Fail to Prepare, Prepare to Fail

Healthcare workers were among the first respondents to the COVID-19 pandemic. Because their occupations required them to be on the frontlines, many lost their lives during the early days and others still suffer from post-viral symptoms or from the psychological aftereffects of the pandemic. The situation highlighted just how unprepared the world was to provide equitable access to medical countermeasures such as tests, vaccines, personal protective equipment, and therapeutics. However, we saw a triumph of science in the diagnostic landscape – accurate PCR tests for confirming SARS-CoV-2 infection were available in laboratories within eight days of the World Health Organization’s (WHO) declaring COVID-19 a Public Health Emergency of International Concern. But when it came to making these tests available to all of the healthcare centers and hospitals that urgently needed them, especially during the early phases of the pandemic, this victory was over as quickly as it came.

A changing world
 

Test manufacturing and supply has traditionally been very centralized; before COVID-19, research, development, and demand for diagnostic tests left the world with limited manufacturing capacity, unstable supply chains, and poor distribution and use of tests globally. Now, key industry players are coming forward to develop and grow local manufacturing capacities coupled with enhanced technology transfer. However, the same cannot be said for many other disease diagnostics. COVID-19 demonstrated what can be achieved when public and private partners work together; now, we need to develop these partnerships further so that new testing technologies can be rapidly introduced in most, if not all, countries. The pandemic triggered the largest-ever global expansion of genomic surveillance capacity and demonstrated the powerful potential of next-generation sequencing technologies to transform disease surveillance and public health readiness for epidemics and pandemics. However, this expansion exposed existing inequities in disease surveillance systems, marked by uneven distribution and gaps in diagnostic testing and genome sequencing capacities in low- and middle-income countries (LMICS).

After almost three years of battling COVID-19, governments must see the value in systematically building diagnostic capacity, prioritizing testing in national health strategies, investing in local manufacturing, and ensuring that effective mechanisms for real-time disease surveillance are in place. Although this need is clear, a survey by the World Innovation Summit for Health (WISH) revealed that lack of access to equipment is a key threat facing national health systems (1). We feel strongly about improving access to accurate and affordable diagnostics simply because no tests exist for 60 percent of the “Blueprint” pathogens identified by the World Health Organization (WHO) as having the greatest outbreak potential (2). This lack of availability and access to reliable, high-quality tests threatens our ability to respond to health emergencies and jeopardizes the achievement of universal health coverage.

Lessons learned
 

The next pandemic is always just around the corner, but countries have learned some tough lessons from COVID-19 that will help them going forward. Speaking at the World Innovation Summit for Health 2022, Commonwealth Secretary-General Patricia Scotland said, “We were all in the same storm, but we were definitely not in the same boat” (3). The virus doesn’t respect borders and we must work hand-in-hand to ensure that nobody – no matter where they are in the world – is left behind. To combat this, one of the early partnerships formed was the ACT-Accelerator, a global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. From research to rollout, the ACT-Accelerator remains the world’s only end-to-end solution aimed at ending the COVID-19 pandemic.

With inequitable access to vaccines, therapeutics, and tests, many LMICs in the global south were largely left out in the cold during the pandemic. Groups such as the United Nations, European Commission, and WHO need to invest in data-enabled health systems for all on an ongoing basis, not only in the time of a crisis or pandemic. These institutions came together to form the ACT-Accelerator, the learnings from which continue to inform our thinking about new pandemic instruments, financing, and core capacities needed for future countermeasures. However, although monkeypox has been prevalent in certain regions for decades now, it only became an issue of global concern once its effects reached high-income nations. Clearly, existing health inequities are not only a matter of preparedness, but also one of prioritization.

COVID-19 taught us that nothing is impossible when there’s a combination of funding and political will. We have seen research and development occur on extremely accelerated timelines because it affected everyone, everywhere. Investing in laboratories and strengthening national surveillance systems has better prepared countries for new waves of COVID-19 and served as a strong foundation for resilient pandemic preparedness.

From a supply chain perspective, we learned that centralized manufacturing does not lead to resilience – revealing how convoluted and fragile our supply chains are. The first few rapid COVID-19 tests were produced from one country, which proved extremely stressful because the whole world depended on a single supply source. All COVID-19 tests require a swab for sampling but, at the start of the pandemic, most swabs were produced in just two factories – one in Lombardi, Italy, and one in the US. The US put export restrictions on those swabs and, when it came down to country equity issues, high-income countries were able to move quickly, not only on the procurement and supply of diagnostic tests, but also on understanding how to use those tests in different circumstances. This meant that LMICs were already falling behind in their testing rates due to a lack of steady supply. Overwhelmed health systems also caused competition for funding and a grave neglect of diseases such as tuberculosis, HIV, and malaria, which then suffered significant setbacks as health systems shifted testing priorities.

Now, many countries around the world rapidly manufacture tests themselves, but this must continue to be an integral part of future pandemic preparedness to ensure supply chain resiliency. Manufacturing hubs and their partners must have a strong access plan to make sure people can get their hands on the necessary tools to keep themselves safe.

Barriers to success
 

Despite many diagnostic successes during the pandemic, the global testing effort still had many shortcomings. Significant challenges remain to be understood and addressed, particularly the global inequity of accessing tests, treatments, and vaccines – especially in remote areas and LMICs.

Testing is the essential first step in any pandemic preparedness plan – identifying the enemy and directing the development of vaccines and treatments. Like many others involved in diagnostic preparedness, we are now working closely with the Coalition for Epidemic Preparedness Innovations (CEPI) on the 100 Days Mission in five key areas (4):

1. Developing diagnostic test kits for high-priority pathogens that can be quickly adapted to any emerging pathogen.
2. Normalizing regular diagnostic testing.
3. Ensuring global access to diagnostic testing through reliable local manufacturing capacity and investments in LMIC testing networks.
4. Global surveillance systems to detect and monitor emerging and re-emerging pandemic threats.
5. Global cooperation and coordination in areas such as testing policy, emergency regulatory authorization, and global data sharing.

Most importantly, pathologists and lab medicine professionals are our gatekeepers; we rely on their warning signals and identification of future threats that may have pandemic potential.Looking ahead, we are interested in exploring the potential of multiplex testing rather than binary testing – a world in which patients and healthcare providers find a quick answer to the question, “What disease does the patient have?” rather than, “Does the patient have X disease?” It sounds futuristic, but we believe it’s an achievable vision within the next few years – as long as diagnostics need to remain high on our collective agenda.