Federal health advisers are backing a first-of-its-kind RSV vaccine to protect newborns by immunizing their moms late in pregnancy.
RSV fills hospitals with wheezing babies each fall and winter, and the virus struck earlier than usual and especially hard in the U.S. this past year.
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 world’s first RSV vaccine, 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.
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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