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11 November 2021
Sebastian
By email: [FYI request #16691 email]
Ref:
H202115494
Tēnā koe Sebastian
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health (the Ministry) on 4 November 2021 for:
..”…all COVID-19 Vaccine Technical Advisory Group meeting minutes, dated since the
6 October.”
Two documents have been identified within scope of your request. The documents are itemised
in Appendix 1. The table in Appendix 1 outlines the grounds under which I have decided to
withhold information. Where information is withheld, this is noted in the document itself.
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.
Nāku noa, nā
Professor Ian Town
Chief Science Advisor
COVID-19 Technical Advisory Group
Appendix 1: List of documents
# Date
Title
Decision on release
1
19 October 2021
Minutes: COVID-19 Vaccine Some information withheld under
Technical Advisory Group
section 9(2)(k) of the Act, to prevent
the disclosure or use of official
information for improper gain or
improper advantage.
2
2 November 2021
Page 2 of 2
Document 1
MINUTES: COVID-19 Vaccine Technical Advisory Group
Date:
Tuesday 19 October 2021
Time:
11:00am to 12:00pm
s 9(2)(k)
Location:
Chair:
Ian Town
1982
Members:
David Murdoch, Elizabeth Wilson, Helen Petousis-Harris, James Ussher, Nikki
Moreland, Peter McIntyre, Sean Hanna,
ACT
Ministry of Health Attendees:
Andi Shirtcliffe, Brooke Hollingshead, Chrisel e Braganza, Edwin Reynolds, Erin
Smith, Fiona Cal aghan, Juliet Rumball-Smith, Pippa Scott
Guests:
Chris James, John Tait, Kris Golding, Susan Kenyon, Ralph Stewart
Apologies:
Caroline McElnay, Daniel Bernal, Ian Frazer, Niki Stefanogiannis, Nikki Turner,
Sue Crengle, Tony Walls,
INFORMATION
1.0
Welcome and previous minutes
Ian Town welcomed all Members and Attendees in his capacity as Chair of the COVID-19 Vaccine
Technical Advisory Group (CV TAG).
Minutes of the last meeting (05 October 2021) were accepted.
OFFICIAL
2.0
Vaccine Rollout and Outbreak THE
The Chair provided an update on the vaccine rollout:
•
‘Super Saturday’ on October 16 provided a major boost to the vaccination rollout with
approximately 130,000 doses administered, and many doses were among Māori and younger
adults. Al data broken dow
UNDER n by DHB is publicly available on the Ministry of Health website.
3.0
Supporting Evidence for Healthcare Worker Vaccination Order
•
The evidence brief that CV TAG provided input into to support the mandatory vaccination of
healthcare workers is being finalised. A brief evidence summary was included with the Cabinet
paper, focussing on the effect of vaccination on transmission.
RELEASED
•
The specifics of any exemption policy were discussed. A smal group of people may be medical y
exempt from the Pfizer vaccine, however, having an alternative vaccine available may also be of
interest to other groups eg, healthcare workers.
•
The finalised evidence brief from CV TAG wil be signed out as a memo and shared with CVIP.
4.0
Decision to Use AstraZeneca
•
The AstraZeneca vaccine may be considered for people who are unable to take the Pfizer
vaccine due to contraindications, or due to issues with their first dose, as wel as those hesitant
about getting an mRNA vaccine.
Document 1
•
The vaccine was considered suitable for anyone eligible and indicated as per the Medsafe data
sheet, however it was noted that the data sheet had no age restrictions in its indication, nor
prescribed dosing intervals.
•
AstraZeneca has been used with a range of dosing intervals (e.g., 4-12 weeks), though some
countries have reduced this to four weeks in an outbreak.
•
The risk of thrombosis and thrombosis with thrombocytopaenia was noted as a concern, with
incident rates higher among younger adults. AusVaxSafety provide comparative data by age for
AstraZeneca and Pfizer and would be a useful resource. It was also noted that the vaccine has
not been trial ed or used among pregnant people.
•
Possible distribution channels for the different groups were queried. Distribution wil likely be
limited to certain centres to reduce the risk of error and due to larger volumes of the vaccine
being needed to avoid waste. Those who had had an adverse event after their first dose could be
referred through primarycare. People with a preference for a non-mRNA vaccine could be
directed to certain vaccine centres with supplies or receive a booking code.
1982
•
The STA team wil draft recommendations for CV TAG to consider this week based on the
Medsafe data sheet and data internationally.
ACT
•
The Ministry of Health’s Policy team may seek advice on Janssen, Novavax or AstraZeneca at a
later date.
5.0
Myocarditis Update
•
An update was provided from STA on the risk of myocarditis according to international evidence.
Data presented at the latest US ACIP meeting on 30 August 2021 and data from Israel indicate
that myocarditis reporting rates fol owing mRNA COVID-19 vaccination cont
INFORMATION inue to be rare
overall, but highest risk tends to occur after the second dose, particularly in younger males.
•
Medsafe also shared the latest data on cases. The safety profile differs to the US in that New
Zealand is seeing more cases after dose 1 than dose 2, however this could reflect the vaccine
rollout with more young people being vaccinated later. Onset tends to be reported in the first five
days for both dose. Data on dosing intervals has not
OFFICIAL been analysed, however it has been noted
that cases have stil occurred at an interval of 6-8 weeks. Overall, the rate is approximately 7 per
mil ion doses after dose 1, and 10 per mil ion doses after dose 2. Peopled aged 30-39 are the
THE
most affected age group in New Zealand overall, and after dose 1, and people aged 20-29 are
most affected after dose 2. Long-term fol ow-up data is expected by end of November.
•
ISMB shared that levels of reporting seem to correlate with the numbers of reports being
received, looking at the nu
UNDER mber of hospitalisations in vaccinated individuals. Every case reported
to CARM is reviewed by a medical assessor, and when there is insufficient data, further
information is requested. If there is a risk of death, biopsies and post-mortems of myocardiums
are requested. No long-term outcome data is currently available.
•
Information on symptoms to watch out for have been provided to all vaccinators, however it is
possible that some centres are stil using older booklets from before the advice was given.
RELEASED
•
Milder cases may benefit from further clinical investigation, and greater standardisation in
management of care may be needed with ECGs and provision of troponins. Accessiblity of the
guidance for general practice and primary care wil be reviewed.
•
As previously noted, people who have myocarditis after their first dose should not be offered a
second dose of an mRNA vaccine, and an alternative vaccine or no further doses should be
considered for those people.
•
No further evidence had emerged that decreasing the dose interval had impacted myocarditis.
•
A clinical research project is one option to consider looking at myocarditis in greater detail.
Document 1
6.0
Decision to Use 5–11-Year-Olds
•
Medsafe are expecting an application from Pfizer in mid-November. The US FDA are reviewing
data for 5-11-year-olds at the end of October.
•
Little information has been provided on the paediatric formulation which Pfizer are currently
trialling, however it may be of importance.
•
STA wil convene a subgroup of CV TAG to discuss priority groups and equity considerations for
recommendations and a Decision to Use.
•
Whether the 5–11-year-olds and 12–15-year-olds who are of lower weight may need a lower
dose was discussed. Medsafe are reviewing whether any dose ranging studies were included in
Pfizer’s initial application.
7.0
Next Steps/Decisions Pending
1982
None.
8.0
Any Other Business
ACT
Booster doses
•
Medsafe are expecting an application from Pfizer for booster doses by the end of October.
•
It was noted that there is significant demand for booster doses among healthcare workers,
especial y those in Auckland who perceive a safety issue having been vaccinated early on.
•
The STA team are drafting recommendations on priority groups for CV TAG’s consideration.
•
A medium and longer strategic term lens looking to periods of greatest risk an
INFORMATION d demand in 2022
wil be factored into the recommendations.
•
Details of a third primary doses for immunocompromised people with a suboptimal immune
response have been accepted by CVIP and wil be announced.
9.0
Agenda items for next meeting
OFFICIAL
VAANZ Ka Mātau, Ka Ora study
THE
•
An extended protocol has been submitted to do additional immunology work, and a further
funding request has been submitted, which wil need to come through CV TAG.
10.0 New Action Items Raised During Meeting
UNDER
#
Agenda item
Actions
Action Owner
Supporting Evidence for
Finalise evidence brief and share
Science and
64
Healthcare Worker
with CVIP and CV TAG
Technical Advisory
Vaccination Order
RELEASED
Draft recommendations for a
Science and
65
Decision to Use AstraZeneca Decision to Use memo shared with
Technical Advisory
CV TAG
Discuss clinical guidance for primary Science and
66
Myocarditis
care with CVIP
Technical Advisory
Convene subTAG to consider
Science and
67
Myocarditis
research
Technical Advisory
Document 1
Convene subgroup to compile
Decision to Use 5–11-Year-
Science and
68
evidence and discuss equity
Olds
Technical Advisory
considerations
Review Pfizer’s application for 12-to-
Decision to Use 5–11-Year-
69
15-year-olds for evidence on
Medsafe
Olds
dosages.
Draft recommendations shared with
Science and
70
Booster doses
CV TAG
Technical Advisory
Meeting closed at
12:11pm Next meeting:
Tuesday 02 November – 11:00am to 12:00pm
1982
Open Actions:
ACT
#
Agenda item
Actions
Action Owner
Updates
Compile further evidence on the Science and
49
Pfizer dosing error
link between dosing intervals
Technical
31/08 – Action raised
and reactogenicity.
Advisory
INFORMATION
Science and
Compile evidence on need for
60
Booster doses
Technical
21/09 – Action raised
booster doses
Advisory
Supporting Evidence
Science and
for Healthcare
Finalise evidence brief and
OFFICIAL
64
Technical
19/10 – Action raised
Worker Vaccination
share with CVIP and CV TAG
Advisory
Order
THE
Draft recommendations for a
Science and
Decision to Use
65
Decision to Use memo shared
Technical
19/10 – Action raised
AstraZeneca
with CV TAG
Advisory
UNDER
Convene subgroup to update
Science and
66
Myocarditis
clinical guidance for primary
Technical
19/10 – Action raised
care
Advisory
Convene subgroup to compile
Science and
Decision to Use 5–
67
RELEASED evidence and discuss equity Technical
19/10 – Action raised
11-Year-Olds
considerations
Advisory
Review Pfizer’s application for
Decision to Use 5–
68
12-to-15-year olds for evidence
Medsafe
19/10 – Action raised
11-Year-Olds
on dosages.
Science and
Draft recommendations shared
69
Booster doses
Technical
19/10 – Action raised
with CV TAG
Advisory
Document 1
Science and
Draft recommendations shared
70
Booster doses
Technical
19/10 – Action raised
with CV TAG
Advisory
Closed Actions Since Last Meeting:
#
Agenda item
Actions
Action Owner
Updates
Science and
21/09 – Action raised
59
Vaccines recognised Request data on positivity rates
for arrivals
from MIQ testing requirements
Technical
Advisory
08/10 - Action closed
1982
Vaccines recognised
5/10 – Action raised
63
for MIQ entry and
Share finalised memos with CV
ACT
RSE workers
TAG
Secretariat
08/10 - Action closed
INFORMATION
OFFICIAL
THE
UNDER
RELEASED
Document 2
MINUTES: COVID-19 Vaccine Technical Advisory Group
Date:
Tuesday 02 November 2021
Time:
11:00am to 12:00pm
s 9(2)(k)
Location:
Chair:
Ian Town
1982
Members:
Elizabeth Wilson, Helen Petousis-Harris, Ian Frazer, James Ussher, Nikki
Moreland, Nikki Turner, Peter McIntyre, Sue Crengle, Tony Walls
ACT
Ministry of Health Attendees:
Brooke Hollingshead, Chriselle Braganza, Daniel Bernal, Edwin Reynolds, Erin
Smith, Fiona Cal aghan, Juliet Rumball-Smith, Pippa Scott
Guests:
John Tait, Kris Golding, Thomas Teunissen, Liam McConnell
Apologies:
David Murdoch, Sean Hanna, Andi Shirtcliffe, Caroline McElnay, Niki
Stefanogiannis
INFORMATION
1.0
Welcome and previous minutes
Ian Town welcomed all Members and Attendees in his capacity as Chair of the COVID-19 Vaccine
Technical Advisory Group (CV TAG).
Minutes of the last meeting (19 October 2021) were accepted.
OFFICIAL
2.0
Vaccine Rollout and Outbreak THE
• Vaccine uptake continues to increase. Vaccination rollout data and case details are available on
the Ministry of Health website.
3.0
Decision to Use AstraZeneca
UNDER
• The finalised recommendations have been shared with the Director-General and CVIP, and the
team is now working on acquiring doses of the AstraZeneca vaccine. As recommended by CV
TAG, this vaccine wil be targeted to those who are contraindicated to the Pfizer vaccine, or
hesitant about receiving an mRNA vaccine.
• Details of implementation wil be brought back to CV TAG to outline delivery dates and how it wil
be operation
RELEASED alised.
• Doses of the Janssen vaccine are stil expected in early 2022.
4.0
Medical exemptions Draft recommendations on the clinical criteria for temporary medical exemptions to the vaccine were
discussed.
• The recommendations were drafted based on ATAGI advice, and are intended to be temporary
exemptions lasting for a maximum of six months.
Document 2
• The recommendations limit medical exemptions to a narrow group of people including: people who
have had anaphylaxis to the first dose, inflammatory cardiac il ness, PCR-confirmed infection, a
serious adverse event to prior dose, or for people who are unable to tolerate vaccination (e.g.
people with severe neurodevelopment conditions).
• Once alternative vaccine(s) are available, there wil be changes to the exemptions, and it wil be
important to ensure that alternative vaccines are suitable e.g., the AstraZeneca ‘s TTS risk in
younger age groups should be considered.
• A temporary exemption should be included for people who experience myocarditis after the first
dose.
• A temporary exemption wil be offered for people who are in clinical trials, e.g., the Valneva clinical
trial. Reasons for this include not placing an undue burden on clinical trial participants and being
unable to retrospectively impose conditions on trial participants that they have not agreed to.
• Discussion occurred on who would have the ability to grant medical exemptions, and further
1982
guidance wil be sought from IMAC and the Ministry’s Clinical Quality and Safety team.
• The draft memo wil be revised and finalised.
ACT
5.0
Booster doses
Draft recommendations on the clinical criteria for booster doses were discussed.
• These were based on the JCVI and ATAGI advice and New Zealand’s original prioritisation
framework.
• CV TAG requested that the criteria be simplified, and the prioritisation framework not be used, due
to New Zealand being in a different context with circulating virus, ample vaccine supply and
INFORMATION
infrastructure to deliver booster doses.
• Boosters for everyone over 30 were discussed with access to a booster dose at least 6 months
after their primary course of vaccination, however there is insufficient data on the risk and safety
for younger people at this stage.
OFFICIAL
• Prioritisation for people at high risk of severe disease (e.g., Māori), and high risk of exposure (e.g.,
healthcare workers), followed by their whānau was discussed.
THE
• Age-criteria for prioritisations raise equity concerns particularly for Māori due to the increased risk
of severe disease and hospitalisation, i.e., a lower age band for Māori should be considered to
provide equivalent protection.
• Concern was expressed that this would divert efforts and attention away from primary vaccination
UNDER
efforts, and therefore first and second doses should be prioritised over booster doses, and an
overarching statement wil be added to the recommendations to this effect.
• The memo wil be updated with the feedback from CV TAG and shared with CVIP once Medsafe
approval occurs.
6.0
‘Fully-vaccinated’ d
RELEASED efinition
• Draft recommendations on the criteria for ‘fully-vaccinated’ within the New Zealand border were
shared, with this defined as being 7 days after a complete course of a COVID vaccine.
• This would be used for vaccine certificates and in areas where vaccines are mandated within New
Zealand’s borders, and is not related to work on which vaccines would be recognised at New
Zealand’s border.
• Which vaccines wil be included under these guidelines (e.g., WHO recognised vaccines vs.
vaccines recognised by a Medsafe Recognised Authority) was discussed, and which vaccines
may benefit from an additional dose.
Document 2
• Heterologous schedules were seen as general y acceptable.
• There was discussion about the risks of mandating vaccinations for people at elevated risk of
adverse events e.g., younger people aged 12-17 and the increased risk of myocarditis after the
second dose, and a single dose may be sufficient
• There was also some discussion about whether younger people with a documented infection may
only need one dose.
• A finalised version of the memo will be distributed.
7.0
Immunocompromised populations and ATAGI’s update guidance
• CV TAG issued guidelines on which immunocompromised populations should be considered for a
third primary dose in September. Since then, ATAGI have updated their guidance to include some
broader groupings, and the Ministry received some feedback from rheumatology and haematology
groups.
1982
• The timing for the third primary dose wil also be updated to be from 4 weeks, rather than 8 weeks,
as some flexibility is needed in relation to the timing of treatment.
ACT
• Guidance wil be updated to reflect this feedback.
8.1
Research Studies: VAANZ further funding request A proposal to extended funding for the Ka Mātau, Ka Ora Study was considered by CV TAG.
• The Ka Mātau, Ka Ora Study is assessing immunogenicity of the Pfizer vaccine in New Zealand
recipients >=16 years old and comparing immune responses by age, ethnicity and presence of co-
morbidities.
INFORMATION
• The research was seen to be of great importance to understanding differences in immune
responses for the Ministry of Health, with funding being drawn from the Ministry’s Post-Event
research funding pool.
• The extension of funding was supported.
OFFICIAL
8.2
Research Studies: Myocarditis research
THE
A request to support research myocarditis fol owing COVID-19 vaccination was also considered.
• An ongoing long-term follow-up study was discussed regarding cases with a clinical diagnosis of
myocarditis and/or pericarditis following vaccination, as reported to CARM.
• CV TAG members were r
UNDER equested to volunteer to form a subgroup to develop plans and present a
proposal for additional research questions to the Post-Event team.
8.3
Research extension: Establishing a foundation for monitoring the safety of COVID-19 vaccines
using primary care data A request to endorse an extension of a research project from the University of Auckland (UoA) was
received.
RELEASED
• The extension wil allow the project to establish background rates of adverse events of special
interest (AESI) of COVID-19 vaccines from hospital discharge data and enable a foundation for
monitoring the safety of COVID-19 vaccines using primary care data.
• CV TAG noted that having baseline rates would be valuable to determine the safety profile of
vaccines and endorsed the proposal.
9.0
Medsafe provisional approval of the Pfizer vaccine extended
Document 2
It was noted that Medsafe provisional approval has be
en extended for a further two years, until November
2023.
10.0 Medsafe Safety Report 33
The latest Medsafe Safety Report was shared with CV TAG for noting and wil be published publicly soon,
with it giving a line of sight to reported adverse events.
11.0 Next Steps/Decisions Pending
None.
12.0 Any Other Business
Decision to Use for 5-11-year-olds
• An initial discussion occurred on the Pfizer vaccine for 5–11-year-olds.
1982
• The recent clinical trial occurred among a relatively small sample of ~2000 children. Rare adverse
events cannot be evaluated in a clinical trial of that size. New Zealand would be able to wait for
the real-world data of the vaccine rol out internationally to evaluated safety and effec
ACT tiveness.
• The benefit:risk ratio was not as obvious for this group as for older populations, as COVID-19
presents as a mild disease in this age group and there appears to be an increased risk of
myocarditis after vaccination in younger age groups.
• Concern was also expressed on including 5–11-year-olds under vaccine certificates and
mandates, with potential effects on education and wel being.
• However, different risks for Māori and 5-11-year-olds vulnerable to severe COVID-19 or
INFORMATION
immunocompromise should be considered
• A subgroup of CV TAG wil be meeting to draft recommendations in the coming days.
13.0 Agenda items for next meeting
Booster doses
OFFICIAL
Decision to use for 5-11-year-olds
THE
14.0 New Action Items Raised During Meeting
#
Agenda item
Actions
Action Owner
UNDER Revise memo with CV TAG’s feedback Science and Technical
70 Medical exemptions
and share with CVIP
Advisory
Science and Technical
71 Booster doses
Revise memo with CV TAG’s feedback Advisory
RELEASED
Science and Technical
72 ‘Fully vaccinated’ definition
Revise memo with CV TAG’s feedback Advisory
Immunocompromised
Revise memo with CV TAG’s feedback Science and Technical
73 populations and ATAGI’s
and share with CVIP
Advisory
update guidance
Meeting closed at
12:01pm Next meeting:
Tuesday 9 November – 11:00am to 12:00pm
Document 2
Open Actions:
#
Agenda item
Actions
Action Owner
Updates
Compile further evidence on the Science and
49 Pfizer dosing error
link between dosing intervals
31/08 – Action raised
Technical Advisory
and reactogenicity.
Supporting Evidence
Finalise evidence brief and
Science and
64 for Healthcare Worker
19/10 – Action raised
share with CVIP and CV TAG
Technical Advisory
Vaccination Order
1982
Convene subgroup to update
Science and
66 Myocarditis
clinical guidance for primary
19/10 – Action raised
Technical Advisory
care
ACT
Convene subgroup to compile
Decision to Use 5–11-
Science and
67
evidence and discuss equity
19/10 – Action raised
Year-Olds
Technical Advisory
considerations
Review Pfizer’s application for
Decision to Use 5–11-
68
12-to-15-year olds for evidence Medsafe
19/10 – Action raised
Year-Olds
on dosages.
INFORMATION
Revise memo with CV TAG’s
Science and
70 Medical exemptions
02/11 – Action raised
feedback and share with CVIP
Technical Advisory
Revise memo with CV TAG’s
Science and
71 Booster doses
02/11 – Action raised
OFFICIAL
feedback
Technical Advisory
‘Fully vaccinated’
Revise memo with C
THE V TAG’s Science and
72
02/11 – Action raised
definition
feedback
Technical Advisory
Immunocompromised
populations and
Revise memo with CV TAG’s
Science and
UNDER
73
02/11 – Action raised
ATAGI’s update
feedback and share with CVIP
Technical Advisory
guidance
Closed Actions Since Last Meeting:
RELEASED
#
Agenda item
Actions
Action Owner
Updates
Science and
Compile evidence on need for
21/09 – Action raised
60
Booster doses
Technical
booster doses
Advisory
01/11 – Action closed
Document 2
Draft recommendations for a
Science and
Decision to Use
19/10 – Action raised
65
Decision to Use memo shared
Technical
AstraZeneca
with CV TAG
Advisory
29/10 – Action closed
Science and
Draft recommendations shared
19/10 – Action raised
69
Booster doses
Technical
with CV TAG
Advisory
01/11 – Action closed
1982
ACT
INFORMATION
OFFICIAL
THE
UNDER
RELEASED
Document Outline
- Documents 1 and 2 H202115494_Redacted.pdf
