Tuesday 22 June 2021

A NSW Legislative Council "Inquiry Into Health Outcomes And Access To Health And Hospital Services In Rural, Regional And Remote New South Wales" has been underway since August 2020, but curiously its terms of reference do not mention gender bias

 

Gender bias takes many forms and the media perhaps more frequently reports on gendered income bias. Such as the longstanding pay gap between the average weekly full-time earnings of males and females, which predominately favours men. Currently Australia's national gender pay gap stands at 13.4 per cent. Or the end of working life disparity between the superannuation outcomes of men and women.


However, it has been apparent for many years now that the health professions, hospitals and governments carry a general societal bias against women into the healthcare sector and that bias barely rates a mention when governments establish terms of reference for parliamentary inquiries into aspects of health service delivery and outcomes.


The NSW Legislative Council Portfolio Committee No.2 - Health’s Terms of Reference for its current Inquiry Into Health Outcomes And Access To Health And Hospital Services In Rural, Regional And Remote New South Wales Health Outcomes And Access To Health And Hospital Services In Rural, Regional And Remote New South Wales is no exception to this lack of consideration of gender bias.


A bias which has the potential to disproportionally affect the health outcomes for females from low income families, those women who identify as Aboriginal or Torres Strait Islander and women living in regional, rural and remote areas.


So these articles below are a timely reminder that the existence of gender bias is indicated in Australia and also of the global scale of such bias.



Australian Institute of Health and Welfare“Cardiovascular disease in women”, report excerpt, July 2019:


1.1 A focus on women


Much of our knowledge of heart disease is based on research conducted primarily among men (McDonnell et al. 2018), which shapes our view of how cardiovascular disease impacts the Australian population. However, it is known that there are important differences between women and men in risk factors for CVD, in symptoms, and in treatment and outcomes.


Need for greater awareness


Many women are unaware of the risk that CVD presents to their health. Their knowledge about heart attack symptoms and CVD as a cause of death is less than optimal—in 2018, for example, only one-fifth (21%) of Australian women correctly perceived heart-related causes to be the leading cause of death (Bairey Merz et al. 2017; Flink et al. 2013; Heart Foundation 2018; Hoare et al. 2017).


2 Cardiovascular disease in women


Women presenting with CVD often have different symptoms than men. These symptoms may not be recognised as CVD, thus increasing the likelihood of a missed diagnosis.

Although men with heart attack typically describe chest pain or discomfort, women are more likely to have non-chest pain symptoms such as shortness of breath, weakness, fatigue and indigestion (Mehta et al. 2016; Wenger 2013), and frequently with worse consequences (Maas et al. 2011; McDonnell et al. 2018; Pagidipati & Peterson 2016).


Women generally present with CVD later in life than do men. Older women are also more likely to have other health conditions, making their CVD more complex to diagnose and treat, which in turn can lead to worse health outcomes (Bennett et al. 2017; Saeed et al. 2017).


Physicians are more likely to underestimate CVD risk in women, and this can influence their diagnosis and treatment (Wenger 2013). Research finds that younger women aged under 55 with acute coronary syndrome are more likely to be misdiagnosed and discharged from emergency departments than men (Bairey Merz et al. 2017; Saw et al. 2014).


Differences in treatment


A number of studies have identified disparities between women and men in CVD treatment and in outcomes. Women with acute coronary syndrome tend to receive fewer medications, are less likely to have their condition treated aggressively and have fewer invasive interventions (Kuhn et al. 2014, 2015, 2017; Pagidipati & Peterson 2016; Saeed et al. 2017).


Similarly, women with ST segment elevation myocardial infarction (STEMI: a type of heart attack) are less likely to receive invasive management, revascularisation or preventive medication at discharge (Khan et al. 2018). Women with stroke are more likely to have a delay in care than men, and are less likely to receive aspirin, statins or thrombolytics (Raeisi-Giglou et al. 2017).


Healthier women


An increased recognition of gender differences in risk factors, presentation, treatment and outcomes will contribute to improving women’s cardiovascular health in Australia.


The Australian Government, the Heart Foundation, the Stroke Foundation and other key stakeholders contribute by building awareness among the public and health-care providers about the risks of CVD to women’s health.


Chronic conditions, including CVD, and preventative health are a priority for action in the National Women’s Health Strategy 2020–2030 (Department of Health 2018). The development and delivery of a national campaign to promote awareness of the different risks for and symptoms of CVD in women is a key action in the current strategy. The ongoing monitoring of the impact of CVD is an important component of policy and programme initiatives that focus on women’s health.



Australian Institute of Health and Welfare, Cardiovascular disease in Australian women — a snapshot of national statistics, June 2019:




Cardiovascular disease is the leading cause of death in women. Decades of grassroots campaigns have helped to raise awareness about the impact of cardiovascular disease in women, and positive changes affecting women and their health have gained momentum. Despite these efforts, there has been stagnation in the overall reduction of cardiovascular disease burden for women in the past decade. Cardiovascular disease in women remains understudied, under-recognised, underdiagnosed, and undertreated. This Commission summarises existing evidence and identifies knowledge gaps in research, prevention, treatment, and access to care for women. Recommendations from an international team of experts and leaders in the field have been generated with a clear focus to reduce the global burden of cardiovascular disease in women by 2030. This Commission represents the first effort of its kind to connect stakeholders, to ignite global awareness of sex-related and gender-related disparities in cardiovascular disease, and to provide a springboard for future research.” [THE LANCET COMMISSIONS, The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030, 16 May 2021]

 

The Lancet, 19 June 2021:


Ana Olga Mocumbi (May 2021) “Women's cardiovascular health: shifting towards equity and justice”


Cardiovascular disease in women is understudied, under-recognised, underdiagnosed, and undertreated globally, despite being the leading cause of death in women worldwide, as highlighted by a new Lancet Commission.1 Several misperceptions contribute to this neglect, notably, the persistent view that cardiovascular disease primarily affects men or only women in high-income countries and results from poor lifestyle choices. The Lancet women and cardiovascular disease Commission1 identifies disparities in prevalence and outcomes of cardiovascular disease in women worldwide, delineates the substantial impact of socioeconomic deprivation in determining these differences, and proposes strategies to address these inequities, increase sex-related research, and support integration of care and strengthening of health systems.1


From 1990 to 2019 there have been large declines in cardiovascular disease age-standardised rates of death, disability-adjusted life-years, and years of life lost.2 There have been declines in age-standardised prevalence of coronary heart disease and stroke mortality rates in men and women in most parts of the world, with greater age-specific reductions in coronary heart disease in men than in women.3


Between 2010 and 2019, the age-standardised cardiovascular disease death rate increased or stagnated in many other parts of the world, including eastern Europe and countries in central, south, and east Asia.2 In a Canadian setting, the 30-day acute myocardial infarction mortality rates declined similarly for women and men from 2000 to 2009, but women younger than 55 years had an excess mortality risk compared with men of the same age.4 Under-representation of young people in clinical studies on cardiovascular disease, as well as worse risk profile due to comorbidities, might contribute to these slow improvements. Importantly, because of women's longer life expectancy, overall deaths from cardiovascular disease are higher in women than in men, and this excess number of cardiovascular disease deaths in women is likely to increase with population ageing. Moreover, the success in declining age-standardised cardiovascular disease mortality over the past decades has been limited to countries with a high Socio-demographic Index (SDI); some countries with a low SDI had the highest cardiovascular disease mortality rate shift from men to women.2


View related content for this article


Poverty continues to affect a considerable proportion of the world's population, determining unique patterns of non-communicable diseases, including cardiovascular disease in young women.5 In countries with a low SDI, where premature cardiovascular disease mortality is largely driven by poverty, poor access to care, and underuse of interventions of proven efficacy, women face the coexistence of an increased prevalence of cardiovascular disease, a rise in metabolic risk factors, and endemic infectious diseases such as tuberculosis, HIV/AIDS, and schistosomiasis. Furthermore, specific risk factors and conditions affect women in countries with a low SDI. Chronic exposure to biomass fuel is common in rural Africa and Asia and contributes to the burden of acute coronary events and stroke,6 affecting predominantly women; this exposure could partly explain the high occurrence of and sex differences in isolated right heart failure in non-smokers in these places.6, 7 Similarly, in poor countries women younger than 40 years are increasingly affected by neglected or poverty-related conditions, such as rheumatic heart disease and endomyocardial fibrosis.8,9 Moreover, maternal mortality remains unacceptably high. About 295 000 women died during and after pregnancy and childbirth in 2017.10 94% of these deaths occurred in low-resource settings, where the maternal mortality ratio was 462 per 100 000 livebirths versus 11 per 100 000 livebirths in high-income countries.10 Since cardiovascular disease is the leading non-obstetric cause of maternal mortality worldwide,11 one should consider the role of disparity in fertility rates, incidence of peripartum cardiomyopathy, and pre-existing uncontrolled arterial hypertension8 as potential determinants of maternal mortality. Indeed, there are a considerable number of maternal deaths due to cardiovascular disease in low-income and middle-income countries.12 Unfortunately, even in the USA, where the maternal mortality ratio was 17·4 maternal deaths per 100 000 livebirths in 2018, the maternal mortality ratio was more than double among non-Hispanic Black women (37·1 per 100 000 livebirths), with more than half of these deaths and near deaths being preventable, and cardiovascular disease being the leading cause.13 Inadequate access to quality and affordable health care along with long-standing health disparities plays a role in this disparity; additionally, social determinants of health can increase the risk of gestational diabetes, peripartum cardiomyopathy, caesarean deliveries, and future cardiovascular disease in neglected communities.


To address the gaps highlighted by this Commission, current knowledge must be used to achieve health equity so that no one is disadvantaged from attaining their full health potential because of their social position or other socially determined circumstance. Reduction of disparities in clinical outcomes requires the prioritisation of high-impact solutions in under-resourced areas, involving tailored strategies for decentralised and integrated care, and support from global and regional partners to improve the availability of interventions for cardiovascular disease prevention and management. Front-line health workers with shared competences for cardio–obstetric care, digital health, and portable ultrasound should be used to deliver decentralised care, improve referral systems, and support surveillance of sex-related outcomes. Digital health provides opportunities to enhance the quality, efficiency, and safety of primary health care, as well as help address racial and ethnic disparities,14 but insufficient digital health competencies among front-line health workers are among the factors that hamper the adoption of digital tools and technologies.15 Finally, as emphasised in the Commission, peer-to-peer supporters and educators in local communities should be used to empower women in improving their ability to access, understand, appraise, and apply health information to promote good cardiovascular health.


In the midst of the COVID-19 pandemic, values of human dignity, solidarity, altruism, and social justice should guide our communities to ensure equitable share of wealth and leveraging of efforts towards the reduction of cardiovascular disease burden in women worldwide. The Commission's recommendations on additional funding for women's cardiovascular health programmes, prioritisation of integrated care programmes, including combined cardiac and obstetric care, and strengthening of the health systems accords with efforts to bridge the gap for the world's worst off.5 Such a shift in women's cardiovascular care would be a major step towards equity, social justice, and sustainable development.


I declare no competing interests.


References


1.Vogel B Acevedo M Appelman Y et al.

The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030.

Lancet. 2021; (published online May 16.)

https://doi.org/10.1016/S0140-6736(21)00684-X


2.Roth GA Johnson C Abajobir A et al.

Global, regional, and national burden of cardiovascular diseases for 10 causes, 1990 to 2015.

J Am Coll Cardiol. 2017; 70: 1-25


3.Bots SH Peters SAE Woodward M

Sex differences in coronary heart disease and stroke mortality: a global assessment of the effect of ageing between 1980 and 2010.

BMJ Global Health. 2017; 2e000298


4.Izadnegahdar M Singer J Lee MK et al.

Do younger women fare worse? Sex differences in acute myocardial infarction hospitalization and early mortality rates over ten years.

J Womens Health. 2014; 23: 10-17


5.Bukhman G Mocumbi AO Atun R et al.

The Lancet NCDI Poverty Commission: bridging a gap in universal health coverage for the poorest billion.

Lancet. 2020; 396: 991-1044


6.Bassig BA Dean Hosgood H Shu XO et al.

Ischaemic heart disease and stroke mortality by specific coal type among non-smoking women with substantial indoor air pollution exposure in China.

Int J Epidemiol. 2020; 49: 56-68


7.Stewart S Mocumbi AO Carrington MJ Pretorius S Burton R Sliwa K

A not-so-rare form of heart failure in urban black Africans: pathways to right heart failure in the Heart of Soweto Study cohort.

Eur J Heart Fail. 2011; 13: 1070-1077


8.Mocumbi AO Sliwa K

Women's cardiovascular health in Africa.

Heart. 2012; 98: 450-455


9.Zühlke L Engel ME Karthikeyan G et al.

Characteristics, complications, and gaps in evidence-based interventions in rheumatic heart disease: the Global Rheumatic Heart Disease Registry (the REMEDY study).

Eur Heart J. 2015; 36 (122a): 1115


10.WHO

Maternal mortality, key facts.

https://www.who.int/news-room/fact-sheets/detail/maternal-mortality

Date: 2019


11.Kassebaum NJ Barber RM Bhutta ZA et al.

Global, regional, and national levels of maternal mortality, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015.

Lancet. 2016; 388: 1775-1812


12.Heemelaar S Petrus A Knight M van den Akker T

Maternal mortality due to cardiac disease in low- and middle-income countries.

Trop Med Int Health. 2020; 25: 673-686


13.Bond RM Gaither K Nasser SA et al.

Working agenda for Black mothers: a position paper from the Association of Black Cardiologists on solutions to Improving Black maternal health.

Circ Cardiovasc Qual Outcomes. 2021; 14e007643


14.López L Green AR Tan-McGrory A et al.

Bridging the digital divide in health care: the role of health information technology in addressing racial and ethnic disparities.

Jt Comm J Qual Patient Saf. 2011; 37: 437-445


15.Jimenez G Spinazze P Matchar D et al.

Digital health competencies for primary healthcare professionals: a scoping review.

Int J Med Inform. 2020; 143104260

https://doi.org/10.1016/S0140-6736(21)01017-5

Copyright

© 2021 Elsevier Ltd. All rights reserved.



Monday 21 June 2021

RBA warns overseas markets are looking to Australia to decarbonise its production processes – including the est. 70% of product the agricultural sector exports


 The Guardian, 19 June 2021:


On Thursday morning, shortly after the resources minister, Keith Pitt, finished his “net zero by 2050: not on your nelly” sortie on the ABC, the governor of the reserve bank, Philip Lowe, touched down in Queensland Nationals country.


Lowe went to Toowoomba to deliver a keynote address at the Australian Farm Institute conference. The speech was principally about household debt, house prices and whether Australians could ever expect a pay rise. But during the questions that followed the presentation, the RBA governor was asked about decarbonisation in the agriculture sector.


Lowe told the conference he was often up late, participating in the international meetings that central bank governors participate in “and a very frequent question that comes up in those meetings is ‘what is Australian business doing to decarbonise?’”.


It is worth letting Lowe explain. “Many international investors are very focused on this issue and it’s particularly important for the agricultural sector because up to 70% of agricultural output in Australia gets exported – so you are relying on overseas markets, and increasingly overseas investors are asking about the carbon content of production, and that is a trend that is only going to continue,” the central bank governor said.


So agriculture has tremendous opportunities here, but we need to find ways to disclose to global investors and global customers the decarbonisation strategy and how successfully we are doing that.


It is a really important issue and it’s going to become more important.”


Lowe inhabits a universe where climate change is real, the science is settled, and global capital has already made its choice.


If you inhabit that world, there’s very little grey area. You can see that transformation is coming. You can see countries are now in a race to prosper in what Scott Morrison now likes to call the “new energy economy”.


That race is only intensifying.


Over the past couple of months, the International Energy Agency has said fossil fuel expansion must end now if the planet is to address the climate crisis; there has been a G7 declaration (with Morrison in attendance) that public financing of unabated coal-fired power must stop this year and a pledge that net zero emissions must be achieved by 2050 “at the latest”; Joe Biden, Yoshihide Suga and Justin Trudeau have pledged much deeper cuts in emissions by 2030; and Boris Johnson says climate action is Britain’s top priority and the UK will deliver a 78% emissions cut by 2035 compared with 1990.



In which the Nationals defend the mining industry against a dreaded national “zero emissions” policy being established



The Guardian, 17 June 2021:


The resources minister, Keith Pitt, believes the National party would be ‘unsupportive’ of any commitment to net zero emissions. Photograph: Mick Tsikas/AAP













The resources minister, Keith Pitt, has fired a warning shot at Scott Morrison, declaring he cannot adopt a policy of net zero emissions by 2050 without the backing of the Nationals.


Morrison has been trying to telegraph a pivot on climate policy since the election of Joe Biden as the US president, signalling Australia wants to achieve net zero as soon as possible and “preferably” by 2050.


The British prime minister, Boris Johnson, wants Australia to unveil more ambitious commitments before the UN’s climate change summit in Glasgow in November, and he maximised Morrison’s comments in London this week by saying Australia had already “declared for net zero”.


Morrison is facing pressure from metropolitan Liberals to make the mid-century commitment, as well as sustained pressure from his global peers to do more to reduce emissions sooner.


The Australian prime minister was at the G7 summit in Cornwall last weekend as leaders committed “to ambitious and accelerated efforts to achieve net zero greenhouse gas emissions as soon as possible and by 2050 at the latest, recognising the importance of significant action this decade”.


But a number of National party figures have been signalling for months they are not on board with Morrison’s climate change shift.


Pitt’s clear public warning shot on Thursday, in the wake of the G7 commitments and Johnson’s quip in London, is significant because the Queensland National is a member of the cabinet.


The resources minister said Australia’s climate policy – currently devoid of an official mid-century commitment – had not changed.


We have not committed to net zero by 2050,” Pitt told the ABC. “That would require the agreement of the Nationals and that agreement has not been reached or sought.”


Asked for his own view, Pitt said: “It is all about the cost and who is paying.”


He said committing to net zero emissions by 2050 would “absolutely cause damage in regional communities” given those communities were reliant on export income from fossil fuels…….


Sunday 20 June 2021

North East NSW tells it like it is to the Legislative Council Inquiry Into Health Outcomes And Access To Health And Hospital Services In Rural, Regional And Remote New South Wales in Lismore on 17 June 2021

 

Ryan Park MLC
Janelle Saffin MLC

NSW Shadow Minister For Health Ryan Park and Labor Member For Lismore Janelle Saffin deserve the region's thanks for both their efforts to spread the word that the state’s north-east would have a chance to speak directly to the NSW Legislative Council Inquiry Into Health Outcomes And Access To Health And Hospital Services In Rural, Regional And Remote New South WalesHealth Outcomes And Access To Health And Hospital Services In Rural, Regional And Remote New South Wales in Lismore on 17 June 2021, for lobbying to have a webcast of this public hearing and for their attendance on the day.


ABC North Coast, 17 June 2021:


A state parliamentary inquiry has heard some rural residents in northern New South Wales are being left "stranded" outside hospitals late at night with no way of getting home.


The NSW Upper House inquiry is examining the challenges people face in seeking medical care in remote, rural and regional areas.


Bonalbo pharmacist Sharon Bird told the inquiry some residents with chronic and complex illnesses are travelling more than 100 kilometres to access health services with virtually no public transport.


She said many residents "give up" on seeing a doctor because "it all gets too difficult".


"Many of my customers have had negative experiences when accessing healthcare in the referral centres," Mrs Bird said.


"Like being abandoned in Lismore in their pyjamas after an emergency ambulance trip with no way to get home again.


"[Many] are reluctant to seek help or call an ambulance again."


Northern NSW Local Health District chief executive Wayne Jones said steps had been taken to ensure such incidents did not happen again.


"Unfortunately we have failed in several of those occasions, but I can tell you it is not the standard of what we have tried to achieve," he told the inquiry.


"We have put memos out to staff reminding them we've increased our own patient transport vehicles locally, we have community transport contracts and we have a clear position that particularly after 8:00pm if people can't find a way home we need to find accommodation for them."


Residents need to 'schedule their accidents'


The inquiry heard the towns of Bonalbo and Coraki had struggled to attract general practitioners, often leaving residents with limited or no access to doctors.


Mrs Bird said Bonalbo had an X-ray machine but no staff to operate it and only one radiographer for two hours a fortnight, so residents would need to "schedule their accidents for that day".


The chair of the Ballina Cancer Advocacy Network Maureen Fletcher also gave evidence, talking about the dire need for increased funding for cancer care coordinators in the region.


She said many patients had "suffered needlessly" because they did not know what services were available before, during and after cancer treatment.


Ms Fletcher said there was one man who lost half his nose after melanoma surgery and felt socially isolated.


"He only found out that a prosthetic nose was available when a fellow patient in hospital asked why he didn't have it," she said.


Flow-on effects


The inquiry also heard from residents who spoke about the difficulties that arose from the region's reliance on south-east Queensland for specialist care.


Andre Othenin-Girard said he suffered on and off from atrial fibrillations and had been waiting almost three years to see a cardiologist on the Gold Coast, which was complicated by the Queensland border closure.


He said he had been hospitalised five times at Lismore Base Hospital while he waited.


The committee has been warned that the access to and availability of medical services could deter highly skilled people and businesses from moving to regional NSW.


Veterinarian Florian Roeber told the hearing he had to make at least 15 trips to the Gold Coast after being diagnosed with a neurological condition.


He said he moved to the state's north from Melbourne and believed he would have had better access to care if he had stayed in the city.


"I kind of regretted my decision to move to regional NSW because it led to a potentially worse outcome for me," Dr Roeber said…...


Problems are not confined to just the Northern NSW Local Health District. At Taree on the Mid-North Coast on 16 June the Inquiry heard the following.....


The Sydney Morning Herald, 17 June 2021:


A NSW hospital serving nearly 100,000 people has been relying on cleaners to look after dementia patients due to severe staffing shortages, a parliamentary inquiry heard.


Doctors, nurses and patients lined up to vent their frustration and despair as the inquiry into regional health travelled to Taree and Lismore for public hearings on Wednesday.


The inquiry heard that at Tamworth, "ghost" operating theatres are being used for storage and for staff to make quiet phone calls because the hospital is struggling to find specialists to use them.


Tamworth has the busiest non-metropolitan emergency department in NSW.


Three senior doctors delivered a scathing assessment of the state of affairs in Taree on the state's mid-north coast, which is serviced by Manning Base Hospital.


"Houston we have got a problem and the problem I'd like to talk to you about is workforce," said Dr Simon Holliday, a rural GP with three decades' experience and a staff specialist at Manning Base Hospital.


He said less than 5 per cent of Australian-trained doctors were choosing to practise in rural areas which was a "disaster" for people living outside capital cities.


Dr Holliday said overseas-trained doctors from developing countries were stepping in to fill the void which was tantamount to "reverse foreign aid".


He said there was an epidemic of burnout among the foreign-trained doctors, who were having a "horrific time" as they were used as "cannon fodder" in understaffed facilities.


Dr Holliday was critical of the Australian Medical Association for refusing to endorse medical conscription, where doctors are made to serve in regional and rural areas.


"Australia needs to start providing Australian-trained workforce for rural areas," he told the upper house committee.


"Today you've heard about the pain and anguish in our community, as in many other regions' communities, and you have the weight of our expectations on your shoulders."


Dr Seshasayee Narasimhan said chronic underfunding had rendered Manning Base an “exhausted and severely downgraded hospital” that was “not appealing for new recruits”.


No one wants to come here,” he said.


The Taree region has only one cardiologist serving a population of nearly 100,000 people and the worst cardiovascular outcomes of anywhere in regional Australia.....


President of the Manning Great Lakes Community Health Action Group Eddie Wood said the hospital's dementia ward had been shuttered without any consultation with the community.


"The cleaners on the ward have been asked to monitor and sit with the dementia patients," he said. "Dementia patients deserve the same level of care as anyone else ... it's horrendous."


Marion Hosking OAM later told the inquiry her son had been present at the hospital when the gardener was brought in to sit beside a troubled dementia patient.


But Mr Wood said assurances from the hospital administrators and local health district that there was no staffing problem further incensed the community.


You say that to the ... first year graduate nurse who is put in charge of a ward,” Mr Wood said.


Mr Wood said only half of the 18 beds in the emergency department were funded and staffed......


When you see your hospital and your staff demoralised and leaving, it’s atrocious,” he said.....


Friday 18 June 2021

A statement from some of the health experts who first told Australians that the AstraZeneca COVID-19 vaccine (ChAdOx1-S) was perfectly safe to administer to all adults, then 'modified' that assurance to safe for all adults 50 years of age & older and now announces that it is only safe for those adults 60 years of age and older

 

Australian Technical Advisory Group, statement excerpts,,

17 June 2021:


A statement from the Australian Technical Advisory Group on Immunisation (ATAGI) on the AstraZeneca COVID-19 vaccine in response to new vaccine safety concerns.


Summary


The Australian Technical Advisory Group on Immunisation (ATAGI) recommends the COVID-19 Pfizer vaccine (Comirnaty) as the preferred vaccine for those aged 16 to under 60 years. This updates the previous preferential recommendation for Comirnaty over COVID-19 Vaccine AstraZeneca in those aged 16 to under 50 years. The recommendation is revised due to a higher risk and observed severity of thrombosis and thrombocytopenia syndrome (TTS) related to the use of AstraZeneca COVID-19 vaccine observed in Australia in the 50-59 year old age group than reported internationally and initially estimated in Australia.


For those aged 60 years and above, the individual benefits of receiving a COVID-19 vaccine are greater than in younger people. The risks of severe outcomes with COVID-19 increase with age and are particularly high in older unvaccinated individuals. The benefit of vaccination in preventing COVID-19 with COVID-19 Vaccine AstraZeneca outweighs the risk of TTS in this age group and underpins its ongoing use in this age group.


People of any age without contraindications who have had their first dose of COVID-19 Vaccine AstraZeneca without any serious adverse events should receive a second dose of the same vaccine. This is supported by data indicating a substantially lower rate of TTS following a second COVID-19 Vaccine AstraZeneca dose in the United Kingdom (UK).


Background


The Australian COVID-19 vaccination program has the overarching goal of protecting all people in Australia from the harm caused by the novel coronavirus SARS-CoV-2.


On 8 April 2021, ATAGI recommended that Comirnaty was the preferred vaccine for people under the age of 50 years due to local and international reports of thrombosis and thrombocytopenia syndrome (TTS) following COVID-19 Vaccine AstraZeneca.


Based on available international data at that time, the estimated risk of TTS was 4-6 per million cases following a first dose of COVID-19 Vaccine AstraZeneca. Given the ongoing risk of COVID-19 outbreaks, low vaccine coverage, and increasing rate of severe COVID-19 outcomes in older individuals, it was considered that the benefits of COVID-19 Vaccine AstraZeneca outweighed the risk in those over 50 years. As such, no preferential recommendation for either vaccine was made in this age group. This advice was reinforced on 23 April 2021 and has been reviewed weekly by ATAGI since then.


Principles underpinning the revised recommendations


In making the decision to revise the previous recommendation, ATAGI has considered several factors that have been monitored closely, including:


  • The potential risk of severe illness and death from COVID-19 over the coming months

  • Minimising harms to people due to adverse events following immunisation

  • Australian data on the age-specific risks and severity of TTS following COVID-19 Vaccine AstraZeneca

  • The expected vaccine supply over the months ahead

  • The impacts of any change in recommendation on the COVID-19 vaccine program……


The risks of TTS after COVID-19 Vaccine AstraZeneca


From early April to 16 June 2021, 60 cases of confirmed or probable TTS have been reported in Australia. This includes an additional seven cases reported in the past week in people between 50-59 years, increasing the rate in this age group from 1.9 to 2.7 per 100,000 AstraZeneca vaccine doses. The revised estimates of risk associated with first doses of COVID-19 Vaccine AstraZeneca are listed in the table below.



TTS is a serious condition in a proportion of individuals who develop it. The overall case fatality rate in Australia (3%; 2 deaths among 60 cases) is lower than has been reported internationally. This is likely to reflect increased detection due to heightened awareness, as well as early diagnosis and treatment. A spectrum of severity of illness has been reported in Australia, from fatal cases and those with significant morbidity, to relatively milder cases. TTS appears to be more severe in younger people.



There are different ways in which the severity of TTS can be measured. The US Centers for Disease Control and Prevention (CDC) defines “tier 1” cases as clots involving unusual sites, such as the veins of the brain (cerebral venous sinus thrombosis) or abdomen (splanchnic thrombosis); these are generally more severe and may potentially lead to long term health complications. In those under 60 years, 52% of TTS episodes are occurring in tier 1 sites compared with 28% in those 60 years and older. Other markers of severity include the requirement for intensive care (33% of TTS in those under 60 years; 15% of TTS cases in those 60 years and older), and fatal cases (both occurring in those < 60 years)……


Second dose recommendations for COVID-19 Vaccine AstraZeneca

ATAGI supports completion of a two-dose schedule with COVID-19 Vaccine AstraZeneca, based on current evidence. The risk of TTS following a second dose of COVID-19 Vaccine AstraZeneca is much lower than the risk following a first dose. The UK has reported 23 TTS cases in 15.7 million people after receiving a second dose, an estimated rate of 1.5 per million second doses (compared to a reported risk of 14.2 per million first doses in the UK).


People of any age without contraindications who have had their first dose of COVID-19 Vaccine AstraZeneca without any serious adverse events should receive the second dose.


Recommendations


  • ATAGI advises that Comirnaty is preferred over COVID-19 Vaccine AstraZeneca from the age of 16 to under 60 years. This is based on recent data regarding TTS cases in Australia and a reassessment of current age-specific risks and benefits of vaccination.

  • ATAGI considers the benefit of vaccination in preventing COVID-19 with COVID-19 Vaccine AstraZeneca outweighs the risk of TTS in people aged 60 and above. For this age group, the benefits of receiving a COVID-19 vaccine are greater than in younger people. The risks of severe outcomes with COVID-19 increase with age and are particularly high in older unvaccinated individuals.

  • COVID-19 Vaccine AstraZeneca can be used in adults aged under 60 years for whom Comirnaty is not available, the benefits are likely to outweigh the risks for that individual and the person has made an informed decision based on an understanding of the risks and benefits.

  • People of any age without contraindications who have had their first dose of COVID-19 Vaccine AstraZeneca without any serious adverse events should receive the second dose.

  • ATAGI reinforces the importance of providing clear communications to people who have received or are considering COVID-19 Vaccine AstraZeneca, and notes guidance documents for consumers, for primary care and for hospitals are being continually revised to accommodate this new recommendation.....


Read full statement here


It is noted that of the 60 cases (29 men and 31 women) to date with confirmed and probable adverse reactions to the AstraZeneca vaccine resulting in thrombosis with thrombocytopenia syndrome (TTS):


  • the majority of people diagnosed with TTS are over 50 years of age - only 6 people aged under 50 years had a TTS diagnosis; 


  • 23 of the 60 individuals listed were diagnosed with the most severe forms of TTS (CDS classification Tier 1);


  • 6 of those with the most severe forms of TTS were aged in 60-65 age group through to the 80+ age group; 


  • Across all age groups, from under 30 years upwards, it was the 70-79 age grouping which had the highest number of TTS diagnoses at 19 cases (comprising Tier 1, Tier 2 & unclassified), with an est. risk rate of 1.8 TTS cases per 100,000 AstraZeneca first doses; and


  • There were 12 new confirmed and probable cases of TTS attributed to the AstraZeneca vaccine in the week of 11-17 June 2021 in Australia, with 5 of those cases being in individuals over 60 years of age and 7 cases in individuals below 60 years of age.