133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
12 February 2025
ASE
By email: [FYI request #26670 email]
Ref: H2025059109
Tēnā koe
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health – Manatū Hauora (the Ministry) on 26 December 2024 for:
“Did the manufacturing processes used to obtain any kind of regulatory approval for any
“COVID-19 vaccines” and covid “vaccine candidates” significantly and material y change
since the applications for approval were first submitted?
As more reports have been indicating that manufacturing methods did significantly change
subsequent to applications for approval being made, what actions has the Ministry of Health
taken to investigate such claims? eg, has the Ministry of Health directly questioned the
suppliers, applicants, and other stakeholders about this?”
As per your previous response ref: H2024041059, regarding any changes to Comirnaty since its
approval, the specific changes to the methods of manufacture of Comirnaty are proprietary to
Pfizer; however, broadly speaking common changes to vaccine manufacture include
improvements in the efficiency of the manufacturing process through the implementation of state-
of-the-art equipment and technologies, upgrades to facilities and processes, replacement of
consumables, extensions or reductions in the time taken for certain steps to be performed,
refinements to product controls based on increased manufacturing experience, and so on.
The Medsafe website describes changed medicine notifications
: https://www.medsafe.govt.nz/.
Various aspects of medicine manufacturing change over time, for all products, including COVID
vaccines. These are evaluated by Medsafe in the same way that new medicine applications are.
Please see the following link for more information on the evaluation process:
medsafe.govt.nz/Consumers/Safety-of-Medicines/Medsafe-Evaluation-Process.asp.
I trust this information fulfils your request. If you wish to discuss any aspect of your request with
us, including this decision, please feel free to contact the OIA Services Team
on:
[email address].
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
Manatū Hauora website at:
www.health.govt.nz/about-ministry/information-releases/responses-
official-information-act-requests. Nāku noa, nā
Chris James
Group Manager
Medsafe
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