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Naturally occurring threats such as influenza, Ebola, and Chikungunya are bypassing borders to emerge in nations oceans away, and exact a continued toll. The Pandemic and highly pathogenic influenzas challenge the globe every year and result in the loss of thousands of human and frequently millions of animal lives, respectively.
Globally prevalent diseases for which countermeasures have already been developed are mutating and defeating what little we have to treat them. Emerging diseases – such as Dengue fever and Chikungunya – are occurring with greater frequency, spreading throughout the United States, and lack treatments. Naturally occurring diseases can also devastate livestock, crops, and dairy or produce supplies, harming millions of people and producing a debilitating effect on the U.S. economy.
Earlier we had SARS, MERS, H1N1 and Zika. And now we are experiencing the COVID-19 pandemic and its variants leading to grim milestone of six million deaths. On December 31, 2019, the 2019-nCoV coronavirus was first reported from Wuhan, China. Media outlets have also linked the coronavirus outbreak to Biowarfare programs. Several media outlets have promoted claims that the reported epicenter of the outbreak in Wuhan, China was also the site of laboratories allegedly linked to a Chinese government biowarfare program.
According to consensus COVID-19 disease isn’t probably a biological weapon and probably wasn’t genetically engineered. The more probable cause is that it is “a laboratory-associated accident” because of poor laboratory biosafety standards. It has demonstrated that even a single viral strain caused by Bio accident can rapidly spread throughout a population and create havoc for years.
India struggled with a second wave, raising more fears about its overwhelmed health care system. In April 2021, Crowds formed outside hospitals in major cities which are filled to capacity. A number of people have died while waiting for oxygen. Families are waiting hours to perform funeral rites.
Synthetic biology has enhanced threat of Bioaccidents, Bioterrorism, Biowarfare
Synthetic biology It can be defined as engineering approach to biology. And it aims to re-design of natural biological systems for useful purposes as well as design and construction of new biological parts, devices, and systems.
Biotechnologies, including synthetic biology, are going to be foundational to the 21st century economy. Synthetic biology is already a multi-billion-dollar industry with broad range of applications in health and medical sector, energy, chemical, environmental, food and agriculture.
Synthetic Biology is also a dual use technology It can be used to benefit or harm people, animals, environments, or nations and has civilian as well as military applications. Synthetic biology can lead to three major types of global threats global pandemics, Biowarfare and Bioterrorism. Biological warfare is the use of biological weapons by Nation-states in warfare, which is prohibited by the Biological and Toxin Weapon Convention. Bioterrorism aims to cause disruption and panic within a population.
Synthetic biology can expand the bio accident scenarios. What if an algae engineered to produce gasoline escapes and it starts to reproduce in rivers, and oceans and become a self-generating oil slick.
Bioterrorism
Next, we consider Bioterrorism is defined as the deliberate release of viruses, bacteria, or other agents to cause illness or death in people, animals or plants. Synthetic biology by editing and modifying the genome of organisms can enable creation of new Bioweapons.
“This can be achieved in a number of ways, such as: via aerosol sprays; in explosive devices; via food or water; or absorbed or injected into skin. Bioterrorism covers a large spectrum of concerns, from catastrophic terrorism with mass casualties to microevents using low technology but producing civil unrest, disruption, disease, disabilities, and death.
We saw earlier that DNA printers can build artificial DNA from scratch with any DNA code you want. You don’t need to find DNA in nature anymore. Scientists would employ DNA or RNA genomic sequences for pathogenic viruses and bacteria that are increasingly freely available online to create bioweapons. The feasibility of assembling an entire, infectious viral genome from synthetic oligonucleotides has already been demonstrated for poliovirus and the Spanish influenza virus
It could allow the development of “a super pathogen” that might be used to alter or eradicate entire populations and even civilization. It could also be used to make radically new weapons, such as pathogens that could be selectively target certain populations or races
The post-9/11 intelligence threat assessments focused heavily on biological weapons in the hands of terrorist groups. Potential biological weapons include anthrax, which, the Centers for Disease Control and Prevention says, “makes a good weapon because it can be released quietly and without anyone knowing”; smallpox, frozen stocks of which are still maintained by the U.S. and Russia; tularemia, also known as rabbit fever, which attacks the skin, eyes, lymph nodes and lungs and was stockpiled by the U.S. military and the former Soviet Union after World War II; and botulism, which is caused by exposure to toxins made by C. botulinum — the most toxic substances known to humankind, which attack the body’s nerves and can lead to respiratory failure.
Thus far, bioweapon production has mostly been pursued by state-actors. However, As the knowledge, skills and tools to produce such pathogens are increasingly available, It is also expanding range of actors who could undertake such efforts and decreases the time required.
The Islamic State of Iraq and the Levant (also known as ISIL and Da’esh) is devastating the Middle East while espousing the value of biological weapons for their ability to cause massive loss of life. The resources necessary to produce biological weapons are more easily obtained by states and terrorists than in years past. Additionally, terrorist organizations, domestic militia groups, and lone wolves have expressed intent to use and shown some capacity to develop biological weapons.
Biological warfare
Biology is considered as future of warfare, and Some consider Biology as the new domain of warfare. We saw in recent Covid -19 the impact of pandemic on military. It degraded military capability The crew in nearly one third of US aircraft carrier fleet got affected. It also affected military preparedness, by restricting the movement of troops and cancellation of training exercises.
Synthetic biology and will enhance military capability by enabling both offensive and defensive applications. Offensive purposes include creating deadly biological weapons, which are hard to detect, trace and contain for which we have no known treatment. Sometimes known as “germ warfare,” biological weapons involve the use of toxins or infectious agents that are biological in origin. This can include bacteria, viruses, or fungi. These agents are used to incapacitate or kill humans, animals, or plants as part of a war effort.
Biological weapons can be difficult to control or predict in a battlefield situation, and there is a large risk that troops on both sides will be affected.
There are many challenges at present to terrorists carrying sophisticated large-scale bioterrorism attacks.. But what about the possibility of state backed terrorists to carry out large scale Bioterrorism attacks.
The Biological Weapons Convention (BWC), or Biological and Toxin Weapons Convention (BTWC), bans biological and toxin weapons by prohibiting their development, production, acquisition, transfer, stockpiling and use. However, the convention’s effectiveness has been limited as there no formal verification body monitoring compliance.
Some countries may continue to engage in dual-use or biological weapons-specific activities thus failing to comply with the BWC. They can access Caches of incompletely destroyed or buried biological weapons materials and then smuggle them to other countries for use in today’s wars and by today’s terrorists.
Advances like CRISPR/Cas9 genome-editing, nanotechnology and biomimetics, allow weaponization of novel, nonbiological threat agents, and they likely fall outside the scope of the BWC.
If biotechnology advances in artificial gene synthesis converge with emerging military technologies, states will face greater risk of accidental release or even deliberate misuse of pathogens as a method or means of warfare.
Biological threats are different from traditional weapons: Germ production is small-scale and far less expensive than creating nuclear arms. Deadly microbes can look like harmless components of vaccine and agricultural work. And living weapons are hard to detect, trace and contain. Biological weapons can be difficult to control or predict in a battlefield situation, since there is a substantial risk that troops on both sides will be affected.
“The Department of State (DOS) assesses that China, Iran, North Korea, Russia, and Syria continue to engage in dual-use or biological weapons-specific activities and are failing to comply with the BWC. Caches of incompletely destroyed or buried biological weapons materials from old state programs can now be accessed again by new state programs, and then smuggled to other regions for use in today’s wars and by today’s terrorists. ” Weapons that once consumed a great deal of time and resources to make now take far less, and it is reasonable to believe that what the United States could accomplish more than 40 years ago, others can accomplish now.
According to an analysis issued by the Middlebury Institute of International Studies at Monterey, North Korea is collaborating with foreign researchers to learn biotechnology skills and build machinery. As a result, the country’s capabilities are increasing rapidly. “North Korea is far more likely to use biological weapons than nuclear ones,” said Andrew C. Weber, a Pentagon official in charge of nuclear, chemical, and biological defense programs under President Obama. “The program is advanced, underestimated, and highly lethal.”
China, for example, invests heavily in biotechnology for commercial and medical gain. Yet, they may also be exploiting biotechnology for military application. Consider China’s interest in biotechnology for national defense. Qiao Liang and Wang Xiangsui, prominent Chinese military thinkers, contemplate biowarfare as a “new domain of warfare” and a legitimate method for conducting armed conflict “beyond the rules.”
Insufficient Biosecurity and Biosafety
Further, the proliferation of the technology in hands of nonstate actors and terrorists who may be alone or in collusion with state actors will change future wars by blurring the conventional lines of distinction drawn in international law between civilians and combatants. This will allow adversaries to target vital state interests without the possibility of being traced, actively monitored, or prevented by current legal and extra-legal systems in place.
There is a reason, therefore, to assume that bio- incidents from bio-warfare and bioterrorism will, continue to haunt countries in the future as biological weapons will be fully integrated into the “hybrid” warfare design and constitute, along with cyber and terrorism, and change the National threat paradigm in the new state-power competition.
The Bipartisan Commission on Biodefense, established in 2014 and co-chaired by former Sen. Joe Lieberman and former Homeland Security Secretary Tom Ridge, warned in 2018 that “the United States is underprepared for biological threats” from both terrorists and “nature itself,” via emerging and reemerging infectious diseases like Covid-19.
Accidents can also result in the release of harmful pathogens. Some laboratory leaders have paid insufficient attention to the details necessary to ensure laboratory biosafety and have inadvertently contributed to the biological threat. Poor biosafety resulted in the unintended release of anthrax from Russian laboratories in 1979, anthrax from a U.S. military laboratory at Dugway Proving Grounds in 2015, and Burkholderia pseudomallei from a Tulane University research center in 2014 Poor biosecurity also increases the biological threat. Even our highest level government laboratories have fallen short in this regard. For example, in 2001, anthrax was illicitly removed from the U.S. Army Medical Research Institute on Infectious Disease and used in the perpetration of the anthrax attacks that year.
The Blue Ribbon Study Panel on Biodefense was established in 2014 to assess gaps and provide recommendations to improve U.S. biodefense. This Panel (through public meetings, targeted interviews, and extensive research) examined the national state of defense against biological attacks and emerging and reemerging infectious diseases, of the order that could cause catastrophic loss of life, societal disruption, and loss of confidence in our government. The United States is underprepared for biological threats. The Nation lacks the leadership, coordination, collaboration, and innovation necessary to respond, according to panel’s finding.
Biodefense
Efficient Biodefense strategy therefore has to tackle all three threats Bio Warfare, Bioterrorism, and Bioaccidents. Preparedness appears to be the most potent defense against possible bioterrorist events. In the longer term, we need to be prepared to detect, diagnose, characterize epidemiologically, and respond appropriately to biological weapons use and the threat of new and reemerging infections.
During the recent decade, progress in the detection, protection, and decontamination of biological warfare agents has emerged since various and sophisticated detection and decontamination methods have been developed and implemented. Policymakers must also focus on vaccine production since vaccines are the best protection against infectious diseases.
There are more vaccine candidates simultaneously in the pipeline for COVID-19 than ever before for an infectious disease. All of them are trying to achieve the same thing – immunity to the virus, and some might also be able to stop transmission. They do so by stimulating an immune response to an antigen, a molecule found on the virus. In the case of COVID-19, the antigen is typically the characteristic spike protein found on the surface of the virus, which it normally uses to help it invade human cells. There are four categories of vaccines in clinical trials: WHOLE VIRUS, PROTEIN SUBUNIT, VIRAL VECTOR and NUCLEIC ACID (RNA AND DNA). Some of them try to smuggle the antigen into the body, others use the body’s own cells to make the viral antigen.
However Covid-19 crisis has demonstrated that Rapid and accurate technologies have to be developed and have to confirm the presence of these agents unambiguously in different ways. Identification of a biothreat agent in very low concentrations is essential. It also should have the possibility to be detected in various matrices. In addition, it should be portable, easy to use, and efficient to detect multiple threat agents.
There is an ongoing academic debate on use of vaccines in biological warfare. Uncertainty of the threats is the major challenging issue in vaccine development. Even though vaccines against smallpox, anthrax, and Ebola viruses seem to have priority, an extensive policy on vaccines covering both military personnel and civilians is needed.
Asha George, the executive director of the Bipartisan Commission on Biodefense, echoed those concerns. “What we’re seeing are all the places where we are vulnerable,” she said. “You can see people not really having thought about what impact a biological event would have on the nation in any number of different sectors.” With the 2009 H1N1 pandemic, she said, a national strategy for pandemic influenza was already in place, though Dr. Deborah Birx, the White House Coronavirus Task Force response coordinator, acknowledged in a news conference on Tuesday that “now we are seeing we have to revise” the flu pandemic preparedness plan.
The government has been criticized for taking too long to create and distribute tests to detect the virus. There are shortages of medical supplies and equipment such as protective masks and ventilators. Anticipating such shortages, the biodefense strategy calls for setting up excess manufacturing capacity to produce these necessities quickly in an emergency.
Biodefense strategy
The White House’s 2018 Biodefense Strategy in alignment with the 2018 National Defense Strategy identifies biological threats – whether naturally, occurring, accidental, or deliberate in origin – as among the most serious challenges facing the United States and the international community.
The document puts significant emphasis on enhancing the national bio-defense enterprise to protect the United States and its partners abroad from biological incidents. It sets out five goals and objectives for ameliorating the risks stemming from the evolving biological risk landscape. They are: (i) Enabling risk awareness to inform decision-making across the bio-defense enterprise; (ii) Ensuring bio-defense capabilities to prevent bio-incidents; (iii) Ensuring bio-defense enterprise preparedness to reduce the impacts of bio-incidents; (iv) Rapidly responding to limit the impacts of bio-incidents; (v) Facilitating recovery to restore the community, the economy, and the environment after a bio-incident.
The United States Government Accountability Office’s “National Biodefense Strategy” report underscored, however, several lapses in the 2018 Biodefense Strategy Report, such as lack of “clearly documented methods, guidance, processes, and roles and responsibilities for enterprise-wide decision-making”[x] complicating coordination of response mechanisms to bio-incidents thus putting the initiative in danger of failing to meet its long-term bio-defense objectives.
“We scrutinized the status of prevention, deterrence, preparedness, detection, response, attribution, recovery, and mitigation – the spectrum of activities deemed necessary for biodefense . We identified substantial achievements, but we also found serious gaps and inadequacies that continue to leave the Nation vulnerable to threats from nature and terrorists alike.” “Our intent is to help remedy the correctable shortfalls by identifying specific short-, medium-, and long-term programmatic, legislative, and policy actions in this report. We urge those in leadership positions to implement our recommendations with utmost haste. Lives are in the balance.”
The lack of coordination at the highest levels impacts a variety of downstream areas of critical importance, including: intelligence activities; full consideration of the interrelationships among animal, environmental, and human health; coordination of medical countermeasure development; attribution of bioterrorist acts; and environmental decontamination and remediation. These critical areas demand better integration and clear prioritization, aligned with funding and investment, in order to inform stakeholders across the biodefense spectrum and enable them to execute a strategy once it is developed.
“Biodefense necessitates complex and sophisticated multi-disciplinary efforts, successful navigation of which requires coordination among government, academia, and industry. Centralized effective leadership is necessary to align these efforts.” The Nation lacks a single leader to control, prioritize, coordinate, and hold agencies accountable for working toward common national biodefense.
Biodefense touches many aspects of society, falling within the purview of national security, homeland security, public health security, and economic security. As such, it requires an enterprise approach – eliminating stovepipes; transcending agency-centric activity; drawing upon stakeholders throughout government, academia, and the private sector; and recognizing the extraordinary breadth of the challenge – to provide flexible solutions that address the full spectrum of the threat.
On the immediate horizon, we cannot delay the development and implementation of strategic plans for coping with civilian bioterrorism. As a result, education and training of the healthcare providers, especially emergency physicians, are the mainstay of the battle against bioterrorism. Emergency departments must be constructed in a way suitable for a possible chaos and overcrowding that may occur when a real event happens. Awareness and preparedness to biological warfare agents must be accepted as a part of national biodefense policy.
Develop, implement, and update a comprehensive national biodefense strategy.
A single, comprehensive, and harmonized National Strategy for Countering Biological Threats is needed that provide a foundation for federal biodefense activities and that needs to be implemented in a coherent, prioritized, and unitary fashion. “The National Security Council should collate all extant biodefense policies, laws, and treaties that promulgate defense responsibilities against intentionally introduced, accidentally introduced, and naturally occurring biological threats. There is need to develop plans to address weaponized pathogens based on recently declassified information from the U.S. biological weapons program.” “Develop a gap analysis based on this comprehensive strategy. Congress should direct the Government Accountability Office (GAO) to analyze gaps in resources mapped against the requirements of the National Biodefense Strategy and estimate resource requirements for small-, medium-, and large-scale events.”
Unifying the biodefense budget
The proposed 2021 budget also anticipates expenditures in bio-research but does not explicitly support or articulate specific bio-weapons defense research and development objectives. Its investments in bio-technologies focus on (1) “$1.3 billion for the Agricultural Research Service, which conducts in-house basic and applied research, develop vaccines, and provide enhanced diagnostic capabilities to protect against emerging foreign animal and zoonotic diseases that threaten the Nation’s food supply, agricultural economy, and public health.”[xii] (2) “$14 billion investment in DOD science and technology programs that support key investments in industries of the future, such as artificial intelligence, quantum information science, and biotechnology.” (3) “HHS bio-defense and emergency preparedness procurement through the BioShield program and the Strategic National Stockpile, and includes $175 million to support Centers for Disease Control’s global health security activities, an increase of $50 million compared to the 2020 enacted level.
Additionally, a unified approach to budgeting is a vital part of any strategic interagency effort, and this is lacking as well. This undoubtedly means that spending is redundant in some areas and deficient in others. A unified approach to budgeting would enhance congressional oversight and allow the White House to better determine whether ongoing programs are aligned with the President’s priorities. Additionally, many biodefense activities would greatly benefit from multiyear funding. The biodefense enterprise is no different from the national defense enterprise, which receives multiyear funding for a variety of its programs.
Recognizing and institutionalizing the one health concept
Sixty percent of infections due to emerging infectious diseases are leaping into the human population via animals (with 72 percent of these coming from wildlife) and at an accelerating rate. Divisions between human and animal health are artificial, since most pathogens of concern often affect both. Viewing them as parts of a whole is what defines a One Health approach to healthy populations. Together, human, animal, and environmental health comprise a dynamic and interconnected system that requires leadership and a strategic and coordinated approach to pull together traditionally fragmented divisions of expertise, responsibility, and authority while working effectively at the human-animal interface. To ensure that Animal health and environmental health agencies are identified and assigned responsibility, and that their activities are fully aligned and coordinated with other biodefense activities and are current with respect to new science and evidence.
Improving intelligence community efforts
The United States continues to invest heavily in medical intelligence under the auspices of the Department of Defense to monitor the research terrain in order to identify the known knowns and known unknowns.
The IC is addressing the biological threat, but overall, the Community is unable to adequately collect and analyze intelligence due to insufficient resource allocation. The priority level placed on addressing the threat is not high enough to warrant the reallocation of resources (including human) necessary for increased collection, analysis, and distribution. IC should develop intelligence collection strategies that address bystanders, who may be able to provide useful information.
Threat information insufficiently shared with emergency services
Emergency service providers might be able to better target their efforts to address biological threats and protect themselves if they had more information regarding the threat, relevant vulnerabilities, and potential consequences. Yet much of the available information about current and potential biological threats is often classified.
Achieving an integrated biosurveillance and biodetection capability
The detection capabilities are behind, too: While DHS has a BioWatch program that gathers air samples in 30 U.S. cities to monitor the threat of bioterrorism, it’s nearly two decades old and takes from 11 to 13 hours to determine whether a biological agent has been deployed.
“Surveillance and detection are the means by which we achieve the earliest possible situational awareness for biological events that affect people, animals, the food supply, and the environment. They are fundamental capabilities that enable us to prevent or mitigate the consequences of these events. They also enable protection of national and local critical infrastructure, and support response and recovery operations. ”
Optimal surveillance and detection require a nationwide array of sensors and detectors at many levels, interconnected and working in parallel. This system must be expansive and address many aspects of disease spread, including human health (e.g., clinical, diagnostic), animal health (e.g., livestock, wildlife, companion), and sociocultural events (e.g., mass gatherings, burials).
Surveillance and detection systems need to work quickly, indicating the presence of an agent in hours, not days or weeks. Such a capability can usefully inform rapid response operations, saving lives and other resources. Along with this capability, methods for information sharing between surveillance and biodefense partners are also needed. Many stakeholders could benefit from improved communication and real-time awareness
Animal health surveillance should not be segregated from the model of comprehensive biosurveillance described. What if, instead of simply identifying the location of an insidious zoonotic outbreak, one could identify its reservoir, the place in the animal world where it is hiding?
Sensitive and specific biosurveillance can be attained only through a distributed network of activities. Medical records, clinical laboratory data, food recall data, human and animal pharmaceutical consumption, food and animal health surveillance, and water and air quality monitoring are examples of existing troves of data that could be shared with National Biosurveillance Integration System (NBIS) with the necessary leadership, correct approach, and comprehensive agreements. In return, the data owners could receive aggregated NBIS data, analyses, or other incentives.
The plan must identify information required by decision makers (federal, state, local, territorial, tribal, private sector) to manage a biological event; these requirements should then be used to determine needed data sources, technology, and operational processes to achieve situational awareness and response capabilities. The plan should encourage and incentivize private sector input.
As of May 2020, Homeland Security has been working on future-oriented enhancements comprising of:
- The Enhanced Passive Surveillance program geared toward delivering a “surveillance system for identifying endemic, transboundary and emerging disease outbreaks in livestock…and identify trigger points to alert officials for action.”
- The BioThreat Awareness APEX program will “develop affordable, effective and rapid detection systems and architectures to provide advance warning of a biological attack at indoor, outdoor and national security events.”
- The Bio-surveillance Information and Knowledge Integration Program seeks to develop a Community of Practice (COP) Platform prototype that integrates multiple data streams to support decision making during a biological event as well as inform training tools for state responders.”[xv]
Establishing an attribution apparatus
The ability to attribute crimes to their perpetrators is a necessary component of effective prosecution. Attribution is a challenge in any context, and becomes increasingly difficult with the involvement of numerous investigators and when unusual or novel weapons are used to execute crimes. This is the case with biocrimes, biological terrorism, and biological warfare. When biological agents are used for attacks, not only must crimes be attributed to particular perpetrators, but the pathogens and their sources must also be correctly identified. The United States has yet to fully establish this capability due to the inherent challenges associated with microbial forensic techniques and related analysis
Establish a national biological attribution decision-making apparatus. They should inform this apparatus with: 1) standards/ burdens of proof in the U.S. criminal justice system; 2) evidence, information, and intelligence regarding the source; 3) accuracy, reliability, timeliness, credibility and defensibility of that evidence, information, and intelligence; and 4) national security considerations. This apparatus should be exercised to inform decisions and to ensure that these decisions are defensible.
Coordinating medical countermeasure efforts
Federally-funded scientific investigators are more likely to engage in early stage research, rather than to use the more private sector approach of focusing on specific product goals and end-user needs. This is one reason that Ebola MCM were not available when they were needed. Need to Prioritize and align investments in medical countermeasures among all federal stakeholders.
Technology solutions
Advances in biomedical and genomic technologies have allowed us to detect and characterize viruses like SARS-CoV-2, and develop countermeasures like vaccines and therapies with unprecedented speed. During Covid-19 mRNA vaccine was rolled out in less than 12 months.
Surveillance through a nationwide network of sensors to rapidly detect and characterize biological events affecting people, animals, the food supply, and the environment. Second, powerful new information technologies and systems have allowed us to collect data in real-time, conduct viral surveillance, and coordinate local, national, and regional health systems.
DARPA has launched multiple programs to Protect soldiers from accidental or harmful use of genome editing technologies: these include preventing warfighters from getting affected from pathogens in battlefield, rapidly identifying pathogens, developing vaccines, and quickly ramping up production.
Managing the distribution of the vaccines
The nation is undertaking a significant logistical challenge: Transporting, distributing and administering a vaccine to hundreds of millions of Americans who are desperate to receive it.
More importantly, any delay or variation typically spreads along a supply chain. That may lead to vaccines being wasted, if more doses than are required are shipped to some locations. There is a lot of emphasis now on transparency and the ability to track shipments and the administration of vaccines in real time. As the supplies increase and more groups are eligible to receive vaccines through different channels, such as pharmacies, doctor’s offices and county health departments, we will likely see shortages and difficulties in moving those shipments quickly enough.
The process we’re seeing now is different from traditional supply chains, where efficiencies are usually realized as cost savings. The main goal for distributing the COVID-19 vaccines should be to have a high throughput across the supply chain, so that a minimal amount of the product — the vaccine — is wasted, says Varun Gupta is an associate professor of supply chain management and analytics at Penn State Behrend.
The vaccines need to be transported and stored at sub-zero temperatures. So far, the Pfizer vaccine has been transported successfully, using dry ice to maintain the temperature in special boxes. It will be interesting to see if that can be scaled up, as there could be supply issues with dry ice, the special boxes and the trucks that can transport them safely, says Gupta. Moderna’s vaccine can be stored and transported using traditional cold-storage supply chains, which are already well-developed and have higher handling capacities. At this point, I am more concerned about the ability of those administering the vaccine to be able to safely handle two different vaccines at different temperatures.
Vials and shipping cartons should not bottleneck the production, as a majority of these are manufactured domestically. The specialized storage boxes and PPE items, such as gloves or safety masks, could present a bigger challenge in the long term, and in large quantities. There already is a latex glove shortage, due to a COVID-19 breakout in Malaysia, at the production plants for the world’s largest producer of gloves.
Taking charge of decontamination and remediation
Environmental remediation is the application of countermeasures to eliminate an agent from a geographically defined area. Additional research is needed to develop standards and protocols for the elimination or reduction of new infections caused by pathogens hiding in a particular environment.
“Natural environments are not pristine and often contain microbes at low levels tolerated by humans. Returning an environment to its baseline level after an event cannot be accomplished without first having measured the baselines and this has not been systematically attempted.” The Nation must be able to decontaminate and remediate affected environments in a coordinated, predictable fashion. This national capacity must be sufficient to address accidents, bioterror threats, and emerging infectious diseases.
Supporting emergency preparedness
The Emergency Services Sector is a critical infrastructure sector that is the Nation’s first line of defense for preventing, preparing for, responding to, and recovering from incidents of many kinds, including biological threats. This sector consists of law enforcement, fire and emergency services, emergency management, emergency medical services, and public works.
The Nation must also demonstrate support for emergency services through improved training, enhanced personal protection, and better intelligence sharing. Provide emergency service providers with the resources they need to keep themselves and their families safe. This will fulfill the Nation’s commitment to these professionals while also helping to ensure their participation in the event of a biological emergency.
Stockpile program
The U.S. launched a national stockpile program 20 years ago as a way to prepare for biological, chemical or nuclear attacks on the homeland. Its goal was initially to prepare for an unusual threat and was very oriented toward specific biological agents. It now houses the country’s largest supply of vaccines and medical supplies for use in a public health emergency, like an outbreak of smallpox and anthrax, or widespread radiation sickness. The stockpile is a work in progress, however. While the CDC now says there is enough smallpox vaccine in the stockpile for every American, it initially housed only 15 million doses, 90,000 of which were available for immediate use.
It was reported in April 2021. the U.S. stockpile of the controversial AstraZeneca Plc coronavirus vaccine has grown to more than 20 million doses, according to people familiar with the matter, even as the shot looks increasingly unlikely to factor into President Joe Biden’s domestic vaccination campaign. Three other vaccines already authorized in the U.S. are going into Americans’ arms at a rate of about 3 million doses per day, with hundreds of millions of additional doses set to be delivered by August.
The U.S. is on pace to have enough vaccine for its entire adult population by the end of May, with another 200 million doses arriving from Moderna and Pfizer by late July. White House officials have said they want a surplus of doses in part to vaccinate children, once a dose is approved for people under 16. Given its issues with younger adults, it’s unclear if the AstraZeneca shot would ever be approved for use by American youngsters.
Creating incentives for hospital preparedness
“We must commit reasonable and sustained levels of financial support to state, local, territorial, and tribal health departments. The federal government must also increase support to hospitals, through tighter management of Hospital Preparedness Program funds, development of Centers for Medicare and Medicaid Services incentives, and accreditation of select hospitals as biodefense specialty centers.”
A stratified hospital system similar to that utilized for Ebola and other specialized pathologies (e.g., trauma, stroke, cardiac care, burns, pediatrics) is needed for infectious diseases. Such a system would require all hospitals to attain the ability to assess patients in order to recognize bioterror agents, as well as emerging and reemerging infectious diseases. All hospitals would also be able to stabilize patients within 48 hours, and then refer patients quickly to higher-level hospitals for more definitive care. Other levels of hospitals would be able to provide increasingly specialized care, depending on the status of these patients.
Lead the way toward establishing a functional and agile global public health response capacity and build international threat awareness reach consensus on priorities, improve regional and cross-border surveillance, and increase regional MCM stockpiling and distribution plans.
Dealing with cyber threats to Pathogen security
While a cyber attack on any health-related system could have enormous consequences to health security and care delivery, an area of particular relevance to biodefense and biosecurity is the vulnerability of pathogen-related data. Such information is commonly shared via the cloud or non-secure networks during the course of scientific business.
Senator Sheldon Whitehouse told the Panel, “There is a considerable bank of information on biological warfare dating back to the biological warfare planning of the United States and the Soviet Union fifty years ago…Unlike a nuclear warhead, that information can travel very readily, and in the hands of terrorists or others who wish us harm, it can be very dangerous. So how do we control the proliferation of that bank of information our countries built back in those days?”
Not only does this historical information still pose a risk, but so does the body of knowledge about pathogens that has expanded since that time. Genetic sequences of pathogens (including those of the most serious threat agents) may be shared. The databases that contain this kind of information are as vulnerable to hacking as any other, and adversaries could use their contents to gather intelligence on U.S. defensive capabilities, or even to engineer bioweapons.
Theft, misuse, or tampering with pathogen data should be considered a national security matter. If cloud-based data sharing, storage, and analysis are to be used for disease research, detection, and characterization, technical and non-technical security measures must be developed and implemented to ensure that no data stored or shared in the cloud are inappropriately manipulated or destroyed. A strategy for sharing information regarding cyber threats, securing pathogen data, and preventing national security breaches is needed.
Reengaging with the biological and Toxin weapons convention
The BWC is a legally binding treaty that entered into force in 1975. Signatory nations agree to never “develop, produce, stockpile or otherwise acquire or retain microbial or other biological agents or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes.”To date, 173 nations have become parties to the convention, but at least five of these countries (China, Iran, North Korea, Russia, and Syria) are suspected of engaging in biological weapons activities despite BWC ratification.
The BWC does not absolutely prohibit the use of biological agents or toxins, but instead prohibits their use as or in biological weapons. The BWC allows these agents and toxins to be used for peaceful purposes, including research and the development of MCM, protective equipment, and detection systems. Such peaceful work can cross the line into offensive work, and a well-known shortcoming of the BWC is that it lacks a verification system to sufficiently restrain countries from engaging in offensive biological weapons programs.
DOD
Since taking office, President Biden has emphasized the importance of bold approaches
to defeat the current coronavirus disease 2019 (COVID-19) pandemic, as well as transform the
Nation’s approach to biodefense. We must prepare to operate in a biological threat environment
and support the National biodefense enterprise, both at home and abroad. To support that vision,
the Department of Defense (DoD) will prioritize biodefense across the full spectrum of
biological threats, from naturally occurring to accidental and deliberate biological incidents.
Secretary of defence in Nov 2021, directed the Department to continue to fortify our
immediate pandemic preparedness and to undertake a comprehensive Biodefense Posture
Review (BPR).
Three principles will guide the Department’ s posture review: 1) Unif-y efforts through an
empowered, collaborative, and integrated approach to biodefense across the Department; 2)
Modernize DoD operations to optimize capabilities, capacity, resilience, and readiness; and 3)
Synchronize biodefense planning with the Department’s new ational Defense Strategy and with
the efforts of other Federal departments and agencies and, as appropriate, allies and partners, to
support national biodefense efforts in alignment with national goals and strategy.
Implement military-civilian collaboration for biodefense
DOD has significant knowledge that it could transfer to the civilian sector in the way of planning, logistics, response, operating in contaminated environments, science, technology, and many other matters. Despite the importance of DOD’s role in providing support to civilian authorities in response to domestic bioincidents, doctrinal clarity for this role is lacking. DOD has not established strong interfaces with the federal, state, local, territorial, and tribal agencies that would be involved in responding to a major biological attack against the United States
DOD force protection and projection are imperiled by the threat of both bioweapons and naturally occurring infectious diseases. Yet U.S. warfighter preparedness for and protection against biological attacks is inadequate. DOD assets and force readiness overseas and within the homeland could be dangerously compromised by a major biological event. Scant consideration has been given to how operations would be conducted in biologically contaminated environments caused by a biological attack or by exposure to infectious disease when engaging in combat or providing humanitarian assistance.
The need for leadership in driving innovation
“Our leaders must give priority to innovative approaches to engaging industry and others toward needed solutions in areas like diagnostics, detection, biosurveillance informatics, personal and collective protection, remediation, and attribution.”
The report recommends Incentivizing Civilian Medical Countermeasure Development, Leaping Ahead to a Modern State of Biodetection, Removing Select Agent Program Impediments to Innovation, and Implementing New Approaches to Global Health Response
Implementing novel approaches to Global health response
International cooperation is a key element in implementing global health strategies. U.S. activities include establishing emergency operations centers, strengthening laboratory biosecurity in developing nations, partnering with international animal health authorities to rapidly detect and manage animal diseases, and implementing and strengthening the International Health Regulations and OIE reporting capacities.
Nowhere is the fragility of the human-animal disease boundary more pronounced than in developing nations, from where the majority of new infectious agents are emerging. Urban areas are nucleation points for infectious disease risk and their populations are dramatically increasing in many of these countries. Because these nations often lack both public health and animal health infrastructures, their capacity for early and effective surveillance and mitigation efforts is challenged
Conclusions
The digitalization of life sciences and the rise of accessible gene-editing tools introduce vulnerabilities that should be of concern to policy-makers and the national bio-security community.
Dramatic improvements are within our reach if we follow a national blueprint for biodefense, establish leadership, and engage in major reform efforts that build on the good work that is already in place.
To mitigate the risks issuing from a rapid pace of technological and biotechnological progress, the international community must invest in the promotion and enforcement of norms of responsible conduct and strengthening the public health infrastructure to detect and effectively respond to disease outbreaks of natural and synthetic nature
The UN Security Council Resolution 1540 calls upon countries to establish and enforce laws prohibiting and preventing the acquisition and transfer of biological weapon-related materials and equipment. There are, however, limited formal verification mechanisms and biological and chemical weapons still pose a significant threat to national security as do synthetically manufactured compounds resulting from scientific and bio-engineering advancement and innovation.
References and Resources also include:
https://www.politico.com/news/2020/03/19/coronavirus-biowarfare-terror-136194
https://www.lawfareblog.com/some-synthetic-biology-may-not-be-covered-biological-weapons-convention
https://globalsecurityreview.com/bio-security-in-the-age-of-global-pandemics/
