Summary

Over 23 million homes in America have significant lead paint hazards and more than 200,000 children have unsafe levels of lead in their blood. Lead poisoning causes significant decreases in math and reading scores and a host of other health problems, all of which are preventable.

The urgent need for homes that support good health has never been clearer: the COVID-19 pandemic has meant more time in our residences, bringing healthy housing to the fore as a national priority. Inadequate housing conditions—such as exposure to lead paint, radon, mold and moisture, pest infestations, structural instability, and fire hazards—cause or exacerbate asthma, allergies, poisonings, falls and injuries, cancer, cardiovascular problems and other preventable illnesses. They needlessly burden our hospitals, schools, communities, and housing finance institutions, exacerbating the housing affordability crisis. Sustainable healthy housing is essential to economic vitality, climate change mitigation, and children’s futures.

This Executive Order establishes a cabinet-level Presidential Task Force on Lead Poisoning Prevention and Healthy Housing to coordinate the nation’s response to lead paint and other housing-related diseases and injuries under the Biden administration. Led by the Secretary of Housing and Urban Development, this Task Force will recommend new strategies, regulations, incentives and other actions that promise to conquer these avoidable problems. With strategic leadership and concerted action, the Task Force can eliminate childhood lead poisoning as a major public health problem and ensure that all American families have healthy homes.

The limited science and technology (S&T) resources available to policymakers in Congress and state legislatures have compounded the severity of the COVID-19 pandemic. To help meet legislators’ S&T needs, the Federation of American Scientists (FAS) organized more than 60 specialists with expertise in all the different aspects of the pandemic to serve on the COVID-19 Rapid Response Task Force. In addition to providing many written briefings to Congressional and state legislative offices, members of the Task Force have so far provided three oral briefings to Congress, including one about the promise of monoclonal antibody (mAb) therapies for COVID-19.

Monoclonal antibodies to counter COVID-19

Many experts believe that mAb therapies have a major role to play in protecting people from COVID-19, serving as a bridge to a vaccine, and safeguarding groups that potentially would not respond to a vaccine, for example, an aged population or immunocompromised individuals. There is certainly precedent for mAb therapies helping people survive deadly diseases; for instance, mAb therapies resulted in statistically significant survival benefits for Ebola patients.

Therapeutic mAbs against COVID-19 are intended to stick to the spike proteins of SARS-CoV-2, which are on the outside of the virus, and block them from being able to attach to receptor proteins on the outside of human cells, which would be needed for viral entry and infection. Most focus has been on the spike protein interaction with the human cell surface receptor ACE2, and recent work shows that the human cell surface protein Neuropilin-1 also has a role in facilitating SARS-CoV-2 entry and infectivity in some human cell types. Designing mAb therapies that interfere with either one or both of these interactions could help explore the range of efficacies of COVID-19 mAbs.

This image was adapted from the San Diego Union-Tribune.

An experimental mAb from Eli Lilly being tested in early-stage clinical trials, while not appearing to help COVID-19 patients who are hospitalized (that testing has been stopped), has shown promise for people with mild or moderate COVID-19 who receive the treatment early and who are not hospitalized, reducing viral load, symptom severity, and eventual hospitalizations. The Food and Drug Administration (FDA) recently granted an Emergency Use Authorization (EUA) for Eli Lilly’s antibody. Under the EUA, the treatment, called bamlanivimab, is supposed to be given to patients as soon as possible after a positive coronavirus test, no more than 10 days after developing symptoms. The treatment should not be used for patients who are hospitalized. It is intended for individuals 12 and older and at risk for developing a severe form of COVID-19 or being hospitalized.

This image was adapted from Eli Lilly

Regeneron has also developed a mAb treatment, and has, like Eli Lilly, stopped its clinical trial in hospitalized patients – in Regeneron’s case, “an independent data monitoring committee warned that the risks might outweigh the benefits for hospitalised patients on high levels of oxygen.” Like Eli Lilly’s drug, Regeneron has reported that its mAB cocktail reduces virus levels in the body and improves symptoms for individuals with COVID-19 who are not hospitalized. Regeneron has also applied to the FDA for an EUA of their mAB therapy, and overall, at least ten COVID-19 antibodies are being tested in clinical trials, with many more under development.

While EUAs can serve to get drugs to patients more rapidly than going through full FDA approval, the use of mAbs outside of clinical trials can make it more difficult to ascertain the therapies’ true effectiveness in different age groups. Furthermore, it could make it harder to enroll volunteers in future clinical trials for alternative therapies, since people may want to take a drug that appears to work, rather than risk possibly getting placebo. Authorizing a low-impact therapeutic could be counterproductive. FDA must take care to only grant EUAs for mAb therapies where the data show they are potent, and clearly delineate the circumstances in which they should be administered to help patients.

Antibodies are expensive and difficult to make, and they are administered at relatively high levels. These factors conspire to limit the number of doses that are produced. By the end of the year, Regeneron is expected to have produced up to 300,000 doses of its cocktail, and Eli Lilly greater than one million. More doses are needed; experts estimate that each day, 10,000 to 15,000 people in the US would be indicated for the drugs based on age and risk factors, even if there’s no further surge of infection.

A major challenge is that manufacturing capacity for monoclonal antibodies is limited, generally actively being used to produce treatments that are needed by patients as therapies for conditions such as cancer, multiple sclerosis, or osteoporosis. Globally, bioreactor capacity for producing mAbs from mammalian cells is spread across 200 facilities, with a total capacity of about 1,500,000 gallons. Constructing new manufacturing capacity requires years, with different types of facilities taking anywhere from 18 months to 7.5 years to come online. Bringing inactive facilities back online is a possibility, but how available such facilities are, and what would be needed to update them for operation, is unclear, and unlikely to happen in the near future. So, COVID-19 mAb manufacturing will need to rely on facilities either in use or in development, at least in the near-term.

Possible roles for government include helping to coordinate the construction of new mAb manufacturing capacity, or the repurposing of existing sites that could serve as bioreactors. Non-traditional mammalian cell lines could be tested to see which produce the highest levels of these mAbs to make the best use of the bioreactor capacity. Also, there are techniques for producing mAb therapies in bacterial or fungal (like brewer’s yeast) cells, in addition to mammalian cells, which could take advantage of existing capacity for microbial fermentation. And regulatory agencies like the Environmental Protection Agency and FDA could help expedite actions like repurposing bioreactor sites or deploying new bioproduction technologies by prioritizing the evaluation of these activities without harming the environment or sacrificing drug safety or efficacy.

Government could also assist with coordination between companies, providing a framework and forum for sharing information about or partnering on manufacturing capacity, or discussing approaches to COVID-19 mAb design that may have already been attempted and that did not pan out. This coordination could even extend to facilitating international collaborations, as COVID-19 mAb development efforts are taking place in countries all around the globe.

Considering COVID-19 is a deadly disease that can also have long-term health impacts for those who survive, the development and deployment of mAb therapies that can be administered soon after infection is detected and reduce the severity of disease are expected to contribute to countering the health effects of the pandemic.

Briefers

The experts who briefed Congress were Megan Coffee, MD/PhD, Clinical Assistant Professor at New York University; Erica Ollmann Saphire, PhD, Professor at the La Jolla Institute for Immunology and lead of the Coronavirus Immunotherapy Consortium; Jill Horowitz, PhD, Executive Director of the Strategic Operations Laboratory of Molecular Immunology at Rockefeller University; John Cumbers, PhD, CEO of SynBioBeta; Eric Hobbs, PhD, CEO of Berkeley Lights; Jake Glanville, PhD, CEO of Distributed Bio; Mike Fisher, PhD, Senior Fellow at the Federation of American Scientists; and Ali Nouri, PhD, President of the Federation of American Scientists.For more information about FAS’ work with Congress, visit our Congressional Science Policy Initiative website.

Categories: Public Health

COVID-19 is estimated to cost the global economy between $8 to 15 trillion USD¹, but it is not the first such outbreak, nor will it be the last. Since the 1970’s, 70% of emerging infectious diseases (EIDs) have been at the human-wildlife boundary², with new infectious diseases emerging at a faster rate than ever before. Further, a common, defining feature of emerging infectious diseases is that they are triggered by anthropogenic changes to the environment. As natural environments degrade (specifically, due to climate change, loss of biodiversity and fragmentation of habitats, or invasive species), they are more likely to harbor infectious diseases and their vectors (animals or plants that transmit a pathogen)².

This memo proposes a series of actions to shift the focus of our existing EID strategies from merely reacting to disease outbreaks – which is economically devastating – to detecting, addressing, and mitigating the major upstream factors that contribute to the emergence of such diseases prior to an outbreak, and would come at orders of magnitude lower cost. Recent analysis of the exponentially rising economic damages from increasing rates of zoonotic disease emergence suggests that strategies to mitigate pandemics would provide a 250:1 to 700:1 return on investment. Even small reductions in the estimated costs of a future pandemic would be substantial. This approach would have greater success at a much lower cost in reducing the impacts of EIDs.

The next administration should

1. launch a strategy aimed at strengthening biosurveillance systems at home and abroad through a global viral weather system for spillover, including harnessing technology and data science to create predictive risk systems;
2. eliminate existing barriers in international development and foreign policy between food security, global health, and environmental sustainability by establishing a coordinator for planetary health;
3. address and alter the incentive structures that facilitate spillover, and create new incentives for investments to reduce the risk for spillover through institutions like the Development Finance Corporation; and
4. through creating the world’s first climate & biodiversity neutral development agency, to ensure that our development investments aren’t facilitating spillover risks.

Challenge and Opportunity

COVID-19

The COVID-19 pandemic represents the greatest global public health crisis of this generation and, potentially, since the pandemic influenza outbreak of 1918. But it is not the only new pathogen to have threatened humanity in that time, nor will it be the last. Scores of infectious diseases threaten humankind: both familiar ones like malaria, tuberculosis, and neglected tropical diseases, and emerging viruses, fungal, and bacterial infections like Ebola, H5N1 avian flu, Zika, severe acute respiratory syndrome and Middle East Respiratory Syndrome. Increasingly, emerging infectious diseases (EIDs) are zoonotic: 60% are shared between wildlife and humans³. Today, the frequency of epidemics is increasing, driven by surging populations, our degradation debt owed to the planet and climate, wildlife trafficking, and globalized trade and travel.

As we have seen with COVID-19, in a thoroughly interconnected world, those of us in developed economies cannot afford to ignore the developing world if we are concerned about disease outbreaks. The failure to address Covid-19 everywhere affects our ability to address it anywhere. Not enough is known about the trajectory of the transmission of COVID-19 in the Global South. Many developing countries, especially in rural communities, are limited in their ability to test and isolate patients due to under-funded healthcare systems that lack medical staff, training, laboratories, reagents, equipment, and trained personnel. They lack the resources and bio-surveillance capacity to identify spillover events, and outbreaks even with large mortality may go undiagnosed when their symptoms mimic other diseases.¹ Moreover, EIDs can exacerbate chaos in failed and failing states, and failed states make ready homes for pandemics.⁴ COVID-19 in fact may have moved between 88-115 million people back into extreme poverty, and potentially 150 million by 2021, setting back efforts to end extreme poverty by 3 years.⁵ This is why the response to COVID-19, and the next pandemics, are not just health problems, but need be framed within a larger development and conservation context that requires investments in restructuring how we address the wicked problems facing our country and our planet.

Accordingly, as we respond to this outbreak, it is even more important to think about how we prevent the next one. The U.S. has invested significant resources to prepare for, monitor, and respond to outbreaks of existing infectious diseases. Although this investment has been insufficient as we have seen in COVID-19, there is a bigger issue: How do we avoid the next 10 pandemics? These “downstream” responses fail to address the origination of novel emerging infectious diseases, i.e. how such diseases initially arise, or the factors that accelerate their spread. We need to focus on factors that greatly contribute to disease emergence: our food systems & supply chains, environmental degradation, climate change, and the movement and trade of wildlife and wildlife products.

Much of the world’s population lives in close proximity to animals and natural environments; such proximity translates into greater disease risks. More than half of the 1,407 recognized infectious diseases are shared between humans and wildlife (“zoonotic”); such zoonotic pathogens are twice as likely to be emerging or reemerging, than are nonzoonotic pathogens. Since the 1970’s, 75% of EIDs have been at the human-wildlife boundary, with new infectious diseases emerging at a faster rate than ever before.⁶ Further, a common, defining feature of emerging infectious diseases is that they are triggered by anthropogenic changes to the environment. As natural environments degrade (specifically, due to climate change, loss of biodiversity and fragmentation of habitats, or invasive species), they are more likely to harbor infectious diseases and their vectors (animals or plants that transmit a pathogen). Understanding and addressing how such environmental changes may affect the spread of disease allows us to mitigate or even prevent outbreaks in the future.

It would be substantially more cost effective, efficient, and safer to prevent these diseases from initial emergence and spread. According to Dobson et al, the estimated cost difference of prevention would be $22.0 to $31.2 billion, compared to the expected costs of COVID-19 of $8.1 to $15.8 trillion, ranging from a 250:1 to 700:1 difference of costs. There are additional ancillary benefits to these upstream approaches, which include ecosystem services and reduced CO2 emissions.

COVID-19 presents us with an unprecedented opportunity to create a world where we anticipate, plan for, and mitigate pandemics before they happen, and even prevent them from emergence. We can address the challenge of EIDs by building the capacity and infrastructure needed to prevent future outbreaks and through addressing the root causes of EIDs. This requires us eliminate the barriers that separate global health programming from investments that address the root causes of environmental degradation, food insecurity, public health, and economic insecurity. It is also an extraordinary opportunity to take a problem-oriented approach to solving conservation & development problems, rather than a disciplinary one, and think about how we create new pathways for industrialization that meet the exigencies of climate change and sustainability.

Climate Change

Climate change expands the range and impact of pathogens, facilitating the spread of EIDs. Warmer temperatures enable pathogens and their vectors to survive and sometimes thrive in habitats previously outside of their tolerance range. It also serves to change weather patterns (like storms or rainfall) that lead to more standing water, and increase the population of mosquitos or other vectors. Climate change may also alter the range and fitness of host predators or competitors that would have limited spread of vectors under previous conditions. Vectors may also be active for longer periods of time during the day (e.g., mosquitos may have more opportunities to transmit a disease because they have more times to bite). Tropical diseases such as malaria, cholera, yellow fever, now reach previously unexposed human populations in South America, Central Africa, and Asia due to the spread of their vectors to new regions. Dengue is expected to reach New York and Washington DC by 2080.

Environmental Degradation and Disease Risk

The destruction and degradation of natural habitats and the stress and defaunation of species communities within them, facilitates the emergence of infectious diseases by increasing the opportunities for disease spread and spillover. 

First, reduced species diversity increases the relative commonness of those species that incubate, carry, and help spread a pathogen (“reservoirs”), increasing disease prevalence. Further, predators are the first to disappear after habitat degradation; the lack of a “regulatory” agent leads to an increase in reservoirs, increasing opportunities for transmission as with Lyme disease in the Eastern U.S. Lower resources could mean less competitors, another regulatory agent. Environmental degradation may also increase shedding rates by stressing animals, encouraging the spread of the disease. Deforestation and degradation of habitats may also facilitate the spread of infectious disease by increasing habitat that favors disease vectors, such as mosquitos (rice paddies around forest edges), or edge habitat that favors invasions by invasive species.

Finally, changes in landscape geometry and makeup, coupled with changes in density in domesticated and wild species, may draw together formerly isolated populations, increasing spillover risks to humans and domesticated animals from wildlife populations, and vice versa. Tropical forest edges create spillover opportunities for novel human viruses, as humans and their livestock are more likely to come into contact with wildlife when more than 25% of the original forest cover is lost.⁷ Environmental degradation, driven by forestry, mining, and agriculture, increases opportunities for hunting wildlife, and the potential for spillover.

Invasive Species, Wildlife Trade, Pet Trade, and Food Systems

The invasion of foreign species (pathogens, vectors, and reservoirs) into novel habitats also spreads infectious disease. Such introductions may happen due to increasing globalization of industry, trade, and tourism; through the pet trade (as what happened with the U.S. outbreak of Monkeypox), through legal or illegal trade in wildlife and wildlife products; or through habitat changes that facilitate invasions by alien plants or animals. Invasive alien species may carry disease into populations previously unexposed to those pathogens. Invasive species may also destroy native species or their food supplies, creating an unbalanced ecosystem more vulnerable to disease. As SARS-COV-2 has shown us, wildlife trade is especially prone to spillover, as the capture, handling, slaughter, and ingestion of wildlife can lead to the transfer of a pathogen from wildlife to humans. Ebola is thought to have arisen due to bushmeat hunting of bats and nonhuman primates; HIV is thought to have arisen due to bushmeat hunting of chimpanzees; MERS is thought to have arisen due to animal husbandry (camels).

Plan of Action

Currently, U.S. policies to combat and address EIDs are focused on costly responses to individual outbreaks, rather than reducing the chance for an outbreak to occur. Artificial barriers between public health responses, food security, animal health, biodiversity conservation, and national security also exacerbate the problem. On the international level, there is a total failure to standardize disease data, link it with environmental change, and assess risks despite scientific evidence linking disease emergence and environmental change. Confronting EIDs more effectively and efficiently requires a multifaceted and multidisciplinary approach. To better understand and address the threat posed by EIDs and develop more effective responses to this threat, this memo recommends the following steps:

Establish a biosurveillance system in the most biodiverse places

A first line of defense against emerging zoonotic viruses is dependent on countries having adequate capacities for monitoring and reducing spillover of viruses from wildlife to people (either directly or through intermediate animals such as livestock). Existing biosurveillance efforts are typically not sufficiently robust, as evidenced most-recently by the spillover of SARS-CoV-2 from animals to people in Wuhan, China.

Through massively better biosurveillance of targeted pathogens through new technologies, including low cost molecular testing to be able to understand opportunities for spillover in the United States, as well as in the Amazon Basin, Wallacea, and the Congo Basin, we can establish a global, integrated monitoring network that forms the basis of an actionable biosurveillance system. Key will be increasing world class lab capacity in the places where spillover is more likely to happen and development of new low cost technologies that can help identify new pathogens, and their reservoirs in situ. With this networked of networked devices, patterns of emergence and spread can also be monitored in near real-time, producing transformative data on the epidemiological and ecological progression of novel pathogens. However, this will require setting up a modern surveillance network in partnership with other health organizations with a large foot print on the ground. These include the CDC, FHI360, WCS, Veterinarians without Borders, and the World Health Organization. It will also require the US to create a Field ParaVets Program, a rapid training program for rapid response and paraveterinarian specialists that would be focused on one-health surveillance and outbreak detection.

Utilizing big data, machine learning, and models from epidemiology, ecology, and evolution, we can begin to develop the integrated frameworks and analytical capacity that will enable a global forecasting system for future pandemics and EIDs. Much like the Global Weather Services enterprise, we can create a system that provides information and services to front-line actors, governments, health agencies, civil society, and front-line communities that enables them to anticipate and respond to the emergence of new diseases. Furthermore, because of the integrated nature of such a Global Biosurveillance System, capitalizing on the ecological and evolutionary understanding described above, we can create actionable insights that will allow conservationists, public health officials, food system agents, and others to move upstream from the emergence of these novel pathogens to turn off the underlying drivers.

Implementation

Creating a Global Viral Intelligence Service for Predicting Pathogen Spillovers. We need a global surveillance network for emerging infectious diseases to gather information on the incidence of disease in populations of wildlife, humans, and domesticated animals, and agriculture, at every stage of the trade supply chain beginning with free-ranging populations and extending to wildlife farms, confiscated animals being smuggled, and animals legally being shipped at points of export, and create adaptive “weather” maps of the risks of disease transmission. This service, would be based within the NIH, and work closely with the Centers for Disease Control, the Defense Threat Reduction Agency, the Armed Forces Health Surveillance Branch, and the USGS National Wildlife Health Center 

Improving Monitoring and Prevention Internationally. The US must take a leadership role to strengthen efforts by UN Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE), UNDP, UNEP, and the World Health Organization, to develop a systematic approach for early detection and rapid response to identify and control emerging infectious disease of human, wildlife, and domesticated animals, including delineating risks from wildlife trade, environmental degradation, and climate change. Through USAID, in partnership with the Defense Threat Reduction Agency, and the Navy Medical Research Centers in Egypt, Lima, and Singapore, the US would develop new funding and technical assistant programs for building disease monitoring lab activity and personnel, building on USAID’s IDENTIFY program, previous programs including PREDICT, PREVENT, IDENTIFY, RESPOND, and DTRA’s Cooperative Biological Engagement Program.

Expansion of Existing Authorities to Defend our Borders. The new administration should expand the mission of APHIS to address not only disease issues that affect agricultural animals but also those associated with zoonotic and wildlife diseases, and increased focus on disease prevention, preparedness, detection, and early response activities. We may give CDC the authority to use pre-import screening, such as a process that assesses disease risk by species and country and determines allowable imports on the basis of that assessment. We may also amend the Lacey Act to strengthen the USFWS’s ability to identify, designate and stop injurious species, including dangerous pathogens from entering the United States, and from moving in interstate commerce if and when they arrive here.

Breaking down barriers between food security, global health, and sustainability

It is clear that how we may address pandemics requires us to break down the barriers – such as the health accounts in USAID – that limit opportunities to take a transdisciplinary approach to how we may address pandemics. Emerging pathogens are not limited to human health or wildlife, but cross over into the disruptive pests and pathogens that address the crops we grow, the food we store, and ecosystems we value. Our solutions to EIDs require us to think more broadly than global health, but think about health systems, food safety and security, wildlife trade, and environmental change.

Implementation

Address the Drivers of Pandemic Emergence. Work with Congress to allow for greater multisectoral programming within USAID to address the underlying drivers of extinction. Proactive efforts that minimize risk of emerging diseases are less costly than the economic and mortality costs of responding to these pathogens once they have emerged. Harnessing intelligence from the Global Viral Intelligence Service, the US should also fund programs to mitigate the underlying factors that facilitate disease emergence, including addressing food systems and global production of feed, food, materials, and their supply chains, and environmental degradation. This includes looking at how we may reduce risk through (1) protecting habitats, conserving biodiversity, reducing deforestation, restoring degraded habitat; (2) prioritizing international transdisciplinary research collaborations under the Ecohealth, OneHealth, and Planetary Health Frameworks; and (3) using ecological interventions to reduce human disease burdens and pandemic risk through experimental management and conservation.

Encourage a whole of government approach through the leadership of the National Security Council. The National Security Council should coordinate both international and domestic approaches to take a multi-disciplinary approach to addressing the upstream factors of pandemics, working in consultation with PCAST, NSTC, CEQ, OSTP, and OMB, and through an interagency process with representation from State, USAID, DFC, DOD, Treasury, HHS, NOAA, NASA, USGS, ODNI, and other relevant federal agencies, through an interagency working group.

Changing the incentives that drive spillover

Regardless of the exact determinants of the origin of COVID-19, this pandemic is primarily due to human behavior. Wildlife wet markets bring together an array of wild animals, in stressful and confined conditions, that would not normally occur. This creates an environment conducive to the spread of disease. Consumption of these wild animals (such as bats, pangolins, and even primates) puts human health at risk by providing an opportunity for the virus to potentially spillover from non-human animals to humans. We need to change the incentives for human behavior, and facilitate that change through modernization of the food system, animal husbandry, and supply chains, and increasing the sustainability of systems to reduce the demand for wildlife products that produce pandemics and decimate wild populations.

Creating new technological systems to better protect the forests tied to direct payments for conservation systems & monitoring (whose value is based on spillover risks & biodiversity value) to change behavior for those at greatest risk of spillover, and who have few other economic choices. Some early attempts exist to change behavior around wildlife trade, such as campaigns in China to reduce the consumption of shark fin soup, that can serve as models for ways to leverage new technologies and behavioral science approaches (gamification, peer networks, positive and negative reinforcement, etc.) to reduce demand for wildlife products. This, coupled with market signals that incentivize proper behavior could produce significant benefit.

Implementation

End Implicit and Explicit Subsidies that Drive Spillover at home and abroad. Many threats to planetary health, including emerging infectious diseases, are unwittingly subsidized and facilitated by the government. These subsidies include those in water use, energy, agriculture, transportation, fisheries, land management, and trade. Ending subsidies domestically may not only support planetary health, but free up revenue to the program. Internationally, subsidies violate the underlying principles of global trade through the World Trade Organization and allow for countervailing measures. Further, parties to the WTO may implement trade related measures at protecting the environment. These would serve to benefit the sustainability of US industry and make our domestic and better regulated products more competitive.

Create new Financial Innovations & Encouraging Investment for Preventing Pandemics. Financial innovations are a powerful class of behavioral incentives. We should consider innovations such as Advanced Market Commitments, Direct Payments for Conservation, Social Impact Bonds & Direct Payments, Franchise Models, and Nutrient and Carbon Trading, coupled with mechanisms such as the Development Credit Authority within the new Development Finance Institution which guarantees up to 50% of “first loss” of an investment to encourage the development of new capital to support Planetary Health and addressing emerging infectious diseases. The SEC could also require companies to report measures on their environmental sustainability, and potential risk from environmental degradation, climate change or pollution on their operations.

Creating a climate & biodiversity neutral development agency

Climate change and biodiversity degradation will be a major driver of the spread of EIDs. To mitigate what is an increasing threat to human security, USAID needs to ensure that its entire portfolio of activities, do not on average, worsen climate change or undermine biodiversity loss. This requires us to think beyond just funding sporadic climate and conservation programs, but thinking about the systematic impact of the Agency’s activities on climate change, and ensuring that US development investments are generating a net impact of zero emissions of the greenhouse gases that cause global warming, and are not driving species defaunation and extinction. Such an approach supports the SDGs, and will allow for countries to find new pathways to industrialization and development. It will enable the Agency to stop contributing to the very problems it is trying to solve such as weather-related humanitarian crises, livelihood re-engineering due to decreasing water levels, and conflict over arable land.

Climate & biodiversity neutrality does not detract from other development goals, such as economic growth. While the United States should invest heavily in encouraging sustainable economic growth –and it is in the environment’s interest to do so — it is imperative that we act in a way that does not worsen the effects of climate change or the extinction crisis. Future economic growth must work to reduce rather than expand emissions of greenhouse gases. Working towards climate & biodiversity neutrality would benefit the people assisted by USAID, as well as the environment. Certain USAID programs are inherently emissions-intensive, such as responding to disasters or building roads. Achieving climate & biodiversity neutrality across the entire basket of USAID foreign assistance activities allows development activities in one country that reduce emissions (such as forestry, biodiversity conservation, and renewable energy) to balance activities in other countries that increase emissions (humanitarian aid missions, roadbuilding). USAID can become, once again, the most forward-thinking development agency, shining as an innovative example among other donor organizations throughout the world.

Implementation

Create an annual estimate, through the annual budget process, of the approximate carbon impact of USAID programs, and create an office within the Policy Bureau to carry out this analysis. This office will lead a Climate Neutral Task Force (CNTF), with representatives from each Washington Bureau and, initially, those Missions that choose to participate in a comprehensive assessment of both their programs and operations. Bureaus will be represented by environment officers and experts in the key sectors — infrastructure & engineering, energy, agriculture, water, and natural resources, and our own operational management. One year appears a reasonable estimate for how long it would take for the CNTF to accomplish the work described in the proposal. We recommend undertaking the emissions assessment process in several self-selected, pilot Missions, in the first year, and then expand to the whole Agency in the next year.

The COVID-19 pandemic has exposed systematic vulnerabilities in the way that wildlife movement and emerging infectious diseases are managed at national and international scales. The next administration should take three key steps to address these vulnerabilities in the United States. First, the White House should create a “Task Force on the Control of Emerging Infectious Diseases”. This Task Force would convene agencies with oversight over animal imports, identify necessary policy actions, determine priority research areas, and coordinate a national response strategy. Second, the next president should work with Congress to pass a bill strengthening live-animal import regulations. Third, U.S. agencies should coordinate with international organizations to address global movement of infectious diseases of animals. Together, these actions would reduce the risk of emerging infectious diseases entering the United States, offer greater protection to citizens from zoonotic diseases, and protect American biodiversity from losses due to wildlife diseases.

Challenge and Opportunity

More than 60% of emerging infectious diseases in humans first originate in animals. More than 70% of these come from wild animals. HIV, for instance, jumped to human hosts from primates in Africa. MERS spread to humans from camels in the Middle East. Of present salience, experts believe that the virus that causes COVID-19 originated from wild animals in China (probably bats).

The risk of animal-to-human “spillover”—and the global spread of zoonotic diseases—increases when wildlife are traded and imported around the world (e.g., for food, traditional medicines, display, pets, etc.). The global spread of COVID-19 has drawn attention to problems such as lack of disease surveillance in wild animal populations and lack of disease testing in many live animals at international borders. International wildlife-trade laws do not account for public-health risks of wildlife trade. These laws also do not require collection of data on zoonotic diseases (i.e., diseases caused by germs that spread between animals and people): data that could help prevent the next pandemic. These problems are exacerbated by accelerating rates of habitat conversion and biodiversity loss coupled with increased volume and speed of international commerce.

The United States is especially susceptible to emerging zoonotic diseases because it is the world’s largest importer6 of legally traded wild animals, yet lacks domestic regulations requiring most imported live animals to be tested for diseases, pathogens, or parasites. Gaps in U.S. statutory and regulatory frameworks governing live-animal imports increase disease risks for humans while also threatening our country’s biodiversity and natural resources. In the United States, four agencies oversee some aspect of live-animal imports—but this oversight is far from comprehensive. The Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) is responsible for assessing the risk of diseases in agricultural imports, but not wildlife species. The Center for Disease Control (CDC) oversees imports of only primates and some species of rodents, bats, or birds known to spread zoonotic diseases. The Fish and Wildlife Service (FWS) is responsible for regulating imports of all wildlife (and imposes stricter standards on species previously identified as injurious), but its mandate does not cover infectious diseases or parasites. The upshot is that imports of most wildlife species to the United States are not assessed for disease risk by any agency. Most disease agents that infect wildlife (except for a small number of known zoonotic diseases) are not monitored by any agency either.

Plan of Action 

The next administration should take three key steps to address systematic vulnerabilities in the way that wildlife movement and emerging infectious diseases are managed in the United States and around the world. 

Create a White House Task Force on the Control of Emerging Infectious Diseases.

This Task Force would convene agencies with oversight over animal imports (including the U.S. Department of Agriculture (USDA), the Department of the Interior (DOI), and CDC) and those supporting research (NSF, NIH) or international assistance (U.S. Department of State, USAID) to determine global research priorities on wildlife disease, and facilitate international cooperation on mechanisms to reduce demand as well as disease risk in the live animal trade. The task-force would use the One Health concept that links human health with animal health and environmental health, and that applies a comprehensive approach to understanding the drivers of disease emergence, the spread of disease, and the impacts on human health.

Work with Congress to pass a bill strengthening live-animal import regulations.

This bill would build on past legislation (e.g., H.R. 6362/S. 3210;11 H.R. 3771/S. 1903;12 and S. 375913) related to wildlife disease. The bill should:

• Reduce risk of zoonotic disease introduction to the United States by increasing surveillance of live-animal imports at U.S. borders. Specifically, Congress should give APHIS the authority to use pre-import screening, such as a process that assesses disease risk by species and country and determines allowable imports on the basis of that assessment. Congress should also expand the mission of APHIS to address not only disease issues that affect agricultural animals but also disease issues associated with zoonotic and wildlife diseases.
• Amend the Lacey Act to strengthen the FWS’s ability to identify, designate, and stop injurious species (including dangerous pathogens) from entering the United States, and from moving via interstate commerce if and when they do enter. Specifically, the Lacey Act should be amended to grant the FWS authority over emergency listing (i.e. one that is accelerated and bypasses the notice and public comment process); authority to list human and wildlife pathogens as injurious species; and authority to regulate interstate commerce in listed injurious species.
• Expand efforts to control illegal wildlife trade. President Obama’s July 2013 Executive Order on Combating Wildlife Trafficking resulted in the development of a holistic national strategy for tackling the entire trade chain of wildlife trafficking. The next administration should strive to implement elements of this strategy that have not yet been implemented, and to build on elements that have. This could include increasing the FWS’s enforcement capacity, strengthening measures to prevent and deter wildlife trafficking, increasing the severity of penalties for wildlife crime, and taking steps to reduce demand (media campaigns, behavior change) for imported wildlife.

Coordinate internationally to address diverse aspects of wildlife movement and emerging infectious diseases.

The next administration should direct USDA (primarily APHIS) and the FWS to lead the following efforts:

• Amend the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) treaty and accompanying resolutions to (i) consider disease risk as a factor in regulating wildlife imports and exports, and (ii) broaden the scope of CITES in tackling domestic markets.
• Strengthen efforts by the UN Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE) to develop a systematic approach for early detection of (and rapid responses to) emerging infectious diseases of human, wildlife, and domesticated animals.
• Expand OIE’s ambit from simply assessing disease risk in livestock trade to one in which OIE works with CITES and country-based labs to expand disease surveillance in all live-animal trade, including by conducting tests. OIE should establish a publicly accessible, centralized, and curated system for monitoring the global incidence and spread of wildlife pathogens in order to facilitate early detection of disease emergence and to document disease spread. Such a system could be modeled on GISAID or EpiFlu.

Conclusion 

Regulatory gaps put Americans at risk of exposure to emerging infectious disease from unregulated and under-regulated imports of wildlife. The next administration should address these gaps by creating a White House task force, strengthening live-animal import regulations, and coordinating with international institutions to reduce the global movement of emerging infectious diseases. The result would be a nation that is healthier and safer—for humans and animals alike.

The U.S. pharmaceutical industry conducts over half the world’s research and development (R&D) in pharmaceuticals and accounts for well over $1 trillion in economic output annually. Yet despite the industry’s massive size, there are still no approved therapies for approximately 95% of human diseases—diseases that affect hundreds of millions in the United States and around the world. The disparity between industry inputs and societally valuable outputs can be attributed to two key market failures. First, many medicines and vaccines have high public value but low commercial potential. Most diseases are either rare (afflicting few), rapidly treated (e.g., by antibiotics), and/or predominantly affect the global poor. Therapies for such diseases therefore generate limited revenue streams for pharmaceutical companies. Second, the knowledge required to make many high-value drugs is either underdeveloped or under-shared. Proprietary considerations may prevent holders of key pieces of knowledge from exchanging and integrating information.

To address these market failures and accelerate progress on addressing the overwhelming majority of human diseases, the next administration should launch a new program that takes an open-source approach to pharmaceutical R&D. Just as open-source software has proven a valuable complement to the proprietary systems developed by computer giants, a similar open source approach to pharmaceutical R&D would complement the efforts and activities of the for-profit pharmaceutical sector. An open-source approach to pharmaceutical R&D will provide access to the totality of human knowledge and scientific expertise, enabling the nation to work quickly and cooperatively to generate low-cost advances in areas of great health need.

Challenge and Opportunity 

Approximately 95% of human diseases (~9,500 in number) lack any approved therapies. At the current rate of discovery, it would take 2,000 years to find therapies for all known human diseases. The result is that hundreds of millions of people in the United States and around the world lack medicines and vaccines that are essential to a healthy life.

Simply put, the status quo with respect to drug development has failed. The pharmaceutical industry expends huge amounts of money—often funded with taxpayer dollars—to develop and procure medicines and vaccines, straining national and personal budgets. Moreover, our legacy system of pharmaceutical R&D is unacceptably slow. It now takes 10–20 years for the pharmaceutical industry to develop a single new medicine or vaccine. Pharmaceutical R&D efficiency is declining exponentially: Moore’s Law in reverse. Finally, investment by the existing pharmaceutical industry is driven by profit potential, not societal need. Hence, diseases that afflict many but offer limited revenue streams continue to remain neglected.

It is time for a transformational change in how our nation approaches pharmaceutical R&D. COVID-19 has made it resoundingly clear that we need more medicines, vaccines, and antibody therapies—and we need them to become available fast and made accessible to all. The response to COVID-19 has also demonstrated the value of open R&D in medicine. Thanks largely to unprecedented levels of collaboration, information sharing, and grassroots innovation, our understanding of the disease and the efficacy of potential treatments has advanced at a remarkable pace. Progress on a vaccine for COVID-19 has been record-breaking in comparison with any previous vaccine. Such openness must be further expanded and become the new normal. Right now, most of our nation’s pharmaceutical R&D enterprise is divided among individual labs or companies, with little communication across disciplines or among different research teams. Pharmaceutical R&D is too often conducted secretly, separately, privately, redundantly, and chaotically. And public funds are given to private pharmaceutical companies without guarantees of affordability or openness. We must move instead towards a world in which pharmaceutical R&D is carried out collaboratively, cooperatively, transparently, flexibly, and efficiently. An important step is making key aspects of pharmaceutical R&D—especially publicly funded R&D that is supported or conducted by government—open source.

Plan of Action

The next president should launch a new effort to support an open-source approach to pharmaceutical R&D. Such an approach would differ from conventional approaches and compliment them in four ways: 

• First, an open-source approach would enable the entire scientific community to work together on challenges that are difficult for any single entity to solve (in keeping with the open-source mantra in software that “with enough eyes, all bugs are shallow”).
• Second, an open-source approach would draw on the sum total of human knowledge, without being constrained by discipline-specific technical expertise, or being limited to knowledge with high profit potential.
• Third, an open-source approach would focus on creating universally accessible medicines and vaccines with substantial public-health benefits, even when those medicines and vaccines do not generate substantial revenue streams.
• Fourth, an open-source approach would create knowledge accessible to all, and accelerate the advance of science.

As explained in an influential 2006 paper, an open-source approach to pharmaceutical R&D would achieve these goals by integrating six foundational capacities: (i) public and open data and other informational resources; (ii) affordable and widely available tools, algorithms, and models; (iii) advanced computation; (iv) crowdsourcing and crowd commentary; (v) generics and low-cost drug manufacturing; and (vi) the power of sharing, collaboration, and community. 

A government-funded effort to support open-source pharmaceutical R&D could take several forms. This effort could be housed at an independent nonprofit center, or could comprise a new program within the National Institutes of Health (NIH)’s National Center for Advancing Translational Sciences (NCATS). This effort could even exist as a part of a new global hub cofounded by the United States in collaboration with other countries and funders. Indeed, entities from Europe, Africa, Latin America, and South Asia are already working on the concept of open source pharmaceutical R&D. The United States should not be left behind.

However, it is important for the heart of this effort to exist outside of the academic and private sectors and their respective incentive structures. Universities are publication-oriented instead of product-oriented. Private entities are generally profit-seeking, and the consulting firms that often win government contracts typically do not conduct scientific research or create new products, let alone new paradigms. The effort should also be nimble and non-bureaucratic, focused on developing societally beneficial therapies, and characterized by an ethos of creativity, a deep feel for the subject, an open source and community spirit, and working for the public good. Possible implementation options could be recommended by a committee of accomplished innovators who have previously taken ideas from concepts to large-scale results in scientific and social realms.

There are five Initial areas of highest impact for open-source pharmaceutical R&D: (i) off-patent repurposing of existing medicines and vaccines, (ii) discovery of entirely new medicines and vaccines, (iii) creation of one or more scientific-information commons built on public data and resources, (iv) creation of open platforms (e.g., a Github for pharmaceuticals) to grow and connect relevant scientific communities, and (v) expanded artificial intelligence and computational capabilities to advance research. Clinical trial funding would be key, in order to translate research into interventions that have direct health impact. Partial precedents for open source pharmaceutical R&D are numerous and include the NIH NCATS COVID-19 OpenData Portal, the Government of India’s Open Source Drug Discovery Initiative, and a new U.S./Europe/South Asia/Africa/Latin America global hub led by NIH NCATS, the European infrastructure for translational medicine (EATRIS), and the Government of Brazil’s Fiocruz.

The next administration should fund this effort with a minimum budget of $100 million in year one and $200 million in year two. We believe that this funding level, a fraction of the billions per new drug required in traditional industry approaches, would be sufficient to first deliver multiple therapeutics that are affordable and serve areas of great health need, and secondly establish a firm paradigm of open-source pharmaceutical R&D. To be truly transformational, the federal government should eventually increase funding to a few billion dollars per year. This effort would directly improve health. But in addition, expect that it could generate four types of economic returns: (i) direct cash savings, in the form of reduced expenditures on health care and hospitalizations by government, with an ROI of potentially more than 100% annually;¹ (ii) some direct revenues, while maintaining openness and affordability; (iii) indirect returns created by improved health; (iv) and other indirect returns.

Federal funding for open-source pharmaceutical R&D should be viewed as an investment with indirect but major returns. By efficiently integrating the capabilities and knowledge of individuals, academics, and industry players in the pharmaceutical sector, open-sourcing R&D will—as already demonstrated in the IT sector—boost markets while delivering materially useful products for all Americans. Initial public investment to create open-source infrastructure for pharmaceutical R&D and unlock new data troves could increase the commercial viability of certain medicine or vaccine opportunities. In turn, this could spur private-capital investment and trigger waves of innovation, similar to ARPANET’s evolution into the Internet. We envision bipartisan support for this powerful approach.

The disconnect between assurances from federal health and science agencies and President Trump’s words continues. Before Wednesday’s hearing in the Senate Health, Education, Labor, and Pensions (HELP) Committee, news broke that the Food and Drug Administration (FDA) has plans to implement special Emergency Use Authorization (EUA) requirements for COVID-19 vaccine candidates. The vaccine EUA requirements proposed by FDA are reported to be more stringent than those for non-vaccine products like hydroxychloroquine or COVID-19 convalescent plasma. FDA Commissioner Hahn alluded to the application of the more stringent standards in his testimony during the hearing, but later in the day the president indicated that his administration may decide to reject the FDA’s proposal.

President Trump may reject FDA COVID-19 vaccine candidate guidelines

On Wednesday, President Trump cast doubt on whether the White House would greenlight FDA’s proposed rules for evaluating COVID-19 vaccine candidates that pharmaceutical companies could submit for approval via the EUA mechanism. An EUA is a temporary clearance for medical products that can be conferred more rapidly and with less documentation than a full approval, which can take six to nine months. Standard EUAs require only that a product “may be effective,” and that the likely benefits to people outweigh the harms. In 2005, the anthrax vaccine was granted an EUA so military personnel considered at high risk of anthrax attack could receive the product, the only instance of an EUA being issued for a vaccine.

Because the vaccine would be administered to a broad population to prevent illness, as opposed to patients suffering from COVID-19, FDA has proposed to strengthen the EUA process. That proposal is now awaiting review in the White House Office of Management and Budget. In a shocking televised press conference, the president characterized the FDA proposal as a “political move.” FDA officials believe a different standard for EUAs for vaccine safety and efficacy, as opposed to EUAs for medical products like hydroxychloroquine (since revoked) and convalescent plasma, is appropriate since vaccines are given to healthy people, not to those who are sick. To earn an EUA, reports indicate the FDA plans to require clinical trial data for COVID-19 vaccine candidates that are close to what is required for a full approval. Specifically, the standards would require monitoring participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot (if the vaccine requires two shots), as well as reaching at least five severe cases of COVID-19 in the placebo group for each trial, and some cases of the disease in the elderly. Regardless, any EUA would be based on less safety data than the standard approval track, so clinical trial participants would be monitored well after an EUA, if one were to be issued.

The public will be able to evaluate FDA-reviewed COVID-19 vaccine candidates

As part of its COVID-19 vaccine candidate evaluation process, FDA plans to get the advice of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of experts in “immunology, molecular biology, recombinant DNA, virology, bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.” These experts are screened for ethical conflicts, and are independent of both the US Government and vaccine-making companies. Notably, the VRBPAC chair recently recused herself from the review of COVID-19 vaccine candidates because she is running Moderna’s COVID-19 vaccine candidate clinical trial.

FDA Commissioner Hahn, pressed by Senator Maggie Hassan (D, NH; 2:29:32 mark in video), made it clear that when a vaccine-making company either submits a COVID-19 vaccine candidate application for full approval or requests an EUA, clinical trial data and the FDA summary assessing the data will be provided to VRBPAC as well as to the entire American public. Dr. Hahn also noted that VRBPAC’s discussion, vote, and recommendations will all be public. The public will then have an opportunity to provide comments. FDA will incorporate feedback from VRBPAC into its process, and make a final decision on approval or EUA.

It is important to note, however, that the VRBPAC recommendations are not binding. In other words, the FDA commissioner, Department of Health and Human Services secretary, or possibly even the president have the authority to grant an EUA, irrespective of VRBPAC’s recommendations.

Even so, the opportunity for the entire science and medical community to review COVID-19 vaccine candidate data should help ensure that the public can learn the extent to which COVID-19 vaccine candidates are known to be safe and effective.

The outlook for COVID-19 vaccine availability

At Wednesday’s hearing, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told the Committee (2:37:41 mark in video) that if all goes well with vaccine-makers’ COVID-19 vaccine candidate clinical trials, that in November, there possibly could be 50 million doses available, about 100 million more doses in December, and roughly 700 million total doses by April. He said that the vaccines will likely be given to healthcare providers and those who are vulnerable due to underlying conditions first. However, Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of VRBPAC, recently told the Washington Post that “It’s hard to imagine how an [emergency use authorization] could possibly occur before December,” indicating the availability of COVID-19 vaccines in November is not certain.

FAS is tracking this situation closely; for an opportunity to contribute to oversight over the COVID-19 vaccine candidate evaluation process, click here.

Additional hearing highlights

Senators seek answers about the guidance on airborne transmission of COVID-19 that was posted and then removed from the CDC website

Dr. Fauci pushes back on Senator Rand Paul in an exchange about herd immunity

Attention called to head of Operation Warp Speed’s potential conflicts of interest

More than 90 percent of Americans remain susceptible to the coronavirus

To review the entire hearing, click here.

The Oval Office, biopharmaceutical executives, and federal agencies have signaled that COVID-19 vaccines could be ready to go this fall; however, leading experts believe that proof of a safe and effective vaccine before Election Day is unlikely. President Trump has said that “we can probably have [a COVID-19 vaccine] sometime in October.” Pfizer and BioNTech executives think they could know whether their joint COVID-19 vaccine candidate works by the end of October, and that the Food and Drug Administration (FDA) will grant it an Emergency Use Authorization (EUA). The Centers for Disease Control and Prevention (CDC) wants states ready to distribute a COVID-19 vaccine as soon as late October, with distribution sites operational by November 1st. While it is certainly important to be primed to distribute life-saving vaccines, a more realistic scenario is that thorough analyses determining the safety and efficacy of COVID-19 vaccine candidates should be possible at the very end of this year, or beginning of next year.

Nevertheless, extremely optimistic COVID-19 vaccine approval timelines that converge with Election Day are being broadcast to the American public, and during Wednesday’s Senate Health, Education, Labor, and Pensions (HELP) Committee hearing, lawmakers demanded assurances that scientific data, not political agendas, will drive the COVID-19 vaccine approval process.

The path forward for phase III COVID-19 vaccine candidates

Three COVID-19 vaccine candidates that could be made available to Americans are currently in phase III clinical trials, and their paths forward rely on the actions that are taken by the vaccine-makers, FDA, the Department of Health and Human Services (HHS, FDA’s parent agency), and the President.

Whereas vaccine candidate clinical trials have historically been designed and executed by biopharmaceutical companies alone, COVID-19 vaccine candidate trials have been overseen by the US Government. To gauge if any of the vaccine candidates prevent or decrease the severity of disease with at least 50 percent efficacy – the bar FDA set at the end of June – tens of thousands of people are being enrolled in each COVID-19 vaccine candidate phase III clinical trial. In fact, on Saturday, Pfizer proposed to FDA that it enroll up to 44,000 participants, almost 50 percent more than the initial target of 30,000. Half are dosed with the vaccine candidate, the other half are dosed with placebo, and, to prevent bias, only a select group of experimentalists – not the trial participants, not the professionals administering the doses – know who gets what. During Wednesday’s hearing, Dr. Francis Collins, the director of the National Institutes of Health, asserted (2:26:10 mark in video) that once 150 people in the entire trial have developed symptomatic disease, it should be possible to determine whether a vaccine candidate is 50 percent effective. However, some experts say that even the point at which the trial reaches 150 cases of disease is unlikely to provide enough time to prove vaccine candidate safety.

Each individual COVID-19 vaccine candidate trial is tracked by a unique Data Safety and Monitoring Board (DSMB). DSMBs are multidisciplinary groups, independent of both the vaccine-maker and the federal government, composed of clinical trials specialists, biostatisticians, bioethicists, immunologists, vaccinologists, and virologists. As trials progress, DSMBs regularly review the data as they accumulate, and make recommendations to the company and to FDA about whether a vaccine has met safety and efficacy standards. Ultimately, DSMBs are only advisory groups, and it is up to the company as to whether it submits a Biologics License Application (BLA) to FDA for their COVID-19 vaccine candidate.

FDA will review the clinical trial data in the BLA for safety and efficacy. Following FDA’s review, the company and the FDA have the option of presenting their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), another expert body independent of both the federal government and the vaccine-maker. If consulted, VRBPAC would provide advice to FDA regarding the safety and efficacy of the vaccine. Regardless, FDA could then approve or deny the vaccine candidate for use.

Alternatively, a vaccine-maker could request an EUA from FDA, which opens up the possibility of a vaccine being approved for use before the conclusion of the clinical trial, which could complicate the trial’s full evaluation of safety and efficacy. Another tool FDA could possibly use is Accelerated Approval, a process that could base vaccine approval only on antibody levels or another surrogate biochemical marker produced in trial participants, rather than measuring actual protection from disease. Notably, HHS, or possibly President Trump, could even overrule an FDA rejection of a request for an EUA.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, believes there would be a moral obligation to end a trial early and make a vaccine accessible if the data from the trial were to be overwhelming that the vaccine candidate is safe and effective.

Federal officials testify that COVID-19 vaccine decisions will be based only on science

During the hearing, Senator Bernie Sanders (D, VT) pressed (1:14:27 mark in video) the witnesses to affirm that the COVID-19 vaccine approval process will only be driven by science. Dr. Collins pledged that he and all US Government scientists will be basing COVID-19 vaccine candidate evaluations and assessments only on science, or else he would have no part in the process. He also expressed cautious optimism that the US will produce a safe and effective vaccine by the end of the year, adding “certainly to try to predict whether it happens on a particular week before or after a particular date in early November is well beyond anything that any scientist right now could tell you and be confident that they know what they’re saying.”

Vice Admiral Jerome Adams, the US Surgeon General, concurred with this sentiment, stating that a COVID-19 vaccine will not be moved along unless it is proven to be safe and effective, that shortcuts will not be taken, and that once approved or authorized by FDA, he and his family would not hesitate to receive the vaccine.

Will words translate into action as Election Day approaches?

Dr. Collins and Vice Admiral Adams are not the only ones giving assurances that science, not political influence, will drive COVID-19 vaccine approval. Career civil servants at FDA reiterated their resolve to working “with agency leadership to maintain FDA’s steadfast commitment to ensuring our decisions will continue to be guided by the best science.” The head of Operation Warp Speed (the US effort to accelerate COVID-19 vaccine development), Dr. Moncef Slaoui, says he will “immediately resign if there is undue interference in this process.” And nine COVID-19 vaccine-making companies have pledged to “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.”

We will be tracking this issue closely as Election Day nears, and will be sure to alert the community to new developments. To review the entirety of this week’s hearing, click here.

Consumer protection and data privacy have come into focus on Capitol Hill over the past few weeks. One week after the leaders of Apple, Google, Amazon, and Facebook testified in front of the House Judiciary Committee, the Senate Commerce Committee held a hearing with the Federal Trade Commission (FTC) on this topic. The FTC aims to protect consumers and businesses from “anticompetitive, deceptive, and unfair business practices through law enforcement, advocacy, and education.” The hearing, titled “Oversight of the Federal Trade Commission” focused on the rise in online scams during the COVID-19 pandemic and how to make it easier for the FTC to protect consumers. The senators’ discussion with the FTC chair and commissioners was informed by expert questions provided by the Day One Project, a science and technology policy project that is developing policy proposals for the next Administration. These questions focused on how the FTC plans to keep up with the consumer risks brought by rapidly changing technology, especially from the major tech companies, and risks brought on by scams from current events, such as the pandemic.

There are numerous scams related to COVID-19 and they can be hard to detect. They range from price gouging and selling defective products to people pretending to be contact tracers, those who claim to provide “miracle” cures, and callers pretending to be from the U.S. government. According to the FTC, these pandemic-related scams have cost Americans over $13 million this year and this number is only growing. Out of the 100 million phishing emails blocked by Google each day, it is estimated that about 18 million of them reference the coronavirus. Others attempt to market products that claim to cure COVID-19, like colloidal silver (tiny silver particles suspended in a liquid), which are actually harmful to one’s health.

To combat these scams, the FTC has produced detailed guidance for businesses and consumers. However, enforcement of consumer protection rules can be challenging. Specifically, the FTC’s regulations have not kept up with an evolving internet landscape and scams take advantage of this. Commissioner Rebecca Slaughter acknowledged (1:21:08) that, especially in cases of price gouging, the FTC’s current oversight abilities are an “imperfect tool.”

Typically when a business or individual is caught using predatory tactics on consumers, the FTC sends out a warning letter. The goal of these letters is to notify the business or individual that they are violating consumer protection rules in the Federal Trade Commission Act. They also threaten legal consequences, such as a federal lawsuit, if the predatory behavior continues. The FTC has sent hundreds of letters to companies making misleading claims about COVID-19 treatments and cures, including those pushing treatments with ozone, vitamin C, 5G shields, and ultraviolet light. FTC Chair Joe Simons notes (1:49:25) that these letters tend to be effective. However, Senator Richard Blumenthal (D-CT) expressed (1:50:35) how it would be easier to combat scams if there was a judgement on the books after the first instance of predatory behavior instead of having to wait until the second occurrence to implement harsher punishments.

Through its work in this area, the Day One Project emphasized that FTC’s penalty structure may not provide proper incentives to deter businesses from engaging in predatory tactics or unfair practices in consumer privacy and protection. Experts working with the Day One Project suggested that new regulations could help. During the hearing, Chair Simons and Commissioner Noah Philips agreed and explained (1:32:50 and 2:34:15, respectively) that allowing the FTC to have targeted rulemaking capabilities and the ability to levy civil penalties can help combat scams and protect consumers’ data. This rulemaking authority would allow the FTC, according to Chair Simons, to change its definitions to “account for changes in technology and changes in business methods.”

While this targeted rulemaking authority would need to be passed by Congress, the members of the committee were receptive to the idea. The consumer protection and data privacy landscape is changing rapidly over time and businesses taking advantage of an unprecedented pandemic threaten the security and wellbeing of consumers every day. It is clear from this hearing that FTC is trying its best to combat these threats but needs more help to do so. Input from forward-leaning organizations like the Day One Project are vital to ensure that Congress is informed about the most pressing issues and has the tools it needs to solve them. This will likely not be the last hearing on this topic and the Congressional Science Policy Initiative encourages its readers to get involved in the policymaking process to help Congress protect citizens from predatory business practices.

More information can be found about the Day One Project here: https://www.dayoneproject.org/about.

To get involved with science policy and the U.S. Congress, sign up here: https://fas.org/congressional-science-policy-initiative/.

Come Tuesday, November 3rd – Election Day – Americans will exist in one of two realities: One reality in which COVID-19 vaccines deemed safe and effective are available to the electorate, or a different reality in which vaccines are still unavailable. Biopharma companies are optimistic their COVID-19 vaccines could be available as early as the fall. At the same time, Congress is concerned political interference from the White House could result in the approval of substandard vaccines. This tension was on full display at yesterday’s House Energy and Commerce Subcommittee on Oversight and Investigations hearing featuring leaders from COVID-19 vaccine-makers AstraZeneca, Johnson & Johnson (J&J), Merck, Moderna, and Pfizer.

The prospect of political interference in COVID-19 vaccine availability

If all goes well, there could be millions of COVID-19 vaccine doses ready to be distributed to Americans this fall. AstraZeneca may have hundreds of millions of doses available as soon as September. Moderna has its sights set on having millions of doses produced by the fall. Pfizer could provide 100 million doses by the end of this year. These hopes are contingent on these companies’ vaccines proving safe and effective in phase three trials involving tens of thousands of people.

But what if US safety and efficacy standards are adjusted, or even disregarded, to serve political interests? That’s the concern Representative Frank Pallone (D, NJ-06), chair of the full committee, raised with the five officials from vaccine-making companies.

At the end of June, the Food and Drug Administration (FDA) established guidance for the approval of COVID-19 vaccines. The guidance states that any vaccine must prove at least 50 percent more effective for COVID-19 prevention when compared against placebo. (The flu vaccine varies between 40 and 60 percent efficacy from one year to another.) Efficacy of 50 percent or more for a COVID-19 vaccine must be shown in a clinical trial enrolling at least 30,000 people of all different races and ethnicities.

Chair Pallone raised the possibility that President Trump could pressure FDA to lower official COVID-19 vaccine standards to well below 50 percent efficacy, or to surreptitiously approve a vaccine even if a company’s internal data show it’s less effective than FDA’s public requirements. The Chair was looking for assurances from the vaccine-makers that they will help guard against possible political interference from the White House. Dr. Mene Pangalos, AstraZeneca’s executive vice president of biopharmaceuticals research and development, stressed that all his company’s clinical data will be published openly, and that since the vaccine will be marketed globally, it will be vetted by many countries’ regulators, in addition to FDA. Moderna’s president, Dr. Stephen Hoge, also committed to publishing his company’s data regardless of whether the vaccine succeeds in clinical trials, and added that independent investigators on a National Institutes of Health (NIH) Data Safety Monitoring Board are conducting oversight of Moderna’s trials. Even so, White House influence on FDA is expected to be monitored closely as the US heads toward Election Day.

The White House has not shied away from pressuring federal agencies responding to the COVID-19 pandemic. Earlier this month, President Trump undermined Centers for Disease Control and Prevention (CDC) guidelines for reducing the risk of spreading COVID-19 at schools. In May, the Administration shelved CDC recommendations “with step-by-step advice to local authorities on how and when to reopen restaurants and other public places.” In April, a research grant funding the study of coronaviruses’ transmission from bats to people was terminated because the White House told NIH to cancel it. And finally, FDA is not immune to pressure from the Administration: A whistleblower alleges the since-rescinded emergency use authorization permitting treatment of COVID-19 patients with hydroxychloroquine was granted as a result of political interference, and there is evidence FDA Commissioner Stephen Hahn took unusual steps to assist a New York medical doctor in obtaining the drug. Congress finds the possibility of political interference from the White House in FDA’s COVID-19 vaccine approval process very worrisome.

Keys to expediting vaccine-making

Vaccines are rarely developed in even less than five years. The development of a safe and effective vaccine and the beginnings of its distribution in less than a year since the emergence of a novel disease would be revolutionary. To expedite COVID-19 vaccine-making, three key tactics have been implemented.

For one, bureaucratic steps are being streamlined to move the vaccine testing process along faster. Unnecessary delays between trial phases have been eliminated, while rigorous studies on vaccine safety and effectiveness have been maintained.

Second, some “plug-and-play” technologies developed in prior vaccine work have been applied to SARS-CoV-2 (the coronavirus that causes COVID-19). For example, Moderna’s vaccine development platform had been used previously to produce influenza virus and Zika virus vaccine candidates, and during the hearing, J&J’s Janssen Vaccines head of clinical development and medical affairs, Dr. Macaya Douoguih, cited her company’s accelerated program that produced an Ebola vaccine as critical to J&J’s efforts to produce 100 million COVID-19 vaccine doses by March 2021.

And third, companies are already scaling up the manufacture of potential COVID-19 vaccines in parallel with the testing phases, so that if a COVID-19 vaccine candidate proves successful in trials, millions of doses will be immediately available. Called at-risk manufacturing – if vaccine candidates do not pass muster, millions of doses would be worthless – vaccine-makers are implementing this capital intensive tactic because of the urgent need for safe and effective COVID-19 vaccines to be available for protection of the public.

Vaccine-makers are optimistic that tens of millions of COVID-19 vaccine doses will be available by the end of this year; however, the US government’s plan for fair and equitable vaccine distribution is yet to be released. CDC has the lead on planning for COVID-19 immunization infrastructure and vaccine distribution to the American people, and the Department of Defense is supporting CDC on logistics. Ensuring all Americans can be vaccinated against COVID-19 demands intensive local-state-federal coordination, as well as cooperation between the public and private sectors. While biopharma companies continue their rapid pursuit of vaccines against COVID-19, there is good reason for both hope and vigilance.

To review the full House Energy and Commerce Subcommittee on Oversight and Investigations hearing, click here.

Breastfeeding can provide important health and financial benefits for new families. But insufficient healthcare coverage, underlying medical conditions, and economic obstacles can make breastfeeding difficult or impossible for many parents. In this memo, a three-pronged approach is proposed—facilitated by an interagency collaboration through the National Advisory Council on Maternal, Infant, and Fetal Nutrition—to transform infant nutrition. First, to increase breastfeeding rates in the United States, the Centers for Medicare & Medicaid Services (CMS) should alter reimbursement policy by reimbursing tele-lactation and nutrition support for all babies covered under Medicaid. Second, the government should partner with the private sector to launch a “Synthesizing Human Milk Grand Innovation Challenge” to catalyze new extramural R&D and innovation efforts to accelerate commercialization of breast-milk alternatives for those that cannot breastfeed. And finally, the government should enact paid parental leave policies to give parents financial flexibility and dedicated time after birth to breastfeed.

Challenge and Opportunity

To ensure that all babies begin their lives on equal footing, swift action should be taken to give as many babies as possible access to breastmilk and high-quality breastmilk alternatives. Though breastfeeding and breastmilk represent only 0.04% of the National Institute of Health (NIH) budget, access to breastmilk and infant nutrition are issues that affect the health and finances of all American families with very young children. For babies, access to breastmilk has been shown to protect against respiratory illnesses, ear infections, gastrointestinal diseases, eczema, and sudden infant death syndrome. For mothers, breastfeeding may help reduce postpartum blood loss and may lower risk of post-partum depression, Type 2 diabetes, rheumatoid arthritis, cardiovascular disease, breast cancer, and ovarian cancer. The U.S. Department of Agriculture (USDA) Economic Research Service has estimated that Medicaid would save at least $172.6 million every year if breastfeeding rates among women, infants, and children increased to medically recommended levels.¹ More broadly, one study highlighted by the American College of Obstetricians and Gynecologists (ACOG) estimated that increasing breastfeeding rates could save $3.6 billion annually in the costs of treating some childhood illnesses.²

While breastfeeding can provide important health and financial benefits for new families, not all babies can breastfeed. 1 in 8 mothers in the United States face lactation dysfunction, which means that they cannot produce enough breastmilk to provide sufficient infant nutrition.³ Medical conditions such as Insufficient Glandular Tissue (IGT), mastitis, postpartum depression and anxiety (PPD/A), and infant birth defects—to name just a few—present challenges to breastfeeding. Adoptive parents can only breastfeed in certain circumstances, and birth mothers may be confused about whether they can breastfeed while on certain medications, may dislike the process of breastfeeding, or face difficulty breastfeeding while transitioning back to work.

For these and other reasons, 75% of babies use infant formula instead of breastmilk to some extent by the time they are 6 months old. A 2007 report from the Department of Health and Human Services (HHS) Agency for Healthcare Research and Quality (AHRQ) found that existing formula-feeding solutions are associated with higher risks for chronic diseases including Type 2 diabetes, asthma, and childhood obesity.⁴ Formula feeding is also linked with higher rates of necrotizing enterocolitis (NEC) for premature infants. More research is needed to understand the underlying biochemical mechanisms of human breastmilk to develop infant formulas that better mimic breastmilk. In addition, infant formula is a major expense for the federal government. Infant formula is the single most expensive item that the federal Special Supplemental Nutrition Program for Woman, Infants, and Children (WIC) provides, and the program spends more on formula than any other food—a total of $927 million in FY 2010.

It is also important to note that paid parental leave is a critical part of the postnatal experience for mothers and babies. Increases in paid parental leave are consistently associated with better infant and child health, particularly in terms of lower infant mortality rates.⁵ Paid parental leave also gives parents the opportunity and flexibility to focus on breastfeeding, which can be extremely time-consuming. The children of educated, well-off mothers are more likely to breastfeed because they have access to paid parental leave, careers with access to breaks for breast pumping, and disposable income to hire support such as night nurses. However, according to a national survey of employers conducted by the Bureau of Labor Statistics (BLS), only 18% of private industry U.S. employees had access to paid family leave through their employers. Paid parental leave in the private sector is voluntary and more prevalent among managerial and professional occupations.

Plan of Action 

CMS, USDA, NIH, state WIC agencies, and the private sector should work together through the National Advisory Council on Maternal, Infant, and Fetal Nutrition to transform U.S. infant nutrition for the better. The following specific actions are recommended:

First, to increase breastfeeding rates in the United States, CMS should alter its reimbursement policy to reimburse bi-weekly tele-lactation and nutrition support appointments for any baby covered under Medicaid during the baby’s first three months of life. Currently, the Affordable Care Act requires private insurance plans and Medicaid expansion programs to cover maternity care—including prenatal screenings and lactation consultations—without cost sharing by the patient. But there is no federal requirement to reimburse for telemedicine. Advocates should encourage the Center for Consumer Information and Insurance Oversight (CCIIO) at CMS to expand mandatory maternal-health coverage to include telehealth and for CMS to implement this policy change. This can be done in collaboration with WIC, which already provides breastfeeding support through state agencies.

Second, the federal government should catalyze new R&D and innovation efforts to accelerate commercialization of high-quality breastmilk alternatives such as

• Organizing a national “Synthesizing Human Milk R&D Summit.” This Summit would bring together formula makers, academic researchers, clinicians, parent and infant advocacy groups, representatives of the public-health community, and government stakeholders. Government stakeholders include NIH, CMS, the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration [FDA], the U.S. Surgeon General, and the U.S. Preventive Services Task Force (USPSTF). The goals for the event include (i) gathering input and commitments from stakeholders to lay the groundwork for a “Synthesizing Human Milk Grand Challenge” (see next bullet); (ii) identifying barriers to developing an infant formula that more closely mimics breast milk; and (iii) generating a white paper to summarize the current understanding of the underlying biochemical mechanisms of human milk.
• Launching a “Synthesizing Human Milk Grand Challenge.” Based on the insights gained by the Synthesizing Human Milk R&D Summit, NIH should launch a “Synthesizing Human Milk Grand Challenge” that awards cash prizes for innovations in development of human breastmilk alternatives. Industry stakeholders should be recruited to match NIH investments in the prize amounts.
• Dedicating extramural academic research funds from NIH as well as funds from the Small Business Innovation Research (SBIR) program to stimulate commercialization of high-quality breastmilk alternatives. These funds would help scale up innovations from the “Synthesizing Human Milk Grand Challenge” and would motivate additional R&D in academic settings to bring infant formula closer to human milk. In addition, a “synthesizing human milk” budget set-aside subpriority should be established as part of the SBIR NIH/NICHD program.
• Only purchasing validated infant formulas with federal funds. WIC should only buy infant formula solutions that demonstrate specific outcomes as outlined by an interagency committee convened by the USDA through the National Advisory Council on Maternal, Infant, and Fetal Nutrition. The committee should include representatives from NIH, CMS, CDC, USDA, FDA, USPSTF, and the American Academy of Pediatrics (AAP).

Third, in the longer term, the federal government should enact paid parental-leave policies that give parents financial flexibility and dedicated time after birth to breastfeed.

Summary

With 1,255 VA medical facilities serving over 9 million veterans each year, the VA — through its Veterans Health Administration — maintains the largest integrated healthcare system in the United States. The VA is a national leader in delivering quality health services and driving innovation in high-priority healthcare issues such as telehealth, precision medicine, suicide prevention, and opioid safety. Yet the VA remains an under-appreciated and underutilized health policy stakeholder, involved in minimal interactions with other federal health agencies and exerting limited influence on the private healthcare system. This is a mistake. The VA is a robust healthcare provider with innovative clinical and operational practices that should be firmly entrenched in the national health policy conversation.

As a remedy, we propose strategically coordinating and consolidating the healthcare innovation, demonstration, and implementation capacities of the VA and HHS in order to ensure care of the highest possible quality across urgent issues. Elevating the VA as a major healthcare policy stakeholder will demonstrate the value of government-run healthcare, promote best practices for building an effective and forward-thinking healthcare system, and advance the VA’s “fourth mission” of supporting national preparedness.

Summary

Pending bipartisan “Cures 2.0” legislation is intended to safely and efficiently modernize healthcare delivery in the wake of the novel coronavirus (COVID-19) pandemic. Such modernization is contingent on access to high-quality data to power innovation and guided decision-making. Yet over 80% of Americans feel that the potential risks of companies collecting their data outweigh the benefits. To ensure the success of Cures 2.0, provisions must be added that bolster public trust in how health data are used.

Addressing the largely unregulated activities of data brokers — businesses that collect, sell, and/or license brokered personal information — offers a budget-neutral solution to the public’s crisis of faith in privacy. Building a well-governed health-data ecosystem that the public can trust is essential to improving healthcare in the United States.