Covid-19 Vaccine Strategy
Science and Technical Advisory Group
M
inutes – Wednesday 7 October (Confidential)
Date & time
10:00 to 11:00AM, Wednesday 7 October
Attendees
Ian Town (Chair)
Justine Daw
David Murdoch (Deputy Chair)
Jonathan Lane
Sue Crengle
Zachary Clarke
Ian Frazer
Emily Robinson
Graeme Jarvis
Peter McIntyre
Nikki Moreland
Helen Petousis-Harris
John Taylor
Nikki Turner
Apologies
Matire Harwood
James Ussher
Item for discussion
Led by
Administration
1.
Apologies
Ian Town
Matire Harwood
James Ussher
2.
STAG Conflicts of Interest
Ian Town
The updated COI register was noted, with any COIs not listed to be declared
3.
Review of minutes from last STAG meeting
Ian Town
The minutes from the meeting on 23 September 2020 were approved
4.
Review of rol ing monthly planner
Ian Town
There are now seven target vaccine candidates under consideration through the
APA process.
With COVAX membership now confirmed, relevant candidates will also need to be
assessed by the STAG’s Science Review Panel. We do not have a clear line of sight
of timing for this or the specific candidates, or if they will be offered to us via
COVAX individually or in groups. However, it is possible that potential candidates
may be presented to New Zealand from 12 October.
Action: MBIE will provide updates on COVAX as soon as they become available.
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Updates
5.
Medsafe regulatory approvals process
Chris James
Chris James (Group Manager, Medsafe) presented on the role of Medsafe as the
authority responsible for the approval and regulation of potential COVID-19
vaccines, and the global regulatory context in which Medsafe operates.
He outlined options for the approvals process (parallel, rolling and abbreviated
assessments) while ensuring that it acts independently to ensure the vaccines
meet internationally-agreed standards for safety and quality.
Discussion included:
Medsafe operates in a global context, and has strong international links.
Regular meetings enable the sharing of the latest information and discussion
on how products may be regulated.
Medsafe considers approvals from other regulators (particularly the EMA, the
US FDA, and the Australian TGA) when reviewing applications, although
approval elsewhere is not a guarantee of approval in New Zealand.
Developers may submit to all regulatory agencies simultaneously, or seek
approval from one of the larger regulatory agencies first. Medsafe has been
encouraging developers approaching the Australian regulator to submit at the
same time.
Medsafe has assessors ready to assess COVID-19 vaccine candidates.
Q:
Any COVID-19 vaccine would be likely to require provisional consent as
the need for early access could mean it is still undergoing clinical
assessment. Is there any indication of the timeframes for this process?
A:
This will depend on a range of factors. This is an issue faced globally,
and it’s important to balance the need for early access with ensuring
any vaccine meets internationally acceptable safety standards.
Medsafe will not cut any regulatory corners. It is looking at ‘rolling
submissions’ where these are being used by others, e.g. the Europeans,
as a way of ensuring the earliest decisions are reached on submissions.
Q:
Does Medsafe review individual patient data and critical safety data as
part of a ‘reliance’ approval?
A:
Medsafe receives and reviews the full set of data (CDT data), it does not
re-calculate clinical trial statistics from raw data.
6.
Proposed ‘Science Summary’ template
The template for the proposed Candidate Summaries was presented and feedback
requested.
Discussion included:
Justine Daw acknowledged the need to close-off the Science Review Panel
documentation to assist purchasing decisions before full and complete
information was known. The Science Summaries will capture more up to date
information, as new information comes to light. They will be updated
regularly, and aim to ensure later decisions can be informed through date-
stamped summary information. These updates will be available to the STAG
to review and likely used by other Taskforce agencies as needed.
2
The STAG highlighted that the Science Summaries would ideally include
formulation details and packaging information for each candidate, as well as
storage requirements, to aid with immunisation projections and planning.
[
Comment: The template will include this information, although the intent was
that the document initially include only public information. We will discuss this
and resolve among the MBIE team].
Action MBIE will present a populated mock-up at the next STAG meeting to
provide a more comprehensive view of the content to be captured by
the Science Candidate Summary.
Discussion
7.
Global WHO Solidarity Protocol for COVID-19 vaccine trials
Ian Town
WHO’s newly launched solidarity trials for COVID vaccines
The Chair confirmed receipt of the WHO circular on solidarity trials for COVID-19
vaccines, and that a response would be prepared.
The STAG agreed that the limited Covid-19 prevalence in New Zealand meant
there was little we could assist with at the moment, but that we should keep
involved in the conversation, and may be better able to contribute in the post-
licensing phases.
8.
Draft decision-making framework for clinical trials via VAANZ Platform
Justine Daw
Justine Daw presented a proposed decision-making framework for clinical trials in
NZ of international COVID-19 vaccine candidates identified through the VAANZ
platform. The Taskforce has asked for a summary on how these decisions will be
made, noting there are close to 200 vaccine candidates in development globally.
The framework will be finalised following Taskforce comment and input.
Justine Daw noted the need to ensure the VAANZ approach aligns with the
broader Taskforce programme objectives by prioritising collective activity and
resources, as appropriate. Comments on the draft decision-making framework
were welcomed.
Discussion included:
In terms of decision-making, the Taskforce will make decisions on which
candidates will progress to clinical trials in New Zealand, with the STAG’s
Science Review Panel providing science input to inform Taskforce decisions.
There was support for the current proposal to prioritise a small range of
priority APA and COVAX candidates, while still retaining flexibility (i.e. to
consider candidates with ties to domestic manufacturing capability).
Q:
The current timeframes (with VAANZ trials scheduled to occur
before October 2021) seem very short. Is this feasible?
A:
The Taskforce aims to be flexible with the contract settings, and there is
potential to extend the funding dedicated to clinical trials. This is yet
to be explored fully to ensure best value from the investment, and is
likely to be informed early in 2021 once the situation clarifies in respect
of clinical trial prospects in New Zealand.
[Budget sensitive] There have been very early discussions regarding the
possibility of a budget bid to support Phase IV trials. This is still to be
worked through as a Taskforce discussion, and is not guaranteed.
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Q:
How much focus does the VAANZ platform have on international
outreach?
A:
Developing research collaborations with international research teams is
one of the primary objectives of the Platform.
9. Questions for STAG comment
Justine Daw
Q:
Are animal virus vectors likely to deliver any materially different
immune responses to human ones? If so, what and why?
A:
Generally speaking, there is lower likelihood that animal virus vectors
have circulating immunity in humans, and so they are more reactogenic
and immunogenic. This is also because they have not co-evolved with
human immune systems.
We will need to be mindful of how we engage with communities on
animal virus vectors, if they are used. It may be worth doing some
research in the communities on this.
Action: Taskforce Communications team to consider this as part of the research
being scoped. The team will be invited back to the STAG when the
programme is shaped up to update the STAG and seek comment.
10.
Meeting close
Ian Town
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