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…
WASHINGTON — A first-of-its-kind RSV vaccine for pregnant women guards their newborns against the scary respiratory virus -– and federal health advisers on Thursday backed Pfizer’s shot despite some lingering questions.
The idea: Give women a single injection late in pregnancy, between 24 weeks and 36 weeks, so they develop RSV-fighting antibodies that pass through the placenta — just like they pass protection against other bugs to their babies. 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.
“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.
“Do you hold hostage the potential benefits of the vaccine” without clear evidence of a problem, Dr. William Gruber, Pfizer’s senior vice president, asked the panelists.
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