Brussels has signed an agreement with the company Moderna to purchase vaccines intended for the prevention of respiratory syncytial virus (RSV).
The mRESVIA vaccine protects against lung diseases such as bronchitis and pneumonia caused by RSV in adults. This contract is valid for up to four years.
RSV is a common respiratory virus that usually causes mild cold-like symptoms. Although most people recover within about a week without medical intervention, RSV can cause severe illness and death in more vulnerable groups, such as the elderly.
In Europe, over 156 thousand adults are hospitalized annually due to RSV complications. At least 39 countries have signed on to the Joint Procurement Agreement to address this issue.
The Joint Procurement Agreement is a mechanism at the European Union level that allows for the joint purchase of vaccines on a voluntary and flexible basis. This mechanism plays an important role in preparing the EU for public health crises or pandemics.
The European Commission has invited all interested parties to submit their comments regarding the commitments proposed by Sanofi. These commitments aim to address competition issues that arose due to a communication campaign which may have negatively affected the only competing flu vaccine recommended for vulnerable patients with risk factors.
At the center of Brussels' investigation is an inquiry into whether Sanofi ran a campaign among healthcare professionals since 2024. This campaign could have harmed the Fluad vaccine produced by CSL Seqirus, as the company hinted that Fluad's scientific basis was inferior to the basis of Efluelda, manufactured by the French firm.
According to the EU executive body, Sanofi may have disseminated information that 'implied that Fluad's evidence base was weaker than Efluelda's.' This contradicts assessments by the European Centre for Disease Prevention and Control, as well as national technical vaccination groups in Germany and France.
Furthermore, Brussels noted that the company might have 'incorrectly presented national vaccination recommendations' and claimed that the recommendation for Fluad in Germany was still subject to 'unresolved scientific objections' from medical societies.
In its preliminary assessment, the European Commission believes that Sanofi may hold a dominant position in the markets for enhanced flu vaccines in Germany and France, and that this behavior could constitute an abuse of that position in violation of general rules.
To alleviate concerns, Sanofi proposed publishing statements on its German and French websites over two years, acknowledging the assessments of technical bodies. In Germany, the company committed to clarifying that the national technical vaccination group concluded that 'Efluelda and Fluad both have a robust evidence base,' and that both vaccines were recommended equivalently for the elderly.
The pharmaceutical company also proposed limiting communication with healthcare professionals, promising not to 'criticize, question, or contradict' national vaccination guidelines, nor to present Fluad in a negative light or suggest advantages of Efluelda without support from health authority-approved information or adequate comparative studies. These Sanofi commitments will be valid until March 2030 and will be monitored by an independent supervisor.
The European Commission will receive feedback from interested parties until August 21. If it deems the proposed measures sufficient, Brussels may make them legally binding.
