RSV immunisation for infants in Europe: are our health systems ready?

23 November 2023

Respiratory Syncytial Virus (RSV) is an urgent and immediate threat to all infants and leads to significant burden to health systems. Nearly every child is infected with RSV by the age of 2, it accounts for 63% of acute lower respiratory tract infections in infants, and it is the most common cause of bronchiolitis and pneumonia in infants. RSV is also a leading cause of hospitalisations for infants in their first year of life and is responsible for a significant outpatient burden. The natural course of RSV infection is also highly unpredictable in infants, as an estimated 72-98.3% of infants hospitalised for RSV were previously healthy and born at term.

Despite this clear burden on health systems, for many years the only approved agent for RSV prophylaxis in Europe was the anti-RSV monoclonal antibody (mAb) Palivizumab, which is typically reserved for a small population of infants at high risk of developing severe RSV disease. However, the monoclonal antibody nirsevimab received approval from the European Medicines Agency (EMA) in 2022 to immunise all infants against medically attended RSV-LRTI (lower respiratory tract infection) during their first RSV season. Although nirsevimab is a monoclonal antibody, its use in public health pursues the same primary prevention goal as vaccines, requiring its robust implementation into immunisation programmes to guarantee equitable access to infants.

With the arrival of this new option for RSV prophylaxis, there are compelling reasons to prioritise RSV prevention and raise public awareness about the public health impact of RSV in Europe. Initial positive national recommendations for nirsevimab have already been made by the Haute Autorité de Santé in France and the Ministerio de Sanidad in Spain, meaning European health systems are now in a critical period where a stronger understanding of how they might implement prophylactic mAbs can help to ensure equity of access for infants.

With the aim of developing a deeper understanding of how health managers can successfully implement an RSV mAb, EHMA conducted 27 interviews with experts from 10 European countries (Austria, Belgium, Finland, France, Germany, Italy, the Netherlands, Norway, Portugal, Sweden) who possess expertise in RSV prevention, paediatric healthcare, and health system management. We also hosted 12 of these experts, representing 8 of the observed countries, to a closed-door roundtable discussion on the topic of RSV mAb implementation at its annual conference. Through analysis of the insights gathered, this white paper provides an in-depth understanding of the challenges and opportunities associated with implementing prophylactic monoclonal antibodies for infants during their first RSV season.

The White Paper

The White Paper

This paper presents policy recommendations for stakeholders with critical roles in the implementation of immunisation campaigns protecting infants in their first RSV season.

  • The need for collaborative networks on RSV prevention, working across the different levels of health system governance. 
  • The importance of targeted education and awareness campaigns for both RSV and for monoclonal antibodies, reaching citizens and the health workforce. 
  • The power of clear guidelines and best practices for the implementation of RSV immunisation programmes using a monoclonal antibody, to which health managers and care providers can look to for direction. 
  • The use of surveillance and monitoring systems to provide invaluable data to health authorities and policymakers, allowing for evidence-based decision-making on RSV. 

This paper was supported by Sanofi.

This paper is based on independent research delivered by EHMA. Sanofi has had no influence or editorial control over the content of this paper, and the views and opinions of the authors are not necessarily those of Sanofi.


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