Dear Therapeutic Goods Administration,

The TGA makes this statement in the Provisional Approval of the Pfizer COVID-19 'vaccine':

"COMIRNATY has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease."

A similar statement is made with respect to the Provisional Approval of the AstraZeneca COVID-19 'vaccine".

The SARS-CoV-2 virus causes the disease known as COVID-19 in some people who have been infected by the SARS-CoV-2 virus. while some infected people are asymptomatic.

People who have been fully vaccinated can still be infected with the SARS-CoV-2 virus and transmit this virus to others while showing no symptoms of COVID-19 themselves according to the statement above subject to further research.

The document or documents I seek are any subsequent documents published by the TGA since 25 January 2021 that contradict the statement made in the Provisional Approval documents as quoted above.

Yours faithfully,
Zaia Daryoush

FOI, Therapeutic Goods Administration

1 Attachment

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT AND REQUEST FOR
AN EXTENSION OF TIME

I am writing to notify you that the Department of Health (department)
received your request on 24 August 2021 for access to documents under the
Freedom of Information Act 1982 (Cth) (FOI Act) being:

Documents relating to the virus

The statutory timeframe for processing your request is 30 calendar days
within which a decision on access to the requested documents is to be
notified. The department may impose a charge for the work involved in
providing access to the documents.  If this request attracts a charge you
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Service level and mobile telephone numbers of all staff will be excluded
from the scope of your request under s22(1)(a)(ii) of the FOI Act.

Request for extension of time 

As a result of the ongoing coronavirus pandemic, the department is dealing
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process your request in accordance with the requirements of the FOI Act,
including locating and providing access to all relevant documents, the
department would be grateful if you would agree to an extension of 30
calendar days for processing your request.  If you agree, the department
will endeavour to provide a decision to you by 23 October 2021.

Please contact the department by 1 September 2021 with your decision to
the 30 day extension of processing time.

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have any questions.

Kind regards

Team Leader - Freedom of Information
Legal Advice & Legislation Branch

Legal and Assurance Division | Corporate Operations Group

Australian Government Department of Health

GPO Box 9848, Canberra ACT 2601, Australia

 

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Dear FOI,
thank you for informing me of the delay, no problem I will wait till 23 October 202.
you can email me on [email address]

Yours sincerely,

Zaia D

TGA FOI, Therapeutic Goods Administration

Dear Ms Daryoush

Thank you for your email below dated 24 August 2021 in which you make the following request under the Freedom of Information Act 1982 (FOI Act):

“The TGA makes this statement in the Provisional Approval of the Pfizer COVID-19 'vaccine':

"COMIRNATY has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease."

A similar statement is made with respect to the Provisional Approval of the AstraZeneca COVID-19 'vaccine".

The SARS-CoV-2 virus causes the disease known as COVID-19 in some people who have been infected by the SARS-CoV-2 virus. while some infected people are asymptomatic.

People who have been fully vaccinated can still be infected with the SARS-CoV-2 virus and transmit this virus to others while showing no symptoms of COVID-19 themselves according to the statement above subject to further research.

The document or documents I seek are any subsequent documents published by the TGA since 25 January 2021 that contradict the statement made in the Provisional Approval documents as quoted above.”

At the outset, I note that the purpose of the FOI Act is to provide access to documents held by the TGA which are not otherwise publicly available. As your request relates to documents “published by the TGA”, the TGA is therefore not required under the FOI Act to search for documents in this instance to assist you. However, to assist you further, I would like to provide you with some publicly available information which is relevant to your request.

I note that, to date, the primary focus of COVID-19 research and development globally has been to develop vaccines that are highly effective at reducing the priority health outcomes of severe disease, hospitalisation, and death. This research forms the basis of regulatory decisions to date. Evidence also continues to emerge on the effectiveness of vaccines in reducing asymptomatic disease, transmission, and against emerging variants. In particular, a growing body of evidence indicates that people fully vaccinated with a COVID-19 vaccine (including the Pfizer and AstraZeneca vaccines) are less likely than unvaccinated persons to acquire SARS-CoV-2 or to transmit it to others. However, this research remains ongoing.

The TGA aims to provide the public with the most updated information on the safety and effectiveness of the COVID-19 vaccines as they are administered across Australia. One way the TGA does this is through the publication of weekly safety reports. The most recent report (dated 2 September 2021) can be found at: https://www.tga.gov.au/periodic/covid-19.... Relevantly, the TGA states, with respect to the effectiveness of the COVID-19 vaccines in preventing infection with the SARS Cov 2 virus, that “Data from the NSW outbreak demonstrates that vaccination protects people from infection and in the small number of vaccinated people who become infected it significantly reduces the severity of disease.” This data can be found at: https://www.health.nsw.gov.au/Infectious....

We also refer you to the most recent update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 1 September 2021. This can be found at: https://www.health.gov.au/news/atagi-upd.... In this update, ATAGI stresses that “vaccination is a key public health intervention to prevent infection, transmission and severe disease due to SARS-CoV-2. ATAGI continues to recommend COVID-19 vaccination for all adults and specific high-risk adolescents.”

The TGA also works in conjunction with the National Centre for Immunisation Research and Surveillance (NCIRS). The NCIRS publishes regularly about the safety and effectiveness of the COVID-19 vaccines. Relevantly, the NCIRS states that: “The COVID-19 vaccines available in Australia are very effective. Clinical trials and real world evidence have found that the vaccines are 70–95% effective in preventing people from getting sick with COVID-19. This means that people who are fully vaccinated are 70–95% less likely to get sick with COVID-19 compared with those who are not vaccinated, if they are exposed to the virus. However, a small proportion of fully vaccinated people may still get the disease. This does not mean the vaccines are not working. There are no vaccines, for any disease, that are 100% effective.” For additional information, please see: https://www.ncirs.org.au/covid-19/covid-...

I trust that this information assists you. I encourage you to check the above resources regularly for the most up-to-date Government information. As the information you have requested is publicly available, I consider your request dated 24 August 2021 to be withdrawn.

Regards

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

From: Zaia D <[FOI #7729 email]>
Sent: Tuesday, 24 August 2021 10:56 PM
To: FOI <[email address]>
Subject: Freedom of Information request - Sars-Cov-2

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,

The TGA makes this statement in the Provisional Approval of the Pfizer COVID-19 'vaccine':

"COMIRNATY has been shown to prevent COVID-19 however it is not yet known whether it prevents transmission or asymptomatic disease."

A similar statement is made with respect to the Provisional Approval of the AstraZeneca COVID-19 'vaccine".

The SARS-CoV-2 virus causes the disease known as COVID-19 in some people who have been infected by the SARS-CoV-2 virus. while some infected people are asymptomatic.

People who have been fully vaccinated can still be infected with the SARS-CoV-2 virus and transmit this virus to others while showing no symptoms of COVID-19 themselves according to the statement above subject to further research.

The document or documents I seek are any subsequent documents published by the TGA since 25 January 2021 that contradict the statement made in the Provisional Approval documents as quoted above.

Yours faithfully,
Zaia Daryoush

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