Printed from https://fyi.org.nz/request/32740-regulatory-status-and-use-of-kostaive-zapomeran-vaccine-in-new-zealand on November 07, 2025 16:25

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Regulatory Status and Use of “Kostaive” (Zapomeran) Vaccine in New Zealand

John Armstrong made this Official Information request to Ministry of Health

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From: John Armstrong

Dear Ministry of Health,

Under the Official Information Act 1982, I request the following information regarding the COVID-19 vaccine known as Kostaive (active substance: zapomeran), developed by CSL Seqirus / Arcturus Therapeutics.

Q1/ Regulatory status
Has Medsafe received any application for approval, provisional consent, or importation of the product known as Kostaive or zapomeran for distribution or administration within New Zealand?

If so, please provide the date the application was received, its current status, and the sponsor name(s).

If no application has been received, please confirm that fact.

Q2/ Administration and distribution
Has Kostaive (or any formulation containing zapomeran) been imported into, distributed, or administered within New Zealand under any authorisation, including provisional consent, clinical trial, compassionate access, or emergency use provisions?

If yes, please provide:

the date(s) and authorisation type(s);

the quantity imported or distributed; and

any associated adverse event reports (in anonymised or aggregate form if appropriate).

Q3/ Clinical trials
Are there any registered or approved clinical trials involving Kostaive or zapomeran currently active or completed in New Zealand?

If so, please provide the trial reference numbers, sponsor names, and trial status, and any associated documentation.

Q4/ Communication and assessment
Please provide any internal Medsafe or Ministry of Health communications, briefing notes, or assessment summaries referencing “Kostaive,” “zapomeran,” or “CSL Seqirus / Arcturus Therapeutics” since 1 January 2023.

Yours faithfully,

John Armstrong

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Kia ora John

 

Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health on 5 November 2025. You
requested:

 

I request the following information regarding the COVID-19 vaccine known
as Kostaive (active substance: zapomeran), developed by CSL Seqirus /
Arcturus Therapeutics.

Q1/ Regulatory status
Has Medsafe received any application for approval, provisional consent, or
importation of the product known as Kostaive or zapomeran for distribution
or administration within New Zealand?

If so, please provide the date the application was received, its current
status, and the sponsor name(s).

If no application has been received, please confirm that fact.

Q2/ Administration and distribution
Has Kostaive (or any formulation containing zapomeran) been imported into,
distributed, or administered within New Zealand under any authorisation,
including provisional consent, clinical trial, compassionate access, or
emergency use provisions?

If yes, please provide:

the date(s) and authorisation type(s);

the quantity imported or distributed; and

any associated adverse event reports (in anonymised or aggregate form if
appropriate).

Q3/ Clinical trials
Are there any registered or approved clinical trials involving Kostaive or
zapomeran currently active or completed in New Zealand?

If so, please provide the trial reference numbers, sponsor names, and
trial status, and any associated documentation.

Q4/ Communication and assessment
Please provide any internal Medsafe or Ministry of Health communications,
briefing notes, or assessment summaries referencing “Kostaive,”
“zapomeran,” or “CSL Seqirus / Arcturus Therapeutics” since 1 January
2023.

 

The reference number for your request is H2025075039. As required under
the Act, the Ministry will endeavour to respond to your request no later
than 20 working days after the day your request was
received: [1]http://www.ombudsman.parliament.nz/

 

If you have any queries related to this request, please do not hesitate to
get in touch ([2][email address]).

 

 

Ngâ mihi 
 
  

OIA Services Team

Ministry of Health  | Manatû Hauora 

M[3]inistry of Health information releases 

 

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2. mailto:[email address]
3. https://www.health.govt.nz/about-ministr...

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