May 18, 2023 – An FDA advisory panel is considering whether to recommend approval of a respiratory syncytial virus (RSV) vaccine for infants.
If approved by the FDA, it will be the primary drug for infants within the United States.
“Before the pandemic, RSV was the leading cause of hospitalization of infants in the United States, so this is a big deal,” said Ofer Levy, MD, director of the Precision Vaccines Program at Boston Children's Hospital NBC News.
Levy is an interim voting member of the FDA Advisory Panel but won't take part in this vote since the FDA is just not required to participate.
The FDA typically follows the recommendations of advisory panels, and the method can take months after the panel approves it.
Babies 6 months of age and younger are particularly vulnerable to severe cases of RSV.
In a clinical trial of seven,400 participants, the vaccine reduced the danger of severe disease in infants by 82% inside three months of birth and by 69% inside six months.
The vaccine from manufacturer Pfizer is meant to be administered to pregnant women within the last trimester, with protection being transferred to the unborn child via the placenta.
Earlier this month, the FDA approved the world's first RSV vaccine for people ages 60 and older. This vaccine is manufactured by GSK.
“Pfizer also submitted an RSV vaccine for older adults for FDA approval this month,” NBC reported. “The FDA advisory panel recommended the shot for people 60 and older in late February. It's the same vaccine that could be given to pregnant women.”
In the United States, as much as 300 children under age 5 and as much as 10,000 people age 65 and older die from RSV every year. the CDC says.