Kia ora John,

  

Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health - Manatû Hauora on 1 April 2026.
You requested:

 

“Can the Ministry of Health respond to both the request for the January
2021 version of Clinical Evaluation report for the Comirnaty (COVID-19
mRNA Vaccine, Application ID 109400) and my request for specific email
correspondence.

I am requesting details of communications from Medsafe and/or the Ministry
of Health to responsible authorities which occurred from September 2019 to
January 2025.

I am also requesting a copies of the Clinical Evaluation report for the
Comirnaty (COVID-19 mRNA Vaccine).
That report's title page has the following details:

"Applicant: Pfizer/BioNTech"
"TT Number TT50-10853"
"Application ID 109400"

These ten questions need to each be considered and answered individually.

1, Can your organisation release the full version of the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) dated January
2021?

2, Can your organisation release pages 59 to 64 of the January 2021
version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA
Vaccine) which contains information on “adverse events”?

3, Can your organisation release pages 64 to 67 of the January 2021
version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA
Vaccine) which contains information on “Serious adverse events and
deaths”?

4, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts related to the Clinical Evaluation report
for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase
“Serious adverse events and deaths” in the email's text or subject line?

5, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts related to the Clinical Evaluation report
for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase
“adverse events” in the email's text or subject line?

6, Can your organisation release any emails or documents sent from
Ministry of Health and/or Medsafe email accounts related to the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which contain
the phrase “public interest” in the email's text or subject line?

7, Can your organisation release any newer versions of the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which were
dated between February 2021 and February 2025?

8, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts which contain a reference to the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) and were sent
to any of the following "responsible authorities" (from the Health
Practitioners Competence Assurance Act 2003)?

"Responsible authorities" from the Health Practitioners Competence
Assurance Act 2003 include:

-Chinese Medicine Council of New Zealand
-Dental Council
-Chiropractic Board
-Dental Council
-Dietitians Board
-Medical Sciences Council of New Zealand
-Medical Radiation Technologists Board
-Medical Council of New Zealand
-Midwifery Council
-Nursing Council of New Zealand
-Occupational Therapy Board
-Optometrists and Dispensing Opticians Board
-Osteopathic Council
-Paramedic Council
-Pharmacy Council
-Physiotherapy Board
-Podiatrists Board
-Psychologists Board
-Psychotherapists Board

9, For each of the "responsible authorities" listed above, can your
organisation provide the number of emails sent from the Ministry of Health
and Medsafe email accounts to that "responsible authority" which contain
both the phrase "adverse event" and the word "Comirnaty" in the email's
text?

10, For each of the "responsible authorities" listed above, can your
organisation provide the number of emails sent from the Ministry of Health
and Medsafe email accounts to that "responsible authority" which contain
both the phrase "adverse event" and the word "mRNA" in the email's text?”
 

The reference number for your request is H2026080991. We will endeavour to
respond to your request as soon as possible and in any event no later than
4 May 2026 being 20 working days after the day your request was received.
If we are unable to respond to your request by then, we will notify you of
an extension of that timeframe.

 

If you have any queries regarding your request, please feel free to
contact the OIA Services Team on [1][email address]. If any
additional factors come to light which are relevant to your request,
please do not hesitate to contact us so that these can be taken into
account. 

 

The Ministry apologises for the delay in responding to your request. Due
to an administrative error, your original request was not logged in our
system and was therefore not actioned at the appropriate time. We
apologise for any inconvenience caused due to this delay. Please be
assured that your request is now being progressed.

 

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: [2][email address] or by calling 0800
802 602.

 

 

Ngâ mihi, 
 
OIA Services Team

Ministry of Health | Manatû Hauora

 

M[3]inistry of Health information releases

 

 

 

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References

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Kia ora,
 
Thank you for your request for official information, received on 1 April
2026 for:
 
1, Can your organisation release the full version of the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) dated January
2021? 
 
2, Can your organisation release pages 59 to 64 of the January 2021
version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA
Vaccine) which contains information on “adverse events”? 
 
3, Can your organisation release pages 64 to 67 of the January 2021
version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA
Vaccine) which contains information on “Serious adverse events and
deaths”? 
 
4, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts related to the Clinical Evaluation report
for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase
“Serious adverse events and deaths” in the email's text or subject line? 
 
5, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts related to the Clinical Evaluation report
for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase
“adverse events” in the email's text or subject line? 
 
6, Can your organisation release any emails or documents sent from
Ministry of Health and/or Medsafe email accounts related to the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine)
which contain the phrase “public interest” in the email's text or subject
line? 
 
7, Can your organisation release any newer versions of the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which were
dated between February 2021 and February 2025? 
 
8, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts which contain a reference to the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) and were sent
to any of the following "responsible authorities" (from the Health
Practitioners Competence Assurance Act 2003)? 
 
"Responsible authorities" from the Health Practitioners Competence
Assurance Act 2003 include: 
 
-Chinese Medicine Council of New Zealand 
-Dental Council 
-Chiropractic Board 
-Dental Council 
-Dietitians Board 
-Medical Sciences Council of New Zealand 
-Medical Radiation Technologists Board 
-Medical Council of New Zealand 
-Midwifery Council 
-Nursing Council of New Zealand 
-Occupational Therapy Board 
-Optometrists and Dispensing Opticians Board 
-Osteopathic Council 
-Paramedic Council 
-Pharmacy Council 
-Physiotherapy Board 
-Podiatrists Board 
-Psychologists Board 
-Psychotherapists Board 
 
9, For each of the "responsible authorities" listed above, can your
organisation provide the number of emails sent from the Ministry of Health
and Medsafe email accounts to that "responsible authority" which contain
both the phrase "adverse event" and the word "Comirnaty" in the email's
text? 
 
10, For each of the "responsible authorities" listed above, can your
organisation provide the number of emails sent from the Ministry of Health
and Medsafe email accounts to that "responsible authority"
which contain both the phrase "adverse event" and the word "mRNA" in the
email's text? 
 
We are contacting you in accordance with section 18B of the Official
Information Act 1982 (the Act) as your request, as it is currently worded,
is for a very large volume of information. Your request may be refused
under section 18(f) of the Act as the information requested cannot be made
available without substantial collation or research.
 
In order to work within a more manageable request, please can you
substantially reduce the scope of your request. This relates to parts 4 to
10 of your request, given you are seeking a potentially vast quantity of
communications with many different keywords and between different parties
over an exceptionally large period of time, from “September 2019 to
January 2025.”
 
Please note that, even with a substantially reduced scope, the Ministry
may still refuse your request under section 18(f) or potentially withhold
relevant information as applicable and appropriate under section 9 of the
Act. Additionally, initial input from the subject matter expert(s) within
Medsafe note there would be no substantive information in scope of parts
4, 5 & 6 of your request.
 
Please respond by Friday 17th April 2026 so that we can consider your
refinement in our response to your request.
 
Please note, under section 15 of the Official Information Act 1982, any
clarification or amendments made to a request within seven working days
after the date it is received, that request may be treated as a new
request and the time limit for the response restarts.
 
We look forward to receiving your response.
Ngâ mihi,
OIA Services Team

Ministry of Health | Manatû Hauora

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Tēnā koe John 

 

Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health – Manatū Hauora (the Ministry) on 1 April
2026. Each part of your request is addressed in turn: 

 

1, Can your organisation release the full version of the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) dated January
2021? 
 
2, Can your organisation release pages 59 to 64 of the January 2021
version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA
Vaccine) which contains information on “adverse events”? 
 
3, Can your organisation release pages 64 to 67 of the January 2021
version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA
Vaccine) which contains information on “Serious adverse events and
deaths”? 
 

This information in scope of these parts is avilabile in a prior response
published on the Ministry’s website at:
[1]www.health.govt.nz/system/files/2021-10/h202106950_-_response.pdf. As
noted in the response letter, any information not suitable for release has
been withheld under the relevant section of the Act. Please refer to the
relevant section of the appendix on pages 2 and 3 for further details. 

 
4, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts related to the Clinical Evaluation report
for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase
“Serious adverse events and deaths” in the email's text or subject line? 
 
5, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts related to the Clinical Evaluation report
for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase
“adverse events” in the email's text or subject line? 
 
6, Can your organisation release any emails or documents sent from
Ministry of Health and/or Medsafe email accounts related to the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine)
which contain the phrase “public interest” in the email's text or subject
line? 
 
8, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts which contain a reference to the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) and were sent
to any of the following "responsible authorities" (from the Health
Practitioners Competence Assurance Act 2003)? 
 
"Responsible authorities" from the Health Practitioners Competence
Assurance Act 2003 include: 
 
-Chinese Medicine Council of New Zealand 
-Dental Council 
-Chiropractic Board 
-Dental Council 
-Dietitians Board 
-Medical Sciences Council of New Zealand 
-Medical Radiation Technologists Board 
-Medical Council of New Zealand 
-Midwifery Council 
-Nursing Council of New Zealand 
-Occupational Therapy Board 
-Optometrists and Dispensing Opticians Board 
-Osteopathic Council 
-Paramedic Council 
-Pharmacy Council 
-Physiotherapy Board 
-Podiatrists Board 
-Psychologists Board 
-Psychotherapists Board 
 
9, For each of the "responsible authorities" listed above, can your
organisation provide the number of emails sent from the Ministry of Health
and Medsafe email accounts to that "responsible authority" which contain
both the phrase "adverse event" and the word "Comirnaty" in the email's
text? 
 
10, For each of the "responsible authorities" listed above, can your
organisation provide the number of emails sent from the Ministry of Health
and Medsafe email accounts to that "responsible authority"
which contain both the phrase "adverse event" and the word "mRNA" in the
email's text? 

 

On the 14 April 2026 the Ministry contacted you in accordance with section
18B of the Act, as these parts of your request, as originally worded, is
for a very large volume of information. The Ministry noted the above
questions may be refused under section 18(f) of the Act as the information
requested cannot be made available without substantial collation
or research. The Ministry noted the following: 

 

In order to work within a more manageable request, please can
you substantially reduce the scope of your request. This relates to parts
4 to 10 of your request, given you are seeking a potentially vast quantity
of communications with many different keywords and between different
parties over an exceptionally large period of time, from “September 2019
to January 2025.” 

  

Please note that, even with a substantially reduced scope, the Ministry
may still refuse your request under section 18(f) or potentially withhold
relevant information as applicable and appropriate under section 9 of the
Act. Additionally, initial input from the subject matter expert(s) within
Medsafe note there would be no substantive information in scope of parts
4, 5 & 6 of your request. 

 

On the 16 April 2026, in relation to 5, 6, 7, 8, 9 and 10, you replied
with the following: 

 

Initially the refinements would be to replace “responsible authorities”
with specifically the “Medical Council of New Zealand”. I have also
refined the email search parameters to specific Boolean operators. Such
searches should be rapid and should not require vast amounts of
time/resources.  If the volume of emails returned is large please provide
the number of document found in each search (this will guide future
refinements if necessary and warranted). 
 
The reworded and refined versions of questions 5-10 are: 
 
5, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts which match the following Boolean search
operators: “Clinical Evaluation” AND “Comirnaty” OR “mRNA”  AND  “adverse
events” (searching email text content, subject lines, and within
attachments if the search function is capable)? 
 
6,  your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts which match the following Boolean search
operators: “Clinical Evaluation” AND “Comirnaty” OR “mRNA”  AND “public
interest” (searching email text content, subject lines, and within
attachments if the search function is capable)? 
 
8, Can your organisation release any emails sent from Ministry of Health
and/or Medsafe email accounts were sent the Medical Council of New Zealand
Which match the following Boolean search operators: “Clinical Evaluation”
AND “Comirnaty” OR “mRNA” (searching email text content, subject lines,
and within attachments if the search function is capable)? 
 
9, Can your organisation provide the number of emails sent from the
Ministry of Health and Medsafe email accounts to the Medical Council of
New Zealand which contain both the phrase "adverse event" AND the word
"Comirnaty" in the email's text? 
 
10, Can your organisation provide the number of emails sent from the
Ministry of Health and Medsafe email accounts to the Medical Council of
New Zealand which contain both the phrase "adverse event" AND the word
"mRNA" in the email's text? 

 

The Ministry is refusing these parts of your request under section 18(f)
of the Act, as the information requested cannot be made available without
substantial collation or research.  

 

To satisfy your request, parameter-based queries would have to be
conducted across the Ministry’s systems. As your keywords relate to many
commonly used terms, or orders of business that remained actively worked
upon throughout the entire period specified, this would yield an
unreasonably high amount of results across all of the email accounts under
the organisation. 

 

All potential results, which for the reasons set out above and given the
wide ranging scope of your questions would likely be in the
thousands, would then need to be individually reviewed to confirm its
relevance to your interests, and then evaluated as to whether the
information can be released (in full) or withheld under the relevant
sections of the Act, as appropriate. This would interfere with the
day-to-day operations of the Ministry, if it were to be undertaken. 

 

Additionally, as noted on the 14 April 2026, subject matter expert(s)
within Medsafe note there would be no substantive information in scope of
parts 4, 5 & 6 of your request. 

 

7, Can your organisation release any newer versions of the Clinical
Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which were
dated between February 2021 and February 2025? 

 

This document has not been updated. As such, your request for a “newer
versions of the Clinical Evaluation report for the Comirnaty” is refused
under section 18(e) of the Act, that the document alleged to contain the
information requested does not exist. 

 

If you wish to discuss any aspect of your request with us, including this
decision, please feel free to contact the OIA Services Team
on: [2][email address].  

 

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: [3][email address] or by calling 0800
802 602. 

 

Ngā mihi,

 

OIA Services Team

Ministry of Health | Manatū Hauora

 

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References

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2. mailto:[email address]
3. mailto:[email address]