ZAPI

Bringing a new vaccine to market takes a long time in part because manufacturers have to prove that their vaccines are beyond reproach, safety-wise. In recent years, pharma companies have been experimenting with ‘platform technologies’ that can speed up this lengthy licensing process. Platform technologies refer to any technology, whether it’s a mechanism, delivery method, or cell line, that we can use as a base for producing different medicinal products.###

IMI’s ZAPI project, recognising that such a platform is essential in the face of the threat of emerging zoonotic disease outbreaks, started working on a plug-and-play vaccine and antibody production platform in 2015. Their platform allows the immunogen of a new virus to be plugged in to produce millions of doses of new doses within months.

The ZAPI partners not only built the technical platform (and put it into practice when COVID-19 struck), they also worked the regulatory side. Now, they have influenced the updated legislative guidelines for veterinary medicine products that will be applicable in all EU countries from 28 January 2022, thus likely shaving years off future authorisation applications.

'That means that there is no need in the licensing procedure to re-discuss the safety of the platform. It’s done,' says Dr Joris Vandeputte, president of the International Alliance for Biological Standardization (IABS). The vaccine developer only has to insert the new immunogen for the new disease, and then go on with final product testing.

'This is really incommensurable, what ZAPI has done here. The big added value is not only the principle, it's also the fact that we have prepared the regulatory authorities. We are sure that thanks to this technology, in six months we can generate not millions, but billions of the antigens needed for vaccines.'

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One way of dealing with the threat of another pandemic like COVID-19 is investing in plug-and-play vaccine technologies that can respond to a wide variety of virus types. IMI’s ZAPI project has created a new methodology for quickly designing and manufacturing a vaccine in the event of a new disease outbreak in humans or animals that consists of the assembly of only two components. ###The only variable is the immunogen, which will change depending on the target pathogen.

Manufacture of a so-called ‘ZAPI-like vaccine’ can take place anywhere. That’s because a guiding objective in the design of the manufacturing process was to keep it very simple by limiting the number of steps involved. Having multiple manufacturing sites is one of the key factors in responding as quickly as possible in the event of a new pandemic as it enables to expand production capacity close to the needs everywhere in the world.

‘We have demonstrated up to a significant scale that this vaccine approach can be readily and rapidly industrialised to supply the large number of vaccine doses which are needed,’ explains ZAPI coordinator Jean-Christophe Audonnet. ‘This is something that everyone can appreciate when you see that SARS-CoV-2 vaccine manufacturers are suffering from shortages or significant capacity reductions compared to the amounts that had been promised initially in the vaccine supply agreements.’

ZAPI-based vaccines are currently being developed for SARS-CoV-2. 'Chinese, UK and US teams are actively working with this MPSP display-based vaccines, most of them using exactly the same MPSP [multimeric protein scaffold particle] as in the ZAPI project, coupled to SARS-CoV-2 RBD subunit,' concludes Dr Audonnet.

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Zoonotic diseases are those that are transmitted from animals to humans. COVID-19 is zoonotic in origin, and experts believe such outbreaks could become increasingly frequent in the future. The best we can do - and must do - is be prepared. ###In 2015, IMI launched ZAPI (Zoonotic Anticipation and Preparedness Initiative) to set up tools and platforms that would be ready to put into production for vaccines and monoclonal antibodies (cloned copies of the body’s natural defences) to efficiently counter emerging or remerging diseases. Much of the project’s work on the Middle East respiratory syndrome (MERS) coronavirus, can be directly applied to SARS-CoV-2, the virus that causes COVID-19, as the two are closely related.

‘This scenario with COVID-19 is exactly the scenario that we are working to prevent in the future – of course it’s never exactly the same virus but one of our models, the MERS coronavirus that occurred a few years ago, has taught us a lot about how to design and manufacture antibodies and to test them,’ says project coordinator Jean-Christophe Audonnet of Boehringer Ingelheim.

‘As we have seen, the diseases are coming very fast, and it’s very difficult to react very efficiently to the different factors. We want to show, however, what is technically possible,’ he continues. ‘It’s a real life experiment now for us. A factor that we need to explore better through dialogue is how we can reduce the timelines for the key decisions - political and regulatory ones. Maybe we have to reflect all together as a society how to overcome this.’

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This month IMI announced a new funding Call in reaction to the spread of COVID-19. The process is being fast-tracked, just like the call for Ebola projects in 2014. However, as IMI Executive Director Pierre Meulien points out in a new opinion piece published on the IMI website, there’s nothing unexpected about the emergence of these epidemics.###

‘Every year, viruses jump from animals to the human population, including certain strains of influenza,’ he writes. ‘The closer we live to animals, the more of these ‘jumps’ we’re going to see.’

The scientific community needs to get ready to respond regardless of where the next virus comes from. In that respect, two ongoing IMI projects now look particularly prescient: the ZAPI project was set up to deliver a platform and technologies to facilitate a rapid response to future disease outbreaks. In 2019, the project demonstrated that certain antibodies can stop the MERS coronavirus from infecting new cells, and they’re now assessing whether the antibodies could also be effective against SARS-CoV-2, the virus that causes COVID-19. COMBACTE-NET, part of the antimicrobial resistance programme, has set up a network of clinical and laboratory sites across Europe that has been mobilised to support global efforts to standardise the information gathered from patients with suspected or confirmed COVID-19.

COVID-19 has put everyone on the alert because there’s so much we don’t know about it. Dr Meulien concludes: ‘In the coming months, the scientific community will no doubt be able to answer more questions about the epidemiology and modes of transmission of the virus, and the story will gradually recede from the headlines. Meanwhile, the projects that will result from the IMI coronavirus call will outlast the news cycle, putting everything in place for the next outbreaks, wherever or however they may emerge.’

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In the run-up to World Immunisation Week 2019, the IMI Programme Office caught up with three projects working in this important area.###

• Vaccines are one of the most effective public health measures out, yet public distrust in immunisation programmes is limiting high vaccine uptake, resulting in outbreaks of vaccine-preventable infectious diseases that had almost disappeared. ADVANCE has paved the way for an open system for actively monitoring vaccine coverage, benefits and risks in Europe. Read more
• Zoonoses are infectious diseases that can be transmitted to humans from animals (and vice versa). IMI's ZAPI project is working to create new platforms and technologies that will facilitate a fast, coordinated, and practical response to new infectious diseases as soon as they emerge. Read more
• Every year, pharmaceutical companies develop vaccines designed specifically to combat the strains of influenza (flu) that are most likely to be in circulation the following winter. However, accurately predicting how much protection a new vaccine would actually offer against emerging virus types is far from easy. The FLUCOP project is developing tools to address this challenge. Read more

World Immunisation Week is organised by the World Health Organization at the end of April every year.