Nirsevimab delivers 83% reduction in RSV infant hospitalizations in a real-world clinical trial setting
- HARMONIE Phase 3b data reinforce nirsevimab’s consistent and high efficacy against infant hospitalizations due to RSV
- Data presented at ESPID add to the body of evidence demonstrating nirsevimab’s protection against RSV-related lower respiratory tract disease (LRTD) and confirm its favorable safety profile in multi-country, real-world conditions
The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large, multi-country European interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular dose of nirsevimab, with data collected in a real-world setting during the 2022-2023 RSV season.1 The trial recruited more than 8,000 infants and took place at nearly 250 sites across
Executive Vice President, Vaccines,
“This winter saw higher rates of RSV-related infant hospitalizations than during pandemic or pre-pandemic years. The HARMONIE data demonstrate the real-world impact nirsevimab has on pediatric hospitalizations, and illustrate its importance for infants, their families and public health.”
Dr
Consultant Pediatrician in Infectious Diseases at St. George’s
“RSV-related chest infections lead to high numbers of infants under 12 months old being hospitalized every year. These data reinforce the potential public health benefit of nirsevimab in terms of helping to reduce the strain on hospitals caused each year by RSV.”
The data from HARMONIE also show that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD (patients whose oxygen level is under 90% and require oxygen supplementation) by 75.71% (95% CI 32.75 to 92.91; P<0.001).1
Additionally, nirsevimab demonstrated a reduction of 58.04% (95% CI 39.69 to 71.19; P<0.001) in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention.1 This means the overall burden on healthcare systems could be reduced significantly if all infants receive nirsevimab. RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 2017.2
Throughout HARMONIE, nirsevimab maintained a favorable safety profile, consistent with the pivotal trial results.
About RSV
RSV is the most common cause of LRTD, including bronchiolitis and pneumonia, in infants.5-8 It is also a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in healthy infants born at term.9-12 Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.12
About HARMONIE
The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large European interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab (<5 kg 50 mg; ≥5 kg 100 mg), compared to no intervention (standard of care), for the prevention of hospitalizations due to RSV-related LRTD in infants under 12 months of age who are not eligible to receive palivizumab.
About Nirsevimab
Nirsevimab, a long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is being developed jointly by
Nirsevimab has been granted special designations to facilitate expedited development by several regulatory agencies around the world. These include Breakthrough Therapy Designation by
Nirsevimab has been granted marketing authorization in the
In
About
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
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References
- Drysdale S, et al. Efficacy of nirsevimab against RSV lower respiratory tract infection hospitalization in infants: preliminary data from the HARMONIE phase 3b trial. Presented at 41st Annual Meeting of the
European Society for Paediatric Infectious Diseases inLisbon , 2023. - Zhang S, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687.
- Madhi S, et al. Nirsevimab efficacy against RSV lower respiratory tract infection in preterm and term infants by subtype: pooled analysis of phase 2b and phase 3 melody trials. Presented at 41st Annual Meeting of the
European Society for Paediatric Infectious Diseases inLisbon , 2023. - Aksyuk A, et al. Nirsevimab immunisation did not alter the distribution of non-RSV viruses relative to placebo in a pivotal Phase 3 clinical study (MELODY). Presented at 41st Annual Meeting of the
European Society for Paediatric Infectious Diseases inLisbon , 2023. - R K. Respiratory Syncytial Virus Vaccines.
Plotkin SA , Orenstein WA, Offitt PA,Edwards KM , eds Plotkin’s Vaccines 7th edPhiladelphia . 2018;7th ed. Philadelphia:943-9. - Nair H, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis.
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- Hall CB, et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics. 2013;132(2):e341-e348.
- Arriola CS, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in
the United States , 2014-15. J Pediatric Infect Dis Soc. 2020;9(5):587-595. - Rha B, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020;146:e20193611.
- Li Y, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis.
Lancet . 2022;399:92047–64. - Faust S, et al. How did the HARMONIE trial recruit over 5000 infants in winter 2022/23? Defining a new model of collaboration for industry-sponsored clinical trials. Presented at 41st Annual Meeting of the
European Society for Paediatric Infectious Diseases inLisbon , 2023. Centers for Disease Control and Prevention . Vaccines & Immunizations.August 18, 2017 . https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. AccessedMay 2023 .- Precision vaccinations. Beyfortus (Nirsevimab) RSV Antibody 2023. https://www.precisionvaccinations.com/vaccines/beyfortus-nirsevimab-rsv-antibody-2023#:~:text=November%204%2C%202022%20%2D%20AstraZeneca%20and,during%20their%20first%20RSV%20season. Accessed
May 2023 .
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