Coalition for Epidemic Preparedness Innovations
The 2015-2016 Ebola epidemic and other outbreaks highlighted the need to better balance incentives for private R&D with coordination efforts to master emerging infectious disease (EID) crises. A new decision-analytic approach aims to move social bargaining processes closer to commitments for action.
CEPI members – including the three task teams and leadership group (see Annex 3 of the CEPI business plan, Coalition for Epidemic Preparedness Innovations 2016) – volunteered their time to engage in this exploratory decision-analytic process.
In the wake of the devastating Ebola epidemic, global thought leaders from governments, industry, and philanthropy agreed that new approaches are needed to speed up vaccine development. They launched an innovative international partnership — the Coalition for Epidemic Preparedness Innovations (CEPI) — to advance the development of medical countermeasures such as vaccines faster and ensure they are available to people during outbreaks.
CEPI aims to advance vaccine candidates through late preclinical studies through proof of concept and safety in humans. It will also establish vaccine manufacturing platforms that are flexible enough to respond quickly to outbreaks of unknown or emerging pathogens, called Disease X.
To do this, CEPI will work with low- and middle-income countries to build their capacities in vaccine testing, assay development, and other areas needed to support vaccine development. The coalition is based on the model of “networked multilateralism” that brings together partners for a limited amount of time to achieve specific goals – in this case, rapid vaccine development.
Before vaccines can be tested in people, they go through preclinical tests with lab-grown cells and laboratory animals like mice or monkeys. This is to see if the vaccine might cause the right kind of defense response in humans and is safe enough to start testing with people.
Once a vaccine is ready for the human test, it goes through multiple phases of clinical trials with thousands of people to see if it works and is safe. The company making the vaccine must test every batch for quality, and FDA reviews the results and inspects the factories. There are also systems to track any possible side effects, like the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink.
The goal of this work is to reduce the time it takes for life-saving vaccines to be produced, delivered and distributed during epidemics and pandemics. This was a key theme of the summit, which was attended by leaders from governments, private philanthropy and industry.
In the wake of COVID-19 and EV71, it’s clear that emerging infectious diseases (EIDs) pose a serious threat to global health security. They not only kill millions of people but also cause immense economic disruption. This is why the world needs to better leverage vaccines to protect against EIDs – and that’s where the Coalition for Epidemic Preparedness Innovations can help.
The existing global vaccine emergency stockpiles managed by UNICEF are being stretched to their limits, particularly for the new EIDs being seen in Africa and beyond. Vaccine manufacturers are therefore working to improve their supply chain efficiency and one of the areas they are focusing on is vaccine stockpiling management.
This includes rethinking ways that vaccines are stored to ensure they can be shipped rapidly when needed. All held stocks are subject to risk of expiry unless specific contractual agreements mitigate this, and this adds up to substantial financial losses for manufacturers. Taking a more holistic view of vaccine stockpiling will require greater collaboration with buyers and the immunization community as a whole.
Vaccines are one of the most powerful tools available against epidemic infectious diseases, which can have devastating humanitarian and economic impacts. Yet, vaccine development can be a long and costly endeavor.
Creating a pipeline of vaccines for EIDs, increasing R&D response speeds to new disease threats, and improving equity through affordable pricing and regional R&D capability strengthening in countries most likely to experience epidemic outbreaks are all important priorities.
This year, CEPI is pursuing an ambitious agenda, which includes a “moonshot” objective to reduce vaccine development timelines to 100 days. The coalition is bringing together public, private and philanthropic organizations to support the development of platforms that can accelerate vaccine development against known diseases and unknown prototype pathogens that could lead to the next Disease X. This is an end-to-end approach to tackling emerging threats. This will ensure that the world has life-saving countermeasures available at a moment’s notice when they need it most. This will require unprecedented speed, coordination and innovation.