Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2016 Aug 25:1:16013.
doi: 10.1038/npjvaccines.2016.13. eCollection 2016.

First vaccine approval under the FDA Animal Rule

David W C Beasley  1   2   3   4   5 , Trevor L Brasel  1   2   4 , Jason E Comer  1   2   4
Affiliations
Editorial

First vaccine approval under the FDA Animal Rule

David W C Beasley et al. NPJ Vaccines. .

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.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

References

    1. FDA. FDA approves vaccine for use after known or suspected anthrax exposure, Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474027.htm (2015).
    1. FDA. November 23, 2015, Approval Letter—Biothrax, Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPro... (2015).
    1. Russek-Cohen, E. et al. A US Food and Drug Administration perspective on evaluating medical products for Ebola. Clin. Trials 13, 105 (2016). - PubMed
    1. Krause, P. R., Cavaleri, M., Coleman, G. & Gruber, M. F. Approaches to demonstration of Ebola virus vaccine efficacy. Lancet Infect. Dis. 15, 627 (2015). - PubMed
    1. Health_Canada. Guidance Document—Submission and Information Requirements fo Extraordinary Use New Drugs (EUNDs), Available at: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/... (2014).

Publication types

LinkOut - more resources