Dear Naveen

Thank you for your email below dated 19 November 2021 in which you make the following query:

"Please share the details of TGA's COVID-19 Vaccine Approval Proces.

Also, share the details of Pfizer, Astra Zeneca, and Moderna vaccine approvals.
How approval was granted and on what basis?
Did TGA perform its own trials to assess the efficacy of the COVID vaccine? Share the details of trials."

At the outset, I note that the purpose of the Freedom of Information Act 1982 (FOI Act) is to provide access to documents, not to provide information or answer specific questions. Further, under the FOI Act, the TGA is not required to create a document or make copies of information which is publicly available.

Notwithstanding that the TGA is not required to answer your questions, I would like to provide you with some publicly available information which is relevant to your request.

COVID-19 vaccines in Australia have been registered using the provisional approval pathway, which is a process that allows for temporary registration of promising new vaccines where the need for early access outweighs the risks. This pathway is available for other prescription medicines, not just vaccines. Further information can be found at: https://www.tga.gov.au/covid-19-vaccine-....

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.

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.

Provisional approval is initially limited to a period of two years. The sponsor can apply for two extensions, up to a maximum of six years. Data from ongoing clinical trials will be key to providing robust evidence of the longer-term effectiveness including duration of protection against COVID-19, the potential need for boosters and to support a sponsor’s application to transition their COVID-19 vaccine to full registration status if they choose to do so. Final results from ongoing clinical trials for these vaccines are expected to be available between 2021 – 2024, depending on the trial. For more information on the approval process for the COVID-19 vaccines, we refer you to: https://www.health.gov.au/initiatives-an....

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. In particular, the AusPAR for each vaccine provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. This includes detailed information about the clinical evidence which supports the safety and efficacy of the vaccines.

In addition to the publication of these comprehensive regulatory documents, the TGA has published additional documents relating to the Pfizer and AstraZeneca COVID-19 vaccines under the Freedom of Information Act. These documents offer a useful summary and analysis of the data submitted to the TGA for the purposes of making a regulatory decision regarding the provisional approval of the COVID-19 vaccines.

For documents that have already been released regarding the Pfizer vaccine, please see the TGA’s Disclosure Log at www.tga.gov.au/foi-disclosure-log for documents released in response to FOI 2389 (FOI documents 1 – 7). For documents released regarding the AstraZeneca vaccine please see the Disclosure Log for documents released in response to FOI 2494 (FOI documents 1 – 7). Please note, some commercially confidential information and personal information has been redacted from these documents.

I also wish to advise that clinical trials to support vaccine registration are typically conducted by sponsors (manufacturers) of those vaccines and publicly published in medical journals. Data from the same trials are submitted by the sponsor to the TGA as part of the provisional registration application. The pivotal clinical trials which support 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.
• For example, peer-reviewed clinical trials on the AstraZeneca vaccine can be found in the Lancet medical journal at:
o https://www.thelancet.com/journals/lance...
o https://www.thelancet.com/journals/lance...
o https://ars.els-cdn.com/content/image/1-...
• Peer-reviewed clinical trials on the Pfizer vaccine can be found in the New England Journal of Medicine at:
o https://www.nejm.org/doi/full/10.1056/NE...
o https://www.nejm.org/doi/full/10.1056/NE...
• Peer-reviewed clinical trials on the Moderna vaccine can be found in the New England Journal of Medicine at:
o https://www.nejm.org/doi/full/10.1056/NE...
o https://www.nejm.org/doi/10.1056/NEJMoa2...

The TGA, like other regulatory agencies around the world, continues to monitor the safety of vaccines and medicines after they are approved to contribute to a better understanding of their safety profile. General information about the safety of medicines and how the TGA monitors safety is available here: https://www.tga.gov.au/medicines-safety. The TGA also ensures there is an independent quality assessment of every batch of vaccine supplied in Australia through vaccine batch release assessment.

I trust that this information assists you. As the information you requested is publicly available, I consider your request dated 19 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.

From: Naveen <[FOI #8111 email]>
Sent: Friday, 19 November 2021 12:08 PM
To: FOI <[email address]>
Subject: Freedom of Information request - COVID-19 Vaccine Approval Process and details of Pfizer, Astra Zenca, and Moderna vaccine approval

REMINDER: Think before you click! This email originated from outside our organisation. Only click links or open attachments if you recognise the sender and know the content is safe.
Dear Therapeutic Goods Administration,

Please share the details of TGA's COVID-19 Vaccine Approval Proces.

Also, share the details of Pfizer, Astra Zeneca, and Moderna vaccine approvals.
How approval was granted and on what basis?
Did TGA perform its own trials to assess the efficacy of the COVID vaccine? Share the details of trials.

Yours faithfully,
Naveen

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"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."

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