Sanofi has made commitments to the European Commission to resolve an antitrust investigation into its promotion of the enhanced flu vaccine Efluelda, following allegations that the company ran a misleading communication campaign against rival manufacturer CSL Seqirus.
The Commission opened a formal investigation in June of this year, alleging that since 2024, Sanofi pursued communications to healthcare professionals in Germany and France suggesting that its Efluelda vaccine had a stronger evidence base than CSL Seqirus's Fluad.
Regulators said this contradicted assessments from the European Centre for Disease Control and national immunisation technical advisory groups (NITAGs) in both countries, which recommend the two vaccines equally for elderly patients.
The Commission's preliminary assessment found Sanofi may hold a dominant position in the enhanced flu vaccine market in Germany and France and that its alleged conduct, which included misrepresenting national vaccination recommendations and suggesting unresolved scientific objections to Fluad, may have restricted competition in breach of Article 102 of the Treaty on the Functioning of the European Union.
To address the concerns, Sanofi has proposed publishing statements on its German and French websites for two years, clarifying that national health authorities regard both vaccines as having comparable evidence bases.
The firm has also offered to distribute the German statement directly to healthcare professionals and to include a prominent citation of the German NITAG recommendation in marketing materials for four years.
Further commitments include refraining from portraying Fluad negatively or claiming Efluelda's superiority unless supported by approved product characteristics or qualifying comparative studies and extending these restrictions to contracted Key Opinion Leaders.
A monitoring trustee would oversee compliance if the commitments are accepted.
The proposed remedies would remain in force until March 2030. Under Article 9(1) of Regulation 1/2003, the commitments procedure allows companies to address competition concerns without a formal finding of infringement.
The Commission has also invited third parties, including competitors and industry stakeholders, to submit feedback by 21st August 2026 before deciding whether to accept Sanofi's proposal.
Sanofi said in a statement that the submission of commitments does not imply any finding of wrongdoing, adding that it "remains confident [it] has acted in full compliance with competition law."
If the Commission ultimately accepts the commitments and Sanofi fails to honour them, the company could face fines of up to 10% of its global annual turnover, or daily penalty payments of 5% of turnover for continued non-compliance.
