Case T-623/22: Judgment of the General Court of 19 November 2025 – SD v EMA (Access to documents – Regulation (EC) No 1049/2001 – EMA documents concerning the messenger RNA vaccine against COVID-19 Comirnaty – Conditional marketing authorisation – Specific obligations – Responses provided by the authorisation holder to the EMA – Partial refusal to grant access – Communication of partially redacted documents after notification of the contested decision – Action for annulment – Time limit for bringing proceedings – Admissibility – Interest in bringing proceedings – Correcting decision – Action which has become devoid of purpose – No need to adjudicate – Protection of the commercial interests of a third party – Document disseminated on the internet following a cyberattack – Overriding public interest)
Date: 2025-11-19
Institutions: General Court
Subjects: access to EU information, admissibility, coronavirus disease, disclosure of information, drug surveillance, epidemic, market approval, vaccination, vaccine








C_202600101EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/101


5.1.2026






Judgment of the General Court of 19 November 2025 – SD v EMA


(Case T-623/22)
                (1)

(Access to documents - Regulation (EC) No 1049/2001 - EMA documents concerning the messenger RNA vaccine against COVID-19 Comirnaty - Conditional marketing authorisation - Specific obligations - Responses provided by the authorisation holder to the EMA - Partial refusal to grant access - Communication of partially redacted documents after notification of the contested decision - Action for annulment - Time limit for bringing proceedings - Admissibility - Interest in bringing proceedings - Correcting decision - Action which has become devoid of purpose - No need to adjudicate - Protection of the commercial interests of a third party - Document disseminated on the internet following a cyberattack - Overriding public interest)
(C/2026/101)
Language of the case: German

Parties


Applicant: SD (represented by: A. Steindl, lawyer)

Defendant: European Medicines Agency (represented by: F. Behre, G. Gavriilidou and H. Kerr, acting as Agents)

Interveners in support of the defendant: BioNTech SE (Mainz, Germany), BioNTech Manufacturing GmbH (Mainz), BioNTech Manufacturing Marburg GmbH (Marburg, Germany) (represented by: P. Bogaert, K. Ewert, lawyers, and B. Kelly, Solicitor)

Re:

By his action under Article 263 TFEU, the applicant seeks the annulment of the decision contained in letter EMA/254928/2022 of the European Medicines Agency (EMA) of 21 July 2022, by which it partially refused access to certain documents requested pursuant to 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 (OJ 2001 L 145, p. 43).

Operative part of the judgment

The Court:






1.


Declares that there is no longer any need to adjudicate on the action in so far as it concerns the data disclosed by the European Medicines Agency (EMA) following the adoption of the correcting decision contained in its letter of 7 February 2024 bearing reference EMA/55289/2024;










2.


Dismisses the action as to the remainder;










3.


Orders the EMA, in addition to bearing its own costs, to pay half of SD’s costs;










4.


Orders SD to bear half of his own costs;










5.


Orders BioNTech SE, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH to bear their own costs.






(1)  
            OJ C 24, 23.1.2023.


ELI: http://data.europa.eu/eli/C/2026/101/oj
ISSN 1977-091X (electronic edition)