Sanofi has avoided a potentially substantial European Union fine after the European Commission accepted its commitments to stop disparaging a rival flu vaccine, closing an antitrust investigation without a formal finding of infringement.
The Commission announced the decision on Wednesday.
It concerns Sanofi’s promotion of its enhanced flu vaccine, Efluelda, against Fluad, made by CSL Seqirus. The two are the main competing enhanced flu vaccines for older and vulnerable patients.
What was Sanofi accused of?
The Commission opened proceedings on 26 June this year, examining whether Sanofi ran a misleading communications campaign aimed at healthcare professionals, primarily in Germany and France.
Regulators were concerned that the messaging suggested Fluad had a weaker evidence base than Efluelda and misrepresented national vaccination recommendations.
The Commission preliminarily considered Sanofi dominant in both markets.
Those recommendations place both vaccines on an equal footing. Since October 2024, Germany’s STIKO has recommended either Efluelda or Fluad for people aged 60 and older, with no preference between them.
The Commission said the campaign contradicted assessments by the European Centre for Disease Prevention and Control and national immunisation advisory groups.
Had it found an abuse of dominance, the Commission could have fined Sanofi up to 10% of its global annual turnover.
Sanofi has maintained that it complied with all applicable laws, and that submitting commitments does not imply any finding of infringement.
What has Sanofi committed to?
The commitments are legally binding and run until March 2030.
Sanofi must not use promotional materials aimed at healthcare professionals in Germany and France to criticise national vaccination recommendations, portray Fluad negatively, or suggest that Efluelda is safer or more effective.
For two years, Sanofi must also publish statements on its German and French websites confirming that national recommendations treat both vaccines as equivalent in protecting older people against influenza, both being supported by a robust evidence base.
The statement must also reach healthcare professionals and key opinion leaders in Germany who received the materials in question. The restrictions extend to contracted key opinion leaders. A monitoring trustee will oversee compliance.
manufacturingchemist
Regulator’s view
Executive Vice-President Teresa Ribera said Sanofi’s engagement had allowed “a very fast and effective outcome," within a year of the Commission’s unannounced inspections.
She rejected suggestions that waiving a fine could encourage other companies to disparage rivals, saying her team “will remain vigilant."
CSL Seqirus welcomed the decision, saying it reinforced the importance of accurate, evidence-based vaccine communications that reflect independent scientific assessments.
The case follows the Commission’s earlier action around disparagement in the Vifor and Teva Copaxone cases, adding to the guidance on how it assesses such conduct.
For manufacturers, the message is that promotional claims about competing products, particularly where they diverge from public health body assessments, can attract competition scrutiny and that early cooperation can lead to faster resolution.
Ribera said the broader aim is for medicines to win on the merits, backed by public health agencies, rather than because rivals have been discouraged from challenging incumbents.
