GOAL 1: Ensure the U.S. government has defined the right MCM capabilities to respond to future public health emergencies and disasters.
Up-to-date risk assessments of the current and evolving threat landscape are critical for preparedness and response planning, and decision-making. These assessments help identify the most critical CBRN, pandemic influenza, and other EID threats to national security and inform USG's MCM development and procurement. They also provide decision-makers with information needed to prioritize threats, support the capabilities needed to deploy and use MCMs effectively, and integrate available solutions into MCM preparedness and response.
ASPR collaborates with the U.S. Department of Homeland Security (DHS) to leverage risk assessments, as well as existing material threat determinations (MTDs), to establish Requirements that (a) assess capabilities, (b) identify gaps, (c) outline solutions, and (d) justify the timely allocation of resources. Such Requirements inform tradeoffs that balance existing resources and constraints and inform MCM procurement and sustainment decisions for both CBRN and emerging threats. To guide PHEMCE's evaluation and prioritization of MCMs, PHEMCE members will:
Objective 1.1 Conduct a comprehensive threat landscape review and update scenarios and modeling to inform Requirements.
Key Milestones:
1.1.1 Continue annual threat briefing for PHEMCE member agencies.
1.1.2 Conduct annual risk analysis that integrates updated intelligence and surveillance information on emerging and re-emerging threats.
1.1.3 Leverage interagency expertise to review and update scenarios and models used to inform Requirements development for 25 percent of the threats each year.
Objective 1.2 Update Requirements for MCM-related activities, including stockpiling, to reflect current and emerging threats and operational plans.
Key Milestones:
1.2.1 Leverage the current risk analysis to ensure that high priority threats are aligned with DHS's list of MTDs, such that as new threats emerge, new MTDs are added, as needed, and rescinded if certain threats wane. These determinations incorporate latest threat information and guide the MCM portfolio.
1.2.2 Use current scenarios and models to finalize requirements for developing and acquiring MCMs and the capabilities required to use and monitor them.
1.2.3 Ensure all populations, particularly vulnerable, at-risk, and historically underserved are considered in updated scenarios and models.
1.2.4 Integrate updated Requirements and MTDs into the MCMPR report.
Objective 1.3 Increase the visibility of current USG capabilities through the development of a comprehensive MCM database for federal partners (ensuring appropriate protections for information contained in the database), which outlines the status of products and technologies from the development pipeline through stockpiling.
Key Milestones:
1.3.1 Ensure PHEMCE members have access to the latest information on products in the MCM pipeline, including how these address updated MTDs and Requirements.
1.3.2 Establish and maintain a comprehensive database of available MCMs across all priority CBRN and emerging infectious disease threats. Database should capture the regulatory approval status for high-risk populations, including pregnant women and children.
GOAL 2: Drive unified action toward developing and sustaining priority MCMs aligned with key USG strategies.
PHEMCE member agencies do not have access to the funds needed to fully support and sustain a robust MCM pipeline and capabilities that ensures full preparedness — from early research to delivery, utilization, and safety monitoring — necessary to meet the established Requirements for a holistic MCM enterprise. At the same time, the PHEMCE is addressing an increasing number of threats, including emerging infectious diseases, some of which do not have established MTDs. This growing gap in projected need versus available funding identified by the PHEMCE MYB makes it challenging for PHEMCE agencies to ensure our nation is best prepared to respond to future public health emergencies or disasters. A well-harmonized set of priorities across interagency partners is critical to ensuring all key stakeholders work together and maximize available resources. Guided by national strategies, including the National Health Security Strategy and National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (NBS), the PHEMCE pursues unified priorities balanced against existing resources. For example, the NBS's implementation plan calls for seven Joint Capabilities Plans (JCPs), many of which are specific to MCMs and relevant to the PHEMCE's scope. Where possible, the PHEMCE's approach is to prioritize broadly acting or threat-agnostic countermeasures, aligning to the goals of the JCPs, to ensure MCMs can be adapted and readily scaled to address novel emerging threats. To this end, the PHEMCE members will:
Objective 2.1 Conduct routine USG MCM portfolio reviews to ensure coordinated action (and avoid duplication) across partners, departments, and agencies.
Key Milestones
2.1.1 Leverage the MCM database (see Objective 1.3) to conduct a comprehensive PHEMCE-wide portfolio review and identify critical gaps and inefficiencies.
2.1.2 Establish a regular review cadence to ensure the portfolio stays up-to-date and aligned with key priorities.
2.1.3 Promote information sharing with key international partners to improve the global preparedness posture.
Objective 2.2 Identify the most critical capability gaps and priorities across MCM development, including platform technologies and threat-agnostic approaches.
Key Milestones:
2.2.1 Identify opportunities for collaboration among priority areas for research and development, from discovery through approval and sustainment. Given limited funds, these priorities will be weighed against existing priorities to minimize risk.
2.2.2 Identify opportunities for development activities to leverage flexible technologies that can adapt more easily to novel, unknown threats.
2.2.3 Identify in advance regulatory mechanisms to support medical product use in identified populations at risk.
2.3.4 Coordinate across interagency partners and maximize resources for the development and use of emerging technologies.
Objective 2.3 Leverage USG plans to develop critical MCM capabilities.
Key Milestones:
2.3.1 Leverage development of Requirements, stakeholder engagements, lessons learned initiatives, table-top exercises, and/or other mechanisms or policy initiatives to update or refine USG plans and policies, including the JCPs.
2.3.2 Identify opportunities to coordinate planning exercises to ensure appropriateness of proposed plans and policies.
2.3.3 Identify innovative approaches to develop MCM capabilities.
2.3.4 Ensure PHEMCE partners share MCM-related strategic plans, playbooks, or other relevant guiding documents to support communication and cross-collaboration.
2.3.5 Incorporate development of new initiatives into PHEMCE's MYB to track and forecast budget needs.
GOAL 3: Optimize and strengthen collaborations with stakeholders.
An effective MCM enterprise is contingent on close coordination and collaboration among all partners.
As required in statute, PHEMCE member agencies routinely engage with non-federal partners. With SLTT public health departments and officials, these occur via routine engagement from ASPR regional offices, formalized webinars, and targeted partnerships and from CDC emergency management, epidemiology, laboratory, clinical and state and local staff who engage with epidemiologic, laboratory, healthcare and regulatory partners. With industry partners, PHEMCE engages via market research, new and existing partnerships, and targeted solicitations. These mechanisms, among others, were actively utilized during recent response efforts and are continuously assessed for improvement opportunities. The PHEMCE will also continue to improve coordination and collaboration between federal and non-federal partners and:
Objective 3.1 Enhance collaboration between federal and non-federal (e.g., industry and nonprofit, SLTT, pharmacies, and healthcare systems) partners to improve engagement for effective MCM decision-making and use.
Key Milestones:
3.1.1 Finalize a PHEMCE stakeholder engagement strategy for engaging non-federal partners, leveraging existing available channels, and developing new mechanisms to fill gaps.
3.1.2 Ensure quarterly engagement with industry partners through appropriate channels.
3.1.3 Ensure regular engagement among federal partners through appropriate channels.
3.1.4 Conduct targeted outreach on specific topics identified and prioritized by PHEMCE members and stakeholders.
3.1.5 Leverage existing cooperative agreements that can support partnership building and collaboration.
Objective 3.2 Identify and develop resources or tools to support collaboration with relevant partners. Tools should improve how MCMs are developed, manufactured, sustained, distributed, used, or monitored for safety and effectiveness.
Key Milestones:
3.2.1 Identify existing tools used across interagency partners for MCM training, deployment, data collection (such as safety and real-world effectiveness monitoring), and guidance development.
3.2.2 Develop a new resource or tool for coordinated partner engagement.
3.2.3 Integrate external feedback into development of resources or tools.
GOAL 4: Strengthen last-mile MCM access efforts to enable a more coordinated and equitable MCM response to a future public health emergency or disasters.
MCM preparedness efforts are only successful if products are able to be used when they are needed by those who need them the most. This requires a concerted effort among key federal and non-federal partners on MCM dispensing, distribution, and administration, including safety and effectiveness monitoring, paying particular attention to challenges faced by vulnerable individuals and underserved communities disproportionately impacted by public health emergencies and disasters. Lessons learned from COVID-19 and mpox provide opportunities to improve last-mile MCM capabilities. The PHEMCE will incorporate recent lessons into USG preparedness efforts to ensure a more coordinated and equitable MCM response during future public health emergencies or disasters. To strengthen last-mile efforts, the PHEMCE members will:
Objective 4.1 Identify last-mile MCM dispensing, distribution, and administration lessons from COVID-19 and mpox, capitalizing on preserving capabilities built during responses and new capabilities that need to be established.
Key Milestones:
4.1.1 Review existing after-action and lessons-learned reports from recent response efforts as well as trainings and exercises. Examples include but are not limited to COVID-19 and mpox. Identify areas of improvement for MCM use that may be addressed by guidance development.
4.1.2 Leverage collaborative tools (Objective 3.2) to engage key federal and non-federal partners on MCM dispensing, distribution, and administration issues experienced during response efforts.
Objective 4.2 Ensure lessons are incorporated into appropriate HHS plans, including product development, acquisition, and stockpiling efforts.
Key Milestones:
4.2.1 Collaborate with interagency partners on developing response plans, as appropriate, to align last-mile roles and responsibilities and reduce duplication of efforts. Where possible, plans should include triggers for release of products.
4.2.2 Develop data-driven tools to address last-mile dispensing and administration and safety monitoring efforts.
4.2.3 Share collected distribution lessons learned with stakeholders, as appropriate.
4.2.4 Where relevant, incorporate last-mile lessons learned into product research and development efforts.
Objective 4.3 Consider MCM needs across ALL populations — focusing on vulnerable, at-risk, and historically underserved communities — to improve equitable deployment and access to MCMs.
Key Milestones:
4.3.1 Review research and development portfolios as well as stockpiled MCMs to identify data gaps, including clinical studies, to address the needs of vulnerable individuals and underserved communities.
4.3.2 Integrate existing efforts analyzing vulnerable and medically fragile populations into planning and response efforts.
4.3.3 Coordinate updates to guidance documents incorporating new information, including lessons learned from recent response efforts.
4.3.4 Identify mechanisms to collect and inform product access and use across underserved communities.
<-- Back Next -->
