In order for a vaccine to get safe use in Australia, it needs to go through a series of rigorous safety checks.
The Therapeutic Goods Administration (TGA) — which is responsible for approving vaccines — carefully assesses the results of vaccine trials, makes sure manufacturing standards are up to scratch, and uses its own laboratories to “assess the quality of every batch of a vaccine before it can be supplied”.
the TGA said following a thorough and independent review of Pfizer’s COVID-19 vaccine submission it decided the vaccine met the high safety, efficacy and quality standards required.
The approval is on a provisional basis, meaning it is valid for two years, and allows the vaccine to be supplied in Australia for people aged 16 and older.
Like any vaccine approved for use in the community, COVID-19 vaccines have been studied extensively across multiple pre-clinical and clinical trials.
The process begins with research on cells and animals in the lab (these are the pre-clinical studies), and then progresses to large-scale testing in humans (these are the clinical trials).
Over a period of several months, more than 43,000 people were involved in the clinical trials for the Pfizer vaccine, and another 23,000 were included in the Oxford-AstraZeneca trials.
Both vaccines were found to be effective at stopping people getting sick (to differing degrees), and both companies reported very few serious side effects (more on those below).
Are they Safe ? Are there any side effects?
People who get immunised may experience some mild side effects, and these have been reported in places where COVID-19 vaccines have been rolled out.
The US Centers for Disease Control describes these as ‘normal signs that your body is building protection’.
Common side effects include:
- pain and swelling in your arm (where you get the jab)
So far, no long-term adverse effects have been reported in people who participated in clinical trials (who were immunised several months ago), but researchers will continue to keep a close eye on them.
Similarly, regulators like the TGA will oversee the safety of COVID-19 vaccines in the community for several years after they have been approved.