Quarterly Newsletter:

October 2023

Issue #9

Editorial

As we bid farewell to summer days and embrace the vibrant return of routine, it's time to refocus on our priorities within the EU health policy agenda. This month, Vaccines Europe published a new report outlining the state of the vaccines industry in Europe. The findings are clear - despite its history of leadership, the EU’s position as a hub for vaccine innovation and manufacturing is at risk. 

Challenges including limited funding, incentives, and support for diverse vaccine types and platforms have posed significant barriers. This has led companies and - in turn - innovation to move elsewhere. Current data shows that there are 56% fewer biotechs involved in vaccine research in the EU compared to the United States. Additionally, there has been a 35% decline in the global share of vaccine clinical trials conducted in the EU since 2000.  

Another issue that adds to the complexity of these challenges is time to access. Concerning data shows that in 30% of Member States, the reimbursement process for new vaccines often extends beyond 6 years. These challenges, while serious, can be overcome by fostering a collaborative environment and pushing for strategic reforms. 

Commission President von der Leyen, in her State of the European Union address, emphasized that Europe will do whatever it takes to maintain its competitiveness. These words hold significance in light of the worrying data spotlighted above.

The vaccines industry stands ready to tackle these challenges head on with the support of the EU and its Member States. In doing this, we can position the EU as a global leader within the vaccine ecosystem once again. The time for action is now, as we continue to face complex issues like climate change, an ageing population, and the threat of antimicrobial resistance.   

Sustainable and innovative vaccine research, development and manufacturing requires a collaborative ecosystem. The health and prosperity of all Europeans is worth the investment. 

Vaccines Europe External Engagement

Events we participated in

• DIA HTA Forum – event by DIA, 25-26 September  

• Meeting on Vaccination and Global Health – event by GSK and Gaspar Casal Foundation (Madrid), 25 September 

• High-level meeting on vaccination throughout the life course - event by the Spanish Presidency, 18 July 

• Tenth industry stakeholder platform on R&D support  - meeting hosted by the EMA

Communications Highlights

New Joiner! 

HIPRA has joined Vaccines Europe! 

As an innovative biotechnological pharmaceutical company, HIPRA focuses on preventive solutions for a variety of pathogens. With over 50 years of experience in vaccine R&D, they lead in research, production, and commercialization of biologics. Originally focused on animal health, in 2020 they responded to the COVID-19 pandemic by leveraging their expertise to develop a recombinant protein-based vaccine. In 2021, HIPRA expanded their efforts with a new Human Health division dedicated to innovative products.  We look forward to this new partnership! 

Vaccines Europe Annual Report 

This week we published Vaccine Europe's 2022 Annual Report, highlighting our dynamic growth and strategic advancements over the past year.  

Our Annual Report highlights how the team has grown over the past 2 years with the addition of new team members and new or increased collaborations with key EU stakeholders. The report also reiterates Vaccines Europe’s position on key policy issues and support to key strategic initiatives. 

Our positive development is demonstrated through activities supporting Vaccines Europe’s strategic priorities of innovation, access and value. Our main focus in 2022 was on the prioritisation of adult immunisation policies in Europe as well as improving the attractiveness of the vaccines industry in the EU.  

As 2023 comes to a close and 2024 approaches, we are committed to continuing to work on every part of the vaccine ecosystem covering research & innovation, regulatory affairs, manufacturing and supply, market access and public policy, immunisation financing and vaccine acceptance. 

EU Attractiveness campaign 

On 18 September, we launched our EU Attractiveness Campaign, a crucial initiative aiming to bolster the attractiveness and position of the EU as a hub for vaccine innovation and manufacturing. The campaign included the publication of a report outlining the state of the vaccines industry in Europe as well as an op-ed in Politico penned by Sibilia Quilici and subsequent entries in Politico’s Healthcare and FairPlay newsletters.  

The report findings make it clear that to ensure the sustainability of the vaccines industry in Europe, strategic reforms, collaborative efforts, and a renewed focus on health for all Europeans is needed.  

EU Flu Day  

Doctors, nurses and pharmacists are a crucial link in European healthcare systems and are key to increasing vaccine confidence and uptake. That’s why this year’s EU Flu Day will focus on how European and national policymakers can empower healthcare professionals for everyone’s protection. 

The fourth edition of EU Flu Day will take place on October 11th and will be hosted by MEP István Ujhelyi.  

Organised by the Steering Group on Influenza Vaccination, on EU Flu Day, policymakers and healthcare players will pledge their support for a set of 10 Policy Recommendations for the EU and national governments to expand influenza vaccine uptake. Register now! 

The vaccines' contribution to unmet medical need in the context of the revision of the EU General Pharmaceutical legislation  

On 13 September, together with the Active Citizenship Network, the Federation of European Academies of Medicine, and the Spanish Association Against Meningitis, we published a joint position paper on unmet medical need (UMN) in the context of the EU General Pharmaceutical legislation. As debates on the legislation continue, including on formalizing a definition of UMN, we are calling for a broad, inclusive, and mission oriented UMN concept. 

Vaccines Europe releases new position paper on data driven decision-making for vaccine preventable cancers   

In our latest paper, Vaccines Europe emphasizes the critical role of comprehensive and timely data in empowering evidence-based public health policies and interventions. Our focus is on fortifying Europe's defenses against vaccine-preventable cancers by targeting key infections - HPV and Hepatitis B.  

As we enter into Liver Cancer Awareness Month, the paper advocates for concrete measures at both EU and national levels, aiming to enhance the collection, sharing, and utilization of data for informed public health policymaking.  

An EU Immunisation Strategy: making Europe more resilient   

This summer, Sibilia Quilici, our Executive Director, provided an insightful analysis in the European Files on what is needed in the revisions of the General Pharmaceutical Legislation to ensure a resilient Europe. She emphasized the pivotal role of vaccination as a linchpin in Europe's health security infrastructure, noting that vaccination not only eradicates and reduces diseases but is a vital component of national security, necessitating dedicated funding and accountability.

In this vein, Vaccines Europe urges European lawmakers to enact an EU Immunization Strategy, focusing on R&D and protection against vaccine-preventable diseases, fostering innovation and contributing to a healthy and prosperous Europe. 

As we brace ourselves for the approaching winter months, prioritizing our immunity against influenza, COVID-19, and RSV is paramount. Portugal has taken significant steps to fortify its population against these seasonal health challenges. In a recent announcement made by the government, Portugal has set an impressive milestone by making flu vaccination free for individuals aged 60 and over, as well as for priority groups starting from the 2023-24 season. This progressive initiative showcases Portugal's commitment to promoting public health and fostering a robust defence against prevalent respiratory illnesses. 

Additionally, pharmacies across Portugal will play a pivotal role in the upcoming 2023-2024 autumn and winter vaccination campaign. They will administer both flu and COVID-19 vaccines concurrently, making vaccination more accessible and convenient for the public. Portugal's proactive approach supports the benefits of expanding vaccination delivery channels to pharmacies thereby increasing uptake while reinforcing the necessity of ongoing COVID-19 vaccination.  

Portugal's dedication to vaccination efforts is reinforced by its achievement in vaccine confidence. The 2022 EU State of Vaccine Confidence Report places Portugal at the pinnacle, ranking it as the number one country in vaccine confidence. Furthermore, a study developed by APIFARMA in April 2023, called “Perception of the Value of Vaccines” targeted to healthcare professionals and the general population, shows that all participants acknowledge the importance of vaccines for public health and to reduce or eliminate some diseases worldwide. They consider that vaccination is not only important for children but also fundamental for adults. This recognition underscores the country's success in instilling trust and conviction among its population regarding the efficacy and safety of vaccines. 

As a result of this level of confidence, Portugal is also a reference in the vaccination against HPV, with 95% VCR (vaccine coverage rate) in girls and boys and moving towards the elimination of HPV and related cancers.

Key Figures

Health Policy Highlights

State of the Union: von der Leyen touts health achievements, promises support for business 

EU Commission President Ursula von der Leyen gave her last State of the European Union address (SOTEU) for the current mandate on 12 September. Health issues were not a major focus this time around, but von der Leyen cite as a success the EU’s joint purchase of vaccines, which “helped vaccinate an entire continent – and large parts of the world”. There is no doubt that an innovative and competitive vaccines industry will be critical to the EU staying ahead of public health threats. 

Speaking of competitiveness, this year’s SOTEU featured a marked shift in favour of industry, with von der Leyen pledging to do “whatever it takes to ensure Europe’s competitive edge”. This would include every new piece of legislation being subject to a “competitiveness check” conducted by an independent board.  

This pro-competitiveness rhetorical shift must be reflected in the EU’s new pharmaceutical legislation. As shown in Vaccines Europe’s report on improving the attractiveness of the vaccines industry, regulatory inefficiency and lack of flexibility are major barriers to timely approval of innovative vaccinations and thus to the EU’s attractiveness to investors. 

Von der Leyen also spoke at length on the importance of artificial intelligence (AI) and the need to invest in digitalisation and AI to improve healthcare. Such investment is sorely needed to maximise the impact of vaccines. The EU and Member States must invest to develop digital infrastructure, high-quality real-world evidence generation and digital environments for clinical trials and manufacturing of vaccines. The Commission also indicated that it would launch an “EU Biotech and Biomanufacturing Initiative” which could have important implications and support for the vaccines sector. 

Resilient EU2030: Spain spells out its ambitions for Europe’s “open strategic autonomy” 

Madrid has long made strategic autonomy a major priority of its presidency of the Council of the EU this year. Now, Spain has detailed its vision for Europe in a report entitled “Resilient EU2030” spelling out “a future-oriented approach to reinforce the EU’s open strategic autonomy and leadership”. Concretely, Spain wants to boost the EU’s resilience and global competitiveness in the fields of energy, digital technology, food and health. 

Noting the decline in the EU’s pharmaceutical production capacity, Resilient EU2030 calls on the EU to enhance its pharmaceutical production capacity. Madrid argues the manufacturing of antibiotics, anaesthetics, haematological and oncological drugs, vaccines and “less profitable medicines”, such as those treating neurodegenerative disorders and paediatric cancers, should be prioritised. 

Spain also wants the EU to identify and develop pharmaceutical production capacities that can be transformed or scaled upon demand. The report cites the Network of Ever-warm Production Capacities for Vaccines and Therapeutics Manufacturing (EU-FAB), an initiative launched by HERA, and Sanofi’s “Evolutive Vaccine Facility” as positive examples. Spain wants similar initiatives to develop and scale up flexible capacity to manufacture essential goods that may experience shortages.  

EU leaders will discuss Spain’s strategic autonomy initiative at the next informal European Council summit in Granada on 6 October. The EU Commission for its part will outline its thinking on the availability of critical medicines in a Communication expected to be released on 17 October. This may build upon a Belgian non-paper (supported by 19 EU Member States, including Spain) calling for an EU Critical Medicines Act to support domestic production of pharmaceuticals. 

What We Are Reading & Watching

Vaccines could avert half a million deaths associated with anti-microbial resistance a year - a news item by the WHO

The R&D landscape for infectious disease vaccines - a study published in Nature

Report of the EMA/ETF workshop on Lessons Learned on Clinical Trials in Public Health Emergencies 

Joint EMA-ECDC press briefing on current state of respiratory diseases and treatments in the EU/EEA

Vaccine value profiles - The vaccines profiled target pathogens identified as priorities by the WHO’s Product Development for Vaccines Advisory Committee