Federal health advisers are backing a first-of-its-kind RSV vaccine to protect newborns by immunizing their moms late in pregnancy
FILE - This electron microscope image provided by the National Institutes of Health shows human respiratory syncytial virus virions, colorized blue, and anti-RSV F protein/gold antibodies, colorized yellow, shedding from the surface of human lung cells. Advisers to the Food and Drug Administration on Thursday, May 18, 2023 debated a first-of-its-kind RSV vaccine to protect newborns by immunizing their moms late in pregnancy.
Pfizer said there were no signs of safety problems but the FDA did ask its scientific advisers to consider whether a slight difference in premature birth between vaccinated moms and those given a dummy shot was of concern. Debate over whether that was really a hint of trouble or just due to chance dominated the panel's daylong meeting.
If the FDA ultimately approves the maternal shot, it would mark a second milestone in the decades-long quest to prevent the respiratory syncytial virus. Earlier this month the FDA approved The company predicts the U.S. could prevent as many as 20,000 infant hospitalizations a year, and 320,000 doctor visits, if enough pregnant women were vaccinated.Vaccine reactions included typically mild injection-site pain and fatigue. As for the prematurity question, vaccinated mothers had slightly more preterm infants –- 5.7% versus 4.7%. The vast majority were born just a few weeks early. That’s better than the nation’s preterm birth rate -- overall in the U.S.
“There is certainty that the vaccine works and will keep infants out of the hospital in the United States as soon as this winter,” he said.
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