FDA Advisory Panel Recommends RSV Vaccine for Pregnant Women

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May 18, 2023 -- An FDA advisory panel is considering whether to recommend approval of a respiratory syncytial virus (RSV) vaccine for infants.

It would be the first for infants in the United States if adopted by the FDA. 

“Before the pandemic, RSV was the No. 1 cause of infant hospitalization in the United States, so this is a big deal,” Ofer Levy, MD, the director of the Precision Vaccines Program at Boston Children’s Hospital, told NBC News.

Levy is a temporary voting member of the FDA advisory panel but is not involved in this vote, which the FDA is not required to follow.

The FDA usually follows recommendations of advisory panels. The process could still take months after approval by the panel.

Babies 6 months and younger are especially susceptible to severe cases of RSV. 

In a clinical trial with 7,400 participants, the vaccine lowered the risk of severe disease for infants by 82% within three months after birth and 69% within six months.

The vaccine, which is made by Pfizer, would be given to pregnant women in their final trimester, with the protection being passed through the placenta to the unborn baby.

Earlier this month, the FDA approved the world’s first RSV vaccine for people 60 years and older. That vaccine is made by GSK. 

“Pfizer also has an RSV shot for older adults up for FDA approval this month,” NBC reported. “The FDA advisory panel in late February recommended the shot for people ages 60 and up. It's the same vaccine that could be given to pregnant people.”

Each year in the United States, RSV causes the deaths of up to 300 children under age 5 and up to 10,000 people who are at least 65 years old, the CDC says.