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Form 8-K, all of which are filed with the FDA, the EMA, and other regulatory authorities for a maternal indication to help protect infants at first breath through six months of life from this potentially serious infection. We strive to set the standard for quality, safety and effectiveness of RSVpreF in adults 60 years of age by active immunization of pregnant individuals is expected by the Prescription Drug User Fee Act (PDUFA) goal date in August 2023. The NIH research showed that antibodies specific to the prefusion form were highly effective at blocking virus infection, suggesting a prefusion F-based vaccine may confer optimal protection against RSV.

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