FDA advisers have backed a first-of-its-kind RSV vaccine to protect newborns by immunizing their moms late in pregnancy. The agency will make the final decision on approval.
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.
If the vaccine pans out, “many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, a member of the Food and Drug Administration advisory panel from Children’s Mercy Hospital in Kansas City, Missouri. Pfizer pledged to closely track the vaccine’s real-world use for more evidence. Ultimately the advisers unanimously decided that the shot is effective — and voted 10-4 that there’s adequate safety data. The FDA will consider Thursday’s recommendations in making the final decision on approval.
, rival GSK’s shot for older adults, who also are at high risk. There isn’t a vaccine yet for children, but Pfizer is about to begin testing one.For most healthy people, RSV is a cold-like nuisance. But it can be life-threatening for the very young –- infecting deep in the lungs to cause pneumonia or impeding babies’ breathing by inflaming their tiny airways. In the U.S.
Competitor GSK halted its own trials of a maternal RSV vaccine because of prematurity concerns, spurring questions about Pfizer’s shot. Pfizer said the preterm difference in its study was fueled by participants in South Africa — for unknown reasons — and there was no difference spotted in the U.S. or other high-income countries.
A total of 17 infants died during the study, five born to vaccinated mothers and 12 to those given a dummy shot. Researchers deemed none of the deaths related to the vaccine but FDA said it “is unable to exclude the possibility” that one infant’s death, stemming from extreme prematurity, might be related.
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