How COVID-19 vaccines are tested and approved

Australia has strict requirements for the testing and approval of vaccines. Learn how clinical trials work, and how vaccines get approved for use.

COVID-19 vaccines – TGA approval process

This video describes the Therapeutic Goods Administration’s process of how they assess and approve vaccines.

covid-19
2:35
Read transcript

00:00

[Music]

00:03

vaccines are one of the most effective

00:05

ways to protect against diseases

00:07

like covert 19. before covert 19

00:10

vaccines can be given to people in

00:12

australia

00:13

they must first be approved by our world

00:15

leading regulator

00:16

the therapeutic goods administration

00:19

known as the tga

00:20

they regulate and approve all vaccines

00:23

medicines and other medical goods in

00:25

australia

00:26

all potential covert 19 vaccines are

00:28

currently going through

00:30

rigorous testing processes they'll be

00:32

carefully assessed for

00:33

safety quality and effectiveness before

00:36

they can be approved

00:37

covet 19 vaccines will only be approved

00:40

if clinical trials can show the benefits

00:43

to australians against covert 19.

00:46

to be approved it must pass a

00:48

comprehensive six-stage

00:50

process and the tga will not cut corners

00:53

[Music]

00:56

a pharmaceutical company or sponsor must

00:59

submit a pre-application

01:01

the tga will look at this against

01:03

clinical data and the need for the

01:05

vaccine

01:09

if the application meets the tga's

01:12

requirements

01:13

the sponsor can then apply to register

01:15

the vaccine for use in australia

01:17

at this point they must include a

01:19

significant amount of clinical and

01:21

non-clinical information

01:23

to support the request

01:26

next the experts at the tga look at the

01:29

available data

01:30

they can ask for more information to

01:32

fill any gaps

01:34

and they can also ask for independent

01:38

advice

01:40

once the vaccine is fully evaluated the

01:42

tga will decide whether to provide

01:44

what they can for an initial

01:46

registration

01:49

the vaccine can now be registered and be

01:52

supplied in australia

01:56

all registered vaccines are closely

01:58

monitored by the tga

01:59

who will respond to any safety issues

02:02

covert 19 vaccines

02:04

will be no different the cga will also

02:07

be checking all

02:08

the covert 19 batches before they are

02:10

released for rollout

02:12

the first approved vaccines will go to

02:14

priority groups

02:15

until we all get vaccinated it's

02:17

important that we continue to be covert

02:20

safe

02:20

by practicing good hygiene physical

02:22

distancing and getting tested

02:24

to learn more visit tga.gov.edu

English (auto-generated)

How COVID-19 vaccines are being tested

Before a vaccine is registered for use, it is tested extensively during development and then in thousands of people. Testing first begins with laboratory research, then animal studies and finally human clinical trials. Clinical trials involve testing the vaccine in volunteers, and are conducted in phases.

Clinical trials must provide scientific evidence which demonstrates that the benefits of a vaccine greatly outweigh any risks.

Phase 1

Phase 1 clinical trials usually include a few dozen healthy adult volunteers. They focus primarily on establishing that the vaccine is safe, and also on demonstrating that the vaccine induces an immune response.
 

Phase 2

Phase 2 clinical trials have hundreds of volunteers, and can include specific groups for whom the new vaccine is intended. For example older adults, children or people with pre-existing medical conditions. These trials aim to test whether the vaccine causes an immune response and confirm that it is safe with minor side effects, such as a mild headache.
 

Phase 3

Phase 3 clinical trials include many thousands of participants. They aim to test whether a vaccine is effective in preventing people from getting the disease – in this case COVID-19. Phase 3 trials also thoroughly assess the vaccine for safety and side effects.

In a Phase 3 trial, researchers usually compare data between vaccinated people and those who received a placebo (like a salt water injection). They compare the frequency of infection, disease severity and any reported side effects between the two groups.

For COVID-19 vaccines, some of these phases have been combined. For example, in Phase 1 and 2 trials, results are analysed after the first few dozen volunteers are studied. The trial then proceeds in hundreds more. Some Phase 3 studies have started once preliminary data from phase 1and 2 trials are available. Having these ‘overlapping’ time frames has helped develop COVID-19 vaccines quickly, to make them available earlier to save lives.

How a vaccine is approved for use in Australia

Before a COVID-19 vaccine is approved for use in Australia, it must pass the Therapeutic Goods Administration’s (TGA) rigorous assessment and approval processes. This includes assessment of its safety, quality and effectiveness.

The TGA is actively monitoring COVID-19 vaccine development both in Australia and around the world, and is also part of a network of international regulators that meet regularly to discuss the development of COVID-19 vaccines.

The TGA is engaging early with vaccine developers, undertaking a thorough and efficient review of vaccine candidates and discussing the application process. Early engagement will not affect the comprehensive review process that clinical trial results are subject to in Australia.  

Last updated: 
13 February 2021

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