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QUESTION ON NOTICE

Question:

21 November 2022

105. If the Federal Health Department doesn’t support mandates, then why is ATAGI restricting exemptions to just a few conditions based on inadequate trials from sponsor who has an inherent conflict of interest? Given the Australian Immunisation Handbook says people can’t be coerced into taking a vaccine how can ATAGI override that by setting rules that completely ignore a person’s individuals characteristics? 106. Myocarditis and Pericarditis are now two well-known risks for young men from the vaccine. Doctors are still refusing to write exemptions for these indications, and I have been contacted by people who have lost their jobs even with an exemption. When will ATAGI lift the exemptions on mandates so doctors are free to issue exemptions subject to their own discretion? 107. Given myocarditis was a known risk for young men as far back as May 2021 why has ATAGI allowed vaccines to be mandated and furthermore still encourage booster uptake knowing it can cause such harm? 108. Dr Christoper Blyth said ATAGI has not provided a recommendation for mandates – is that correct – if so when then why has ATAGI defined the exemptions so narrowly?

Answer:

Question Number: 203
PDR Number: SQ22-000573
Date Submitted: 21/11/2022
Department or Body: Department of Health

105. The Australian Government does not impose COVID-19 vaccination mandates and maintains that COVID-19 vaccination is voluntary, as are all vaccinations in Australia. During the COVID-19 pandemic some state and territory enacted public health orders that set mandatory vaccination requirements for certain professions. In making its recommendations on the use of COVID-19 vaccines in Australia, Australian Technical Advisory Group on Immunisation (ATAGI) is guided by the best available scientific evidence combined with the collective medical expertise from Australia and overseas and is not limited to data provided by vaccine product sponsors. ATAGI’s recommendations are informed by a thorough review of all current and emerging evidence on COVID-19 vaccines sourced from clinical studies and scientific journals, monitoring of local and international epidemiological data, international program settings, national vaccination coverage and also considers operational flexibility where appropriate. All ATAGI statements are extensively referenced, including links to the best available medical evidence. In respect to temporary and permanent medical exemptions, ATAGI has developed guidance for vaccination providers on the acute major medical conditions that are contraindications to receiving a COVID-19 vaccination. State and territories may also accept other categories of exemptions. ATAGI indicate two contraindications that indicate a medical exemption can be reported in the Australian Immunisation Register (AIR). They are a contraindication to all COVID-19 vaccines or an acute major medical illness.

Permanent medical contraindications can be reported to the AIR for an individual where there is:
• previous instance of anaphylaxis (to vaccine/vaccine component), and/or
• significant immunocompromise (live attenuated vaccines only).

Temporary vaccine medical contraindication can be reported to the AIR due to a non-permanent contraindication for the following:
• acute major medical illness
• significant immunocompromise of short duration (live attenuated vaccines only), and
• the individual is pregnant (live attenuated vaccines only).

Further guidance on medical exemptions to assist vaccination providers can be accessed at: www.health.gov.au/resources/publications/atagi-expanded-guidance-ontemporary-medical-exemptions-for-covid-19-vaccines. 106. Myocarditis and pericarditis are rare adverse events associated most often with mRNA COVID-19 vaccines which are known to occur more commonly among younger people aged 16-40 and among males and more likely after the second dose. Importantly, most myocarditis and pericarditis linked to mRNA vaccination has been mild and patients have recovered quickly. ATAGI advises the benefits of vaccination in protecting against COIVD-19 greatly outweigh the rare risk of myocarditis and pericarditis, however younger people (particularly males) aged under 40 years are encouraged to speak with their usual healthcare provider about the benefits and risks of a booster dose. ATAGI advise people with a history of myocarditis or pericarditis can receive a COVID-19 vaccine, but should consult a GP, immunisation specialist service or cardiologist about the best timing of vaccination and whether any additional precautions are recommended. More information is located on the department’s website at: www.health.gov.au/resources/publications/covid-19-vaccination-guidanceon-myocarditis-and-pericarditis-after-covid-19-vaccines. Authorised medical practitioners use their clinical judgement to determine an individual’s eligibility for a medical exemption. See additional information on medical exemptions in response to Question 105. ATAGI has no role in determining or imposing COVID-19 vaccination mandates and maintain that COVID-19 vaccination is voluntary, as are all vaccinations in Australia. Under public health orders, states and territories and some individual employers may impose mandates. See additional information on this in response to Question 105. 107. ATAGI has no role in determining or imposing COVID-19 vaccination mandates. COVID-19 vaccination is voluntary, as are all vaccinations in Australia. ATAGI advises the benefits of vaccination in protecting against COVID-19 greatly outweigh the rare risk of myocarditis and pericarditis, however younger people (particularly males) aged under 40 years are encouraged to speak with their usual healthcare provider about the benefits and risks of another dose. Importantly, most myocarditis and pericarditis linked to mRNA vaccination has been mild and patients have recovered quickly. Additionally, not all cases of myocarditis and pericarditis that occur are caused by the vaccine, these conditions occur in the general population from a variety of causes. ATAGI continually reviews and closely monitors local and international data and reports of all adverse events following COVID-19 immunisation including rare but serious cases of myocarditis and/or pericarditis. ATAGI’s Guidance on Myocarditis and Pericarditis following mRNA vaccination is informed by the best available evidence. Most recently this document was updated on 29 September 2022. 108. The Department of Health and Aged Care can confirm that ATAGI has no role in determining or imposing COVID-19 vaccination mandates. More information on ATAGI’s role is located on the department’s website at: www.health.gov.au/committees-and-groups/australian-technical-advisory-group-onimmunisation-atagi-covid-19-working-group#:~:text=Contact- ,Role,of%20Health%20and%20Aged%20Care In respect to medical exemptions, ATAGI advise that contraindications to COVID-19 vaccines are rare. If someone cannot receive one COVID-19 vaccine, they are often able to safely receive another. Consequently, the medical circumstances for a person to receive a medical exemption is rare. Authorised medical practitioners use their clinical judgement to determine an individual’s eligibility for a medical exemption. More information on ATAGI’s guidance on medical exemptions is located in response to Question 105.