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The historic, ongoing toll of COVID-19 on health and economic stability worldwide highlights the critical need to make R&D for broadly protective coronavirus vaccines a global priority. SARS-CoV-2, which emerged in 2019 to cause the COVID-19 pandemic, was the third coronavirus in just the past two decades to have emerged from an animal reservoir to cause human epidemics. Severe acute respiratory syndrome coronavirus (SARS-CoV) emerged in 2003, followed by Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012.
Coronaviruses can be highly lethal. MERS-CoV has a 35% case-fatality ratio (CFR), meaning that about one third of infections result in death. For SARS-CoV, approximately 1 in 10 infections result in death (10% CFR). Fortunately, these two coronaviruses do not spread efficiently from person to person. Although SARS-CoV-2 has a much lower CFR, the virus is highly transmissible and has spread rapidly worldwide, resulting in far more deaths. By the end of 2022, SARS-CoV-2 infections had caused more than 650 million confirmed COVID-19 cases and more than 6.6 million deaths.
Beyond the global scourge of the current COVID-19 pandemic, even more concerning is the threat of a new coronavirus in the future that could be both highly transmissible and highly lethal. Thousands of different coronaviruses are circulating in animals worldwide, particularly in bats but also in other mammals and in birds. The trends of the past 20 years are intensifying, with increasing risk of coronaviruses spilling over from animal reservoirs to people, fueled by the rapid expansion of human populations into animal habitats and an increasingly interconnected world.
The limited durability and immunologic protection of currently available SARS-CoV-2 vaccines further highlight the crucial need for a new, proactive approach to develop coronavirus vaccines that provide better and longer protection against both circulating and future SARS-CoV-2 variants and other coronaviruses that have not yet emerged. Currently available COVID-19 vaccines have proven to be safe and effective for the prevention of severe disease and death, and form the backbone of the global public health pandemic response. However, these vaccines do not provide sufficient protection against infection, transmission, and the relentless emergence of new variants that evade the immune response.
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The Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, with funding from the Bill & Melinda Gates Foundation and The Rockefeller Foundation, created this research and development (R&D) roadmap for broadly protective coronavirus vaccines (referred to as the Coronavirus Vaccines Roadmap [CVR]) to serve as a strategic planning tool to facilitate R&D, coordinate funding, and promote stakeholder engagement. The ultimate goal of the CVR is to generate broadly protective vaccines against species and strains of the Coronaviridae virus family.
Primary audiences for this roadmap include academic basic and translational scientists, clinical researchers, funders, public health policymakers, government officials, industry scientists, business leaders, regulators, and advocacy specialists.
Over the past two decades, three novel and significantly pathogenic coronaviruses have emerged from animal reservoirs to cause human epidemics or pandemics. Severe acute respiratory syndrome coronavirus (SARS-CoV) emerged in 2003, followed by Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012 and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in 2019. Coronaviruses can be highly lethal to humans, as illustrated by the 35% case-fatality ratio (CFR) for MERS-CoV and the 10% CFR for SARS-CoV. Fortunately, neither MERS-CoV nor SARS-CoV have been shown to spread efficiently between humans. SARS-CoV-2 has a much lower CFR, but because of its high transmissibility, by the end of 2022 had led to more than 650 million reported COVID-19 cases and more than 6.6 million deaths worldwide (WHO 2022a).
The emergence of future coronaviruses that are both highly pathogenic and highly transmissible represents a real and present threat that underscores the critical need for a coordinated R&D initiative to develop broadly protective coronavirus vaccines.
Additionally, the limited durability and immunologic protection (including limited protection against infection) conferred by available SARS-CoV-2 vaccines and natural infection, and the continuing emergence of new viral variants, further highlight the crucial need for a new, proactive approach to develop vaccines that provide greater durability and target continually emerging variants.
Advancing a global R&D agenda for broadly protective coronavirus vaccines is a large, complex endeavor that requires ongoing investment, communication, and coordination among researchers; representatives from governments, industry, multilateral, and nongovernmental organizations; regulators; and public health policymakers. This roadmap provides a framework and timeline to align the coordination, leadership, and investment necessary to achieve these ambitious goals.
A critical overarching goal of R&D efforts for broadly protective coronavirus vaccines is to develop vaccines that are available and appropriate for use worldwide. The speed of bringing initial SARS-CoV-2 vaccines to market was a spectacular accomplishment; however, multiple factors resulted in gross inequities in access to vaccines in remote and low-resource settings. Disparities were fueled by products whose cold-chain and technical requirements limited their use, protection of national interests in the face of limited supply, and global inequities in technical and public health capacity, financing, technology transfer, and manufacturing capabilities.
Future vaccine development must ensure that global equity is a core principle of R&D, and that programs anticipate and resolve issues that may undermine this objective.
Going forward, early and continuous engagement at the community, national, regional, and international levels will be essential to accomplish equitable distribution and uptake of future coronavirus vaccines.