title: Licensure strategy for pre- and post-exposure prophylaxis of biothrax vaccine: the first vaccine licensed using the FDA animal rule.
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.
authors: a Biodefense Division , Emergent BioSolutions Inc ., Gaithersburg , MD , US.
authors: Janice
authors: J
authors: Longstreth
authors: a Biodefense Division , Emergent BioSolutions Inc ., Gaithersburg , MD , US.
authors: Mario H
authors: MH
authors: Skiadopoulos
authors: a Biodefense Division , Emergent BioSolutions Inc ., Gaithersburg , MD , US.
authors: Robert J
authors: RJ
authors: Hopkins
mesh_terms: D000818:Animals; D000881:Anthrax / Q000517:prevention & control*; D022122:Anthrax Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D017277:Drug Approval; D006801:Humans; D007115:Immunization Schedule; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D056990:Post-Exposure Prophylaxis / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D022122:Anthrax Vaccines; C493276:Biothrax
keywords: AVA; Anthrax; Bacillus anthracis; BioThrax; animal rule; post-exposure prophylaxis; pre-exposure prophylaxis; vaccines