ALC-0159 correspondence

Maxwell 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: Maxwell

Dear Ministry of Health,

I am writing as a New Zealand citizen.

The Gazette notice for Comirnaty / COVID-19 mRNA vaccine (https://www.medsafe.govt.nz/COVID-19/Com...) states a number of conditions which are still "under review" according to the Medsafe overview page as of today Tue 12 Oct 2021 (https://www.medsafe.govt.nz/COVID-19/sta...).

Can you please supply all related correspondence with regards to conditions 40-42, 45-49, 51 in the above Gazette notice, specifically with respect to ALC-0159, the synthetic lipid nanoparticle.

This correspondence should include original and updated information regarding control of raw materials, pharmacokinetic and toxicity studies, intermediate, impurities and starting material reports, discussion papers, evaluations, specifications, method validation reports, stability data, emails, etc. held or received by Medsafe and/or related agencies.

I look forward to your response.

Yours faithfully,

Maxwell

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Tēnā koe Maxwell, 

 

 

Thank you for your email. Please be advised on 12 October 2021,  the
Ministry provided a response to your previous, identical, request for
information. The reference for the response is: H202113809. 

 

 

Ngā mihi, 

 

OIA Services Team

[1]www.health.govt.nz

[2]Ministry of Health information releases

[3]Unite against COVID-19

 

 

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From: Maxwell <[FOI #17152 email]>
Sent: Tuesday, 12 October 2021 00:58
To: OIA Requests <[email address]>
Subject: Official Information request - ALC-0159 correspondence

 

Dear Ministry of Health,

I am writing as a New Zealand citizen.

The Gazette notice for Comirnaty / COVID-19 mRNA vaccine
([4]https://www.medsafe.govt.nz/COVID-19/Com...)
states a number of conditions which are still "under review" according to
the Medsafe overview page as of today Tue 12 Oct 2021
([5]https://www.medsafe.govt.nz/COVID-19/sta...).

Can you please supply all related correspondence with regards to
conditions 40-42, 45-49, 51 in the above Gazette notice, specifically with
respect to ALC-0159, the synthetic lipid nanoparticle.

This correspondence should include original and updated information
regarding control of raw materials, pharmacokinetic and toxicity studies,
intermediate, impurities and starting material reports, discussion papers,
evaluations, specifications, method validation reports, stability data,
emails, etc. held or received by Medsafe and/or related agencies.

I look forward to your response.

Yours faithfully,

Maxwell

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References

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1. http://www.health.govt.nz/
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/
4. https://www.medsafe.govt.nz/COVID-19/Com...
5. https://www.medsafe.govt.nz/COVID-19/sta...
6. https://scanmail.trustwave.com/?c=15517&...
7. https://scanmail.trustwave.com/?c=15517&...

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Maxwell left an annotation ()

Dear OIA Services,

Before you use Section 9(2) to refuse the above request, I refer you to the Ombudsmen's advice:

============================

"A mere assertion of prejudice will not be sufficient; nor will vague and unsubstantiated
references to ‘commercial sensitivity’ or ‘confidentiality’."

Agencies must be able to:

1. demonstrate that the third party has a commercial position; and
2. explain how release of the information at issue would be likely unreasonably to prejudice
that position."

============================

While it is clear that the third party may have a commercial position, if you choose to refuse this request, can you kindly elaborate by listing each correspondence item of those requested, explaining how it's release unreasonably prejudices the third party's position.

Yours sincerely,

Maxwell

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