TOPLINE
Human cases of highly pathogenic avian influenza are rising against the backdrop of this year’s mpox public health emergency of international concern, underscoring the real threat of a new domestic or international biological incident. The incoming administration must address the lessons of the last pandemic to ensure preparedness for the biothreats of the near future. Ensuring a robust U.S. biodefense also requires committing to global health security efforts and ensuring emerging biothreats can be contained wherever they occur, before they reach the United States.
The Problem
The United States and the world as a whole remain underprepared for the next major biological incident, whether of natural, accidental, or deliberate origin. Even as a new strain of mpox spreads, declared by the World Health Organization (WHO) in August to be a public health emergency of international concern, the lessons of the last pandemic have yet to be definitively gathered and comprehensively addressed. President-elect Donald J. Trump will take office for a second term on January 20, 2025, exactly five years to the day after the United States Centers for Disease Control and Prevention (CDC) reported the first laboratory-confirmed case of COVID-19 in the United States. COVID-19 has claimed the lives of more than one million U.S. citizens and more than seven million people globally (likely many more). While many might prefer to close the book on COVID now that the crisis is over, its biodefense and nonproliferation lessons remain all too relevant as Trump prepares for a return to the White House. Of the twenty countries most affected by COVID-19 prior to March 2023, the United States had the second highest number of deaths per 100,000 in the world. The government’s struggle to track rates of infection, hospitalization, and deaths; provide clear, trusted guidance to at-risk populations; and relieve pressure on hospitals and supply chains all point to significant challenges to overcome before the next major biological incident. International systems, too, failed to meet the challenge of the crisis – a key report pointed to crucial delays by the World Health Organization (WHO) and governments in declaring an emergency, hesitancy to take critical steps to stem the spread of the virus, failure to address deep inequities in access to protective supplies therapeutics, and more. Although COVID-19 was most likely a pandemic of natural or accidental origin, the same detection, diagnosis, reporting, and response systems would be tested nationally and internationally in the event of a deliberate attack using biological agents. Work has been done locally and globally to compile and start addressing the hard lessons of the COVID-19 pandemic. However, much more work remains to strengthen basic health and emergency response systems at home and abroad, even as a new strain of mpox spreads around the world – declared by the WHO to be a public health emergency of international concern – and the threat of other biological incidents increases, whether due to natural causes or the accidental or deliberate release of bioengineered pathogens.
Essential Context
In the five years since the onset of the COVID-19 global pandemic, several conditions driving toward increased biological threats such as climate change, emerging disruptive technology, and technology convergence have only intensified. Climate change drives increased transmission of infectious diseases from wildlife to humans and raises the risk of novel emerging human infectious diseases. The risk of zoonotic outbreaks is clearly illustrated by the highly pathogenic avian influenza (H5N1) that continues to circulate in poultry and cattle in the United States, with human cases now ticking upwards also. Meanwhile, advances in biological engineering open up increasing opportunities – for both good and ill – to redesign organisms, engineer them to have new abilities, and even synthesize an organism’s entire genome or create an entirely new organism. Risks from other emerging disruptive technologies have also accelerated. For example, the results of an experiment developed for the Spiez Convergence Conference and published in March 2022 starkly illustrated the risk artificial intelligence and machine learning (AI/ML) presents for the development of new biothreats as well as beneficial vaccines and medicines. By reversing an AI algorithm designed to reject toxic molecules in the search for therapeutic ones, the researchers identified 40,000 toxic molecules within six hours. The convergence of these and other disruptive technologies must also be taken into account, as summed up by the Scientific Advisory Board to the Organisation for the Prohibition of Chemical Weapons (OPCW): “Significant advances in the fields of nanotechnology, proteomics, nanomaterials, polymers, liposomes, encapsulation sciences, and AI can be leveraged in the production of not only new defensive countermeasures and vaccines, but also organisms, biotoxins, and bioregulators with characteristics that render them more useful for carrying out a biochemical warfare attack.”
Meanwhile, the United States faces a number of challenges to progress on a wide range of biodefense initiatives, as documented by the Government Accountability Office (GAO) in a series of reports over the past several years. In a status summary of its 452 recommendations for federal agencies and Congress related to COVID lessons, the GAO found that 220 recommendations remained unimplemented as of August 2024. While many of these recommendations relate to economic and financial planning for a pandemic, others such as an unfulfilled mandate for HHS to create a “near real-time nationwide public health situational awareness capability” are directly pertinent to biodefense priorities for the next emergency. And the root causes of U.S. failures during the pandemic run deeper and broader, encompassing basic healthcare inequities, preparedness challenges at the state and local level, coordination issues between federal, state, and local authorities, as well as political polarization, low trust in government and public health, disinformation, inadequate testing and data collection, and more. Some commentators have also noted that the lack to date of a comprehensive, bipartisan review of the U.S. government’s COVID-19 response hampers a full accounting of the gaps and challenges encountered as well as an authoritative analysis of the remedial measures required.
Progress toward better preparedness at the global level has also been patchy. On the positive side of the ledger, the World Health Assembly finalized key updates in June, 2024 to the International Health Regulations (IHR), the main legal mechanism governing international prevention of and response to the spread of diseases. The changes define a pandemic emergency and establish national IHR points of contact and a Committee of States Parties to coordinate action on implementation. However, divisions over vaccine access equity and other contentious issues prevented the assembly from meeting the June 2024 deadline for finalizing a new international convention or other legal instrument on pandemic preparedness and response (the Pandemic Preparedness Instrument) convention, despite three years of negotiations. The WHO’s Intergovernmental Negotiating Body reported in mid-November that the accord would not be adopted in December either, as hoped. Negotiations continue, now aiming for agreement by May 2025.
More troubling, the Independent Panel led by former New Zealand Prime Minister Helen Clark and former Liberian President Ellen Johnson Sirleaf found in June 2024 that critical political attention has waned and progress has slowed on global preparedness efforts for the next pandemic. Looking to the future, the Global Preparedness Monitoring Board (GPMB), set up in the aftermath of the 2014-15 Ebola outbreak in West Africa to serve as a high-level monitoring mechanism to ensure that preparedness reforms were implemented around the world, emphasized in this year’s report that simply learning lessons from COVID-19 and previous biological incidents is not enough, noting that “[t]he next pandemic will likely be different from the last, requiring adaptive, innovative and inclusive approaches to preparedness and response.”
Policy Recommendations
“America First” efforts should focus on preparing domestically for the next major biological incident. Ensuring that the United States is fully prepared for the next major biological incident, whether of natural, accidental, or deliberate origin, should be a top priority for the Trump administration. Control of both houses of Congress for the next two years provides a golden opportunity to pass any critical legislation to improve preparedness and response by:
- Addressing equity in basic healthcare
- Restoring trust in government, public health, and science
- Maintaining and empowering the Office of Pandemic Preparedness and Response Policy.
- Setting up an independent, bipartisan commission to review the U.S. COVID-19 response
- Pressing Congress to address the top priority biodefense and COVID lessons learned items GAO has identified for its action
- Ensuring HHS addresses the GAO’s high priority recommendations for improving its leadership and coordination of public health emergencies
Putting America First also means committing to global health security. As COVID, H5N1, Mpox, and countless other international infectious disease emergencies have demonstrated, diseases do not respect borders. Shutting down international travel and commerce is as devastating economically as the health problem it would be deployed to remedy. The best offense against an infectious disease of international concern remains a strong defense wherever in the world it might emerge or spread. The United States must recommit to the cause of Global Health Security and do its part to ensure that every country is prepared for an infectious disease emergency, has equitable access to low-cost PPE, testing, vaccines, and therapeutics, and is ready to respond domestically and collaborate internationally on the global response. The United States must:
- Prioritize good-faith participation in the remaining negotiations to finalize the new international pandemic preparedness instrument
- Support implementation of the updated International Health Regulations
- Affirm commitment to the Global Health Security Strategy
