Is Europe Prepared for the Future of Vaccines Innovation?

Introduction

Each year, vaccines help protect people of all ages worldwide against nearly 30 vaccine-preventable diseases. Second only to clean drinking water, vaccines save more lives (around 2-3 million) than any other public health intervention. Vaccination plays a fundamental role in helping to protect people from diseases that would otherwise decimate communities and weaken societies. That is why vaccines are widely seen as one of the best investments in healthcare that any government can make.

The recent life science revolution, the exponential growth of new insights into host-disease interactions, and the discovery of disruptive technologies are enabling us to re-think vaccinology and to develop new vaccines we could not have imagined even a few years ago. Unlocking this potential means we are on the verge of developing vaccines for more diseases and populations, faster and more efficiently than ever before.

Careful preparation is required to fully realize the potential of tomorrow’s vaccines. Many current challenges related to development, licensure, and administration of vaccines must be overcome. Now is the time to for Europe to lead the way to ensure successful development of the next generation of vaccines and delivery to patients who need them.

New Vaccines Will Bring Unprecedented Health Benefits

Advancements in vaccinology, immunology, and new technologies have the potential to fundamentally change the dynamics of vaccine development by enabling us tackle new disease targets previously believed out of reach, and  to test, manufacture, and deliver vaccines faster. Moreover, these breakthroughs highlight new opportunities to expand protection offered by vaccination for all stages of life, a concept we call “lifecourse immunisation” [see Figure 1].

Promising new technologies include antigen delivery platforms like GSK’s self-amplifying mRNA (SAM), generalised modules for membrane antigen (GMMA), and bioconjugation, which can potentially speed up discovery, increase potency and efficacy, simplify and accelerate manufacturing, and reduce scale-up time and costs to make vaccines accessible to broader populations. Adjuvants substances designed to enhance the immune response to vaccines also create new possibilities.

Adjuvants have been used in vaccines since the 1930s, but today scientists have a deeper understanding of how the human immune system interacts with pathogens. With a new generation of adjuvanted vaccines we will be able to target populations with sub-optimal immune responses, including older adults at risk of developing diseases like respiratory syncytial virus (RSV) and Chronic Obstructive Pulmonary Disease (COPD), and people living in developing countries and exposed to global killers like tuberculosis and Malaria.

These new technologies open opportunities for a step-change in vaccine discovery, and will help expand new fields of vaccine development. For example, the area of therapeutic vaccines is growing and has great potential for patients. GSK is already working on vaccines for patients suffering from chronic diseases like Hepatitis B infection, which can lead to liver cancer¹, and COPD, a debilitating respiratory disease that is becoming more prevalent globally.¹

In addition to therapeutic vaccines, we are also setting our sights on vaccines that address antimicrobial resistance (AMR), a growing threat to public health and modern medicine³. For example, GSK has begun clinical studies for a vaccine against an often-devastating infection with bacteria called C. difficile, a major cause of gastroenteritis-associated illness, antibiotic use, and death worldwide.⁴

Europe Can Play a Lead Role in the Transformation of Vaccine Innovation

Europe is poised to drive the transformation of vaccine innovation. The EU-funded and multi-stakeholder led Innovation Partnership for a Roadmap on Vaccines in Europe (IPROVE), outlines the science and technology investments required for vaccines innovation and charts a scientific course forward.⁵  GSK contributed to this roadmap and we remain a committed partner to implement its objectives. In this spirit, we offer the following recommendations for a stronger European vaccine research and innovation (R&I) enterprise:

1. Build Upon the IMI Partnership Model 

Europe has led multi-sectoral partnerships in public health and medicine with the Innovative Medicines Initiative (IMI1 and IMI2). Now in its second decade, the IMI has built an unparalleled network of public and private researchers who have translated basic immunology insights into tangible vaccine development milestones⁶. With 13 IMI projects on vaccines, GSK and other vaccine companies have contributed substantially to major advancements in vaccine R&I in Europe and beyond.⁷

The Horizon Europe and new health innovation partnership programs offer a timely opportunity to build upon this successful model for the future. To build a true partnership, we urge European Institutions to move beyond the current structure where the role of industry is often limited to a contributor rather than an integral partner in the process of bringing vaccines to the market. As we have demonstrated, industry brings unique expertise, experience and capabilities that significantly contribute to innovation, and therefore should be integrated as a key partner across the spectrum of R&I activities.

2. Commit to Transform & Accelerate Vaccine Development

Given the rapid progress in life science and vaccine technologies, concerted action is needed to realize the full potential of future vaccines. Constant innovation is needed in vaccine development, which is complex and currently takes as long as two decades or more.⁸  To accelerate the critical pathway from discovery to delivery, we need to transform research, development, and licensure.

The IPROVE roadmap identified a need for a multidisciplinary approach to vaccinology. By harnessing analytical tools and data sources available today and in the future, we can identify targets and reach decision points faster, by exploiting our rapidly evolving understanding of microbiology, genetics, immunology, structural and systems biology, and bioinformatics.

We also need to take a closer look at clinical trials to identify opportunities to modernise and streamline whilst maintaining the highest safety standards. The IPROVE roadmap calls for innovative design and harmonisation of clinical trials data and development of analyses frameworks, including use of novel analytical tools to streamline data collection during trials and profile volunteers earlier in the process. Advances in immunology, disease modelling, in silico modelling, including the analysis of big data and the application of machine learning and artificial intelligence, provide opportunities to innovate, de-risk and accelerate the vaccine-development process.

In addition, more effort and collaboration are needed to develop controlled human infection models (CHIMs) which are especially helpful for the development of vaccines and can provide early evidence of clinical efficacy and samples for cutting-edge immunological research. CHIMs are particularly needed for the development of universal or broadly protective vaccines against influenza, RSV, and C. difficile.

Finally, we recommend expanding beyond mainly disease-driven IMI projects toward projects that encompass technology-oriented research, including vaccine adjuvants, platform technologies, antigen discovery, and systems-immunology. By doing this, Europe will more quickly open new fields of vaccine development like therapeutic and AMR vaccines for patients throughout the life course.

3. Foster a Competitive and Innovation-Friendly Environment for Vaccines

A supportive and innovation-friendly R&I environment is essential to drive the development of new vaccines.  Europe has a long history of leading the world in vaccine discovery. Today, the vaccine R&I and manufacturing footprint in Europe is substantial. Continuous investment in vaccine research, development, and production represents a major public health strength and economic asset for Europe.

Ensuring a competitive and innovative vaccine development and manufacturing landscape requires commitment to policies that drive private sector investment. This requires an appropriate balance between “push” mechanisms (e.g. capacity, capability, funding, tax incentives and infrastructure) and “pull” mechanisms (e.g. clear target product profiles, more predictable and stable demand, and improved procurement policies). More fundamentally, it requires a viable and sustainable pricing and access environment for vaccines in Europe.  Policy change will require sustained political will, but will ensure Europe remains a global leader in this vitally-important sector.

Conclusion

We are on the brink of a new era of vaccines in which the scientific and technological advances across the life sciences will revolutionise vaccine development. To fully enable the potential of future breakthroughs, a clear scientific roadmap of actions has been proposed that would improve the way vaccines are evaluated, licensed, used, administered, monitored, and financed.  The European Institutions are positioned to be at the forefront of this transformation. What is needed now is sufficient political drive to enable this ambition, including implementation of appropriate legal, economic and structural measures that will best incentivise, reward, and accelerate vaccine innovation in Europe.

1 – Hepatitis B Foundation. Risk Factors for Liver Cancer. https://www.hepb.org/research-and-programs/liver/risk-factors-for-liver-cancer/.
2 – Quaderi, SA and Hurst, JR. The unmet global burden of COPD. Glob Health Epidemiol Genom. 2018; 3:e4. Available at, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5921960/.
3 – Toner E, et al. Antimicrobial resistance is a global health emergency. Health Security 2015 13:3 153-55. https://www.liebertpub.com/doi/full/10.1089/hs.2014.0088.
4 – Abt Mc, MKenney PT, Pamer EG. Clostridium difficile colitis: pathogenesis and host defence. Nature Reviews Microbiology 2016; 14:609-620. Available at, https://www.nature.com/articles/nrmicro.2016.108.
5 – A strategic European roadmap for the vaccines of tomorrow: a joint stakeholder reflection. March 2016. Available at, http://iprove-roadmap.eu/wp-content/uploads/2016/06/IPROVE-ROADMAP_JUNE2016_WEB.pdf.
6 – Denoel P. et al. Impact of Innovative Medicines Initiative on vaccine development. Nature Reviews Drug Discovery 2018; 17:769–770.
7 – Ibid.
8 – International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The complex journey of a vaccine: the steps behind developing a new vaccine (2019). Available at, https://www.ifpma.org/wp-content/uploads/2019/07/IFPMA-ComplexJourney-2019_FINAL.pdf

Dr. Emmanuel hanon Senior Vice President, Head of R&D, GSK Vaccines	Dr. Rino Rappuoli Chief Scientist, GSK Vaccines	Dr. Philippe Denoel Head of External R&D, GSK Vaccines