Quarterly Newsletter:

March 2024

Issue #11

Editorial

This month, we commemorated International Women's Day with a renewed focus on inspiring inclusion and empowerment - a theme that is particularly relevant to healthcare. As a woman working in the healthcare sector, I have seen the impact that inclusive and effective healthcare programs can have - improving lives and protecting the health of us and our loved ones.  

Cervical cancer stands as the second most common cancer in women aged 15-44 in the EU, with 58,169 new cases annually. This data underscores the critical importance of vaccination as a preventive measure against HPV, which can lead to cervical cancer and other HPV-related cancers affecting individuals of all genders. Further, HPV is responsible for approximately 14,700 annual anogenital cancers, with 5,400 occurring in men. 40% of all cancers are preventable and these statistics underscore the urgent need for concerted and impactful efforts targeting adolescents and adults to combat HPV and its associated cancers. 

Despite these statistics and the proven effectiveness of vaccination, significant disparities persist in HPV vaccination coverage rates (VCR) across EU member states. While Portugal stands out as the only country meeting Europe’s Beating Cancer Plan (EBCP) target of a 90% VCR for girls, five countries struggle with VCRs below 50%, with Bulgaria maintaining a VCR below 10% for the past decade.  

The recent publication of the Council recommendation on vaccine preventable cancers demonstrates progress within the EU on this important topic to strengthen national efforts to reach, by 2030, the objective set in EBCP of fully vaccinating at least 90% of the EU target population of girls and boys. Member States should expand access to vaccination services to include schools and pharmacies to reach healthy and young populations and catch up unvaccinated young and adult people at least until the age of 26. As such, it is important that VCRs are regularly measured using both national and European digital data systems to calculate the time needed to reach the targets set by EBCP. 

Following much work among all stakeholders in the health sector, I was encouraged to see an increased acknowledgment of the need to bolster the role of the European Centre for Disease Control (ECDC) in ensuring quality and timely data collection for HPV vaccination. To ensure the full potential of the ECDC can be realised, one aspect of the Recommendation that I hope to see amended is the lack of a quantitative VCR target for boys. To ensure HPV immunisation programs have the greatest impact, we must be striving toward prevention for all.  

The Council Recommendation offers a pivotal opportunity for Europe to strengthen endeavours in addressing vaccine-preventable cancers through increased vaccination uptake, monitoring of vaccine programs, and access to health data to inform evidence based decision making. By leveraging this opportunity, we can move closer towards achieving our collective goal of eliminating HPV-related cancers and reaffirm our commitment to inclusivity, empowerment, and health equity.

Vaccines Europe External Engagement

Events we participated in

• EU-JAMRAI2 Launch - event by the European Joint Action on AMR and Healthcare-Associated Infections (Paris), 13 February

• Strengthening vaccination policies towards the 2024 European elections: from recommendations to concrete experiences  – event by Active Citizenship Network (Brussels), 14 February

• Healthy ageing and longevity in Europe: How do we prepare for the 100-year life? - event by ILC Europe (Brussels), 6 March 

• Chat with Professionals – Career Twists and Turns - event by DIA Europe (Brussels), 13 March

Public Consultations

• EFPIA/VE response to the European Commission’s proposals for amendments to Regulation 1234/2008 - 29 February

Communications Highlights

EU Immunisation Strategy: From Progress to Excellence  

As we inch closer to the EU Elections in June, Vaccines Europe Executive Director Sibilia Quilici shared her hopes for the next mandate in a new blog. She sees this new chapter as an opportunity to strengthen vaccine innovation, foster collaboration among Member States toward equitable access, and ensure sustainable immunisation programs, envisioning a Europe that leads in vaccine breakthroughs and prioritizes public health toward a healthier, more prosperous future.

Council recommendation on vaccine preventable cancers 

On 31 January, the European Commission published its proposal for a Council recommendation on vaccine preventable cancers. In light of this, Vaccines Europe and EFPIA put out a joint statement supporting the call for strengthened data collection by the ECDC and improved practices across Member States as well as the Commission’s intention to promote R&D and innovation for HBV and HPV vaccines. With strong immunisation policies and programmes that are effectively implemented, we have a unique possibility to eliminate disease and infection-associated cancers.  

#VaccineVoices

As part of our engagement efforts on vaccine preventable cancers, Vaccines Europe has put forward a new series featuring interviews with experts (#VaccineVoices). The latest iteration, published 20 March, features Professor Pierre Van Damme, Infectious Disease and Vaccinology Expert at the University of Antwerp, discussing how healthcare providers can support vaccine confidence toward empowering patients in informed decision making. You can find the video on X and LinkedIn.  

International Women’s Day 

This month under the theme of #InspiringInclusion, Vaccines Europe colleagues and Board Members celebrated International Women’s Day with a series of quotes on X and LinkedIn. The overarching sentiment focused on the importance of ensuring diverse voices in the scientific community, workplaces and public health initiatives toward a healthier, more equitable future for all. 

Pandemic Preparedness: Partnerships in Protection

As we approach the May deadline for a WHO pandemic agreement, in a timely blog Marc Lacey, Global Pandemic Head at CSL Seqirus underscores the urgency of pandemic preparedness amid evolving infectious disease landscapes. He emphasizes the importance of collaboration between healthcare providers, industry leaders, and governments, highlighting the societal and economic toll of pandemics like COVID-19.  With looming threats such as avian flu, he stresses the importance of proactive preparation, leveraging partnerships, and learning from past experiences to better tackle future threats. 

Long COVID: Understanding and combatting an increasing burden  

To mark International Long-COVID Awareness Day on 15 March, Chantal Friebertshaeuser, SVP & General Manager, Europe, Middle East, Australia and Canada (EMEAC) at Moderna discusses the crucial role played by vaccination in managing COVID-19 and potentially reducing the risk of long COVID. She notes that increasing the awareness and understanding of long COVID is key to acknowledge and address the challenges it poses. 

COVIDRIVE expands its scope beyond COVID-19

Named id.DRIVE, this new European partnership focuses on all infectious diseases, studying their burden and impact on serious illness, the effectiveness of vaccines and other prevention methods, and diagnostics and therapeutics beyond COVID-19. The id.DRIVE public-private partnership includes 8 partners, with AstraZeneca, Janssen, GSK, Novavax, Valneva and Pfizer as pharmaceutical company partners, P95 a small and medium enterprise (SME) and Fisabio, a Spanish regional public health institute. 

Vaccines Europe partners with the EUVABECO consortium 

Vaccines Europe is pleased to be a part of EUVABECO, and initiative supported by the European Commission under the EU4Health program. The project aims to improve vaccination practices among EU member states for routine immunisation and in the event of future epidemics by providing operational and technical tools. Our contribution as the vaccine industry is through an electronic leaflet for flexible vaccine distribution linked to a portable European digital vaccination card. Stay tuned for more updates!

Mission Board on Vaccination in Europe publishes consensus paper

Last week, the Mission Board on Vaccination in Europe, of which Vaccines Europe is a dedicated member, launched its first consensus paper. The publication offers actionable recommendations for strengthening immunisation targets at both European and national levels. Through an innovative ‘mission approach’ guided by the principle of equity, these recommendations reflect four pillars: data and evidence for decision making, beliefs, perceptions and vaccine confidence, access to vaccination and convergence and alignment.

Chaired by Walter Ricciardi, EU Mission Board on Cancer Chair and Full Professor of Public Health at the Catholic University of the Sacred Heart, Rome, the MBVE is a multi-disciplinary collaboration that brings together vaccinologists, public health experts, health economists, health care professionals, academics, civil society organisations, patient representatives, and industry.

As we near the end of March, it's important to not only reflect on the recent influenza vaccination season but consider how we can enhance our efforts moving forward in anticipation of the next winter season. 

The winter of 2023/2024 saw the launch of a public vaccination program for influenza under the Österreichisches Impfprogramm (ÖIP), marking a significant milestone in our collective commitment to public health. While the introduction of this program was an important step in Austria’s work to increase flu vaccination, there were some challenges in its implementation. The Austrian Association of Vaccine Manufacturers (ÖVIH) has meticulously evaluated these challenges, identifying areas for improvement to ensure the success of future vaccination campaigns. 

One of the primary concerns highlighted by our assessment is the need to streamline logistics and communication channels within the vaccination program. Inconsistent procedures across federal states led to confusion among both healthcare providers and individuals seeking vaccination. Standardizing these processes nationwide will be paramount to optimizing efficiency and accessibility. 

Furthermore, the importance of enhancing the distribution model and vaccine ordering system for participating doctors cannot be underestimated. Delays in vaccine delivery and limited choice in vaccine selection posed significant obstacles during the previous season. By addressing these logistical challenges, we can better equip healthcare providers to meet the vaccination needs of our communities. 

In addition to addressing logistical hurdles, the importance of expanding vaccination outreach to alternative locations, such as schools, pharmacies and workplaces is clear. By diversifying our vaccination efforts, we can reach a broader demographic and further bolster our influenza prevention strategies. Equally crucial is the implementation of comprehensive vaccination education campaigns tailored to various demographic groups. By providing accurate information and dispelling misconceptions surrounding vaccination, we can foster greater confidence and uptake among the public. 

As we look ahead to the next winter season, the ÖVIH remains committed to collaborating with stakeholders across the healthcare landscape to implement these necessary improvements. Together, we can build upon the foundation laid by the ÖIP and work towards achieving our shared goal of safeguarding public health. 

Key Figures

Health Policy Highlights

EU Commission takes the next steps in the fight against vaccine-preventable cancers 

On 31 January, the European Commission published its proposal for a Council Recommendation on vaccine-preventable cancers. The proposal aims to support Member States’ efforts in the fight against vaccine-preventable cancers by boosting the uptake of vaccines against human papillomaviruses (HPV) and Hepatitis B (HBV). Vaccines Europe welcomes this proposal as an important first step towards a European Immunisation Strategy. 

The Council Recommendation is part of Europe’s Beating Cancer Plan. Its recommendations aim to increase vaccine uptake by expanding routine vaccination and catch-up programmes and increasing access by providing it free of charge and/or fully reimbursed and offering it in schools and educational settings.  

The Commission’s proposal also includes measures to increase Member States’ monitoring of vaccine coverage rates via electronic registries, hereby acknowledging the importance of comprehensive and timely data collection in the fight against vaccine-preventable cancers. The European Centre for Disease Control (ECDC) has a mandate to set up dedicated dashboards to display the available national data on HPV and HBV vaccination by the end of 2024.

The recommendation has now moved to the Council of the European Union where Member States will discuss and amend the proposed text. The Belgian Presidency is aiming to formally approve the Council Recommendation at the final health ministerial conference on 21 June.  

EU JAMRAI-2: EU launches its biggest project against AMR to date 

The European Commission has launched a new Joint Action on antimicrobial resistance (AMR). EU JAMARAI 2 brings together all 27 EU Member States, as well as Iceland, Norway and Ukraine with the aim of reducing citizens’ risk of exposure to antibiotic-resistant bacteria. Areas of work will include infection prevention and control, surveillance and monitoring, prudent use of antimicrobials, awareness raising and innovation. Presenting the project, Commissioner for Health Stella Kyriakides noted that AMR is responsible for over 35,000 deaths in the EU and costs health systems 11.7 billion euros every year. 

Vaccines Europe was pleased to attend EU JAMRAI-2’s launch event and welcomes the One Health approach taking into account human, animal and environmental health. AMR cannot be solved by one actor alone but must be confronted using every available tool. By acknowledging the unique potential of vaccines to prevent antibiotic use for viral and bacterial vaccine-preventable infections, we recognise the central role of vaccines and immunisation in the fight against AMR - a missing piece of the EU-JAMRAI-2. Vaccines Europe looks forward to contributing as a member of the EU JAMRAI-2 Stakeholder Forum, supporting the Joint Action’s mission of implementing concrete actions to monitor, prevent and effectively tackle AMR. 

The ENVI Committee approves reports on the Pharma Package

The European Parliament’s health committee (ENVI) has approved its reports on the General Pharmaceutical Legislation. 

As part of the Directive, MEPs voted to bring the baseline duration for Regulatory Data Protection (RDP) up to 7.5 years, with the possibility for extensions and the maximum period of RDP capped at 8.5 years. The Commission’s proposal of linking RDP incentives to launching new medicinal products in all 27 EU member states has been removed. Instead, marketing authorisation holders will be required to submit pricing and reimbursement applications in all requesting member states within 12 months. 

When it comes to the provisions of the Directive and Regulation, the ENVI Committee agreed on an extended scope for Environmental Risk Assessments (ERA), further requirements for transparency of R&D financial support, and the introduction of electronic patient information leaflets (ePIL) for products intended for administration by qualified healthcare professionals (including vaccines). 

The agreed texts also provide a broader definition of vaccines, aligning with the EMA guidelines for assessment, in parallel with a detailed definition of platform technologies, paving the way for a future-proof and innovation-ready legislation. 

During its Plenary session of 10 April, the European Parliament will have a final vote on the legislation and formally adopt the Parliament’s final position. Member states in the Council have started discussions on the files but are not expected to formally agree on a negotiating position before the second half of 2025, after which interinstitutional negotiations can begin. 

Pandemic Accord: countries gridlocked as May deadline looms

The WHO’s Intergovernmental Negotiating Body held its eighth meeting (INB8) but little progress was made on a global Pandemic Accord. Such an agreement would seek to strengthen prevention, preparedness and response ahead of the next pandemic. This includes questions about equitable access to health care and pandemic prevention tools such as vaccines. 

There are disagreements between countries of the Global North and Global South on issues such as intellectual property rights and a Pathogens Access and Benefit Sharing system (PABS). In a statement delivered by Thomas Cueni, IFPMA Director General on Thursday, 21 March, IFPMA voiced its support of reaching an agreement. IFPMA stressed that building on the Berlin Declaration, biopharmaceutical companies from both developed and developing countries are willing to accept mandatory commitments to delivering equitable access to essential medical countermeasures provided that this system is workable.

IFPMA highlighted that the Accord needs to preserve what worked well in the COVID-19 pandemic – the rapid access to pathogens and genetic sequence information and the innovation system delivering fast and on record scale – but it must also fix what did not work well: the equitable rollout of medical countermeasures.

The WHO has circulated a new draft text of the pandemic accord which is currently being discussed during INB9, which began on March 18 and will continue until March 28. This may be negotiators' last chance to agree on a text prior to the deadline for adoption set for the World Health Assembly (WHA) at the end of May, however a potential added session may take place during the last week of April.

What We Are Reading, Attending & Watching

Improving Vaccine Assessment Pathways and Decision Making in the Polish Immunization Program - a publication in Vaccines and the result of a collaboration between VE and the Polish NVIG

Global cancer burden growing, amidst mounting need for services - a report by the WHO

Health as a key for economic resilience - a publication by Business at OECD

The staggering cost of doing nothing: Implementation of RSV programs in Europe - an event by PROMISE, 22 February

Recommendations for healthcare professionals, organisations, and authorities to address vaccine hesitancy - publications by Vax-Trust covering key countries (BE, CZ, FI, IT, PL, PT, UK)