Dear Ministry of Health,
I am writing to request information under the Official Information Act 1982 (OIA).

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.

Yours faithfully,
Alisha Riley