The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access.

Respiratory syncytial virus (RSV) is the second most common pathogen causing infant mortality. Additionally, RSV is a major cause of morbidity and mortality in older adults (age ≥60 years) similar to influenza. A protein-based maternal vaccine and monoclonal antibody (mAb) are now market-approved to protect infants, while an mRNA and two protein-based vaccines are approved for older adults. First-year experience protecting infants with nirsevimab in high-income countries shows a major public health benefit. It is expected that the RSV vaccine landscape will continue to develop in the coming years to protect all people globally. The vaccine and mAb landscape remain active with 30 candidates in clinical development using four approaches: protein-based, live-attenuated and chimeric vector, mRNA, and mAbs. Candidates in late-phase trials aim to protect young infants using mAbs, older infants and toddlers with live-attenuated vaccines, and children and adults using protein-based and mRNA vaccines. This Review provides an overview of RSV vaccines highlighting different target populations, antigens, and trial results. As RSV vaccines have not yet reached low-income and middle-income countries, we outline urgent next steps to minimise the vaccine delay.
Competing Interests: Declaration of interests JT and NIM received support for attending meetings or travel from the ResViNET Foundation. UMC Utrecht (LJB and NIM) received grants from AbbVie, AstraZeneca, The Bill & Melinda Gates Foundation, the Dutch Lung Foundation, The Gates Medical Research Institute, GlaxoSmithKline (GSK), Janssen, MedImmune, MeMed, Merck, Novavax, Pfizer, and Sanofi; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Ablynx, AstraZeneca, Bavaria Nordic, GSK, Janssen, MabXience, MedImmune, MEDtalks, Merck, Moderna, Novavax, Pfizer, Sanofi, and Virology Education. LJB is founding chairman of the ReSViNET Foundation. UJB was supported by the Division of Intramural Research of the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH); and is named as an inventor on patents for live-attenuated RSV, with royalties paid to the National Institutes of Health by Sanofi Pasteur. ADC received grants from The Bill & Melinda Gates Foundation and WHO. CC received grants from Sanofi Pasteur, the Centers for Disease Control and Prevention, The Bill & Melinda Gates Foundation, and the Task Force for Global Health. RD received grants from Pfizer, Merck, MedImmune, and AstraZeneca; consulting fees from Pfizer, Merck and GSK; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Pfizer, Merck, Sanofi Pasteur, GSK, MedImmune, and AstraZeneca; and participated on a data safety monitoring boards or advisory boards for Pfizer, Merck, and GSK. BSG is named as an inventor on patents for RSV vaccines and mABS; received royalties from the NIH; and consulting fees from GSK, Pfizer, AstraZeneca, Sanofi Pasteur, and Exevir. RAK received grants from the NIH and Sanofi Pasteur. YL received grants from GSK, Merck, and WHO; consulting fees from Pfizer and WHO; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Pfizer; and support for attending meetings or travel from Pfizer. AJP received grants from The Bill & Melinda Gates Foundation, Wellcome, Cepi, the Medical Research Council, the NIH and Care Research, AstraZeneca, the European Commission, and the Serum Institute of India; royalties from AstraZeneca for the development of COVID-19 vaccines; consulting fees from Shionogi; is chair of the Joint Committee on Vaccination and Immunization of the Department of Health and Social Care; and has been member of the Strategic Advisory Group of Experts on Immunization for WHO. All other authors declare no competing interests.
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