Ref. Ares(2025)1922721 - 11/03/2025
EUROPEAN COMMISSION
EUROPEAN HEALTH EMERGENCY PREPAREDNESS AND RESPONSE AUTHORITY
The Director-General
Brussels
HERA.3/
Frédéric Baldan,
CEBiz SA
Avenue des Arts 56
1000 Brussels
By email transmission only:
ask+request-15475-
xxxxxxxx@xxxxxxxx.xxx
Subject:
Your application for access to documents - EASE 2025/0438
Dear Mr Baldan,
Nous nous référons à votre demande enregistrée le 26 janvier 2025 sous le numéro de
référence susmentionné. Veuillez noter que la traduction française de cette réponse suivra
prochainement.
1. Scope of your request
Your request refers to:
«
1. La copie de tous les documents, sous n'importe quelle forme, ayant permis à Madame
Kyriakides d'affirmer "L'évolution continue des variants de la COVID-19, en association
avec d'autres virus respiratoires, reste une menace pour la santé.". Qui plus est, les
documents ayant permis à Madame Kyriakides d'évaluer l'importance de cette menace
entrainant la nécéssité d'acheter un "vaccin".
2. La copie de tous les documents, sous n'importe quelle forme, ayant permis de définir le
besoin de 146 millions de doses.
3. La correspondance entre HERA et les Etat membres, notamment les échanges qui
concernent la demande des Etats membres d'acheter ces doses supplémentaires et en
particulier ceux qui traitent du "besoin d'avoir accès à un vaccin à ARNm contre la COVID-
19, y compris dans la formulation destinée aux enfants."
4. Les documents relatifs à la description du produit et son prix. Rappelant que le prix des
concurrentset connus et que l'appel d'offre est public.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111
5. Les documents qui ont permis à HERA de considérer qu'il était conforme à la recherche
de la protection de la Santé d'utiliser le produit de Moderna chez les enfants.
6. Tous les documents, sous n'importe quelle forme, formant la bases contractuelle avec
Moderna
(incluant toutes mentions à l'étude des effets secondaires, l'efficacité du produit sur le blocage
de la transmission ainsi que pour la santé individuelle ; la responsabilité du fabricant en cas
d'effets secondaires). »
English translation:
1. Copies of all documents, in any form, which allowed Ms Kyriakides to state “The
continuous evolution of COVID-19 variants, in combination with other respiratory viruses,
remains a threat to health.” Moreover, the documents which enabled Ms Kyriakides to assess
the significance of this threat that led to the need to purchase a ‘vaccine’.
2. Copies of all documents, in any form, which made it possible to define the need for
146 million doses.
3. The correspondence between HERA and the Member States, in particular exchanges
concerning the Member States’ request to purchase these additional doses and in particular
those dealing with the ‘need to have access to a mRNA vaccine against COVID-19, including
in the formulation intended for children’.
4. Documents relating to the description of the product and its price. Recalling that the price
of known competitors and that the call for tenders is public.
5. The documents that allowed HERA to consider that it was in line with health protection
research to use Moderna’s product in children.
6. All documents, in any form, forming the contractual basis with Moderna
(including all references to side-effects, the efficacy of the product on transmission blocking
and for individual health; responsibility of the manufacturer in case of side effects).
2. Identification and assessment of the documents
We have examined your request under the provisions of Regulation (EC) No 1049/2001 (1)
regarding public access to documents.
As regards your request under point 1, we regret to inform you that the Commission
does not hold any specific document that would correspond to the description given in your
application.
(1) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding
public access to European Parliament, Council and Commission documents (hereinafter referred to as the
‘Regulation’).
2
However, for your information, we would like to refer you to publicly available data of the
WHO and the ECDC, which demonstrate that COVID-19 is still a threat to health. The
links are available in the footnote (2).
As regards your request under point 2, we have identified one document containing this
information based on which the Commission established the total maximum ceiling of 146
million doses:
• Document 1 - Results of the survey conducted with Joint Procurement Agreement
countries (Ares(2025)1833772).
Having examined the document requested under the provisions of the Regulation, we
regret to inform you that your application cannot be granted, as disclosure is prevented by
the exception to the right of access laid down in Article 4(2), first indent of the Regulation.
Pursuant to Article 4(2), the Commission shall refuse access to a document where
disclosure would undermine the protection of commercial interests of a natural or legal
person.
Please note, that the volume of 146 million doses is the maximum ceiling that contracting
authorities could purchase if they would have a need during the whole duration of the
framework contract. In order to establish the need of the Member States and the ceiling,
we had consulted the contracting authorities prior to launching the call for tender and asked
them about their estimated possible needs in case of crisis.
Document 1 contains information related to the economic capacities and commercial
strategies of participating contracting authorities. Specifically, it includes details on the level
of interest and commitment of contracting authorities in the joint procurement, their strategic
stock levels, and the degree of flexibility they are willing to consider in the procurement’s
design. Disclosure of these sensitive economic interests could risk undermining contractual
negotiations, competitive positions, and strategic economic policies of the contracting
authorities concerned. As a result, after the necessary redactions, the document would lose its
meaning, because it contains only personal data and specific figures from the contracting
authorities. According to paragraph 69 of the Judgment of 12 July 2001, Mattila v Council
and Commission, T-204/99, EU: T:2001:190, partial access can be denied when the
remaining content would not be useful to the applicant.
Given the sensitivity and the potential negative implications associated with the release of the
information contained in the results of the survey document, access is denied in order to
protect the commercial interests of the affected contracting authorities, in accordance with
Article 4(2) of the Regulation. As additional context, please note that the framework
(2)
COVID-19 epidemiological update – 22 December 2023
COVID-19 epidemiological update – 15 March 2024
Interim public health considerations for COVID-19 vaccination roll-out during 2023
Communicable disease threats report, 31 December 2023 - 6 January 2024, week 1
Interim analysis of COVID-19 vaccine effectiveness against hospitalisation and death using electronic health
records in six European countries Public health and social measures for health emergencies and pandemics in the EU/EEA: recommendations
for strengthening preparedness planning
Statement on the antigen composition of COVID-19 vaccines
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contract signed with Moderna is fully flexible and does not bind the contracting authorities
to make any purchase. The participating countries already have other and may also have
further contracts to purchase Covid-19 vaccines, and their negotiating position would be
undermined if the information included in the document becomes public.
As regards your request under point 3, we have identified one document as falling
within the scope of your request:
• Document 2 - Assessmen
t Note (Ares(2023)8626025).
Having examined the document requested under the provisions of the Regulation, we have
come to the conclusion that it may be partially disclosed. Some parts of the document have
been blanked out as their disclosure is prevented by the exceptions to the right of access
laid down in Article 4(1)(b) and Article 4(2), first indent of the Regulation.
Please see the detailed justification below under point 3 of this letter.
As regards your request under point 4, we have identified one document as falling
within the scope of your request:
• Document 3 - Framework contract (Ares (2025)563884).
Having examined the document requested under the provisions of the Regulation, we have
concluded that it may be partially disclosed. Some parts of the document have been
blanked out as their disclosure is prevented by the exceptions to the right of access laid
down in Article 4(1)(b) and Article 4(2), first indent of the Regulation.
Please see the detailed justification below under point 3 of this letter.
As regards your request under point 5, we have identified one document as falling
within the scope of your request:
• Document 4 – EMA overview of Spikevax.
This document is publicly available on the EMA website in the European public
assessment report for Spikevax vaccine. The link is available in the footnote (3).
For additional context, please note that each application for authorisation of a medicinal
product for human use is assessed by the European Medicines Agency (EMA), in particular
by its Committee for Medicinal Products for Human Use. In accordance with Regulation
(EC) No 726/2004, the Commission authorises a medicinal product for human use on the
basis of the opinion issued by the EMA, as it did for the Spikevax vaccine (developed by
the pharmaceutical company Moderna) by authorising it on 23 July 2021 for adolescents
aged 12 to 17 years, on 2 March 2022 for children aged 6 to 11 years and on 20 October
2022 for children aged 6 months to 5 years.
(3)
https://www.ema.europa.eu/en/documents/overview/spikevax-previously-covid-19-vaccine-moderna-
epar-medicine-overview_en.pdf
4
As regards your request under point 6, we have identified the same document as the one
provided in reply to question 4. Please refer to our comments above.
3. Reasons for partial disclosure
a. Protection of the privacy and integrity of individuals- Article 4(1)(b) of the
Regulation
With regard to the documents 2 and 3, full disclosure is prevented by the exception concerning
the protection of privacy and the integrity of the individual outlined in Article 4(1)(b) of the
Regulation, because they contain the following personal data:
– the names/initials and contact details of natural persons;
– other information relating to an identified or identifiable natural person, such as
professional background, role etc.
Article 9(1)(b) of the Data Protection Regulation does not allow the transmission of these
personal data, except if you prove that it is necessary to have the data transmitted to you for a
specific purpose in the public interest and where there is no reason to assume that the
legitimate interests of the data subject might be prejudiced.
Consequently, pursuant to Article 4(1)(b) of the Regulation, access cannot be granted to the
personal data contained in the requested document, as the need to obtain access thereto for a
purpose in the public interest has not been substantiated and there is no reason to think that
the legitimate interests of the individuals concerned would not be prejudiced by disclosure of
the personal data concerned.
b. Protection of the commercial interests of a legal person - Article 4(2), first
indent, of the Regulation
Document 2 contains a possible pricing bracket which was established based on input
provided by possible contractors. Full disclosure of that information would undermine the
protection of the legitimate interests of the tender participants.
Document 3 contains references to commercially sensitive information related to the
development, production, fill and finish, delivery of COVID-19 vaccines, as well as scientific
information on the vaccines, their prices, the schedule to deploy them, the production capacity
of vaccines manufacturers, their know-how. The document also contains other information
carrying a commercial value for the contractor such as subcontractors and affiliated
companies, business strategies, delivery schedules and pricing strategy. Full disclosure of
those information would undermine the protection of the legitimate interests of the contractor.
Giving access to the requested information could distort competition in current and future
procedures, because of its commercial value or because its disclosure can prejudice the
legitimate interests of economic operator.
As such, the documents you requested must be protected in view of the exception to the
right of access based on protection of commercial interest laid down in the first indent of
Article 4(2) of the Regulation. It should be concluded that access to your request can be
partially granted.
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4. Overriding public interests
The exceptions to the right of access provided for in Article 4(2) of the Regulation must be
waived if there is an overriding public interest in disclosing the requested documents. In
your request, you do not put forward any arguments to establish the necessity to have
the data transmitted for a specific purpose in the public interest. Therefore, the above-
mentioned exceptions to the right to access apply.
5. Reuse of public documents
You may reuse public documents, which have been produced by the European Commission
or by public and private entities on its behalf based on the
Commission Decision on the
reuse of Commission documents. You may reuse the documents, disclosed free of charge
and for non-commercial and commercial purposes, provided that the source is
acknowledged and that you do not distort the original meaning or message of the
documents. Please note that the Commission does not assume liability stemming from the
reuse.
6. Means of redress
In accordance with Article 7(2) of the Regulation, you are entitled to make a confirmatory
application requesting the Commission to review this position.
Such a confirmatory application should be addressed to the Secretariat-General of the
Commission within 15 working days upon receipt of this letter. You can submit it in one of
the following ways:
by mail:
European Commission
Secretariat-General
Transparency,
Document
Management
&
Access
to
Documents
(SG.C.1)
BERL 7/076
B-1049 Bruxelles
or by email to: xxxxxxxxxx@xx.xxxxxx.xx
Yours faithfully,
Laurent MUSCHEL
Acting Director-General
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Signé par voie électronique le 11/03/2025 11:22 (UTC+01) conformément à l’article 11 de la décision (UE) 2021/2121 de la Commission
