A first-of-its-kind RSV vaccine for pregnant women guards their newborns against the scary respiratory virus -– and federal health advisers debated Thursday if Pfizer’s shot is ready to roll out.
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 and in an analysis posted ahead of Thursday’s meeting, FDA’s reviewers agreed “the safety data seem generally favorable.” But the FDA did ask its scientific advisers to consider whether a slight difference in premature birth between the two groups was of concern.
“All young infants are at risk of severe disease with RSV,” but postponing infection even by a few months lessens that risk, said CDC’s Dr. Katherine Fleming-Dutra.Pfizer’s vaccine isn’t intended to prevent RSV infection but to avoid the worst outcomes. In late-stage testing, six infants born to vaccinated mothers had a severe RSV illness in their first three months of life compared to 33 infants whose mothers received a dummy shot.
Vaccines always get close safety scrutiny but regulators are especially mindful of a major setback in the 1960s when an experimental RSV shot worsened infections in children. Eventually scientists figured out the problem and the RSV vaccines in the pipeline today are made with safer, modern methods -- yet still were tested first in older adults.FDA’s advisers already have recommended approving Pfizer’s vaccine for older adults, and the agency is expected to make a decision by month’s end.
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