Printed from https://fyi.org.nz/request/32733-kostaive-self-amplifying-mrna-in-new-zealand on January 29, 2026 06:40

Kostaive self-amplifying mRNA in New Zealand

John Armstrong made this Official Information request to Pharmaceutical Management Agency

The request was successful.

From: John Armstrong

Dear Pharmaceutical Management Agency,

I seek information for Kostaive self-amplifying mRNA as listed on pg 10, section 8 - Market Analysis, in a prior response received from Pharmac, reference H2025072586, Procurement Plan for Covid-19 vaccine RFP.
https://fyi.org.nz/request/32255-supply-...

It states: "Pharmac staff are aware of four Covid-19 vaccines that may be available in New Zealand". These were then listed as follows:
1/ Kostaive (Seqirus) self-amplifying mRNA.
2/ Spikevax (Moderna) mRNA
3/ Comirnaty (Pfizer) mRNA
4/ Nuvaxovid (Biocelect /Novavax) attenuated protein subunit

Q1/ Is Kostaive currently in circulation and being administered in NZ?
Q2/ Has Kostaive been administered in the past in NZ, please provide dates?
Q3/ Please supply documentation of clinical trials for Kostaive in NZ?
Q4/ Please supply Medsafe's approval and consent for distribution of Kostaive in NZ.

Yours faithfully,

John Armstrong

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From: Web Enquiry
Pharmaceutical Management Agency

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From: John Armstrong

Dear Pharmaceutical Management Agency,

Thank you for your response received via email on the 11th November 2025. However, the response does not reflect in this FYI thread. In the interests of transparency to any potential public viewers can you please post your response here.

In addition can Pharmac please supply an updated response explaining how you answered "No" when your own documentation states:
"Pharmac staff are aware of four Covid-19 vaccines that may be available in
New Zealand" as witnessed in as listed on pg 10, section 8 -
Market Analysis, in a prior response received from Pharmac, reference
H2025072586.

Yours faithfully,

John Armstrong

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From: Ministerial
Pharmaceutical Management Agency

Kia ora John

Thank you for your request for official information, which Pharmac received on 25 November 2025. The reference number for your request is: 2025-26-108

You should receive a response from us on or before 23 December 2025. This is within the 20 working day limit set out in the Official Information Act.

Please contact us if you have any questions.

Ngā mihi,

Government Services | Pharmac

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From: Ministerial
Pharmaceutical Management Agency

Ministerial would like to recall the message, "F-2571 Re: Official Information request - Kostaive self-amplifying mRNA in New Zealand".
This e-mail message and any accompanying attachments may contain confidential information. If you are not the intended recipient, please do not read, use, disseminate, 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: Ministerial
Pharmaceutical Management Agency

Kia ora John

Thank you for your request for official information, which Pharmac received on 25 November 2025. The reference number for your request is: 2025-26-108

You should receive a response from us on or before 23 December 2025. This is within the 20 working day limit set out in the Official Information Act.

Please contact us if you have any questions.

Ngā mihi,

Government Services | Pharmac

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From: Ministerial
Pharmaceutical Management Agency

Attachment OIA response letter 2025 26 108.pdf
203K Download View as HTML

Kia ora John

Please find attached a response to your request for official information.

Ngā mihi,
Government Services | Pharmac

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SPENCER JONES left an annotation ()

Public Annotation – Context and Related FYI Threads (Kostaive / sa-mRNA)

This request sought clarification of PHARMAC’s earlier answer regarding Kostaive (zapomeran), a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine.

PHARMAC’s clarification explains that references to Kostaive in its documentation were prospective (“may be available”) and that the earlier “No” response referred to current availability at the time. 

For readers seeking broader context, the following FYI requests help distinguish funding/market scanning (PHARMAC) from regulatory approval / trials / importation (Medsafe/Ministry of Health), and provide a wider governance backdrop.

Related FYI requests for context
1. FYI #32740 — Regulatory Status and Use of “Kostaive” (zapomeran) in New Zealand (Ministry of Health / Medsafe)
This companion thread asks directly about applications, importation, administration, trials, and internal references. The Ministry’s response confirms that no clinical trials for Kostaive have been conducted and states the medicine is not approved in New Zealand (with refusal for certain aspects under s18(g)(i)). 
2. FYI #32255 — Supply agreement / procurement plan context (PHARMAC / MoH thread)
This is the upstream context for the “Market Analysis” wording (“may be available in New Zealand”) that triggered the Kostaive follow-up. It is useful for tracking how horizon-scanning language appears in procurement/planning documentation and how agencies treat it as distinct from current supply or use. 
3. FYI #32475 — Legal advice & Cabinet papers on Medicines Act provisional consent and Medicines Amendment Act 2021 (Ministry of Health)
This provides broader Medicines Act governance context (legal interpretation, privilege withholding, and what is/was documented about provisional consent and amendment rationale). It helps readers place “availability” and regulatory decision-making within the larger statutory environment. 
4. FYI #32155 — Purchase of Pfizer Comirnaty JN.1 / XBB.1.5 (Ministry of Health)
Included as context on how procurement, funding, and product lifecycle questions are handled in the COVID-19 vaccine setting, and how the State documents vaccine decisions over time. 
5. FYI #30900 — Obligation to transfer OIA to correct holder (Ministry of Health)
Relevant for process: when PHARMAC does not hold regulatory material, transfer issues can arise. This thread is useful background on how cross-agency custodianship is treated in practice. 

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Practical takeaway for researchers

Taken together, these threads show a consistent distinction in official records between:
• Horizon scanning / market analysis (“may be available”) and
• Regulatory approval / trials / importation / administration (“approved”, “conducted”, “held”, “not held”).

That distinction matters for interpreting language in procurement and planning documents versus what has actually been authorised or used.

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SPENCER JONES left an annotation ()

FYI #32733 (this request): https://fyi.org.nz/request/32733-kostaiv...

FYI #32740 (MoH/Medsafe status/trials/import): https://fyi.org.nz/request/32740-regulat...

FYI #32255 (procurement/market analysis context): https://fyi.org.nz/request/32255-supply-...

FYI #32475 (Medicines Act legal advice / Cabinet papers): https://fyi.org.nz/request/32475-legal-a...

FYI #32155 (purchase of Pfizer JN.1/XBB.1.5): https://fyi.org.nz/request/32155-purchas...

FYI #30900 (transfer obligation/process): https://fyi.org.nz/request/30900-obligat...

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Things to do with this request

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