Risk/Benefit to Pregnant Women

J Bruning made this Official Information request to Ministry of Health

The request was successful.

From: J Bruning

Dear Ministry of Health,

The January 2021 Clinical Evaluation stated: Administration of COMIRNATY in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.

Q(1) Please provide the dates and titles of all risk/benefit analyses undertaken which reviewed the data/science of risks and benefits to the pregnant mother and fetus for the primary course of injection of Comirnaty BNT162b2. This includes for those who have immunocompromised conditions and healthy women.

On 3 November 2021 the Memo 'Temporary Medical Exemptions for the COVID-19 Vaccine: COVID-19 Vaccine Technical Advisory Group (CV TAG) recommendations' stated 'Pregnancy is not a valid reason for exemption in the absence of
any of the criteria listed in the above table. Pregnancy is associated with higher
risk from COVID-19 compared to the general population and therefore this group
are a priority for vaccination.'

Q(2) As it is well known that doctors are extremely precautious and often refrain from prescribing drugs without a long safety profile, please can you provide:
(a) The latest reviews/reports/advice justifying and specifically applied as rationale for the above statement that pregnancy is higher risk, as at November 2021.
(b) The scientific literature provided to doctors between October 2021- February 2022 justifying this recommendation.

In February 2022 the CVTAG recommended that 'A booster dose of the COVID-19 vaccine should be given from 3 months after the primary course to all eligible people aged 18 years and over, including immunocompromised individuals and pregnant persons.'

Q(3) Please provide the CV-TAG reviews/reports/advice which considered the risk benefit of booster doses of Comirnaty BNT162b2 to pregnant women, including for those with immunocompromised conditions and healthy women.

Thank you

Yours faithfully,

J Bruning

Link to this

From: OIA Requests

Attachment image.png
89K Download

Kia ora


Thank you for your request for official information. The reference number
for your request is: H2023022968


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 related to this request, please do not hesitate to
get in touch. 


Ngā mihi 


OIA Services Team 

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

show quoted sections


Visible links
1. http://www.ombudsman.parliament.nz/
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/

Link to this

From: OIA Requests

Attachment H2023022968 J Bruning response.pdf
3.5M Download View as HTML

Kia ora J Bruning
Please find attached a letter regarding your request for
information. 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.
Ngā mihi
OIA Services Team

show quoted sections

Link to this

Things to do with this request

Ministry of Health only: