Academic Journal
Licensure strategy for pre- and post-exposure prophylaxis of biothrax vaccine: the first vaccine licensed using the FDA animal rule.
| Title: | Licensure strategy for pre- and post-exposure prophylaxis of biothrax vaccine: the first vaccine licensed using the FDA animal rule. |
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| Authors: | Longstreth, Janice, Skiadopoulos, Mario H., Hopkins, Robert J. |
| Source: | Expert Review of Vaccines; Dec2016, Vol. 15 Issue 12, p1467-1479, 13p |
| 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. [ABSTRACT FROM PUBLISHER] |
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| ISSN: | 14760584 |
| DOI: | 10.1080/14760584.2016.1254556 |
| Database: | Complementary Index |
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