Understanding FDA-Approved Labeling and CDC Recommendations for Use of Vaccines.

Autor:	Meissner HC; Department of Pediatrics, Tufts Medical Center, Boston, Massachusetts; cmeissner@tuftsmedicalcenter.org., Farizo K; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Pratt D; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Pickering LK; Department of Pediatrics, School of Medicine, Emory University, Atlanta, Georgia; and., Cohn AC; National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Jazyk:	angličtina
Zdroj:	Pediatrics [Pediatrics] 2018 Sep; Vol. 142 (3).
DOI:	10.1542/peds.2018-0780
Abstrakt:	Adherence to recommendations for the use of licensed vaccines ensures maximum individual and societal benefits from the national immunization program. The US Food and Drug Administration (FDA) licenses a vaccine once it determines that data submitted by the manufacturer reveal that the vaccine is safe and effective for its intended use. For each US-licensed vaccine, the FDA-approved prescribing information contains detailed information for health care providers to ensure safe and effective use. Centers for Disease Control and Prevention recommendations for the use of a licensed vaccine often are based on additional considerations, such as disease epidemiology, public acceptance, vaccine supply, and cost. Our objective in this article is to explain the reasons for the differences between FDA-approved prescribing information and Centers for Disease Control and Prevention recommendations for vaccine use. Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose. (Copyright © 2018 by the American Academy of Pediatrics.)
Databáze:	MEDLINE
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