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Australian Covid 19 Vaccination Policy 1
Australian Covid 19 Vaccination Policy 1
AUSTRALIAN COVID-19
VACCINATION POLICY
Source: CSIRO
Executive Summary 1
1 Introduction 2
Purpose 2
Australia’s COVID‑19 Vaccine and Treatment Strategy. 2
7 Communications strategy 17
Making safe and effective COVID-19 vaccines Implementation Plans, which will articulate how
available to all Australians is a key priority of the it will give effect to its responsibilities under
Australian, State and Territory governments. this Policy.
This Australian COVID-19 Vaccination Policy
Key responsibilities of the Australian Government
(Policy) outlines the approach to providing
will include the regulation of vaccines, their
COVID-19 vaccines in Australia.
acceptance from manufacturers, storage and
It sets out key principles, such as that COVID-19 transport to specified sites within States and
vaccines will be made available for free to all Territories, setting funding policy, ensuring that
Australian citizens, permanent residents, and most appropriate data collection and monitoring
visa-holders. Further, it outlines how COVID-19 systems are in place, and the national
vaccines will be accessible on a rolling basis, communications and information effort.
dependent on vaccine delivery schedules and
States and Territories’ responsibilities include
the identification of groups for most urgent
ensuring appropriately qualified and trained
vaccination.
workforce for vaccines delivered at their
This Policy also describes the shared and vaccination sites, providing sites where
separate responsibilities of the Australian, State vaccinations can safely take place, and ensuring
and Territory governments, as well as other key that immunisation providers at state and territory
stakeholders. Each jurisdiction, including the vaccination sites remain compliant at all times with
Australian Government, will develop supporting their safety, ethical, and reporting obligations.
• The Australian immunisation context; Provide Australians with safe and effective vaccines under a targeted and
responsive national COVID-19 vaccination policy and immunisation program.
• Roles and responsibilities of governments Policies and programs will be based on up-to-date health advice.
and other key stakeholders in a COVID-19
pandemic vaccination program;
• Information on the vaccines purchased by
the Australian Government;
• Key features of the vaccination program,
including how doses will be made available
to those identified by medical experts
as most in need and where and how
vaccination will take place;
• How vaccine safety will be monitored;
• How data will be collected and reported to
support public health outcomes, including
the digital solutions that will be used to
support consumers and clinicians through
the vaccination process; and
• How accurate, timely information on
COVID-19 vaccines and vaccination will
be made available to consumers and
clinicians.
The TGA rigorously assesses vaccines for safety, who represent the people for whom the vaccine is • to inform immunisation policy and research;
The National Immunisation quality and efficacy before they can be used in intended. The results must demonstrate that the • as proof of vaccination for entry to child
Program (NIP) Australia. Vaccines receive the same high level benefits of the vaccine greatly outweigh the risks. care and school, and for employment
of scrutiny as other prescription medicines and purposes;
Many immunisations in Australia are provided The TGA also requires vaccine manufacturers to
related therapeutic goods.
through the NIP. The NIP was set up by the meet manufacturing quality standards. As a further • to monitor vaccination coverage across
Australian and state and territory governments in The TGA regulates therapeutic goods through: check, TGA laboratories assess the quality of Australia; and
1997. It aims to increase national immunisation every batch of a vaccine before it can be supplied
• pre-market assessment; • for eligibility for Family Tax Benefit and
coverage to reduce the number of cases of in Australia.
• post-market monitoring and enforcement Child Care Subsidy payments.
diseases that are preventable by vaccination
in Australia. The NIP is a collaborative initiative of standards; and The Office of the Gene Technology The AIR Immunisation History Statement (IHS)
involving all levels of government (Australian, displays all immunisations that an individual
• licensing of Australian manufacturers Regulator (OGTR)
state and territory, and local), healthcare and verifying overseas manufacturers' has had that are recorded on the AIR. The
providers, administrators and researchers. The OGTR is responsible for the regulation IHS can be viewed and printed via Medicare
compliance with the same standards as
The program positively affects the health of all of genetically modified organisms (GMOs) Online, myGov or the Express Plus Medicare
their Australian counterparts.
Australians at some point in their lives – either in accordance with the Gene Technology Act mobile app. Vaccination providers can print
directly through vaccination or indirectly through Therapeutic goods are divided broadly into 2001. The objective of the Act is to protect the an IHS on behalf of their patient. Immunisation
reduced transmission of infectious diseases two classes: medicines and medical devices. health and safety of people, and to protect the information on My Health Record is updated via a
(community immunity). Vaccines are categorised as medicines. environment, by identifying risks posed by or as a daily feed from AIR data.
Medicines must be entered as either 'registered' result of gene technology, and by managing
or 'listed' medicines on the Australian Register of those risks through regulating certain dealings Monitoring immunisation coverage and
Therapeutic Goods (ARTG) before they may be with GMOs. administration will be key to ensuring vaccination
supplied in or exported from Australia. course completion as well as assisting with any
The OGTR will be required to approve and license adverse event reporting.
any COVID-19 vaccines being administered in
Australia that use GMOs. These include all the
adenovirus vaccines and some of the mRNA
vaccines. Protein subunit vaccines will not
generally require OGTR approval.
Robust, vaccine‑specific programs Clear lines of responsibility across The Australian Government COVID-19 Jurisdictional implementation plans will be
Implementation Plan will also include particular required to demonstrate how identified priority
supporting free access governments requirements for vaccination in residential aged groups for vaccination will be reached, and how
The initial roll-out of COVID-19 vaccination during Australian, State and Territory governments care and residential disability settings; Aboriginal this approach will ensure the needs of vulnerable
the pandemic will not fall under the NIP. It must are committed to successful immunisation of and Torres Strait Islander peoples; culturally and groups are met. While each jurisdiction will
draw from the strengths of the NIP – including Australians with a safe and effective linguistically diverse communities; and vulnerable have different considerations, such as varying
the reliance on robust regulatory pathways, COVID-19 vaccine. groups. requirements for rural and remote delivery, there
timely application of expert scientific and should be a broad level of consistency across
Clear lines of responsibility are required to ensure State and Territory Governments are each
medical advice, and effective cross-jurisdictional these plans as a whole.
that this complex process is well managed, and it responsible for:
coordination and delivery mechanisms – while
is clear who is accountable at each stage of the In addition, the Australian, State and Territory
adopting sufficient flexibility to ensure the safe, • ensuring appropriately qualified and
process. The sections on vaccine roll-out in this governments will work together to ensure that
efficient, effective and transparent delivery of trained workforce to support delivery of
document indicate responsibilities for specific the needs of the following groups are met:
a pandemic-context vaccination program over an its jurisdictional implementation plan, in
actions. Broadly: residential aged care and residential disability
acceptable time period. collaboration with relevant peak bodies and
settings; Aboriginal and Torres Strait Islander
The Australian Government is responsible for: training providers;
The TGA and the OGTR will continue to peoples; culturally and linguistically diverse
independently discharge their regulatory duties. • selecting and purchasing vaccines; • authorising, under State and Territory communities; and vulnerable groups. This will be
It is expected that initial regulatory approval legislation, the selected workforce identified done in consultation with relevant stakeholders
• formally accepting vaccines from suppliers
for use of COVID-19 vaccines is likely to occur in the Commonwealth and State and including the Aboriginal and Torres Strait Islander
and ensuring that they meet the required
through the TGA’s provisional determination Territory implementation plans to possess Community Controlled Health Organisations
standards;
and registration pathway. The vaccines will and administer COVID-19 vaccines; (ACCHOs).
be provisionally registered in the Australian • safely transporting vaccine doses to
• identifying specific vaccination sites The Australian, State and Territory governments
Register of Therapeutic Goods on the basis storage and administration sites within
(including in external territories) in will also work together to ensure doses of vaccine
of clinical data, with subsequent rolling review each State and Territory, and between
accordance with the Policy and in line are distributed to where they are most needed,
of additional clinical data as they become these sites and vaccination locations where
with the Commonwealth implementation based on live information on need and uptake at
available with the aim to achieve full registration it determines necessary;
plan that meet or exceed the minimum vaccination locations.
as soon as possible. The TGA will actively and • specifying priority populations, drawing requirements; and
comprehensively monitor any COVID-19 vaccines from advice from ATAGI;
for safety after they are supplied in Australia, in • ensuring that immunisation providers
accordance with its legislation. • establishing overarching principles for remain compliant at all times with their
immunisation scheduling; safety, ethical, and reporting obligations.
The COVID-19 vaccination will be free for all
Medicare-eligible Australians and all visa-holders, • specifying minimum training requirements
excluding visa sub-classes 771 (Transit), 600 for the immunisation workforce and
(Tourist stream), 651 (eVisitor) and 601 (Electronic providing guidance on appropriate
Travel Authority). workforces for the various phases of the
immunisation program;
While the Australian Government strongly
supports immunisation and will run a strong • specifying types of and minimum
campaign to encourage vaccination, it is not requirements for vaccination locations;
mandatory and individuals may choose not to • clinical governance of vaccine
vaccinate. There may however, be circumstances administration;
where the Australian Government and other
• developing and delivering the national
governments may introduce border entry or
communications campaign; and
re-entry requirements that are conditional on proof
of vaccination. • setting data collection and reporting
requirements and adverse event monitoring
via the TGA.
Funding
Charges should not be levied to consumers for Managing the most effective and efficient roll-out Other eligible health professionals and
COVID-19 immunisation. of COVID-19 vaccine(s) will require significant organisations can apply to become recognised
coordinated data and reporting mechanisms. vaccination providers and access the AIR using
Consistent with the shared funding responsibility A consumer- and clinician-centred approach to Services Australia’s Health Professionals Online
for immunisation, the Australian Government and designing digital, data and reporting systems Service (HPOS).
State and Territory Governments will determine will help to manage public demand, minimise
the approach to funding of the COVID-19 The Australian Government is undertaking a
reporting overhead, and improve efficacy of
vaccination program. Possible options include review of AIR functionality to support this role,
the rollout. This Australian Government has
amending the existing National Partnership including an anticipated large number of new
commenced work on this approach and is
Agreement on COVID-19 Response and/or the registrants and new providers, to ensure technical
identifying key system capabilities and gaps.
National Partnership on Essential Vaccines. capacity to fulfil the key monitoring role.
Any activity-based payments should be designed
to incentivise the administration of second doses Australian Immunisation Register Digital Health
required for COVID-19 immunisation. (AIR)
My Health Record (MHR) will play a key role for
The Australian Government may also establish For the COVID-19 vaccine, the AIR will be used to, Australians as an authoritative record of their
direct funding relationships, if needed, to support among other things: vaccinations. MHR is already connected to the
vaccination across particular populations. • monitor immunisation coverage levels and AIR and it supports mobile app connectivity to
service delivery, which can help to identify potentially enable the generation of immunisation
regions at risk during disease outbreaks; certificates.
• measure vaccination coverage at a local, Importantly, MHR is already integrated into public
state and national level. and private health care settings (such as public
hospitals and general practice). It is integrated
• determine an individual's immunisation with myGov, giving Australians easy access to
status, regardless of who immunised them their health information. Using MHR for direct
• provide an Immunisation History Statement engagement with clinicians and consumers can
to prove their immunisation status for help ensure successful rollout – for instance,
child care, school, employment or travel by delivering personalised messages to
purposes consumers reminding them to have their second
dose of a vaccine.
It is highly likely that two doses of a COVID-19
vaccine will be required for immunisation. Further,
each patient will need to have two doses of Pharmacovigilance
the same vaccine, i.e. two doses of the Oxford Pharmacovigilance is defined by the World Health
vaccine or two doses of the UQ vaccine. Organization as the science and activity related
The AIR will be the unifying national system to to detecting, assessing, understanding and
monitor both overall immunisation levels and preventing adverse effects and other medicine-
individual immunisation status. It will be mandatory related problems. Monitoring for adverse events
for vaccination providers to make timely following the COVID-19 will be important for
recordings of any COVID-19 vaccinations into AIR. clinician and consumer safety and confidence in
the vaccination program. The TGA collects and
Medical practitioners, midwives and nurse evaluates information related to the benefit-risk
practitioners with a Medicare provider number are: balance of medicines in Australia to monitor their
• automatically recognised as vaccination safety and, where necessary, take appropriate
providers by the AIR. action. Currently, a National Adverse Events
Following Immunisation (AEFI) reporting form is
• authorised to record or get immunisation
used to report adverse reactions to vaccination
data from the AIR.
to the TGA, in addition to reporting to State and