FDA analysts have flagged concerns over the risk of preterm birth for the shot, which is given to pregnant people to protect infants from RSV in their first months of life.
A panel of independent experts will consider Thursday whether the Food and Drug Administration should approve an RSV vaccine designed to protect babies by vaccinating pregnant people, potentially paving the way for the first RSV shot for infants, weeks after the agency approved the country’s first shot for the common, but potentially deadly, infection.
RSV, which stands for respiratory syncytial virus, is a common respiratory infection that typically causes mild illness in healthy adults but can trigger severe, possibly fatal, disease in younger children, older adults and those with underlying medical issues. As protective antibodies can be passed from mother to developing fetus, the maternal shot, given to pregnant people between 24 and 36 weeks of pregnancy, also protects children in their first months of life.
Evidence from Pfizer’s late stage clinical trial, which included nearly 7,400 pregnant people, indicated the shot was 82% effective at preventing severe disease for the first three months after birth and 69% for the first six months. The shot was also 51% effective at preventing doctor’s visits for RSV-related illness within the first six months of life, the trial found.released ahead of the meeting, with relatively standard side effects reported like injection site pain, muscle pain and headaches—though FDA experts flagged a slightly higher rate of preterm births among vaccine recipients.
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