Australia: What are the criteria for obtaining a COVID-19 vaccine medical exemption in NSW?

New South Wales doctors have had their hands tied by the medical regulators and governments when it comes to granting exemptions for COVID-19 vaccines.

Despite the avalanche of people applying for vaccination exemptions to enable them to enjoy the 'freedoms' expected to be handed back to 'double vaccinated' people in the next month or so, New South Wales Health has issued doctors with a  pro forma checklist which will ensure that very few will be able to get one.

The checklist is followed by notes which direct that:

"A patient must have medical contraindications to all of the COVID-19 vaccines available for use in Australia in order to be exempted from COVID-19 vaccination requirements under public health orders. If a patient has a medical contraindication to one brand of COVID-19 vaccine, they may be able to be offered an alternate brand, if suitable".

For all vaccines, having had a serious adverse reaction to a first dose is a reason to obtain a medical exemption from the second one.

For the Pfizer and Moderna vaccines, the only other listed reason is a history of anaphylaxis to a component contained in the vaccines.

The excipients (inactive substances that drive the drug's active substances) for the Pfizer vaccine are listed on the  Therapeutic Goods Administration's (TGA's) product information page, and include:

• (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315),
• 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159),
• Distearoylphosphatidylcholine (DSPC),
• Cholesterol,
• Potassium chloride,
• Monobasic potassium phosphate, and
• Dibasic sodium phosphate dihydrate.

The page states, "The active ingredient is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)".

In practical terms, it could be extremely difficult for a person to establish that any previous adverse reaction to a drug resulted from an ingredient contained in a COVID-19 vaccine. This is because any particular drug may contain several active and inactive ingredients, and isolating the specific ingredient in a previously-used drug that caused an adverse reaction may be almost impossible.

For AstraZeneca, the possible reasons are a history of anaphylaxis to a vaccine component, a history of capillary leak syndrome or a history of one of four specific medical conditions: cerebral venous sinus thrombosis (CVST), heparin-induced thrombocytopenia (HIT), idiopathic splanchnic vein thrombosis or antiphospholipid syndrome (APLS) with thrombosis.

In relation to components, the TGA's page on the vaccine states, "COVID-19 Vaccine AstraZeneca contains the excipients histidine, histidine hydrochloride monohydrate, sodium chloride, magnesium chloride hexahydrate, disodium edetate (EDTA), sucrose, ethanol absolute, polysorbate 80 and water for injections."

As to active ingredients, the document states, "COVID-19 Vaccine AstraZeneca is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2. Following administration, the S glycoprotein of SARS-CoV-2 is expressed locally stimulating neutralizing antibody and cellular immune responses."

A doctor can record an "other specified medical contraindication", but the pro forma document itself is extremely prescriptive and restrictive, and government vaccination directions strongly discourage exceptions being those listed. Conscientious objection does not appear to be an option.

The vaccines have not been tested for potential carcinogenic or genotoxic effects.

Given the health departments directions, combined with the joint statement by the Medical Board of Australia and the Australian Health Practitioner Regulatory Agency (AHPRA) warning members they  risk disciplinary action for undermining the national vaccination program, many are sceptical about the impartiality of advice they might get from a GP.

To make the situation even more confusing, the Federal (national) health policy states that vaccines have always been,  and remain, voluntary.

For many, there is inconsistency between the state directions and federal rhetoric, a situation amplified by the NSW Premier's assertion that "only those who are double-vaccinated will get back their freedoms".

In the eyes of many Australians, the state government's directions make clear that vaccination  is not voluntary at all for anyone who wishes to live a semi-formal life – but amounts to a form of coercion.

The Hippocratic Oath essentially requires medical doctors to carry out their duties in the best interests of their patients.

But there are concerns that the directives are creating an environment whereby doctors are unable to use their best judgement for each particular patient they see, and that many are being silenced from expressing any concerns they may have about government vaccine programs, or particular vaccines themselves.

It is a situation which has the potential to undermine the oath taken by doctors as well as endanger patients, while at the same time representing a slippery slope towards  'health authoritarianism'.

Several groups, including the  Australian Council of Trade Unions, have criticised the coercive approach adopted by governments in Australia.

They have expressed the view that while governments as well as employers should encourage people to have COVID-19 vaccines, the current approach whereby whole industries are being forced to have the injections or face losing their jobs and the ability to live semi-normal lives is unfair and counter-productive.

Such an approach, it is said, can create tensions and divisions both within workplaces and in the community generally, when it's important more than ever than people remain united.

There are also concerns about the Federal Government's policy of  shifting the responsibility of having people vaccinated away from itself and onto employers under threat of bearing the legal responsibility of any spread, as well the State Government's policy of placing the burden of policing COVID-19 orders onto already-struggling businesses.

It's very clear that there is a large group of people in Australia who simply don't have confidence in the safety of the vaccination, short or long term, and don't want to risk their own health, at least not yet.

According to some reports, there have been more than 400 Covid vaccine-related deaths in Australia and the Therapeutic Goods Administration (TGA) has received tens of thousands of instances of adverse reactions.

Of course the numbers themselves don't paint the full story – there could be any number of underlying health factors that contributed to vaccine reactions and deaths including health complications, age etc.

While authorities insist that adverse reactions and deaths are rare and are usually the result of other underlying conditions, a lot of people would still like to have this information easily available, so they can make an informed choice about which, if any, of the vaccinations they want to have.

If the Government insists on making it exceptionally difficult for people to be exempt from the vaccination, and is promising a future based on 'freedoms' for the vaccinated, then it needs to acknowledge that there is still some work to be done to build confidence in the vaccine for those who remain hesitant.

Many other countries around the world have indemnified Covid-19 vaccine manufacturers, and some have gone a step further establishing compensation schemes for individuals who are affected.

The Australian Federal Government has only agreed to foot the bill for compensation in the event that a person successfully sues a Covid-19 vaccine supplier for 'serious side effects', which puts the onus on the sufferer (or their family) to prove their case and pursue compensation through the courts – a lengthy, expensive and stressful process that few can afford.

Under the current Australian system, there is also a lack of clarity regarding the definition of 'serious side effects' and whether there is a cap on compensation.

Indemnity does not extend to GPs themselves, and they are currently bound by strict directives. The risk of them insisting that a patient get vaccinated, and the patient then suffering a severe life-threatening or life-altering side-effect leaves GPs vulnerable to potential lawsuits as well.

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