(Feb. 11, 2021) On February 4, 2021, the Australian Parliament passed the Australian Immunisation Register Amendment (Reporting) Bill 2021 (Cth), which amends the Australian Immunisation Register Act 2015 (Cth) (AIR Act) to “require recognised vaccination providers to report certain information in relation to certain vaccinations administered both within and outside Australia”; “authorise the collection and use of Commonwealth assigned identifiers”; “introduce civil penalties should recognised vaccination providers not comply with the reporting requirements”; and “create a power for the secretary to require recognised vaccination providers to produce information if they do not comply with the reporting requirements.”
In a press release issued upon the introduction of the bill on December 3, 2020, the minister for health and aged care explained that
[c]urrently, not all vaccine providers make a record in the Australian Immunisation Register (the AIR) when a vaccine is administered, which means that individuals or health professionals may not have access to vaccination history. This information could be vital in an emergency, when undertaking medical treatment and in managing an individual’s health and wellbeing.
The effect of the amendments in the Bill is to ensure all vaccination providers report vaccines given, including any COVID-19 vaccine, to the AIR.
These changes will ensure that every Australian can access their vaccine history through this safe and secure register and support the administration of COVID-19 vaccines and other lifesaving vaccines, including those against the flu and meningococcal.
The explanatory memorandum to the bill states that
[t]he AIR is a whole of life, national immunisation register that captures vaccines administered to those living in Australia. The AIR Act provides that the purposes of the AIR relate to supporting Australian vaccination programs and vaccination matters more broadly.
Currently, there is no statutory mechanism by which the Commonwealth can require vaccination providers to report vaccines administered. Vaccination providers are encouraged to report all vaccines administered to the AIR however, as reporting is voluntary, not all vaccines administered are reported.
Reporting to the AIR is maintained at high levels and the data entered is sufficiently reliable for the administration of childhood immunisations due to a number of existing policy and program settings which encourage reporting. Reporting of adolescent and adult other vaccines is lower and less reliable.
Noting the significant investment to be made by the Australian Government in the purchase and introduction of a COVID-19 vaccine, and the National Immunisation Program more generally, tracking and tracing of all vaccines administered to the Australian public will be essential.
In his press release, the minister also explained that
[t]he AIR provides Australians with an Immunisation History Statement (IHS) which displays all immunisations that an individual has had that are recorded on the AIR. The IHS can be viewed and printed via Medicare Online, myGov, the Express Plus Medicare mobile app, or My Health Record. Vaccination providers can print an IHS on behalf of their patient.
In addition, as explained by the minister in his second reading speech on the bill, and in the explanatory memorandum, AIR data is used
- to monitor the effectiveness of vaccines and vaccination programs, including adverse events;
- to identify any parts of Australia at risk during disease outbreaks;
- to inform immunisation policy and research;
- as proof of vaccination for entry to child care and school, and for employment purposes;
- to monitor vaccination coverage across Australia; and
- to demonstrate eligibility for family tax benefit and childcare subsidy payments.
Phased Implementation of Mandatory Reporting
One of the primary purposes of the bill is to “enable the Government to track and trace every COVID-19 vaccine administered.” (Explanatory Memorandum at 3.) The government has therefore proposed a staged implementation of the bill, which will be included in the Immunisation Register Rule 2015 (Cth), with the mandatory reporting of
- COVID-19 vaccinations (should one or more safe and effective vaccines meet all necessary regulatory requirements for supply in the Australian market) and influenza vaccinations from 1 March 2021; and
- All National Immunisation Program (NIP) vaccinations from 1 July 2021. (Explanatory Memorandum at 1.)
COVID-19 Vaccinations in Australia
The Australian government has entered into four separate agreements for the supply of COVID-19 vaccines, investing more than AU$3.3 billion (about US$2.55 billion) for early access to 134 million doses, dependent on regulatory approval of the different vaccines. On January 25, 2021, the Therapeutic Goods Administration announced that it had “granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.” The provisional approval, which applies to use in individuals aged 16 years or older, is valid for two years and enables the vaccine to be legally supplied in Australia.
The agreement related to the Pfizer/BioNTech vaccine provides that
- 10 million doses will be available from early 2021
- these doses will be manufactured offshore
- Australia will have the option to purchase additional doses where supply is available.
The Department of Health website explains that
[t]he COVID-19 vaccine will be voluntary, universal and free. The Government aims to have as many Australians as possible choose to be vaccinated for COVID-19.
If people choose not to have a COVID-19 vaccine, this will not affect their family’s eligibility for Family Tax Benefit Part A or childcare fee assistance which only includes National Immunisation Program vaccines for those aged under 20 years.
A Department of Health page related to vaccine distribution further explains that
COVID-19 vaccines will be free for all Australian citizens, permanent residents and temporary visa-holders as per the Australian COVID-19 Vaccination Policy.
The page then provides an overview of the distribution plan, including making doses initially available in hospital hubs in urban and rural locations around Australia, and government-managed teams going out to aged care and disability care facilities, then extending availability at other locations, including “GP respiratory clinics, General Practices that meet specific requirements, Aboriginal Controlled Community Health Services, and state-run vaccination clinics.” The vaccination program “will commence with priority groups including aged care and disability care residents and workers, frontline healthcare workers, and quarantine and border workers.”