HHS Announces Actions to Counter Biological Threats, Enhance Pandemic Preparedness, and Achieve Health Security

The U.S. Department of Health and Human Services (HHS) today announced actions the department will take following National Security Memorandum 15, signed by President Biden, directing implementation of the 2022 National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security.

The strategy and implementation plan detail a coordinated approach to address the challenges from naturally occurring, deliberate, and accidental biological threats. These threats are among the most serious threats facing the U.S. and the international community. The 2022 strategy builds on the 2018 National Biodefense Strategy, incorporating lessons learned during the COVID-19 pandemic, and laying out a comprehensive implementation plan with bold, concrete actions to transform our health security.

HHS Actions to Support Implementation of the National Biodefense Strategy

HHS, including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Administration for Strategic Preparedness and Response (ASPR) will lead the implementation of a range of actions in the National Biodefense Strategy and its implementation plan, which integrates elements of the American Pandemic Preparedness: Transforming Our Capabilities.  HHS will draw on support from experts across the federal government, as well as provide expertise to support actions led by other federal departments and agencies.

HHS is already executing the strategy with existing funding. Fully achieving these transformative objectives, however, will require the support of Congress to provide additional resources, including the President’s $82 billion request for HHS over five years for pandemic preparedness and biodefense.

Examples of HHS efforts to support implementation of the National Biodefense Strategy include:

Strengthening early warning and awareness of pandemics and biological threats

HHS will lead efforts to improve early warning of biological threats and data availability to support real-time, evidence-based decision-making, including:

• Improving disease detection and reporting: Develop domestic capability to improve detection and reporting of disease outbreaks, conduct rapid genomic sequencing and analysis, and support the development of global systems to share information, data, and samples internationally and across industry sectors. Such improvements are essential to prevent or limit the impact of significant biological incidents, both domestically and internationally.
• Accelerating advanced detection technologies: Accelerate research and innovation for advanced biodetection capabilities for clinical and environmental settings, to enable large-scale, affordable, and routine surveillance for novel pathogens.
• Enhancing hospital data collection: Maintain and enhance an enduring domestic all-hazards hospital data collection capability to enable comprehensive data reporting for biosurveillance, situational awareness, and emergency response operations at the federal, state, local, tribal, and territorial levels.
• Improving data analysis to enhance early warning: Enhance capacity for rapid analysis, modeling, baselining, forecasting, and reporting to monitor and evaluate the health threat landscape, using a One Health approach, and improve early warning capabilities.

Enhancing diagnostic capabilities

To strengthen federal capabilities to effectively mitigate the impact of, respond to, and recover from future bioincidents, HHS will expand capabilities in essential areas, including:

• Routinely employing infectious disease diagnostics in medical care and public health;
• Obtaining data from diagnostic tools and sharing these data with federal and state, local, tribal, and territorial public health authorities;
• Regularly testing and evaluating national diagnostics capabilities including manufacturing, capacity, and deployment; and
• Incorporating biosafety and biosecurity considerations throughout diagnostics design and development.

HHS will also work with other departments and agencies to enhance diagnostics capability and capacity to:

• Deploy at least one authorized pathogen-agnostic test within twelve hours, for thousands of samples on the first day, and tens of thousands of samples per day within one week, of determination of a nationally or internationally significant biological incident;
• Develop and produce sufficient quantities of pathogen-specific tests that can be deployed within 30 days of determination of a potential nationally or internationally significant biological incident, in sufficient quantities to support the response to and containment and control of significant biological incidents; and
• Develop, validate, and produce authorized pathogen-specific rapid tests, such as point of need tests with a test run time under 30 minutes within 90 days of determination of a potential nationally or internationally significant biological incident.

Enhancing vaccine and therapeutic capabilities

HHS will work with other departments and agencies to enhance vaccine and therapeutic capacity and capability to:

• Develop, design, test, and authorize safe and effective vaccines against any human or animal viral threat for which a candidate vaccine has been developed within one hundred days after determination of a potential nationally or internationally significant biological incident;
• Produce sufficient quantities of safe and effective vaccines to vaccinate the United States population within one hundred thirty days of the determination of a potential nationally or internationally significant biological incident; and,
• Identify, test, authorize, manufacture and deploy new or repurposed therapeutics that reduce mortality, morbidity, or transmission by at least fifty percent within ninety days (for repurposed therapeutics) and six months (for new therapeutics) of determination of a potential nationally or internationally significant biological incident.

HHS, together with other departments and agencies, will drive towards achieving the above transformational bold outcomes, recognizing the need for sufficient resources and aggressive action to achieve these objectives.

Expanding Personal Protective Equipment (PPE) surge capacity

HHS will work with others in the federal government to maintain a minimum 90-day PPE surge capability, using both commercial distribution channels as well as stockpiles to support control of pandemics and outbreaks. This capability will be informed by an analysis of the quantities of PPE needed to protect the healthcare and critical infrastructure workforce in any catastrophic biological incident or pandemic. HHS also will assess PPE capacity needs to cover vulnerable populations and a diversity of body types, including children.

HHS will safeguard the PPE supply chain diversity for public and animal health through policy, incentives, regulation, and other tools to reduce dependence on a single region, source, or product. Diversity in this context includes a diverse set of products, such as N95 filtering facepiece respirators and elastomeric respirators, and domestic suppliers.

HHS will also support whole-of-government efforts to accelerate innovations in PPE design and manufacturing for enhanced effectiveness, usability, comfort, affordability, reusability, and fit capabilities, including for use by the general population.

Strengthening the public health workforce

HHS will recruit, train, and sustain a robust, flexible, permanent cadre of essential critical health infrastructure workers, public health laboratory scientists, technicians, and data quality managers to support surveillance and response testing and reporting and support the recruitment of One Health experts and dedicated animal and environmental disease epidemiologists, who are critical frontline workers for human and animal disease control at relevant state and territorial agencies and departments, in all 50 states.

Build innovative clinical-trial infrastructure

HHS will work with other departments and agencies to maintain and expand flexible clinical-trials infrastructure, with the goal of administering candidate countermeasures to participants within 14 days of the identification of a viable countermeasure. This effort will expedite the evaluation of safe and effective vaccines, therapeutics, and diagnostics for all segments of the population during a nationally or internationally significant biological incident.

HHS, together with other departments and agencies, will drive towards achieving the above transformational bold outcomes, recognizing the need for sufficient resources and aggressive action to achieve these objectives.

Ongoing HHS Biodefense Activities

Already, HHS has worked aggressively to prevent, detect, and respond to pandemics and other biological incidents in a number of critical areas

Vaccines

• In January 2020, NIH’s National Institute of Allergy and Infectious Diseases (NIAID) rapidly generated a stabilized SARS-CoV-2 spike protein for use in COVID-19 vaccine development. This crucial breakthrough in structure-based vaccine design resulted from years of investment in basic research and led to development of safe and effective COVID-19 vaccine candidates in less than one year.
• NIH’s sustained investment in universal influenza vaccines has produced multiple candidates in advanced preclinical and early clinical development.
• The Biomedical Advanced Research and Development Authority (BARDA), within ASPR, established the Beyond the Needle program, awarding $6.8 million to 10 small biotechnology companies and universities to accelerate development and commercialization of alternative routes of vaccine administration, such as microneedle skin patches, intranasal, and oral vaccines.
• The Federal Retail Pharmacy Program, a partnership between the CDC and 21 pharmacy organizations, has administered more than 284 million COVID-19 vaccine doses, including in communities of color and other underserved populations.

Antiviral Medications

• NIH and BARDA launched the Antiviral Program for Pandemics, developing oral anti-viral medications against pandemic threats. Specifically, NIH established nine multidisciplinary Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern. In addition, NIH began high-throughput screening of compounds to identify potential therapeutic drugs for pandemic use.

Diagnostics and Data Analytics

• BARDA leveraged pre-COVID-19 investment in molecular diagnostics platforms to accelerate 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. As a result of these investments to date, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations and one 510(k) clearance for COVID-19 tests that have been supported by BARDA funding. BARDA efforts have resulted in more than one-fifth of the total U.S. molecular lab test volume.
• NIH 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 RADx has been a partnership with the FDA 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.

Manufacturing

• FDA established the Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals to enhance coordination of science, regulatory, and policy activities for advanced manufacturing.
• BARDA launched the National Biopharmaceutical Manufacturing Partnership (BioMAP) to expand manufacturing capacity for medical countermeasures in the United States.

International Engagements

• HHS is leading engagement with international counterparts in the Group of 7 (G7), the Group of 20 (G20), and at the World Health Organization to strengthen the global health security architecture and improve global prevention, preparedness, and response for future epidemics and pandemics.
• The HHS Office of Global Affairs (OGA) works with health ministry partners around the world to help strengthen pandemic prevention, preparedness and response capacities, focusing on strengthening local and regional health systems, driving investments in global health security, and expanding countries’ ability to prevent, detect, and respond to emergencies.
• As part of strengthening the global health architecture, OGA plays a critical role in the U.S. Government commitment to the negotiation of a new pandemic accord. This work directly supports the approach to treat global health security and pandemic preparedness and response as top national security priorities.  The pandemic accord is an opportunity to better guard against future pandemic threats, including by applying the lessons learned from our collective COVID-19 and other outbreak response efforts to promote transparency, accountability, improved coordination, and rapid action.
• HHS, along with partners from the U.S. Department of the Treasury, U.S. Department of State, and U.S. Agency for International Development, spearheaded the Financial Intermediary Fund for Pandemic Prevention, Preparedness and Response (FIF) at the World Bank, with broad support from the G20. The FIF will provide a dedicated stream of additional, catalytic funding to strengthen the capacities of low- and middle-income countries to prevent, prepare for, and contain pandemic threats, through investments and technical support for critical capacity gaps at the national and regional levels.

Other Actions

• Early warning: CDC established the Center for Forecasting and Outbreak Analytics, which seeks to enhance the Nation’s ability to use data, models, and analytics to enable timely, effective decision making in response to public health threats.
• Communications: CDC’s Vaccine Task Force created an Insights Unit that collects data from 24 sources on the public’s questions and concerns, and the circulation of mis- and disinformation that affects vaccine confidence—then works with partners to mitigate impact through communication strategies.
• Workforce safety: Through the Worker Training Program, NIH has trained tens of thousands of frontline workers (e.g., construction workers, day care workers, healthcare workers, first responders, etc.) on COVID-19 health and safety issues such as PPE, environmental controls, and vaccines.