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Number needed to immunize to prevent RSV with extended half-life monoclonal antibody |
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| Institution: | 1. Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ 07033, USA;2. Center for Communicable Disease Dynamics, Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA 02115, USA;1. Population Health Sciences, University of Bristol, Bristol, UK;2. School of Cellular and Molecular Medicine , University of Bristol, Bristol, UK;3. NIHR Health Protection Research Unit in Evaluation of Interventions, University of Bristol, Bristol, UK;4. Paediatric Emergency Department, Bristol Royal Hospital for Children, Bristol, UK;1. University Hospitals Case Medical Center, Rainbow Babies and Children''s Hospital, Cleveland, OH;2. Case Western Reserve University, Cleveland, OH;1. Inserm U1153, Obstetric, Perinatal and Paediatric Epidemiology, Sorbonne Paris cité, “Risks in pregnancy” University Hospital Department, 75014 Paris, France;2. Université Paris Descartes, 75006 Paris, France;3. URC-CIC P1419, Cochin-Port Royal Hospital, AP-HP, F-75014 Paris, France;4. Department of Neonatal Medicine, Cochin-Port Royal Hospital, AP–HP, 75014 Paris, France;5. Department of neonatology, Jeanne-de-Flandre Hospital, CHRU Lille, 59037 Lille cedex, France;1. Department of Health Sciences, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands;2. Regional Epidemiology and Health Economics, Sanofi Pasteur, Swiftwater, PA, USA;3. Clinical Epidemiology Program, Veterans Affairs Medical Center, White River Junction, Vermont, USA;4. Department of Community Health Sciences, College of Medicine, University of Manitoba, Winnipeg, MB, Canada;5. George & Fay Yee Center for Healthcare Innovation, University of Manitoba, Winnipeg Regional Health Authority, Winnipeg, MB, Canada;6. Brown University, School of Public Health, Department of Health Services, Policy and Practice, USA;7. Providence VA Medical Center, Center of Innovation in Long-Term Services and Supports, USA;8. Department of Medical Microbiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands;9. Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada;10. Unit of PharmacoTherapy, -Epidemiology & -Economics (PTE2), University of Groningen, Department of Pharmacy, Groningen, the Netherlands;11. Department of Economics, Econometrics & Finance, University of Groningen, Faculty of Economics & Business, Groningen, the Netherlands;12. Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA;1. Sanofi Pasteur, Swiftwater, PA, USA;2. Sanofi Pasteur, Toronto, ON Canada;3. Sanofi Pasteur, Campus Sanofi Lyon, Lyon, France |
| Abstract: | BackgroundRespiratory syncytial virus (RSV) is one of the most important respiratory pathogens in young children. Infants <6 months of age and infants and young children with extreme pre-term birth, and cardiac and pulmonary co-morbidities experience the highest incidence of severe RSV disease. There are no licensed vaccines; immunoprophylaxis is recommended for the highest risk children. Extended half-life RSV monoclonal antibodies (EHL-mAbs) are under development intended for immunization of all infants and high-risk children <2 years of age. We modeled the anticipated public health benefits of RSV EHL-mAb immunization using the number needed to immunize (NNI).MethodsWe combined RSV hospitalization, outpatient and outpatient lower respiratory tract infection (LRI) incidence estimates and a range of immunization efficacies to estimate the annual NNI. We calculated the absolute incidence rate reduction (ARR) by multiplying the incidence rates by immunization efficacy. NNI was calculated as the reciprocal of the ARR.ResultsFor an RSV EHL-mAb with 70% efficacy, 6–18 infants would need to be immunized to prevent one RSV-associated outpatient visit, and 13–33 infants would need to be immunized to prevent one RSV-associated LRI outpatient visit. To prevent one RSV-associated hospitalization, 37–85 infants 0–5 months of age, and 107–280 infants 6–11 months of age would need to be immunized.ConclusionsPublic health benefits, such as disease cases averted due to immunization, are essential elements in consideration of candidate vaccines for a national immunization program. An RSV EHL-mAb of moderate efficacy could have high impact. These data provide an additional perspective for public health decision making. |
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