Good morning Jaay,

Thank you for your email below dated 6 November 2021 in which you make the following statement:

““Covid-19 vaccines are frequently cited as safe and effective. Notwithstanding these assurances, persons in Australia and overseas are reported to have died and suffered serious injuries within 48 hours of being injected with covid-19 vaccines.
a. please provide a document describing the accepted definitions of the words 'safe' and 'effective' when applied to a provisionally approved medicine.
b. please provide a document describing how many deaths/serious injuries are required for a provisionally approved medicine to be deemed 'unsafe'.”

At the outset, I note that under the FOI Act, the TGA is not required to create a document or make copies of information which is publicly available. Further, for reasons outlined below, the TGA does not hold documents relevant to all aspects of your query.

However, to assist you further, I would like to provide you with some publicly available information which is relevant to your request.

Publicly available information regarding provisional approval

The TGA does not hold a discrete document ‘describing the accepted definitions of the words 'safe' and 'effective' when applied to a provisionally approved medicine’. The COVID-19 vaccines currently available in Australia have all been provisionally approved by the TGA. The provisional approval pathway balances the benefits of early access with the uncertainties inherent to the fact that additional data are required. This pathway is available for other prescription medicines, not just vaccines. Further details of the provisional approval pathway are available at: www.tga.gov.au/provisional-approval-path...

Before a COVID-19 vaccine can be provisionally approved in Australia, the TGA must establish the acceptable safety, quality and efficacy of the vaccine based on a comprehensive evaluation of a wide range of information. This includes clinical studies, non-clinical and toxicological studies, chemistry, risk management and manufacturing information. The pivotal clinical trials supporting the safety and effectiveness of vaccines in the provisionally approved age groups have been peer-reviewed, published in reputable medical journals and are publicly available.

A large team of clinical and scientific experts at the TGA carefully review this data and seek advice from the Advisory Committee on Vaccines (ACV), an independent clinical expert committee, prior to a senior medical officer making a regulatory decision. Even though this is an expedited process, no element of the evaluation is rushed, and no data are overlooked. A vaccine is only provisionally approved by the TGA if this rigorous process is completed and the benefits are considered to be much greater than any potential risks. As part of the provisional approval, sponsors are also required to continue to submit evidence of longer-term safety and efficacy to the TGA.

The TGA has published a range of regulatory documents relating to the provisional approval of each COVID-19 vaccine, which provides detailed information regarding the evaluation process and the data that were considered. These include the Australian Public Assessment Report (AusPAR), the Product Information (PI) and the Consumer Medicine Information (CMI), and they are available at: www.tga.gov.au/covid-19-vaccines. You may be particularly interested in the AusPAR, which summarises the information and data considered by the TGA in assessing the risks and benefits (include safety and efficacy) of the vaccine.

Publicly available information regarding adverse events

The TGA is committed to the transparent and accurate reporting of adverse events. All reports submitted to the TGA are evaluated, duplicate reports are rejected, and the information contained therein is uploaded to the Database of Adverse Event Notifications – medicines (DAEN). The DAEN contains information on all adverse events reported following administration of a medicine, including the COVID-19 vaccines.

The appropriate action taken by the TGA in response to Adverse Event Reports will depend on an assessment of the circumstances. The TGA regulates medicines, including the COVID-19 vaccines, based on an assessment of risks against benefits. The risk-benefit approach assures consumers that the products they take are safe for their intended use, while still providing access to products that are essential to their health needs. More information can be found at https://www.tga.gov.au/how-tga-regulates.

Reporting of an adverse event and publication of an adverse event in the Database of Adverse Event Notifications (available on the TGA website at https://www.tga.gov.au/database-adverse-...) does not mean the event was related to the relevant medicine. There might be no relationship between the adverse event and the medicine - it may be a coincidence that the adverse event occurred when the medicine was taken, and the symptom may be related to an underlying illness or to other factors. Expert analysis and review of adverse event reports is needed to determine whether there may be a link between reported events and medicines. If you wish to see further information on the TGA’s guide to adverse events reporting, you may wish to consider the following: https://www.tga.gov.au/adverse-event-rep....

The TGA analyses adverse event report data and reviews individual reports to identify possible safety issues for investigation. If these investigations confirm a safety signal, the TGA takes appropriate action. There is not a predefined number of adverse event reports that leads to removal of a product from the market, as the type of action depends on the nature of the safety issue identified, including its likelihood and severity and the potential to mitigate the risk (such as through patient selection or monitoring), and the impact of the safety issue on the balance of benefits and risks for the product. Therefore, the TGA does not hold a discrete document which “describes how many deaths/serious injuries are required for a provisionally approved medicine to be deemed 'unsafe'.”

A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation. The uniform recall procedure for therapeutic goods (UPTRG) is available here: https://www.tga.gov.au/publication/unifo.... This webpage sets out all the steps in the recall procedure and explains which party is responsible for each step.

As set out on the TGA website, recall actions vary on a case-by-case basis depending on the deficiency of the therapeutic good and the risk the deficiency poses to public health and safety. Recall actions are classified according to the potential risk posed to patients/consumers by the defective goods. The classifications are as follows:
• •Class I - Most serious safety-related - recall action occurs when there is a reasonable probability that the use of, or exposure to, the deficient therapeutic good(s) will cause serious, permanent or long term adverse health consequences or death.
• •Class II - Urgent safety-related - recall action occurs when the use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
• •Class III - Lowest risk - recall action occurs when the use of, or exposure to, the deficient therapeutic good(s) is not likely to cause adverse health consequences and they are therefore not safety related.

All recalls actions undertaken since 1 July 2012 are contained and classified in the publicly searchable System for Australian Recall Actions (SARA), available at https://apps.tga.gov.au/PROD/SARA/arn-en.... If you wish to obtain information about a specific recall action, you can search the name of the responsible therapeutic good in the SARA . If you wish to see further information on Australian recalls actions, you may wish to consider viewing this site: https://www.tga.gov.au/about-australian-....

The TGA also publishes a weekly safety report for COVID-19 vaccines. All weekly safety reports remain available on the TGA website at this address: https://www.tga.gov.au/periodic/covid-19....

As the information you have requested is not held by the TGA, and noting you have been provided with publicly available information to assist further, I consider your query dated 6 November 2021 to be withdrawn.

Freedom of Information

Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [email address]
PO Box 100, Woden ACT 2606, Australia
Web: www.tga.gov.au

Important: This transmission is intended only for the use of the addressee and may contain confidential or legally privileged information. If you are not the intended recipient, you are notified that any use or dissemination of this communication is strictly prohibited. If you receive this transmission in error please notify the author immediately and delete all copies of this transmission.

The Department of Health acknowledges the Traditional Custodians of Australia and their continued connection to land, sea and community. We pay our respects to all Elders past and present.

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