133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
18 March 2024
Erika Whittome
By email: [FYI request #25124 email]
Ref:
H2024037361
Tēnā koe Erika
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 7 March 2024 as a follow up to information provided to
you on 30 January 2024 under reference H2023033891. You requested:
“I am stil waiting on the complete information requested for these conditions, especially a
items 3,4,5 and very importantly the reports. Eg where are any sub clinical reports on
myocarditis and pericarditis?”
The Ministry would like to add some further context to your earlier response around this topic.
In regards to item 3 you asked for copies of any reports on the duration of efficacy and the
requirement for booster doses within five working days of them being produced. We referred you
to the data sheets for the vaccine as they had been updated to reflect the need for booster
vaccines. The Ministry did not receive any reports fulfilling this obligation. However, the Ministry
did receive a request to change the datasheet, hence this is why we referred you to them.
Medsafe does note that the efficacy of these vaccines changes rapidly in any case due to the
strain changes and how many doses the individual has had and whether they have had COVID-
19 previously.
In regards to item 4 you asked to provide any reports on efficacy including asymptomatic infection
in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and
results from post marketing studies, within five working days of them being produced. Again, the
Ministry did not receive any reports in the sense of a review of information, but any changes were
processed through a changed Medicine notification.
In regards to item 5 you for the final Clinical Study Reports for Study C4591001 and Study
BNT162-01 to be provided within five working days of being produced. The Ministry has nothing
further to add to the answer we provided you in response H2023033891 as this requirement was
removed by Medsafe as it was no longer considered clinically relevant due to changes in disease
landscape and evolving variants.
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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