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