Experts Warn on Safety of New RSV Treatments for Infants

A recent safety review by the U.S. Food and Drug Administration (FDA) concerning two approved preventive treatments for respiratory syncytial virus (RSV) in infants has raised concerns among pediatric health experts. They caution that this unusual step could undermine public trust and impact child health.

Dr. Zachary Binder, an associate professor of pediatrics, noted, “All approved medications already go through routine surveillance after approval. That process has ensured the safety and efficacy of medications for decades. Deviating from it raises concern.” RSV is the leading cause of hospitalization among infants in the United States. The American Academy of Pediatrics states that nearly all children are infected with RSV by age 2, with infants under 1 at the highest risk for severe illness.

Currently, there are two primary prevention options available. The first 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 the RSV season. Dr. Binder clarified that “infants are not receiving an RSV vaccine. They’re receiving a monoclonal antibody, which provides direct protection during their most vulnerable months.”

Clinical trials and preliminary real-world data indicate that both maternal vaccination and the infant monoclonal antibody treatment can reduce RSV-associated hospitalizations by approximately 70% to 80%. Dr. Binder added, “Both options have been shown to be safe. The monoclonal antibody demonstrated no higher rate of serious adverse events than placebo in clinical trials.”

Experts emphasize that these preventive measures are crucial, as RSV is highly contagious, spreading easily through respiratory droplets and contact with contaminated surfaces. RSV and influenza share similar symptoms, often starting with cold-like signs such as congestion, cough, and fever. While older children typically recover without complications, younger infants are at greater risk.

“The major dangers for children are respiratory distress and dehydration,” Dr. Binder pointed out, warning that respiratory distress can progress rapidly, potentially requiring oxygen or breathing assistance. Infants, with their smaller airways and immature immune systems, are particularly vulnerable. In contrast, older children tend to experience RSV and flu as severe colds, which are generally manageable at home.

Though Dr. Binder has not yet observed a surge in RSV or influenza cases this season, he expects an increase as the holiday season approaches. Increased travel and indoor gatherings historically lead to seasonal spikes in respiratory viruses during late fall and winter. He remarked, “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, he noted, “Flu season started very early. We saw a lot of cases in the emergency department in early fall, continuing throughout the winter.” He cautioned that respiratory virus activity often escalates later in the winter, indicating a potential for increased illnesses.

Dr. Binder emphasized the importance of RSV prevention tools, stating, “These tools can keep babies out of the hospital. 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, a trusted public education resource from the American Academy of Pediatrics.