Since 2006, ASPR’s BARDA has supported the advanced research and development of new MCMs. To drive innovation in the MCM enterprise, BARDA established the Combatting Antibiotic-Resistant Bacteria Accelerator (CARB-X) in FY 2016, the Division of Research Innovation and Ventures (DRIVe) in FY 2018 and partnered with Johnson and Johnson in FY 2019 to establish the DC JLabs. BARDA will continue to explore innovative approaches for strengthening the MCM enterprise.
BARDA
The FY 2021 request is $1.4 billion, which is $150 million less than the FY 2020 enacted budget. BARDA funding supports the ARD, PBS, and PI programs. BARDA works with public and private partners to transition candidates for MCMs from early development into the advanced and late-stages of development and approval. BARDA has successfully advanced 54 innovative products to the Food and Drug Administration (FDA) for approval, including 10 during 2019 alone. ASPR will continue to develop and maintain a robust stockpile of MCMs capable of responding to 21st century health threats.
ARD
Within BARDA, the FY 2021 request for ARD is $562 million, which is flat compared to the FY 2020 enacted level. ARD bridges gaps in national preparedness addressed by no other federal agency, specifically, the late stages of development necessary to reach licensure for MCMs designed to prevent, diagnose, or treat illnesses or injuries from CBRN. The ARD also addresses emerging infectious diseases, pandemic influenza, and antimicrobial resistance. In partnership with industry, BARDA created a pipeline that addresses the medical consequences of 14 CBRN threats. ARD has supported 27 products that have transitioned under PBS with 16 of these products now procured for the SNS.
The FY 2021 request supports $160 million for Combatting Antibiotic-Resistant Bacteria (CARB) and activities including CARB-X. CARB-X is a collaboration between BARDA, National Institutes of Health, Boston University, the UK and German Governments, the Bill and Melinda Gates Foundation and the Wellcome Trust. CARB-X aims to identify, build, and manage a portfolio of innovative antibacterial MCMs. As of January 2020, CARB-X has made awards to 53 different companies with six projects that have moved into human clinical trials. CARB-X is currently investing in 35 candidates that include three novel vaccines targeting drug-resistant superbugs, 14 non-traditional approaches to treating bacterial infections, 16 next-generation antibiotics, and four diagnostic platforms, such as rapid point-of-care diagnostics and hospital laboratory-based diagnostics. CARB-X will continue to make strategic investments to move the field forward.
PBS
The FY 2021 request for PBS is $535 million, which is $200 million less than the FY 2020 enacted level. After successful advanced development of MCMs, BARDA supports late-stage development and procurement of promising products through PBS. Once licensed and approved, PBS transitions MCMs to the SNS. The FY 2021 request includes late stage development and procurement of a next-generation anthrax vaccine, new antibacterial drugs, chemical agent MCMs, a product to temporize burn injuries resulting from chemical agents, and MCMs to detect and treat acute exposure to ionizing radiation. Intravenous formulations of stockpiled smallpox antiviral drugs will be made available for special populations and those who are severely ill.
In FY 2020, Congress provided ASPR with an additional $535 million to support ongoing Ebola efforts. This critical investment bolsters ASPR’s partnerships with the private sector to develop and purchase Ebola vaccines, therapeutics and diagnostics. The supplemental funds are critical to effective preparedness and response efforts that address the ongoing Ebola outbreak in the Democratic Republic of Congo. During December 2019, a milestone in global health security was achieved when the FDA approved Merck’s ERVEBO vaccine, the first vaccine for preventing the Ebola virus disease. This is a safe and effective tool in the fight against Ebola.
PI
The FY 2021 request for PI activities is $306 million, which is $50 million above the FY 2020 enacted level. Funds are critical to domestic pandemic preparedness and national security infrastructure. Funds will sustain previous investments; ensure that influenza vaccines and therapeutics are available to mount an effective and timely pandemic response; maintain overall pandemic readiness; and, ensure effective international pandemic preparedness. The additional FY 2021 resources will be used to expand domestic manufacturing for non-egg based vaccines and adjuvants, modernize vaccine technology in ways that decrease manufacturing timelines, develop better antivirals especially for hospitalized patients, and transition diagnostics to home-based. BARDA’s strategy accelerates the transition to modern, egg‑independent, cell- or recombinant-based approaches.
In 2019, President Trump signed Executive Order (EO) 13887 entitled, “Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health,” directing federal agencies to collaborate to improve the effectiveness, production, and supply of influenza vaccines to combat seasonal epidemics and pandemics. The EO seeks to:
- Reduce the United States’ reliance on egg‑based influenza vaccine production;
- Expand domestic capacity of alternative vaccine production methods that allow a more agile and rapid response to evolving and emerging influenza viruses;
- Advance the development of new broadly protective and longer lasting influenza vaccines; and,
- Promote increased influenza vaccine immunization across the population.
ASPR contributes to the EO by working with industry to expand domestic manufacturing capacity and advance the development of a next generation influenza vaccines. ASPR also contributes through alternative vaccine delivery technology and vaccine adjuvant formulations, as well as development and testing of novel influenza diagnostics and antiviral drugs.
To address the potential catastrophic medical consequences of 21st century threats, a tiered regional system based on existing local healthcare coalitions and centers of speciality care is being developed.
HPP
The FY 2021 budget request for HPP is $258 million, which is $18 million below the FY 2020 enacted level. HPP provides formula‑based cooperative agreements to state, local, and territorial partners. As the only source of federal funding for health care delivery system readiness, HPP focuses on health care provider coordination that enables an effective response to save lives and mitigate negative health outcomes for those impacted by public health and medical emergencies. HPP supports regional health care system readiness through health care coalitions (HCC). HCCs are groups of health care and response organizations that play a critical role in ensuring that each member has what is needed to respond to emergencies and planned events. Preparedness includes addressing medical surge capabilities, access to real-time information and communication systems, and disaster-specific education and training for health care personnel.
SPOTLIGHT on the Regional Disaster Health Response System (RDHRS)
The RDHRS demonstration program provides funding directly to hospitals and health systems. Two pilots, which were initiated at the end of FY 2018 at Nebraska Medicine and Massachusetts General Hospital, focus primarily on building and maturing the partnerships required to effectively prepare for, and respond to, the management of patients in disasters, including those that facilitate rapid expansion of medical surge capacity of the existing health care system, coordination of patient and resource movement to support the response, and the swift involvement of specific clinical specialists. Advancements in the RDHRS pilots reduce the need for federal support during multi-state, regional responses while simultaneously ensuring that the wealth of assets and expertise held in private sector health care can be used during disasters.
PEO
The FY 2021 budget includes $27 million in budget authority for PEO activities, which is a $2.5 million increase to the FY 2020 enacted level. The increase provides $1.3 million to establish an Insider Threat Program, $600,000 for additional Secretary’s Operation’s Center (SOC) staff to meet requirements of the new Incident Response Framework, and $600,000 for infrastructure and technology improvements to ensure the readiness of the primary HHS Continuity of Operations site and its synchronization with the SOC. This request includes $5 million in three-year funding to prepare for, and respond to, National Special Security Events, public health emergencies, and other events.
NDMS
The budget requests $88 million for NDMS, which is $31 million above the FY 2020 enacted level. The request supports operations, logistics support, and regional emergency coordination, to prepare for, and respond to, public health emergencies and disasters. The increase in requested resources includes funding for pediatric speciality care projects, portable dialysis sustainment, medical responder training, and the emPOWER program. In FY 2019 NDMS, in collaboration with HPP, awarded two cooperative agreements to support a coordinated regional pediatric disaster care capability.
MRC
The FY 2021 budget requests $4 million for MRC, which is $2 million below the FY 2020 enacted level. The request supports overarching national and regional coordination and technical assistance to MRC unit leaders to guide the development and sustainment of the units. This includes identifying and/or sharing training resources for unit leaders and volunteers, best practices in volunteer recruitment and retention, and other topics critical to unit leaders.
PRI
The FY 2021 budget request includes $15 million for the new PRI initiative that supports two innovative projects: portable/in-home dialysis care and the manufacture of sterile saline on demand. Together, the projects conduct research and development on portable dialysis platforms that can create dialysate from potable water sources and ensure the safety of patients using the technology at home or in a temporary outpatient care facility. PRI will provide a prototype that extends the capabilities of the next-generation home hemodialysis systems under evaluation by the FDA. The PRI program will engineer demonstration units and begin validation of sterile saline on-demand technologies.
ASPR supports public health agencies’ ability to quickly detect, diagnose, monitor and respond to 21st century health threats.
SNS
The FY 2021 request of $705 million for the SNS is level with the FY 2020 enacted level. To improve America’s readiness against national disasters, including naturally or man-made disease threats, the SNS engages in the procurement, maintenance, and use of MCMs. In coordination with the Public Health Emergency Medical Countermeasures Enterprise, the SNS is implementing strategies to meet the national priorities for federal stockpiling and to maintain and improve response capabilities as well as address inventory gaps. Through this, the enterprise is more productive and effective at developing, stockpiling, and using the MCMs needed to save lives and protect America from 21st Century health security threats.
Spotlight on The Last Mile
In the event of a large-scale biological attack, the U.S. federal government has a challenging task: to dispense lifesaving antibiotics and other medicines as quickly as possible. Partnering with SLTT as well as industry is critical to accomplish this mission. The Last Mile is a collaborative effort within ASPR to examine new initiatives and improve existing processes. The Last Mile is piloting distribution and delivery efforts in seven major U.S. cities, and promotes collaboration with several federal and private partners. For example, the Last Mile is establishing public-private partnerships with hotels to help dispense medications during public health emergencies. The Last Mile addresses staffing challenges and the distribution and dispensing of oral antibiotics, which is a frequently identified gap. Building on the work of the SNS and the Center for Disease Control’s Division of State and Local Readiness, innovative distribution and dispensing strategies are under development for both the state and local levels.
ASPR is a leader in preparedness for, response to, and recovery from 21st century health security threats. ASPR provides clear policy direction and improved threat awareness, while securing adequate resources that help manage the next health threat.
Policy and Planning
The FY 2021 budget includes $20 million to support ASPR’s activities to develop, evaluate, implement, and align strategies, policies, plans, and requirements to ensure a strong foundation for public health and health care preparedness, response, and recovery. The request is $5 million above the FY 2020 enacted level in order to support ASPR’s coordination, implementation, and assessment of the National Biodefense Strategy (NBS). The NBS sets the course for the nation to combat serious bio-threats, whether they arise from natural outbreaks of disease, accidents involving high consequence pathogens, or the actions of terrorists or state actors. This request also supports the requirements of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, such as the National Health Security Strategy, the National Biodefense Science Board, and the National Advisory Committee on Children and Disasters.
Operations
The FY 2021 request includes $31 million for ASPR’s Operations, which is level with the FY 2020 enacted budget. These funds ensure that goals are met and human capital is strategically managed, including workforce leadership. ASPR aligns its financial resources with strategic priorities and conducts annual planning using multiyear strategies. Funding ensures that resources, acquisitions, and grants are managed in holistic, nimble, and flexible ways. Funding for ASPR Operations also provides risk, quality, and performance management.
