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

Abstract 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...

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Main Authors: Yugenia K. Hong-Nguyen, Joseph Toerner, Lucia Lee, Maria C. Allende, David C. Kaslow
Format: Article
Language:English
Published: Nature Portfolio 2024-10-01
Series:npj Vaccines
Online Access:https://doi.org/10.1038/s41541-024-01002-y
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author Yugenia K. Hong-Nguyen
Joseph Toerner
Lucia Lee
Maria C. Allende
David C. Kaslow
author_facet Yugenia K. Hong-Nguyen
Joseph Toerner
Lucia Lee
Maria C. Allende
David C. Kaslow
author_sort Yugenia K. Hong-Nguyen
collection DOAJ
description Abstract 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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publishDate 2024-10-01
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series npj Vaccines
spelling doaj-art-b1c082fe06f04592bb451be24cb56ade2025-08-20T03:05:52ZengNature Portfolionpj Vaccines2059-01052024-10-01911310.1038/s41541-024-01002-yRegulatory review of benefits and risks of preventing infant RSV disease through maternal immunizationYugenia K. Hong-Nguyen0Joseph Toerner1Lucia Lee2Maria C. Allende3David C. Kaslow4U.S. Food and Drug Administration (FDA)U.S. Food and Drug Administration (FDA)U.S. Food and Drug Administration (FDA)U.S. Food and Drug Administration (FDA)U.S. Food and Drug Administration (FDA)Abstract 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.https://doi.org/10.1038/s41541-024-01002-y
spellingShingle Yugenia K. Hong-Nguyen
Joseph Toerner
Lucia Lee
Maria C. Allende
David C. Kaslow
Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization
npj Vaccines
title Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization
title_full Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization
title_fullStr Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization
title_full_unstemmed Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization
title_short Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization
title_sort regulatory review of benefits and risks of preventing infant rsv disease through maternal immunization
url https://doi.org/10.1038/s41541-024-01002-y
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