First vaccine approval under the FDA Animal Rule

David W.C. Beasley, Trevor L. Brasel, Jason E. Comer

Research output: Contribution to journalReview articlepeer-review

37 Scopus citations


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.

Original languageEnglish (US)
Article number16013
Journalnpj Vaccines
StatePublished - Aug 25 2016

ASJC Scopus subject areas

  • Immunology
  • Pharmacology
  • Infectious Diseases
  • Pharmacology (medical)


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