This is an HTML version of an attachment to the Official Information request 'Risk Management Plan'.




133 Molesworth Street 
PO Box 5013 
Wellington 6140 
New Zealand 
T+64 4 496 2000 
10 May 2021
Virginia Crawford 
By email:  [FYI request #15189 email] 
Ref:   
H202104627  
Dear Virginia Crawford  
Response to your request for official information 
Thank you for your request under the Official Information Act 1982 (the Act) on 19 April 2021 for 
missing information in the Risk Management Plan. Information in response to each part of your 
request is below. 
Request 1: Your Risk Management Plan (RMP) mentioned the following "missing 
information". Use in pregnancy and while breast feeding Use in immunocompromised 
patients use in frail patients with co-morbidities use in patients with autoimmune or 
inflammatory disorders interaction with other vaccines. Could you please provide an 
update on each of the above? Is that information coming solely from Pfizer or are other 
sources included? What information do you have regarding VAED/VAERD? 
Medsafe does not hold this information as it is the responsibility of the vaccine company.  
Medsafe has not received an update to the risk management plan (RMP) since the public 
summary was published on its website or since the European Medicine Act (EMA) published the 
full report.   
Please be advised, all information within the scope of your request for ‘information regarding 
VAED/ VAERD’ is publicly available on the Medsafe website: www.medsafe.govt.nz/COVID-
19/Comirnaty-RMP.pdf or can be found here: www.ema.europa.eu/en/documents/rmp-
summary/comirnaty-epar-risk-management-plan_en.pdf 
Request 2: Please could you explain the rationale for making it mandatory for front line 
staff to be injected with a vaccine that is stil  experimental, when you are STILL insisting 
that they are being regularly tested?  
The Act enables people to request official information from the Director-General and the Ministry 
of Health (the Ministry). However, the Act only applies to information that is already held by the 
Ministry. There is no obligation for the Ministry to create information in order to respond to a 
request. The Ministry is also not obliged to provide an opinion. This part of your request is 
therefore refused under section 18(g)(i) of the Act, as it is not held by the Ministry and there are 
no grounds for believing it is held by another agency subject to the Act. 
Information regarding testing and vaccination of front-line staff is publicly available at: 
• www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-
19-information-specific-audiences/covid-19-resources-border-sector
• www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-
19-vaccines/covid-19-vaccine-strategy-and-planning


 
I trust this information fulfils your request. 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/responses-official-
information-act-requests.  
 
Yours sincerely 
 
Clare Perry 
Deputy Director-General 
Health System Improvement and Innovation  
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