Kia ora Catherine
  
Thank you for your request for official information. The reference number
for your request is: H2023032271
  
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/  
  
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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
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Ngā mihi
 
OIA Services Team
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases 
U[5]nite against COVID-19
 
 

------------------- Original Message -------------------
From: Catherine Jamieson <[FYI request #24365 email]>;
Received: Mon Oct 09 2023 12:34:28 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Follow up questions to H2023031262

Dear Ministry of Health,

This is a request for information pursuant to the Official Information Act
and are questions arising from OIA response H2023031262.

1. How many reports of deaths have been reported to CARM where Covid 19
vaccines are an associated product?

2. Why have the events reported through SMARS decreased from that reported
earlier in the year?

3. What is the rationale for not including reports at
[6]https://www.medsafe.govt.nz/safety/repor...
where death was the only reported reaction? 
If a cause of death is established are those reports then included in the
line listing?
Was this approach applied to the line listings published with the Covid-19
Safety Reports?
If it was applied to some and not others please identify which had this
approach applied.

4. What is the rationale for removing the term death in the line listing?

5. What is the rationale for not including bivalent product adverse
reactions in this line listing? 
Are these reports held in a different database? 
If so what is that database and where are its contents reported?

6. What is the reason for the format change in the ‘Report ID’ column of
the line listing?  Is this number in the last (approx) 1000 lines of the
line listing the report identification number? 
Has the number provided to a reporter at the point of making an adverse
event changed or is that number still an AEFI number?

7. ‘The MedDRA numeric codes ...were only included in the COVID-19 vaccine
downloads due to a feature of the database being used at the time.’

The MedDRA numeric codes have disappeared from the line listing format. 
The words ‘at the time’ infer this database is not being used any longer. 
The new database is not live yet so what database is being used if the
previous one isn’t being used any longer?

8. Please provide reporting and data governance requirements covering
adverse events that CARM and Medsafe must or does adhere to, including any
domestic or international legislation and convention. 

Please provide copies of current policies and procedure documents covering
the collection, storage and use of adverse event data not limited to
Covid-19.  Please specify if and where the Covid 19 data processes deviate
from normal.

9. Please explain the justification for denying previous requests for
assessment (AEFI-A) numbers of reports where death has been reported, on
grounds that it breaches privacy.  The use of an AEFI-A number anonymises
the report to the extent that it is not even possible for the reporter to
identify with ease and certainty the report they made due to them being
supplied an AEFI number at the time of reporting that bears no
resemblance  to the assessment number.  I request you reconsider your
position and supply AEFI-A numbers, for all reports they have been
allocated to, to date where death has been reported.

Yours faithfully,

Catherine Jamieson

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Kia ora Catherine

 

Please find attached a letter regarding your request for information.  

 

Ngā mihi 

  

OIA Services Team

Manatū Hauora | Ministry of Health

M[1]inistry of Health information releases 
U[2]nite against COVID-19 

 

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References

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