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.

Publikováno v: NPJ vaccines [NPJ Vaccines] 2024 Oct 31; Vol. 9 (1), pp. 210. Date of Electronic Publication: 2024 Oct 31.