Licensure strategy for pre- and post-exposure prophylaxis of biothrax vaccine: the first vaccine licensed using the FDA animal rule. (1st December 2016)

• Record Type: Journal Article
• Authors: Longstreth, Janice; Skiadopoulos, Mario H.; Hopkins, Robert J.
• Is Part Of: Expert review of vaccines. Volume 15:Number 12(2016)
• Page Start: 1467
• Page End: 1479
• Publication Date: 2016-12-01
• Subjects: Anthrax -- vaccines -- BioThrax -- AVA -- Bacillus anthracis -- post-exposure prophylaxis -- pre-exposure prophylaxis -- animal rule; Vaccines -- Periodicals; Vaccination -- Periodicals; 615.37205
• DOI: 10.1080/14760584.2016.1254556
• Languages: English
• ISSNs: 1476-0584

Abstract

ABSTRACT: Introduction : 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.