Ares(2020)6822297
Minutes: Steering Board meeting, 6 November 2020
1. Update on the vaccination documentation
indicated that while all Member States had a vaccines registers, it
might be important for Member States to ensure digital/electronic documentation of
vaccine and that interoperability of vaccination documentation (for travelling, etc.) was
crucial.
seems to have a solution in place, which could be explored with the other
Member States.
The Commission informed that
gave a presentation in the Health Security
Committee on electronic COVID-19 testing and vaccination certificates, a project in
collaboration with WHO to facilitate international travel. The project included a first pilot
on digital and verifiable international vaccination certificate. The Members were
informed that the app was very user friendly and could be used by other Member States.
The HSC or the E-health Network will follow up with collecting reactions from countries
on this app also to ascertain what kind of certificate or format of certificate would be
useful and what is used in other countries.
The Members were also informed that the eHealth Network had a first discussion on the
vaccination passport that raised several questions, including on the free movement of
persons in the absence of such passport.
Depending on the implementation architecture, there could be
, as well as the possibility of involving
countries outside EU/EEA.
It was agreed that this topic would be further discussed with the experts in the eHealth
Network,
.
.
placed
ensuring that supplies are available in time for national
deployment of COVID-19 vaccines.
5. Update from AstraZeneca on Clinical trials, manufacturing and approval
In a dedicated session, AstraZeneca provided an update on clinical trials, manufacturing and
approval.
In a very comprehensive presentation, Members were provided with:
• an update on the clinical development;
• explanations regarding the technology behind the vaccine candidate and that the vaccine
;
• a full picture on the global clinical development plan;
• explanations of the results of the clinical trials so far.
The Members were also updated on the
regulatory and release process. During the
presentation, the company presented the standard regulatory and release process and provided an
extensive explanation of the COVID vaccine accelerated development, appraisal and release
process.
The company outlined the different phases in the pre-approval and post approval and explained
how the parallel procedures could shorten the usual development process keeping the standards
as high as during a normal process.
An update on the
supply was also provided. Members were informed that:
• all order forms and binding allocation were received;
•
Member States still needed to provide distribution hub details;
• an updated preliminary delivery schedule would be provided during November;
• detailed plans were being updated as process development continues and more
information becomes available regarding production, testing and release timelines
become clear .
• Member States were asked to provide as soon as possible the outstanding Customer Set
Up Forms ( received so far).
A
Q&A session followed where the Members of the Steering Board were able to ask all
relevant the questions (eg. vaccine platform, clinical trials, shelf life, price, distribution etc.)
6. AOB
stressed that (i) a clear
communication was necessary regarding the different
stages of the market authorisation and that (ii) any vaccine outside the portfolio that the
Members might want to purchase outside the portfolio can only be used if a
market
authorisation will be granted in Europe.
Discussions on the
carried in both these meeting and revised tables were
distributed reflecting the feedback from the MSs
.
r.
In light of the good work already carried out in the Steering Group and the early start of the
, the Members were invited to complete the
Vaccine Order forms with the
number of doses
by the time the opt-
out period runs out (i.e.
18 November).
This would allow the Commission to complete the order procedure
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