Printed from https://fyi.org.nz/request/16486-regarding-the-moh-management-of-the-covid-19-comirnaty-study-groups on December 22, 2024 23:24

Regarding the MOH management of the "Covid 19 Comirnaty" study groups

Anna McAfee made this Official Information request to Ministry of Health

The request was partially successful.

From: Anna McAfee

Dear Ministry of Health,

Regarding the Pfizer Covid- 19 Comirnaty trial.

Please provide information and documentation regarding the process/s you are using to ensure the validity of the clinical trial;

1/ How are trial participants being followed up with, and how often?

2/ How many New Zealanders are the MOH planning on having in the control group, to ensure a valid study?

2/ How often are trial participants being contacted, to ensure that any ADR's are reported to CARM?

3/ What makers are in place as far as adverse reactions, or deaths, that would see the study paused or stopped?

4/ What statements are being made in the informed consent process, that ensure that all participants are fully aware that;
a) This intervention is in a clinical trial/ experimental phase.
b) This treatment has known and documented risks, known fatalities associated with administration and unknown risks in the long term.
c) This treatment does not prevent participants from contracting the virus, or transmitting it to others within their community.

Yours faithfully,

Anna McAfee

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From: Medsafe

Dear Anna
Thank you for your email.   
Companies which wish to run a clinical trial on a medicine which has been
approved in New Zealand do not have to obtain Medsafe approval or inform
Medsafe before they start their trial.  As Comirnaty is approved in New
Zealand I am unaware of any trials which are being conducted using
Comirnaty.  
The WHO has a Vaccine Tracker with link to trials are been or have been
run -
[1]https://www.who.int/publications/m/item/...
You can also search on the NZ/Australia clinical trial registry
[2]https://www.anzctr.org.au/- and the US registry
- [3]https://clinicaltrials.gov/
I hope this is of help
Kind regads
Becci

[4]ANZCTR
COVID-19 studies are our top priority. For all other studies, we recommend
commencing the registration process concurrently with your ethics
submission and allowing at least 8 weeks for registration to be completed
from date of first submission as we are experiencing 4 week turn-around
time in review of submissions and resubmissions.
www.anzctr.org.au

[5][IMG] [6]Home - ClinicalTrials.gov
ClinicalTrials.gov is a resource provided by the U.S. National
Library of Medicine. IMPORTANT: Listing a study does not mean it
has been evaluated by the U.S. Federal Government.Read our
disclaimer for details.. Before participating in a study, talk to
your health care provider and learn about the risks and potential
benefits.
clinicaltrials.gov

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References

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1. https://www.who.int/publications/m/item/...
2. https://www.anzctr.org.au/
3. https://clinicaltrials.gov/
4. https://www.anzctr.org.au/
5. https://clinicaltrials.gov/
6. https://clinicaltrials.gov/
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