Pfizer/BioNTech reports to satisfy Provisional Consent conditions

Mr T. Baker made this Official Information request to Ministry of Health

The request was successful.

From: Mr T. Baker

Dear Ministry of Health,

Please provide all reports provided to date by Pfizer to satisfy Comirnaty Provisional Consent conditions:
- "52) Provide any reports on the duration of efficacy and the requirement for booster doses within five working days of these being produced."
- "54) Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced."
- "56) Provide Periodic Safety Update Reports according to the same schedule as required by the EMA."
- "57) Provide monthly safety reports, as well as all safety reviews they conduct or become aware of."

Yours faithfully,

Mr T. Baker

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From: OIA Requests


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Kia ora Mr Baker,

 

Thank you for your request for official information received on 4 July
2021 for:

 

"Please provide information related to the following:

- Total number of Covid-19 PCR tests that the New Zealand Government
and/or Ministry of Health has performed and funded to date.

- Total cost that the New Zealand Government and/or Ministry of Health has
incurred on Covid-19 PCR testing to date.

- The cost incurred or funded by the New Zealand Government and/or
Ministry of Health per Covid-19 PCR test over time.

- Information related to Covid-19 PCR test laboratory processing
contracts:

a) Dates contracts were issued for tender;

b) Names of laboratories that tendered;

c) Dates same tenders were finalised and contract signed;

d) Duration of laboratory testing contracts; and

d) Dates contracts were re-tendered, if applicable."

 

A second request for official information was received on 4 July 2021 for:

 

“Please provide all reports provided to date by Pfizer to satisfy
Comirnaty Provisional Consent conditions:

- "52) Provide any reports on the duration of efficacy and the requirement
for booster doses within five working days of these being produced."

- "54) Provide any reports on efficacy including asymptomatic infection in
the vaccinated group, vaccine failure, immunogenicity, efficacy in
population subgroups and results from post-marketing studies, within five
working days of these being produced."

- "56) Provide Periodic Safety Update Reports according to the same
schedule as required by the EMA."

- "57) Provide monthly safety reports, as well as all safety reviews they
conduct or become aware of."

 

 

We have combined these two requests, and the Ministry’s reference number
for your request is: H202108049.

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 2 August 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.

 

Ngâ mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

 

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From: OIA Requests


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Kia ora,

 

Please find attached a response to your official information act request

 

Ngā mihi 

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

 

 

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From: Mr T. Baker

Dear OIA Requests,

Thankyou for your reply.

Relating to PCR tests, please clarify the following:
- Does the government fund the District Health Boards for PCR tests, and if so, how much per test?
- Please clarify which laboratory is contracted to provide PCR test services, and when this contract was 1) Initially tendered, and 2) Executed/signed.
- Does the cost per test reduce to $63/test on 1 October 2021? (Sep 2020 and Oct 2021 are mentioned, I think one of the dates is an error).

Regarding the Provisional Consent documents, Pfizer has released information relating to both Conditions 52 and 54, including here: https://cdn.pfizer.com/pfizercom/2021-07.... For example, Pfizer state: "...vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination."

When does the Ministry anticipate receiving reports in relation to this? I expect the Ministry is fully aware of the work that Pfizer is undertaking in this regard.

Yours sincerely,

Mr T. Baker

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From: OIA Requests


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Kia ora Mr Baker,

 

Thank you for your follow up request for official information received on
21 July 2021 for:

 

"Relating to PCR tests, please clarify the following:

- Does the government fund the District Health Boards for PCR tests, and
if so, how much per test?

- Please clarify which laboratory is contracted to provide PCR test
services, and when this contract was 1) Initially tendered, and 2)
Executed/signed.

- Does the cost per test reduce to $63/test on 1 October 2021? (Sep 2020
and Oct 2021 are mentioned, I think one of the dates is an error).

 

Regarding the Provisional Consent documents, Pfizer has released
information relating to both Conditions 52 and 54, including here:
[1]https://scanmail.trustwave.com/?c=15517&...
For example, Pfizer state: "...vaccine efficacy in preventing both
infection and symptomatic disease has declined six months
post-vaccination."

 

When does the Ministry anticipate receiving reports in relation to this? I
expect the Ministry is fully aware of the work that Pfizer is undertaking
in this regard."

 

The Ministry's reference number for your request is: H202108894.

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 18 August 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: [2][email address]

 

 

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2. mailto:[email address]

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From: Kristie Saywell

Good morning T. Baker,
 
I refer to your Official Information Act request to the Ministry of Health
(REF:H202108049) which has been transferred to individual district health
boards for response.
 
This is an acknowledgement email from Hawke’s Bay DHB that the partial
transfer request has been received and your OIA with our DHB has given the
Ref:OIA2021087.
 
Under the Official Information Act 1982, we have 20 working days from
receipt of referral.  Therefore we anticipate a response back to you on or
before 23 August 2021.
 
If we are unable to respond to your request within the required 20 working
days, we will notify you of an extension of that timeframe. If any
additional factors come to light which are relevant to your request,
please do not hesitate to contact us so that these can be taken into
account.
 
 
Nâku noa, nâ
Kristie Saywell
OIA Coordinator and Communications Advisor
Communications Service
Hawke’s Bay District Health Board
Private Bag 9014, Hastings 4156
T: 06 878-8109 Extn: 6326
 
 
 
 
 

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From: OIA Requests


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Attachment H202108894 Response.pdf
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Kia ora,

 

Please find attached a response to your official information act request

 

Ngā 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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Anyone:
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