The One Health education panel included: Dr. Laura Kahn from Princeton University and the Founder of One Health Initiative; Dr. Deborah Thomson, Founder of OneHealthLessons.com; and Dr. Olga Pena, Mitacs Canadian Science Policy Fellow. Dr. Rowland asked each panelist a series of questions regarding the value of teaching students about One Health, how it helps support the goals of international organizations, and the challenges we face.
The most sobering point during this panel was made by Dr. Pena, who said “One Health disrupts human-centric views.” Too often, we are blinded to the interconnectedness of the human, plant, animal, and environmental conditions. What humans do affect the health of the rest of the planet, and what happens in Mother Nature affects the health of humans. Maintaining human-centric views will not only be harmful to the planetary condition but to humanity as well.
Sustainability is a challenge for One Health. Historically, the health sector has been reactive to threats, not proactive. Once a threat subsides, so does interest and funding. Dr. Thomson emphasized the best way to sustain efforts is to talk to the people who are most curious, most interested, and most willing to learn: children. If we want to change policies in the future, we need to reach the future politicians. For efforts to be sustainable, One Health education must also be tailored to the local community, traditions, and beliefs. Partnerships at the local level must be developed, and community leaders must be taught and empowered so they can continue teaching.
Unfortunately, providing education about One Health is challenging without the appropriate funding and resources. The panelists stated frustrations with finding funding for something as interdisciplinary as One Health, and even less funding for education because “education is not a product.” Building synergistic relationships that exchange funding for expertise, such as government agencies partnering with organizations and universities, is one way around this challenge, but it is not common enough to be a sufficient solution.
The One Health government panel included: Dr. Casey Barton Behravesh from CDC; Dr. Jane Rooney from USDA; and Mr. John Haynes from NASA. They answered a series of questions about how One Health is incorporated into the agencies, how agencies can work together, and how agencies can empower One Health work.
The most important takeaway from this panel was that One Health relies on partnerships. Despite the name, One Health is a team sport and no one person or one agency can accomplish its objectives. Like the education panel, this panel was concerned about funding and resources in the government for One Health, showing that interest and investment must come from the highest levels of government. In December 2017, there was an interagency workshop with subject matter experts and high-level agency voting members to come up with priority zoonotic diseases and generate recommendations on how to move One Health forward. Coronaviruses were on the list, and the workshop included suggestions for how to prepare for coronaviruses. Unfortunately, the resources were not there to follow through with the recommendations. Two years later, the COVID-19 pandemic has obviated the consequences of this lack of commitment and resources.
Of all the panel members in this meeting, Mr. Haynes impressed me the most, perhaps because he was the most surprising participant. Prior to the meeting, I had no understanding of how NASA would be involved in One Health, let alone serve as one of the leading agencies promoting the concept. Apparently, I was not alone; Mr. Haynes elaborated on how NASA attends public health and other medical conferences to raise awareness about what NASA is doing and how it should be incorporated into the health sector. NASA has an air and health quality applications program, and it has been very active during the COVID-19 pandemic. One program, for example, is modeling how the Saharan dust plume impacts public health, and specifically if the plume is associated with greater morbidity and mortality from COVID-19. There is no public health school in the United States that includes environmental remote sensing observations like those that this program offers in its curriculum. Mr. Haynes believes, and I am convinced, that this is a problem as most public health students and professionals have no idea these data are there and how valuable they can be for disease issues.
Now more than ever, it is important to be actively engaged in global health security. If you would like to watch any of the side meetings or the Ministerial Meeting, click here.
By Dr. Nathan Myers, Advisor to the Continuity of Supply Initiative
As this is being written, vaccines to protect against COVID-19 are being distributed all over the United States and around the world. If the vaccine proves to be the decisive tool for ending the pandemic, it will be the result of innovation, scientific research, collaboration, and coordination in regard to creating, distributing, and dispensing the vaccine. We must never lose sight of the fact, however, that vaccines have become so vital because of critical failures in other areas of the medical and public health systems. The same elements that allowed for the rapid development of vaccines in this pandemic must be applied in other areas to make vaccines less critical for the next major public health emergency. One such area is procurement of personal protective equipment (PPE).
A Forbes.com article by Jessica Gold reports on Center for Disease Control and Prevention (CDC) statistics indicating that 287,010 healthcare workers have been infected with the novel coronavirus with 953 providers succumbing to the illness. The article attributes these deaths, in large part, to inadequate protection, including a shortage of adequate PPE. The article notes that some personnel lacked access to N-95 masks and were forced to create their own makeshift protection. A BMJ study by Liu and colleagues found that 420 healthcare providers who were reassigned to work with COVID-19 positive patients in Wuhan, China did not contract the disease after being provided with proper PPE and the training to use it correctly. The article cites studies indicating that masks, gloves, eye protection, and gowns, if available and used correctly, can provide adequate protection against the virus. The article advises that national leaders must facilitate the ability of healthcare workers to abide by safety guidelines to protect themselves through ensuring a durable supply of PPE.
Organizations like the National Association of County and City Health Officials (NACCHO) recognized in a 2013 report the benefits of cooperative purchasing for public health organizations. They noted “piggy-backing” as being the most useful in an emergency, because organizations could join existing contracts and save time by not having to negotiate their own arrangements. Through the use of true cooperative procurement, CoSI seeks to remove the need for piggy-backing by creating efficient, effective, and resilient systems during normal times that can flex to meet the challenges of emergencies. A 2014 article by Rego, Claro, and de Sousa notes that improvement of purchasing strategies in the healthcare field usually involves increased centralization facilitated by information sharing using current communication technologies. Costs are reduced through order consolidation. In their view, this makes horizontal cooperation between healthcare institutions to reduce cost and pool supply chain knowledge a reasonable approach. Rego, Claro, and de Sousa go on to cite sources regarding the advantages of cooperative purchasing at the supply chain level, which include more favorable terms with suppliers, reduced purchasing efforts, development of purchasing expertise, better informed selection and standardization, and improved ability to respond to emergency situations. The one disadvantage noted at the supply chain level was coordination costs when the size of the cooperative increases.
Healthcare institutions as well as state and local governments found themselves in fierce competition for limited resources when the pandemic hit. Healthcare institutions had been placing themselves in a precarious situation for years by relying on “just in time” purchasing and a thinly stretched, international supply chain to meet their needs. Rather than trying to address the situation to allow for more effective and equitable distribution, the federal government sought to outbid those entities to which they should have been offering aid. Some suppliers opted to provide PPE to the highest bidder rather than honoring contracts, leaving institutions at the mercy of unscrupulous profiteers who provided substandard material at hugely inflated prices. Hospital systems, public health organizations, and governments at all levels, as well as suppliers of PPE, must recognize that it is in the interest of everyone that a stable and resilient procurement system is in place to prevent the disruption seen during COVID-19 in the future.
During the pandemic, some state governors formed procurement coalitions to leverage the combined purchasing power of their states to obtain better pricing for equipment as well as better performance in the provision of goods. States also shared unneeded resources with states more heavily impacted by COVID-19. As chair of the National Governors Association, Governor Andrew Cuomo of New York is in a position to advance the idea of creating a national procurement coalition. Such proposals speak to the need to extensively review and revise the legal framework and resourcing of healthcare procurement agencies that hindered the COVID-19 response. It should be emphasized that CoSI is not proposing a “one-size-fits-all” approach to procurement, but rather a model for a master agreement that different regions, states, and localities can modify to meet their particular needs.
Nevertheless, a true cooperative procurement agreement will require considerable work on the part of the lead procurement agency in regard to procurement planning, proposal evaluation, and contract administration. While group purchasing will be used, each individual healthcare provider must be held responsible for upholding their part of the agreement. As previously noted, innovative scientific research, as well as collaboration and coordination, will be just as vital in regard to improving procurement as it has been in developing, distributing, and dispensing a vaccine.
For one, procurement agencies can employ surveillance techniques and use data collected by a variety of stakeholders to identify signals or trends indicating that a greater supply of PPE will be needed. Additionally, program evaluation techniques can be employed to evaluate supplier performance in a range of circumstances, as well as the degree to which the procurement system works after an emergency event. Healthcare institutions must collaborate to determine the metrics by which suppliers’ performance will be evaluated, as well as coordinate to effectively administer contracts and make sure that individual institutions are meeting their commitments.
One of the many important lessons from the COVID-19 pandemic is that the American healthcare system cannot afford to rely on procurement systems that function well during routine operations, but are not designed to facilitate adequate supplies at a reasonable cost during a public health emergency. That is why the Continuity of Supply Initiative is working to design and promote procurement master agreements that will facilitate true cooperative procurement in which suppliers and purchasers will honor the terms of the agreement in routine and emergency situations, while the market leverage created by institutions banding together will allow supplies to be purchased at the best price. In order for the system to be sustainable, (1) both suppliers and healthcare providers will need to maintain consistent vigilance for emergencies, (2) supplier performance needs to be evaluated using evidence-based techniques and consistent metrics, and (3) healthcare institutions must regularly coordinate on the administration of the contract.
It is important to honor the memories of the healthcare providers lost during the COVID-19 pandemic. Part of that will be reforming the healthcare system in the US to make sure that supplies of PPE will be adequate when the next emergency occurs. The Continuity of Supply Initiative will continue to promote the concept of true cooperative procurement as an efficient, effective, and resilient way to achieve that goal.
Felicitations to President Joe Biden and Vice President Kamala Harris! This week marked the inauguration of our 46th president, but also the one-year anniversary of the first SARS-CoV-2 diagnosis in the US. Biden has grand plans to kick off his tenure, not the least of which is an ambitious plan to vaccinate 100 million Americans in 100 days.
Procuring PPE through Innovation, Evaluation, and Coordination: A Strategy for True Cooperative Procurement
Dr. Nathan Myers, an associate professor of political science and public administration at Indiana State University and an advisor to Continuity of Supply Initiative (CoSI), discusses the need for a more efficient, effective, and resilient system for the continued procurement of personal protective equipment (PPE) during a major emergency. Myers proposes the creation of a framework for a master agreement between suppliers and healthcare providers in which PPE would remain available at reasonable prices during normal circumstances and across a range of emergency situations. Read Myers’ article here.
COVID-19 Update
As of 22 January 2021, one year after the first case of SARS-CoV-2 infection was detected in the US, our country has had 24.7 million total cases and 410,000 deaths. Globally, there have been 96.2 million total cases and 2.06 million deaths. The Food and Drug Administration (FDA) has granted emergency use authorization to two mRNA vaccines, and 17,546,374 doses have been administered as of 21 January.
The B1117 variant of SARS-CoV-2, shown to be highly transmissible, has now been detected in 12 states. This variant is believed to have emerged in September in the UK and is now the dominant strain circulating there. Several lines of evidence indicate that B117 transmits more efficiently than other variants of the novel coronavirus. New variants identified in the United Kingdom, South Africa and Brazil that appear to be more transmissible than previous strains are not proving to be more lethal. The modeled trajectory of B1117 in the US finds rapid growth in the early months of 2021, with the strain becoming the predominant variant in March. According to Dr. Anthony Fauci, though the COVID-19 vaccines may not be as effective against new, more contagious strains of the coronavirus, getting vaccinated remains critically important.
That said, a coronavirus virus variant found in South Africa in late 2020, called 501Y.V2, has sparked some concern regarding immunity and vaccine efficacy. The 501Y.V2 lineage carries many mutations in the SARS-CoV-2 spike protein, which is the immune system’s prime target, including some changes linked to weakened antibody activity against the virus. According to Tulio de Oliveira, a bioinformatician at the University of KwaZulu-Natal in South Africa, there is now proof of several reinfections with 501Y.V2 in the country. Two South African teams will soon test the 501Y.V2 variant with serum from people who participated in COVID-19 vaccine trials, but similar studies are ongoing at laboratories worldwide.
The Independent Panel’s Second Report on Progress
The Independent Panel for Pandemic Preparedness and Response released its second report on progress, which was informed by the review of hundreds of documents, expert consultations across many sectors, case studies, submissions received by the Panel from Member States, academia, civil society, and citizens, and nearly 100 interviews with those at the frontlines of pandemic preparedness and response. The Independent Panel was established by the World Health Organization and is tasked with “charting what went wrong, what lessons can be learnt from that, and what could be done better in future.” Ultimately, the report emphasizes an unequivocal message: course correction in pandemic response is needed immediately. The Independent Panel strongly recommends that all countries immediately and consistently adopt the public health measures which will reduce the spread and the impact of COVID-19: mask-wearing, social distancing, and contact tracing and isolation. There were critical early failures in the global and national responses to the pandemic, and there were pre-existing failures to prepare adequately for a pandemic threat, despite years of warnings and red flags. Further, the pandemic has revealed the inequalities both within and between nations, and the response has deepened these inequalities. Despite these many issues, this crisis has created a unique opportunity to “reset the system” to correct structural inequalities in health.
The Biden-Harris Administration Pandemic Response & Vaccinations Plans
Newly inaugurated President Joe Biden and Vice President Kamala Harris released a National Strategy for COVID-19 Response and Pandemic Preparedness, which outlines seven goals: (1) restore trust with the American people; (2) mount a safe, effective, and comprehensive vaccination campaign; (3) mitigate spread through expanding masking, testing, treatment, data, workforce, and clear public health standards; (4) immediately expand emergency relief and exercise the Defense Production Act; (5) safely reopen schools, businesses, and travel, while protecting workers; (6) protect those most at risk and advance equity, including across racial, ethnic and rural/urban lines; and (7) restore US leadership globally and build better preparedness for future threats.
Biden’s COVID-19 response team consists of several notable experts. Dr. Beth Cameron, NTI’s vice president for global biological policy and programs, is leading the White House biodefense council. Dr. Rochelle Walensky is the director of the Centers for Disease Control and Prevention (CDC); she will “have her hands full rehabilitating morale and the CDC’s public image.” Economist Jeffrey Zients is the COVID-19 response coordinator. Xavier Becerra is nominated as the Secretary of Health and Human Services. David Kessler, former Commissioner of the Food and Drug Administration (FDA), will lead the new iteration of Operation Warp Speed (OWS). Dr. Anthony Fauci, a familiar and trusted public health figure, will be Biden’s chief medical adviser.
The Biden administration was also left with quite a mess created by the Trump administration’s false claim that a stockpile of millions of COVID-19 vaccine doses would be made available for immediate distribution. Unfortunately, no such stockpile exists. Biden’s $1.9 trillion stimulus plan includes an emergency vaccination and relief package that aims to administer 100 million shots during his first 100 days in office. The plan identifies priority groups, starting with adults ages 65 and older and essential frontline workers, including teachers and grocery store clerks. The Federal Emergency Management Agency (FEMA) will establish 100 federally-supported vaccination centers across the country. Of these funds, $400 billion are earmarked for combating the pandemic, including $50 billion to escalate COVID-19 testing, $20 billion to boost vaccination efforts, and funds to hire 100,000 public health workers.
Retraction of US Withdrawal from WHO
Biden, on his first day as president, wrote a letter to António Guterres, secretary-general of the United Nations, that retracts the US intention to withdraw from the World Health Organization. The US withdrawal was initiated on 6 July 2020 and would have been effective on 6 July 2021. Biden acknowledged that the “plays a crucial role in the world’s fight against the deadly COVID-19 pandemic as well as countless other threats to global health and health security.” The letter makes clear that the US will “continue to be a full participant and a global leader in confronting such threats and advancing global health and health security.”
A Threat to Confront: Far-Right Extremists and Nuclear Terrorism
A new article, co-written by Biodefense MS alumnus Rebecca Earnhardt, highlights the threats from far-right extremists and nuclear terrorism. Acts of violence by far-right extremists are on the rise in the United States, and national security experts are considering whether US far-right extremist groups that espouse violence can carry out something catastrophic. Adding fuel to this fire, recent events raise questions regarding if greater focus should be given in the United States on far-right, domestic extremist threats. These extremists create a unique danger as a result of their prevalence in federal institutions – the military – and the possibility that they might infiltrate nuclear facilities to access sensitive information and nuclear materials. The nexus of violent far-right extremist ideology and terrorism is not new; however, the adoption of accelerationism to this dangerous ideology is spurring the desire to destabilize society. The authors encourage a “robust response to violent far-right extremist threats vis-a-vis nuclear security is necessary to minimize risk.” Read the full article here.
Cyberattack on European Medicines Agency
The European Medicines Agency (EMA), an agency of the European Union that evaluates and supervises medicinal products, experienced a cyberattack targeting documents related to COVID-19 medicines and vaccines. EMA revealed that some of these unlawfully acquired documents have been leaked on the internet. The leaked materials include internal/confidential email correspondence dating from November, which relate to evaluation processes for COVID-19 vaccines. EMA also announced that some of the correspondence were “manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.” Near the turn of the year, two EU marketing authorizations for COVID-19 vaccines were granted, pending an independent scientific assessment. Given the high SARS-CoV-2 infection rate in the EU, vaccines are urgently needed to protect citizens from the virus. Criminal efforts to undermine trust in vaccines could leave much of the country susceptible.
The World Health Organization (WHO) Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety. The LBM4 suite consists of one core document and seven subject-specific monographs which were developed in order to accommodate diverse interests and requests for learning more specific details, supplementing the core document. Readers are encouraged to start with the core document and learn the subject explained in each monograph accordingly. Download the LBM4 here.
Event – The Chemical and Biological Non-Proliferation Regime after COVID-19
The COVID-19 global pandemic and recent cases of chemical weapon use – in Syria and against the Skripals and Alexey Navalny – have demonstrated the multifaceted nature of biological and chemical threats that States face in the twenty-first century. These threats have also underscored the importance of strengthening the international norms against the hostile misuse of chemical and biological sciences enshrined in the 1975 Biological and Toxin Weapons Convention (BTWC) and the 1997 Chemical Weapons Convention (CWC). But the centerpiece of international efforts to prevent the misuse of modern chemistry and biology – The Chemical Weapons Convention and the Biological and Toxin Weapons Convention – rarely come to the attention of Parliament and public. A recent report from the Parliament Joint Committee on National Security Strategy stated that “future biological risks to the UK will evolve rapidly, originating within or beyond its borders.” These risks include serious disease outbreaks but also the “slow burn” threat of antimicrobial resistance as well as misuse of harmful biological substances.
This webinar will discuss the difficulties of integrating the various means of governance related to biosecurity and national security. The event will also review the state of the BTWC and CWC and identify practical opportunities to strengthen these critical Conventions and guarantee their relevance against the backdrop of rapid scientific and technological advancement and growing international instability. Register here.
Event – Emerging SARS-CoV-2 Variants: What You Need to Know
B.1.351 in South Africa. B.1.1.7 in the United Kingdom. These emerging coronavirus variants, some billed as more contagious forms of SARS-CoV-2, have dominated reports as they popped up across the globe within the last couple months. Genetic mutation is anticipated, especially for RNA viruses as they multiply, but at what point should clinicians and the scientific community become concerned? With a novel pathogen like SARS-CoV-2, there are still many unknowns. How did these variants emerge? Are they indeed more transmissible? Do they cause more serious disease? What does the scientific evidence support? What should the public response be? Will the developed vaccines provide coverage against these variants? Join MJH Life Sciences for a COVID-19 Coalition webinar event, “Emerging SARS-CoV-2 Variants: What You Need to Know,” for an enlightened conversation with a panel of frontline experts, including a virologist, an epidemiologist, and an immunologist, hosted by Dr. Carlos del Rio. Register here.
We are days away from a transition of power, welcoming the Biden-Harris administration. A large study in the UK found that those who have had COVID-19 may be immune to reinfection for several months. The Sentinel from the Combating Terrorism Center at West Point features commentary on the terrorism and counterterrorism challenges that the new administration will face.
Limitations of Quarantine
HyunJung Kim, a Biodefense PhD candidate, recently published an article in Monthly Chosun, an influential news media outlet in South Korea, explaining the different origins of emergency use authorization (EUA) policies between the US and South Korea. After the 2001 Amerithrax attacks, the US developed its EUA policy with a focus on homeland security, enabling the use of MCMs, while Korea’s EUA policy was developed with a focus on disease containment, only issuing approvals for diagnostic kits. The public health authority of South Korea has hesitated to use COVID-19 vaccines, comparing them to the efficacy and comprehensive use of diagnostic kits in the early days of COVID-19. Political leaders have praised themselves and emphasized their achievements, but they have neglected what the next steps should be. Kim recommends revising the EUA laws in Korea to allow for emergency use of vaccines and therapeutic drugs.
Memo to the President: Reimagining Public Health Preparedness and Response
Dr. Daniel Gerstein, alumnus of the Biodefense PhD Program and senior policy researcher at the RAND corporation, highlights the unevenness of the US response to the pandemic that has challenged the United States politically, economically, and societally as never before in our nation’s history. In fact, the pandemic and the faltering response is upending 200 years of emergency management doctrine. Adding insult to injury, many Americans are losing trust and confidence in their government. Gerstein points out that as we near a transition of power in the US, the death toll for the first year of the pandemic is approaching the number of all Americans killed in World War II. He believes that a reimagining of US public health preparedness and response is needed to heal the national psyche and restore American confidence in itself and around the world.
Ambassador Bonnie Jenkins and Women of Color Advancing Peace and Security Voted 2020 Arms Control Persons of the Year
Ambassador Bonnie Jenkins, the Founder and Executive Director of Women of Color Advancing Peace and Security (WCAPS), and WCAPS itself have been voted the 2020 Arms Control Persons of the Year! Ambassador Jenkins and WCAPS were nominated for catalyzing support and action from leaders and practitioners in the national security and foreign policy communities to increase diversity into their ranks and boards of directors and pursue concrete steps to “root out institutional racism” in the governmental and non-governmental sectors in the field. WCAPS is a platform devoted to women of color that cultivates a strong voice and network for its members while encouraging dialogue and strategies for engaging in policy discussions on an international scale. Their vision is to advance the leadership and professional development of women of color in the fields of international peace, security, and conflict transformation. After the protests in 2020 against the police killings of George Floyd and other Black people, WCAPS organized a solidarity statement endorsed by leaders and individuals from 150 organizations and launched working groups to develop concrete strategies and tools to attack the problem.
COVID-19 Update
The B117 variant of SARS-CoV-2 is a new enemy that we are better equipped to fight than we were when the novel coronavirus first hit the world. We understand how this virus spreads, the health strategies that can help contain it, and how to effectively treat those infected with it. The “old” virus is helping us battle the new one, because people who have already had COVID-19 are highly resistant to B117. We must keep in mind that the new variant has two key advantages: pandemic fatigue throughout the population and the variant’s faster spread.
A large study in the United Kingdom of 20,000 healthcare workers suggests that most people are immune for several months after infection with SARS-CoV-2 for the first time. In fact, this research – called SARS-CoV-2 Immunity and Reinfection Evaluation (SIREN) – found that immune responses from past infection reduce the risk of catching the virus again by 83% for at least 5 months. Throughout COVID-19, reports of reinfections of with SARS-CoV-2 have been rare, but the cause of much concern. In the study, less than 1% of the approximately 6,600 participants who had already had COVID-19 suffered a repeat infection. According to SIREN lead investigator Susan Hopkins, the study data suggest that natural immunity might be as effective as vaccination, at least over the five-month period the study has covered so far.
The World Health Organization (WHO) sent a team of international experts to China to investigate the origins of the COVID-19 pandemic. The team was initially denied entry, but will be allowed into the country this week. WHO chief Tedros Adhanom Ghebreyesus stated that studies would begin in the city of Wuhan where the first human cases of SARS-CoV-2 were identified.
To be better prepared for future biological threats, the WHO released guidance for laboratories on maximizing the impact of SARS-CoV-2 sequencing now and other emerging pathogens in the future. Sequencing supports the monitoring of a disease’s spread and the evolution of a virus. Indeed, genomic sequencing of SARS-CoV-2 enabled the world to develop diagnostic tests and other tools for outbreak management.
How COVID Unlocked the Power of RNA Vaccines
In 2013, Andy Geall’s team at Novartis’s US research hub in Cambridge, Massachusetts was asked if their new vaccine technology could be used against a novel strain of avian influenza. Within a couple weeks, the team had synthesized the RNA, assembled the vaccine, and tested the vaccine in cells and mice. At the time, however, the ability to manufacture clinical-grade RNA was limited and Novartis sold its vaccine business a couple years later. Today, as we battle SARS-CoV-2, two RNA vaccines have won emergency approval from public health authorities in several countries, including the US. In short, the era of RNA vaccines is here and all of the major pharmaceutical companies are testing the technology. As a more streamlined technology, RNA vaccine development allows researchers to fast-track many stages of vaccine research and development. RNA vaccines carry the directions for producing the proteins of invaders, aiming to “slip into a person’s cells and get them to produce the antigens, essentially turning the body into its own inoculation factory.” Additionally, this technology is “build for speed.” Using the genetic sequence of a pathogen, scientists can swiftly extract a potential antigen-encoding segment, insert that sequence into a DNA template, and synthesize the corresponding RNA before packaging the vaccine for delivery into the body. This technology may finally enable the creation of a universal flu vaccine, one of the holy grails of vaccine development. Despite its many advantages, there are some kinks to unravel. The need for cold storage of these vaccines can be a major hurdle for distribution. Also, a double dose tends to be needed for efficacy against a disease, a requirement that could lower immunization uptake and adherence. Finally, there is the concern of side effects, namely severe reactions characterized by fatigue or muscle pain. Though these effects are temporary, they may disincentive vaccination.
Biden’s Foci
Biden and his team plan to restructure and expand the operations of the White House National Security Council (NSC) with new senior positions on global health, democracy and human rights, and cyber and emerging technology. This planned expansion signals a significant shift in priorities. Additionally, a “stronger position on China than has been the case in past Democratic administrations” is expected. Also, Russia will again have its own NSC senior director. So far, most of Biden’s top national security picks are veterans of the Obama administration. These include Jake Sullivan as national security adviser, Antony Blinken as secretary of state, and Yohannes Abraham as NSC chief of staff. Dr. Elizabeth Cameron, a biologist and biodefense expert, wrote the Obama “pandemic playbook” as NSC director for global health security and she will return as the senior director for global health security and biodefense.
The incoming Biden administration announced its COVID-19 plan. The Biden-Harris administration is committed to: (1) listening to science; (2) ensuring that public health decisions are informed by public health professionals; and (3) promoting trust, transparency, common purpose, and accountability in our government. The plan consists of seven key points: (1) ensure all Americans have access to regular, reliable, and free testing; (2) fix personal protective equipment (PPE) problems for good; (3) provide clear, consistent, evidence-based guidance for how communities should navigate the pandemic and the to make it through; (4) effective, equitable distribution of treatments and vaccines; (5) protect older Americans and others at high risk; (6) rebuild and expand defenses to predict, prevent, and mitigate pandemic threats, including those coming from China; and (7) implement mask mandates nationwide.
National Security Challenges in 2021
Bruce Hoffman and Jacob Ware discuss the challenges that the Biden administration will face in regard to terrorism and counterterrorism. The administration will be forced to grapple with old threats, including the Islamic State and al-Qa`ida, but also the ever-changing and deteriorating domestic terrorism landscape. Hoffman and Ware assert that the battle for the safety of the American homeland remains fraught with challenges and risks that will require enduring vigilance and energy, as well as a new set of counterterrorism policies, to more effectively address the totality of the new terrorism threat. Read the full analysis here.
David Lasseter, Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, supports the Under Secretary of Defense for Policy and Assistant Secretary of Defense for Homeland Defense & Global Security by developing and overseeing the implementation of strategies and policies of all Countering Weapons of Mass Destruction policy issues. These policy issues include preventing the proliferation of WMD-related materials; the DoD Cooperative Threat Reduction (CTR) Program; and Chemical, Biological, Radiological and Nuclear (CBRN) defense; and overseas Oceans Policy for the Department, which includes advancing global mobility through freedom of navigation policy. In a recent interview with the Combating Terrorism Center at West Point, Lasseter addresses the security implications of the COVID-19 pandemic, the biological threat landscape, the changes in perspective about the likelihood or impact of bio-threats, emerging biotechnologies, and the types of terrorist threat actors or groups are the most cause for concern when it comes to weaponizing biology. He mentions several threats across the chemical, biological, radiological, and nuclear (CBRN) threat spectrum. For instance, the lack of transparency on nuclear modernization in China is a concern. Russia continues to violate international arms control treaties and repeatedly use banned weapons, like Novichoks. North Korea comes with a mountain of baggage: WMD development, proliferation, and use; nuclear, chemical, biological capabilities and delivery systems; a history of proliferation and aggressive rhetoric against the United States. Beyond specific country concerns, the threat of dual-use technology and science is always a worry.
Upcoming Event – Combating Wildlife Crime and Reducing the Transmission of Zoonotic Diseases
The Stimson Center is hosting a discussion, “Combating Wildlife Crime and Reducing the Transmission of Zoonotic Diseases,” that will include representatives from Congress, the US Government, Ambassadors, and scientific experts on combating wildlife crime. Wildlife crime is transnational, organized, and often fueled by corruption. It devastates the security of communities, while destroying ecosystems and wildlife. In addition, evidence that COVID-19 jumped from a zoonotic-host has led to renewed calls to further regulate the wildlife trade. In response, the Global Initiative to End Wildlife Crime is encouraging States to amend international law by adding a fourth Protocol on wildlife crime to the UN Convention Against Transnational Organised Crime; and incorporating public and animal health criteria into the Convention on International Trade in Endangered Species. The discussion is scheduled for 25 January at 10 am EST. Register here.
The US Environmental Protection Agency’s (EPA) Office of Research and Development hosts a free Homeland Security Research Webinar Series. The next webinar is “COVID-19: UV-C Devices and Methods for Surface Disinfection.” EPA researchers are evaluating ways to disinfect large spaces (schools, businesses, mass transit), including the use of alternative methods to kill viruses, such as ultraviolet light (UV-C), that claim to reduce or eliminate virus transmission via surfaces. Because these disinfection devices can be considered pesticide devices, they are regulated by the EPA. Researchers are assessing UV-C methods and technologies on multiple materials against SARS-CoV-2 and potential surrogate viruses. This webinar will be held on 21 January from 2-3 EST. Register here.
Happy New Year! 2020 was a tumultuous year and 2021 is off to a rocky start; however, the COVID-19 vaccines give us hope for a healthier and safer year. January is One Health Awareness Month! For Biodefense graduate students looking for a fascinating course to round out your spring semester, Dr. Robert House is offering a course on the development of vaccines and therapeutics.
2020 Recap
SARS-CoV-2, the causative agent of COVID-19 that emerged in China, took over the world in 2020. The United States suffered 21,299,340 total cases and 361,123 total deaths from COVID-19. The world suffered 87,186,540 total cases and 1,883,761 total deaths. The first case in the US was identified on 20 January 2020, the same day the Chinese posted the genetic sequence of SARS-CoV-2. The start of 2020 also saw the impeachment trial of President Donald Trump.
February was the month of the COVID-19 testing fiasco in which test kit availability was severely limited and some available kits were found to be contaminated. Also, in February, phase one of the Economic and Trade Agreement Between the United States of America and the People’s Republic of China went into effect. This agreement commits China to undertake structural changes to open up its economy and improve its trade regime, benefitting the United States in the process by increasing China’s importation of US goods.
On 10 March, Italy entered lockdown and on 11 March, the World Health Organization (WHO) finally declared the COVID-19 pandemic. By mid-March, areas of the US began lockdown and Americans were urged to stay at home as much as possible.
Studies showed that mask-wearing substantially reduced transmission, and on 3 April, the Centers for Disease Control and Prevention (CDC) announced that masks were vital weapons against SARS-CoV-2. This declaration was met with confusion given the previous opposing statements by various US leaders that masks were ineffective.
Amidst the pandemic, in May, George Floyd was killed in Minneapolis, Minnesota by a white police officer, sparking nationwide protests supporting the Black Lives Matter movement. Additionally, this tragic event spurred important discussions about racial health disparities in the US, an issue seen in the COVID-19 data. For every 10,000 Americans, there were 38 coronavirus cases: 23 for whites, 62 for Blacks, and 73 for Hispanics.
When fall arrived, the big debate about sending children back to school in-person arose, with many districts opting to remain virtual. Sadly, on 18 September, Supreme Court Justice Ruth Bader Ginsburg passed away at the age of 87. A mere eight days later, Amy Coney Barrett was nominated as Ginsburg’s successor.
The presidential election held last November resulted in a new incoming president and vice president: Joe Biden and Kamala Harris. They will be sworn into office on 20 January 2021. By the tail end of 2020, two newly developed COVID-19 vaccines were granted emergency use authorization by the Food and Drug Administration (FDA) and the first shot was administered on 14 December.
Now, let us all bid adieu to 2020! Although 2021 is off to a rough start, the imminent change in US leadership and the continued administration of COVID-19 vaccines may, finally, turn our luck around.
Looking Ahead in 2021
After nearly a year into the COVID-19 pandemic, vaccinations are underway, diagnostic testing has increased, and some therapeutic treatments are showing promise, giving experts a clearer picture of what the future holds. In a prediction that we all hope comes to fruition, Dr. Anthony Fauci stated that by the end of 2021, the US could “approach some level of normality.” Unsurprisingly, this forecast depends on the vaccination of 75-85% of the population as well as the continuation of mask-wearing and social distancing. Experts expect that an “overwhelming majority of the population” will be able to get vaccinated by the second quarter of 2021. Hopefully, in summer 2021, we will be able to have large outdoor gatherings without masks. In the latter half of the year, workers may be able to return to their offices. Sometime in mid- or late-2021, we may be able to enjoy indoor dining and a movie without a mask. Safe travel may resume, but gradually.
On 20 January, of course, president-elect Joe Biden will assume office; however, the events on 6 January at the Capitol Building have added concern to an amicable transition-of-power. Last Wednesday, a throng of Trump supporters stormed the Capitol Building in DC in a raucous attempt to prevent Congress from certifying Biden as the election winner. On Thursday, Congress certified president-elect Joe Biden and vice president-elect Kamala Harris’ victory. On 23 July, the Olympics are scheduled to begin in Japan, over a year after the original start date. What will it look like – a bubble with virtual streaming?
A Farewell to Arms Control
Dr. John R Walker, former Head of the Arms Control and Disarmament Research Unit in the Foreign and Commonwealth Office, shares his insights from a 40-year career in arms control. Science and technology (S&T) will always offer risks and benefits to society. Walker states that we cannot ban technologies or lines of scientific inquiry, though many are inarguably dual-use, because such restrictions could inhibit advances in medicine, neuroscience, plant health, and several other disciplines. Instead, he encourages understanding the possible implications of S&T to ensure their safe and acceptable applications. Patience and persistence of purpose are the keys to establishing arms control and disarmament agreements. In recent years, multilateral negotiations have grown more “ill-tempered and polarized,” requiring “inexhaustible supplies of patience and persistence in the face of multiple challenges and frustrations.” Understanding the long and complex history of arms control treaties can lead to better decisions. According to Walker, we are in a never-ending process when it comes to arms control and disarmament: “Events are but one chapter, one closes and we move on to the next one.” Finally, diplomacy matters, as do the personalities at the negotiation table.
Spring Course with Dr. Robert House: Development of Vaccines and Therapeutics
As the world waits anxiously for a COVID-19 vaccine and various therapies against this virus move through the drug development pipeline, BIOD students have an opportunity to learn from a world-class expert with decades of experience developing MCMs against a range of biological threats. Dr. Robert House holds a PhD in medical parasitology and is Senior Vice President of Government Contracts at Ology Bioservices. Ology Bioservices was recently awarded $37 million from the Department of Defense to support the advanced development of a monoclonal antibody cocktail against COVID-19. The Department of Defense has also awarded Ology Bioservices with a contract valued at $11.9 million to work with Inovio on DNA technology transfer to rapidly manufacture DNA vaccines. Previously, Dr. House worked for over a decade at DynPort Vaccine Company, where he held the positions of Vice President of Science and Technology, Chief Scientific Officer, and President. During this time, he earned extensive experience in winning and managing large USG-funded programs for developing medical countermeasures. This Spring, Dr. House will be teaching the Development of Vaccines and Therapeutics course (BIOD 766), which will explore how the US Government is developing MCM against these threats. Students will learn about the various threat agents, the context of regulatory considerations, and the specifics of how MCMs are developed.
Taking Back Control: A Resetting of America’s Response to COVID-19
The Rockefeller Foundation released a report outlining a plan to reset the US response to the COVID-19 pandemic. The report considers schools to be a critical component, because prolonged closures can negatively impact the success of students throughout their careers and functioning schools are central economic players. To safely teach our youth in schools, an estimated $42.5 billion in federal funding is needed for testing in schools, students should be tested at least weekly, and teachers and staff should be tested at least twice weekly. The plan recommends that the first wave of reopening schools should prioritize all of the nation’s 56,000 public elementary schools by 1 February, requiring about 85 million tests per month. Several weeks later, the 18,000 middle schools could reopen with 70 million tests per month. By 1 March, the nation’s 25,000 high schools could reopen. The report lists several executive actions for achieving its outlined goals, ranging from an executive order that clarifies liability protections for those who make good faith efforts to provide reliable testing to investments in the expansion of PCR laboratory throughput to prioritizing teachers for vaccines. Read the full report here.
A ‘Come as You Are’ Vaccination Plan
Dr. Daniel Gerstein, alumnus of the Biodefense PhD Program and senior policy researcher at the RAND corporation, describes the poorly coordinated and slow-moving distribution of COVID-19 vaccines as another part of the “come as you are” pandemic response of the US. By 29 December, 2.13 million doses of the Pfizer-BioNTech vaccine were administered, which is a mere fraction of the year-end goal. The sluggish rollout of vaccines could undermine the advantages of their exceptionally speedy development. Operation Warp Speed (OWS) is a partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DoD) established to accelerate the development of vaccines and therapeutics for COVID-19. Once vaccines were manufactured and moved to distribution points, state, local, territorial, and tribal authorities assumed responsibility for further distribution and administering the vaccine through public and private industry vendors. The lack of a centralized federal system to provide real-time vaccine availability information is causing severe delays and disruptions in distribution beyond first priority health workers. Several governors have already shared their worries about delays, shorting of deliveries, and a lack of accurate information on the status of anticipated deliveries. Additionally, there has been a communication failure regarding when and how Americans will get vaccinated.
New Websites for the BWC & UNODA
The Biological Weapons Convention (BWC) has a new website! The BWC is a multilateral disarmament treaty that effectively prohibits the development, production, acquisition, transfer, stockpiling and use of biological and toxin weapons. Read the latest related to the BWC at its new website, www.un.org/disarmament/biological-weapons. Information – official documents, statements, presentations – pertaining to all official meetings and conferences of the United Nations Office for Disarmament Affairs (UNODA) can be found at: https://meetings.unoda.org/.
One Health Awareness Month 2021
January 2021 is One Health Awareness Month! US Senate Resolution 462 declared January 2020 as the first US One Health Awareness Month, which occurred just before the COVID-19 pandemic. In support, the One Health Commission and Louisiana One Health in Action created the One Health Awareness Month 2020 Social Media Campaign to urge collaborations between animal, environmental, plant, human, and public health scientists. For instance, today’s (8 January) topic is antimicrobial resistance (AMR) and One Health. To help spread the word, you can use the hashtags #OneHealth and #OneHealthAwarenessMonth!
SARS-CoV-2 Variant B117
A new variant strain of SARS-CoV-2 – dubbed SARS-CoV-2 VOC 202012/01, or B117 – contains a series of mutations that became highly prevalent in London and southeast England in December 2020. Earlier this week, the United Kingdom issued another lockdown to quell a third surge in cases, driven in part by the spread of B117. The variant has now been detected in 40 countries, including the United States. The first identified case of the B1117 variant in the US occurred in Colorado on 28 December. As of 7 January 2021, there have been 52 B117 lineage cases in the US across California, Colorado, New York, Georgia, and Florida. According to the Centers for Disease Control and Prevention (CDC), there is no evidence that this new variant causes more severe illness or increased risk of death; however, it does spread easier and quicker than other strains. Dr. Anthony Fauci stated that the mutations of this variant allow the virus to better bind to the receptors of cells, aiding its transmission. At present, researchers think that the existing COVID-19 vaccines will likely protect against B117, but more data are needed to confirm.
COVID-19 Open Data
On 18 December, the US Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) started publishing the COVID-19 Community Profile Report publicly on their websites, which provides the American people with the same community level information that is available to federal personnel. The Community Profile Report (CPR) is generated by the Data Strategy and Execution Workgroup in the Joint Coordination Cell of the White House COVID-19 Task Force, and it provides aggregate information on the overall status of areas across the country. The CPR is managed by an interagency team with representatives from multiple agencies and offices within HHS (including CDC, the Assistant Secretary for Preparedness and Response, and the Indian Health Service). Access the CPR here.
Genetic Data and Marketing: Challenges, Opportunities, and Ethics
A new study in the Journal of Marketing is the first to systematically assess the implications of individual-level genetic data owned by private firms and government in the field of marketing. The direct-to-consumer genetic testing (DTC-GT) industry has exploded over the last 20 years with over 30 million customers already. Concurrently, many countries have launched large-scale, publicly-funded genetic data collection efforts, creating vast datasets that are increasingly used by companies such as AirBnB and Spotify for marketing purposes. This study reviews current research in behavioral and social genetics to develop a framework that features the genome as a source of consumers’ profiles and actions. The researchers then survey the range of potential uses of genetic data for marketing strategies and research, noting serious ethical challenges. Such applications include the use of “genetic measures as bases for segmentation and targeting” as well as the use of genetic data for “creative strategies that leverage consumers’ fascination for their genomes.” The authors outline four unique features of genetic data that create ethical challenges: (1) individuals can easily be identified by a small fraction of their genetic data; (2) these data are informative about one’s relatives; (3) these data are predictive, to some degree, of almost every human trait; and (4) these data are immutable. These four features present a serious threat to consumer autonomy and privacy.
The Pandora Report 