COVID-19 vaccines will play an important role in fighting the coronavirus pandemic and, as is the case with other vaccines, play a vital role in national and global public health programs.
Australia’s Therapeutic Goods Administration (TGA) is the organisation responsible for assessing and approving COVID-19 vaccines for use in Australia through careful consideration of the benefits and risks. The TGA’s processes for determining this are extremely rigorous, comprehensive – and independent.
The TGA’s work, however, is not conducted in isolation. 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.
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.
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.
If the TGA approves it, you can be assured it will work against COVID-19 by dramatically reducing the number of people becoming severely ill or who die from the virus.
Following approval, our role continues as we closely monitor vaccine safety and assess the quality of every batch being supplied in Australia.
It is important Australians know the TGA is conducting a full review of COVID-19 vaccines – but in a compressed timeframe and as our highest priority.
This has been made possible in Australia because of our success in keeping transmission levels low in the community. 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.
Just to make the comparison between Australia and these other countries clear, to date more than 373,000 people have died in the US from COVID-19, with the figure in the UK more than 83,000. Tragic though all deaths to COVID-19 are, we can be grateful the figure in Australia has been limited to just over 900.
The approach taken in Australia will ensure people have greater confidence in the vaccines, to achieve the best possible public health outcome.
How have we managed to fast track the evaluation process without any compromise to our standards? We have been accepting data from sponsor companies on a rolling basis to give us a head start, and we have worked with them to get quick responses to any questions.
We have different teams assessing different aspects of the vaccine submissions in parallel and have significantly increased the number of people working on vaccine regulatory reviews and safety. And our dedicated teams of experts worked through the Christmas-New Year period.
Our highly trained staff working around the clock to assess the COVID-19 vaccines include clinical and medical officers, scientists (microbiologists, immunologists and those specialising in chemistry, biotechnology, toxicology and pharmacology), pharmacists, and experts in statistics and manufacturing.
You may have read or heard that the TGA pores over many thousands of pages of data and information as part of its evaluation process for any given vaccine. What exactly are we looking at?
We look at everything from the efficacy and toxicology of vaccines in a laboratory environment, to manufacturing processes, to the vials of product that go to doctors’ surgeries and hospitals, to clinical trial data, and detailed safety information.
One report received by the TGA just last week on the safety of a single vaccine in mice ran to 827 pages!
On current indications, the TGA is on track to decide whether to approve the first COVID-19 vaccine later this month. This decision will include careful consideration by an independent expert committee. The time taken will be comparable the that taken by regulatory authorities in countries such as New Zealand, South Korea and Japan that have similarly low caseloads of COVID-19.
The Australian Government expects to start rolling out COVID-19 vaccines to high priority groups from mid-to-late February.
My job – and that of my colleagues at the TGA – is to assure Australians these vaccines are safe, effective and have met the same high standards we require for all medicines.
By Adjunct Professor John Skerritt. Professor Skerritt is the Commonwealth Department of Health’s Deputy Secretary for Health Products Regulation and leads the Therapeutic Goods Administration.
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