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WHO preferred product characteristics for monoclonal antibodies for passive immunization against respiratory syncytial virus (RSV) disease in infants - Key considerations for global use.

ABSTRACT: World Health Organization (WHO) preferred product characteristics describe preferences for product attributes that would help optimize value and use to address global public health needs, with a particular focus on low- and middle-income countries. Having previously published preferred product characteristics for both maternal and paediatric respiratory syncytial virus (RSV) vaccines, WHO recently published preferred product characteristics for monoclonal antibodies to prevent severe RSV disease in infants. This article summarizes the key attributes from the preferred product characteristics and discusses key considerations for future access and use of preventive RSV monoclonal antibodies.

SUBMITTER: Sparrow E

PROVIDER: S-EPMC9176315 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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WHO preferred product characteristics for monoclonal antibodies for passive immunization against respiratory syncytial virus (RSV) disease in infants - Key considerations for global use.

Sparrow Erin E Adetifa Ifedayo I Chaiyakunapruk Nathorn N Cherian Thomas T Fell Deshayne B DB Graham Barney S BS Innis Bruce B Kaslow David C DC Karron Ruth A RA Nair Harish H Neuzil Kathleen M KM Saha Samir S Smith Peter G PG Srikantiah Padmini P Were Fred F Zar Heather J HJ Feikin Daniel D

Vaccine 20220217 26

World Health Organization (WHO) preferred product characteristics describe preferences for product attributes that would help optimize value and use to address global public health needs, with a particular focus on low- and middle-income countries. Having previously published preferred product characteristics for both maternal and paediatric respiratory syncytial virus (RSV) vaccines, WHO recently published preferred product characteristics for monoclonal antibodies to prevent severe RSV disease ...[more]

PMID: 35184927

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Project description:BackgroundPalivizumab, a monoclonal antibody and the only licensed immunization product for preventing respiratory syncytial virus (RSV) infection, is recommended for children with certain high-risk conditions. Other antibody products and maternal vaccines targeting young infants are in clinical development. Few studies have compared products closest to potential licensure and have primarily focused on the effects on hospitalizations only. Estimates of the impact of these products on medically-attended (MA) infections in a variety of healthcare settings are needed to assist with developing RSV immunization recommendations.MethodsWe developed a tool for practicing public health officials to estimate the impact of immunization strategies on RSV-associated MA lower respiratory tract infections (LRTIs) in various healthcare settings among infants <12 months. Users input RSV burden and seasonality and examine the influence of altering product efficacy and uptake assumptions. We used the tool to evaluate candidate products' impacts among a US birth cohort.ResultsWe estimated without immunization, 407,360 (range: 339,650-475,980) LRTIs are attended annually in outpatient clinics, 147,240 (126,070-168,510) in emergency departments (EDs), and 33,180 (24,760-42,900) in hospitals. A passive antibody candidate targeting all infants prevented the most LRTIs: 196,470 (48% of visits without immunization) outpatient clinic visits (range: 163,810-229,650), 75,250 (51%) EDs visits (64,430-86,090), and 18,140 (55%) hospitalizations (13,770-23,160). A strategy combining maternal vaccine candidate and palivizumab prevented 58,210 (14% of visits without immunization) LRTIs in outpatient clinics (range: 48,520-67,970), 19,580 (13%) in EDs (16,760-22,400), and 8,190 (25%) hospitalizations (6,390-10,150).ConclusionsResults underscore the potential for anticipated products to reduce serious RSV illness. Our tool (provided to readers) can be used by different jurisdictions and accept updated data. Results can aid economic evaluations and public health decision-making regarding RSV immunization products.

Dataset Information

WHO preferred product characteristics for monoclonal antibodies for passive immunization against respiratory syncytial virus (RSV) disease in infants - Key considerations for global use.

Publications

WHO preferred product characteristics for monoclonal antibodies for passive immunization against respiratory syncytial virus (RSV) disease in infants - Key considerations for global use.

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