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.
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.
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.
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.
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.