Doctors Raise Alarm Over FDA Review of Infant RSV Vaccines
The antibody shots are about 80% effective at preventing babies from ending up in intensive care because of RSV. The drugmakers behind them maintain they're safe.
Doctors Worry About FDA Scrutiny of RSV Shots to Protect Babies
Federal health officials are taking a closer look at the safety of antibody shots designed to protect infants from respiratory syncytial virus, a move that has left many pediatricians concerned about the potential impact on one of the most significant advances in infant health in recent years. The Food and Drug Administration has been reviewing reports of adverse events associated with the shots, prompting questions about whether access to the treatments could be restricted or delayed during the upcoming RSV season. Doctors who have seen firsthand the devastation RSV can cause in young children say any disruption to the availability of these shots could have serious consequences.
The antibody shots, which have been shown to be approximately 80 percent effective at preventing babies from ending up in intensive care because of RSV, have been widely praised by the medical community since their introduction. RSV is one of the leading causes of hospitalization among infants, filling pediatric wards each winter with babies struggling to breathe. Before the shots became available, doctors had few tools to protect the most vulnerable newborns and young infants from the virus, which can cause severe bronchiolitis and pneumonia.
The pharmaceutical companies behind the antibody treatments maintain that their products are safe and that the benefits far outweigh the risks. They point to extensive clinical trial data and real-world evidence gathered since the shots were rolled out to support their position. Representatives from the drugmakers have said they are cooperating fully with the FDA review and remain confident that the safety profile of the shots will hold up under scrutiny.
Pediatricians and infectious disease specialists across the country are urging regulators to move carefully, warning that pulling back on the shots or undermining public confidence in them could lead to a surge in infant hospitalizations and deaths during RSV season. Many doctors say they have already seen a dramatic decline in severe RSV cases since the shots became widely available and fear that any disruption could reverse those gains. They are calling on the FDA to be transparent about its findings while ensuring that families continue to have access to a tool that has proven critical in keeping babies out of the hospital.