FDA ADVISERS BACK PFIZER’S RSV VACCINE FOR PREGNANT WOMEN
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.
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.
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, Mo.
The idea: Give women a single injection between 24 weeks and 36 weeks of pregnancy so they develop RSVfighting antibodies that pass through the placenta — just like they pass protection against other bugs to their babies.
In Pfizer’s international study of nearly 7,400 pregnant women, maternal vaccination proved 82 percent effective at preventing severe RSV during babies’ most vulnerable first three months of life. At age 6 months, it still was proving 69 percent protective against severe illness.
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.
Pfizer pledged to closely track the vaccine’s realworld 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.