Global & Disaster Medicine

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PHEMCE High-Priority Threats

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.


What is the PHEMCE?

The PHEMCE is an interagency coordinating body led by the HHS Assistant Secretary for Preparedness and Response, comprising the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, and interagency partners at the Departments of Defense, Veterans Affairs, Homeland Security, and Agriculture. It coordinates the development, acquisition, stockpiling, and recommendations for use of medical products that we need to effectively respond to a variety of high consequence public health emergencies, whether naturally occurring or intentional.

 

EXECUTIVE SUMMARY

The 2017-2018 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP) describes the priorities that the U.S. Department of Health and Human Services (HHS), in collaboration with its interagency partners, will implement over the next five years. This strategy updates the 2016 PHEMCE SIP and fulfills the annual requirement established by Section 2811(d) of the Public Health Service (PHS) Act, as amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). The annual PHEMCE SIP provides the blueprint the Enterprise will use to enhance national health security through the procurement and effective use of medical countermeasures (MCM). Starting with this iteration of the SIP, the PHEMCE is retitling its SIP to reflect a more forward-focused strategic document by referring to the year the PHEMCE developed it as well as the following year. For example, the PHEMCE developed this SIP in 2017; therefore, it is the 2017-2018 PHEMCE SIP. The PHEMCE examines the SIP goals and objectives annually by taking into consideration the progress achieved and the remaining strategic gaps in MCM preparedness. During the development of the 20172018 PHEMCE SIP, the PHEMCE examined the goals and objectives articulated in the 2016 PHEMCE SIP and determined that no changes were necessary at this time.

The streamlined 2017-2018 PHEMCE SIP provides:

1) a summary of the major recent accomplishments;

2) new activities;

3) updates to the activities from the 2016 PHEMCE SIP; and

4) specific information required annually under PAHPRA reporting mandates.

The 2016 PHEMCE SIP identified priority activities in the near-term (fiscal year (FY) 20172018), mid-term (FY 2019-2020), and long-term (FY 2021 and beyond) timeframes. The PHEMCE maintained these timeframes in the 2017-2018 PHEMCE SIP. The PHEMCE is still pursuing activities detailed in the 2016 PHEMCE SIP unless otherwise noted in this document. All activities described are contingent on available appropriations.

 


Public Health Emergency Medical Countermeasures Enterprise

PHEMC

Public Health Emergency Medical Countermeasures Enterprise

The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) coordinates Federal efforts to enhance chemical, biological, radiological and nuclear threats (CBRN) and emerging infectious diseases (EID) preparedness from a medical countermeasure (MCM) perspective. The PHEMCE is led by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes three primary HHS internal agency partners: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as well as several interagency partners: the Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), the Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA).

Compass PHEMCE Strategy and Implementation Plans
The HHS PHEMCE Strategy articulates the strategic direction and will guide policies and decisions for the end-to-end mission of the PHEMCE.  The HHS PHEMCE Implementation Plan identifies priorities across the PHEMCE mission areas.   Learn More >>
Budget PHEMCE Multiyear Budget
The multiyear budget highlights spending plans for the various HHS agencies within the PHEMCE and provides Congress and our external stakeholders with information on funds that have been invested in specific threat areas and future plans for investments in specific threat areas, based on availability of funds.​​ Learn More >>
Manufacturing facility 2010 PHEMCE Review
The vision to combat emerging infectious diseases, pandemics, and bioterrorism is simple: our nation must have the nimble, flexible capability to produce MCMs rapidly in the face of any attack or threat, whether known or unknown, novel or reemerging, natural or intentional.    Learn More >>
Clinician with test tubes. PHEMCE Mission Components
The PHEMCE coordinates medical countermeasure-related efforts within HHS and in cooperation with PHEMCE interagency partners.  This is a complex mission space and many Federal agencies have responsibilities that are critical to its success.  Learn More >>
U.S. Flag PHEMCE Governance
The PHEMCE evolved to address a wider array of challenges, including CBRN threats, pandemic influenza, and emerging infectious diseases.  Under this new paradigm, the PHEMCE is better positioned to address the range of cross-cutting activities that comprise the MCM development process. Learn More >>

South Korean sources: Pyongyang is conducting heat and pressure resistance tests to see whether anthrax germs can survive at temperatures of 7,000 degrees or higher, the level an ICBM encounters when it re-enters Earth’s atmosphere.

Asahi Simbun

Slideshow image 1: The type of illness a person develops depends on how anthrax spores enter the body. All types of anthrax can cause death if they are not treated with antibiotics.

CDC


US and South Korean intelligence agencies say North Korea has experimented with microbes including anthrax, cholera, and plague, and are thought to have had the smallpox virus since at least the mid-1990s

The Hill

CIDRAP

Express

The Koreas at Night


Soligenex, the company developing a heat-stable ricin vaccine, received an additional $2.5 million in funding from the National Institute of Allergy and Infectious Diseases (NIAID), for work on RiVax, their ricin vaccine.

Soligenix

“….RiVax® is Soligenix’s proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin. With RiVax®, Soligenix is a world leader in the area of ricin toxin vaccine research.

RiVax® contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax® that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax® induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals…..”

 

“…..About Ricin Toxin

Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact it is readily extracted from by-products of castor oil production.  Ricin comes in many forms including powder, mist or pellet. Ricin can also be dissolved in water and other liquids.

The US Centers for Disease Control and Prevention estimates that the lethal dose in humans is about the size of a grain of salt.

Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure. 

Ricin is especially toxic when inhaled. Ricin works by entering cells of the body and preventing the cells from making the proteins it needs. 

Without the proteins, cells die, which is eventually harmful to the entire body.

There are currently no effective treatments for ricin poisoning.

The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack…..”


Protecting the nation from deadly pathogens, man-made or natural: More difficult under the Prez’ budget.

NY Times

“….The Office of Public Health Preparedness and Response, which tracks outbreaks of disease, would be cut by $136 million, or 9.7 percent. The National Center for Emerging and Zoonotic Infectious Diseases — a branch of the Centers for Disease Control and Prevention that fights threats like anthrax and Ebola — would be cut by $65 million, or 11 percent.

The C.D.C.’s Center for Global Health would lose $76 million, or 18 percent. Its Emergency Operations Center, which conducts real-time monitoring of outbreak responses, and its Select Agents Program, which sets regulations in lethal toxin labs and helps researchers stay ahead of bioterrorists, face unspecified cuts as well…..”


In Ready or Not? Protecting the Public from Diseases, Disasters and Bioterrorism, 26 states and Washington, D.C. scored a six or lower on 10 key indicators of public health preparedness.

TFAH

Ready or Not? examines the nation’s ability to respond to public health emergencies, tracks progress and vulnerabilities, and includes a review of state and federal public health preparedness policies. Some key findings include:

  • 26 states increased or maintained funding for public health from Fiscal Year (FY) 2014-2015 to FY 2015-2016.
  • Just 10 states vaccinated at least half of their population (ages 6 months and older) against the seasonal flu during the 2015-2016 flu season (from July 2015 to May 2016).
  • 45 states and Washington, D.C. increased the speed of DNA fingerprinting using pulsed-field gel electrophoresis (PFGE) testing for all reported cases of Shiga toxin-producing E. coli O157, a measure of a state’s ability to detect foodborne outbreaks.
  • 10 states have a formal access program or a program in progress for getting private sector healthcare staff and supplies into restricted areas during a disaster.
  • 30 states and Washington, D.C. met or exceeded the overall national average score (6.7) of the National Health Security Preparedness Index (as of 2016).
  • 32 states and Washington, D.C. received a grade of C or above in States at Risk: America’s Preparedness Report Card, a national assessment of state-level preparedness for climate change-related threats – which have an impact on human health.

In addition, the report examined trends in public health preparedness over the last 15 years, finding successes and ongoing concerns.

  • One-third of funds for health security and half of funds for healthcare system preparedness have been cut: Health emergency preparedness funding for states has been cut from $940 million in fiscal year (FY) 2002 to $660 million in FY 2016; and healthcare system preparedness funding for states has been cut by more than half since FY 2005 – down to $255 million.
  • Some major areas of accomplishment: Improved emergency operations, communication and coordination; support for the Strategic National Stockpile and the ability to distribute medicines and vaccines during crises; major upgrades in public health labs and foodborne illness detection capabilities; and improvements in legal and liability protections during emergencies.
  • Some major ongoing gaps: Lack of a coordinated, interoperable, near real-time biosurveillance system; insufficient support for research and development of new medicines, vaccines and medical equipment to keep pace with modern threats; gaps in the ability of the healthcare system to care for a mass influx of patients during a major outbreak or attack; and cuts to the public health workforce across states.

The Ready or Not? report provides a series of recommendations that address many of the major gaps in emergency health preparedness, including:

  • Requiring strong, consistent baseline public health Foundational Capabilities in regions, states and communities-so that everyone is protected.
  • Ensuring stable, sufficient health emergency preparedness funding to maintain a standing set of foundational capabilities alongside a complementary Public Health Emergency Fund which would provide immediate surge funding during an emergency.
  • Improving federal leadership before, during and after disasters – including at the White House level.
  • Recruiting and training a next generation public health workforce with expert scientific abilities to harness and use technological advances along with critical thinking and management skills to serve as the Chief Health Strategist for a community.
  • Reconsidering health system preparedness for new threats and mass outbreaks by developingstronger coalitions and partnerships among providers, hospitals, insurance providers, pharmaceutical and health equipment businesses, emergency management, and public health agencies.
  • Prioritizing efforts to address one of the most serious threats to human health by expanding efforts to stop Superbugs and antibiotic resistance.
  • Improving rates of vaccinations for children and adults – which are one of the most effective public health tools against many infectious diseases.

Ready or Not? was released annually from 2003-2012, and more recently, TFAH has released Outbreaks: Protecting Americans from Infectious Diseases, from 2013-2015.The report was supported by a grant from the Robert Wood Johnson Foundation (RWJF).

Score Summary:

A full list of all of the indicators and scores and the full report are available on TFAH’s website. For the state-by-state scoring, states received one point for achieving an indicator or zero points if they did not achieve the indicator. Zero is the lowest possible overall score, 10 is the highest. The data for the indicators are from publicly available sources or were provided from public officials.

10 out of 10: Massachusetts

9 out of 10: North Carolina and Washington

8 out of 10: California, Connecticut, Iowa, New Jersey, Tennessee and Virginia

7 out of 10: Colorado, Delaware, Florida, Indiana, Maryland, Michigan, New Hampshire, New Mexico, New York, North Dakota, Oregon, Rhode Island, South Carolina, Utah and Wisconsin

6 out of 10: Arizona, Arkansas, District of Columbia, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maine, Minnesota, Mississippi, Montana, Nebraska, Ohio, Pennsylvania, Texas and Vermont

5 out of 10: Alabama, Missouri, Oklahoma, South Dakota and West Virginia

4 out of 10 Nevada and Wyoming

3 out of 10: Alaska and Idaho


Trump & Deadly Disease

NY Times

  • “…..President Trump’s budget would cut funding for the National Institutes of Health by 18 percent.
  • It would cut the State Department and the United States Agency for International Development, a key vehicle for preventing and responding to outbreaks before they reach our shores, by 28 percent.
  • And the repeal of the Affordable Care Act would kill the billion-dollar Prevention and Public Health Fund, which provides funding for the Centers for Disease Control and Prevention to fight outbreaks of infectious disease.
  • (While the budget also calls for the creation of an emergency fund to respond to outbreaks, there is no indication that it would offset the other cuts, or where the money would come from.)
  • We are already witnessing an outbreak of influenza in birds — the H7N9 strain, in China — that could be the source for the next human pandemic. Since October, over 500 people have been infected; more than 34 percent have died. Most victims had contact with infected poultry, yet three recent clusters appear to be from person-to-person transmission. Will H7N9 mutate to become easily transmitted between humans? We don’t know. But without sufficient supplies of a vaccine, we are not prepared to stop it…….”

Emergent Biosolutions gets Health Canada approval for Botulism antitoxin

Emergent

Emergent BioSolutions Inc.  today announced that Health Canada has approved the company’s New Drug Submission (NDS) for its botulism antitoxin, BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)]. BAT is indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients…….

Emergent has an existing ten-year contract, executed in 2012, to supply BAT to the Canadian Department of National Defense as well as the Public Health Agency of Canada and individual provincial health authorities. In addition, Emergent has been supplying BAT to the U.S. Strategic National Stockpile as part of a $450 million contract with the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. BAT, which was licensed by the U.S. Food and Drug Administration in 2013, is the only botulism antitoxin available in the U.S. for treating naturally occurring, non-infant botulism, and for administering to patients under emergency conditions…..”

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