Nirsevimab, a long-acting monoclonal antibody, could save lives and prevent thousands of infants from being hospitalized with severe illness
ITASCA, IL -- The American Academy of Pediatrics recommends that all infants -- and especially those at high risk --receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious and sometimes deadly.
Nirsevimab, a long-acting monoclonal antibody, is given by injection. The antibody boosts the immune system, adding an extra layer of defense against severe illness from respiratory syncytial virus. The AAP emphasized the need for equity in access to nirsevimab while acknowledging that, as with any new product, it will not be immediately available in all clinical settings. AAP also recommends continued use of palivizumab, another monoclonal antibody product, during the 2023-2024 RSV season for children at high risk of severe RSV illness since nirsevimab is unlikely to be broadly available.
“Pediatricians are sadly familiar with the dangers of RSV and its devastating consequences for some families,” AAP President Sandy Chung, MD, FAAP, said. “We are eager to offer all infants this protection and urge federal officials to see that it is made available and affordable in all communities.”
Nirsevimab, which was approved by the U.S. Food and Drug Administration under the brand name Beyfortus and recommended by the Centers for Disease Control and Prevention, was shown to reduce the risk of medically attended cases of respiratory syncytial virus by 75% in clinical trials.
The AAP recommends a single dose of nirsevimab for:
For eligible infants and young children who cannot access nirsevimab during the 2023-2024 season, AAP recommends continued use of palivizumab, which includes a series of monthly doses. Nirsevimab and palivizumab are both antibody shots that help prepare the immune system to prevent illness. The RSV activity in the United States usually begins in the late fall and extends through spring.
AAP’s clinical recommendations for nirsevimab are published in Red Book Online, the Academy’s pediatric infectious diseases manual. Recommendations will be updated as needed.
Dr. Chung has urged federal officials to improve the infrastructure for delivering nirsevimab in a letter to Mandy K. Cohen, MD, MPH, Director of the CDC and Chiquita Brooks-LaSure, administrator of the Centers for Medicare and Medicaid Services (CMS).
The AAP has called for a comprehensive strategy to ensure equitable access to nirsevimab in hospitals, birthing centers and ambulatory practice settings. Currently, there is not the infrastructure in place to ensure all children can access the product, which Dr. Chung called “alarming.” Without significant structural changes, families living in lower-income and under-resourced communities, as well as those with infants at greatest risk for severe RSV illness, may face challenges accessing it.
The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.