TRIM Ref: D21-3367690
Mr Tim Murphy
By Email: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Mr Murphy,
FREEDOM OF INFORMATION REQUEST FOI 3277
Notice of Decision
1. I refer to your request dated 27 October 2021 under the
Freedom of Information Act
1982 (
the FOI Act) for access to the following documents:
“1. Documents pertaining to trials done on the safety of the Covid19 vaccines on
pregnant woman.
2. Documents on the affects of fertility in prenatal woman”
Decision maker
2. I am the TGA officer authorised to make a decision on your request under the FOI
Act.
Request too voluminous to process
3. The TGA has now undertaken a preliminary search and retrieval for the documents
coming within the scope of your request. As a result, TGA officers have indicated that
your request includes documents that are too voluminous to process, and otherwise,
the information you have requested is publicly available.
4. In relation to item 1 of your request, your request includes a number of monthly
safety reports and Periodic Safety Update Reports received by the TGA from vaccine
sponsors. These reports contain, on average, approximately 8,000 pages, with some
reports containing in excess of 13,000 pages.
5. As this item of your request was found to be too voluminous to process, the TGA has
not continued processing the remainder of your request. However, the relevant line
areas have indicated that a significant proportion of the safety reports are likely to
be relevant to your request. The TGA currently holds 48 reports which may be
relevant, containing approximately 8,000 pages on average.
6. Further, a number of additional documents, additional to the safety reports
provided by the sponsor, are likely to be relevant to item 1 of your request. There
are further technical areas within the TGA where searches have not been completed
which are likely to hold additional relevant documents. Therefore, the total number
of relevant documents (and pages contained within such documents) remain too
voluminous to process.
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6232 8644 Fax: 02 6232 8112
Emai
l: xxxx@xxx.xxx.xx
https://www.tga.gov.au
7. As the items of your request mentioned above have been found to be too voluminous
to process, the TGA has not continued processing item 2 of your request.
Requirement to undertake a request consultation process
8. Under paragraph 24(1)(a) of the FOI Act, I, as a decision maker must consult you if
I am satisfied that a “practical refusal reason” exists in relation to your request. A
practical refusal reason exists if the work involved in processing the request would
substantially and unreasonably divert the resources of the TGA from its other
operations. A copy of the sections of the FOI Act that set out the consultation process
(sections 24, 24AA and 24AB) is at
Attachment A.
9. In deciding whether the processing of your request would involve a substantial and
unreasonable diversion of resources such that a practical refusal reason exists, I am
required under section 24AA(2) of the FOI Act to consider the resources that would
have to be used in the following activities:
• identifying, locating and collating the documents;
• deciding whether to grant or refuse access to each document and/or to provide
an edited copy which would include examining each document and consulting
with any person (including those that I would be required to consult under the
FOI Act);
• making a copy or edited copy of each document; and
• notifying any interim or final decision on the request (including to any third
party consulted in the event that a decision is made to give access to the
documents despite the objections of the relevant third party).
10. In coming to a view that a practical refusal reason exists in relation to your request,
I have had regard to the following:
• the estimated volume of documents involved, and the work involved in
processing them. There are likely to be a significant number of further
documents captured by the scope of item 1 of your request, including other
safety reports which contain an average of 8,000 pages each.
• this figure also does not include documents captured by the scope of item 2 of
your request.
• each of these documents are likely to include commercially valuable
information and business information of vaccine sponsors, in relation to which,
consideration would need to be given about whether an exemption should be
claimed and whether consultation with the relevant third party is required, and,
if so, preparation of schedules for the third party detailing all relevant
documents.
• the number of affected third parties. There are likely to be at least four relevant
third parties, including the sponsors for each COVID-19 vaccine provisionally
approved in Australia.
• as you would appreciate, the TGA would need to write to each third party
individually, attach copies of their documents, and consider the responses
provided and any requested redactions. I would then need to make a decision
on these documents, considering these submissions. In addition, if any of the
third parties objected to release of documents and I disagreed with them, then
I would need to provide them with a decision.
• that advice on the data and sensitivity of the information in these documents
would need to be provided by specialised technical staff at the TGA (i.e. senior
medical officers, nurses, pharmacists and scientists), a majority of whom are
presently engaged in ongoing analysis and monitoring of the safety and efficacy
of COVID-19 vaccines.
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• the assumption that a substantial number of those documents may be capable
of being made available (even if in edited form with exempt material redacted),
the time taken to appropriately edit each document and to make copies.
• the fact that any decision letter would need to list each document in an
attachment setting out the outcome of the consideration of whether exemptions
apply.
11. I consider that the number of pages contained within the relevant documents falling
within the scope of your request, the fact that much of the information is
commercially valuable information, combined with the number of third parties, and
the necessary consequential work associated with considering whether the
documents may be lawfully disclosed, would have a substantial effect on the
operations of the TGA.
12. I find that the work involved in processing this request would be an unreasonable
diversion of the TGA’s resources, including TGA officers engaged in safety
monitoring of medicines and vaccines. As to the critical work that these officers
perform, I note that analysis and investigation of medicine and vaccine safety issues,
and associated regulatory actions, are of significant public health impact. As you
would appreciate, if these officers are required to consider large FOI requests, this
diverts their time and attention from undertaking their primary role as evaluators.
13. In addition, the administrative team providing critical support to the TGA’s
evaluators and the other safety monitoring business of the TGA and the FOI team
are also currently dealing with a high volume of COVID-19 related FOI requests.
Processing your request would tie up resources of those teams that would otherwise
be involved in supporting evaluators, the broader operations of the TGA’s medicines
safety monitoring business and processing other FOI requests. In this regard, the
FOI Guidelines state that a relevant matter in deciding whether a practical refusal
reason exists is “the impact that processing a request may have on other work in the
agency or minister’s office,
including FOI processing (my emphasis) (see
paragraph 3.117 of the FOI Guidelines).
14. I also note that there are likely to be significant charges imposed on you for
processing your request (as calculated in accordance with the
Schedule to the
Freedom of Information (Charges) Regulations 2019) based on the number of
documents, the number of pages contained within the documents, and multiple
third parties.
Guidance on accessing the TGA’s publicly available information
15. I note that paragraph 3.117 of the FOI Guidelines indicates another matter I may
take into account in deciding whether a practical refusal reason exists is whether
there is a significant public interest in the documents requested and what
information is published. I consider that there is a public interest in evidence
supporting the safety and efficacy of COVID-19 vaccines that will be used in
Australia.
16. To a very large degree, that interest has already been met by publication of the
regulatory documents for COVID-19 vaccines and other relevant information.
17. The TGA has published a range of regulatory documents relating to the provisional
approval of each COVID-19 vaccine, which provide detailed information regarding
the evaluation process, the data that were considered, and any adverse effects.
These include the Australian Public Assessment Report (
AusPAR), the Product
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Information (
PI) and the Consumer Medicine Information (
CMI), and they are
available at
: www.tga.gov.au/covid-19-vaccines.
18. The PI is the key source of information for health professionals as it provides a
summary of the scientific information relevant to the safe and effective use of a
prescription medicine, including vaccines. The PI is approved by the TGA, and
sponsors must submit an application to the TGA to make any change to the PI. The
PI includes information about the structure and results of clinical trials, as well as
any adverse events observed from post-market surveillance. The TGA works with
COVID-19 vaccine sponsors to ensure the PI remains up to date and can mandate
updates to the safety information included in the PI.
19. The public interest in evidence supporting the safety and efficacy of COVID-19
vaccines is also met through the publication of a weekly safety report which
provides the outcomes of our ongoing monitoring and safety investigations. All
weekly safety reports remain available on the TGA website at:
https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report.
20. Further, I wish to advise you that there is no evidence, credible scientific theory, or
known biologically plausible mechanism that COVID-19 vaccines cause infertility in
humans. There is also no evidence that antibodies formed from COVID-19
vaccination cause any problems with pregnancy, including the development of the
placenta. One disproven theory that COVID-19 vaccines cause infertility is based on
the idea that the spike protein of SARS-CoV-2 and the Syncytin-1 protein (which help
placenta development) are the same. They are not.
21. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists
(RANZCOG) and ATAGI have released a joint statement recommending that:
• Pregnant women are a priority group for COVID-19 vaccination and should
be routinely offered the Pfizer vaccine (Comirnaty) or Spikevax (Moderna)
at any stage of pregnancy.
• Pfizer (Comirnaty) and Spikevax (Moderna) are mRNA vaccines
• Women who are trying to become pregnant do not need to delay
vaccination or avoid becoming pregnant after vaccination.
• There is no evidence of increased risk of miscarriage or teratogenic risk
with mRNA or viral vector vaccines.
• Global evidence has shown that the Pfizer and Moderna vaccines are safe
for pregnant women.
• Pregnant women have a higher risk of severe illness from COVID-19.
• Their babies also have a higher risk of being born prematurely.
• COVID-19 vaccination may provide indirect protection to babies by
transferring antibodies through the placenta (for pregnant women) or
through breastmilk (for breastfeeding women).
The full statement is available at:
https://ranzcog.edu.au/statements-
guidelines/covid-19-statement/covid-19-vaccination-information
22. A number of studies regarding the effect of COVID-19 vaccines on fertility and
pregnancy are also available in the public domain. For example, the following animal
studies for Pfizer and Moderna vaccines have not shown any negative effects on
fertility or pregnancy:
• Bowman CJ, Bouressam M, Campion SN, et al. “Lack of effects on female
fertility and prenatal and postnatal offspring development in rats with
BNT162b2, a mRNA-based COVID-19 vaccine.”
Reproductive Toxicology
2021, available at:
Page 4 of 6
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8163337/.
• United States Food and Drug Administration. Emergency Use
Authorization (EUA) for an Unapproved Product Review Memorandum.
Accessed August 10, 2021.
https://www.fda.gov/media/144673/download
23. In relation to research on COVID-19 vaccines and male fertility, the following study
is also available in the public domain: Gonzalez DC, Nassau DE, Khodamoradi K, et
al., 2021. Sperm Parameters Before and After COVID-19 mRNA Vaccination, JAMA,
https://jamanetwork.com/journals/jama/fullarticle/2781360.
24. The public interest is also met by the publication of several relevant documents on
the TGA FOI disclosure log in response to previous FOI requests. You may
particularly wish to consider FOI-2289 (Document 1). This Pfizer study is a
combined fertility and developmental study of BNT151b1, BNT162b2 and
BNT162b3 by Intramuscular Administration in the Wistar Rat.
25. I also wish to advise you that details of current clinical trials, including trials
conducted on the safety of COVID-19 in pregnant women, are available in the public
domain. You can search for information about clinical trials using COVID-19
vaccines by searching clinical trial registries. These registries include detailed
information about the status of clinical trials. More information is available at:
https://www.australianclinicaltrials.gov.au/clinical-trial-registries. Key clinical
trial registries containing information on major clinical trials of the COVID-19
vaccine are available at:
•
https://www.clinicaltrialsregister.eu/ctr-search/search
•
https://clinicaltrials.gov/ct2/results?cond=COVID-19
26. Further information is also publicly available at
https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/is-it-
true/is-it-true-do-covid-19-vaccines-cause-infertility. More information can also
be found in th
e COVID-19 vaccination decision guide for women who are pregnant,
breastfeeding or planning pregnancy, which is regularly updated as more
information and new vaccines become available.
27. I consider that insofar as any interest is served by the release of the documents in
question, the public interest has already been met through the publication of the
supporting regulatory documents, the COVID-19 weekly safety reports, and publicly
available clinical information.
28. I find that the balance of interests does not favour the expenditure of considerable
resources by the TGA. The above diversion of TGA resources would, in my view, be
substantial, and is likely to cause serious delays to, and potentially compromise, the
TGA’s performance of its regulatory functions under the
Therapeutic Goods Act 1989.
Having regard to the importance of the prompt and proper performance of the TGA’s
regulatory functions, I consider that this diversion of resources would be
unreasonable in the circumstances.
Notification of request consultation process
29. I am notifying you of my intention to refuse to give access to the documents that
come within the scope of your request.
30. Before deciding to refuse access to documents, I am required under
paragraph 24(1)(a) of the FOI Act to undertake a request consultation process in
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accordance with section 24AB of the FOI Act and provide you with the opportunity
to refine the scope of your request.
31. Accordingly, you are now afforded fourteen (14) calendar days from your receipt of
this letter in which to contact the TGA to discuss a revision of the scope of your
request.
32. Before the end of the 14-day consultation period, you must do one of the following:
• withdraw your request;
• make a revised request; or
• indicate that you do not wish to revise your request.
33. If you have not contacted the TGA within 14 days of receiving this letter to do one of
the above or consulted the TGA to discuss revising the scope of this request, your
request is taken to have been withdrawn.
34. If you wish to refine the scope of your request, you may contact the TGA FOI team
on (02) 6289 4630 or at
xxx.xxx@xxx.xxx.xx.
35. Please note that if you indicate that you do not wish to revise your request or revise
your request in such a way that I am still of the view that processing it would
substantially and unreasonably divert TGA resources from other operations, I may
refuse your request under paragraph 24(1)(b) of the FOI Act.
Yours sincerely,
Authorised and electronically signed by
Olivia Cocks
Director
Pharmacovigilance Branch
Therapeutic Goods Administration
24 November 2021
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