25 outbreaks in 20 years
New infectious diseases are emerging at an increasing frequency in the EU and other regions of the world, with the potential to profoundly impact public and animal health, and strongly disrupt local and international economies. The majority of these diseases are zoonoses, meaning they originate in or are transmitted by animals. In the last 20 years, there have been 25 documented emerging diseases that moved from wild or domestic animals to human populations. It is highly probable that zoonoses that spread rapidly (many of them are insect-borne diseases) in one or several EU countries will continue or increase due to environmental and demographic changes. The EU has already been affected by many zoonoses over the past 20 years, for example, West Nile virus, chikungunya and influenza H5N1.
Too many delays in vaccine delivery
Due to the unpredictable nature of the zoonotic outbreaks, the rapid development of containment and control programmes is critical to the well-being of both human and animal populations. Current vaccine development platforms, however, may not be appropriate to come up with effective products that can trigger a protective response. Additionally, in most cases these platforms rely on cell lines from mammals, which may not be readily available and may not yield enough material to address outbreaks. Furthermore, long regulatory processes for product approval may delay their applications. All of this results in unacceptable delays in vaccine delivery to the populations in needs.
Collaborative approach needed
Zoonoses clearly demonstrate that the health of the people is closely interlinked with the health of the animals and the environment – these types of diseases require a ‘One Health’ approach to research, which includes measures in the human and veterinary field. Today, no individual organisation has either the expertise or the resources available to ensure full readiness for delivering efficient control tools against future outbreaks. Therefore, close collaboration among governmental regulatory agencies, academic groups and industrial partners is a must for achieving such an ambitious objective.
What does ZAPI bring to the table?
By bringing together more than 20 partners, including leading human and veterinary research institutions, non-governmental organisations, regulatory agencies, academic groups and manufacturers, ZAPI aims to shorten the time to respond to emerging infectious diseases by using a multidisciplinary, One Health approach. The project aims to produce both platforms for the rapid production of veterinary vaccines and antibodies to protect the human population. The project also aims to ensure fast-track registration and implementation of the control tools after the emergence of the disease.
More specifically, the project is working towards:
- creating platforms that allow rapid identification and production of antibodies capable of neutralising emerging viruses;
- creating platforms suitable for rapid increases in the production of vaccines;
- enabling the development of quality control assays that do not make use of animals;
- establishing protocols for fast track registration of developed products.
Focusing on three key viruses
It is less expensive to control new infectious diseases in animals compared to the high costs triggered when the disease spreads to people. Therefore, the focus of the project is on three pathogens which occur first in animals before moving to people.
- Rift Valley fever virus causes recurrent outbreaks among ruminants (e.g. cattle, sheep and goats) and humans across the African continent, several islands of the Western Indian Ocean, and the Arabian peninsula. It is transmitted by mosquitoes. Infection can cause severe illness and/or death in animals and humans, as well as economic losses due to death and abortion among infected livestock.
- Schmallenberg virus is associated with abortions, stillbirths and malformations in ruminants in Asia, Africa and Oceania. It emerged in Europe for the first time in 2011 and is transmitted by mosquitoes. No evidence of human infection has been reported but related viruses have zoonotic potential.
- Middle East respiratory syndrome coronavirus first emerged in the Arabian peninsula in 2012, causing severe lower respiratory tract disease in humans. Approximately 36% of the reported patients have died. Camels are likely to be a major animal source of infection in humans.
Significant impact while reducing animal testing
ZAPI’s innovative approaches aim to result in significant scientific and technological impact, leading to a faster response to newly emerging viruses. Furthermore, the ZAPI platform will reduce the number of animal experiments necessary for the development of vaccines, and will minimize the need for control tests in animals for the regulatory release of commercial vaccine batches.
Achievements so far
A year after the launch, the project is already yielding its first results. The results generated so far confirm the initial hypothesis that it should be possible to generate viral vaccines based on small subunits expressed in systems other than the classical mammalian or avian cells. Additionally, some of the project milestones have already been achieved ahead of schedule including the generation of key neutralizing antibodies against all 3 target viruses. In addition, a consensus on industrial and regulatory processes needed to deliver key vaccines and/or antibodies in quantities needed to address outbreaks was obtained; methodology to determine constraints and criteria for the selection of systems for industrial scale-up; as well as innovative advances for the design in vitro QC assays, and innovative advances in the design of vaccine candidates were developed.