Vaccination Requirements in Australia: Know the Types of Vaccines Accepted in the Country for Future Travel Plans23 July 2021
Australia has entered into five separate agreements to secure more than 195 million doses of COVID-19 vaccines, if they prove to be safe and effective. The Australian Government has invested over $350 million to support vaccine research and development. The investment will contribute to the global effort to find successful vaccines and treatments to stop the spread of COVID-19.
Before a COVID-19 vaccine is approved for use in Australia, it must pass the Therapeutic Goods Administration’s (TGA) rigorous assessment and approval processes. This includes assessment of its safety, quality and effectiveness.The TGA is actively monitoring COVID-19 vaccine development both in Australia and around the world, and is also part of a network of international regulators that meet regularly to discuss the development of COVID-19 vaccines.
The TGA is engaging early with vaccine developers, undertaking a thorough and efficient review of vaccine candidates and discussing the application process. Early engagement will not affect the comprehensive review process that clinical trial results are subject to in Australia.
Provisionally Approved Vaccines
Pfizer/BioNTech COVID-19 vaccine was approved by the TGA for use in Australia on 25 January 2021, after a rigorous assessment and approval process. This includes assessment of its safety, quality and efficacy. The decision is based on quality data (chemistry and manufacturing), nonclinical data (pharmacology and toxicology), and clinical data (including safety and efficacy data from large-scale clinical trials). The approval is subject to certain strict conditions, such as the need for Pfizer to continue providing data to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.
AstraZeneca is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the active immunisation of individuals 18 years and older for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The use of this vaccine should be in accordance with official recommendations and given in two doses 4 to 12 weeks apart. The Australian Technical Advisory Group on Immunisation has recommended that the interval between first and second dose is 12 weeks. However if this interval is not possible, for example because of imminent travel, cancer chemotherapy, major elective surgery, a minimum interval of 4 weeks between doses can be used.
Phase Three Trials
Moderna COVID-19 vaccine is the second mRNA vaccine that the Australian Government has committed to through an advance purchase agreement. If approved by the TGA, this agreement will provide access to the current Moderna vaccine (available in the second half of 2021) and variant-specific versions of the vaccine to address longer term immunity and emerging viral variants. Supply of the variant-specific form of Moderna vaccine is expected in the first half of 2022.
Novavax is developing a vaccine for Coronavirus (COVID-19). If it is proven safe and effective and is approved for use, it will be available in Australia in the second half of 2021. It is anticipated that 51 million doses will be available, which will supply enough doses to cover Australia’s whole population. Doses for Australia may be manufactured in several locations across Europe. The Novavax vaccine is one of nine vaccines supported by the Coalition for Epidemic Preparedness Innovations, a global partnership to accelerate vaccine development.
COVAX is aiming to mobilise 2 billion doses for the world by the end of 2021, addressing the acute phase of the pandemic. It is coordinated by Gavi with help from member countries, the Coalition for Epidemic Preparedness Innovations (CEPI), the World Health Organization, and UNICEF.
Australian Government Department of Health. (2021, June 28). Australia’s vaccine agreements. Retrieved June 28, 2021, from Australian Government Department of Health: https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/covid-19-vaccine-government-response/australias-vaccine-agreements
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