Publications

On February 8 and 9, 2022, the Johns Hopkins Center for Health Security co-hosted a virtual dialogue session with the Regional Centre for Biotechnology of the Department of Biotechnology in the Indian Ministry of Science and Technology. The meeting focused on successes, challenges, opportunities, and lessons learned in the COVID-19 responses in India and the United States, and how COVID-19 responses can continue while also preparing for future health security crises.

The dialogue focused on COVID-19 developments that occurred since the last meeting in January 2021. Discussions centered around national response efforts, mass vaccination, surveillance approaches, causes and biosecurity implications of COVID-19 misinformation and disinformation, synthetic biological risks, global biosecurity governance, and the need for future collaboration among countries and within the scientific community.

The meeting convened senior thought leaders, scientists, public health practitioners, and medical experts from the United States and India. In accordance with the dialogue format, participants offered insights based on personal expertise and did not represent the government of either country in an official capacity.

On December 14 and 16, 2021, the Johns Hopkins Center for Health Security held a second virtual meeting of the Southeast Asia Strategic Multilateral Biosecurity Dialogue. The ongoing impacts of the COVID-19 pandemic, including health risks as well as quarantine requirements and other travel restrictions, necessitated hosting the meeting virtually. Additionally, many of our dialogue participants play important roles in their country’s COVID-19 response, which makes it difficult for them to take time away from work for travel. In order to maintain the relationships that are so critical to the success of this dialogue and to share lessons from national-level COVID-19 response activities, we held a second virtual meeting, which built on the topics and challenges discussed in our previous meeting in February 2021.¹

As of September 2021, mortality in the United States due to the SARS-CoV-2 virus had exceeded the death toll from the 1918 influenza pandemic. COVID-19 was the ultimate test of healthcare and public health capacity and capability across the United States. From its acute onset and throughout its extended duration, the COVID-19 pandemic has overwhelmed hospitals, disrupted businesses, and caused lasting economic harm. It has also illuminated and exploited major vulnerabilities within the US healthcare and public health systems. The impact of the pandemic on hospitals, and to a lesser extent on public health departments, has been explored elsewhere, but relatively little has been written about the impact on primary care services. Operating largely in silos and chronically underfunded disciplines, primary care providers and public health practitioners in the United States have struggled to respond to the numerous waves of the pandemic, which have caused high levels of morbidity and mortality and jeopardized health systems in communities across the country, especially those that are most vulnerable. It is crucial that the lessons learned from the COVID-19 pandemic must be shared.

Masks and respirators have played an essential role in the response to the COVID-19 pandemic for both healthcare workers and the public. However, the masks and respirators that both healthcare workers and the public have needed to rely upon leave much to be desired. Despite drawbacks in terms of comfort and fit, the ubiquitous disposable masks and disposable N95 respirators used by the vast majority of healthcare workers have not appreciably improved since the mid-1990s. During the COVID-19 pandemic, the public has been advised to wear masks as well. Masks have long been known to be effective means of “source control” (ie, reducing transmission of respiratory droplets from the wearer to others). More recently evidence has accumulated that properly constructed and worn masks as well as respirators afford a limited but not inconsequential degree of protection to the wearer as well. Existing masks and respirators run the gamut in terms of effectiveness and wearability. In a future large-scale outbreak or pandemic, it is possible to increase the protection of healthcare workers and the public from infection through more efficient, well-fitting, and comfortable masks. The design and manufacture of better masks and respirators are possible by harnessing emerging technologies, the innovative research and development spirit evidenced since the early days of the COVID-19 pandemic, and the availability of resources to support technological innovation.

On February 10 and 11, 2021, the Johns Hopkins Center for Health Security hosted a virtual meeting of the Southeast Asia Strategic Multilateral Biosecurity Dialogue. Due to health risks stemming from the COVID-19 pandemic as well as associated restrictions and protective measures implemented around the world, the dialogue meeting originally scheduled to be held in Cebu, Philippines, during 2020 was postponed. To continue the productive dialogue between the participating countries, a virtual meeting was held to specifically address challenges and lessons from the countries’ experiences with COVID-19.

Memish and colleagues,¹in their response to our Comment,² perceive conflict between the current best-practice risk management advice on physical distancing and the scientific evaluation of cancelling or continuing mass gathering events during the coronavirus disease 2019 (COVID-19) pandemic. Although we have already acknowledged the need to balance these two considerations in order to maintain public understanding and trust, we do not accept that conflict is inevitable as our approach requires all mass gatherings to be considered in context, including the prevailing advice on physical distancing and movement restrictions. An open and transparent process to explicitly consider the risks of a mass gathering can, in fact, promote public confidence in the decision.

The COVID-19 pandemic has shown that health-related misinformation and disinformation can dangerously undermine the response to a public health crisis. Contradictory messaging and active subversion have reduced trust in public health responders, increased belief in false medical cures, and politicized public health measures aimed at curbing transmission of the disease. Setbacks in the COVID-19 response have highlighted that health-related misinformation or disinformation can lead to more infections, deaths, disruption, and disorganization of the effort. The public health response and communication environment in the United States have been disrupted by significant distrust in government, exacerbated by confusing and conflicting messages from leaders. As a result, information voids have developed, easily filled by false or misleading information and directly targeted by perpetrators of disinformation. Taken together, the spread and consequence of public health misinformation and disinformation can lead to a range of outcomes that have national security implications and require effective response.

On January 26 and 27, 2021, the Johns Hopkins Center for Health Security hosted a virtual dialogue discussion, focused on coronavirus disease 2019 (COVID-19) responses in India and the United States. The session explored lessons learned thus far and the path forward for both nations in responding to the pandemic. The meeting was held in collaboration with the Regional Centre for Biotechnology of the Department of Biotechnology in the Indian Ministry of Science and Technology.

Among the most pressing issues in preparing for the global response to a pandemic are the design, development, manufacture, and dissemination of vaccines. In 2018 and 2019, we conducted 48 interviews with prominent leaders in public health, pandemic preparedness, vaccine design, and vaccine manufacturing about how they would respond to a sudden, urgent need to manufacture 2 billion or more doses of vaccine. Little did we know that this scenario would become a dire global challenge a few months later with the onset of COVID-19. The response to this pandemic has shown that when leading vaccine manufacturers are fully engaged in a global response, it might be possible for them to manufacture substantial doses of vaccine on timelines faster than previously envisioned. It is now hoped that hundreds of millions of doses of vaccine will start to be produced sometime in the end of 2020 or the start of 2021, and that billions of doses of vaccine could be produced in the months that follow. Whether these timelines can be met or not, it is crucial now, while the world is fully attuned to the terrible consequences of pandemics, to begin preparing the system of global manufacturing for future pandemics. The following insights and recommendations are taken from our interviews with leading experts and our own analysis.

Since its recognition as a pandemic in early 2020, novel coronavirus disease 2019 (COVID-19) has touched nearly every corner of US society. However, some populations and environments have been affected far more severely than others. Vulnerable populations—especially those subject to structural racism, discrimination due to disability, and financial insecurity—tend also to be particularly susceptible to the economic consequences of and severe disease and death from COVID-19. In addition, the institutions, industries, and systems that are fundamentally important to our lives and our democracy have, in some cases, become places where severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads readily if allowed to gain a foothold. In these places, it can be difficult to prevent the introduction of the virus or control the spread of SARS-CoV-2 once it is introduced.

The COVID-19 pandemic will continue for the foreseeable future, but widespread vaccination could hasten its end. At least 165 candidate vaccines for the SARS CoV-2 virus are in development around the world and there is hope that one or more of these candidates will soon be shown to be sufficiently safe and effective to achieve emergency use authorization in the United States. When a vaccine has been authorized for use, it will initially be in limited supply. During this period of scarcity, a plan is needed for how to allocate and distribute the limited supply—which groups should be prioritized to receive the vaccine first and which groups can wait until later. This difficult and potentially contentious topic is being actively discussed in the United States by the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) and the National Academy of Medicine (NAM), as well as globally at the World Health Organization (WHO) and elsewhere. The purpose of this report is to offer an additional ethics framework for use in making decisions about allocation of SARS-CoV-2 vaccine during this initial period of scarcity in the United States and make related suggestions about vaccine distribution. Our approach takes into account considerations of medical risk, public health, ethics and equity, economic impact, and logistics. We note where our approach aligns or differs from the 2018 CDC guidance for vaccine allocation in a severe influenza pandemic, which is the most recent pandemic vaccine guidance from the US government.

The impact of the COVID-19 pandemic in the United States has been profound. Despite initial declines in cases in May 2020 following implementation of stringent stay-at-home orders, cases are resurging in most states. The number of deaths has been rising in many states, with hospitalization rates for COVID-19 now again matching or exceeding numbers seen at the peak in New York City in March and April. Hospitals are under pressure or approaching a crisis in many places around the country. This resurgence is stressing many sectors of society, from businesses to education to health care. Unlike many countries in the world, the United States is not currently on course to get control of this epidemic. It’s time to reset.

This brief report describes concrete policy actions at the federal, state, and local levels that are needed to get control of the COVID-19 pandemic in the United States.

Before an infectious disease outbreak of any size can be addressed and before illness can be treated, it must be first be identified through the diagnosis of cases. Diagnostic testing is a mainstay of not only clinical medicine but also epidemiologic investigation. Limitations surrounding access to diagnostic testing have dominated much of the current response to COVID-19 and highlight the need to have more rapid, convenient, and equitable access to testing. Looking ahead, through the increasing diffusion of health technology to consumers and patients, it is becoming more feasible for diagnostic testing to be placed in the hands of the patient. Such tests when used to diagnose infectious disease, and coupled to information technology, could have a transformative benefit for future pandemic response.

The Johns Hopkins Center for Health Security conducted this study to develop an expert assessment of the promise and challenges posed by at home infectious diagnostic technologies. A major aim of this study is to inform pandemic preparedness activities that rely on diagnostic technologies and determine how at home approaches can integrate with and augment the existing diagnostic paradigm.

In the aftermath of severe acute respiratory syndrome (SARS) outbreak, the WHO fundamentally revised the International Health Regulations (IHR), which entered into force in 2007. The 196 States Parties to the IHR recognised that certain public health events pose a significant risk to the global community and should be designated as a Public Health Emergency of International Concern (PHEIC). Under Article I of the IHR, a PHEIC is defined by three criteria: an extraordinary event which ‘constitute[s] a public health risk to other States through international spread of disease and…potentially require[s] a coordinated international response.’ The IHR (Annex 2) provides a ‘decision instrument’ that guides States Parties as to which health events have the potential to become PHEICs, thus requiring reporting to WHO. [Annex 2 of the IHR provides a decision instrument for States Parties to assess which events detected by national surveillance systems would require notification to the WHO. This includes a single case of smallpox, poliomyelitis due to wild-type poliovirus, human influenza caused by a new subtype and SARS. Other health events that have the potential to cause international public health concerns or serious impact trigger an algorithm to determine if notification to WHO is required. Criteria for this algorithm include determining if the event is serious, unusual or unexpected, has a significant risk of international spread, or poses a significant risk of international travel or trade restrictions. If two of the criteria are true, then notification to WHO is required under the IHR]. The IHR also empowers the WHO Director-General (DG) to convene an Emergency Committee (EC) which consists of international experts brought together on an ad-hoc basis. The EC provides their advice on whether the current situation should be considered a PHEIC, and what Temporary Recommendations should be given to Member States to bolster the response and control the outbreak. Ultimately, however, the WHO DG has sole authority to declare a PHEIC and make Temporary Recommendations for Member States to follow.¹

The rapid evolution and spread of the COVID-19 pandemic have revealed insufficiencies in the US health system to respond to a public health emergency, resulting in healthcare worker infections and deaths.¹ Nurses have played and will continue to play a pivotal role in the response, yet compelling evidence from nurses in the field reveals a lack of access to personal protective equipment; inadequate knowledge and skills related to pandemic response; a lack of decision rights as they relate to workflow redesign, staffing decisions, and allocation of scarce resources; and a fundamental disconnect between frontline nurses and nurse executives and hospital administrators. These issues were brought to light in a recent survey conducted by the American Nurses Association, which found that 87% of nurses fear going to work, 36% have cared for an infectious patient without having adequate personal protective equipment (PPE), and only 11% felt well-prepared to care for a COVID-19 patient.² The efforts put forth by frontline nurses in caring for patients and ensuring the sustainability of health system operations during the COVID-19 pandemic, despite these challenges, is inspiring. However, there is a critical and compelling need to identify and understand the gaps and inadequacies in the US health system that have contributed to a lack of pandemic readiness, both within and outside of the nursing workforce, including in emergency planning and the procurement and allocation of resources such as PPE and ventilators.

As public health professionals around the world work tirelessly to respond to the COVID-19 pandemic, it is clear that traditional methods of contact tracing need to be augmented in order to help address a public health crisis of unprecedented scope. Innovators worldwide are racing to develop and implement novel public-facing technology solutions, including digital contact tracing technology. These technological products may aid public health surveillance and containment strategies for this pandemic and become part of the larger toolbox for future infectious outbreak prevention and control.

Most elementary schools, middle schools, and high schools across the United States have been closed since March in an effort to reduce the spread of COVID-19. Schools that are able to do so have replaced classroom education with remote learning, using a range of tools and approaches. As of the publication of this report, governors from most US states have recommended or ordered that schools remain closed for the remainder of this academic year, affecting more than 50 million public school students. While a few schools may reopen before the end of the current school year, most schools, students, and their families in the United States are now facing uncertainty about whether or how schools will resume for in-class learning in the fall.

This operational toolkit has been developed to help business owners who are considering reopening or expanding their operations to determine their establishments’ risk of transmission of COVID-19 and how to reduce it.

As displayed in the figure below, the Operational Toolkit consists of 3 parts: an instruction manual; a business risk worksheet; and an assessment calculator.

As some governments begin to lift strict public health measures and move into the next phase of their outbreaks of COVID-19, local, state, and federal authorities are planning for the gradual reopening of businesses and resumption of economic activity. While planning for a staged approach to business resumption must be coordinated by local, state, and federal authorities, individual organizations should start planning for how they will restart or expand their operations so that modification and mitigation measures will already be in place when work can resume and the new ”business as usual” can commence.

This operational toolkit allows business leaders to work through a 4-stage process to obtain an overall risk score for their business and to identify considerations for reducing both operational and individual level risks posed by COVID-19. The overall score represents the inherent risk of exposure to COVID-19 that may occur in a business and possible changes to daily operations and policies that can lower the inherent risk of exposure. This toolkit is intended to provide businesses with a starting point in their planning to reopen or expand their operations by identifying their risk levels for contributing to the spread of COVID-19 and providing them with a list of mitigation measures to implement that will increase the safety of their employees, clients, customers, and community. 

The 3 parts of the Operational Toolkit include:

1. An Instruction Manual (PDF)
   Instructions that explain how to complete the 4-stage Business Risk Worksheet and Assessment Calculator.
    
2. A Business Risk Worksheet (PDF)
   A 4-stage step-by-step worksheet for you to report and understand your business’s overall risk of spreading COVID-19 and how your business operations can be made safer.
    
3. An Assessment Calculator (XLSX)
   An Excel spreadsheet you will fill out to receive a calculated risk score and a modification score.

The COVID-19 (COVID) pandemic has led to unprecedented action and innovation in the US healthcare system; at the same time, it has presented extraordinary challenges and risks. Through dramatic augmentation of surge capacity, deferral of other services, and implementation of crisis standards of care, hospitals in many locations have been able to absorb the blow of the first peak of COVID cases and continue to provide lifesaving care to both COVID patients and others with life-threatening emergencies. But many communities are just beginning to experience the full force of the pandemic, and in every location, the healthcare response to COVID has come at a very dear price. Healthcare facilities have sustained huge financial losses, and healthcare workers’ health and well-being have been put at high risk. New standard operating procedures and work processes have been improvised, and many old lessons have had to be relearned.

The global reach of infectious disease pandemics typically necessitates a similarly ubiquitous public health intervention: mass vaccination. The development and large-scale deployment of a vaccine requires substantial investment and a coalition of stakeholders to undertake research and development (including phase I to III clinical trials), manufacturing, and widespread administration. Recent efforts by national and international funders and researchers to advance the state of vaccinology for pandemics and other infectious disease emergencies have focused largely on expediting the R&D phase1. There has been comparatively less attention paid to modernizing, optimizing, and therefore accelerating other aspects of the vaccine enterprise—namely, manufacturing, distribution, and administration. The current COVID-19 pandemic plainly underscores the need to vastly accelerate mass vaccination in every phase.