Kia ora Catherine,
  
Thank you for your request for official information. The reference number
for your request is: H2024036528
  
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 
[4]Ministry of Health information releases 
 
 
 

------------------- Original Message -------------------
From: Catherine Jamieson <[FOI #25838 email]>;
Received: Thu Feb 22 2024 13:38:19 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Treatment of reports where death
is the only reported reaction

Dear Ministry of Health,

There are questions that remain either unanswered or unsatisfactorily
answered from request H2023032533.  Some questions have been reworded
slightly which is why I have put in  a new request.

1. What mechanism is used to remove reports where death is the only
reported reaction and reported terms of death from line listings, both in
the Safety reports and at the links supplied in H2023032268 and
H2023032271 for the Comirnaty Original/monovalent and bivalent vaccines
respectively.  (The supplied links in the OIA response numbers do not
appear to still work - please supply links to where these can be accessed
now.)

For each of these line listings please advise if it was a manual or
automated process to remove/not include the reports where death is the
only reported reaction? If automated please provide the date(s) at which
it became automated for each of the locations.  If it is manual what
department of what agency does this?

2. Is the practise categorising death as an outcome and not a reaction and
therefore reports being considered invalid where death is the only
reported reaction applied with vaccines and medicines other than the Covid
vaccines?

3. Have I received an answer specific to the circumstance where death is
the only reported reaction in any subsequent report? 

What is the treatment when an update is made to an existing report(s)
where death is the only reported reaction in the update? Are the initial
and any subsequent reports then removed from the line listing? 

If whether a subsequent report, indicating only that the subject has died
(no other reactions,) results in all lines in the line listing relating to
the patient being deleted is dependant on different circumstances of a
case please indicate what these dependant variables could be ie timeframe
between reports etc.

4.  There are AEFI- A numbers that were included in Safety Report 46 that
are not included in the line listing posted 28/8/23 under 'Reports and
Publications on the Medsafe website.  The Ministry of Health has declined
my request to be supplied with a suite of all reasons for this on the
grounds that there is no statutory obligation to 'create new information,
compile information they do not hold or provide or prove an opinion'.   
Has there been any form of analysis or audit done on why these reports
ceased to be published in the line listing, in order to establish accuracy
of the file? If so please provide anything referencing the results of that
audit or analysis.   Are some of them reports where death is the only
reported reaction in a subsequent report?

5. This question was asked and the following response given.  Please
provide the results or any material arising from Medsafe's further
investigation. 

Question: 'Furthermore, allowing for the omitted reports there are 355
more AEFI-A numbers in the line listing posted 28/8/23 than in Safety
Report 46 yet there are in the realm of 13,000 less lines in the line
listing posted 28/8/23. In addition there are duplicate rows in the line
listing posted 28/8/23 and there do not seem to be duplicate rows in
report 46. Can you please provide explanation as to what has caused this
unusual presentation? Please include any communications, procedure or
policy documents or reports that reference the reason for this or provide
explanation partial or full.'

Answer: 'Manatū Hauora did not hold any information within scope of this
part of your request. However, there may have been an issue transferring
data between databases. Medsafe will look into this further.'

6. Please provide an org structure document of CARM as it was for 2021-23
and org structure of whatever replacement structure now sits within
Medsafe.

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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