Licensure strategy for pre- and post-exposure prophylaxis of biothrax vaccine: the first vaccine licensed using the FDA animal rule

Expert Rev Vaccines. 2016 Dec;15(12):1467-1479. doi: 10.1080/14760584.2016.1254556.

Abstract

The availability of a licensed anthrax vaccine that is safe, effective, and easy to administer for both pre- and post-exposure prophylaxis is critical to successfully manage and prevent potential anthrax attacks. BioThrax® (Anthrax Vaccine Adsorbed; AVA) is the only licensed anthrax vaccine in the US. Areas covered: Recent licensed improvements to BioThrax vaccine for pre-exposure prophylaxis (PrEP) have included an intramuscular (IM) five-dose schedule (in 2008) and a three-dose IM primary series at 0, 1 and 6 months (in 2012). Post-exposure prophylaxis (PEP) - three doses given subcutaneously (SC) at 0, 2, and 4 weeks - was licensed in 2015. We review the anthrax disease and vaccine literature that supported these licensure efforts. Expert commentary: This PEP licensure is the first time the FDA's Animal Rule has been used to license a vaccine. Additional improvements such as fewer vaccine doses and reduced time to protection are desirable for a PEP vaccine and are being pursued with next generation vaccine candidates.

Keywords: AVA; Anthrax; Bacillus anthracis; BioThrax; animal rule; post-exposure prophylaxis; pre-exposure prophylaxis; vaccines.

Publication types

  • Review
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Animals
  • Anthrax / prevention & control*
  • Anthrax Vaccines / administration & dosage*
  • Anthrax Vaccines / immunology*
  • Drug Approval*
  • Humans
  • Immunization Schedule
  • Injections, Intramuscular
  • Injections, Subcutaneous
  • Post-Exposure Prophylaxis / methods*
  • United States
  • United States Food and Drug Administration

Substances

  • Anthrax Vaccines
  • Biothrax