Ares(2020)6522141
Steering Board meeting, 31 July 2020
The
started the meeting inviting all Member States to finalise their national
procedures related to the approval of the Agreement on the Covid-19 vaccines, and prepare for
the conclusion of the Advance Purchase Agreements.
The Commission expressed the gratitude to all Member States for co-operation and added that
there is only one Member State which has to conclude the national procedures in order to
approve the Agreement.
Member States were encouraged to communicate as soon as possible the contact details for the
secured emails. If any of the contact representatives will change, the Member States have to
inform the Commission well in advance.
The Commission asked the Members of the Steering Board to respect the confidentiality of the
information on the potential vaccine candidates shared during the Steering Board meetings.
Scientific Committee with independent experts on the potential vaccine candidates
The Steering Board representative invited the Member States to participate in the Scientific
Committee, where will be presented the scientific opinion of the independent experts on the
potential vaccine candidates. Member States are invited to nominate their independent
academic experts and leaders of the scientific boards, which might provide relevant expertise
on the Covid-19 vaccines platforms.
At the first meeting of the Scientific Committee, which took place on 27 July, the experts from
,
and the
presented their opinion on several vaccine candidates. The
Steering Board representative mentioned that the experts from
and
expressed their interest to share their expertise in the next meeting of the Scientific Committee,
which will take place on
.
The Steering Board representative invited the independent researchers and the lead experts to
provide a written opinion, which will be further circulated to the Member States by secured
emails, in strict confidentiality.
Addressing the questions of the Members of the Steering Board, the Commission noted that
Member States can delegate their experts to the meeting of the Scientific Committee, if they
have signed the declaration of confidentiality and absence of conflict of interest.
The Commission confirmed that meeting with the Scientific Committees will take place before
concluding the Advance Purchase Agreements with the manufacturers.
Update on AstraZeneca contract
The Commission received a proposed draft Advance Purchase Agreement from AstraZeneca
and proposed some further amendments. The Commission is currently discussing some liability
aspects with the company.
The Commission emphasised that the access to vaccine doses will be allocated to Member
States based on a pro rata, according to the population distribution key. The Member
States, which accept to participate in the purchase of the AstraZeneca vaccine, can receive
as a maximum the corresponding population pro-rata percentage of the total purchased
quantity. Should they decide they do not want the vaccine, they will need to opt out
explicitly.
The Commission confirmed that the upfront payment for AstraZeneca will be covered by the
ESI fund. Two important aspects of the contract with AstraZeneca remain to be clarified:
the logistics (the company plans to have only distribution hubs in the EU and
ways of distribution);
the
, which might slightly
without exceeding a
.
In this regard, the Commission requested the company to provide a possible
to the Member States. In turn, AstraZeneca underlined the
importance of its capacity to produce in Europe, as a vaccine manufacturer, and addressed for
support to the Member States.
The Commission noted that the vaccine regimen of AstraZeneca will consist of 2 vaccine doses
and the distribution schedule is already
.
Addressing the questions of the Members of the Steering Board, the Commission
reiterated that in case a Member State does not agree with the conclusion of an APA or
the terms of the contract, it has the right to opt out within 5 working days from the
Commission’s communication that it intends to conclude the APA with the vaccine
manufacturer. According to the Article 4, the Member States which decide to accept the
Advance Purchase Agreement have to communicate the number of doses of the vaccine
they intend to purchase.
The Commission encouraged the Member States to consult their independent experts and to
actively participate in the meetings of the Scientific Committee with the independent experts
and with the vaccine producers. In this context, Member States requested to receive the written
scientific opinion of the independent experts before the draft APA is proposed to the Member
States.
Member States will receive the draft APA with AstraZeneca in the following
, as soon as
it will be concluded.
Update on ongoing negotiations with vaccine producers
The Commission and the representatives of the Joint Negotiation Team updated the Member
States on the ongoing negotiations with the other vaccine producers:
• Sanofi – further to a constructive discussion, the Commission and the company reached
on the
.
The representative of the Joint Negotiation Team highlighted that the Sanofi vaccine
complements the potential vaccines of the other candidates, in terms of technology and
risk diversification. The technology platform used by the vaccine candidate is well
The Commission suggested to the Member States to reflect on their potential vaccine portfolio.
As agreed by the Steering Board, the Commission started the negotiations with Valneva and
The Commission invited the companies to present their proposals for the vaccine
candidates. Further discussion with the companies were planned
.
provided more details on their clinical development plan. The Commission will
schedule a separate meeting with the vaccine producer.
Concerning the question related to the conditional marketing authorisation, the Commission
noted that almost all the companies will have the conditional marketing authorisation compliant
with the delivery schedule of the vaccine. In case of
the Commission asked for
additional details on the regulatory approval.
Following the discussion in the Steering Board, the Commission contacted the other interesting
candidates:
. The Commission is not ready yet to enter into the
negotiations with these companies. Nevertheless, it will keep a close co-operation with the
vaccine producers.
The Commission contacted two promising candidates
and Novavax. Novavax
would be available to attend a Scientific meeting with the Member States. Both companies will
analyse their distribution capacity for the EU and confirm it to the Commission by early
September.
An Excel file including the companies which contacted the Commission and a few details on
the vaccine candidates was sent to the Member States.
Update on GAVI and COVAX Facility
reassured the Member States that
the EU is fully committed on the COVAX Facility, on both sides: research financing aspects
and AMC, following the governance pillar of COVAX Facility in the GAVI Board.
.
Estimated numbers of people for vaccination
The latest state of play is presented in the table below:
Member State
Number of
% of priority
Estimated number of
priority group
groups accept
people for
vaccination
vaccination
ESTIMATED TOTAL (status of 4 August 2020)