Vaccines are complex biological products. A minor change in the manufacturing process can affect the safety, efficacy and quality of the vaccine that is injected into a person’s arm. In a world where widespread vaccine coverage is crucial to ending the acute phase of this pandemic, it is critical that COVID-19 vaccines undergo thorough safety and quality checks before they are released for use, just as other vaccines for routine immunisations do.
Australia has shared millions of COVID-19 vaccines with our neighbours in the Pacific and Southeast Asia since March 2021. Each vaccine batch has passed an independent ‘batch release assessment’ to confirm consistent safety, efficacy and quality.
In Australia and for any vaccine doses being shared to our regional neighbours from Australia’s domestic supplies, the responsibility to ensure that this happens falls to the Therapeutic Goods Administration (TGA), our national medical products regulator.
Dr Natasha Brockwell, Biological Technical Expert at TGA, explained that there are two steps which the TGA takes to a conduct batch release assessment of COVID-19 vaccines.
First, TGA experts review the documents that are supplied by the vaccine sponsor (for example, AstraZeneca or Pfizer) which describe in detail how the vaccine was made, tested, shipped and stored.
Second, TGA's dedicated laboratories carry out a wide range of tests, including assessments to confirm what the vaccine is made of, that the active ingredient in the vaccine is present at the correct strength, and that the vaccine is not contaminated with any microorganisms or external matter that shouldn’t be there. Dr Brockwell noted that as different COVID-19 vaccines use different technologies, the testing protocols differ between vaccines also.
The TGA laboratories publish the test results on the TGA website by batch number and date, including results for all COVID-19 vaccine batches Australia has shared with our region. Official certification which confirms the detailed test results is also shared by the TGA’s Regional Regulatory Support Program Team with regulatory authorities in countries receiving doses shared by Australia.
‘Sharing transparent and timely information about batch-testing is just one way the TGA is supporting regulatory authorities in the Pacific and Southeast Asia’, said Michael Wiseman, who leads TGA’s Regional Regulatory Support Program. Staffed by medical doctors, pharmacists, and laboratory and regulatory scientists, the team is providing technical assistance including activities related to regulatory approvals, Good Manufacturing Practice standards, and vaccine safety monitoring.
By working in close partnership with neighbouring countries, the Australian Government, through the TGA, is playing an active role in supporting our region to reach the goal of widespread access to and uptake of safe and effective COVID-19 vaccines.