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COVID-19 vaccine: Information for consumers and health professionals
Find out answers to the common types of questions you may have about how the TGA assesses and monitors a vaccine for safety, quality and effectiveness.
How is a COVID-19 vaccine approved?
The Therapeutic Goods Administration (TGA) is responsible for assessing all COVID-19 vaccines before they can be used in Australia. There are a number of stages in the regulatory process, including:
Find out more about the COVID-19 vaccine approval process.
How does the TGA evaluate a vaccine?
Before a vaccine is approved for use in Australia it must pass the TGA's rigorous assessment and approval processes. This includes assessment of its safety, quality and effectiveness.
The TGA will formally evaluate the information provided by the vaccine's sponsor (usually a pharmaceutical company) which includes data on clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information.
The evaluation is carried out in multiple stages by technical experts, and involves seeking further information and clarification from the sponsor as required. The TGA's evaluation is also informed by the advice of the Advisory Committee on Vaccines, an independent committee of external experts.
The decision to approve a new vaccine is always made by the TGA on the basis that the benefits outweigh the risks for the intended population.
How does the TGA test for safety, quality and effectiveness?
The TGA considers the safety, quality and effectiveness of every ingredient in a vaccine before we register the vaccine for use in Australia.
We carefully assess the results of clinical trials and the way in which the trials were conducted. We look at how trials were designed, if they were conducted for a sufficient amount of time, and if there were enough participants in the trial that represented the people for whom the vaccine is intended.
We also require vaccine manufacturers to meet manufacturing quality standards. As a further check, our laboratories assess the quality of every batch of a vaccine before it can be supplied in Australia.
We are working closely with international regulators to collaborate and share information as evaluations progress.
What is the provisional approval pathway?
The provisional approval pathway is a process that allows for temporary registration of promising new medicines and vaccines where the need for early access outweighs the risks.
It is anticipated that sponsors of COVID-19 vaccines will apply to the TGA for registration using the provisional approval pathway. This approach is consistent with the mechanisms being used by other international regulators to assess and evaluate COVID-19 vaccine applications.
The provisional pathway is only one of a number of pathways that a sponsor may use to apply for the approval of a vaccine. This page will be updated if a different approval process is used. It's also important to note that an evaluation under the provisional pathway is still a full review, and the TGA does not have a mechanism for emergency use authorisations.
Once the TGA delegate has approved a vaccine for registration, it is included in the Australian Register of Therapeutic Goods (ARTG) as a provisionally registered medicine and available to be administered by health professionals.
The provisional registration is for an initial period of two years, with the option to apply for up to two extensions, up to a maximum of six years.
Sponsors may apply for full registration when there is more clinical data to confirm the safety of the vaccine.
The provisional approval pathway consists of five steps: provisional determination, pre-market registration, the provisional registration period, extension of provisional registration and transition to full registration.
What vaccines have been provisionally registered?
The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY.
Information about TGA's assessment and how the regulatory decision was made is available in the Australian Public Assessment Report (AusPAR). Product Information (pdf,992kb) and Consumer Medicines Information (pdf,206kb) is also available.
The TGA is continuing to evaluate other COVID-19 vaccines with the greatest priority.
Find out more about COVID-19 vaccine: Provisional registrations.
Can COVID-19 vaccines be used in the frail and elderly (over 85)?
Pfizer's vaccine, COMIRNATY, is provisionally approved by the TGA for patients 16 years and older and there is no cap on the upper age range. However, clinical trial data for use in the frail elderly (greater than 85 years of age) is limited.
It should be noted that this age group is extremely susceptible to the impacts of the COVID-19 infection and on a population basis the benefits of vaccination are considered to outweigh the risks. However, like any medical intervention in this group, the benefits of vaccination versus the potential impact of even relatively mild adverse events (for example fever, nausea) in the frail elderly should be carefully considered on a case-by-case basis. The TGA approved Product Information for the Pfizer vaccine includes a statement on this fact.
It is not expected that the potential for mild adverse events following immunisation will be of any significance in the vast majority of individuals vaccinated with the Pfizer BioNTech vaccine.
When will I get access to the COVID-19 vaccine?
The Australian Government is committed to providing all Australians with access to safe and effective COVID-19 vaccines as soon as they are available.
As doses will initially be limited, access to vaccines during the early period of the roll out will be made available to highest priority groups.
Visit the Getting vaccinated for COVID-19 page on health.gov.au for more information.
Can I import COVID-19 vaccines or buy vaccines online?
No. Do not import COVID-19 vaccines or buy vaccines from websites.
The Australian Government is offering safe, effective and free COVID-19 vaccines to all Australians. For current and reputable information about how you can get a COVID-19 vaccine, visit health.gov.au.
Vaccines bought online are likely to be unsafe and ineffective. These vaccines could also be counterfeit (fake). People or websites claiming to sell a COVID-19 vaccine may not deliver any product, and they may instead steal your money or your personal information.
Scammers may create websites, advertise through social media or use SMS messages that look genuine. Always verify the information by checking an independent or trusted source.
The TGA is working closely with the Australian Border Force (ABF) to stop unlawful imports of COVID-19 vaccines. The TGA takes action against suspected illegal activity. Breaking the laws related to therapeutic goods in Australia can result in substantial penalties, fines or imprisonment.
If you suspect someone is breaking the law, report illegal or questionable practices online to the TGA.
How is the TGA working with international regulators?
The TGA is part of a network of international regulators that meet regularly to discuss the development of COVID-19 vaccines. We will utilise our work-sharing arrangements with comparable international regulators to expedite the evaluation of any new vaccines without compromising on our strict standards of safety, quality and effectiveness.
How will COVID-19 vaccine safety be monitored after a vaccine is approved for use?
The TGA continues to monitor the safety of vaccines after they are registered in Australia so that we can detect and respond to any safety concerns. The TGA's safety monitoring processes for vaccines are well established and include:
- reviewing and analysing reports of suspected side effects (also known as adverse events) submitted by health professionals and consumers
- requiring pharmaceutical companies to have risk management plans for the vaccines they supply
- working with international regulators to assess significant adverse events detected overseas
- working with state and territory health departments and clinical experts to ensure a coordinated approach
- reviewing medical literature and other potential sources of new safety information.
Pharmaceutical companies also have legal obligations to monitor, collect, manage and report on safety data, known collectively as their 'pharmacovigilance responsibilities'.
We are further enhancing the TGA vaccine safety monitoring system so that we can rapidly detect, investigate and respond to any emerging safety issues related to COVID-19 vaccines.
Anyone can report suspected side effects (also known as adverse events) directly to us, or via other channels - see 'How do I report a suspected side effect from a COVID-19 vaccine?' Like other medicines regulators around the world, the TGA collects reports of suspected side effects from health professionals and consumers and analyses them to detect signals for possible safety issues for investigation.
Some people who receive COVID-19 vaccines (or their carers) will be sent follow-up SMS messages with a survey to ask if they have experienced any potential side effects. Replying to the survey if you receive it means you are playing a part in contributing to vaccine safety monitoring in Australia. The Australian Government routinely runs this type of 'active surveillance' using SMS messaging through the AusVaxSafety surveillance system to monitor the safety of vaccines in Australia.
Learn more about how you can report suspected side effects associated with a COVID-19 vaccine.
Could I experience a side effect after receiving a COVID-19 vaccine?
Like other medicines, all vaccines can cause side effects. Most side effects are mild and temporary. The TGA carefully assesses all vaccines to ensure that the expected benefits outweigh the potential risks before allowing them to be registered in Australia.
Trials of COVID-19 vaccines have reported side effects such as pain at the injection site, fever or muscle aches. When they occur, these side effects usually last for 1-2 days.
Monitoring these products will be ongoing. We quickly evaluate new information as soon as it becomes available to ensure that the benefits of COVID-19 vaccines continue to outweigh the risks and to take any appropriate actions to safeguard the health and safety of the Australian public.
It is important to understand that when you immunise a very large number of people, it is inevitable that some will experience adverse events that people may suspect are side effects caused by the vaccine. However, even when the suspected side effect is serious, it is possible - even likely - that it may not have been caused by the vaccine. The timing may be coincidental. There is an expected 'background rate' of coincidental adverse events. This is why the TGA investigates the reports it receives to determine if there is a genuine safety concern related to the vaccine.
How do I report a suspected side effect from a COVID-19 vaccine?
Vaccines, like any medication, can have side effects. Side effects are usually minor and temporary. Common ones include low-level fever and pain or redness where the injection was given. More information about each vaccine is provided in the Consumer Medicine Information (CMI) leaflet, which you can find on our website at www.ebs.tga.gov.au.
If you think you may be experiencing a significant side effect (also known as an adverse event) to a COVID-19 vaccine, you should seek advice from a health professional.
The TGA encourages health professionals and consumers to report suspected side effects following immunisation with COVID-19 vaccines. Every report is valuable and contributes to our safety monitoring.
Reporting suspected side effects is easy. You can lodge a report online to the TGA or with the public health unit in your state or territory. Alternatively, you can ask your health professional to report on your behalf, or report to and obtain advice from a pharmacist by calling the NPS MedicineWise Adverse Medicine Events line on 1300 134 237 (9am-5pm Monday-Friday).
Further information about how to report suspected side effects to a COVID-19 vaccine is available on our website.
What will the TGA do if a safety concern for a COVID-19 vaccine is detected?
While the TGA is making every effort to expedite the availability of one or more vaccines to protect against COVID-19, our rigorous safety standards will not be compromised. We are strengthening the monitoring processes for collecting and analysing reports of suspected side effects (also known as adverse events) relating to these products.
If we suspect there is a safety issue with a vaccine, we will immediately conduct a thorough investigation of the issue. If we determine that the safety concern is significant, we will respond appropriately. We may require the vaccine sponsor to add warnings to the Product Information for the vaccine, provide safety information to vaccine providers, make changes to labelling or packaging or in very serious cases suspend use of the vaccine during the investigation. We notify the community of safety concerns through alerts published on our website and via state and territory health department websites.
Further FAQs and information on how COVID-19 vaccines will be regulated for safety and efficacy is available in the ICMRA statement for healthcare professionals.