HealthIndustryResearch & Innovation

Harnessing the power of partnerships to develop life-saving vaccines

By Dr. Pierre MEULIEN, Executive Director, Innovative Medicines Initiative (IMI)

It is universally well accepted that vaccination is one of the most effective lifesaving public health interventions the world has as its disposal. So far, two mammalian diseases have been officially wiped out through vaccination campaigns. Smallpox, which plagued the human race for thousands of years (it was responsible for about 400,000 deaths in Europe every year in the 18th century) was officially eradicated in 1980. Rinderpest, which caused infections in cattle, buffalo, antelope, deer and related species, was eradicated in 2010.

Many other diseases have been and are being controlled today through massive vaccination campaigns worldwide. These include diphtheria, tetanus, polio, some forms of meningitis, otitis, whooping cough, pneumonia, hepatitis A&B, measles, rubella, mumps, chicken pox, influenza and others.

Europe plays an important part in securing the production of these vaccines. Indeed 80% of the world’s vaccines are produced on European soil and we can also boast some of the best groups involved in vaccine research and development in the world.

This is one reason why so much vaccine oriented research is funded through the Innovative Medicines Initiative (IMI), a public-private partnership (PPP) between the European Union and the European pharmaceutical industry.

Vaccine research lends itself well to the PPP model because there are many areas where there is a need for collaboration between industry, academic researchers and others to create multi-stakeholder groups that have the expertise, data and resources to address major gaps and solve challenges in vaccine research and development. Only by working together in this way can we hope to accelerate the time from the research bench to clinical assessment in humans.

Over the past 11 years of IMI we have invested over EUR 430 million (from public, private and philanthropic sources) in 17 projects covering a whole host of issues. The IMI vaccine portfolio can divided roughly into two main chapters. The first includes projects covering general bottlenecks in vaccines R&D, including ways of assessing vaccine efficiency, manufacturing quality, and vaccine safety, for example. The second is about how Europe responded to the pandemic threat of Ebola in 2014.

Spotlight on Ebola

When the Ebola crisis broke in Africa in 2014, there was no vaccine, no rapid diagnostic, no anti-viral therapy; in short, nothing that we could offer patients or those at risk in order to squash the epidemic. The IMI Governing Board reacted immediately by allocating a significant budget and launching a series of Calls for proposals for European and African groups to accelerate research on vaccines, rapid diagnostics, manufacturing platforms and clinical trials platforms.

To date, we have invested over EUR 300 million in this area and the resulting IMI projects have been spectacular in how they have enabled valuable implementation in the field. One vaccine went from bench to the clinic within one year, while another project worked on analysing the immune responses to another Ebola vaccine both in Europe and Africa.

Three rapid diagnostics are being field-trialled as we speak and manufacturing at scale strategies have been worked out in yet another project. The project teams have also been working with social scientists and technologists to ensure public acceptance of the local campaigns through educational and outreach programmes.

Within our Ebola portfolio there are projects focused on rapid diagnostics which are badly needed for this disease. It is so important to be able to detect as quickly as possible whether people presenting with symptoms have Ebola (in which case they need to be isolated) or another illness. Four IMI projects are dealing with this issue and have mobilised laboratories in Europe and Africa as well as small biotech companies and the diagnostic industry to provide creative solutions. Currently several of the resulting prototypes have been approved to be used in field trials in the current DRC outbreak.

We have another project called ZAPI (‘Zoonoses anticipation and preparedness initiative’), which brings together experts in human and animal health to create new platforms and technologies that will facilitate a fast, coordinated and practical response to new infectious diseases as soon as they emerge. The project has chosen three viruses that have been known to make the leap from animal to human. These are Rift Valley fever (usually infecting cattle, sheep, camels and goats), Schmallenberg virus (cattle sheep and goats), and Middle East Respiratory Syndrome (MERS, whose usual reservoirs include bats and camels).

Addressing some of the biggest challenges in vaccines research

The other part of the IMI vaccine portfolio deals with some hot topics in vaccinology. For example, while we know a lot about how antibodies neutralise incoming pathogens, we know a lot less about how cellular immunity works, and what potential markers of immunity could be in different settings. Here, IMI’s FLUCOP project is looking at many immunological parameters to decipher which markers correlate with a protective response to flu vaccines. The results of this project are currently being used to design future influenza vaccines and could help us design the ultimate universal flu vaccine.

We are also looking at vaccine safety as the bar for safety in vaccination is set extremely  high and for good reason  as vaccines are used mostly in prevention strategies and therefore intervening in healthy populations where safety should be paramount. Thanks to our projects, we now understand much more about the human immune system and how to harness this optimally in order to maximise the desired immune response against a specific infectious agent while minimising the risk of adverse events.

Taking action on vaccine hesitancy

Finally, we need to address the issue of vaccine hesitancy in Europe. There has been a lot of misinformation coming from the anti- vaccine lobby which needs to be countered by evidence based data covering the epidemiology of disease in Europe and the positive impact of the use of vaccines. IMI’s ADVANCE project’s 47 partners come from 19 EU countries and include the vaccine industry, the European Centre for Disease Prevention and Control, the European Medicines Agency, national public health laboratories and academic experts. The project has delivered a blueprint of an efficient and sustainable vaccination benefit- risk assessment tool that is acceptable to all stakeholders. This is a major achievement and provides a platform for solid monitoring of the benefits and safety of vaccines.

Recently ADVANCE has driven the creation of a not-for–profit international organisation called VAC4EU. Its goal is to provide, in a consistent and stable manner, the evidence that the European citizen and policy makers have been asking for. Hopefully this will increase the confidence that the EU citizen has in vaccines so that we can together avoid dramatic situations like the recent explosion of cases of measles in 47 European countries, solely due to a decrease in vaccination rates.

We have a collective responsibility to share solid evidence on the benefits of vaccination so that our populations can remain immunised against the most deadly diseases that historically had such a devastating impact on our societies.

Introducing IMI

The Innovative Medicines Initiative (IMI) was set up in 2008 as a public-private partnership between the European Union (rep- resented by the European Commission) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

For 2014-2020, IMI’s total budget is EUR 3.276 billion. Of this, EUR 1.638 billion comes from Horizon 2020, the EU’s funding programme for research and innovation. EFPIA companies have committed EUR 1.425 billion to the programme, and up to EUR 213 million can be committed by other organisations that decide to con- tribute to IMI as Associated Partners in individual projects.

At IMI, our goal is to improve the medicines development process and make it more efficient, and to ensure that patients will have faster access to better and safer medicines. We do this by funding collaborative projects that bring together all key groups involved in life science research. Through our projects, we are funding innovative solutions to the most pressing medical burdens of our time, including antimicrobial resistance, dementia, and diabetes.

Over a decade in, we are globally recognised as a pioneer of open innovation and an attractive model for successful public-private partnerships (PPPs) in research.

Interested? Find out more at imi.europa.eu