It’s difficult participating in a race when you cannot clearly see the finish line, and that’s what we have been facing with the COVID-19 pandemic this whole year.
We have known for some time this race is not a sprint, and probably not a marathon – more an ultramarathon with hurdles thrown in for good measure!
We have already jumped plenty of these hurdles together – and none that I can see ahead appear too high for us to clear.
A safe and effective vaccine is the key to winning this race.
Medical researchers have made huge progress – and remarkably quickly, especially given there has never been a successful vaccine for a coronavirus, and several of the most promising vaccines are based on new technology.
Some people might ask: how are we on the cusp of having a safe and effective COVID-19 vaccine so quickly?
The simple answer is that there has been unprecedented global cooperation among governments and researchers. Let me be clear, especially as far as Australia is concerned: we are taking no shortcuts.
We are not there yet – but I am very confident we can jump the remaining hurdles. I believe a vaccine is likely to be available to Australians from as early as next March.
Other countries, such as the United States and United Kingdom, have emergency use provisions that allow for public access prior to full safety and efficacy assessment, where they are facing an immediate health crisis with an increasing daily loss of life.
The UK has already used these provisions for the Pfizer vaccine. In Australia, there is a series of robust regulatory steps we must take before any COVID-19 vaccine is approved for widespread use.
Each process is appropriate for each country’s circumstances.
The TGA’s proactive work with international regulators and vaccine developers is helping to speed up this process, while ensuring all critical checks and balances remain in place.
So far, sponsors of three potential COVID-19 vaccines – AstraZeneca Pty Ltd, Pfizer Australia Pty Ltd, and Janssen-Cilag Pty Ltd – have indicated by seeking and being granted provisional determination that they will make applications for approval.
The TGA has already been provided with early data for two of these vaccines (AstraZeneca and Pfizer). The next step is for the sponsors to submit all the required data on, for example, clinical studies, toxicology studies, chemistry, manufacturing and risk management so that the TGA can complete its evaluation.
Even once a COVID-19 vaccine is registered, it is standard practice for the TGA to continue to closely examine it through more clinical trials, surveillance and monitoring, including quality assessment of every batch.
If a vaccine or vaccines clear these hurdles, Australia is well prepared.
The roll out of a new vaccine to all Australians who choose to be vaccinated is a big logistical hurdle, but we have the best minds across the country mapping this out, looking at data for each COVID-19 vaccine.
And we have already secured agreements for four vaccines totalling more than 134 million doses, and are monitoring vaccine developments around the world. We are also part of the international COVAX agreement which provides access to a range of other potential vaccines. Our Vaccination Plan ensures that we have broad access – all our eggs are not in the one basket.
Importantly, the Australian Government has made it clear a COVID-19 vaccine will not be mandatory in Australia, but will be free and strongly encouraged.
Australia has a strong immunisation record, and this pandemic has already shown Australians’ willingness to do what it takes to protect themselves and others.
Much work has been undertaken to decide who should have first access to a vaccine. While this will depend on the effectiveness and safety of any vaccine, it is likely the first doses will be made available to those with an increased risk of becoming very sick or dying from the virus, those at an increased risk of exposure and those working in services critical to the functioning of our society.
In particular our health and medical workers and our elderly Australians in residential aged care will be among the first to be offered the vaccine, subject to approvals.
There is also scope for prioritising groups in the event of an outbreak.
It is only when a sizable proportion of the Australian population is vaccinated that we will round the last bend and the finish line will emerge. It is then we can dream of a normality that isn’t just “COVID normal”.
Our goal is that we'll be able to provide a vaccine to all Australians who seek to be vaccinated before the end of 2021.
Australians have jumped many COVID-19 hurdles to date. But we need to keep to the rulebook. That means maintaining physical distancing, hand and respiratory hygiene, environmental cleaning and staying at home and getting tested when experiencing symptoms. This continued vigilance has put us in such an enviable position worldwide.
I am buoyed by the progress to make a COVID-19 vaccine (or vaccines) a reality, and look forward to the day when this race is finally run and won.