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, according to analytics company GlobalData
The company’s latest report: Vaccines for Emerging Infectious Diseases: Funding, R&D, and Global Partnership Strategies, finds that philanthropic organisations 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*.
Paul Jeng, PhD, Infectious Diseases Analyst at GlobalData, said: “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 organisations to subsidise vaccine development by purchasing a vaccine before licensure.”
GlobalData’s 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.
Jeng added: "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.”
GlobalData found that adaptive clinical trial design will play a major role in the pivotal studies of pipeline vaccines for EIDs.
“KOLs interviewed by GlobalData believed 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, randomised 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,” concluded Jeng.
*major EIDs include Zika, Ebola, MERS, Lassa, Marburg, Severe Acute Respiratory Syndrome (SARS), Chikungunya, CCHF, West Nile, Dengue, Yellow Fever, H5N1