Literature DB >> 28447498

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

Marion F Gruber1, Philip R Krause1.   

Abstract

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

Mesh：

Substances：

Year:  2017        PMID： 28447498     DOI： 10.1080/14760584.2017.1324304

Source DB:  PubMed          Journal:  Expert Rev Vaccines        ISSN： 1476-0584            Impact factor:   5.217


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  3 in total

Review 1.  Pneumococcal whole-cell and protein-based vaccines: changing the paradigm.

Authors:  Michael E Pichichero
Journal:  Expert Rev Vaccines       Date:  2017-12       Impact factor: 5.217

2.  Zika vaccine pre-clinical and clinical data review with perspectives on the future development.

Authors:  Stephen J Thomas; Alan Barrett
Journal:  Hum Vaccin Immunother       Date:  2020-07-23       Impact factor: 3.452

Review 3.  Immunological Assays used to Support Efficacy of Zika Virus Vaccines.

Authors:  Kenneth H Eckels; Rafael A De La Barrera; Joseph Robert Putnak
Journal:  Trop Med Infect Dis       Date:  2019-06-28
  3 in total

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