Pediatric Investigation international GPPA recommendation: mAb protection against RSV as standard care for all infants

Respiratory syncytial virus (RSV), a leading cause of lower respiratory infections in infants, affects over 33 million children under five years worldwide annually, resulting in over 3 million hospitalizations and over 100,000 deaths. In 2022 and 2023, the early onset of the RSV season coincided with the COVID-19 pandemic and influenza epidemic, overloading hospitals worldwide and straining healthcare systems. These concerning statistics underscore the immediate need for widely available, safe, and effective preventive interventions for all infants, not just those with risk conditions.

Despite the heavy RSV-related burden in infants, effective vaccines or medications for infants are not available. Although palivizumab, a monoclonal antibody (mAb), provides protection, its applicability is restricted because it needs to be administered monthly via intramuscular injection and is recommended for a small percentage of infants with specific underlying medical conditions. Advanced emerging strategies for RSV prophylaxis, such as maternal RSV immunization and long-acting prophylactic mAbs, hold significant promise for lowering hospitalization rates and the burden of respiratory infections due to RSV in infants.

In a recent article published in Pediatric Investigation on February 11, 2025, the urgent need for widely available preventive strategies to combat RSV was thoroughly discussed. The recommendations confirmed that mAbs represent the best available preventive measure.

Real-world evidence highlights that a single dose of long-acting mAbs at the start of RSV season can provide season-long protection to infants. “Our recommendation presents a clear position that prophylactic mAbs offer a powerful means of protecting all infants during their first RSV season,” explains Professor Kunling Shen, Capital Medical University, China. “As of June 2024, a growing number of countries—including the United States, Spain, the United Kingdom, Luxembourg, and Austria—are recommending prophylactic mAbs to protect infants and young children from RSV,” adds Prof. Shen.

The Global Pediatric Pulmonary Alliance (GPPA), World Health Organization, and its Strategic Advisory Group of Experts on Immunization advocate that all global and regional organizations, medical societies, and health agencies collaborate on universal infant protection against RSV with mAbs.

GPPA’s recommendations also emphasize the crucial role of pediatricians in monitoring regulatory progress and contributing their expertise to policy development. According to Prof. Shen, "To truly protect all infants, countries should make prophylactic mAbs available at no cost to parents or healthcare organizations by including them in the National Immunization Program (NIP) through childcare centers, communities, and vaccination clinics." She further adds, "In regions where prophylactic mAbs are not yet part of the national immunization program, pediatricians should work with health authorities to find ways to reach all infants, perhaps by integrating them into existing vaccine management systems."

Prophylactic mAbs should be administered shortly before or at the start of the RSV season, which usually lasts from winter to early spring. The timing and duration of RSV seasons vary, and providers can adjust their timing with guidance from public health authorities. This strategy has demonstrated an impact on lowering RSV-related respiratory infections and transforming pediatric care.

While RSV poses a serious threat to the health of infants and young children, prophylactic mAbs offer safe and effective protection for an entire season. Backed by substantial clinical studies and real-world evidence that indicate a healthier future for infants and young children, this promising strategy has garnered the support of international health organizations. This recommendation has paved the way for reforms in clinical practices and policies that may improve the quality of life of all infants.

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Reference

DOI: 10.1002/ped4.12465

Authors: Kunling Shen, Lance E. Rodewald, Yonghong Yang, Gary Wing-Kin Wong, Leyla Namazova-Baranova, Lanny J. Rosenwasser, Adel S. Alharbi, Anne B. Chang, Anne Gog, Antonella Muraro, Basil Elnazir, Bernard Kinane, Chris O’Callaghan, Eitan Kerem, Hilary Hoey, Jim Buttery, Jiu-Yao Wang, Kazunobu Ouchi, Rosemary Horne, Rina Triasih, Ruth A. Etzel, Varinder Singh, Spencer Li, Yu Guan, and The Global Pediatric Pulmonary Alliance Council

About Professor Kunling Shen
Dr. Kunling Shen was a Professor at the Beijing Children’s Hospital, Capital Medical University, National Center for Childern’s Health, China, and is a Foreign Academician of the Russian Academy of Sciences, a Foreign Academician of the Royal Irish Medical Association, and the Founding President of Global Pediatric Pulmonology Alliance (GPPA). Her areas of expertise include pneumonia, atypical pneumonia, mycoplasma pneumonia, and asthma. She has published over 100 publications in reputed journals.