PROMISE

Respiratory Syncytial Virus (RSV) is a very common virus that causes serious chest infections, especially in babies and young children, but also in older adults and people with weakened immune systems or existing heart or lung conditions. Each year, RSV causes over 3.6 million hospitalisations and about 100 000 deaths in children. The virus can lead to illnesses like bronchiolitis and pneumonia and puts major pressure on hospitals every winter.

The PROMISE project builds on the results of the IMI RESCEU project, which greatly increased understanding of RSV surveillance, presence, progression and disease burden, as well as investigating potential biomarkers and publishing guidelines to help national and regional governments to develop robust strategies to prevent and treat RSV.

The project investigated the impact of COVID-19 on RSV globally, utilising data from 36 sites in 20 countries. It was observed that a significantly higher proportion of children aged between 12 and 24 months were hospitalised with RSV-associated acute lower respiratory infection (ALRI) in high and upper-middle-income countries during the pandemic years compared to 2019.

RSV can cause substantial health issues for pregnant people and their developing children. Yet little is known about the impact of RSV on pregnant people, and the PROMISE project were the first to publish an analysis of the RSV burden in this population. The study found that the incidence of RSV in pregnant people was comparable to the incidence of RSV in adults older than eighteen with underlying medical conditions. The results are important to inform countries that are currently debating whether to include RSV vaccines in maternal vaccination programmes.

The project also evaluated at-risk populations and found that risk for RSV hospitalisation is 1.5 to 3- fold higher in adults older than 45 with asthma; 2- to 4-fold higher in those with chronic obstructive pulmonary disease, ischemic heart disease, stroke and diabetes; and 3- to 7-fold for those with kidney disease. PROMISE also carried out a study in Scotland that indicated that lower socioeconomic status can predispose individuals to RSV and other respiratory infections.

To help clinicians evaluate how serious an individual case of RSV might be, PROMISE developed a modified RSV bronchiolitis severity score and validated it. To track incidences of RSV during the winter season, the project published European RSV Surveillance Bulletins once every two weeks in 2023-2024. Two generic protocols on measuring the effectiveness of maternal RSV vaccines and monoclonal antibodies were published, and the project has been playing a key role in a global effort to develop an RSV genotype standard for RSV sequencing. In addition, the consortium developed rules of collaboration between the public health institutions and the EFPIA partners with the aim to ensure transparency and build trust in public-private partnerships.

PROMISE carried out a long-term follow-up study on children that were involved in RESCEU’s studies to determine the relationship between RSV infection during infancy and childhood asthma. The project collected clinical data from infants with RSV infections of different severity and analysed data from 97 infants with non-medically attended RSV episodes, finding in those cases that parents reported impacts on their quality of life, with impairment in usual daily activities, worries, anxiety and work absenteeism.

PROMISE also furthered scientific understanding of the RSV virus and how it behaves in the body, in particular shedding light on how the immune system responds to RSV. One study suggested that white blood cells in RSV patients are activated to become inflammatory before being recruited to the airways in response to an RSV infection.

A static multi-cohort model that was capable of evaluating the cost-effectiveness of RSV vaccination strategies in older adults, based on the latest available vaccine product and disease burden information, was developed by the project. This will help national bodies to evaluate the cost-effectiveness of RSV vaccination.

As the project closed, the RSV bulletin was handed over to the ECDC and WHO Europe to continue. PROMISE also has had meaningful engagement with the European Medicines Agency and National Immunization Technical Advisory Groups regarding the two generic protocols for studying vaccine effectiveness that were developed by the project. PROMISE developed a data visualisation dashboard to demonstrate its results, and this has been transferred to ReSViNET.