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. 
 
 

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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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