Subject(s)
Anthrax/history , Bioterrorism/history , COVID-19 , Public Health Administration , Public Health/legislation & jurisprudence , COVID-19/prevention & control , History, 21st Century , Humans , Pandemics/prevention & control , Public Health Administration/history , Public Health Administration/trends , State Government , United StatesABSTRACT
The Emergency Use Authorization (EUA) originated in 2004 because of the need for emergency medical countermeasures (MCMs) against potential bioterrorist attacks. The EUA also proved useful in dealing with subsequent pandemics and has emerged as a critical regulatory pathway for therapeutics and vaccines throughout the Coronavirus Disease 2019 (COVID-19) pandemic. With the EUA process in the USA, we witnessed emergency authorizations, their expansions, as well as withdrawal of previously authorized products, which exemplifies the dynamic nature of scientific review of EUA products. EUAs proved vital for the first group of COVID-19 vaccines, including the temporary pause of one vaccine while emergency safety issues were evaluated. Although this review on the EUA is primarily focused on the USA, distinctions were made with other jurisdictions such as Europe and Canada with respect to the emergency authorizations of the vaccines. Finally, we discuss some important differences following EUA and formal new drug/vaccine application (NDA/BLA) approvals.
Subject(s)
Antiviral Agents/standards , COVID-19 Vaccines/standards , COVID-19/prevention & control , Drug Approval/legislation & jurisprudence , Emergencies/history , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Bioterrorism/history , Bioterrorism/prevention & control , COVID-19/epidemiology , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , Canada/epidemiology , Civil Defense/history , Drug Approval/history , Emergencies/epidemiology , Europe/epidemiology , History, 21st Century , Humans , Pandemics/prevention & control , United States/epidemiology , COVID-19 Drug TreatmentABSTRACT
Microbial Forensics is a field that continues to grow in interest and application among the forensic community. This review, divided into two sections, covers several topics associated with this new field. The first section presents a historic overview concerning the use of microorganisms (or its product, i.e. toxins) as harmful biological agents in the context of biological warfare (biowarfare), bioterrorism, and biocrime. Each case is illustrated with the examination of case reports that span from prehistory to the present day. The second part of the manuscript is devoted to the role of MF and highlights the necessity to prepare for the pressing threat of the harmful use of biological agents as weapons. Preventative actions, developments within the field to ensure a timely and effective response and are discussed herein.