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Updated: Oct 18, 2025

An Improved and High Throughput Respiratory Syncytial Virus RSV Micro-neutralization Assay
Published on: January 26, 2019
Bringing Preventive RSV Monoclonal Antibodies to Infants in Low- and Middle-Income Countries: Challenges and
Jintanat Ananworanich1,2, Penny M Heaton1
1Bill & Melinda Gates Medical Research Institute, Cambridge, MA 02139, USA.
Insights
New monoclonal antibodies (mAbs) show promise for preventing severe respiratory syncytial virus (RSV) lower respiratory tract infections (LRTIs) in infants, particularly in low-resource settings. Affordable, long-acting mAbs could protect vulnerable infants until vaccines are available.
Area of Science:
- Pediatrics
- Infectious Diseases
- Immunology
Background:
- Respiratory syncytial virus (RSV) is a primary cause of infant lower respiratory tract infections (LRTIs), with highest mortality in neonates and in low- and middle-income countries (LMICs).
- Current RSV prevention strategies are limited; no maternal or infant vaccines are approved, and existing monoclonal antibodies (mAbs) like palivizumab are costly and require frequent administration, hindering use in LMICs.
Purpose of the Study:
- To highlight the urgent need for safe, effective, and affordable RSV mAbs for infants in LMICs.
- To discuss the potential of next-generation, half-life extended mAbs, such as nirsevimab, as a viable prevention tool.
- To explore strategies for making RSV mAbs accessible and implementable in LMICs.
Main Methods:
- Review of current RSV burden, existing interventions, and emerging mAb technologies.
- Analysis of the potential benefits and challenges of implementing new mAbs in LMICs.
- Discussion of manufacturing efficiency improvements and stakeholder collaboration.
Main Results:
- Next-generation mAbs offer potential for season-long protection with a single dose, improving feasibility for LMICs.
- Manufacturing efficiency improvements present an opportunity to reduce costs and enhance affordability.
- Integration into healthcare systems and surveillance for resistance are key challenges.
Conclusions:
- Developing affordable, long-acting RSV mAbs is critical for reducing infant mortality in LMICs.
- Successful implementation requires addressing healthcare delivery complexities and fostering global partnerships.
- Continued research and investment in manufacturing are essential for equitable access to RSV prevention.
Abstract:
Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infections (LRTIs) in infants. Most deaths occur in infants under 3 months old, and those living in low and middle-income countries (LMICs). There are no maternal or infant RSV vaccines currently approved. An RSV monoclonal antibody (mAb) could fill the gap until vaccines are available. It could also be used when a vaccine is not given, or when there is insufficient time to vaccinate and generate an antibody response. The only currently approved RSV mAb, palivizumab, is too costly and needs monthly administration, which is not possible in LMICs. It is imperative that a safe, effective, and affordable mAb to prevent severe RSV LRTI be developed for infants in LMICs. Next generation, half-life extended mAbs in clinical development, such as nirsevimab, show promise in protecting infants against RSV LRTI. Given that a single dose could cover an entire 5-month season, there is an opportunity to make RSV mAbs affordable for LMICs by investing in improvements in manufacturing efficiency. The challenges of using RSV mAbs in LMICs are the complexities of integrating them into existing healthcare delivery programs and surveillance systems, both of which are needed to define seasonal patterns, and monitor for escape mutants. Collaboration with key stakeholders such as the World Health Organization and Gavi, the Vaccine Alliance, will be essential for achieving this goal.
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