23.8.2021

EN

Official Journal of the European Union

C 338/42

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(Case T-418/21)

(2021/C 338/52)

Language of the case: French

Parties

Applicants: Virginie Alauzun (Saint-Cannat, France) and 774 other applicants (represented by: F. Di Vizio, lawyer)

Defendants: European Commission, European Medicines Agency (EMA)

Form of order sought

The applicants claim that the Court should:

—annul the European Commission’s implementing decision of 31 May 2021 EMEA/H/C/005735/II/0030 on the grounds of infringement of essential procedural requirements and failure to state reasons in connection with the conditional marketing authorisation;

—in the alternative, annul the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), delivered on 28 May 2021, by which the EMA recommended a conditional marketing authorisation for the vaccine Comirnaty, manufactured by BioNTech and Pfizer;

—order the EMA and the Commission to pay all of the applicant’s costs.

Pleas in law and main arguments

In support of their action against the Commission Decision of 31 May 2021 amending the conditional marketing authorisation for the medicinal product for human use ‘Comirnaty — COVID-19 mRNA (nucleoside modified) vaccine’ granted by Decision C(2020) 9598(final), the applicants rely two pleas in law.

1.First plea in law alleging breach of essential procedural requirements and failure to state reasons. The applicants submit in this regard that the contested decisions do not demonstrate that the vaccine in question falls within the scope or meets the requirements of Articles 2 and 4 of Regulation No 507/2006. (1) In fact, according to the applicants, the conditional marketing authorisation in question does not meet the condition of the existence of an emergency or a life-threatening disease for the public concerned. The applicants add that the authorisation in question cannot be based on a positive benefit/risk balance or constitute a response to unmet medical needs. Finally, the applicants consider that the benefit to public health of the contested authorisation cannot outweigh the risk inherent in the fact that additional data are still required.

2.Second plea in law alleging infringement of the fundamental right to integrity of the person and of the fundamental right to life provided for in Articles 3 and 2 respectively of the Charter of Fundamental Rights of the European Union.

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Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ 2006. L 92, p. 6).