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Biological agents that might be used as weapons of Bioterrorism Example of Anthrax: Bacillus anthracis Ramatoulaye BARRY M2 AREIPS November 15th 2016 TABLE OF CONTENTS I- Bioterrorism 1- Overview 2- Categorisation II- Regulation 1- In Europe : Guidance document on use of medicinal products for the treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism 2- In USA : The Bioterrorism Act III- Example of Anthrax 1- Overview 2- Context 3- Recommendations Ramatoulaye BARRY 2 I- BIOTERRORISM Ramatoulaye BARRY 3 1- Overview A bioterrorism attack is the deliberate release of viruses, bacteria, or other germs used to cause illness or death in people, animals, or plants Biological agents : - found in nature spread through the air, through water, or in food could be changed extremely difficult to detect Ramatoulaye BARRY 4 2- Categorisation Three categories, depending on: - How easily they can be spread The severity of illness they cause Two classifications: - The EMA Categorisation - The CDC Categorisation Ramatoulaye BARRY 5 2- Categorisation The Centers for Disease Control and Prevention CDC = the leading national public health institute of the United States ☛ To protect public health and safety through the control and prevention of disease Ramatoulaye BARRY 6 2- Categorisation CDC Categorisation Category A: The highest priority - easily spread or transmitted high death rates public panic special action for public health preparedness Examples: Anthrax and Smallpox virus Ramatoulaye BARRY 7 2- Categorisation CDC Categories Category B: The 2nd highest priority - moderately easy to spread moderate illness rates and low death rates specific enhancements of CDC's laboratory capacity and enhanced disease monitoring Example: Brucellosis Ramatoulaye BARRY 8 2- Categorisation CDC Categories Category C: The 3rd highest priority Emerging pathogens - easily available easily produced and spread high morbidity and mortality rates and major health impact Example: H1N1 Ramatoulaye BARRY 9 II- REGULATION Ramatoulaye BARRY 10 1- In Europe Guidance document on use of medicinal products for the treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism = a guidance document on the use of medicinal products for treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500049399.pdf Ramatoulaye BARRY 11 2- In the US The Public Health Security and Bioterrorism Preparedness and Response Act of 2002: the Bioterrorism Act The events of Sept. 11, 2001: need to enhance the security of the United States Signed by President BUSH into law June 12, 2002 Divided into 5 titles : - Title I: National Preparedness for Bioterrorism and Other Public Health Emergencies - Title II: Enhancing Controls on Dangerous Biological Agents and Toxins - Title III: Protecting Safety and Security of Food and Drug Supply - Title IV: Drinking Water Security and Safety - Title V: Additional Provisions http://www.fda.gov/RegulatoryInformation/Legislation/ucm148797.htm Ramatoulaye BARRY 12 III- Example of Anthrax Ramatoulaye BARRY 13 1- Overview A serious infectious disease Gram-positive, rod-shaped bacteria : Bacillus anthracis Ramatoulaye BARRY 14 1- Overview Different types of Anthrax: All type of Anthrax can cause death Ramatoulaye BARRY 15 1- Overview Focus on Inhalation Anthrax Symptoms - Fever - Chills - Drenching sweats - Profound fatigue - Minimally productive cough - Nausea or vomiting - Chest discomfort Ramatoulaye BARRY 16 2- Context The 2001 Anthrax attacks/ Amerithrax - Concentrated anthrax spores were used for bioterrorism in the United States - Delivered by mailing postal letters containing the spores One week after the September 11 attacks Ramatoulaye BARRY 17 3- Recommendations EU Guidance on the use of medicines for the treatment and prevention of biological agents Ciprofloxacine : - First line treatment - First line prophylaxis Ramatoulaye BARRY 18 3- Recommendations - Treatment Ciprofloxaxine : 400 mg iv twice daily followed by 500 mg orally twice daily Duration : 60 days - Prophylaxis Ciprofloxacine: 500 mg orally twice daily Duration : 60 days Ramatoulaye BARRY 19 To conclude Bioterrorism: A concerning threat In Europe: Difficulty to harmonise advices Ramatoulaye BARRY 20 Thank you ! Ramatoulaye BARRY 21 Bibliography http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000248.jsp& mid=WC0b01ac05800533a5 http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/ WC500049399.pdf http://www.fda.gov/RegulatoryInformation/Legislation/ucm148797.htm https://emergency.cdc.gov/bioterrorism/overview.asp Ramatoulaye BARRY 22