FDA approves RSV vaccine for moms-to-be to guard their newborns

abcnews.go.com:

U.S. regulators have approved the first RSV vaccine for pregnant women to protect their newborns

WASHINGTON — U.S. regulators on Monday approved the first RSV vaccine for pregnant women so their babies will be born with protection against the scary respiratory infection.

RSV is notorious for filling hospitals with wheezing babies every fall and winter. The Food and Drug Administration cleared Pfizer's maternal vaccination to guard against a severe case of RSV when babies are most vulnerable — from birth through 6 months of age.

The next step: The Centers for Disease Control and Prevention must issue recommendations for using the vaccine, named Abrysvo, during pregnancy. (Vaccinations for older adults, also at high risk, are getting underway this fall using the same Pfizer shot plus another from competitor GSK.)

“Maternal vaccination is an incredible way to protect the infants,” said Dr. Elizabeth Schlaudecker of Cincinnati Children’s Hospital, a researcher in Pfizer’s international study of the vaccine. If shots begin soon, “I do think we could see an impact for this RSV season.”

RSV is a coldlike nuisance for most healthy people but it can be life-threatening for the very young. It inflames babies’ tiny airways so it’s hard to breathe or causes pneumonia. In the U.S. alone, between 58,000 and 80,000 children younger than 5 are hospitalized each year, and several hundred die, from the respiratory syncytial virus.

Last year’s RSV season was extremely harsh in the U.S., and it began sickening tots in the summer, far earlier than usual.

Babies are born with an immature immune system, dependent for their first few months on protection from mom. How the RSV vaccination will work: A single injection late in pregnancy gives