First vaccine approval under the FDA Animal Rule

David W C Beasley; Trevor L Brasel; Jason E Comer

doi:10.1038/npjvaccines.2016.13

First vaccine approval under the FDA Animal Rule

NPJ Vaccines. 2016 Aug 25:1:16013. doi: 10.1038/npjvaccines.2016.13. eCollection 2016.

Authors

David W C Beasley^{1

2

3

4

5}, Trevor L Brasel^{1

2

4}, Jason E Comer^{1

2

4}

Affiliations

¹ Office of Regulated Nonclinical Studies, University of Texas Medical Branch, Galveston, TX, USA.
² Department of Microbiology and Immunology, University of Texas Medical Branch, Galveston, TX, USA.
³ Sealy Center for Vaccine Development, University of Texas Medical Branch, Galveston, TX, USA.
⁴ Galveston National Laboratory, University of Texas Medical Branch, Galveston, TX, USA.
⁵ World Health Organization Collaborating Center for Vaccine Research, Evaluation and Training on Emerging Infectious Diseases, University of Texas Medical Branch, Galveston, TX, USA.

Abstract

The US Food and Drug Administration's Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical. In November, 2015 BioThrax became the first vaccine to receive approval for a new indication via this pathway. The basis for this approval and use of Animal Rule or other non-traditional approval pathways for licensure of vaccines for serious conditions are discussed.

Publication types

Editorial

Grants and funding

UC7 AI070083/AI/NIAID NIH HHS/United States