In this article, originally published in the RACGP newsGP, I provide comment regarding vaccine hesitancy in light of the recent developments in 14 countries – Fears AstraZeneca pause in Europe could give rise to vaccine hesitancy in Australia. Read the discussion that follows.
At least 13 countries have raised the alarm about possible links between the coronavirus vaccine and blood clots. How will GPs address these concerns with patients?
Germany, France, Italy, Spain and Slovenia are among the latest European countries to pause the rollout of the Oxford University/AstraZeneca coronavirus vaccine amid blood clot concerns.
They join Norway, Denmark and Iceland who were the first countries to suspend use of the vaccine, after a 60-year-old woman suffered a blood clot and died after being inoculated.
But with preparations for the vaccine’s rollout well underway across general practice, Melbourne GP Dr Magdalena Simonis fears the move threatens to undo the work that has already been done to curb vaccine hesitancy.
‘This is going to make matters worse for GPs who’ve already had to address the issue of vaccine hesitancy with patients,’ she told newsGP.
‘Those fence sitters are going to be the ones that withdraw or recoil from the option of having the vaccine, and they’re the ones that we were hoping that we would be able to bring along.
‘The ones that are committed to the bigger picture of social contribution – vaccinate yourself so you can protect others, not just yourself – they’re probably not going to be swayed away by this.’
The steps taken in Europe have been branded an ‘overreaction’ by some experts. Both the World Health Organization (WHO) and the European Medicines Agency (EMA) have said there is no evidence the vaccine causes clotting issues.
To date, 17 million people have received the Oxford University/AstraZeneca vaccine and only 11 instances of blood clot have been reported.
‘Data from the phase 3 clinical trials and real-world rollouts suggest blood clots and other “thromboembolic” events occur no more frequently in people vaccinated with the AstraZeneca shot than they do in the general population,’ Associate Professor Nigel Crawford, Director of SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community) at Murdoch Children’s Research Institute, said.
Nationals Senator Matt Canavan and Federal MP Craig Kelly have called for the Australian Government to follow Europe’s steps. But the Australian Government, which has secured more than 53 million doses of the vaccine, has reaffirmed its commitment to the rollout from phase 1b.
Associate Professor Crawford said while it is important to investigate safety concerns thoroughly, there is a risk in pausing rollouts.
‘We would urge extreme caution in pausing rollouts while investigations are underway, because once a vaccine rollout is paused, it can sometimes dent vaccine confidence so much that it struggles to recover,’ he said. ‘As seen in Japan with the Human Papillomavirus vaccine.’
According to Associate Professor Holly Seale, a Social Scientist and Deputy Chair for the Collaboration on Social Science and Immunisation, many Australians stream their news from overseas and use channels such as WhatsApp and WeChat, which open up the possibility for conflicting information.
‘It may not be … misinformation being spread in those, it’s just that it’s different information and it’s information that is relevant to a vaccine program happening overseas,’ she told newsGP.
‘So different vaccines, different recommendations, different eligibility groups, and also this element about whether or not vaccine programs are being stopped or started.
‘We don’t necessarily have a campaign right now for how we address that kind of void and … that we need to be maybe not countering it, but acknowledging it, and just highlighting why there are differences here in our program.’
What’s reassuring, Associate Professor Seale says, is that research indicates a GPs’ recommendation has far more influence than media on vaccine decision-making for the vast majority.
‘Yes, we’ve got to be mindful of the messages going out. But how much influence does that have compared to a recommendation from a GP?’ she said.
‘It’s important to note that we know that the primary prompt for people getting vaccinated still comes down to receiving that recommendation or information from a source that they trust.
‘That vaccine decision-making doesn’t necessarily come down to what you see in the paper or on social media – it could play a role for some people, but it’s not for everybody.’
Associate Professor Seale says low health literacy has a direct link to people’s willingness to receive a vaccine – a key issue, given around 60% of Australia’s population has inadequate health literacy levels.
‘What we need to be careful of is that if people do have individual concerns, or they have the need for some personalised information about their own health situation and whether or not the vaccines are recommended for them, that that time is given for those conversations to be had and those conversations to be had potentially in language, or at a time when it doesn’t feel like it’s rushed, and that questions and answers are given priority,’ she said.
However, Dr Simonis says restrictions posed by the TGA on discussions around vaccines may have implications.
‘If the TGA is placing those sorts of restrictions on the kinds of conversations that would actually be pretty much a first in our history,’ she said.
‘So that’s a pretty significant precedent.
‘The concern here for the whole of the Commonwealth is that our recovery is dependent on being able to function as a normal society, again, without the restrictions that COVID-19 has placed on business and interaction.
‘The emphasis there should be on national health and having a cohesive message for being a part of this big picture, to get Australia back on track, and keep your neighbours and loved ones safe.’
While experts have been looking to the northern hemisphere’s experience for guidance in the lead up to the rollout, Dr Simonis says it is important that people trust in the data emerging locally, and the efforts of the Therapeutic Goods Administration (TGA).
‘These are countries where there is already COVID prevalent in their communities, and they may well be vaccinating people who were already maybe in the early stages of the disease – we have no idea,’ she said.
‘In the UK, where they’ve rolled out so many millions of doses, they have witnessed not an increase in blood clots, but a decrease in the number of people overwhelming their hospitals. That is the measure that we need to be going by.
‘The TGA of all the watchdogs is probably one of the most stringent. We tend to follow suit when there’s adequate evidence, and the fact that TGA hasn’t, must mean that there is enough evidence in favour of the vaccine.’
Chief Medical Officer Professor Paul Kelly said on Tuesday there had been more than 11 million people vaccinated in the UK without evidence of an increase in blood clots.
‘While the European Medicines Agency is investigating these events, it has reinforced its view that the AstraZeneca COVID-19 vaccine is successful in protecting against COVID-19, and should continue to be used in the rollout,’ he said.
‘Our focus during the vaccine rollout remains the safety of all Australians. With a vaccine rollout like this, we need to monitor carefully for any unusual events. We will find them, but this does not mean that every event following a vaccination is caused by the vaccine.
‘We take these events very seriously and investigate, just as countries overseas are currently doing as a precautionary measure.’
Originally published: www1.racgp.org.au/newsgp/clinical/fears-astrazeneca-pause-in-europe-could-give-rise
The European Medicines Agency’s safety committee is investigating whether there is any evidence the vaccine causes clotting issues. (Image: AAP)
Australia is pushing ahead with the #COVID #vaccine rollout. But GP @drmsimonis fears the pause in Europe may impact locally: ‘This is going to make matters worse for GPs who've already had to address the issue of vaccine hesitancy with patients’. #newsGPhttps://t.co/rP7Zy5jdrk
— newsGP (@newsGPau) March 16, 2021
Associate Professor Magdalena Simonis AM is the Immediate Past President of the AFMW (2020-2023), former President of VMWS (2013 & 2017-2020) and current AFMW National Coordinator (2024-2026). She is a full time clinician who also holds positions on several not for profit organisations, driven by her passion for bridging gaps across the health sector. She is a leading women’s health expert, keynote speaker, climate change and gender equity advocate and government advisor. Magda is member of The Australian Health Team contributing monthly articles.
Magdalena was awarded a lifetime membership of the RACGP for her contributions which include past chair of Women in General Practice, longstanding contribution to the RACGP Expert Committee Quality Care, the RACGP eHealth Expert Committee. She is regularly invited to comment on primary care research though mainstream and medical media and contributes articles on various health issues through newsGP and other publications.
Magdalena has represented the RACGP at senate enquiries and has worked on several National Health Framework reviews. She is author of the RACGP Guide on Female Genital Cosmetic Surgery and co-reviewer of the RACGP Red Book Women’s Health Chapter, and reviewer of the RACGP White book
Both an RACGP examiner and University examiner, she undertakes general practice research and is a GP Educator with the Safer Families Centre of Research Excellence, which develops education tools to assist the primary care sector identify, respond to and manage family violence . Roles outside of RACGP include the Strategy and Policy Committee for Breast Cancer Network Australia, Board Director of the Melbourne University Teaching Health Clinics and the elected GP representative to the AMA Federal Council. In 2022. she was award the AMA (Vic) Patrick Pritzwald-Steggman Award 2022, which celebrates a doctor who has made an exceptional contribution to the wellbeing of their colleagues and the community and was listed as Women’s Agenda 2022 finalist for Emerging Leader in Health.
Magdalena has presented at the United Nations as part of the Australian Assembly and was appointed the Australian representative to the World Health Organisation, World Assembly on COVID 19, by the Medical Women’s International Association (MWIA) in 2021. In 2023, A/Professor Simonis was included on the King’s COVID-19 Champion’s list and was also awarded a Member (AM) in the General Division for significant service to medicine through a range of roles and to women’s health.