U.S. FDA panel backs Pfizer’s RSV vaccine for protecting infants

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The FDA’s advisory committee voted unanimously that available data supported the vaccine’s efficacy for giving the shot to women in their second or third trimesters of pregnancy to prevent lower respiratory tract infection and severe disease in infants up to 6 months of age.

The expert panel voted 10-4 that the data also supports the safety of the vaccine for that patient population, paving the way for likely U.S. approval.