FDA approves first RSV vaccine for pregnancy to protect newborns

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FDA approves first RSV vaccine for pregnancy to protect newborns
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Expectant parents could soon have another new option this fall to protect their newborns from RSV, the most common cause of hospitalization in American infants.

to the committee suggest it would not be cost effective to issue recommendations for giving both shots, which together were modeled to cost $700 for each child before insurance. Beyfortus would effectively be a backup, under their

, largely offered only to babies born to parents who did not get Abyrsvo during pregnancy or who are at higher risk of severe disease.Further complicating the new recommendations are a handful of very rare preterm births seen in babies of moms who received Abrysvo during pregnancy. While the number in Pfizer's trial was too small to be statistically significant, it came after a larger uptick in preterm births was big enough to force GSK to halt a separate RSV vaccine trial in pregnant women"We have had long discussions about whether or not there could, or is not, a biologic plausibility to this," the CDC's Katherine Fleming Dutra told the ACIP at aThis puzzled some on the FDA's vaccines panel earlier this year as well.

"I'm troubled, as everybody is, by the prematurity issue. And I'm not sure that running it through another maybe season is going to give us an answer. And I think we've heard that observational studies, as we go forward, will fairly quickly give us an answer if there is a problem there," Dr.

"The available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo," the agency said.

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