133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
12 August 2021
Athina Andonatou
By email: [FYI request #14982 email]
Ref:
H202108633
Tēnā koe Athina
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 18 July 2021 as
a follow up of your previous request (reference H202103354).
Please find a response to each part of your request below.
“The link you provided me only covered Sittings of 7 November 2017 to 2 September
2020, so I was not able to see the Statements of Indemnity informing the public of those
decisions that were provided to the House of Representatives on 11 February 2021.
Please send me the correct link.”
The Ministry has been in contact with the Ministry of Business, Innovation and Employment
(MBIE) regarding this part of your request as it is a fol ow up from MBIE’s part of a previous OIA
transfer. MBIE has provided the following links for each individual indemnity
statement:
Pfizer:
o
www.parliament.nz/resource/enNZ/PAP_108020/594cae3df86bd50cd51884cb29
9ca93a650df927.
Novavax:
o
www.parliament.nz/resource/enNZ/PAP_108022/078f83d8d627e2d967f1521c2d
27d6cae4a42832.
AstraZeneca:
o
www.parliament.nz/resource/enNZ/PAP_108023/60064690a748132f1b98525abf
d8a0224a7a91ce.
Janssen:
o
www.parliament.nz/resource/enNZ/PAP_108024/26cec0146f2f3a8a72d9380cd0
a3a7ccdcb01db5.
“1) The due diligence process used to assess the performance and delivery of Pfizer’s vaccine”
On 29 July 2021, you clarified that you were seeking information regarding how the
effectiveness of the vaccine is measured and what definition of ‘effective’ is being used. The
measures of efficacy and effectiveness of the vaccine are publicly available. You can find
information at the following links:
•
www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-
19-vaccines/covid-19-vaccine-effectiveness-and-protection#How-effective.
•
www.medsafe.govt.nz/profs/PUArticles/June2021/Spotlight-on-Comirnaty-vaccine.html.
•
https:/ pubmed.ncbi.nlm.nih.gov/33301246/
•
www.nejm.org/covid-vaccine.
“2) What information you used to inform your decision that Pfizer has not been reckless in the
development of its vaccine?”
On 29 July, you clarified that you were seeking evidence used to determine that Pfizer’s COVID-
19 vaccine (Comirnaty) was fit for purpose. Medsafe has interpreted this as a request for
information regarding the efficacy, safety and quality of Comirnaty. The documents to support
the assessment are commercially sensitive. As such, this part of your request is withheld under
section 9(2)(b)(i ) of the Act where its release would likely unreasonably prejudice the
commercial position of the person who supplied the information.
However, the standards for efficacy, safety and quality of vaccines are publicly available from
the clinical trials and trial protocols, which can be found at the links above and also here:
https:/ covid19.trackvaccines.org/vaccines/.
“3) You quote that "This assessment has been reinforced through Medsafe’s extensive review
of the safety and effectiveness of the vaccine, with Medsafe granting provisional approval for its
use on 3 February 2021". However, not all of the conditions of Medsafe's provisional approval
have been addressed so how can you truly say their has been an extensive review of the safety
and effectiveness of the vaccine?”
We note that this is an opinion of Medsafe’s assessment process. Medsafe has thoroughly
reviewed the information provided and granted provisional approval by assessing all the
information that is available. While the Act enables people to request official information from
the Ministry of Health (the Ministry), it only applies to information the Ministry holds. There is
no obligation to create information in order to respond to requests, nor is the Ministry obliged to
provide an opinion. The Act does not support requests in which a requester quotes information
or asserts an opinion and then seeks some form of comment on it, couched as a request for
official information. This part of your request is refused under section 18(g)(i) of the Act on the
grounds that the information requested does not exist.
“4) You quote that “It is not unexpected for pharmaceutical companies to seek indemnities from
governments in circumstances where clinical trials are restricted, or where a purchase
agreement is concluded before full trials are completed". Which of these categories does the
indemnity granted for the Pfizer vaccination fall under?”
The Ministry has been in contact with MBIE regarding this part of your request. MBIE has
advised that it was of the view that both categories applied when considering COVID-19 vaccine
indemnities.
“5) Please provide the criteria ACC uses to diagnose a "treatment injury" and what evidence
one would have to supply to be provided treatment and support for injuries caused by a
vaccination.
6) Finally, please provide me with details of how many people have successfully been awarded
treatment and support for any vaccine related injury.”
On 28 July 2021, parts 5 and 6 of your request were transferred to Accident Compensation
Corporation (ACC). You can expect a response to that part of your request from ACC in due
course.
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Under section 28(3) of the Act you have the right to ask the Ombudsman to review any
decisions made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry of Health website at:
www.health.govt.nz/about-ministry/information-releases.
Nāku noa, nā
Clare Perry
Deputy Director-General
Health System Improvement and Innovation
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