REPORT: The Biden-⁠Harris Administration Roadmap for Pandemic Preparedness and Response

President Biden came into office facing the worst public health crisis in more than a century. COVID-19 was wreaking havoc on our country - closing our businesses, keeping our kids out of school, and forcing communities into isolation and lockdown. In the first year of the pandemic, nearly 400,000 Americans died of COVID-19.

Even before taking office, President-elect Biden recognized that the U.S. needed an emergency response that was worthy of the crisis it faced - a response that would leave no stone unturned and that would leverage the full force of the federal government, the innovation of the private sector, and the determination of the American people. Building on decades of research and planning efforts, President Biden, on his first full day in office, released the first comprehensive National Strategy for the COVID-19 Response and Pandemic Preparedness. This strategy focused on building a response to this virus that would give people the tools and transparent communication they needed to protect themselves, reopen our schools, and get our economy moving again.

The following report outlines the numerous actions the Biden-Harris Administration took to combat COVID-19 both nationally and globally, and it serves as a roadmap for how the U.S. can effectively respond to pandemics and public health threats in the future. In addition to this public-facing report, this Administration is leaving behind a three-step playbook that future Administrations can use to continue to protect the nation and effectively respond to any future biological threat.

1 - Taking Immediate Action to Respond to the COVID-19 Pandemic

Standing Up the Largest Vaccination Program in Our Country's History

In President Biden's first year of office, the Biden-Harris Administration worked hand-in-hand with doctors, nurses, businesses, unions, community organizations, governors, mayors, and citizens across every state, Tribe, and territory to put vaccines at the center of the United States' COVID-19 response. These vaccines still remain the best tools available to lower the risk of hospitalization and death.

The Administration stood up the largest free vaccination program in American history: mobilizing 90,000 vaccination locations; standing up mass vaccination sites with the ability to administer more than a combined 125,000 shots a day; deploying over 9,000 federal personnel to support vaccinations nationwide - including over 5,000 active-duty troops, and launching vaccinefinder.org to provide current information on locations for vaccination. Another part of the federal government's strategy to ensure access to COVID-19 vaccines for the American public was the Federal Retail Pharmacy Program (FRPP) for COVID-19 Vaccination. Pharmacies are readily accessible in the majority of communities in the U.S. - with most Americans living within five miles of a pharmacy. Recognizing this, the federal government made pharmacies a key part of its COVID-19 vaccination strategy, partnering with 21 retail and long-term care pharmacies to vaccinate Americans in more than 41,000 locations nationwide, including long-term care pharmacies.

As a result of these efforts, over 270 million people received at least one shot of a COVID-19 vaccine by May 2023. Additionally, a December 2022 analysis from the Commonwealth Fund suggested that COVID-19 vaccinations saved over 3 million American lives and successfully prevented over 18 million hospitalizations.

Increasing the Country's Testing Supply

Under the leadership of the Biden-Harris Administration, America's testing supply increased substantially, allowing Americans to quickly get answers without having to go to a doctor's office, and to make informed decisions about their day-to-day activities. Less than a month after taking office, the Administration announced a $650 million investment to expand COVID-19 testing for schools and underserved populations, as well as an $815 million investment to increase domestic manufacturing of testing supplies so that we would have a more reliable supply when needed. The Administration, through HHS, also partnered with the private sector to develop and scale manufacturing of tests suitable for home use. Free testing sites were available at 21,500 locations around the country. This was made possible by federal action to expand pharmacy testing sites, a federal surge in free testing sites, delivery of tests to thousands of community health centers and rural health clinics, and $10 billion in American Rescue Plan (ARP) funding to provide tests to K-12 school districts. The Administration also invested nearly $6 billion in ARP funding to cover free testing for uninsured individuals, and to support testing in correctional facilities, shelters for people experiencing homelessness, and mental health facilities. To reach people experiencing homelessness, the U.S. Housing and Urban Development (HUD) collaborated with the Department of Health and Human Services (HHS) to provide tests across major U.S. cities.

The Biden Administration also stood up COVIDtests.gov through which Americans could order tests that were sent by the United States Postal Service directly to their homes - for free. By the end of the Public Health Emergency in May 2023, the Administration had distributed more than 750 million free COVID-19 tests, shipped directly to more than 85 million households. The Administration had also coordinated more than 50 million diagnostic tests in-person at pharmacy and community-based sites.

Collectively, these actions gave Americans the opportunity to keep both themselves and their communities safe, while getting back to school, work, and time with family and friends. Additionally, the Lancet Public Health journal recently published a study showing that making diagnostic tests available quickly during the COVID-19 pandemic mitigated an estimated 7 million hospitalizations and saved approximately 1.4 million lives.

Increasing Treatment Options for Americans

The Biden-Harris Administration also increased investment in the development, manufacturing, and procurement of COVID-19 treatments, which helped to minimize the severity of COVID-19 infections. By March 2022, about 5 million antiviral treatment courses were available to Americans, and the President announced the Test-to-Treat initiative to help make it easier for people at high risk of severe disease and those with limited financial means to quickly access free oral antiviral treatments. By April 2022, the U.S. government purchased 20 million treatment courses-more than any other country in the world and took action to nearly double the number of locations where Americans could get oral antivirals. The Administration also provided medical providers with more guidance, education and tools to help them understand and prescribe these treatments, and to help them inform the choices that the American people made about receiving safe and effective treatments.

2 - Ensuring an Equitable Pandemic Response and Recovery

On his first day in office, understanding that the pandemic had exacerbated severe and pervasive health and social inequities in America, President Biden issued an Executive Order on Ensuring an Equitable Pandemic Response and Recovery - which included the establishment of the COVID-19 Health Equity Task Force. From the start, the Administration took action to empower communities to improve access for all Americans to tests, therapeutics and vaccines.

In addition, the Administration supported partners through an all-of-society effort that increased response and recovery initiatives in support of communities in every corner of the country. In some communities, local chambers of commerce worked with business leaders to encourage flexibilities such as paid time off for their employees who needed to travel to a vaccination or testing center. In other communities, due to the Administration's efforts, child care providers offered drop-in services for caregivers to get vaccinated. Some public transit authorities and ride-sharing companies provided free rides to vaccination sites, while churches, civic organizations, barbershops, and beauty salons opened their doors to be trusted spaces for testing or for vaccinations.

Ten months into the Biden-Harris Administration's term, deaths had declined nearly 90% in Black, brown, and Indigenous communities; the gap in vaccination rates between Black and Latino/Hispanic adults and white adults had closed; and nearly 100% of schools were open for in-person instruction.

Investing in the Hardest-hit and Highest-risk communities:

The Biden-Harris Administration invested over $785 million from President Biden's American Rescue Plan to support organizations that were building vaccine confidence across communities which historically had lower vaccination levels, including communities of color, rural populations, and low-income populations. The Administration bolstered the efforts of Tribal communities seeking to increase awareness of options to mitigate the spread of the virus, and it expanded public health systems' ability to respond to the needs of older adults who have been among the highest risk for infection or death from COVID-19.

Additionally, recognizing that the pandemic had tremendous impacts on disabled individuals and resulted in new members of the disability community, the Administration prioritized Long COVID services, supports, and research in the context of disability; established a call line dedicated to ensuring individuals with disabilities can equitably utilize the Administration's at-home test distribution program; ensured disabled individuals and other high-risk individuals could access at-home testing; and invested American Rescue Plan (ARP) resources to build COVID-19 vaccine confidence and access among people with disabilities.

Putting Community Health Centers at the Forefront of the Response:

Community Health Centers played a vital role in the Administration's efforts to ensure an equitable response, as they served as the single largest source of comprehensive primary health care for medically underserved urban and rural communities. Because of the Administration's efforts, these centers tested millions of patients for COVID-19, distributed millions of vaccine doses, increased access to telehealth in order to improve and expand patient care, and offered treatment options such as oral antiviral medications and monoclonal antibody therapy. Additionally, through its COVID-19 Testing Supply and COVID-19 N95 Mask Programs, the Administration enabled health centers to distribute millions of N95 masks, COVID-19 at-home test kits, and COVID-19 point-of-care testing supplies, at no charge to their patients and community members.

Supporting Community-Based Organizations in Vaccine Outreach to High-Risk Communities:

Through community-based organization vaccine outreach, the Administration was able to focus on empowering local trusted messengers and providing educational materials that served the most vulnerable populations. The Administration translated materials into 14 languages, and these were used by community- and faith-based organizations around the country, as well as by doctors' offices, pharmacies, health centers, employers, and other groups. These education and outreach efforts allowed the Administration to reach the unvaccinated, deploy information about the importance of boosters, support pediatric vaccination efforts, and provide other important COVID-19 updates through trusted community members.

Building the Workforce to Support Underserved Communities:

President Biden's American Rescue Plan provided a total of over $1.1 billion for community health, outreach, and health education workers-the largest ever one-time investment in the nation's community health workforce. In the fall of 2022, the Administration invested $225 million in American Rescue Plan funds to train over 13,000 Community Health Workers (CHWs) - responding to the acute need to expand the health care workforce and address pandemic-related burnout. This effort supported apprenticeship programs for workers at over 500 health care and public health sites nationally, including emergency departments, community health centers, state and local public health departments, mobile health clinics, shelters, housing programs, faith-based organizations, and other locations where high-risk populations access care and receive services. The Administration also rapidly deployed over 14,000 community outreach workers through over 150 national and local organizations to deepen COVID-19 vaccine confidence, increase vaccination rates, and serve as trusted messengers in underserved communities. These actions built upon the efforts of the roughly 50,000 CHWs who were already working in American communities before the pandemic.

3- Getting America Back on its Feet

Countless lives were saved by the Administration's efforts to ensure all Americans had access to safe tests, treatments and vaccines. In addition, robust support to employers minimized the impact of the COVID-19 pandemic. Thanks to these efforts, families nationwide were able to get back to work and school and the country's economy recovered faster and more broadly than any of the other leading economies in the world.

Progress By the Numbers

• In May 2023, compared to January 2021, COVID-19 deaths had declined by 95% and hospitalizations were down nearly 91% in the U.S.; those who were not vaccinated were more likely to be hospitalized or to die of COVID-19, compared to people who were vaccinated.

• With the largest domestic vaccination program in history, the U.S. made it possible for over 270 million people to receive at least one shot of a COVID-19 vaccine by May 2023. At its peak, the Biden Administration COVID-19 vaccination program administered over 4 million vaccines in one day, or over 2,700 vaccines a minute, into the arms of the American people. Lifesaving treatments were widely available and used, with more than 15 million courses administered.

• Through COVIDTests.gov, the Administration has delivered more than 921 million free COVID-19 tests - shipped directly to more than 85 million households - as of January 2025.

• Through the Administration's efforts, more than 50 million diagnostics tests were administered in-person at pharmacy and community-based sites.

As a result of the Biden-Harris Administration's efforts, the economic recovery from the pandemic in the U.S. was historic. The American Rescue Plan (ARP) accelerated that economic recovery throughout 2021 and made it more resilient to challenges: one analysis found that the ARP resulted in 4 million more jobs and nearly doubled GDP growth - and that without it, the United States would have come close to a double-digit recession in spring 2021. The results of the ARP have also been historically equitable, with major progress against child poverty, food insecurity, and unemployment for low-income communities and communities of color.

Additionally, the Biden-Harris Administration's COVID-19 response ensured that schools could reopen and families could get back to work. By the end of March 2020, all public schools in the United States were closed to slow the spread of the novel coronavirus SARS-CoV-2. In November 2020, 19 percent of districts remained fully remote, with 45 percent using hybrid models and 36 percent fully in person. Shortly after the start of the Biden-Harris Administration, in early May, 2021, just over 3 months after taking office, only 1 percent of districts across the country were fully remote, and over half of schools were fully in person.

These changes are reflected in the public's perception of the pandemic's impact on their lives. According to Gallup public opinion polling, in December 2020, 3/5^th of Americans believed that COVID-19 in the U.S. was getting worse. By June 2021, that percentage had fallen to three percent of Americans. Additionally, over half of Americans worried about catching COVID in December 2020, and that number fell to less than 20% by June 2021.

Today, although much progress has been made, the Administration continues to ensure that Americans have what they need to stay safe, including by continuing to provide free COVID-19 tests through COVIDtests.gov. In addition, the Administration has extended the authorities which allow pharmacists and pharmacy technicians to continue to administer vaccines, allowing other healthcare workers to focus on other tasks that only they can perform. And, the Administration's $5 billion investment in Project NextGen continues to accelerate and streamline the rapid development of the next generation of coronavirus vaccines and treatments through public-private collaborations.

In addition to addressing the immediate impact of COVID-19 infections, the Biden-Harris Administration recognized that millions of Americans continue to experience symptoms for months and sometimes years after their acute COVID-19 infection. To help better understand why this occurs and to develop potential treatments, the Biden-Harris Administration has dedicated billions of dollars to research efforts, developed the first-ever National Research Action Plan on Long COVID, and created an Advisory Committee on Long COVID.

4 - Ensuring the World Responded and Recovered from COVID-19

While the Biden-Harris Administration implemented all of these programs to help Americans fight COVID-19 here at home, the Administration also recognized that helping the rest of world quickly and effectively respond to the pandemic was critical to both our domestic and the broader global recovery. The United States committed to bringing the same urgency to international response and recovery efforts that we demonstrated domestically. On day one, President Biden called on his National Security Advisor to advance global health security, international pandemic preparedness, and global health resilience to support the global response to the COVID-19 pandemic. This included re-establishing the National Security Council's team focused on health security and biodefense.

• Restoring Partnerships with Critical, Life-saving Institutions: As soon as President Biden entered office, he ensured that the U.S. reversed its decision to withdraw from the World Health Organization - which was essential to coordinating a global response during the pandemic. In early 2021, United States committed $4 billion to support COVAX, the multilateral effort that aimed to accelerate the development and manufacturing of COVID-19 vaccines and to support equitable access for every country in the world. In two years, the United States provided over $16 billion to vaccinate the world, save lives, and build stronger health security. The United States also convened world leaders at two Global COVID-19 Summits, accelerating response efforts and mobilizing $3.2 billion in commitments to vaccinate the world, save lives, and build stronger health security.

• Vaccinating the World: The United States donated more COVID-19 vaccines than any other country, and it was the first country to announce a purchase of vaccine doses solely for donation to other countries. The U.S. was also the first country to ensure the African Union could start receiving up to 110 million doses of Moderna at a reduced rate negotiated by the United States - and it was the first country to negotiate a deal to send vaccines directly to humanitarian settings and conflict zones to vaccinate displaced persons. Between May 2021 and February 2024, the Biden-Harris Administration donated - in partnership with COVAX, Caricom, the African Vaccine Acquisition Trust (AVAT), and bilaterally - nearly 700 million doses of COVID-19 vaccines to countries around the world. This included over 44 countries and economies in Sub-Saharan Africa, 31 countries in the Western Hemisphere, and 26 countries in Southern, Central, and Eastern Asia.

The COVID-19 pandemic also led to a dropoff in routine childhood immunization in many countries around the world, as they surged scarce resources to pandemic response. As a result, we began to see the reemergence of vaccine-preventable diseases, from measles to polio. In 2024, the United States Government pledged $1.58 billion to support Gavi, The Vaccine Alliance, over the next five years. This commitment builds on a 24-year partnership that has immunized over a billion children and saved 17 million lives. The new funding aims to vaccinate the next billion children within a decade, saving over eight million lives by reaching unvaccinated children, expanding vaccinations for diseases like malaria and cervical cancer, and enhancing emergency health preparedness. The United States, through Gavi, also supports the launch of the African Vaccine Manufacturing Accelerator, which will help African countries produce vaccines locally, promoting vaccine equity and swift responses to future health crises. In addition, the United States supports the Coalition for Epidemic Preparedness Innovations (CEPI), which is working to accelerate the development of life-saving vaccines against emerging disease threats, and to transform capability for rapid countermeasure development in response to future threats. Notable achievements include: the FDA approval of the world's first Chikungunya vaccine and technology transfer to regional producers for regional supply to LMICs; the advancement through clinical development of vaccine candidates against Lassa, Nipah, and coronaviruses, among others; and the launch of a new Disease X Vaccine Library with six viral families prioritized as high risk.

• Delivering Life-Saving Resources: In addition, the U.S. government delivered life-saving resources like oxygen, treatments, PPE, and other essential supplies worth more than $1 billion to countries experiencing outbreaks by March 2022. This included countries that were most affected by the pandemic. As an example, as India battled a devastating wave of the Delta variant, the United States delivered supplies worth more than $100 million to provide urgent relief. This included 15 million N95 masks, 1 million rapid diagnostic tests, and vaccine manufacturing supplies to help India make over 20 million doses of COVID-19 vaccines. In addition, the U.S. consistently provided immediate support to allies such as Brazil that were seeing disproportionate cases and deaths due to the pandemic - through providing much-needed ventilators, vaccines, personal protective equipment, and support for struggling businesses and communities.

• Providing Technical Assistance and Supporting Vaccine Manufacturing: U.S. public health experts across multiple federal agencies worked side-by-side with on-the-ground providers - providing technical assistance in vaccine program implementation, care provision, and outbreak investigation. The United States respects countries' right to protect public health and to promote access to medicines for all. Toward that end, the United States endorsed negotiations of a temporary waiver of WTO intellectual property rules to support access to COVID vaccines.

In addition, the U.S. increased the world's capacity to manufacture vaccines and fostered an enabling environment for innovation, including by spurring African manufacturing. For example, the U.S. International Development Finance Corporation (DFC) provided a $3.3 million technical assistance grant and a follow-on $15 million loan to Institute Pasteur de Dakar (IPD) in Senegal to expand flexible vaccine manufacturing capacity for both routine and outbreak vaccines. IPD also received support from other U.S. government agencies on regulatory strengthening, workforce development and training, and research and development.

5) Managing Current Public Health Threats

The tools and strategies that the Biden-Harris Administration developed in response to the COVID-19 pandemic are applicable to a range of biological threats, including avian flu, Marburg, Ebola, mpox, COVID-19 variants, and others.

As an example, the National Wastewater Surveillance System has allowed the U.S. to glean more specific information on where avian flu is found in the environment, often before the first human or animal case has been confirmed. Additionally, Traveler-based Genomic Surveillance, which was among the first to detect multiple Omicron variants up to six weeks before they were reported elsewhere in the United States, continues to screen for other threats including new COVID-19 variants. Hospital data reporting also provides granular information on which hospitals may see strain due to admissions from COVID-19, Flu, and RSV each respiratory season.

Avian Flu: Protecting Human and Animal Health

Avian flu, or Influenza A(H5N1), was first detected in dairy cattle in the U.S. in late March 2024. While we have seen this virus in birds for decades and the risk to the general public remains low, the Administration immediately knew that the spread to cows and other mammals demanded serious attention and action. Within twenty-four hours of confirmation of the first case, interagency coordination groups began meeting at the senior leader and technical levels to synchronize support to State and local public health and agriculture officials. Since then, the interagency has worked with government, industry and other partners to ensure we keep communities healthy, safe, and informed - by monitoring and stopping transmission, keeping animals healthy, ensuring that our Nation's food supply remains safe, and safeguarding the livelihood and well-being of American farmers and farmworkers. In total, since USDA began supporting state-led efforts to mitigate the risk of avian flu in poultry in 2022, the Biden-Harris administration has dedicated nearly $2.8 billion to this important work.

Monitoring the Virus and Stopping Transmission: Within a few weeks of the outbreak, USDA took action to stop the spread of the virus, issuing a federal order in April 2024 that mandated avian flu testing of all lactating dairy cattle moving between states. USDA also stood up a voluntary program for states and farmers to test their herds, implement biosecurity and created incentives for them to do so. By the end of 2024, USDA and its partner laboratories had run over 110,000 tests on dairy cattle and made more than 1,000 staff deployments to support response and traceback efforts on the ground, including 221 personnel currently deployed. In October 2024, USDA announced a nationwide milk testing initiative, requiring states to comprehensively monitor and respond to the presence of the virus in America's dairies. Today, 28 states - representing nearly two-thirds of America's dairy production - have joined this program. The remaining states are working to stand up the necessary infrastructure.

CDC has also been closely tracking the virus through a collaborative effort between CDC and many partners, including state, local, and territorial health departments; public health and clinical laboratories; clinics; and emergency departments. These include systems to monitor case reporting, laboratory monitoring at both public health and clinical labs, emergency department visits, hospitalizations, and assessing wastewater. These systems build on developments over the last four years as a result of the COVID-19 pandemic. Altogether, they provide us with early warning signs on where the virus is spreading, as well as visibility on whether there is any severe disease from avian flu. When human cases have been reported, CDC has engaged and supported state and local health officials with technical support, including the deployment of experts to the field to support public health investigations.

Since the start of the outbreak, USDA and CDC have been monitoring virus specimens using the latest techniques, to inform our response. When new human cases are reported, CDC's national laboratory confirms the findings and performs timely genomic sequencing and other analysis to monitor for any concerning changes in the virus, as well as any potential impacts on our treatments and vaccines. This information has been released in technical reports and the sequences are made available on public servers. Similarly on the animal side, genetic sequences from this outbreak are shared by USDA, with over 4,500 raw or curated sequences having been posted to GISAID (the Global Initiative on Sharing Avian Influenza Data) or the National Center for Biotechnology Information (NCBI) Sequence Read Archive. USDA continually monitors these sequences for any potentially concerning changes and immediately shares any such findings with CDC.

Protecting Workers and the Public: Learning from bottlenecks and shortages in the very early COVID-19 response, the Administration has spent the last several years refilling our Strategic National Stockpile to ensure that we have the PPE, antivirals, tests, vaccines, and more that the country needs to prepare for future health emergencies. As a result, HHS was immediately able to offer support to states. To date, we have delivered nearly 4 million pieces of PPE and thousands of antivirals to protect workers. USDA also set up a program that reimburses farmers when they purchase PPE for their workers, and post-exposure prophylaxis with Tamiflu is also promptly offered to workers with any known exposure. We have also taken steps to build trust with impacted communities along the way - investing $5 million in campaign to educate and test farmworkers. In total, USDA and CDC have deployed over 100 federal workers into the field to support response and support workers.

As we protect workers today, we are also preparing for any possible scenario tomorrow. The CDC and NIH are tracking changes in the virus so we can see whether it's becoming more adaptable to humans. We have already prepared nearly 5 million doses of vaccines so they're ready if we need them. Further, by the end of the first quarter of 2025, we will have stockpiled 10 million doses of vaccine to inoculate humans against bird flu. And we've invested $176 million in Moderna to develop next-generation mRNA vaccines that can rapidly respond to any adaptations in the virus, with phase 3 trials beginning shortly. In addition to vaccines, we have 68 million courses of influenza antivirals on hand in the Strategic National Stockpile to treat those who may become infected with the virus. We have made 3,000 courses available to affected communities.

Preserving Animal Health: Research suggests the virus travels via surfaces related to normal business operations such as vehicles, milking equipment, and people's clothing. That's meant that biosecurity practices-like limiting visitors, disinfecting work apparel, and separating animals of different species- were essential to reduce the spread and keep cows healthy. In early May 2024, USDA launched assistance for producers with H5N1 affected premises to improve on-site biosecurity in order to reduce the spread of the virus. This includes financial support for protecting workers with PPE, funding for disposal of milk, reimbursement for veterinary costs, and payments for shipping laboratory Samples. As of January 2025, over 500 farms have utilized these programs to date. Later that month, USDA expanded support for producers to stop the spread through cattle, by issuing a rule to compensate eligible producers with positive herds who experience a loss of milk production. So far, over 300 producers have applied to the program with tens of millions of dollars in payments distributed. Additionally, USDA accelerated efforts to develop a first-of-its-kind bovine vaccine for the virus, and candidates have already entered field safety trials. USDA also announced in early January 2025 that work would begin to build a new stockpile of avian flu vaccines for poultry.

Ensuring the Safety of Our Food Supply: We have 100 years of data showing pasteurization works, but it was essential for our Administration to confirm that this was still the case with this new pathogen. USDA and the Food & Drug Administration (FDA) began testing retail dairy samples from across the country to ensure the safety of the commercial pasteurized milk supply and conducted laboratory experiments to reaffirm that pasteurization inactivates the virus. USDA similarly conducted research to confirm that cooking beef to proper temperature inactivates the virus, which it does. USDA also sampled muscle tissue from culled cattle at beef processing facilities as part of our robust ongoing surveillance programs. Today, we are confident that pasteurized milk, as well as properly cooked meat and eggs, are safe for consumers.

Mpox, Marburg, Measles and More: Managing Additional Public Health Threats

The Biden-Harris Administration has also mounted a robust response to other infectious disease threats that have emerged since 2021, including Marburg and Mpox. On Day 1 of the multiple Marburg and Mpox responses, medical countermeasures existed and were ready to be deployed at home and around the world as a result of U.S. preparedness efforts. In the case of Marburg, the United States had invested in experimental vaccines and therapeutics in order to be able to quickly deploy, test, and eventually seek regulatory approval for new countermeasures.

Mpox Domestic and Global Responses:

• In early 2022, an outbreak of clade II mpox (then known as Monkeypox) rapidly spread globally and domestically. Shortly after the first U.S. case was identified in May 2022, the Administration deployed tens of thousands of doses of an FDA-approved vaccine and hundreds of courses of an investigational therapeutic from the Strategic National Stockpile to support domestic efforts to control spread and treat patients. We also rapidly scaled up testing capacity from 6,000 to 80,000 tests per week and, by October 2022, over one million doses of JYNNEOS had been administered to individuals at heightened risk of exposure to mpox, over 40,000 treatment courses had been distributed across the country, and domestic cases of clade II mpox had decreased by 90%. Today the mpox vaccine, which is effective against both clades of mpox, is also now commercially available with an ample supply at health departments and local pharmacies.

• During the 2022 response, the Biden-Harris Administration also stood up a White House National Monkeypox Response Team and, in collaboration with a diverse group of community-based and civil society partners, promoted equitable access to vaccines, therapeutics and testing and made significant strides in reaching vulnerable populations where they were with trusted community messengers. Among the many successes of this group were the planning and execution of multiple "pop up" sites at events where at-risk individuals could learn more about mpox and, if they chose to do so, protect themselves by getting vaccinated against mpox.
• When a new clade of mpox began spreading internationally in 2024, the Biden-Harris Administration was poised to act quickly. Within weeks of WHO's declaration of a public health emergency of international concern, President Biden announced in September 2024 that the United States was prepared to commit at least $500 million and to donate up to one million doses of mpox vaccines to support African countries in preventing and responding to this outbreak. We are delivering on that commitment, with two-thirds of our global mpox funding pledge fulfilled already, and all one million of the pledged mpox vaccine doses available now for countries that are ready to receive them.

• Most biological threats emerge outside the United States, which means that Americans will be safer when countries around the world are prepared to prevent, detect and respond to threats when they emerge. As part of the implementation of the National Biodefense Strategy, the United States Government continues to work with more than 50 countries around the world - including most mpox-affected countries and those at-risk of an mpox outbreak - to build stronger global health security capacities, ensuring countries are better prepared to stop outbreaks at their source while protecting U.S. national and homeland security.

• Domestically, in 2024, the Administration has continued to focus on additional preparedness steps to increase awareness of mpox risks; provided updated recommendations to prevent, detect, and treat both clades; and expanded wastewater surveillance to provide an early warning of mpox activity and community spread. In addition, the United States continued to build on the critical testing landscape created during the 2022 outbreak and can not only detect both clades of mpox, but can also differentiate between clade I and clade II mpox.

Global Marburg Response:

In September 2024, Rwanda's Ministry of Health announced an outbreak of Marburg Virus Disease (MVD), a rare, viral hemorrhagic fever similar to Ebola. Over the last four years, the Biden-Harris Administration has responded to 11 Ebola or Marburg outbreaks. Immediately after learning of the outbreak in Rwanda, in partnership with the Government of Rwanda, the United States committed millions of dollars to address urgent health gaps in Rwanda and surrounding countries, through provision of technical assistance with surveillance and contact tracing, infection prevention and control guidance, case management, risk communication and community engagement, safe and dignified burials, donation of laboratory test kits, and point of entry exit screening at Rwanda's airport and neighboring border crossings. Within 8 days of learning of the outbreak, the United States Government worked with the Government of Rwanda, WHO, CEPI, and other critical partners to share experimental vaccine doses with Rwanda, and into the arms of healthcare workers at high risk of exposure, an unprecedented public health achievement. The United States also contributed tests, treatments and PPE, to support response efforts and protect health workers. This support has been made possible through the United States robust investments in science and research over the last 10 years. On December 20, the outbreak was declared over by the Government of Rwanda, with one of the lowest case fatality ratios (22%) of any Marburg outbreak in history.

Domestic Measles Response:

As the number of children protected from measles infections continues to decline due to declining vaccine coverage and misinformation, multiple jurisdictions have had to rapidly respond to measles outbreaks. The administration has deployed experts to support local responses and has distributed additional vaccine doses to support targeted vaccination campaigns, which are effective in ending outbreaks. The Administration has underscored that while the measles vaccine is highly effective and provides durable protection, 93-95% vaccine coverage is needed to maintain community protection. An unvaccinated individual exposed to the virus has a 90% chance of developing disease - therefore vaccination is critical to this response.

6) Building the Infrastructure for Future Biological Threats

The Biden-Harris Administration has also taken historic actions, building on policies from prior administrations, to protect Americans from biological threats that may emerge in the future.

Replenishing the Strategic National Stockpile:

The Strategic National Stockpile (SNS) was created in 1999 to "provide for the emergency health security of the United States …in the event of a bioterrorist attack or other public health emergency." Historically, the SNS holds vaccines and therapeutics to protect the country from any number of chemical, biological, radiological, or nuclear events. Many of these medical countermeasures are not commercially available and the SNS is the only source for these critical supplies in the country-and in some instances the world. Under the Biden-Harris Administration, the SNS's budget increased by 25% - allowing it to secure more of the vaccines, therapeutics and medical supplies needed to protect the country from public health emergencies and disasters.

Since the beginning of the COVID-19 pandemic, the Strategic National Stockpile distributed more than 27,000 tons of medicines, equipment, and supplies to support the country's public health and health care needs. Early in the pandemic, the Strategic National Stockpile (SNS) deployed 90% of its overall inventory of personal protective equipment (PPE) - nearly 72 million items - as well as 100% of its Federal Medical Stations, which served as alternate care sites across the country. Much of this PPE was purchased ten years before with funds from the H1N1 outbreak-and had not been restocked.
Since President Biden took office, the SNS has dramatically increased its stockpiled quantities of PPE and ventilators-with supplies that were made in America where possible. The SNS now has 70 times the number of N95 respirators, 34 times the number of gloves, 50 times the number of isolation gowns, and 10 times the number of ventilators than it had before the pandemic. Restocking the SNS to these levels has allowed it to make PPE available to communities impacted by COVID1-9, H5N1 and other infectious disease outbreaks. In 2022, the SNS provided nearly 300 million N95 masks to retail pharmacies and community health centers for free -the largest deployment of personal protective equipment in U.S. history. Under President Biden, the SNS has also assigned staff to state public health departments and completed a series of tribal consultations and urban Indian confers to ensure all communities understand what tools it has available and how to access them in times of emergency or disaster.

Expanding Surveillance Capabilities:

At the start of the COVID-19 pandemic, because of years of underinvestment in modernizing data systems, some state, local, tribal, and territorial jurisdictions still relied on fax machines to transmit public health data and the U.S. struggles to collect, analyze and share essential data on the presence of SARS-CoV-2 in communities, the rate of transmission, and the impact on hospitals. Throughout our response, the U.S. government has expanded our surveillance capabilities to monitor disease and better inform the public. These steps include:

• Increasing the number of healthcare facilities which provide automated, near real-time electronic case reporting to local, state, tribal, territorial and federal public health officials from less than 200 in 2020 to over 48,000 in 2024 and supporting public health authorities to adopt the Trusted Exchange Framework and Common Agreement (TEFCA) to further enable the exchange of public health data across the healthcare ecosystem to help rapidly identify emerging outbreaks.

• Standing up a National Wastewater Surveillance System, which routinely reports early warning information from over 1,500 sites covering over 150 million people in the United States.

• Scaling up genomic sequencing, which is important to detect new pathogens including variants. At the start of the COVID-19 pandemic, only 23 public health labs demonstrated advanced molecular detection surveillance capabilities. By the end of 2022, this number expanded to 68 public health laboratories, and CDC launched 5 Pathogen Centers of Excellence. The average turnaround time for public health laboratories to publish genome sequences has dramatically improved - decreasing from 96 to 40 days. Some laboratories able to sequence in less than two days.

• Developing a COVID-19 Variant Playbook, which served to assess the disease severity and transmissibility of a new variant immediately, and to expedite the rapid laboratory evaluation of the effectiveness of vaccines, tests, and treatments against any variant.

• As a result of close collaboration between the CDC, the Centers for Medicare and Medicaid Services and industry stakeholders, over 80% of all hospitals from across America are now sharing critical data on emergency department visits and hospital admissions.

Advancing Capabilities in RNA Vaccine Technologies:

With investments totaling over $400 million, the Administration has also been advancing capabilities in RNA vaccine technologies to guard against future pandemics. To further these efforts, multiple companies are currently partnering with HHS to develop RNA vaccines that may allow for a faster, more sustainable response capability against multiple threats, lower the requirement for needles, simplify storage requirements, or investigate new methods of administration.

Strengthening Domestic PPE Supply Chain:

Given gaps in domestic capacity for critical PPE, this Administration, in an effort to minimize foreign reliance, the President signed the "Make PPE in America Act" in 2021. The statute requires that the Departments of Homeland Security (DHS), Health and Human Services (HHS) and Veterans Affairs (VA) (collectively referred to as "covered agencies") issue long-term contracts for PPE containing only materials and components that are grown, reprocessed, reused or produced in the U.S. This requirement is critical to strengthening our domestic manufacturing capabilities and promoting the production of essential PPE in the United States. The statute recognizes the power of leveraging the federal government's buying power as a catalyst to increase market participants, support competition and the health of the domestic PPE industry.

A sustained federal commitment to procure PPE from domestic sources supports the health of the domestic PPE industry. Since the enactment of the Make PPE in America Act, covered agencies took actions to support a long-term domestic federal procurement strategy, model demand, and more closely align their acquisition strategies to send a government-wide demand signal to the PPE industry, while working collaboratively with the Defense Logistics Agency (DLA) and the Office of Management and Budget (OMB) to implement the Make PPE in America Act.

Stopping Outbreaks at their Source and Transforming our Biopreparedness Capabilities:

In 2022, President Biden signed National Security Memorandum 15 on Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security. This NSM launched a new National Biodefense Strategy and Implementation Plan, which envisions "a world free from catastrophic biological incidents" and directs a coordinated, whole-of-government effort to prepare for biothreats. It includes an ambitious five-to-ten-year vision for developing moonshot biodefense capabilities, including the ability to develop new vaccines within 100 days and repurpose therapeutics within 90 days.

The most effective way to limit the impact of biological threats is to stop them at their source. The United States is working with countries and partners around the world to ensure they have the capacity to identify and stop emerging threats before they grow into regional or global threats. To advance that goal, the administration published an updated Global Health Security Strategy, laying out our commitment to working with foreign partners in order to continue building our capacity to prevent, detect, and respond to biological threats wherever they emerge. The Administration took several concrete actions to support these transformative efforts. The U.S. Government reached the ambitious goal of directly supporting 50 countries in building their health security capacity, which is one of the most powerful prevention tools we have in this space. The United States has also leveraged financial resources and diplomatic channels to mobilize support for 50 additional countries to strengthen their health security capacities, for a total of more than 100 countries receiving support.

Limitations in the existing global systems to finance pandemic prevention, preparedness, and response left countries and financial institutions ill prepared to effectively contain COVID-19. On day one, President Biden called on his Administration to transform the existing financing institutions and to cultivate new financing sources for global health security that are more effective and sustainable, and that are less dependent on U.S. government assistance. The United States was instrumental in the creation of the Pandemic Fund in 2022, the only multilateral financing facility dedicated exclusively to pandemic preparedness financing for low- and middle- income countries. The Pandemic Fund made significant progress in its first two years, awarding grants totaling $885 million, which mobilized an additional $6 billion in investments, to support 75 countries and economies across six geographic regions. The United States is also working to evolve Multilateral Development Banks to be better equipped to respond to the increasing frequency, scope, and complexity of global challenges, including pandemics. The Biden-Harris Administration strongly supported the establishment of the International Monetary Fund Resilience and Sustainability Trust and its goal of supporting low-income and vulnerable middle-income countries to access long-term, affordable financing to address longer-term challenges, such as health emergencies. During the COVID-19 pandemic, many countries and institutions lacked the liquidity to procure the medical countermeasures (MCM) needed to mount effective and timely responses. The U.S. Development Finance Corporation helped develop and lead a G7 Surge Financing Initiative, through which G7 development finance institutions (DFIs), the European Investment Bank, the International Finance Corporation, and global and regional health stakeholders are developing and deploying innovative financing tools to accelerate access to MCMs in health emergencies.

While there will always be new or evolving biological threats, developing effective countermeasures for known threats is a critical piece of preparedness. For example, the U.S. government invested billions of dollars in mRNA technology in advance of the COVID-19 pandemic. These public investments translated into millions of lives saved in the United States and around the world, and were crucial to developing the mRNA vaccine technology that can be leveraged in a future pandemic, as well as potentially treating other diseases. For example, the Department of Defense and the National Laboratories are leveraging Artificial Intelligence for rapid development of medical countermeasures. The Administration is executing a whole-of-government implementation plan for strengthening capabilities in early warning, vaccines, therapeutics, diagnostics, clinical trials, and PPE.

Strengthening Research Capacity and Oversight:

The lives saved and hospitalizations avoided as a result of the COVID-19 therapeutics and vaccines were the result of decades of foundational research investments. Because viruses and bacteria are constantly changing and the frequency of naturally occurring biological outbreaks is increasing, the Biden-Harris Administration published the American Pandemic Preparedness Plan in the fall of 2021. In addition, the administration has continued to invest more than $7 billion annually in research by Federal, academic and industry researchers in new ways of protecting Americans from tuberculosis, HIV and other infectious diseases that remain leading causes of illness in our nation. These investments are crucial to ensure our nation is prepared for future threats and to deter those who are seeking asymmetric advantages over the US.

In 2024, the Administration also released an updated policy to enhance oversight of research. This update to standards that were originally released in 2012 will reduce the likelihood of accidental outbreaks and deliberate misuse of life science research, while ensuring that lifesaving research proceeds.

Supporting Global Biosafety and Biosecurity:

Expanding biosurveillance capacity and the rapid evolution of technology are critical for health security, but can also elevate the risk of accidental and deliberate incidents. The Biden-Harris Administration has taken significant steps to minimize the chances of laboratory accidents; reduce the likelihood of deliberate use or accidental misuse; ensure effective biosafety and biosecurity practices and oversight; and promote responsible research and innovation. The Biden-Harris Administration knows that in order to protect the domestic population, investing in global biosafety and biosecurity practices and oversight is essential. These efforts - which minimize the chances of laboratory accidents, reduce the likelihood of deliberate use or accidental misuse, and more - have been critical as we expand biosurveillance capacity. For example, the United States secured inclusion of biosafety and biosecurity as a critical component of the Pandemic Fund grants to support laboratory systems. One of the projects, the Caribbean Public Health Agency Train-the-Trainer Workshop on the Safe Transportation of Infectious Substances, resulted in certified trainers well-positioned to serve as national trainers and advisors in biosafety and safe transport protocols, ensuring safer practices across the region. The U.S. global health security bilateral partnerships also build capacity in biosafety and biosecurity: the final global health security report of the Administration showed that global health security partner countries with at least two years of U.S. Government support demonstrated a net improvement in biosafety and biosecurity capacity from 2018 to 2023. The Administration also supported the 2024 World Health Assembly resolution on Strengthening Laboratory Biological Risk Management, which calls for improvements to biosafety and biosecurity practices globally.

Standing up the Office of Pandemic Preparedness and Response Policy:

Recognizing the growing threat of pandemics, the Administration stood up the Office of Pandemic Preparedness and Response Policy (OPPR) in August of 2023. This is a permanent office in the Executive Office of the President charged with leading and coordinating actions related to preparedness for, and response to, known and unknown biological threats or pathogens that could lead to a pandemic and/or to national security. OPPR assumed the duties of the COVID-19 Response Team and Mpox team at the White House and has continued to coordinate and develop policies and priorities related to pandemic preparedness and response.

Because every successful response to a biological event has required a synchronized, integrated team, OPPR has worked with federal, state and local health partners, and has engaged with a broad array of private sector, academic and other stakeholders to ensure lessons from the response to COVID-19 and other recent outbreaks inform future plans and response efforts. Recent accomplishments include:

• Partnering with multiple industry stakeholders to resolve supply chain issues affecting the availability of a new immunization, reducing infant hospitalizations by more than 80%.
• Partnering with leaders from the European Union, the Republic of Korea, Japan, India and multiple industries to develop a process to quickly recognize and address supply chain issues affecting availability of medications in the US and partner countries.
• Partnering with leaders from the Long-Term Care industry to improve vaccination rates for residents of long-term care facilities.
• Partnering with leaders from across the domestic healthcare enterprise to identify and mitigate constraints to our national preparedness for future biological events and to create a collaborative committed to continuing to mitigate future challenges.
• Partnering with community support organizations to identify best practices from the COVID-19 pandemic and to develop strategies to sustain outreach to historically medically underserved communities to ensure all Americans can access their healthcare options.

Conclusion

As of result of the Biden-Harris Administration's efforts, the COVID-19 pandemic no longer disrupts our daily lives, our children are back in schools, our economy is stronger than ever and families have been able to resume their pre-pandemic routines. As new viruses and other biological threats have continued to emerge, we have remained vigilant in monitoring and responding to each threat. From investments into research for new tests and treatments for diseases, to launching the largest vaccination program in our country's history, to expanding the nation's surveillance capabilities, to replenishing the Strategic National Stockpile, the Biden-Harris Administration has transformed our nation's pandemic preparedness and response.

In order to ensure that future Administrations are prepared for any threat that emerges, the Biden-Harris Administration will also leave behind a three-step internal playbook with nearly 300 pages of guidance on how to rapidly and effectively respond to biological threats from all sources - naturally occurring, accidental and deliberate.

• Step 1: Within 24 hours of notification of a serious biological threat, NSC convenes Departments and Agencies for a biological incident notification and assessment (BINA).
• Step 2: If the threat poses a significant risk to the United States, within 24-48 hours Departments and Agencies establish an Incident Response Coordination Structure (IRCS), with agency leadership and support roles pre-determined in a playbook.
• Step 3: Departments and Agencies operationalize a rapid and effective response, with coordination by the IRCS and leadership from the White House. The playbook includes detailed operational annexes to address many scenarios that commonly arise during biological incident responses.

Under the Biden-Harris Administration, we have exercised this three-step playbook numerous times, including in recent weeks. All Departments and Agencies have received final versions of the Playbook, and the Biden-Harris Administration will give copies to the incoming Administration to ensure they are prepared to act on day one of a crisis to protect the American people.

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