Regulating vaccines at the FDA: development and licensure of Zika vaccines

Marion F Gruber; Philip R Krause

doi:10.1080/14760584.2017.1324304

Regulating vaccines at the FDA: development and licensure of Zika vaccines

Expert Rev Vaccines. 2017 Jun;16(6):525-527. doi: 10.1080/14760584.2017.1324304. Epub 2017 May 4.

Authors

Marion F Gruber¹, Philip R Krause¹

Affiliation

¹ a Office of Vaccines Research and Review , Center for Biologics Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , MD , USA.

PMID: 28447498
DOI: 10.1080/14760584.2017.1324304

No abstract available

Keywords: Accelerated approval; US FDA; Zika; animal rule; immune response; infectious disease; licensure pathways; surrogate marker; vaccine approval process; vaccine development.

Publication types

Editorial

MeSH terms

Clinical Trials as Topic
Drug Approval*
Humans
Licensure
United States
United States Food and Drug Administration
Viral Vaccines / immunology*
Viral Vaccines / isolation & purification*
Zika Virus Infection / prevention & control*

Substances

Viral Vaccines