medsafe conditional approval of Pfizer vaccine interim reports

Tracy Livingston 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). You can complain to the Ombudsman.

From: Tracy Livingston

Dear Ministry of Health,
There were 58 conditions on the conditional approval of the Pfizer vaccine for NZ. These included requests for interim reports as follows:

5. Any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process should be evaluated. Due date: July 2021. Interim report: March 2021.
.
DNA, lipid and elemental impurities. Due dates: July 2021; July 2021, Interim: March 2021; July 2021.
.
28. The in-house controls applied to the raw materials and solvents used should also be detailed, as should the control of any potentially genotoxic contaminants. Due date: July 2021, Interim: February 2021.

Since it is now mid-April I presume Medsafe has those reports. Since New Zealanders lives and health is at stake, I would like copies of those three interim reports, and any others that Medsafe requested, at your earliest convenience.

Yours faithfully,

Tracy Livingston

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Ministry of Health


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Kia ora

Thank you for your request for official information received on 15 April
2021 for:

There were 58 conditions on the conditional approval of the Pfizer vaccine
for NZ. These included requests for interim reports as follows:

5. Any homology between translated proteins (other than the intended spike
protein) and human proteins that may, due to molecular mimicry,
potentially cause an autoimmune process should be evaluated. Due date:
July 2021. Interim report: March 2021.
.
DNA, lipid and elemental impurities. Due dates: July 2021; July 2021,
Interim: March 2021; July 2021.
.
28. The in-house controls applied to the raw materials and solvents used
should also be detailed, as should the control of any potentially
genotoxic contaminants. Due date: July 2021, Interim: February 2021.

Since it is now mid-April I presume Medsafe has those reports. Since New
Zealanders lives and health is at stake, I would like copies of those
three interim reports, and any others that Medsafe requested, at your
earliest convenience.

The Ministry's reference number for your request is: H202104571.

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 14 May 2021, being 20
working days after the day your request was received.  

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: [email address]

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From: OIA Requests


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Kia ora

 

Please find attached a letter regarding your request for official
information.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [email address]

 

 

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From: Tracy Livingston

Dear Chris James
Where are those medsafe conditional approval of Pfizer vaccine interim reports as promised - I can't find them easily.

Yours sincerely,
tracy

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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

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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From: OIA Requests

Kia ora Tracy,
Thank you for your follow up email.
Medsafe have not received 'interim reports', these dates were for Pfizer
to advise Medsafe of their progress. As you were advised, all reports
received from Pfizer to address the conditions are withheld in full under
the following sections of the Official Information Act 1982 (the Act): 

* Section 9(2)(b)(ii) as its release would likely unreasonably prejudice
the commercial position of the person who supplied the information.   

* Section 9(2)(ba)(ii) to protect information that is subject to an
obligation of confidence and making it available would likely damage
the public interest. 

Please refer to the following link for an
update: [1]https://www.health.govt.nz/news-media/ne...
and: [2]https://www.medsafe.govt.nz/COVID-19/sta...
Under section 28(3) of the Act, you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [3][email address] or by phone on 0800
802 602. 

Ngā mihi  

  

Jan Torres

Acting Manager, OIA Services  

Office of the Director-General 

[4]Ministry of Health information releases   

[5]Unite against COVID-19 

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From: Tracy Livingston <[FOI #15191 email]>
Sent: Sunday, 14 November 2021 17:47
To: OIA Requests <[email address]>
Subject: Re: Response to your request for official information
(H202104571)
 
Dear Chris James
Where are those  medsafe conditional approval of Pfizer vaccine interim
reports as promised - I can't find them easily.

Yours sincerely,
tracy

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Virginia Crawford left an annotation ()

This is a standard response from Medsafe when they don't want to reveal critical information, which might attract criticism. I suggest you refer this to the Ombudsman.

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Things to do with this request

Anyone:
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