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 antib...

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Published inVaccine Vol. 41; pp. S7 - S40
Main Authors Fleming, Jessica A., Baral, Ranju, Higgins, Deborah, Khan, Sadaf, Kochar, Sonali, Li, You, Ortiz, Justin R., Cherian, Thomas, Feikin, Daniel, Jit, Mark, Karron, Ruth A., Limaye, Rupali J., Marshall, Caroline, Munywoki, Patrick K., Nair, Harish, Newhouse, Lauren C., Nyawanda, Bryan O., Pecenka, Clint, Regan, Katie, Srikantiah, Padmini, Wittenauer, Rachel, Zar, Heather J., Sparrow, Erin
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier Ltd 03.11.2023
Elsevier Limited
Subjects
Age
Allergy and Immunology
Antibiotics
Antibodies, Monoclonal - therapeutic use
Bacterial infections
burden of disease
Child
child health
Child, Preschool
Children
Children & youth
Childrens health
cost effectiveness
Disease prevention
Economic analysis
Economic models
Economics
Humans
Immunization
Immunization, Passive
Infant
Infants
Infections
Influenza
Licenses
Maternal & child health
Monoclonal antibodies
Mortality
Newborn babies
Nonprofit organizations
Organizations
Patient admissions
Pediatrics
Pneumonia
Pregnancy
Prenatal care
Prophylaxis
Public health
Public private partnerships
Respiratory syncytial virus
Respiratory Syncytial Virus Infections - prevention & control
Respiratory Syncytial Virus Vaccines
Respiratory Syncytial Virus, Human
respiratory tract diseases
Respiratory tract infection
Respiratory Tract Infections
Risk groups
social benefit
stakeholders
Surveillance
Vaccines
Viruses
Womens health
Online AccessGet full text
ISSN0264-410X
1873-2518
1873-2518
DOI10.1016/j.vaccine.2022.09.081

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Abstract 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.
AbstractList 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.
AbstractRespiratory 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.
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.
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.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.
Author Cherian, Thomas
Wittenauer, Rachel
Jit, Mark
Kochar, Sonali
Baral, Ranju
Li, You
Limaye, Rupali J.
Khan, Sadaf
Nyawanda, Bryan O.
Nair, Harish
Higgins, Deborah
Marshall, Caroline
Karron, Ruth A.
Zar, Heather J.
Ortiz, Justin R.
Fleming, Jessica A.
Sparrow, Erin
Feikin, Daniel
Munywoki, Patrick K.
Newhouse, Lauren C.
Srikantiah, Padmini
Pecenka, Clint
Regan, Katie
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  organization: Center for Vaccine Innovation and Access, PATH, 2201 Westlake Ave Suite 200, Seattle, WA 98121, United States
– sequence: 2
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  surname: Baral
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  organization: Center for Vaccine Innovation and Access, PATH, 2201 Westlake Ave Suite 200, Seattle, WA 98121, United States
– sequence: 3
  givenname: Deborah
  surname: Higgins
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  email: dhiggins@path.org
  organization: Center for Vaccine Innovation and Access, PATH, 2201 Westlake Ave Suite 200, Seattle, WA 98121, United States
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  email: sakhan@path.org
  organization: Maternal, Newborn, Child Health and Nutrition, PATH, 2201 Westlake Ave Suite 200, Seattle, WA 98121, United States
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  email: sonalikochhar@yahoo.co.in
  organization: Global Healthcare Consulting and Department of Global Health, University of Washington, Hans Rosling Center, 3980 15th Ave NE, Seattle, WA 98105, United States
– sequence: 6
  givenname: You
  surname: Li
  fullname: Li, You
  email: you.li@njmu.edu
  organization: School of Public Health, Nanjing Medical University, No. 101 Longmian Avenue, Jiangning District, Nanjing, Jiangsu Province 211166, PR China
– sequence: 7
  givenname: Justin R.
  surname: Ortiz
  fullname: Ortiz, Justin R.
  email: jortiz@som.umaryl
  organization: Center for Vaccine Development and Global Health, University of Maryland School of Medicine, 685 West Baltimore Street, Baltimore, MD 21201-1509, United States
– sequence: 8
  givenname: Thomas
  surname: Cherian
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  email: cheriant@mmglobalhealth.org
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– sequence: 9
  givenname: Daniel
  surname: Feikin
  fullname: Feikin, Daniel
  email: feikind@who.int
  organization: Department of Immunization, Vaccines and Biologicals, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland
– sequence: 10
  givenname: Mark
  surname: Jit
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  email: mark.jit@lshtm.ac
  organization: London School of Hygiene & Tropical Medicine, University of London, Keppel St, London WC1E 7HT, United Kingdom
– sequence: 11
  givenname: Ruth A.
  surname: Karron
  fullname: Karron, Ruth A.
  email: rkarron@jhu.edu
  organization: Center for Immunization Research, Johns Hopkins University, Department of International Health, 624 N. Broadway, Rm 117, Baltimore, MD 21205, United States
– sequence: 12
  givenname: Rupali J.
  surname: Limaye
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  email: rlimaye@jhu.edu
  organization: International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, United States
– sequence: 13
  givenname: Caroline
  surname: Marshall
  fullname: Marshall, Caroline
  email: cmarshall@who.int
  organization: Department of Immunization, Vaccines and Biologicals, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland
– sequence: 14
  givenname: Patrick K.
  surname: Munywoki
  fullname: Munywoki, Patrick K.
  email: oha6@cdc.gov
  organization: Center for Disease Control and Prevention, KEMRI Complex, Mbagathi Road off Mbagathi Way, PO Box 606-00621, Village Market, Nairobi, Kenya
– sequence: 15
  givenname: Harish
  surname: Nair
  fullname: Nair, Harish
  email: harish.nair@ed.ac.uk
  organization: Centre for Global Health, Usher Institute, University of Edinburgh, Edinburgh EH8 9AG, United Kingdom
– sequence: 16
  givenname: Lauren C.
  surname: Newhouse
  fullname: Newhouse, Lauren C.
  email: lnewhouse@path.org
  organization: Center for Vaccine Innovation and Access, PATH, 2201 Westlake Ave Suite 200, Seattle, WA 98121, United States
– sequence: 17
  givenname: Bryan O.
  surname: Nyawanda
  fullname: Nyawanda, Bryan O.
  email: bnyawanda@kemricdc.org
  organization: Kenya Medical Research Institute, Hospital Road, P.O. Box 1357, Kericho, Kenya
– sequence: 18
  givenname: Clint
  surname: Pecenka
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  email: cpecenka@path.org
  organization: Center for Vaccine Innovation and Access, PATH, 2201 Westlake Ave Suite 200, Seattle, WA 98121, United States
– sequence: 19
  givenname: Katie
  surname: Regan
  fullname: Regan, Katie
  email: kregan@path.org
  organization: Center for Vaccine Innovation and Access, PATH, 2201 Westlake Ave Suite 200, Seattle, WA 98121, United States
– sequence: 20
  givenname: Padmini
  surname: Srikantiah
  fullname: Srikantiah, Padmini
  email: padmini.srikantiah@gatesfoundation.org
  organization: Bill & Melinda Gates Foundation, 500 5th Ave N, Seattle, WA 98109, United States
– sequence: 21
  givenname: Rachel
  surname: Wittenauer
  fullname: Wittenauer, Rachel
  email: rwitten1@uw.edu
  organization: Department of Pharmacy, University of Washington, Health Sciences Building, 1956 NE Pacific St H362, Seattle, WA 98195, United States
– sequence: 22
  givenname: Heather J.
  surname: Zar
  fullname: Zar, Heather J.
  email: heather.zar@uct.ac.za
  organization: Department of Paediatrics & Child Health and SA-MRC Unit on Child & Adolescent Health, Red Cross Children’s Hospital, University of Cape Town, Klipfontein Road, Rondebosch, Cape Town 7700, South Africa
– sequence: 23
  givenname: Erin
  surname: Sparrow
  fullname: Sparrow, Erin
  email: sparrowe@who.int
  organization: Department of Immunization, Vaccines and Biologicals, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland
BackLink https://www.ncbi.nlm.nih.gov/pubmed/37422378$$D View this record in MEDLINE/PubMed
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DOI 10.1016/j.vaccine.2022.09.081
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Snippet Respiratory syncytial virus (RSV) is the predominant cause of acute lower respiratory infection (ALRI) in young children worldwide, yet no licensed RSV vaccine...
AbstractRespiratory syncytial virus (RSV) is the predominant cause of acute lower respiratory infection (ALRI) in young children worldwide, yet no licensed RSV...
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SubjectTerms Age
Allergy and Immunology
Antibiotics
Antibodies, Monoclonal - therapeutic use
Bacterial infections
burden of disease
Child
child health
Child, Preschool
Children
Children & youth
Childrens health
cost effectiveness
Disease prevention
Economic analysis
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Economics
Humans
Immunization
Immunization, Passive
Infant
Infants
Infections
Influenza
Licenses
Maternal & child health
Monoclonal antibodies
Mortality
Newborn babies
Nonprofit organizations
Organizations
Patient admissions
Pediatrics
Pneumonia
Pregnancy
Prenatal care
Prophylaxis
Public health
Public private partnerships
Respiratory syncytial virus
Respiratory Syncytial Virus Infections - prevention & control
Respiratory Syncytial Virus Vaccines
Respiratory Syncytial Virus, Human
respiratory tract diseases
Respiratory tract infection
Respiratory Tract Infections
Risk groups
social benefit
stakeholders
Surveillance
Vaccines
Viruses
Womens health
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