European Commission launches antitrust probe against Sanofi over alleged misleading vaccine marketing

CSL Seqirus' Fluad sales were $901 million in the last fiscal year, down 14%, underscoring the financial stakes in the Sanofi–CSL Seqirus competition over enhanced flu vaccines.
The European Commission has issued a Preliminary Assessment identifying the competition concerns and giving Sanofi the opportunity to propose commitments to address those concerns before formal proceedings proceed.
The formal antitrust investigation follows earlier regulatory actions, including unannounced inspections; reports indicate raids on Sanofi offices in September, illustrating the timeline and persistence of the scrutiny.
Regulators allege that Sanofi ran a misleading communication campaign that portrayed Fluad as inferior to Efluelda, including claims of weaker evidence and representations of national vaccination recommendations, with notes of unresolved scientific objections from German medical societies.
The European Commission has opened a formal antitrust investigation into French drugmaker Sanofi over its marketing of the flu vaccine Efluelda, according to Fierce Pharma. Regulators allege Sanofi ran a misleading campaign that portrayed rival CSL Seqirus's Fluad as inferior — potentially steering doctors away from a vaccine recommended by major European health bodies.
The probe, announced June 26, 2026, follows unannounced raids on Sanofi offices in September 2025. The Commission has already issued a Preliminary Assessment laying out its concerns and is giving Sanofi a chance to propose fixes before the case goes further, Benzinga reported.
Both Efluelda and Fluad are enhanced flu vaccines for people over 60. Regulators say Sanofi told healthcare professionals in France and Germany that Fluad had a weaker base of scientific evidence than Efluelda. That contradicts guidance from the European Centre for Disease Prevention and Control, which recommends Fluad, Insight EU Monitoring reported.
In Germany, the situation was especially pointed. The Brussels Times reported that Sanofi allegedly told German doctors that the national recommendation for Fluad still faced "unresolved scientific objections" from local medical societies. Regulators say that framing was misleading. EU Executive Vice-President Teresa Ribera said the probe shows the Commission's "determination to address disparagement practices that can unduly damage competition and informed choices."
This is not the first time EU regulators have gone after a drugmaker for badmouthing a rival. In 2024, Teva was fined €462.6 million for running a disparagement campaign against a competing multiple sclerosis drug. In 2023, CSL Vifor settled a similar case involving an iron treatment and agreed to a 10-year monitoring period, according to Endpoints News.
Regulators are using Article 102 of the EU treaty, which bans companies from abusing a dominant market position. If Sanofi is found guilty, it could face fines of up to 10% of its total global annual revenue. Sanofi's market cap stands at roughly €100 billion, making the financial stakes significant.
The commercial stakes for CSL Seqirus are real. Fluad brought in $901 million in sales last fiscal year — but that was down 14% from the year before, according to Fierce Pharma. CSL even delayed plans to spin off its vaccine unit in October 2025, citing a "remarkable" drop in flu vaccination rates across key markets.
If the Commission forces Sanofi to retract its claims or change its messaging, Fluad could regain lost ground in France and Germany. Those are two of Europe's biggest flu vaccine markets, and both were specifically named in the probe.
Sanofi is not backing down. A company spokeswoman said: "Sanofi is confident that it has acted, and continues to act, in full compliance with all applicable laws and regulations." The company also stressed that opening proceedings "does not in any way prejudge the outcome," according to Medical Xpress.
Sanofi does have options short of a full ruling. The Commission is allowing the company to propose commitments — formal changes to its marketing practices — that could resolve the case without a final finding of wrongdoing. Sanofi's stock barely moved after the announcement, trading up 0.3% at around €73.97, suggesting investors had already factored in the regulatory risk after last year's raids.
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