The Therapeutic Goods Administration (TGA) has assured the Australian community it will not approve a vaccination for the COVID-19 pandemic unless it is proven to be safe and effective during and after clinical trials.
In a statement issued last week (15 January), the Department of Health’s Deputy Secretary for Health Products Regulation who leads TGA, Adjunct Professor John Skerritt, said the Administration’s process for assessing and approving a COVID-19 vaccine was extremely rigorous, comprehensive and independent.
“The TGA and its regulatory counterparts around the world are collaborating extremely closely – in fact, on a daily basis – about COVID-19 vaccines, ensuring the global knowledge bank grows and is shared for the benefit of all,” Professor Skerritt said.
“In deciding whether to approve a vaccine, the TGA evaluates all of the scientific and clinical information provided by the vaccine’s sponsor, as well as other available evidence,” he said.
“We will only approve a vaccine for use if it is demonstrated to be safe and effective during and after clinical trials – and if the manufacturer can show it can be produced in a high quality, consistent and controlled manner.”
Professor Skerritt said that following approval of a vaccine, the TGA’s role would continue as it monitored vaccine safety and assessed the quality of every batch supplied in Australia.
He said it was important Australians knew that the TGA was conducting a full review of COVID-19 vaccines in a compressed timeframe and as its highest priority.
“This has been made possible in Australia because of our success in keeping transmission levels low in the community,” he said.
“Other countries, for instance the United States and United Kingdom, which are facing extremely serious pandemic situations, have taken decisions to grant temporary emergency authorisations.”
Professor Skerritt said COVID-19 vaccines were expected to begin rolling out to high priority groups in Australia from mid-to-late February.
