3.1.2022

EN

Official Journal of the European Union

C 2/45

(Case T-695/21)

(2022/C 2/62)

Language of the case: French

Parties

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

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:

—declare that the European Commission (EC) unlawfully failed to include carcinogenicity and genotoxicity testing in the preclinical phase for the mRNA-technology vaccines;

—order the European Commission to include carcinogenicity and genotoxicity testing in the preclinical phase for mRNA-technology vaccines not yet authorised under the EMA procedure;

—order the European Commission to include carcinogenicity and genotoxicity testing in the pharmacovigilance phase for mRNA-technology vaccines already authorised under the EMA procedure;

—request the Commission to disclose the following information:

—the clear legislative basis as to why the testing at issue was not included in the preclinical and pharmacovigilance testing phases;

—the regulation setting out the mandatory checks required for the authorisation of mRNA-technology vaccines.

—order the European Commission to pay all the costs of the applicants.

Pleas in law and main arguments

In support of the action, the applicants allege an infringement of EU law and a failure to act on the part of the Commission. The applicants submit in that regard that the Commission did not comply with its obligation arising under Article 168 TFEU to guarantee a ‘high level of human health protection’ by granting a conditional marketing authorisation to mRNA-technology vaccines in the absence of carcinogenicity and genotoxicity studies.