Question Number: 201
PDR Number: SQ22-000571
Date Submitted: 21/11/2022
Department or Body: Department of Health
189. No. Moderna’s Australian facility will produce respiratory mRNA vaccines and pandemic mRNA vaccines as they are developed and registered by Australia’s Therapeutic Goods Administration (TGA). 199. In a pandemic scenario, the facility will be capable of producing up to 100 million doses of mRNA vaccines a year. The Australian Government will purchase COVID-19 (SPIKEVAX) as required and may purchase other respiratory vaccines as they are developed and approved. The TGA is responsible for assessing vaccines and other medicines before they can be used in Australia. The TGA has comprehensively evaluated each of the provisionally registered COVID-19 vaccines to ensure that they meet Australia’s high standards of safety, quality, and efficacy based on the information available at the time of application. The TGA provisionally approves vaccines only if this rigorous process is completed and the benefits are considered to be much greater than any potential risks. This formal regulatory approval means that the vaccines can be lawfully supplied in Australia. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment. For more information about the provisional registration process, please visit the TGA website at: www.tga.gov.au/covid-19-vaccines.