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QUESTION ON NOTICE

Question:

21 November 2022

196. The TGA says the vaccines are provisional to last sometime in 2023 or 2024. How are they compiling their data when not all doctors, hospitals, medical industry etc are not even notifying the TGA, ATAGI, CDC, FDA, NIH of adverse events. How does the TGA retrieve information and statistics from so they can form a conclusion if it works or not? 216. Was testing performed on vaccines that were given after their initial expiry date to ensure their safety? If not, why not?

Answer:

Question Number: 221
PDR Number: SQ22-000591
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 196 Conditions of provisional registration for all COVID-19 vaccines in Australia also require the submission of study reports to collect confirmatory safety and efficacy data. These requirements are listed in the Australian Public Assessment Report for each vaccine and are published on the Therapeutic Goods Administration (TGA) website. For a product to move from a provisional to full registration, additional data submissions are required. In addition to the submission of confirmatory data, the conditions of provisional registration for all new COVID-19 vaccines in Australia include submission of monthly safety summary reports for the first six months, and six monthly periodic safety update reports. These reports include summaries of national and global post-market adverse event data. Sponsors of vaccines are also mandated to report certain adverse events to the TGA within specific timelines. Whilst not all Australian consumers, doctors and hospitals are mandated to make an adverse report to the TGA, there is still a very large data base of information. Because of our close working relationship with other global regulators and organisations such as the US CDC and the UK NHS and leadership of the ICMRA global vaccine safety program, we have had access to safety data from the vaccine rollout in billions of people globally. Within Australia the TGA also uses other data sources and partners with research organisations such as the National Centre for Immunisation Research and Surveillance who deliver Australias active surveillance of COVID-19 vaccines. Question 216 The TGA independently assesses the quality of every batch of COVID-19 vaccine supplied in Australia. As part of this assessment, the TGA Laboratories carries out a range of tests, including assessments for composition, identity, potency and purity. This testing is conducted before the batch is deployed in Australia. Additional testing after the initial expiry date is not required because the manufacturer must provide evidence to support both the initial shelf life and for any proposed extensions. The TGA’s expert evaluators review the methods and materials used to produce the vaccines, as well as the testing methods and results used to determine the quality of the vaccine. This includes the methods and data used to set the shelf life for the product (Stability testing for prescription medicines: 14.4 Biological medicines: specific requirements, available at: www.tga.gov.au/book/144-specificrequirements-stability-biological-medicines)