On September 3, 2021, the White House Office of Science and Technology Policy and the National Security Council released the American Pandemic Preparedness Plan: Transforming Our Capabilities, which outlined the transformational capabilities needed to directly address future threats. Since its release one year ago, the U.S. Government has worked diligently to advance progress towards implementing a number of the transformational capabilities outlined in the plan
Today, the White House Office of Science and Technology Policy (OSTP), in coordination with relevant departments and agencies across the U.S. Government, released the First Annual Report on Progress Towards Implementation of the American Pandemic Preparedness Plan, which details crucial advancements towards pandemic preparedness, including providing priority areas for investment and additional efforts needed in the years ahead.
The Biden-Harris Administration is creating transformative capabilities in vaccines, therapeutics, and diagnostics research and development (R&D) that is producing tools to stop, treat, and detect pandemic threats. The plan is also strengthening early warning of emergent threats – so that the nation has the concrete capability to detect viral threats anywhere in the world within days or weeks of their emergence. This is leading to new approaches and systems to detect new threats – as well as old threats like Polio – by genome sequencing, wastewater sampling, and stronger global early warning networks to aggregate and analyze pathogen data.
Tracking threats circulating in human populations has also improved by combining diagnostic, epidemiological, sequencing, and environmental data. And, as a key component of future response, the U.S. Government is now placing increased emphasis on public engagement, trust building, and recognition and resolution of previous harms and challenges in public health.
The following are examples of many recent efforts demonstrating how the Biden-Harris Administration is taking an all-of-government approach to fostering innovation and mitigating the threat of future pandemics.
Transforming our Defenses
The COVID-19 vaccine investments by the U.S. Government demonstrated unprecedented acceleration of safe and effective vaccine development, with investments in six vaccines yielding positive clinical trial results and four of the six vaccines receiving Emergency Use Authorization – including two vaccines with pediatric authorizations.
- A number of Federal departments and agencies – including the OSTP – worked together to launch the Clean Air in Buildings Challenge in March, which served as a call to action for building managers and maintenance professionals. As part of the launch, the Environmental Protection Agency released a practical guide for building managers, contractors, homeowners, and business owners to create an action plan for cleaner indoor air. Also, the Centers for Disease Control and Prevention (CDC) published Ventilation in Buildings and Improving Ventilation in Your Home, which describes how indoor air quality can be improved as part of a layered approach.
- The Environmental Protection Agency, CDC, and the Department of Energy worked with the Department of Education to develop Efficient and Healthy Schools resources and guidance for improving indoor air quality in schools.
- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) established a Vaccine Analytics and Assays Center of Excellence to support vaccine manufacturing, including improved vaccine production, quality, and lessened requirements for cold chain. (The NIIMBL consortium has catalyzed progress across many of the key areas emphasized in the annual assessment.)
Rapid Acceleration of Diagnostics
Through U.S. Government support and public private partnerships, many diagnostic tests for SARS-CoV-2 were rapidly developed during the COVID-19 pandemic. The Biomedical Advanced Research and Development Authority (BARDA) used pre-COVID-19 investment in molecular diagnostics platforms to speed up the availability of SARS-CoV-2 tests and combination SARS-CoV-2 plus influenza tests across laboratory, point-of-care, home-use, and limited testing resource settings such as nursing homes and clinics. To date, 29 Emergency Use Authorizations have been supported by BARDA funding, and BARDA has supplied more than one-fifth of the total molecular lab test volume.
- The National Institutes of Health launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing, with future potential to address other pathogens such as influenza and respiratory syncytial virus. A key contribution of the RADx has been a partnership with the Food and Drug Administration on the Independent Test Assessment Program. The effort accelerated review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public.
- The RADx Tech/Advanced Technology Platforms programs have supported the production of more than three billion tests and test products, 44 Food and Drug Administration Emergency Use Authorizations, over 100 companies, and brought the first over-the-counter test for at-home use through the diagnostic pipeline. Additional RADx programs created a Variant Task Force to monitor test performance against coronavirus “variants of concern,” reduced barriers to test reporting, and reduced testing disparities in underserved populations.
Health Equity Efforts
Innovative state and local health departments have been using real-time data to identify and describe underlying disparities that were exacerbated by the COVID-19 pandemic. Public health leaders used these data to inform the allocation of medical countermeasures, including diagnostics, vaccines, therapeutics, and personal protective equipment to at-risk communities and regional healthcare workers.
- From April 2021 through January 2022, National Institutes of Health and CDC conducted the “Say Yes! COVID Test” program. The program aimed to provide multiple communities with up to 1,000,000 free at-home rapid antigen COVID-19 diagnostic tests through online orders and community distribution, and to evaluate the feasibility and impact of large-scale home test distribution. At its conclusion, this innovative community health initiative deployed in 10 communities delivered over 6.8 million tests across the country in 10 different states. This information contributed to the design of the large Federal free home test program that the Biden-Harris Administration launched in January 2022.
Innovation is critical to advancing pandemic preparedness. For innovation to actually reach and benefit all Americans, however, innovation must be coupled with readiness and scalability. To ensure readiness, the U.S. Government views the pandemic innovation ecosystem and pandemic preparedness more broadly as a portfolio, from early investment through scaling.
- Manufacturing USA is a national network created to secure U.S. global leadership in advanced manufacturing through large-scale public-private collaboration on technology, supply chain, and workforce development. The 16 manufacturing innovation institutes, sponsored by the Departments of Commerce, Defense, and Energy, cover a broad range of industrial sectors relevant to pandemic response and preparedness, including the Commerce sponsored NIIMBL (biopharmaceutical manufacturing), and the Defense-sponsored BioMADE (bioindustrial manufacturing), AmericaMakes (additive manufacturing), and ARM (advanced robotics). Examples of this effort include two recent announcements of grants for advanced research to address the COVID pandemic.
- The Defense Advanced Research Projects Agency (DARPA) launched the Nucleic Acids On-Demand Worldwide program to facilitate rapid, distributed manufacturing of nucleic acid-based vaccines and therapeutics. The program aims to develop deployable technologies for the production of a hundred to thousands of doses of mRNA or DNA-based vaccines and therapeutics in days, facilitating rapid access to early clinical trial material. Early results indicate that rapid, cell-free production of DNA and mRNA-based vaccines can be generated in under one week.