Photo contributed by Zachary Binder
The recent safety review of two approved RSV preventive treatments for infants initiated by the U.S. Food and Drug Administration is unusual and could have unintended consequences for public trust and child health, pediatric health experts say.
“All approved medications already go through routine surveillance after approval,” said Zachary Binder, MD, associate professor of pediatrics. “That process has ensured the safety and efficacy of medications for decades. Deviating from it raises concern.”
Respiratory syncytial virus, or RSV, is the leading cause of hospitalization among infants in the United States. According to the American Academy of Pediatrics, nearly all children are infected with RSV by age 2, and infants under 1 are at the highest risk for severe disease.
Two primary prevention options are available. One is an RSV vaccine administered during pregnancy, allowing protective antibodies to pass from mother to baby before birth. The second is a long-acting monoclonal antibody given directly to infants during RSV season.
“It’s important to clarify that infants are not receiving an RSV vaccine,” Binder said. “They’re receiving a monoclonal antibody, which provides direct protection during their most vulnerable months.”
Clinical trials and early real-world data show that both maternal vaccination and infant monoclonal antibody protection reduce RSV-associated hospitalizations by approximately 70 to 80 percent.
“Both options have been shown to be safe,” Binder said. “The monoclonal antibody demonstrated no higher rate of serious adverse events than placebo in clinical trials.”
Pediatric health experts emphasize that these tools are especially important because RSV is highly contagious and spreads easily through respiratory droplets and contact with contaminated surfaces. RSV and influenza are common viral illnesses that often begin with cold-like symptoms such as congestion, cough and fever. While older children typically recover without complications, younger infants face greater risks.
“The major dangers for children are respiratory distress and dehydration,” Binder said. “Respiratory distress can progress quickly and may require oxygen or assistance with breathing.”
Infants have smaller airways and immature immune systems, making them more vulnerable to complications. For older children, RSV and flu usually resemble severe colds. “In older kids, these illnesses are uncomfortable but usually manageable at home,” Binder said. “In babies, they can become serious.”
While Binder has not yet seen a surge in RSV or influenza cases this season, that will likely change. Increased travel, indoor gatherings and school attendance historically contribute to seasonal spikes in respiratory viruses during late fall and winter.
“I fully expect to see a significant increase in all respiratory illnesses, including RSV and flu, during the upcoming holiday season,” he said.
“Last year’s flu season started very early,” Binder said. “We were seeing a lot of cases in the emergency department in early fall, and it continued throughout the winter.” While this season has not followed the same pattern, Binder cautions that respiratory virus activity often escalates later in the winter.
Binder emphasized that RSV prevention has the potential to significantly reduce hospitalizations and severe illness in infants. “These tools can keep babies out of the hospital,” he said. “It’s essential that decisions about them remain grounded in data and long-established safety processes.”
For families seeking reliable information on RSV prevention, pediatricians recommend HealthyChildren.org, the American Academy of Pediatrics’ trusted public education resource.
