia’s limited Pfizer supplies.

It may be some time before people with disability under 50 living in residential care are vaccinated. Yet the government continues to roll out Pfizer in residential aged care where AstraZeneca could be used, further demonstrating the low priority of the disability sector.

It appears little has been learned from the government’s earlier pandemic response (or lack thereof) concerning people with a disability. This group is being forgotten once again.

Getting back on track

In the Senate’s recent COVID-19 committee we heard confirmation aged-care residents had been prioritised over disability-care residents as they’re perceived to be at higher risk. This has angered many in the disability community who were not told the phase 1a group would be broken into sub-groups.

The government has some way to go in mending its relationship with the disability community. In addition to bungling the vaccine rollout, at the moment there’s significant concern over proposed reforms to the NDIS.

What we need now is a clear plan to roll out vaccinations, not only to people with disability in residential care settings, but also those in the wider community and their support workers. The government needs to set a clear timeframe for vaccinating disability-care residents and staff — and stick to this.

The World Health Organization argues community engagement is key to a successful vaccination rollout. In this light, commonwealth and state governments need to do some substantial work to engage people with disability and the broader sector to turn this situation around.




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The Conversation


Helen Dickinson, Professor, Public Service Research, UNSW and Anne Kavanagh, Professor of Disability and Health, Melbourne School of Population and Global Health, The University of Melbourne

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

We’re gathering data on COVID vaccine side effects in real time. Here’s what you can expect


CDC/Unsplash

Natasha Yates, Bond UniversityAlthough the country’s vaccine rollout is not progressing entirely as planned, thousands of Australians continue to receive their COVID vaccines every week.

As a general practitioner administering the AstraZeneca vaccine, I find it strange that my patients all know about the very rare potential complications — such as blood clots — yet often don’t know what side effects they can realistically expect.

Side effects show the vaccine is working

Vaccines work by training our immune system to fight disease.

Many of the side effects we experience after a vaccination (of any sort, not just against COVID-19) are actually because our immune system is doing its thing. If we train for a sport we expect to get sore muscles from training, as well as when we actually compete. Training our immune system is no different.

Possible reactions to vaccines include headache, fever, injection site pain, muscle and joint pain, and fatigue.

Side effects tend to vary slightly between different vaccines, and different people will experience them differently.




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Reporting side effects generates information

Because COVID vaccines are so new, Australia’s Therapeutic Goods Administration (TGA) has requested every reaction suspected to be from a COVID vaccine be reported. This is happening in a number of ways.

For doctors and nurses administering COVID vaccines, reporting adverse events is mandatory. Of course, many adverse events only occur after a person has left the clinic, so patients are advised to self-report any symptoms or side effects that concern them.

A senior woman uses an iPad on the couch.
Even if what you’re experiencing is a known side effect, it’s worth reporting.
Shutterstock

You can report any side effects via the health-care setting where you had your vaccination (if they have a system for this), via the NPS MedicineWise Adverse Medicine Events line on 1300 134 237, or through the TGA.

Many vaccination centres also send out SMS questionnaires after your vaccine. Innovative software including Vaxtracker and Smartvax are facilitating this.

As a result, we’ve been able to gather a large amount of data about both the Pfizer and the AstraZeneca vaccines since their rollout began in Australia. We no longer need to rely on drug company trial results.

A government-funded research organisation collates the data from these reporting mechanisms, and weekly updates on COVID-19 vaccine safety are freely available.




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A snapshot of the current data

More than 200,000 Australians — over two-thirds of people surveyed through these mechanisms so far — have participated in feeding back data.

Some 51.8% of respondents have reported some kind of adverse event, but only 1.2% experienced events serious enough for them to seek medical attention.

The types of events people have reported for both the Pfizer and AstraZeneca vaccines are similar to those reported in clinical trials, and what we’re seeing in other countries. They include fatigue, headaches, pain/swelling at the injection site, muscle aches, chills, fever and joint pain.

Symptoms appear to be more pronounced after the second dose, which fits with our understanding that they generally indicate a natural immune response rather than anything more sinister (we have a more developed immune response after the second dose). Symptoms usually resolve within three days of vaccination.

How does this compare to other vaccines?

According to Australian data collected on the influenza vaccine in 2020, only 5.5% of people reported any adverse event, with just 0.3% being serious enough to see a doctor about.

You could therefore say the COVID-19 vaccine is causing side effects much more often. It’s possible there’s a biological reason for this — our immune systems may be fighting harder than they do when faced with influenza vaccines.

But there may be a behavioural reason for higher reports too. Perhaps people are being hyper-vigilant about any apparent reaction they’re experiencing to COVID vaccines, possibly inducing what we call a “nocebo” response. This is when negative expectations around a treatment cause patients to report more negative effects than they would have otherwise.

It’s fair to say no vaccine has been as highly scrutinised by the public as the COVID vaccines.

A young man looks at a thermometer.
Some people will develop a fever following a COVID vaccine.
Shutterstock

Certain groups may be more likely to get side effects

Are women more likely to have an adverse reaction to a COVID vaccine? While this may seem fairly simple to answer from the data, confounding features make it more complex.

While women do report minor reactions more often, is that partly because they’re more conscientious at reporting? We know women are more likely to seek help for their health in general. The answer to this question continues to be debated.

One group that clearly does have more pronounced reactions is younger people. This is probably because their immune systems mount a stronger response to the vaccine.

Managing side effects

Whichever vaccine you receive, remember side effects are common and expected.

If you’re concerned, the government’s side effect checker asks questions which can help you ascertain whether your reaction is normal, or whether it’s more serious and you should seek medical attention.

It’s fine to take paracetamol or ibuprofen for symptom relief, but taking these pre-emptively is not recommended for COVID-19 vaccines.

Notably, between 4.7% and 23.2% of people are reporting missing work or routine duties for a short period (generally up to one day) following the vaccine. I suggest my patients have their vaccine — especially the second dose — just before a day off work, if possible.




Read more:
5 ways our immune responses to COVID vaccines are unique


There’s excellent ongoing research happening to define the “real world” side effects from COVID-19 vaccines. Many of us can play a part, and this information can inform us as a community about what to expect.

While serious but rare side effects are making the headlines, the realistic expectation for most of us is that we may feel mildly unwell, and may need to take a day off our regular commitments, especially after our second dose.The Conversation

Natasha Yates, Assistant Professor, General Practice, Bond University

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

3 doses, then 1 each year: why Pfizer, not AstraZeneca, is the best bet for the long haul


Nathan Bartlett, University of NewcastleLast week, the chief executive of Pfizer said anyone who receives its COVID-19 vaccine will probably need to have a third dose within 6-12 months after being fully immunised, and then likely one dose every year going forward.

We’ll need these because it’s likely that, for many of us, immunity will begin to wane within that time frame. The vaccine will also need to be tweaked to cover new coronavirus variants as they emerge.

The advantage of mRNA vaccines like Pfizer’s is they’re much easier to update than the “viral vector” vaccines like AstraZeneca’s. We should still use AstraZeneca now for over-50s, but our best long-term strategy is to use mRNA COVID-19 vaccines, and therefore to develop the capacity to manufacture them here in Australia.

Immunity to coronaviruses doesn’t last

We know our immunity to different coronaviruses wanes over time. This is true for the four common cold (endemic) coronaviruses that circulate all the time — there are always sufficient numbers of people who have lost their immunity to ensure these viruses can persist and continue to cause respiratory illnesses.

Our immunity to SARS-CoV-2, the virus that causes COVID-19, also seems to wane quickly, although the rate at which this happens can be quite variable. Data suggest immunity acquired from the Pfizer shot is pretty robust for six months, but it isn’t clear how quickly our immunity is lost after that. However, it’s reasonable to predict that within 12 months of a population being vaccinated, a substantial number of people will have likely lost protection against SARS-CoV-2. This will particularly be the case if the prevalent SARS-CoV-2 strain circulating at that time is substantially different from the virus against which people were originally vaccinated.

This relates to the fact that some coronavirus variants have mutations that reduce the effectiveness of vaccine-induced immunity. They’ve been described as “variants of concern” and include a virus that originated in South Africa, which has reduced the efficacy of both the AstraZeneca and Pfizer vaccines. As the pandemic surges around the world, more variants will certainly crop up.

Both waning immunity and viral variants will conspire to reduce our protection over time. So we’ll need booster shots, ideally updated to deal with the viral variant that poses the greatest threat.

Using AstraZeneca is not our best long-term solution

I understand why Australia’s government originally prioritised getting the AstraZeneca vaccine. It’s easier to manufacture, store and distribute. It made sense in the early stages of the pandemic. And it’s still an effective vaccine that people, here and abroad, should be receiving as soon as possible — any immunity is better than none and you will certainly be protected from severe COVID-19.

But as time goes on, using the AstraZeneca shot isn’t the best long-term strategy.

One reason for this is what immunologists call “vector immunity”. The AstraZeneca and Johnson & Johnson vaccines use a viral vector, which is an inactivated (cannot replicate) form of a common type of virus called an “adenovirus”. They use this adenovirus as a delivery vehicle to get DNA into our cells to give them the instructions to develop immunity against the coronavirus. However, you can’t be repeatedly immunised with this type of vaccine because you’ll likely develop immunity to the adenovirus vector (the delivery vehicle) itself. When that happens your immune system interferes with the delivery vehicle getting into your cells and the effectiveness of these vaccines would erode over time.

What’s more, in a very, very small number of people, this viral vector seems to be linked with an extremely rare but serious blood clotting syndrome. In these people, it’s thought that a consequence of the immune response to the viral vector is their immune systems make “auto-antibodies”. These are antibodies that, in addition to fighting a foreign invader (or targeting the adenovirus-based vector used in the AstraZeneca vaccine), also attack our own cells. In this case, these auto-antibodies are attacking blood cells called platelets, leading to the blood clots and low platelet counts seen in around 1 in 250,000 people vaccinated with the AstraZeneca shot.

There are also clotting concerns with the Johnson & Johnson vaccine, which is also an adenovirus-vector-based vaccine, after six women developed the condition in the United States out of 6.8 million given the shot. However, this link is yet to be proven for this vaccine.




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What is thrombocytopenia, the rare blood condition possibly linked to the AstraZeneca vaccine?


By contrast, mRNA vaccines like Pfizer’s (and Moderna’s) can be updated much more quickly. Pfizer just needs to rework its RNA sequence to cover variants, which is a minor modification. Nothing changes about the delivery system of the vaccine, so reapproval will likely be much easier. Regulatory bodies have indicated there will be a quick path for approval for vaccines updated for variants.




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Why we’ll get COVID booster vaccines quickly and how we know they’re safe


The mRNA vaccines consist of a lipid-based delivery system that protects the mRNA and gets it into cells. Then, the cells can start manufacturing the spike protein to present to your immune system. There’s no protein in the vaccine itself, so there’s no chance of developing immunity to the vaccine components.

mRNA vaccines are our best bet going forward

There’s a fear among researchers, including myself, that we’ll be chasing our tails with these new variants. We’ll identify a new variant and set out to update our vaccines against it, but by the time the formulation is updated, approved, manufactured and distributed, we may already be dealing with another variant, or many variants across different locations.

It’s absolutely vital Australia develops the ability to make mRNA vaccines onshore, particularly if new variants pop up here or in our region. This will be far more effective than waiting months to get new shots from overseas.




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Australia may miss out on several COVID vaccines if it can’t make mRNA ones locally


Federal health minister Greg Hunt has indicated Australia is interested in developing this capacity.

Right now, the AstraZeneca vaccine still has a role in Australia’s current vaccine strategy. We have it and we can make more of it, so let’s get it out there for over-50s as well as give those under 50 the opportunity to make an informed choice to have this vaccine.

So few Australians currently have immunity to the virus, we remain vulnerable to outbreaks. If there are new outbreaks, we would have to rely on lockdowns, masks and other strategies again, and could find ourselves back to where we were last year. And let’s not forget people will become ill and some will die. The vaccine rollout is lagging, and we really need to catch up as soon as possible.

But as time goes on, the AstraZeneca vaccine will become less attractive, and mRNA vaccines such as Pfizer’s should eventually take its place.The Conversation

Nathan Bartlett, Associate Professor, School of Biomedical Sciences and Pharmacy, University of Newcastle

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

Forget JobKeeper — what the government and the country need now is a JabMaker plan


original.

Mark Kenny, Australian National UniversityForget last week’s healthy 5.6% unemployment rate.

It might be “comfortably below” the Coalition’s 6% threshold for commencing “fiscal repair” (another term for unpopular spending cuts), but the government is under unforeseen political pressure and is anything but relaxed and comfortable.

In any event, this 5.6% figure was from March, which is an important detail because it predated the wind-up of the JobKeeper wage subsidy.

Who knows what that means.

It could mean nothing much or we might see an uptick in jobs lost — employees shed from debt-addled “zombie” firms, which survived the crisis only to perish in the recovery.

At $90-plus billion, the JobKeeper wage subsidy scheme was the biggest single program in Australian history. And by any metric, it was a shining success. Any metric that is, if you exclude the country’s fourth biggest pre-pandemic export sector, education.

Higher education’s ‘long COVID’

Universities suffered a triple COVID hit — denied access to the JobKeeper program due to the way they were structured, denied overseas students from whom (admittedly too much) revenue was relied upon and denied any certainty about their return due to a snail-paced vaccine rollout.




Read more:
The government keeps shelving plans to bring international students back to Australia. It owes them an explanation


As a result, a country that led the world through the 2020 pandemic trails it in 2021 through a bungled recovery program, while perhaps permanently hobbling one of its most lucrative and reliable exports.

Ever innovative, Australia may have found a way to give its university sector and therefore its own future growth the economic version of long COVID.

A terrible start to 2021

Politically, Prime Minister Scott Morrison’s options at the start of 2021 looked pretty inviting. Flush with that 2020 success — a combination of good judgement, good luck, and state government front-footedness — Morrison was riding high in public opinion. Inevitably, talk turned to a possible spring election to capitalise.

Labor’s end of the see-saw was weighed down. Doubts were aired about leader Anthony Albanese’s cut-through, his chances in an early poll, the pros and cons of a challenge.

Treasurer Josh Frydenberg and Prime Minister Scott Morrison walking through a doorway.
Talk of an early election in 2021 has melted away.
Lukas Coch/AAP

But events since have changed everything. Two months of attempting to politically nuance a series of negative stories and allegations regarding the treatment of women in politics have damaged the government, consumed its oxygen, and pricked the prime minister’s inflated reputation as the supreme pragmatist.

His unwillingness to get in front of the problem has instead evinced a strange defensiveness. His grudging late-stage efforts at political rescue have been less effective for their pointless delay and for the tightly qualified nature of the language used.

The Christine Holgate saga is merely the latest iteration.

It was clear weeks ago that Holgate had been prejudicially forced from her job at Australia Post. The most senior political leverage in the land had been summarily and publicly applied. A prime ministerial apology was the obvious solution, not just for her but for him also.

The vaccine ‘eekout’

Twice-weekly national cabinet meetings began again on Monday, in a sign the prime minister understands the seriousness of Australia’s vaccine bungles.
But his reluctant acknowledgement of multiple problems in the rollout to date reinforces his instinctive stubbornness.

The abject helplessness of Australia at the vaccine stage is also all the more jarring for its contrast with the 2020 suppression of the virus and the glowing vaccination expectations the government itself created.

Australians line up at a Melbourne vaccination centre.
Australia’s vaccination rollout has been plagued by supply issues and health concerns.
James Ross/AAP

On these grounds alone, the prime minister’s political judgement is questionable. Australians were promised a world-class vaccine program in which we would be at the front of the queue. What it would lack in immediacy (a luxury of zero community infection, we were assured) would be more than made up for in logistical precision.

In fact, it has failed to materialise. Opaque and piecemeal, the rollout feels more like an eekout.

What will decide the next election?

Now, the Coalition looks to the May 11 Budget for political salvation.

Even with a jobless number of just 5.6%, it has limited political capital to spend and must use the balance sheet to repair its political stocks rather than the nation’s books.

JobKeeper, JobSeeker, and even JobMaker, have either gone or will not make enough difference to matter at the ballot box next year.

What the government really needs is what the country needs — JabMaker.




Read more:
To abandon vaccination targets is to abandon the mantle of leadership


After all, it’s the jabless rate rather than the jobless rate that could decide the next election. It currently sits “comfortably” around 95%, with no certainty that the population will be vaccinated this calendar year.

The end of October target has been junked, replaced with … nothing.

Compare that to calamitous America where they expect to reach the full adult population by the end of July.

Last week, the US inoculated roughly the entire population of Australia. On one of those days alone, 4.6 million people received jabs of either Pfizer or others such as Moderna, and Johnson & Johnson.

Australia is well and truly “jab-ready”.

Its government, not so much.The Conversation

Mark Kenny, Professor, Australian Studies Institute, Australian National University

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

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.




Read more:
New coronavirus variant: what is the spike protein and why are mutations on it important?


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.




Read more:
The UK variant is likely deadlier, more infectious and becoming dominant. But the vaccines still work well against it


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.




Read more:
Why we’ll get COVID booster vaccines quickly and how we know they’re safe


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.