Kia ora Alisha,

  

Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health - Manatû Hauora on 28 February
2026. You requested:

 

“My request relates to the regulatory evaluation and subsequent
provisional consent process for the Pfizer mRNA COVID-19 vaccine
(Comirnaty) in New Zealand, specifically focusing on the period leading up
to its referral to the Medicines Assessment Advisory Committee (MAAC).

Please provide the following information and documents generated between 1
November 2020 and 10 February 2021:

Internal Medsafe communications (including emails, memos, and briefing
notes) authored by, sent to, or copying Dr. Chris James regarding the
safety, efficacy, and quality evaluation of the Pfizer mRNA vaccine.

Official Medsafe reports, drafts, or risk-benefit assessments that
detailed "unresolved concerns" or requirements for "additional quality,
safety and efficacy data" prior to the provisional consent being granted.

All correspondence and official documentation between Medsafe and the MAAC
regarding the decision to refer the Pfizer vaccine authorization to the
MAAC.

The final briefing or recommendation document Medsafe provided to the MAAC
or the Director-General of Health regarding the Pfizer mRNA vaccine.

I understand that the Royal Commission of Inquiry into COVID-19 Lessons
Learned has placed a suppression order on the interview transcript of Dr.
Chris James. However, as noted in Phase Two - Minute 6 of the Inquiry,
original documents held by Crown agencies remain fully subject to the OIA.
I am requesting the underlying agency documents, not the Inquiry
testimony.

If any part of this request is refused or withheld, please provide the
specific section of the OIA that applies to each redaction or refusal. If
you need to clarify the scope of this request to process it more
efficiently, please contact me.”

 

The reference number for your request is H2026079420. We will endeavour to
respond to your request as soon as possible and in any event no later than
27 March 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. 

 

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

 

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