133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
Steph Williams
By email: [FYI request #18097 email]
Ref:
H202200100
Dear Steph
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 4 January 2022
for information relating to safety data from human trials for people aged 5-11 years for the
Comirnaty formula. You specifically requested:
“Can you please provide the safety data from human trials (trials in which the humans were
5-11 years of age) for the COMIRNATY formula containing the Tris buffer which is to be
administered to 5-11 year olds in New Zealand.
To be clear, I am NOT requesting safety data from the COMIRNATY formula containing the
PBS buffer.”
The information that you have requested in is publicly available at the following link:
www.nejm.org/doi/full/10.1056/NEJMoa2116298.
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 website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.
Yours sincerely
Chris James
Group Manager Medsafe