PHEMCE High-Priority Threats

The PHEMCE will continue to address MCM needs to protect against high-priority threats for which the Secretary of Homeland Security made a determination pose a material threat sufficient to affect national security or PHEMCE leadership determines to have the potential to threaten national health security.

This year, the PHEMCE added three chemical agents (chlorine, phosgene, and vesicants); otherwise, the high-priority threats are unchanged from those listed in the 2016 PHEMCE SIP. The PHEMCE high-priority threats are (in alphabetical order by threat area):

Biological Threats

• Bacillus anthracis (anthrax)* and
• Multi-drug resistant B. anthracis (MDR anthrax)*
• Burkholderia mallei (glanders)* and
• Burkholderia pseudomallei (melioidosis)*
• Clostridium botulinum toxin (botulism)*
• Ebola virus (Ebola hemorrhagic fever)*
• Emerging infectious diseases4
• Francisella tularensis (tularemia)*
• Marburg virus (Marburg hemorrhagic fever)*
• Pandemic influenza
• Rickettsia prowazekii (typhus)*
• Variola virus (smallpox)*
• Yersinia pestis (plague)*
• Chemical Threats
• Acetylcholinesterase inhibitor nerve agents*
• Chlorine5
• Cyanide salts (potassium and sodium cyanide)*
• Hydrogen cyanide*
• Phosgene5
• Vesicants*
• Radiological* and Nuclear* Threats(*) indicates threats identified under the following authorities related to MCMs: (1) emergency use authorities that rely on section 564(b)(1)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); (2) priority review vouchers PRVs) under section 565A of the FD&C Act;6 and, (3) procurements of security countermeasures under section 319F-2 of the PHS Act.

4 EIDs continue to remain a high-priority threat for the PHEMCE. The PHEMCE developed a risk assessment framework to assess whether specific emerging pathogens should be included explicitly as a high-priority threat. These pathogens may be included if PHEMCE leadership determines they have the potential to affect national health security.

5 The PHEMCE added additional chemical threat agents to the high-priority threat list after considering multiple factors, including recent reported intentional use of agents as weapons, accidental releases, availability of agents in industry, and health impacts of exposure.

6 It is possible that a drug product meeting the requirements of section 565A (material threat MCM priority review vouchers (PRVs)) also may meet the requirements of section 524 of the FD&C Act (which enables sponsors of certain tropical disease applications to receive PRVs). However, under section 565A(e), the same application is not permitted to receive more than one voucher. U.S. Food & Drug Administration (2017). Tropical Disease Priority Review Voucher Program. https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm534162.htm and U.S. Food & Drug Administration (2017). 21st Century Cures Act: MCM-Related Cures Provisions. https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryand PolicyFramework/ucm566498.htm#prv.

History Channel

“…..Blocked fire exits and the lack of a fire-safety plan caused most of the deaths…..”

IBT

“….A team of researchers from University of Colorado (CU) in Boulder found during the past 100 years, Earth’s slowdowns have correlated surprisingly well with periods with a global increase in magnitude 7.0 and larger earthquakes……”

GSA

GSA Annual Meeting in Seattle, Washington, USA – 2017

BBC

Operation Lentus

CAF response to forest fires, floods, and natural disasters in Canada

NATOMY OF AN OUTBREAK

A Disease Threat Anywhere is a Threat Everywhere.

Today’s world is more connected than ever. In as little as  36 hours¹, a pathogen from a remote village can spread to all major cities in six continents. That is why it is critical to detect, report and respond to outbreaks in a timely manner.

1. Incident Occurs

A new or existing pathogen is introduced to a community and starts to spread.

Humans or animals start to feel ill or even die with similar symptoms.

CDC performs 24/7 global disease monitoring to identify potential incidents.

2. Outbreak Suspected

An outbreak is suspected. There are several ways to detect and verify  a disease through reported cases or from event information.

Local clinics and hospitals see more people with symptoms such as fever, persistent diarrhea, cough and unexplained bleeding.

Laboratory confirms cases of disease found at local clinic.

Disease detective and surveillance teams capture and organize information about events that are a potential risk.

Teams monitor official and unofficial reports of potential disease events from a wide variety of sources including media, rumors, blogs, community members, etc.

CDC works with partners and Ministries of Health to find potential  outbreaks through routine reporting of symptoms, lab test  results and official and unofficial reports.

3. Investigation Started

Countries conduct lab tests or send specimens for testing.

CDC trains countries how to test, handle and safeguard samples.

Disease detectives investigate to determine the source and size of the outbreak.

CDC trains disease detectives around the world to stop the outbreak at the source.

Lab results confirm if patients test positive or negative for illness.

Health authorities are alerted.

4. Reporting

Authorities report disease outbreak to appropriate national and international organizations in accordance with the International Health Regulations.

5. Global Response Initiated

CDC’s global rapid responders are deployed when a country requests additional support to:

Implement infection prevention and control measures and distribute medical countermeasures

Conduct public health communication and education

Enhance local surveillance systems to track outbreaks

Improve local lab testing for faster diagnosis

CDC is at the frontline of disease detection and response, working 24/7  to protect the health, safety, and security of American people. CDC’s work

ensures that outbreaks are contained before they can spread and reach the U.S.

1. Jonas, Olga B.. 2013. Pandemic Risk. World Bank, Washington, DC. © World Bank. https://openknowledge.worldbank.org/handle/10986/16343 License: CC BY 3.0 IGO.

This is a snapshot of an outbreak investigation and does not reflect all the steps that may occur. Information presented in this example depicts a prompt outbreak identification. Several factors affect the investigation and can prolong the timing and results. Delays in response activities can lead to outbreaks spreading quickly and spillover to other communities.