133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
29 October 2021
Erika
By email: [FYI request #17003 email]
Ref:
H202113690
Tēnā koe Erika
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 2 October 2021
for:
“Please share the Medsafe meeting minutes prior to 30th Sep 2021 regarding this
decision to remove statements on transmission
Given the text has been removed from the data sheet, a person or group made this
decision to remove the text, be it in a meeting or email. I can understand if there were no
minuted actions from a meeting. Kindly share the written email with the decision and its
background for the outcome to remove this text from the Cominarty data sheet. Kindly share the decision and minutes to remove this statement about virus transmission
from the page. To avoid misinformation, the data sheet and the questions and answers
should not have confusing or contradictory information.
As you were advised on 4 October 2021, there was no meeting to discuss the removal of this
statement on the Medsafe website.
Further to this, on 5 October 2021 you were advised that this wording has not been removed
from the Comirnaty datasheet, it was never included in this. The datasheet can be found here:
www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf. The statement was originally included in the link you provided on the Medsafe COVID-19
Therapeutic Products – Questions and Answers page. However, this has since been updated to
the following:
www.medsafe.govt.nz/COVID-19/q-and-a.asp. The decision to remove this statement from the website was verbal, therefore your request is
refused under section 18(e) of the Act, that the information requested does not exist.
Medsafe did not receive data on risk of transmission from randomised controlled trials submitted
with the vaccine application. However, since approval, significant evidence has been published
indicating reductions in transmission of COVID-19 from the Pfizer Comirnaty vaccine.
Medsafe considered the public could be confused by the messages. Therefore, Medsafe chose
to remove that sentence from the website as it was not conducive to keeping the public
informed regarding the latest research about vaccines reducing transmission.
A summary of currently available data regarding transmission of COVID-19 can be found on the
US CDC science brief page here:
www.cdc.gov/coronavirus/2019-ncov/science/science-
briefs/fully-vaccinated-people.html. Medsafe publishes up to date information regarding the Comirnaty vaccine, including its clinical
efficacy and safet
y:www.medsafe.govt.nz/profs/PUArticles/June2021/Spotlight-on-Comirnaty-
vaccine.html. Information regarding the approval process of the vaccine can be found here:
www.medsafe.govt.nz/COVID-19/vaccine-approval-process.asp.
More scientific studies and research regarding the vaccine can be found on PubMed
here:
https://pubmed.ncbi.nlm.nih.gov/ and the New England Journal of Medicine here:
https://www.nejm.org/coronavirus. 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. Nāku noa, nā
Catherine Marnane
Acting Group Manger
Medsafe
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