Classification of respiratory syncytial virus (RSV) as notifiable disease

Subject: Classification of respiratory syncytial virus (RSV) as notifiable disease

RSV is a common, contagious respiratory virus that leads to over 270 000 hospitalisations and approximately 20 000 in-hospital deaths each year in adults over 60 in Europe1. It is also a leading cause of acute lower respiratory tract infections in infants. The World Health Organization established RSV case definitions in 2018 and many EU countries have respiratory sentinel surveillance in place. However, RSV is still not a mandatory reportable disease at EU level. The lack of a common uniform surveillance case definition for RSV prevents better understanding of its prevalence and limits the interpretation of data by the European Centre for Disease Prevention and Control (ECDC). Discussions by the ECDC on the revision of the case definitions of EU communicable diseases under epidemiological surveillance were reportedly ongoing in December 2022, during which the inclusion of RSV was being considered.

1. Does the Commission intend to add RSV to the list of notifiable diseases?

2. Following an intense RSV season last year, does the Commission envision any other measures to help contain the circulation of RSV?

Submitted: 20.9.2023

1 ‘Respiratory syncytial virus disease burden in adults aged 60 years and older in high‐income countries: A

systematic literature review and meta‐analysis’, Savic, M., 2022, Influenza and Other Respiratory Viruses – Wiley Online Library (https://onlinelibrary.wiley.com/doi/full/10.1111/irv.13031).

Answer given by Ms Kyriakides on behalf of the European Commission (29 November 2023)

As per Article 13 of Regulation EU 2022/2371 (2) that entered into force in December 2022, the list of notifiable diseases at EU level and the corresponding case definitions must be established and updated by means of implementing acts.

The Commission is undertaking this work in coordination with the European Centre for Disease Prevention and Control (ECDC) and has also consulted the World Health Organisation. This work is expected to be finalised in the first quarter of 2024, upon approval by Member States in the Comitology Committee.

In August 2023, the ECDC issued guidelines for integrated surveillance (3) of respiratory viruses including coronavirus disease 2019 (COVID-19), seasonal influenza, and respiratory syncytial virus (RSV). Strengthening surveillance is important to enable collection of evidence related to the impact of preventive measures.

This is also echoed by the Health Security Committee in its opinion ‘Preparing for winter 2023/2024 to address respiratory infections caused by SARS-CoV-2 and other viruses’ (4).

The ECDC Director issued a statement (5) in September 2023 and the ECDC also provided promotional material for social media (6) to promote vaccination.

Furthermore, the European Medicine Agency (EMA) has recommended granting a market authorisatio n (7) for a vaccine against disease caused by the RSV.

1 ∙ ⸱ ‘Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: A systematic literature review and meta-analysis’,

Savic, M., 2022, Influenza and Other Respiratory Viruses — Wiley Online Library (https://onlinelibrary.wiley.com/doi/full/10.1111/irv.13031). 2 ∙ ⸱ https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2022:314:FULL&from=EN 3 ∙ ⸱ https://www.ecdc.europa.eu/en/publications-data/integrated-respiratory-virus-surveillance-respisevere-and-respisurv-reporting-protocol 4 ∙ ⸱ https://health.ec.europa.eu/system/files/2023-10/security_winter2023-2024_respiratory-infections_opinion_en.pdf 5 ∙ ⸱ https://www.ecdc.europa.eu/en/news-events/ecdc-director-protect-peoples-health-autumn-through-vaccination-and-other-preventive 6 ∙ ⸱ https://www.ecdc.europa.eu/en/publications-data/social-media-card-co-circulation-sars-cov-2-rsv-and-influenza-puts-vulnerable 7 ∙ ⸱ https://www.ema.europa.eu/en/news/first-rsv-vaccine-protect-infants-6-months-age-older-adults