"Vaccines for Emerging Infectious Diseases: Funding, R&D, and Global Partnership Strategies" finds that philanthropic organizations and public-private partnerships like the Coalition for Epidemic Preparedness Innovations (CEPI) are filling a niche for funding translational and clinical vaccine research, allowing development of vaccines for diseases such as Lassa fever to occur even in the absence of an ongoing epidemic. As of November 2018, there were 235 vaccines in preclinical investigation, clinical development, or marketed for twelve major EIDs.
Although development of interventions for emerging infectious diseases (EIDs) has traditionally been limited by a lack of market incentives, novel funding mechanisms and global partnerships for outbreak preparedness are expanding the commercial prospects for vaccine developers.
EIDs are uniquely challenging for vaccine development due to unpredictable clinical incidence or geographical patterns. In response to recent global outbreaks, such as the 2013-2016 West African Ebola epidemic, global partnerships have been formed to stimulate vaccine development with a blend of push and pull market incentives. Chief among these are advanced market commitments (AMCs) from health organizations to subsidize vaccine development by purchasing a vaccine before licensure.
The report also finds that 90.2% of marketed or experimental vaccines for major EIDs are still in preclinical or clinical development, leaving significant opportunity for drug developers to enter relatively open disease landscapes for numerous indications.
There is a wide gap in the stage of vaccine development for different EIDs. For instance, there have been 57 planned, ongoing, or completed clinical trials for vaccines to prevent Ebola virus disease, and Merck's Phase III product, V920, is expected to receive FDA approval in 2019. However, the majority of EIDs do not have any licensed vaccine products. Some EIDs including Middle East Respiratory Syndrome (MERS) and Crimean-Congo Hemorrhagic Fever (CCHF) have had experimental vaccines tested in fewer than six clinical trials. Adaptive clinical trial design will play a major role in the pivotal studies of pipeline vaccines for EIDs.
KOLs believe that regulators and vaccine developers are moving towards adaptive clinical trials that factor in rapid surges and declines in disease incidence. Instead of requiring a single large, randomized Phase III trial for vaccine approval, new strategies include collecting and combining data across multiple outbreaks, and expanding avenues for post-marketing studies to evaluate safety and clinical benefit.
Major EIDs include Zika, Ebola, MERS, Lassa, Marburg, Severe Acute Respiratory Syndrome (SARS), Chikungunya, CCHF, West Nile, Dengue, Yellow Fever, H5N1.
This report covers current and future challenges for the development and deployment of vaccines for EIDs, focusing on vaccine platform technology and research, funding mechanisms, and collaborative global partnerships.
Overview of EIDs: Background, drivers of transmission, and overview of key EIDs.
Clinical Trial Design: How vaccine for EIDs clinical trials are being designed and what regulatory strategies are being explored.
Vaccine Platform Technologies: How the current platform technologies for vaccines compare.
Pipeline Assessment for Key EIDs: What are the pipeline vaccine products in development for key EIDs.
Funding and Market Incentives: How vaccine development is being incentivized in the public and private spaces.
Global Collaborations: How global and public-private partnership organizations are supporting vaccine development.
Vaccine Preparedness: The current and future challenges face vaccine preparedness from a surveillance and infrastructure perspective.
Key Topics Covered:
1. Preface 1.1 1.2 Abbreviations 1.3 Related Reports 1.4 Upcoming Related Reports
2. Executive Summary 2.1 Key Findings 2.2 KOL Insights on Vaccines for Emerging Infectious Diseases
3. Overview of Emerging Infectious Diseases 3.1 Defining Emerging Infectious Diseases (EIDs) 3.2 Drivers of Emerging Infections & Routes of Transmission 3.3 Key EIDs 3.4 Ebola Virus Disease 3.5 Zika Virus Disease 3.6 Middle East Respiratory Syndrome (MERS) and Other EIDs
4. Clinical Trial Design 4.1 Clinical Trial Design Challenges 4.2 Randomization Units 4.3 Selection of Clinical Trial Population and Comparator 4.4 Additional Strategies for Vaccine Approvals 4.5 Unmet Needs in Clinical Trial Design
5. Vaccine Platform Technologies 5.1 Overview of Vaccine Platform Technologies 5.2 Vaccine Platforms By Stage of Development 5.3 Live-attenuated Vaccines 5.4 Viral Vector-Based Vaccines 5.5 DNA Vaccines 5.6 Whole-Inactivated Vaccines, Subunit Vaccines, and VLPs
6. Funding and Market Incentives 6.1 Funding Sources for Vaccines for EIDs 6.2 Push and Pull Incentives 6.3 Challenges for Funding of Vaccine Development 6.4 Lessons from the Ebola and Zika Outbreaks
7. Global Collaborations for Vaccine Development 7.1 Global Vaccine Development Fund and Priority Diseases 7.2 Coalition for Epidemic Preparedness Innovations (CEPI) 7.3 Vaccine Preparedness 7.4 Global Virome Project (GVP) and Other Public-Private Partnerships
8. Pipeline Vaccines for Key Emerging Infectious Diseases 8.1 Clinical Development of Vaccines for EIDs 8.2 Ebola Vaccine Pipeline 8.3 Zika Vaccine Pipeline 8.4 MERS-CoV Vaccine Pipeline
9. Surveillance and Healthcare Infrastructures 9.1 Disease Surveillance for EIDs 9.2 Logistical Challenges for Vaccine Delivery 9.3 Vaccine Preparedness 9.4 Unmet Needs in Basic Vaccine Research