133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
26 January 2022
Raff Potter
By email: [FYI request #18127 email]
Ref:
H202200180
Dear Raff
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 10 January 2022
for information relating to the safety data from human trials for people aged 5-11-year-olds 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 clinical data submit ed to Medsafe by Pfizer to support the application for approval of a new
strength and formulation (containing trometamol, also known as tris buffer) of Comirnaty for use
in children aged 5 to 11 years old is withheld under section 9(2)(b)(i ) of the Act, where its release
would unlikely unreasonably prejudice the commercial position of the person who supplied the
information.
Please note that the primary clinical study conducted to support this application used vaccine
batches of the same formula as Comirnaty that is used for people aged 12 years and older (i.e.,
containing PBS buffer). Medsafe considered that the two formulations were suf iciently
comparable to allow use of the clinical study to support the safety and efficacy of the new
formulation in children aged 5 to 11 years old.
The clinical trial information can be found at:
https:/ clinicaltrials.gov/ct2/show/NCT04816643.
An evaluation of the results can be found at:
https://www.nejm.org/doi/full/10.1056/NEJMoa2116298.
Further information can be found in the data sheet:
https:/ medsafe.govt.nz/profs/Datasheet/c/Comirnaty0.2mlOrangeCapinj.pdf.
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
Derek Fitzgerald
(Acting) Group Manager
Medsafe
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