Kia ora Simon,

 

Thank you for your request for official information received on 3
September 2021 for:

 

“I would like a copy of any and all minutes taken of meetings held by
Medsafe pertaining to efficacy and clinical safety issues surrounding the
Pfizer clinical trials of BNT162b2 mRNA COVID-19 Vaccine.

 

I am specifically interested in Medsafe's independent analysis and
appraisal of the above mentioned trials.

 

I would also like copies of any and all correspondence between Medsafe and
the COVID Vaccine Technical Advisory Group pertaining to any and all
safety concerns regarding BNT162b2. These concerns include but are not
necessarily restricted to the clinical trial design; the exclusion of
subjects from both the placebo and treated groups in the analysis of
published data (N Engl J Med. 2020; 383: 2603-2615; FDA website); the use
of disease-specific endpoints instead of "all cause mortality and
morbidity"; and what advice was given.”

 

The Ministry's reference number for your request is: H202111774.

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 1 October 2021, being
20 working days after the day your request was received.

 

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.

 

Ngâ mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

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References

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1. mailto:[email address]

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Kia ora Simon,  

Thank you for your request for official information, received on 3
September 2021 requesting: 

“any and all minutes taken of meetings held by Medsafe pertaining to
efficacy and clinical safety issues surrounding the Pfizer clinical trials
of BNT162b2 mRNA COVID-19 Vaccine.

I am specifically interested in Medsafe's independent analysis and
appraisal of the above mentioned trials.
I would also like copies of any and all correspondence between Medsafe and
the COVID Vaccine Technical Advisory Group pertaining to any and all
safety concerns regarding BNT162b2. These concerns include but are not
necessarily restricted to the clinical trial design; the exclusion of
subjects from both the placebo and treated groups in the analysis of
published data (N Engl J Med. 2020; 383: 2603-2615; FDA website); the use
of disease-specific endpoints instead of "all cause mortality and
morbidity"; and what advice was given.” 

The Ministry of Health has decided to extend the period of time available
to respond to your request under section 15A of the Official Information
Act 1982 (the Act) as further consultation is required.

You can now expect a response to your request on, or before, 8 October
2021. 

You have the right, under section 28 of the Act, to ask the Ombudsman to
review my decision to extend the time available to respond to your
request.

Ngâ mihi 

****************************************************************************
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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Kia ora Simon,         

         

        

Please find attached a response regarding your request for
information.        

        

     

Ngā mihi   

   

OIA Services Team   

   

   

[1]Ministry of Health information releases   

[2]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

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1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/

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