133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
24 November 2021
Tess McCawe
By email: [FYI request #17452 email]
Ref:
H202115491
Dear Tess
Response to your request for official information
Thank you for your follow up request under the Official Information Act 1982 (the Act) to the
Ministry of Health (the Ministry) on 4 November 2021 for:
“all documentation relevant to the process and criteria used to determine that AE9128 is
not of special interest.”
Adverse events of special interest (AESIs) are pre-specified medically significant events that
have the potential to be causally associated with the vaccine and must be carefully monitored.
AESI can be serious or non-serious and can include:
•
Events of interest due to their association with COVID-19 infection.
•
Events of interest for vaccines in general (e.g., to the specific vaccine type or
adjuvants).
The list of AESIs for the Comirnaty vaccine takes into consideration the lists of AESIs from expert
groups such as the Brighton Collaboration, manufacturers and other regulatory authorities. The
AESI list changes based on the evolving safety profile of vaccines. It is important to note that
although these adverse events may occur after being vaccinated with a COVID-19 vaccine in
New Zealand, they are rare and may not necessarily be related to the vaccine. Medsafe and
CARM review the reports to determine whether the vaccine may have played a role in the
occurrence of these events. More information on AESIs is available in the safety reports
published at:
www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp.
As stated in the response to your previous request, the final report number for adverse event
AE009128 is AEFI-A-033854. This report included the following AEFIs:
• Abdominal pain (10000081)
• Chest discomfort (10008469)
• Dizziness (10013573)
• Dry throat (10013789)
• Headache (10019211)
• Hypoaesthesia (10020937)
• Palpitations (10033557)
• Paraesthesia (10033775)
• Tremor (10044565)
As none of these events are included in the list of AESIs, they were not classified as AESIs. This
does not mean that the events were not experienced as significant, rather that they are consistent
with common side effects to vaccination with any vaccine.
I trust this information fulfils 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.
Please note that this response, with your personal details removed, may be published on the
Ministry website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests. Yours sincerely
Chris James
Group Manager
Medsafe
Page 2 of 2
