Substantial Burden of Nonmedically Attended RSV Infection in Healthy-Term Infants: An International Prospective Birth Cohort Study.

Background: During the first year of life, 1 in 4 infants develops a symptomatic respiratory syncytial virus (RSV) infection, yet only half seek medical attention. The current focus on medically attended RSV therefore underrepresents the true societal burden of RSV. We assessed the burden of nonmedically attended RSV infections and compared with medically attended RSV.
Methods: We performed active RSV surveillance until the age of 1 year in a cohort (n = 993) nested within the Respiratory Syncytial Virus Consortium in EUrope (RESCEU) prospective birth cohort study enrolling healthy term-born infants in 5 European countries. Symptoms, medication use, wheezing, and impact on family life were analyzed.
Results: For 97 of 120 (80.1%) nonmedically attended RSV episodes, sufficient data were available for analysis. In 50.5% (49/97), symptoms lasted ≥15 days. Parents reported impairment in usual daily activities in 59.8% (58/97) of episodes; worries, 75.3% (73/97); anxiety, 34.0% (33/97); and work absenteeism, 10.8% (10/93). Compared with medically attended RSV (n = 102, 9 hospital admissions), Respiratory Syncytial Virus NETwork (ReSViNET) severity scores were lower (3.5 vs 4.6, P < .001), whereas duration of respiratory symptoms and was comparable.
Conclusions: Even when medical attendance is not required, RSV infection poses a substantial burden to infants, families, and society. These findings are important for policy makers when considering the implementation of RSV immunization. Clinical Trials Registration. ClinicalTrials.gov (NCT03627572).
Competing Interests: Potential conflicts of interest. M. A. v. H. has received honoraria for participation in advisory boards from Sanofi and Moderna and acted as a principal investigator in randomized clinical trials for Pfizer. T. H. has received honoraria for lectures or participation in advisory boards or data monitoring committees from Janssen, Sanofi, and MSD. A. J. P. is part of RESCEU (Respiratory Syncytial Virus Consortium in Europe), and his university received grant funding from the European Commission’s Innovative Medicines Initiative for this work. Oxford University has received grant funding from the Medical Research Council, Wellcome Trust, Bill & Melinda Gates Foundation, Serum Institute of India, and AstraZeneca. A. J. P. is a contributor to intellectual property licensed by Oxford University Innovation to AstraZeneca. A. J. P. is chair of the UK Joint Committtee of Vaccination and Immunisation and was a member of the World Health Organization’s Strategic Advisory Group of Experts on Immunization until 2022. S. C. provided clinical study advice or acted as principal investigator for GSK, Pfizer, MedImmune, Ablynx, Gilead, Ark Biosciences, Shionogi, and Janssen/Alios, with fees paid to the University of Edinburgh. F. M.-T. has received honoraria from GSK, Biofabri, Pfizer Inc, Sanofi Pasteur, MSD, Seqirus, and Janssen for taking part in advisory boards and expert meetings and for acting as a speaker in congresses outside the scope of the submitted work. F. M.-T. has also acted as principal investigator in randomized controlled trials of the aforementioned companies as well as Ablynx, Gilead, Regeneron, Roche, Abbott, Novavax, and MedImmune, with honoraria paid to his institution. A. D.-U. has been a subinvestigator for clinical trials sponsored by Pfizer and GSK and observational studies sponsored by Sanofi, with all funds paid to her institution. A. D.-U. has received funding for attending the Asociación Española Pediatría (Pediatric Spanish Association) meeting in 2022. L. J. B. has regular interaction with pharmaceutical and other industrial partners. He has not received personal fees or other personal benefits. University Medical Center Utrecht (UMCU) has received major funding (>€100 000 per industrial partner) for investigator-initiated studies from AbbVie, MedImmune, AstraZeneca, Sanofi, Janssen, Pfizer, MSD, and MeMed Diagnostics. UMCU has received major funding for the RSV GOLD study from the Bill & Melinda Gates Foundation. UMCU has received major funding as part of the public-private RESCEU and PROMISE projects, funded by the Innovative Medicines Initiative, in partnership with GSK, Novavax, Janssen, AstraZeneca, Pfizer, and Sanofi. UMCU has received major funding from Julius Clinical for participating in clinical studies sponsored by MedImmune and Pfizer. UMCU received minor funding (€1000–€25 000 per industrial partner) for consultation and invited lectures by AbbVie, MedImmune, Ablynx, Bavaria Nordic, MabXience, GSK, Novavax, Pfizer, Moderna, AstraZeneca, MSD, Sanofi, Genzyme, and Janssen. L. J. B. is the founding chair of the ReSViNET Foundation. J. G. W. has been an investigator for clinical trials sponsored by pharmaceutical companies, including AstraZeneca, Merck, Pfizer, Sanofi, and Janssen, with all funds paid to UMCU. J. G. W participated in the advisory board of Janssen and Sanofi, with fees paid to UMCU. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
(© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)