The role of vaccines innovation in Europe’s biotech strategy

A sector already delivering for Europe

Europe remains one of the world’s leading vaccine development and manufac turing ecosystems and a global supplier of vaccines. Leading Vaccines Europe, I see this strength up close every day. It is factories running, pipelines advancing, and scientists working to solve problems that did not exist a decade ago, while continuing to refine the vaccines already protecting millions. The trade figures speak for themselves. In 2024, the EU exported approximately $24.5 billion worth of vaccines worldwide, rep resenting 7.9% of total EU pharmaceutical exports, while importing $3.4 billion, gen erating a trade surplus of $21.1 billion. This is equivalent to 10.9% of the total EU pharma ceutical trade surplus. Europe’s leadership was also evident during the COVID‑19 pandemic. By January 2022, the EU had produced approximately 40% of the world’s COVID‑19 vaccine exports showing what a strong domestic vaccine industry can deliver when it matters most. This was only possible because the underlying research platforms, manufacturing infrastructure and regulatory expertise already existed in Europe. What makes this sector distinctive is not just its scale, but its complexity.

Developing a vaccine requires exceptional scientific and technical expertise, long‑term investment and highly specialised manufacturing capabilities. From discovery to approval, timelines can extend over a decade.

The sector depends on strong disease surveillance networks, gen erations of accumulated know‑how, and an ecosystem that is difficult to rebuild once lost. The vaccines industry is also one of the most research‑intensive sectors in Europe, and that pipeline of innovation remains strong. Vaccines Europe’s latest pipeline review shows member companies are currently developing 91 vaccine and monoclonal antibody candidates targeting infectious diseases, emerging health threats and AMR. This is an industry not simply responding to today’s challenges but actively preparing for tomorrows. Immunisation has come a long way from relying on a narrow set of technologies. Today’s vaccine platforms span a much broader range, enabling protection against a wider array of pathogens and allowing approaches tailored to age, socioeconomic status, geography and other population needs. This diversity is a strategic asset: the more vaccine technologies available, the better placed the world is to respond quickly when new health threats emerge. It is exciting to see this level of innovation on our doorstep. It is now up to Europe to ensure it continues to grow.

Yet, the vaccine sector is not spared from the decline affecting Europe’s innovative research‑based pharmaceutical industry, whose share of global clinical trials has halved over the past decade. This trend is reflected in immunisation research. Vaccine trials increased globally during the COVID‑19 pandemic, however the EEA’s global share of immunisation trials has since fallen from 17% in 2018 to 8% in 2023. This decline has been sharpest in Phase 3 and Phase 4 trials, as activity shifts increasingly toward Asia and Oceania. Disparities across EEA countries add a further layer of frag mentation to Europe’s vaccine innovation ecosystem. I have watched this trend deepen. Increasingly, Europe risks being treated as the cautious choice rather than the obvious one.

Getting the policy environment right

The EU has a real opportunity to keep growing vaccine capacity in Europe, and the proposed Biotech Act I is a step in the right direction, signalling that Europe’s health sector is a strategic industrial and scientific asset. While vaccines are covered by default under the Act as biotechnologies and med icines, the initiative is an opportunity to ensure that the vaccine sector is considered on its own terms, accounting for the specificities of its unique ecosystem. Having engaged closely following the publication of the Biotech Act I, I believe it is important that a sector with distinct needs is not overlooked by being treated as identical to other biotechnologies.

The vaccine lifecycle depends on strong surveillance systems, preparedness planning, sustainable manufacturing capacity, and long‑term public health strategies. If Europe wants to maintain its global leadership, it needs policy that actively safeguards the com petitiveness of its vaccine industry. Targeted policy refinements would help ensure that the specificities of the vaccine ecosystem are fully reflected in the implementation of the EU Biotech Act I.

Good decisions depend on good data. Yet, gaps and delays in epidemiological and vaccine‑effectiveness data continue to slow public health decision‑making, resilience of the supply chain, and hold back innovation. The Act should ensure that high‑quality data is independently and promptly available.

The regulatory framework needs the same scrutiny. The Act currently exempts certain advanced GMO‑based therapies from envi ronmental assessment requirements ‑ but vaccines are left out. Closing this gap, for example through a clear exemption for eligible vaccines in the EU’s Clinical Trials Regulation, would cut red tape for next‑generation vaccines and the further development of existing vaccines while continuing to maintain strong environmental or public health protections. Finally, there’s the question of strategic recognition. The Act creates a new category of “Strategic Health Biotechnology Projects” to support Europe’s most competitive, resilient and technologically advanced health initiatives. Vaccines are a natural fit. They prevent disease, depend on advanced manu facturing, and deliver outsized public health and economic returns. The same logic applies to the Act’s biodefence‑focused strategic projects. Explicitly recognising prevention in both categories would enhance Europe’s ability to spot and respond to biological threats, including through tools like the EU Biothreat Radar.

Unlocking investment in prevention

The Global Health Resilience Initiative similarly recognises Europe’s role as a global health leader. Delivering on that ambition requires a strong and competitive European vaccine ecosystem. Safeguarding Europe’s vaccine industry is essential not only for health security, but also for economic resilience, tech nological leadership, and strategic autonomy. To ensure that the EU can lead on shaping the future of global health, sustained investment in vaccine innovation, manufacturing capacity, and enabling policy frameworks must remain central to that ambition. Overall, a strong manufacturing and supply side is necessary but not sufficient. Preparedness and resilience also depend on demand. Part of this comes down to manufac turers’ ability to engage with the bodies that set vaccination recommendations, but it is just as much a matter of Member States clearly signaling their future vaccine needs. Europeans are facing converging challenges that will shape Europe’s future resilience and prosperity.

The population is ageing: it is pro jected that by 2050, there will be nearly 130 million Europeans aged 65+. As Europe’s popu lation ages, healthcare systems face a double pressure in rising demand for healthcare services while the working‑age population financing those systems continues to shrink.

With a demographic winter looming, the case for preventive care has never been stronger. Keeping people healthy for longer is a social and fiscal imperative. Adult immunisation pro grammes alone can generate returns of up to 19 times the initial investment. Yet in most EU Member States, less than 0.5% of healthcare budgets are allocated to immunisation. This is difficult to reconcile with the scale of benefits it delivers. As highlighted in a recent DG ECFIN Economic Brief, the New Economic Governance Framework (NEGF) offers a real opportunity to help address this imbalance. The framework aims to support Member States in imple menting targeted structural reforms that improve the cost‑effectiveness and fiscal sustainability of healthcare systems. Under this framework, Member States can commit to reforms which increase growth, resilience, and long‑term fiscal sustainability, in exchange for longer adjustment periods to rebalance public finances. In Belgium, the government doubled expen diture on prevention in Wallonia. Italy offers another example, treating prevention as fundamental to tackling the healthcare costs of an ageing population. Its 2026 budget law allocates €238 million a year over three years for prevention and early diagnosis, with a further €247 million earmarked for 2026 alone. These are the examples I point to when I am asked whether change is possible. Not investing in preventive care today will simply shift the burden into the future, where costs resurface as more expensive and far less predictable. In this context, preventive measures with the highest return on investment, particularly immunisation and screening, should be rec ognised not simply as healthcare expenditure, but as strategic investments that can signifi cantly reduce avoidable disease burden and long‑term costs, while strengthening Europe’s preparedness, resilience, and competitiveness. A policy moment

Europe cannot afford to miss

Together, the EU Biotech Act I and the NEGF provide a unique opportunity to position vaccine innovation and preventive care as strategic assets for Europe’s future. By better aligning industrial policy, public health, and long‑term fiscal sustainability, Europe can reinforce its preparedness, resilience, com petitiveness, and global leadership. The vaccine industry stands ready to con tribute. The opportunity is there to translate this ambition into action.