Commission seeks feedback on commitments offered by Sanofi over possible anticompetitive conduct regarding the promotion of a flu vaccine for vulnerable patients

The European Commission invites comments on commitments offered by Sanofi to address competition concerns regarding a communication campaign that has possibly disparaged the only rival flu vaccine recommended for vulnerable patients with risk factors.

The Commission's investigation

Sanofi, headquartered in France, is a multinational company active in the research, development, and manufacturing of innovative prescription medicines, vaccines, and healthcare solutions. One of the vaccines offered by Sanofi is an enhanced flu vaccine, which is specifically designed to provide greater protection against flu for people over 60.

In the EU, this vaccine is marketed under the brand name ‘Efluelda' and competes with another enhanced flu vaccine marketed by the company CSL Seqirus under the brand name ‘Fluad'.

On 26 June 2026, the Commission opened a formal investigation and - in parallel - adopted a Preliminary Assessment summarising the main facts of the case and identifying its preliminary competition concerns.

The Commission found that Sanofi may be dominant in the market for enhanced flu vaccines in Germany and France. Also, the Commission has indications that since 2024 Sanofi may have pursued a misleading communication campaign aimed at health-care professionals (HCPs):

• suggesting that the evidentiary basis for Fluad is weaker than that for Efluelda, in contradiction to the findings of the European Centre for Disease Control and national immunisation technical advisory groups (NITAGs) in Germany and France;
• misrepresenting national vaccination recommendations;
• suggesting that the national vaccination recommendations for Fluad in Germany remains subject to unresolved scientific objections from medical professional societies.

By doing so, Sanofi may have restricted competition on the market for enhanced flu vaccines in Germany and France, in breach of Article 102 Treaty on the Functioning of the EU (TFEU).

The offered commitments

To address the Commission's preliminary concerns, Sanofi has offered the following commitments relating to proactive communication:

• To publish a statement on its German website, for a period of two years, acknowledging the ECDC's and German NITAG's assessment. The statement clarifies that the German NITAG has assessed Efluelda and Fluad and concluded that they both have a robust evidence base, and that therefore the German NITAG has recommended them equally for elderly people, over standard flu vaccines. Sanofi has also offered to distribute this statement to German HCPs;
• To publish a statement on its French website, for a period of two years, clarifying that the French NITAG's current recommendation treats Fluad and Efluelda as equivalent;
• To include, for a period of four years, a prominent citation of the current German NITAG recommendation in German marketing and promotional material for enhanced flu vaccines.

In addition, in its communications with HCPs about enhanced flu vaccines in both Germany and France, Sanofi has offered to refrain from:

• criticising, casting doubt on or contradicting the applicable national vaccine recommendations issued by the relevant NITAG;
• portraying Fluad negatively, or suggesting that Efluelda is safer or more effective, unless such suggestion is based on the summaries of product characteristics (SmPCs) approved by the competent health agencies at EU or national level, or on head-to-head comparative studies meeting specified criteria;
• using statements implying or suggesting that the evidence base supporting Fluad is weaker than that supporting Efluelda, including through mischaracterisation or selective presentation of scientific studies involving Fluad.
• including statements as previously described when providing input to so-called Key Opinion Leaders for their interactions with HCPs in France and Germany concerning enhanced flu vaccines. Sanofi also offers to include in its new contracts with such Key Opinion Leaders a clause referring to its commitments.

The commitments offered by Sanofi would remain in force until March 2030. Their implementation would be monitored by a monitoring trustee who will report regularly to the Commission.

The Commission invites all interested parties to submit their views on Sanofi's proposed commitments no later than 21 August 2026. The full text of the commitments is available on the Commission's competition website.

Background

Article 102 TFEU prohibits the abuse of a dominant position that may affect trade and prevent or restrict competition within the Single Market. The implementation of Article 102 TFEU is defined in Regulation 1/2003.

Article 9(1) of the Regulation 1/2003 enables companies investigated by the Commission to offer commitments in order to meet the Commission's concerns and empowers the Commission to make such commitments binding on the companies. Article 27(4) of Regulation 1/2003 requires that before adopting such decision, the Commission shall provide interested third parties with an opportunity to comment on the offered commitments (“the market test”).

If the market test indicates that the commitments are a satisfactory way of addressing the Commission's competition concerns, the Commission may adopt a decision making them legally binding on Sanofi. Such a decision would not conclude that there is an infringement of EU antitrust rules, but would legally bind Sanofi to respect the commitments it has offered.

If the company does not honour such commitments, the Commission may impose a fine of up to 10% of its worldwide annual turnoverwithout having to find an infringement of EU antitrust rules, or a periodic penalty payment of 5% per day of its daily turnover for every day of non-compliance.

For more information

More information, including the full text of the commitments, will be available on the Commission's competition website, in the public case register under the case number AT.40998.