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 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