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.
Highlights
Respiratory syncytial virus (RSV) is a global disease that places a high and underappreciated burden on the economy and healthcare services. It is the leading preventable cause of acute lower respiratory tract infection (LRTI) deaths in children 6 months of age or younger; most deaths occur in low- and middle-income countries (LMICs) [1]
There is one approved RSV monoclonal antibody (mAb), palivizumab, a prophylactic against LRTI caused by RSV that has been used for the past two decades
As there are more available data from RSV mAb or vaccine trials, a neutralizing antibody titer may be established as a correlate of protection against RSV, which could allow for a smaller phase 3 to be conducted using biomarker endpoints
Summary
Respiratory syncytial virus (RSV) is a global disease that places a high and underappreciated burden on the economy and healthcare services. It is the leading preventable cause of acute lower respiratory tract infection (LRTI) deaths in children 6 months of age or younger; most deaths occur in low- and middle-income countries (LMICs) [1]. There is currently no approved vaccine against RSV. RSV mAbs are proven to prevent RSV LRTI in preterm infants and are currently being used in infants at high risk for severe RSV disease. The only type approved is not accessible and affordable for widespread use in LMICs. The high rate of RSV infection, especially among infants and young children, underscores the need for safe, effective, and affordable prevention of RSV disease
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