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

Autor: Hong-Nguyen YK; U.S. Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA. yugenia.hong-nguyen@fda.hhs.gov.; Center for Biologics Evaluation and Research (CBER), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA. yugenia.hong-nguyen@fda.hhs.gov.; Office of Vaccines Research and Review (OVRR), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA. yugenia.hong-nguyen@fda.hhs.gov.; Division of Clinical and Toxicology Review (DCTR), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA. yugenia.hong-nguyen@fda.hhs.gov.; Chase Brexton Health Care, 5500 Knoll North Dr. #370, Columbia, MD, 21045, USA. yugenia.hong-nguyen@fda.hhs.gov., Toerner J; U.S. Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Center for Drug Evaluation and Research (CDER), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Office of Immunology and Inflammation (OII), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Division of Hepatology and Nutrition (DHN), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA., Lee L; U.S. Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Center for Biologics Evaluation and Research (CBER), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Office of Vaccines Research and Review (OVRR), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Division of Clinical and Toxicology Review (DCTR), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA., Allende MC; U.S. Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Center for Biologics Evaluation and Research (CBER), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Office of Vaccines Research and Review (OVRR), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Division of Clinical and Toxicology Review (DCTR), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA., Kaslow DC; U.S. Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Center for Biologics Evaluation and Research (CBER), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Office of Vaccines Research and Review (OVRR), 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.; Immediate Office of the Director, 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA.
Jazyk: angličtina
Zdroj: NPJ vaccines [NPJ Vaccines] 2024 Oct 31; Vol. 9 (1), pp. 210. Date of Electronic Publication: 2024 Oct 31.
DOI: 10.1038/s41541-024-01002-y
Abstrakt: 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.
(© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
Externí odkaz: