Topic 9.3
How do regulatory authorities ensure that vaccines are safe and effective for public use?
Before vaccines can be used in Australia, they must be assessed and approved by regulatory authorities like the Therapeutic Goods Administration (TGA). Independent experts evaluate data to ensure vaccines meet safety and effectiveness standards.
Regulatory Authorities
In Australia, after all the trials are complete, the company that developed the vaccine shares their data with the Therapeutic Goods Administration (TGA). They need approval before they can use their vaccine in Australia. Experts at the TGA check to make sure the trials were done properly. They decide if the vaccine is safe and effective.
The Advisory Committee on Vaccines (ACV) is an independent committee of medical and scientific experts. They also review the trial data and help the TGA decide whether a vaccine can be used in Australia.
This process can take up to a couple of years.
Vaccine Monitoring
The TGA continues to monitor vaccines for safety and effectiveness. This includes special at-risk groups that weren’t included in phase III work.
In Australia, there are two main ways to monitor vaccine safety:
1. Passive surveillance: people who think they have suffered a serious side effect from the vaccine (called an “adverse event”) can report it to the TGA. The data is publicly available through the Database of Adverse Event Notifications (DAEN).
2. Active and enhanced surveillance: medical clinics text people who had the vaccine and ask if they had a reaction. AusVaxSafety collects these responses. They also collect data from doctors who give vaccines.
This combined data is used to actively look for potential safety issues with vaccines. The researchers who performed the Phase I, II and III clinical trials also continue to study how well the vaccine works and its safety (known as Phase IV trials).
The Advisory Committee on Vaccines
So what happens if AusVaxSafety thinks there might be a problem? They ask another group (The Advisory Committee on Vaccines) to also have a look. The ACV will advise them if they think something needs to be done.
The TGA also keeps an eye out for problems in other countries that haven’t occurred yet in Australia through the International Coalition of Medicines Regulatory Authorities (ICMRA).