Impact of U.S. FDA Memo on COVID-19 Vaccine Safety Monitoring – Internal Risk Assessment or Policy Review (Nov–Dec 2025)
SPENCER JONES made this Official Information request to Ministry of Health
Currently waiting for a response from Ministry of Health, they must respond promptly and normally no later than (details and exceptions).
From: SPENCER JONES
Tēnā koe,
Under the Official Information Act 1982, I request the following information from Medsafe and/or the Ministry of Health:
1. Any internal risk assessments, technical reports, safety reviews, pharmacovigilance summaries, or internal correspondence since 28 November 2025 that discuss, refer to, or were prompted by the U.S. FDA internal memo reportedly linking at least 10 child deaths to COVID-19 vaccines, as cited in media reports published by:
• Stuff NZ (30 Nov 2025),
• NZ Herald (30 Nov 2025), and
• STAT News (29 Nov 2025), including reference to FDA official Vinay Prasad and vaccine safety signal concerns.
2. Any meeting minutes, inter-agency emails, or briefing papers referencing this FDA development and any implications for New Zealand’s COVID-19 vaccine programme, including:
• impacts on the Childhood Immunisation Schedule,
• monitoring of adverse events following immunisation (AEFIs) in children,
• or changes to public health messaging, informed consent procedures, or practitioner alerts.
3. Any formal correspondence with:
• the U.S. FDA,
• the World Health Organization (WHO),
• Medsafe’s clinical advisory group(s),
• the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB),
• or Pfizer/BioNTech,
regarding this memo or its claims.
4. If no such documents exist, please confirm this explicitly under section 18(e) and confirm whether the Ministry or Medsafe has formally evaluated the claims made in the media coverage as of the date of this response.
Please provide this information in searchable, electronic format. I am making this request in the public interest and for transparency purposes.
Kind regards,
Spencer Jones
From: OIA Requests
Kia ora Spencer
Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health on 3 December 2025. You
requested:
1. Any internal risk assessments, technical reports, safety reviews,
pharmacovigilance summaries, or internal correspondence since 28 November
2025 that discuss, refer to, or were prompted by the U.S. FDA internal
memo reportedly linking at least 10 child deaths to COVID-19 vaccines, as
cited in media reports published by:
• Stuff NZ (30 Nov 2025),
• NZ Herald (30 Nov 2025), and
• STAT News (29 Nov 2025), including reference to FDA
official Vinay Prasad and vaccine safety signal concerns.
2. Any meeting minutes, inter-agency emails, or briefing
papers referencing this FDA development and any implications for New
Zealand’s COVID-19 vaccine programme, including:
• impacts on the Childhood Immunisation Schedule,
• monitoring of adverse events following immunisation (AEFIs)
in children,
• or changes to public health messaging, informed consent
procedures, or practitioner alerts.
3. Any formal correspondence with:
• the U.S. FDA,
• the World Health Organization (WHO),
• Medsafe’s clinical advisory group(s),
• the COVID-19 Vaccine Independent Safety Monitoring Board
(CV-ISMB),
• or Pfizer/BioNTech,
regarding this memo or its claims.
4. If no such documents exist, please confirm this explicitly
under section 18(e) and confirm whether the Ministry or Medsafe has
formally evaluated the claims made in the media coverage as of the date of
this response.
Please provide this information in searchable, electronic format. I am
making this request in the public interest and for transparency purposes.
The reference number for your request is H2025076512. 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/
Please be advised that due dates for requests received on 27 November 2025
onwards will take into account the summer holiday period (25 December 2025
to 15 January 2026). Please refer to this guide for an explanation of
the [2]statutory obligations under the Official Information Act 1982.
If you have any queries related to this request, please do not hesitate to
get in touch ([3][email address]).
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
M[4]inistry of Health information releases
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SPENCER JONES left an annotation ()
This request was submitted in response to multiple credible media reports (Stuff NZ, NZ Herald, STAT News) from 29–30 November 2025, referencing an internal U.S. FDA memo linking at least 10 child deaths to COVID-19 mRNA vaccines.
The article quotes FDA sources acknowledging that fatalities occurred in close temporal proximity to vaccination in children, and that current surveillance systems may lack sufficient granularity to definitively rule out vaccine-related causality in rare or catastrophic outcomes.
Given the continued inclusion of mRNA COVID-19 vaccines in New Zealand’s childhood immunisation schedule and the recent extension of Medsafe’s provisional approval for Comirnaty, this OIA seeks to determine whether:
• Medsafe or the Ministry of Health has reviewed this new U.S. information;
• Any internal risk assessments or policy adjustments have occurred as a result;
• Any communications with the FDA, WHO, CV-ISMB, or Pfizer have addressed these concerns;
• There are gaps in pharmacovigilance or adverse event detection that could be mitigated in New Zealand.
This request is made in the public interest, especially in light of previous OIA refusals under sections 18(e) and 9(2)(g)(i), which have shielded safety review details from public scrutiny.
A follow-up request will be filed if this is declined or partially withheld.
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