A Research and Development (R&D) Roadmap for Broadly Protective Coronavirus Vaccines: A Pandemic Preparedness Strategy

Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 22 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines.

A research and development (R&D) roadmap for broadly protective coronavirus vaccines: A pandemic preparedness strategy.

Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 26 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Dose, Infection, and Disease Outcomes for Coronavirus Disease 2019 (COVID-19): A Review.

The relationship between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) dose, infection, and coronavirus disease 2019 (COVID-19) outcomes remains poorly understood. This review summarizes the existing literature regarding this issue, identifies gaps in current knowledge, and suggests opportunities for future research. In humans, host characteristics, including age, sex, comorbidities, smoking, and pregnancy, are associated with severe COVID-19. Similarly, in animals, host factors are strong determinants of disease severity, although most animal infection models manifest clinically with mild to moderate respiratory disease. The influence of variants of concern as it relates to infectious dose, consequence of overall pathogenicity, and disease outcome in dose-response remains unknown. Epidemiologic data suggest a dose-response relationship for infection contrasting with limited and inconsistent surrogate-based evidence between dose and disease severity. Recommendations include the design of future infection studies in animal models to investigate inoculating dose on outcomes and the use of better proxies for dose in human epidemiology studies.

A Research and Development (R&D) roadmap for influenza vaccines: Looking toward the future.

Improved influenza vaccines are urgently needed to reduce the burden of seasonal influenza and to ensure a rapid and effective public-health response to future influenza pandemics. The Influenza Vaccines Research and Development (R&D) Roadmap (IVR) was created, through an extensive international stakeholder engagement process, to promote influenza vaccine R&D. The roadmap covers a 10-year timeframe and is organized into six sections: virology; immunology; vaccinology for seasonal influenza vaccines; vaccinology for universal influenza vaccines; animal and human influenza virus infection models; and policy, finance, and regulation. Each section identifies barriers, gaps, strategic goals, milestones, and additional R&D priorities germane to that area. The roadmap includes 113 specific R&D milestones, 37 of which have been designated high priority by the IVR expert taskforce. This report summarizes the major issues and priority areas of research outlined in the IVR. By identifying the key issues and steps to address them, the roadmap not only encourages research aimed at new solutions, but also provides guidance on the use of innovative tools to drive breakthroughs in influenza vaccine R&D.

Development and deployment of COVID-19 vaccines for those most vulnerable.

Development of safe and effective COVID-19 vaccines is a global priority and the best hope for ending the COVID-19 pandemic. Remarkably, in less than 1 year, vaccines have been developed and shown to be efficacious and are already being deployed worldwide. Yet, many challenges remain. Immune senescence and comorbidities in aging populations and immune dysregulation in populations living in low-resource settings may impede vaccine effectiveness. Distribution of vaccines among these populations where vaccine access is historically low remains challenging. In this Review, we address these challenges and provide strategies for ensuring that vaccines are developed and deployed for those most vulnerable.

COVID-19: The CIDRAP Viewpoint Part 5: SARS-CoV-2 Infection and COVID-19 Surveillance: A National Framework

From the Introduction: Effective surveillance of an emerging infectious disease such as COVID-19 [coronavirus disease 2019] poses unique challenges. Public health agencies have had to significantly increase their disease surveillance capacities to be able to rapidly identify new COVID-19 patients, follow up with their contacts, monitor disease trends over time, and identify hot spots of disease transmission, often with limited testing. Despite this increase in COVID-19 surveillance capacities, gaps remain. It's essential, therefore, to outline the main goals of COVID-19 surveillance and address key challenges to its effective implementation.COVID-19 (Disease);Public health surveillance;Epidemiology

COVID-19: The CIDRAP Viewpoint Part 3: Smart Testing for COVID-19 Virus and Antibodies

From the Introduction: Testing for SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2]--the virus that causes COVID-19 [coronavirus disease 2019]--is one part of the complex system required to address the pandemic. Testing is essential to confirm infection in cases and contacts, guide patient care, inform our understanding of transmission dynamics, prepare the health system for case surges, and inform the level of economic activity consistent with public health goals for limiting SARS-CoV-2 transmission. Technology to conduct molecular, antigen, and serology tests is now available, and additional technologies will be made available soon. The requirements for SARS-CoV-2 testing are unprecedented in both their urgency and the need for scalability, which present both technical and policy challenges. Current plans for clinical and public health laboratory testing do not sufficiently address the infrastructure needed to perform such tests. Critical guidance and coordination at the federal level is needed to meet the SARS-CoV-2 testing demand.COVID-19 (Disease);Disaster response--Plans

COVID-19: The CIDRAP Viewpoint Part 4: Contact Tracing for COVID-19: Assessing Needs, Using a Tailored Approach

From the Introduction: In situations involving major outbreaks or high rates of endemic disease, contact tracing is most effective either early in the course of an outbreak or much later in the outbreak when other measures have reduced disease incidence to low levels. In the latter instance, contact tracing is more manageable and can be used to eliminate remaining small foci of infection. Contact tracing, for example, was key in the late stages of the smallpox eradication program and has played an important role toward global polio eradication. [...] While contact tracing can be a valuable public health tool, its success depends on certain characteristics of the pathogen;the epidemiology of the disease involved;the thoroughness and follow-up of the contacts identified;the availability of rapid testing, preventive treatment and/or a vaccine;and the acceptance and effectiveness of quarantine for those potentially incubating an infection and of isolation for those found to be infected. Characteristics of the pathogen that influence the potential success of contact tracing include the routes of transmission (such as via aerosol, contaminated surfaces, or bodily fluids), the incubation period, the serial interval (the time between contact with a primary case and development of symptoms in a secondary case), the asymptomatic ratio (the percentage of infected people who remain completely asymptomatic during the course of their illness), the timeframe that people can transmit the disease before they develop symptoms, and the degree to which asymptomatic people can transmit the pathogen.Public health;Public health surveillance;Epidemiology;COVID-19 (Disease)

Influenza response planning for the centers of excellence for influenza research and surveillance: Science preparedness for enhancing global health security.

BACKGROUND: The Centers of Excellence for Influenza Research and Surveillance (CEIRS) network, funded by the US National Institutes of Health, has been operational since 2007 and is tasked with conducting research to improve understanding of influenza viruses. Recently, CEIRS developed an Influenza Response Plan (IRP) to improve science preparedness for the network. METHODS: Development of the IRP involved a collaborative process between project staff, CEIRS center directors or their designees, and NIAID CEIRS leadership (referred to as the Pandemic Planning Advisory Committee [PPAC]). Project staff identified and summarized the response capabilities of each center and then worked with the PPAC to identify and rank research priorities for an emergency response using a modified Delphi method. RESULTS: Key elements of the response plan include tables of response capabilities for each CEIRS center, a framework that outlines and ranks research priorities for CEIRS during an emergency situation, and an operational strategy for executing the research priorities. CONCLUSIONS: The CEIRS IRP highlights the importance of enhancing science preparedness in advance of an influenza pandemic or other influenza-related zoonotic incident to ensure that research can be carried out expeditiously and effectively in emergency situations and to improve global health security.