Medsafe vs Ministry of Health advice for children and pregnant women to receive Comirnaty
Erika Whittome made this Official Information request to Ministry of Health
Response to this request is delayed. By law, Ministry of Health should normally have responded promptly and by (details and exceptions)
From: Erika Whittome
Dear Ministry of Health,
I understand that Medsafe is an agency inside the Ministry of Heath. The medsafe safety data sheet for the pfizer vaccine regarding children says
"Paediatric use
The safety and efficacy of COMIRNATY in children aged less than 12 years of age have not yet been established." (page 4 of https://www.medsafe.govt.nz/Profs/datash...).
The Ministry of Health advice for children ( https://www.health.govt.nz/news-media/ne... dated Jan 2022) says :
"The child (paediatric) Pfizer vaccine is now available for 5–11 year-olds at centres throughout New Zealand, including walk-ins, drive-throughs, hauora providers, community pharmacies, and general practices."
I am requesting the information on how the medsafe safety data sheet info was considered and modified into the MoH's advice on their website with no safety or efficacy statements regarding children.
Kindly supply all the minutes, memos and correspondence for publishing the ministry of health's advice for this product for children.
The same goes for pregnant women. The Medsafe safety datasheet above says:
"4,6 Pregnancy
There is limited experience with use of COMIRNATY in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition or post-natal development (see Section 4.6 Fertility, pregnancy and lactation, Fertility)." (page 5).
The MoH advice (https://www.health.govt.nz/news-media/me...) says:
"The Ministry of Health has also updated its booster advice for pregnant people and those who are severely immunocompromised."
and
“Pregnant people are at high risk for severe outcomes from COVID-19 infection, and those who are unvaccinated are more likely to have complications during pregnancy if they contract COVID-19. The Pfizer booster vaccine can be given at any stage of pregnancy at least four months after the second dose, and we encourage pregnant people to discuss the timing with their midwife, obstetrician, or general practitioner.
from https://www.health.govt.nz/news-media/me... dated July 2021.
AND
"if you’re pregnant, you’re definitely in group 3 and can book your vaccination from today by calling the COVID Vaccination Healthline on 0800 28 29 26."
(from https://www.health.govt.nz/news-media/me... dated July 2021.)
Kindly supply all the minutes, memos and correspondence for publishing the ministry of health's advice for this product for pregnant women after the medsafe safety datasheet declares a distinct lack of human testing, safety or efficacy data.
Yours faithfully,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Thank you for your request for official information. The reference number
for your request is: H2024038488
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/
If you have any queries, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account.
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: [3][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
[4]Ministry of Health information releases
------------------- Original Message
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E Whittome prioritisation request.pdf
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Kia ora Erika
Please find attached a letter from the Ministry of Health regarding your
requests for information.
In addition to the requests noted in the letter, the Ministry asks that
you also consider the OIA you’ve recently submitted on 9 April 2024. A
copy of which is attached for ease of reference.
If you have any queries, please feel free to get in touch. We look forward
to your response.
Ngâ mihi
OIA Services Team
[1]Manatû Hauora information releases
[2][IMG] [3][IMG] [4][IMG] [5][IMG]
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References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://www.facebook.com/minhealthnz/
3. https://twitter.com/minhealthnz
4. https://www.youtube.com/minhealthnz
5. https://www.linkedin.com/company/ministr...
From: Erika Whittome
Dear OIA Requests,
It is unfortunate that there is no existing documentation or publications relating to the information I request in this OIA. However this does not diminish the importance or the actions of the MoH and the information around their actions spending public money. I will copy and paste from the Official Information Act:
The purposes of this Act are, consistently with the principle of the Executive Government’s responsibility to Parliament,—
(a)to increase progressively the availability of official information to the people of New Zealand in order—
(i)to enable their more effective participation in the making and administration of laws and policies; and
(ii)to promote the accountability of Ministers of the Crown and officials,—
and thereby to enhance respect for the law and to promote the good government of New Zealand:
(b) to provide for proper access by each person to official information relating to that person:
(c)to protect official information to the extent consistent with the public interest and the preservation of personal privacy.
Yours sincerely,
Erika Whittome
From: OIA Requests
Kia ora Erika,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health – Manatû Hauora (the Ministry) on 26 March
2024 for:
“1. I am requesting the information on how the medsafe safety data sheet
info was considered and modified into the MoH's advice on their website
with no safety or efficacy statements regarding children.
Kindly supply all the minutes, memos and correspondence for publishing the
ministry of health's advice for this product for children. ministry of
health's advice for this product for children.
2.The same goes for pregnant women.
Kindly supply all the minutes, memos and correspondence for publishing the
ministry of health's advice for this product for pregnant women after the
medsafe safety datasheet declares a distinct lack of human testing, safety
or efficacy data.”
The Ministry publishes information on its website to enhance transparency
and accessibility of information. These undergo a thorough review process
by the relevant subject matter experts within the Ministry and Medsafe to
ensure the material is accurate and relevant.
Information contained in medicine data sheets may sometimes be complex. It
is therefore useful for this information to be distilled into clear and
concise messaging that can be easily understood by the general public and
effectively communicated through other channels (for example [1]Ministry
news items as referenced in your request). Refining information from data
sheets may result in the exclusion of certain technical details to ensure
clarity and relevance to the target audience. It is also important to note
that advice may evolve over time, leading to updates or revisions in
subsequent communications. Some of this advice may have been provided by
external agencies such as Health New Zealand – Te Whatu Ora.
Your request for “minutes, memos and correspondence for publishing the
ministry of health's advice” is refused under section 18(e) of the Act, as
no information has been identified. When there is a topic that is of high
interest to the public the Ministry’s relevant team/ workstream will
decide to publish additional information to supplement complex information
pieces on our website.
Ngâ mihi
OIA Services Team
Manatû Hauora | Ministry of Health
M[2]inistry of Health information releases
U[3]nite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/news-media/ne...
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence
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