欧洲疾控中心-欧洲2025_26冬季保护婴儿免受呼吸道合胞病毒病侵害的快速科学建议（英）-2025.11_18页_636kb

ECDC RSV Immunisation Summary for EU/EEA Countries (2025/26 Winter Season)

Core Content

Respiratory Syncytial Virus (RSV) is a common respiratory virus that disproportionately affects infants, particularly those under six months of age, and can lead to severe illness such as bronchiolitis and pneumonia, requiring hospitalisation and, in rare cases, resulting in death. The 2025/26 RSV season is beginning in Europe, with increased detections and rising rates of influenza-like illness, posing a heightened risk to vulnerable groups, especially infants.

Main Points

• Epidemiology of RSV in Infants:

  • RSV infections peak in infants aged 0–4 years.
  • The youngest infants (0–2 months) account for a high proportion of ICU admissions.
  • RSV-associated hospitalisations are most common in children under two years old.
  • Comorbidities like prematurity and chronic lung disease increase the risk of severe disease.

• Immunisation Products:

  • Two RSV immunisation products have been authorised in the EU: Beyfortus (long-acting mAb for infants) and Abrysvo (maternal vaccine for pregnant individuals).
  • A third long-acting mAb, Enflonsia, has received a positive opinion from the EMA but is awaiting final authorisation.

• Implementation in EU/EEA Countries:

  • 23 countries have issued RSV immunisation recommendations.
  • 16 countries have implemented funded universal long-acting mAbs programmes for infants.
  • 3 countries recommend long-acting mAbs for high-risk infants.
  • 3 countries use maternal vaccination exclusively.
  • 1 country has implemented a combined strategy of maternal vaccination and infant mAbs.
  • 2 countries have maternal vaccination recommendations but no funding.

• Immunisation Coverage:

  • Coverage for RSV mAbs and maternal vaccines varies across countries.
  • Spain reported 90.1% nirsevimab uptake for infants <6 months.
  • In Ireland, a pilot programme achieved 83% uptake among infants.
  • In the UK, maternal vaccination coverage reached 54.7% by March 2025.

• Effectiveness and Safety:

  • RSV mAbs and maternal vaccines show strong efficacy against severe disease and hospitalisation.
  • Efficacy estimates range from 72% to 95.2%.
  • Safety profiles are generally good, with no significant adverse effects reported in the three months post-immunisation.

• ECDC Recommendations:

  • Raise Awareness: Educate the public and healthcare providers on RSV risks, prevention, and immunisation options.
  • Strengthen Surveillance: Integrate RSV surveillance with existing respiratory infection networks to understand disease trends, severity, and age distribution.
  • Monitor Safety and Effectiveness: Implement systems to track the impact and safety of immunisation products.
  • Promote Immunisation Acceptance: Use targeted communication strategies to increase acceptance among healthcare professionals and the public.
  • Support Evidence-Based Decision-Making: Use data from successful programmes and ongoing monitoring to inform national immunisation policies.

Key Strategies for RSV Immunisation

Surveillance and Monitoring

• Surveillance systems should monitor:
  • Changes in RSV epidemiology across age groups.
  • Co-circulation of respiratory viruses and their impact.
  • Genetic and phenotypic changes in RSV strains that may affect vaccine efficacy.
  • Burden of RSV disease over time.
  • Risk factors for severe illness to inform future recommendations.

Evidence Gaps

• Research is ongoing to address key questions, including:
  • Duration of immunity and protection.
  • Differences in vaccine effectiveness by RSV type.
  • Effectiveness in specific high-risk groups.
  • Cost-effectiveness in different healthcare settings and populations.

Conclusion

ECDC advises EU/EEA countries to strengthen RSV prevention through immunisation, enhance surveillance, and improve communication to increase acceptance and ensure equitable access. Ongoing monitoring of safety and effectiveness will be essential to guide future policy decisions.