European Commission Makes Sanofi’s Antitrust Commitments Binding

On October 13, 2026, the European Union’s (EU) European Commission made Sanofi’s commitments not to disparage a competing flu vaccine legally binding.

The Commission found that Sanofi’s enhanced flu vaccine in the EU, Efluelda, competes with the EU’s only other enhanced flu vaccine, CSL Seqirus’s Fluad. From 2024 through fall 2025, Sanofi marketed Efluelda to healthcare professionals in Germany and France, in which it (1) suggested weaker evidence supported Fluad compared to Efluelda; (2) misrepresented national vaccine recommendations; and (3) suggested Germany’s national vaccination recommendations were subject to unresolved scientific objections.

On June 26, 2026, the Commission opened a formal antitrust investigation under Article 102 of the Treaty on the Functioning of the EU (“TFEU”) and adopted findings that Sanofi may dominate the EU’s enhanced flu vaccine market and that Sanofi’s marketing communications potentially violated the TFEU. Specifically, Article 102 of the TFEU prohibits “abuse by one or more undertakings of a dominant position within the internal market or in a substantial part of it . . . in so far as it may affect trade between Member States.”

In response to the Commission’s investigation, Sanofi made commitments pursuant to Article 9(1) of Council Regulation 1/2003 to avoid further action by the Commission. Sanofi offered commitments to (1) avoid publication or communication of critical or derogatory statements to healthcare providers in Germany and France regarding Fluad, especially as compared to Efluelda, until March 2030; (2) publish corrective statements on Sanofi’s German and French websites; and (3) send said statements to healthcare providers and Key Opinion Leaders in Germany.

The Commission made Sanofi’s commitments binding within seven days of notice to Sanofi of the Commission’s decision.  Prior to this, the Commission performed a market test on Sanofi’s commitments from July 8 through August 21 and found these commitments satisfactory. Sanofi faces a penalty of up to 10% of its worldwide annual turnover or 5% of its daily turnover for every day of non-compliance.

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