On Monday, May 4, world leaders and philanthropic organizations pledged $8.1 billion to the COVID-19 response to support research, manufacturing and distribution of possible diagnostics, vaccines and treatments. Spearheaded by the European Union, the pledging event brought leaders together virtually to highlight the critical need for international cooperation to mitigate the crisis. The U.S., conspicuous by its absence, did not contribute to this coordinated financing pool.
With such concerted efforts to bring new technologies to market more rapidly than ever before, it will be important to ensure their affordability and accessibility. “These new tools can help us to fully control the pandemic, and must be treated as global public goods available and affordable for all,” said Antonio Guterres, UN Secretary-General.
As countries prepare to reopen, mass testing will be of paramount importance to ensure a safe and measured strategy. Rapid and accurate testing of both symptomatic and asymptomatic individuals, paired with rigorous contact tracing and strict quarantining of those testing positive, will continue to be essential to contain the spread. Viewing immunity as a prerequisite to open economies and return to some semblance of “normalcy,” countries are relying on antibody testing to determine who has recovered from COVID-19. However, the World Health Organization (WHO) has emphasized that there is as of yet no reliable evidence to correlate the presence of antibodies with immunity from COVID-19.
As testing comes to the forefront of national and local responses, the issue of access will become more heated. From the outset of the pandemic, we have seen disparities in who gets tested and who does not. Inequities – often associated with race and socio-economic factors – will only deepen without proper safeguards in place.
This week’s issue of Rabin Martin’s COVID-19 Briefing explores the intersection of testing, safety and access. What will it take to ensure we create high-quality, effective diagnostic products expeditiously while ensuring safety and equity of access? Click here to read our previous COVID-19 Briefings.
The New Testing Paradigm: Access for a Few?
Dr. Tedros Adhanom Ghebreyesus, Director General, World Health Organization
As warm weather approaches for many, decisionmakers are facing tough choices about how to move forward with their pandemic response. Photos of crowded beaches and parks signal a collective weariness – and, for some, rejection – of government mandated stay-at-home orders. Mass testing has been recommended as a required step toward relaxing restrictions on social distancing, yet questions remain around the reliability and accuracy of current tests on the market. Further, there are equity concerns about a strategy based on testing.
The social determinants of health must be considered as local officials begin to roll-out mass testing campaigns. For example, in the U.S. there are increasing reports of racial and economic bias and discriminatory practices during the pandemic response, with African-Americans who show symptoms of the virus less likely to be referred for testing. These delays in diagnosis can be particularly harmful for minority groups with higher rates of chronic conditions, such as diabetes, heart disease and obesity, which are associated with more severe cases of COVID-19.
Challenges for Diagnostic Testing
The U.S. lags behind testing efforts due to a shortage of test kits and other challenges early in the response. A report by Nature found that thousands of diagnostic tests were going unused in U.S. labs, pointing to larger problems beyond supply. Regulatory hurdles, limited resources and disjointed infrastructure have also stymied efforts to increase access to testing. Research laboratories that have retrofitted their operations to accommodate an anticipated influx of COVID-19 tests for analysis have not seen that demand and are working well below capacity.
Globally, testing of healthcare workers remains a top priority, but necessary equipment and services associated with testing, such as swabs and training of personnel, are not consistently in place so that essential healthcare workers and other people who are most at risk have access to testing when it is needed. The Lancet notes that expanded testing among both symptomatic and asymptomatic healthcare workers will be a critical strategy to ensure the health of patients and the integrity of health systems more broadly.
“Many hospitals are denying or delaying testing of nurses who have been exposed or are even showing symptoms,” said Zenei Cortez, President of National Nurses United. In the U.K., a survey by the Royal College of Nursing (RCN) found that nurses working outside of the National Health Service network were less likely to be offered a test. This inequality of access is unacceptable said Dame Donna Kinnair, Chief Executive and General Secretary of the RCN: “All health and care staff must be able to access testing so they can work safely and without worry.”
Uncertainties of Antibody Testing
Antibody testing might not prove to be the silver bullet needed to determine immunity and thus support the end of lockdowns. However, serological antibody testing can prove valuable for the pandemic response because it allows nations to better understand the burden. Israel is readying a national serological test of 100,000 people to assess the breadth of its epidemic. Similarly, Germany has announced antibody testing of a representative nationwide sample, “hoping to gain valuable insight into how deeply the virus has penetrated the society at large…and whether immunity might be developing.” These efforts are intended to provide data and insights that can direct contact tracing and resource allocation to hardest hit regions.
Private Sector Insights
On Wednesday, May 6, Rabin Martin, as the Secretariat for the Private Sector Roundtable for Global Health Security (PSRT), hosted an eleventh call in a series on the latest health impacts of COVID-19. The call featured Dr. Sandro Galea, Dean and Robert A. Knox Professor, School of Public Health, Boston University.
Dr. Galea discussed how the social determinants of health are relevant to high-income countries as well as low- and middle-income ones and are especially important to consider in the global response to COVID-19.
Beginning with an overview of social determinants, he used the example of mapping diabetes incidence in Boston to the city’s public transportation network to show how social determinants influence population health outcomes. The data show significant disparities in diabetes between communities that are only a mile or two apart. These differences are particularly striking in a city with the highest per capita population of doctors in the United States. Although all residents live near world-class hospitals, the incidence of diabetes is twice as high in the southern vs. the northern part of the city, which correlates with the disparities in income and education levels in these communities.
Dr. Galea’s overarching message was that many aspects of health are driven by where you live, what you eat, where you play, your type of work and wages. It is critically important to “understand how the world around us shapes our health.” Social determinants are the “ubiquitous factors” that we don’t see and, consequently, don’t pay attention to when we talk about health. These include quality of housing, gender equity, air quality, livable wages, presence/absence of violence and availability of affordable nutritious food, among others. Instead we often focus on behavior change even though “the efforts to encourage healthy eating are futile if we don’t pay attention to higher-level upstream determinants.”
He outlined four of the most important social determinants that are driving health globally and are connected directly to COVID-19:
- Urbanization – the majority of the world now lives in urban areas and the built environment affects exercise, quality of education, risk of infection, congregation and more – yet this is something we create and control
- Population aging – more people are over 65 than under 5 for the first time in history. “We cannot think about COVID-19 without recognizing that it’s a disease among people who are older – both in high- and low-income countries – and population aging is why we haven’t seen an explosion of cases in lower- and middle-income countries (LMICs)”
- Migration – the enormous number of people living in unstable conditions makes it difficult to put structures in place to mitigate disease; notably, the recurrent COVID-19 cases in Singapore were all in migrant communities that had not been on the government’s radar
- Climate change – which will shape health for the next 30-40 years, especially deteriorating air quality and conditions that lead to large-scale disasters
In addition to these determinants, LMICs are also worse off compared to high-income countries because of more fragile health systems, which are less resilient and adaptable, and vast economic inequalities. For people barely subsisting, it is “impossible to withstand the stressor of a pandemic or a lockdown and its consequences.” Dr. Galea added that, because of the differences in social determinants, the western approach to lockdown is not applicable to other regions.
In terms of recommendations for the COVID-19 response, Dr. Galea argued that the solution is to stratify risk and to target resources (especially Office of Development Assistance funding) toward testing, contact tracing and strategic isolation of people at high risk – adding that mass physical distancing is unrealistic in LMICS. He called this the right approach for both LMICs and high-income countries and “the only supportable approach in LMICS.” He urged against a “one size fits all blanket shutdown of economies and societies,” because it will only mitigate the virus’ transmission in the short term, but will not work in the long term, noting that economic damages will haunt these countries longer than COVID-19.
He concluded that we need to understand rapidly who is at risk and focus attention on those populations with strategies built on risk stratification. He predicted that the path forward will require grappling with civil liberties issues and employer expectations of being present at work. The challenge before us is how to balance risks and make uncomfortable decisions – and to do so very quickly.
In just over four months since the first reported case of COVID-19 in China, the world is approaching 4 million cases. The U.S. remains the most active epidemic hotspot, suggesting the pandemic is far from over. With 1,229,089 cases and 73,435 deaths, the U.S. accounts for a third of global burden.
States hit hard early in the crisis, such as New York, are experiencing a decline in new cases due to the extensive measures put in place to flatten the curve. Concerningly, incidence is increasing elsewhere in the U.S. and hotspots are arising in new cities such as Chicago and Los Angeles and in rural areas such as Nebraska. The continued rise in cases, cresting this week at 25,500 a day, has left experts troubled by mixed messaging by the Trump administration and the concurrent state-level initiatives to phase out social distancing regulations.
Worldwide, as of Thursday, May 7 at 9:30 am ET, the Center for Systems Science and Engineering at Johns Hopkins University reported 3,778,179 confirmed cases and 264,437 deaths attributed to COVID-19.
One explanation for the U.S.’s slow introduction of testing at the outset of the pandemic has focused on the onerous regulations required for FDA approval – though the delays caused by inefficiencies in Federal efforts to coordinate production and distribution of tests and supplies cannot be discounted. In an effort to course correct as it began reviewing antibody tests, the FDA published wide, flexible guidelines that allowed for a proliferation of unverified tests to enter the market. An evaluation of 14 antibody tests in late April spurred criticism that the agency’s leniency had allowed faulty products to reach consumers. On Monday, May 4, the FDA backtracked and released new stricter policy guidelines for antibody tests: companies must submit applications for emergency use authorizations within 10 days of the policy change or withdraw their product from the market.
On Thursday, April 30, AstraZeneca entered a partnership with the Jenner Institute to manufacture and distribute the Institute’s vaccine candidate, currently known as ChAdOx1 nCoV-19. Phase I clinical trials of the vaccine began last week in Southern England; data are expected next month.
During its Q1 earnings call on Tuesday, May 5, Regeneron announced it is beginning large-scale manufacturing in anticipation of starting clinical trials of its artificial antibody cocktail in June. Pending favorable results, the antibody cocktail could be available for commercial use in the fall.
After launching trials in Germany late last month, Pfizer and BioNTech initiated the U.S. Phase I/II clinical trials of four mRNA vaccine candidates on Tuesday, May 5. Preparing for positive results, Pfizer is planning to invest at risk to scale up vaccine production to generate millions of doses by the end of 2020.
On Tuesday, May 5, Sanofi announced it plans to enroll thousands of people for trials of the experimental vaccine it is developing in partnership with GlaxoSmithKline. Early stage trials are set to begin in September, but the companies hope the large number of subjects will expedite the process and yield important data.
From the Experts
“Comprehensive, coordinated public health measures are critical to slow transmission and to save lives. But even countries that have taken such steps remain in jeopardy. And the virus is still likely to strike many countries that are least able to cope. In an interconnected world, none of us is safe until all of us are safe.”
António Guterres, Secretary-General, United Nations
Monday, May 4
“In the space of just a few hours we have collectively pledged 7.4 billion euros ($8.1 billion) for vaccine, diagnostics and treatment. This will help kick-start unprecedented global cooperation.”
Ursula von der Leyen, President, European Commission
Monday, May 4
“How many deaths and how much suffering are you willing to accept to get back to what you want to be, some form of normality, sooner rather than later?”
Anthony Fauci, Director, NIAID
Monday, May 4
“The fundamental question we’re not articulating is how much is a human life worth?”
Andrew Cuomo, Governor, State of New York
Tuesday, May 5
“We need to increase our preparedness for the future. And we need to fight inequality and put rights and people at the center of the response.”
Winnie Byanyima, Executive Director, UNAIDS
Wednesday, May 6
“Let us be clear: without a corona vaccine we will never be able to live normally again. The only real exit strategy from this crisis is a vaccine that can be rolled out worldwide. Despite all our efforts, it is still not certain that it will be possible to develop a vaccine against the coronavirus. In the worst case, we will be able to do nothing but try to limit the damage.”
Peter Piot, Director, London School of Hygiene & Tropical Medicine
Wednesday, May 6
Reports from International Governments and Bodies
- WHO COVID-19 Information and Guidance
- WHO Situation Reports, May 4, May 5, May 6
- CDC Coronavirus Resource Page
- COVID-19 Health Systems Response Monitor
- NCD Alliance COVID resources relevant to NCDs
Funding and Policy Trackers
- International Monetary Fund Policy Tracker
- Kaiser Family Foundation Coronavirus Policy Tracker
- U.S. Chamber of Commerce Foundation Corporate Aid Tracker
- Devex Interactive Funding Tracker
Resource Pages and Market Research Literature
- JAMA Resource Center
- The Lancet COVID-19 Resource Centre
- 2019 Novel Coronavirus Research Compendium (NCRC)
- WIPO COVID-19 IP Policy Tracker
- The COVID Tracking Project
- PharmaIntelligence: Coronavirus – What will the Impact Be?
- Health Affairs Resource Center
- STAT Preparedness Tool
- International Association of National Public Health Institutes COVID-19 Resources
- Primary Health Care Performance Initiative Forum
- U.S. Global Leadership Coalition COVID-19 Issue Briefs
- Prevent Epidemics Weekly Science Review
What We’re Reading
- Profits and Pride at Stake, the Race for a Vaccine Intensifies – David E. Sanger, David D. Kirkpatrick, Carl Zimmer, Katie Thomas and Sui-Lee Wee; The New York Times
- In the Race for a Coronavirus Vaccine, We Must Go Big. Really, Really Big. – Susan Athey, Michael Kremer, Christopher Snyder and Alex Tabarrok; The New York Times
- How A.I. Steered Doctors Toward a Possible Coronavirus Treatment – Cade Metz; The New York Times
- Efforts to Beat Back the Coronavirus are Critical. They’re Also Making Clinical Trials Harder – Andrew Joseph, STAT News
- Will poor countries get the coronavirus treatments they need? – Andrew Jack, Financial Times
- Nations Back Push for Universal Access to COVID-19 Vaccines – James Paton, Bloomberg
- Should Covid-19 Investors Leave Money on the Table? – Suerie Moon and Nadya Wells, Barron’s
- ICT COVID-19 Response: Partnering with Technology Companies to Combat COVID-19 – World Economic Forum
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About Rabin Martin
Rabin Martin is a global health strategy firm working at the intersection of private sector capabilities and unmet public health needs. Rooted in our mission to improve health for underserved populations, we design strategies, programs and partnerships that both deliver public health impact and drive business results. We leverage our deep knowledge and networks across a wide range of geographies and health areas to develop tailored solutions for every client engagement. We have helped many clients create bold global health initiatives and innovative multi-sector partnerships. Our specific areas of expertise include infectious disease and vaccines, non-communicable diseases, rare diseases, maternal and child health, and universal health coverage. Our clients and partners include multinational health care companies, multilateral institutions, government agencies, large foundations and leading NGOs. Rabin Martin is part of the Omnicom Public Relations Group.
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