FDA Safety Review of RSV Treatments Raises Concerns Among Experts

The U.S. Food and Drug Administration (FDA) has initiated a safety review of two approved preventive treatments for Respiratory Syncytial Virus (RSV) in infants, prompting concerns from pediatric health experts regarding potential impacts on public trust and child health. According to Dr. Zachary Binder, an associate professor of pediatrics, the routine surveillance of approved medications has ensured their safety and efficacy for decades. He warned that deviating from this established process could raise significant concerns.

Respiratory Syncytial Virus is a leading cause of hospitalization among infants in the United States. The American Academy of Pediatrics notes that nearly all children are infected with RSV by the age of two, with infants under one year old facing the highest risk for severe complications. Two primary prevention strategies are currently available: a maternal vaccine administered during pregnancy, which allows protective antibodies to pass to the baby before birth, and a long-acting monoclonal antibody given directly to infants during RSV season.

Dr. Binder clarified, “It’s important to note that infants are not receiving an RSV vaccine. They are receiving a monoclonal antibody, which provides direct protection during their most vulnerable months.” Clinical trials and early real-world data indicate that both maternal vaccination and monoclonal antibody treatments can reduce RSV-associated hospitalizations by approximately 70% to 80%. Binder emphasized that both options have been shown to be safe, stating, “The monoclonal antibody demonstrated no higher rate of serious adverse events than placebo in clinical trials.”

The urgency of these preventive tools is heightened, as RSV is highly contagious, spreading easily through respiratory droplets and contact with contaminated surfaces. Symptoms often resemble those of common colds, 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 explained. Infants are particularly vulnerable due to their smaller airways and developing immune systems, which can lead to serious complications.

In contrast, older children usually experience RSV and flu symptoms that resemble severe colds. “In older kids, these illnesses are uncomfortable but usually manageable at home,” Binder noted. “In babies, they can escalate quickly and become serious.”

As of now, Binder has not observed a surge in RSV or influenza cases this season, although he anticipates a significant increase as the holiday season approaches. Increased travel, indoor gatherings, and school attendance historically contribute to spikes in respiratory viruses during late fall and winter. He cautioned, “I fully expect to see a significant increase in all respiratory illnesses, including RSV and flu, during the upcoming holiday season.”

Reflecting on last year’s trends, Binder noted, “Last year’s flu season started very early, with numerous cases in emergency departments by early fall, continuing throughout winter.” He acknowledged that, although this season has not yet followed the same pattern, respiratory virus activity often escalates later in the winter months.

Dr. Binder underscored the potential of RSV prevention strategies to reduce hospitalizations and severe illness in infants. “These tools can keep babies out of the hospital. It is essential that decisions surrounding them remain grounded in data and established safety processes.” For families looking for reliable information on RSV prevention, pediatricians recommend visiting HealthyChildren.org, the American Academy of Pediatrics‘ trusted public education resource.