Pfizer Safety Trials

Jai Ganesh made this Official Information request to Ministry of Health

Response to this request is long overdue. By law Ministry of Health should have responded by now (details and exceptions). The requester can complain to the Ombudsman.

From: Jai Ganesh

Dear Ministry of Health,

What are the particular clinical trials referred to here: https://www.health.govt.nz/our-work/dise...

What are the particular ongoing clinical trials that are being referred to?

What metrics is Medsafe looking at from the overseas rollouts? Do they take into consideration adverse events? If so, how come Takata can recall 30M airbags after 30 deaths but Medsafe cannot?

What is the process Medsafe follows when it comes to vetting medicines?

Does Medsafe conduct independent tests of their own or do they take the manufacturer's word for it?

"Monitoring clinical trial participants
To understand the long-term efficacy and safety of the vaccine, participants in the clinical trials are tracked for at least two years from their second dose of the Pfizer vaccine.

Participants will:

have their health monitored
attend regular follow-up visits.
This is closely observed by Pfizer/BioNTech and an independent group of experts called the Independent Data Monitoring Committee. They decide if a clinical trial can continue"

Who is the Independent Data Monitoring Committee being referred to?

Pfizer unblinded their participants so how are the follow ups and data valid especially in light of this: https://www.bmj.com/content/375/bmj.n2635

Yours faithfully,

Jai Ganesh

Link to this

From: OIA Requests

Kia ora,

 

Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...

 

In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
here: [2]http://www.ombudsman.parliament.nz/

If you have any questions while we're processing your request, please let
us know via [3][email address]

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

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References

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1. https://www.health.govt.nz/our-work/dise...
2. http://scanmail.trustwave.com/?c=15517&a...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

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From: OIA Requests


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Kia ora Jai,

 

Thank you for your request for official information. The Ministry's
reference number for your request is: H202115965.

 

As required under the Official Information Act 1982, the Ministry 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/

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [2][email address]

 

-----Original Message-----
From: Jai Ganesh <[FOI #17519 email]>
Sent: Thursday, 11 November 2021 12:24 am
To: OIA Requests <[email address]>
Subject: Official Information request - Pfizer Safety Trials

 

Dear Ministry of Health,

 

What are the particular clinical trials referred to here:
[3]https://www.health.govt.nz/our-work/dise...

 

What are the particular ongoing clinical trials that are being referred
to?

 

What metrics is Medsafe looking at from the overseas rollouts? Do they
take into consideration adverse events? If so, how come Takata can recall
30M airbags after 30 deaths but Medsafe cannot?

 

What is the process Medsafe follows when it comes to vetting medicines?

 

Does Medsafe conduct independent tests of their own or do they take the
manufacturer's word for it?

 

"Monitoring clinical trial participants

To understand the long-term efficacy and safety of the vaccine,
participants in the clinical trials are tracked for at least two years
from their second dose of the Pfizer vaccine.

 

Participants will:

 

have their health monitored

attend regular follow-up visits.

This is closely observed by Pfizer/BioNTech and an independent group of
experts called the Independent Data Monitoring Committee. They decide if a
clinical trial can continue"

 

Who is the Independent Data Monitoring Committee being referred to?

 

Pfizer unblinded their participants so how are the follow ups and data
valid especially in light of this:
[4]https://scanmail.trustwave.com/?c=15517&...

 

Yours faithfully,

 

Jai Ganesh

 

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References

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2. mailto:[email address]
3. https://www.health.govt.nz/our-work/dise...
4. https://scanmail.trustwave.com/?c=15517&...
5. mailto:[FOI #17519 email]
6. mailto:[Ministry of Health request email]
7. https://scanmail.trustwave.com/?c=15517&...
8. https://scanmail.trustwave.com/?c=15517&...

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From: OIA Requests


Attachment H202115965 Response.pdf
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Kia ora Jai

Please find attached a letter regarding your request for information.

Ngā mihi

OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]

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From: Jai Ganesh

Dear OIA Requests,
Thanks for that, has Medsafe sighted Pfizer's trial data found here: https://phmpt.org/pfizers-documents/ the third link 5.3.6 . If so, how come NZ is bucking the fatality probabilities from the report?

Yours sincerely,

Jai Ganesh

Link to this

From: OIA Requests

Kia ora,

 

Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...

 

Please be advised that due dates for requests received from 29 November
2021 onwards take into account the following periods:

 

Christmas (25 December 2021)

Summer Holidays (25 December to 15 January)

New Year's Day (1 January 2022)

Day after News Year's Day (2 January 2022)

 

If you'd like to calculate the due date for your request, you can use the
Ombudsman's online calculator here: [2]http://www.ombudsman.parliament.nz/

If you have any questions while we're processing your request, please let
us know via [3][email address]

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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References

Visible links
1. https://www.health.govt.nz/our-work/dise...
2. http://scanmail.trustwave.com/?c=15517&a...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

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