Medsafe Methods of Assessing Covid Vaccines

Virginia Crawford made this Official Information request to Ministry of Health

The request was partially successful.

From: Virginia Crawford

Dear Ministry of Health,

Could you please explain exactly what method(s) Medsafe will use to ensure that the vaccines coming into New Zealand are both safe and effective?

Approximately how long will this process take?

Yours faithfully,

Virginia Crawford

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From: OIA Requests

Morena Virginia

Thanks for your email. Information on the process that Medsafe will use to ensure that any vaccines are safe and effective, and the roll out, are outlined on the Ministry of Health website here: https://www.health.govt.nz/our-work/dise...

I trust this meets the needs of your request. 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: [email address] or by calling 0800 802 602.

Ngā mihi

OIA Services
Office of the Director-General | Ministry of Health
 
E: [email address]
 
-----Original Message-----
From: Virginia Crawford <[FOI #14492 email]>
Sent: Wednesday, 20 January 2021 7:19 am
To: OIA Requests <[email address]>
Subject: Official Information request - Medsafe Methods of Assessing Covid Vaccines

Dear Ministry of Health,

Could you please explain exactly what method(s) Medsafe will use to ensure that the vaccines coming into New Zealand are both safe and effective?

Approximately how long will this process take?

Yours faithfully,

Virginia Crawford

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From: Virginia Crawford

Dear OIA Requests,

Thank you for your prompt reply and link to further information.

I see from the Medsafe website that they rely on information from outside sources. No further testing is carried out in New Zealand.

The trials for all of these vaccines are still in progress. For example, the primary Pfizer vaccine trial is estimated to be completed on July 30th 2021 and the full study completion date is estimated to be January 27th 2023.

https://clinicaltrials.gov/ct2/show/NCT0...

If trials are still in progress, how can Medsafe be sure that these vaccines are "safe and effective" by the time they are used in New Zealand?

Already there are reports of very serious side effects (and even deaths) from covid vaccines in various parts of the world.

Yours sincerely,

Virginia Crawford

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Ministry of Health


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Kia ora

Thank you for your request for official information received on 20 January
2021 for:

"Thank you for your prompt reply and link to further information.
I see from the Medsafe website that they rely on information from outside
sources.  No further testing is carried out in New Zealand.
The trials for all of these vaccines are still in progress.  For example,
the primary Pfizer vaccine trial is estimated to be completed on July 30th
2021 and the full study completion date is estimated to be January 27th
2023.
[1]https://scanmail.trustwave.com/?c=15517&...
If trials are still in progress, how can Medsafe be sure that these
vaccines are "safe and effective" by the time they are used in New
Zealand?
Already there are reports of very serious side effects (and even deaths)
from covid vaccines in various parts of the world. "

The Ministry's reference number for your request is: H202100314.

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 18 February 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

Thank you for your request for official information received on 21 January
2021 for:

        "Whilst I understand that treatment costs would be met by ACC in
the event of serious side effects from a covid vaccine, what I really want
to know is if monetary compensation would be available to anyone suffering
damage (or even death).  If the vaccine(s) is deemed "safe and effective"
by government agencies, then it should follow that monetary compensation
be awarded if the vaccine is shown to be unsafe.

To facilitate acceptance and uptake of the vaccine(s) by the general
populace, people  should have the reassurance of compensation if something
goes wrong. Will the government give that reassurance?"

The Ministry's reference number for your request is: H202100306.

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 19 February 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: Yuuki Smithers


Attachment H2020100314 V.Crawford Response.pdf
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Kia ora Virginia,

On behalf of Chris James, Group Manager, Medsafe, please see attached the response to your OIA request.

Ngā mihi

Yuuki Smithers
Senior OIA Advisor | OIA Services | Office of the Director-General | Ministry of Health
E: [email address]

-----Original Message-----
From: Virginia Crawford <[FOI #14492 email]>
Sent: Wednesday, 20 January 2021 10:44 am
To: OIA Requests <[email address]>
Subject: RE: Official Information request - Medsafe Methods of Assessing Covid Vaccines

Dear OIA Requests,

Thank you for your prompt reply and link to further information.

I see from the Medsafe website that they rely on information from outside sources. No further testing is carried out in New Zealand.

The trials for all of these vaccines are still in progress. For example, the primary Pfizer vaccine trial is estimated to be completed on July 30th 2021 and the full study completion date is estimated to be January 27th 2023.

https://scanmail.trustwave.com/?c=15517&...

If trials are still in progress, how can Medsafe be sure that these vaccines are "safe and effective" by the time they are used in New Zealand?

Already there are reports of very serious side effects (and even deaths) from covid vaccines in various parts of the world.

Yours sincerely,

Virginia Crawford

-----Original Message-----

Morena Virginia

Thanks for your email. Information on the process that Medsafe will use to ensure that any vaccines are safe and effective, and the roll out, are outlined on the Ministry of Health website here: https://www.health.govt.nz/our-work/dise...

I trust this meets the needs of your request. 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: [email address] or by calling 0800 802 602.

Ngā mihi

OIA Services
Office of the Director-General | Ministry of Health

E: [email address]

-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #14492 email]

Disclaimer: This message and any reply that you make will be published on the internet. Our privacy and copyright policies:
https://scanmail.trustwave.com/?c=15517&...

If you find this service useful as an Official Information officer, please ask your web manager to link to us from your organisation's OIA or LGOIMA page.

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From: Virginia Crawford

Dear Yuuki Smithers,

These vaccines are all still being trialed and some of these trials will not be completed until 2023.

Does this mean that Medsafe will recommend that these vaccines be used "under emergency", as is happening in most of the world? Surely they cannot be fully licensed in New Zealand while they are still being trialed?

Yours sincerely,

Virginia Crawford

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Ministry of Health


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Kia ora

Thank you for your request for official information received 1 February
2021 for:

"These vaccines are all still being trialed and some of these trials will
not be completed until 2023.

Does this mean that Medsafe will recommend that these vaccines be used
"under emergency", as is happening in most of the world? Surely they
cannot be fully licensed in New Zealand while they are still being
trialed?"

The Ministry's reference number for your request is: H202100619.

As required under the Official Information Act 1982 we will endeavour to
respond to your request no later than 2 March 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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legal privilege.
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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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From: OIA Requests


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Kia ora Virginia,

 

On behalf of Chris James, Group Manager, Medsafe, please see attached the
response to your OIA request.

 

 

Ngā mihi

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

 

 

 

 

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immediately and delete this message.
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From: Virginia Crawford

Dear OIA Requests

Thank you for your detailed reply, which is most informative.

I note that this vaccine has been provisionally approved with 58 conditions.

If any or some of these conditions are not fulfilled to your satisfaction by the scheduled reporting date, what will be the effect?

In particular, the following condition:

"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".

Vaccinations are scheduled to commence on 20th February, which is before the reporting deadline of March 2021. This appears to be in breach of your own provisional approval, is it not?

Yours sincerely,

Virginia Crawford

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From: OIA Requests

Kia ora

Thank you for your request for official information received on 12 February 2021 for:

“I note that this vaccine has been provisionally approved with 58 conditions.

If any or some of these conditions are not fulfilled to your satisfaction by the scheduled reporting date, what will be the effect?

In particular, the following condition:

'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'.

Vaccinations are scheduled to commence on 20th February, which is before the reporting deadline of March 2021. This appears to be in breach of your own provisional approval, is it not?"

The Ministry's reference number for your request is: H202101196.

As required under the Official Information Act 1982, the Ministry will endeavour to respond to your request no later than 12 March 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]

-----Original Message-----
From: Virginia Crawford <[FYI request #14492 email]>
Sent: Friday, 12 February 2021 2:26 pm
To: OIA Requests <[email address]>
Subject: Re: OIA Response H202100619 V.Crawford Response

Dear OIA Requests

Thank you for your detailed reply, which is most informative.

I note that this vaccine has been provisionally approved with 58 conditions.

If any or some of these conditions are not fulfilled to your satisfaction by the scheduled reporting date, what will be the effect?

In particular, the following condition:

"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".

Vaccinations are scheduled to commence on 20th February, which is before the reporting deadline of March 2021. This appears to be in breach of your own provisional approval, is it not?

Yours sincerely,

Virginia Crawford

-----Original Message-----

Kia ora Virginia,

 

On behalf of Chris James, Group Manager, Medsafe, please see attached the response to your OIA request.

 

 

Ngā mihi

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

 

 

 

 

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Please use this email address for all replies to this request:
[FYI request #14492 email]

Disclaimer: This message and any reply that you make will be published on the internet. Our privacy and copyright policies:
https://scanmail.trustwave.com/?c=15517&...

If you find this service useful as an Official Information officer, please ask your web manager to link to us from your organisation's OIA or LGOIMA page.

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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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From: OIA Requests


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Kia ora Virginia,

 

On behalf of Chris James, Group Manager, Medsafe, please see attached the
response to your OIA request.

 

 

Ngā mihi

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

 

 

 

 

 

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If you have received this message in error, please notify the sender
immediately and delete this message.
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From: Virginia Crawford

Dear OIA Requests,

You have not replied to the second of my questions, i.e.

Vaccinations are scheduled to commence on 20th February, which is before the reporting deadline of March 2021. This appears to be in breach of your own provisional approval, is it not?"

Vaccinations have now commenced - have you received satisfactory interim reports as mandated by your provisional approval?

Yours sincerely,

Virginia Crawford

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Virginia Crawford left an annotation ()

Complaint made to Ombudsman 3/4/21

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Virginia Crawford left an annotation ()

The Ombudsman has informed me that the Ministry of Health is now formulating a reply.

Link to this

From: Virginia Crawford

Dear OIA Requests,

According to the Ombudsman on 31st May, "the Ministry has advised that this question was unfortunately overlooked and that it is now urgently preparing a response."

I hope you will now be able to answer this question promptly and not delay things further by the usual 20 working days. This issue was originally raised back in February!

Yours sincerely,

Virginia Crawford

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From: OIA Requests


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Kia ora Virginia

 

Thank you for your email and our apologies for the delay in providing you
with a response to:

 

“Vaccinations have now commenced - have you received satisfactory interim
reports as mandated by your provisional approval?”

 

Information on the progress of the conditions has been made publicly
available on Medsafe’s website:
[1]https://www.medsafe.govt.nz/COVID-19/sta...

 

I trust this information fulfils your request.

 

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: [email address] or by calling 0800 802
602.

 

 

Ngā mihi

 

OIA Services Team

 

[2]Ministry of Health information releases

[3]Unite against COVID-19

 

 

-----Original Message-----
From: Virginia Crawford <[FOI #14492 email]>
Sent: Monday, 7 June 2021 12:32 pm
To: OIA Requests <[email address]>
Subject: Re: OIA Response H2021001196

 

Dear OIA Requests,

 

According to the Ombudsman on 31st May, "the Ministry has advised that
this question was unfortunately overlooked and that it is now urgently
preparing a response."

 

I hope you will now be able to answer this question promptly and not delay
things further by the usual 20 working days.  This issue was originally
raised back in February!

 

Yours sincerely,

 

Virginia Crawford

 

-----Original Message-----

 

Kia ora Virginia,

 

 

 

On behalf of Chris James, Group Manager, Medsafe, please see attached the 
response to your OIA request.

 

 

 

 

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

 

 

 

 

 

 

 

 

 

 

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Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:

[6]https://scanmail.trustwave.com/?c=15517&...

 

If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.

 

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From: Virginia Crawford

Dear OIA Requests,

Thank you, but you have not replied to my specific question:

"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".

This is part of Condition No 5, which is not included in the conditions you say have been satisfied.

The above is particularly important, as evidence around the world suggests there could be a problem here (in regard to miscarriages for instance). Dr Ashley Bloomfield has just recently confirmed that the vaccine is perfectly safe for pregnant women. Evidence suggests that this is not the case and women are not being advised of the potential risk.

Please address this issue urgently.

Yours sincerely,

Virginia Crawford

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