medsafe conditional approval of Pfizer vaccine interim reports

Tracy Livingston made this Official Information request to Ministry of Health

The request was partially successful.

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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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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