Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization.

NPJ Vaccines

U.S. Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.

Published: October 2024

In August 2023, FDA approved Abrysvo for active immunization of pregnant individuals at 32 through 36 weeks gestational age to prevent lower respiratory tract disease (LRTD), including severe LRTD, caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. A pragmatic approach to narrow the interval of use of Abrysvo in pregnant individuals balanced benefits of vaccine effectiveness against potential risks to infant and mother.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528063PMC
http://dx.doi.org/10.1038/s41541-024-01002-yDOI Listing

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