Medsafe Methods of Assessing Covid Vaccines

Virginia Crawford made this Official Information request to Ministry of Health

Response to this request is delayed. By law, Ministry of Health should normally have responded promptly and by (details and exceptions)

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]
 

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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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References

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

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Ministry of Health


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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]

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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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From: OIA Requests


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Attachment H202100619 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

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

 

 

 

 

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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

Link to this

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]

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Link to this

From: OIA Requests


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Attachment H2021001196 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

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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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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