Value profile for respiratory syncytial virus vaccines and monoclonal antibodies.

Respiratory syncytial virus (RSV) is the predominant cause of acute lower respiratory infection (ALRI) in young children worldwide, yet no licensed RSV vaccine exists to help prevent the millions of illnesses and hospitalizations and tens of thousands of young lives taken each year. Monoclonal antibody (mAb) prophylaxis exists for prevention of RSV in a small subset of very high-risk infants and young children, but the only currently licensed product is impractical, requiring multiple doses and expensive for the low-income settings where the RSV disease burden is greatest. A robust candidate pipeline exists to one day prevent RSV disease in infant and pediatric populations, and it focuses on two promising passive immunization approaches appropriate for low-income contexts: maternal RSV vaccines and long-acting infant mAbs. Licensure of one or more candidates is feasible over the next one to three years and, depending on final product characteristics, current economic models suggest both approaches are likely to be cost-effective. Strong coordination between maternal and child health programs and the Expanded Program on Immunization will be needed for effective, efficient, and equitable delivery of either intervention. This 'Vaccine Value Profile' (VVP) for RSV is intended to provide a high-level, holistic assessment of the information and data that are currently available to inform the potential public health, economic and societal value of pipeline vaccines and vaccine-like products. This VVP was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships and multi-lateral organizations, and in collaboration with stakeholders from the WHO headquarters. All contributors have extensive expertise on various elements of the RSV VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using only existing and publicly available information.

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Declaration of Competing Interest The authors JAF, RB, DH, SK, LCN, CP, KR, and ES report financial support from Bill & Melinda Gates Foundation; YL reports financial support from Wellcome Trust and a professional relationship with Pfizer; JRO reports a professional relationship with Pfizer, Moderna Therapeutics, and Seqirus Inc.; MJ is a guest editor for the Vaccine supplement on Value Profiles for Vaccines and Monoclonal antibodies for Priority Pathogens; RAK reports financial support from the United States National Institutes of Health, Bill & Melinda Gates Foundation, and a professional relationship with GSK Vaccines SRL; HN reports financial support from Pfizer, Innovative Health Initiative, Bill & Melinda Gates Foundation, and the World Health Organization and a professional relationship with Sanofi, GSK, Novavax Inc., Merck Sharp & Dohme UK Ltd., AbbVie Inc., Janssen Pharmaceuticals, and ReSViNET Foundation; RW reports financial support from PATH; and HJZ reports financial support from Bill & Melinda Gates Foundation, South African Medical Research Council, Pfizer, Merck & Co. Inc., AstraZeneca Pharmaceuticals LP and a professional relationship with Sanofi and the World Health Organization. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. To mitigate the potential for undue influence from industrial manufacturers, the first/corresponding author and the last author, neither of whom have relevant conflicts of interest, were responsible for the final version of this manuscript.