Covid-19 Vaccine Strategy
Science and Technical Advisory Group
Minutes – Wednesday 27 January 2021
( Confidential)
Date & time
10:30 am to 12:00 pm, Wednesday 27 January
Attendees
Ian Town (Chair)
Chriselle Braganza (MBIE)
David Murdoch (Deputy Chair)
Simon Rae (MBIE)
Sue Crengle
Caroline McElnay (MoH)
Graeme Jarvis
Chris James (Medsafe)
Peter McIntyre
Dan Bernal (MoH)
Nikki Moreland
Fiona Callaghan (MoH)
Helen Petousis-Harris
Kris Golding (MoH)
Nikki Turner
Allison Bennet (MoH)
Sarah Mitchell (MoH)
James Ussher
Ian Frazer
Apologies
Matire Harwood, John Taylor
Item for discussion
Led by
Administration
1.
Apologies
Ian Town
Matire Harwood, John Taylor
2.
Introductions
Everyone
All attendees provided a brief introduction.
Updates
3.
Immunisation planning and transition
Ian Town
Ian Town gave an update on the Immunisation Programme underway at Ministry
of Health (MoH) and the transition process from MBIE to MoH.
Key points were:
Seven workstreams have been identified at MoH, each of which will be
involved in individual activities including landing the vaccines, storage,
logistics, staff training, and sequencing etc.
A phased handover is underway from MBIE to MoH, ranging from contract
management to roll-out. This is a well-advanced, cross- agency piece of
work that will be subject to written agreements.
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In anticipation of the leadership role transferring to MoH, measures have
been taken to galvanise internal efforts towards the Immunisation
Programme, which sits broadly within the COVID directorate.
4.
Medsafe approvals
Chris James
Medsafe has been working with the four vaccine developers for several months
to understand the timelines for generating data. To streamline this process,
Medsafe has allocated dedicated assessors to each of the four vaccine
candidates, all of which are rolling assessments. At the end of an assessment for
each vaccine, Medsafe consults a ministerial expert advisory group, medicines
assessment advisory committee(MAAC), for recommendations and advice.
Key points were:
Data from Pfizer has been assessed as available and there have been no
roadblocks to date. Questions have been sent to Pfizer for extra
information, with quick turnaround of answers within a week. A risk-benefit
analysis will be prepared by the Ministry and provided to Medsfae/MAAC
for review. A meeting has been set with MAAC for 2nd February, with the
approval dependent on MAAC’s recommendation. The approval will most
likely be provisional, which means that conditions can be put onto the
approval that requires Pfizer to provide updated clinical data as it becomes
available.
A formal application has been received from Janssen but little clinical data is
currently available, with more expected in February.
Medsafe have started assessing data from AstraZeneca informally, with a
formal application yet to be received.
Medsafe has initiated conversations with Novavax’s contracted company in
NZ, however data is yet to be provided for assessment.
Medsafe is working with MoH to gain support for conducting post-market
monitoring of the vaccines to identify safety signals rapidly and to inform
the Immunisation Programme.
Discussion points:
Medsafe does not stipulate explicitly which groups the vaccine can be given
to. Approval will be based on the data available, for Pfizer the current
indication is likely to be 16+.
The delicate nature of the Pfizer vaccine and the need for it to be handed
carefully including cold chain was discussed. Medsafe will work with the
Immunisation Programme to ensure that logistical information is conveyed
to people who need to administer the vaccine.
Medsafe is closely linked with the global regulatory community and uses
expertise and assessments from regulatory colleagues. They have also been
working closely with the Australia’s Therapeutic Goods Administration,
including discussing technical assessments and questions for the vaccine
developers.
It will be crucial to have effective media communication around provisional
approvals for vaccines to ensure public confidence. Medsafe is working with
communications teams to ensure this occurs.
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Discussion
5.
Decision to Use Framework and Terms of Reference
Kris Golding/Ian
Town
Kris Golding provided an overview of the Decision to Use Framework that will be
presented to Cabinet shortly. This Framework addresses the need to provide
advice on which vaccines in the portfolio can be best used for particular reasons
within the Immunisation Programme.
Key points were:
The Framework centres around four key questions that cover the context
and timeline for the decision, the key pieces of information that will build
the foundations of advice, and the risks and benefits.
The STAG/new expert advisory group (EAG) is expected to provide advice on
key pieces of information such as science, clinical and technical assessments
of the vaccine, including who to use the vaccine for (i.e. specific population
groups such as children).
The COVID-19 Immunisation Implementation Advisory Group (IIAG) have
been involved in the sequencing framework and will be consulted for advice
on operational use, e.g. processes and implementation.
Ian Town acknowledged the STAG’s ongoing commitment to providing
vaccine advice and recommendations. The STAG will be briefed about the
processes and timelines and will be asked to reconvene urgently on short
notice to provide advice on deployment of the first tranche of vaccines.
Discussion points:
Sue Crengle recommended that Te Tiriti o Waitangi assessments should be
included within all groups instead of a separate group to avoid risk of
marginalisation. Ian Town explained that the IIAG is very focussed on treaty
and equity issues and will provide advice on these issues in parallel with the
EAG.
Clear media communication and availability of transparent science advice
will be key to ensuring public confidence on the vaccines in our portfolio,
especially considering the speed at which the vaccines were developed.
Work is underway towards this and will feed into the national immunisation
campaign. Māori providers and leaders wil also be included in the
communication campaign.
There was some concern regarding overlap between roles of the IIAG and
the new EAG in providing advice. The terms of reference (TOR) will be
updated accordingly to accurately reflect the roles of the advisory groups.
It was noted that it would be good for the STAG to have an update from the
IIAG with regards to where things stand so that they are appropriately
informed.
Actions:
1) Ian Town to send out explanation of the role of the IIAG along with the
meeting minutes to the STAG.
2) Kris/Allison to debrief on the Framework and ensure that the risk of leaving
out Te Tiriti o Waitangi issues is mitigated.
3) The TOR will be fine-tuned to capture the roles of the IIAG and the new EAG
more clearly.
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4) MoH has developed an A3 roadmap summarising the critical decision points
and will share these with the STAG.
6.
Surveillance and research
Ian Town
Ian Town gave a brief overview of the cohort surveillance work proposed by Dr
Fran Priddy from Vaccine Alliance Aotearoa New Zealand (VAANZ), which
includes aspects discussed in the 2 December 2020 workshop on
Surveillance,
post-marketing and associated needs for NZ and Polynesia. A second workshop
will be held in the near future with STAG members and researchers from primary
and secondary care to discuss this research and the proposal from VAANZ. This
work will also set expectations on New Zealand’s contributions to the
international literature from outcomes of our Immunisation Programme.
7.
Vaccine questions for the STAG and new expert advisory group
Caroline
McElnay
MoH has been receiving vaccine questions from various sources, including the
Prime Minister. These can be straightforward questions or really deep technical
questions, which are currently being addressed by the Science and Technical
Team but will eventually need to be answered by qualified experts as part of an
expert advisory group (EAG). Ultimately, MoH needs to sign off on a decision and
requires the STAG/EAG to land on a position for these questions. Examples of
questions were sent to the STAG before the meeting and they were requested to
comment.
Key points:
An immunisation training package is being put together and there are some
pressing questions that also require advice and answers.
It was noted that timeframes are generally very tight and the questions may
need to be answered offline via email rather than during meetings.
8.
Other matters
Ian Town
No other matters were raised.
9.
Meeting close
Ian Town
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