Quarterly Newsletter:

December 2022

Issue #6

Editorial

Preventing life-threatening and debilitating infectious diseases seemed impossible for a long time. Today, it is a normal part of life – thanks to vaccines. Vaccination saves millions of lives every day, improves quality of life, preserves healthcare systems and contributes to socio-economic advancement. 

We have come a long way in the journey of prevention, with vaccines available to prevent a wide spectrum of infectious diseases. However, we are still lacking prevention and treatment solutions for many diseases, and new pathogens or novel strains of known microorganisms regularly appear. During the COVID-19 crisis, we were all reminded of the importance of preparedness as the next health crisis could be right around the corner.  

The vaccine industry is continuously working to develop a wide range of vaccine technologies to efficiently tackle emerging and future threats, and to deliver a diverse portfolio of vaccines that closely match the needs of populations.  

The first-ever pipeline review of the Vaccines Europe member companies illustrates this commitment to innovation. By the end of July 2022, pipelines included 100 vaccine candidates using 10 different technology platforms. These vaccines in development are designed to help address global challenges of today and tomorrow, such as health emergency situations, zoonoses and arboviruses, antimicrobial resistance, socio-economic and demographic changes, as well as the dangers posed by climate change. Recognising that technology continuously evolves, Vaccines Europe members also dedicate significant efforts (54% of vaccine candidates) to incremental innovation by further developing existing vaccines. 

The European ecosystem is home to scientific excellence and has been a fertile soil for innovation, as illustrated by the existence of the largest Health Public-Private Partnership in the world running continuously since 2004. The Innovative Health Initiative (IHI) program is building upon IMI (Innovative Medicines Initiative) success with a renewed, expanded cross-sectorial scope with its joint public-private strategic research and innovation agenda supporting a Vaccine to Vaccination end-to-end ambition. 

To allow continuous innovation to happen, we need a well-funded research ecosystem in Europe, appropriate incentives that encourage the timely discovery and development of innovative products, an enabling regulatory environment, and a supportive Intellectual Property framework, as well as effective financing and evidence-based policy recommendations. 

Vaccine development is a complex endeavour requiring a collaborative public-private quality-driven cooperative ecosystem. The health of people and our societies is worth the investment. 

Key Figures

Vaccines Europe External Engagement

Building public trust as a pathway to vaccine acceptance: Expert Conference on Vaccination organised by the Czech Presidency of the Council of the European Union, 21-22 November

Sibilia Quilici, Executive Director of Vaccines Europe, participated in two sessions of the conference. In Block I: Building vaccine acceptance through communication, she highlighted the value of vaccination to public health in controlling, eliminating and eradicating vaccine-preventable diseases and associated cancers. Sibilia emphasised the important role the innovative vaccine industry plays in strengthening vaccine confidence through the research, development and manufacturing of high quality, safe and effective vaccines. She also shared some examples of industry efforts to tackle vaccine hesitancy, such as Vaccines Today and #VaccinesForLife campaigns. Finally, Sibilia underlined the importance of partnerships and collaborations at all levels - global, regional, national and local, to understand the complex factors leading to vaccine hesitancy, address it and boost vaccine confidence.

In Block II: Future of vaccination, accessibility and development of innovative vaccines, Sibilia highlighted that Intellectual Property is the heart of innovation and it needs to be safeguarded. She gave a short overview of the Vaccines Europe pipeline review 2022, and emphasised that developing new vaccines isn't enough, they also need to reach the people who need them. Enhancing vaccine market access pathways is crucial for reducing the time to population access. Sibilia concluded that only by working together and continuing dialogue at different steps of the vaccine journey, we can build resilient immunisation systems and increase vaccine coverage rates.

Read more here or watch the full recordings here.

European Public Health Conference, 9-11 November

Vaccines Europe organised a lunch symposium on 'Enhancing pathways for vaccine assessments and national decision-making - a driver of resilient health systems', chaired by Prof. Walter Ricciardi. Sibilia Quilici opened the session by presenting the four principles we propose should underpin the design and functioning of vaccine assessments and decision-making pathways: timeliness, inclusiveness, consistency and transparency. She emphasised that enhancing vaccine assessment and decision-making pathways can contribute to stronger immunisation programmes and thereby more resilient health systems. A panel discussion followed with input from Prof. Maarten Postma from the University of Groningen, Elena Petelos from Maastricht University and Martine Ingvorsen from the European Commission. Watch the recording of the session here.

Vaccines Europe also participated in the workshop on ‘The need to account for vaccine specificities in the implementation of the EU Regulation on Health Technology Assessment’ organised by the European Public Health Association and co-chaired by Chiara de Waure and Elena Petelos. 

Read more here. 

Other events we participated in

• Pro-vaccination Forum (Romania), 25 November
• Alliance in Healthcare (Czech Republic), 21 November
• European Cancer Summit, 16-17 November 
• Public health and disease prevention - What benefits for an adult immunisation policy in Europe? (Belgium), 7 November
• Vaccination and Public Health Conference (Greece), 3 November
• VACCINE Forum (Poland), 21 October 
• Biotech Atelier (Bulgaria), 28 September

Communications Highlights

The first pipeline review of Vaccines Europe members reveals there are 100 vaccines in development

On 1 December, the first pipeline review of Vaccines Europe member companies was published. It was accompanied by a blogpost from Sibilia Quilici, Executive Director of Vaccines Europe, examining the key findings from the report and what that means for the future of vaccine innovation in Europe. Throughout December, we're taking a closer look into the pipeline review and how it's addressing the health challenges of tomorrow through a social media campaign.

Protecting adults from vaccine-preventable diseases

The COVID-19 pandemic has shown that infectious diseases can have a devastating impact on adults. Throughout December, we're communicating about the urgent actions needed to protect adults from vaccine-preventable diseases.

In a video created in partnership with the European Vaccines Initiative (EVI) Sibilia Quilici emphasised on the importance of building robust immunisation schedules for adults, as we have for children. She also explained that it is crucial sustainable immunisation financing exists in all EU Member States. Prof. Paolo Bonanni from the University of Florence shared Italy's experience with building a vaccination calendar for people at all stages of life, and how this has better prepared the country for upcoming health challenges. 

Watch the full documentary created by EVI here. 

Four principles to improve access to vaccines across Europe

In a third of EU countries, it takes more than 6 years for a newly approved vaccine to be included in the country's National Immunisation Programme. Vaccines Europe calls for embracing 4 principles to enhance vaccine market access pathways and decision-making: timeliness, inclusiveness, consistency and transparency. This video, part of our social media campaign, explains what these principles mean and gives examples of how they can be implemented, showing how that can reduce the time and fight inequalities in access to vaccines for the population, support the shift towards life-course immunisation, improve vaccine confidence and support building resilient healthcare systems.

Vaccines Europe Events

Beating Cancer through prevention: A call for action on vaccine-preventable cancers across Europe

Hosted by MEP Nicolás González Casares and organised by Vaccines Europe, the event Beating Cancer through prevention: A call for action on vaccine-preventable cancers across Europe took place on 25 October 2022 at the European Parliament, featuring EU and national stakeholders who led a constructive discussion on the most effective ways to raise awareness on vaccine-preventable cancers.  The panellists exchanged views on the urgent need to incentivise more action on promoting vaccination against Human Papillomavirus (HPV) and Hepatitis B virus (HBV), significantly improving data collection and addressing existing challenges and opportunities at the EU and Member State level. The discussion also involved sharing best practices and ideas for new strategies that reflect the goals of the Europe’s Beating Cancer Plan and make use of available EU funding instruments. 

Making influenza vaccination a priority across Europe

Hosted by MEP Dolors Montserrat and the Steering Group on Influenza Vaccination, the webinar Making influenza vaccination a priority across Europe brought together key stakeholders from across Europe to shine a light on the key challenges and opportunities of influenza vaccination. In this third annual EU Flu Day event, speakers focused on the importance of vaccinating at-risk groups, the threat of coinciding COVID-19 outbreaks and the role of efficient public communication. The panellists also shared best practices and stressed the importance of a coordinated approach between the EU and Member States. 

Health Policy Highlights

Ensuring vaccines don’t get left behind in the revision of the pharmaceutical legislation

The revision of the pharmaceutical legislation is a once-in-a-generation opportunity to increase Europe’s competitiveness when it comes to research and manufacturing. In the context of shaping Europe’s future research ecosystem, accounting for vaccine specificities will be crucial in ensuring that Europe remains attractive to the innovative vaccines industry, which will help build resilient healthcare systems and ultimately benefit European citizens. 

Vaccines Europe recently published its first ever pipeline review which shows a promising future for vaccines and vaccination in Europe. To allow continuous innovation to happen, we need to ensure Europe’s research ecosystem remains dynamic and well-funded, with regulatory flexibilities and a supportive IP framework. We must also improve market access pathways for vaccine assessments, by improving timelines, inclusiveness, consistency, and transparency of assessments. Last, we must improve the procurement practices for vaccines in Europe, with guiding principles for Member States, to allow for fair competition, timely access to a diversified portfolio of vaccines and reliable supply.   

In addition to this, Europe can play a key role in encouraging Member States to strengthen immunisation programmes, ensure sustainable financing for prevention, build necessary infrastructures for adult immunisation programmes, improve vaccination coverage rates and ensure timely monitoring. These are all essential pillars of a robust and resilient healthcare system with prevention at its core. 

Vaccines Europe remains committed to working in early, open and continued dialogue, collaboration and coordination with all stakeholders, to ensure equity in access to vaccination to build resilient societies. 

Welcoming the Council Conclusions on vaccination under the Czech Presidency

EU ministers of health have endorsed the Council Conclusions on “Vaccination as one of the most effective tools for preventing disease and improving public health”, one of the Czech Presidency’s key priorities under their Presidency programme. The Conclusions outline that, although vaccination policy is a responsibility of Member States, a more coordinated EU approach would be beneficial to prevent and limit the spread of epidemics and vaccine-preventable diseases.  

Focusing on the need to combat vaccine hesitancy, the text highlights that there is no one-size-fits-all solution, and vaccination hesitancy depends on context, country and vaccines concerned. However, EU health ministers call on the Commission to create an Expert Forum on Vaccine Hesitancy, and issue a Communication and tailored recommendations to Member States on how to tackle vaccine hesitancy. It also outlines the need for the Commission to work with Member States to develop training opportunities for health professionals, and develop awareness-raising activities.  

The Conclusions also outline the need to build on best practices and lessons learned from the COVID-19 pandemic and invite Member States to promote adult and childhood vaccination campaigns, improve vaccination coverage among healthcare professionals, and promote health education and health literacy. To advance digitalisation, the Commission is encouraged to explore interoperable national immunisation information systems and develop a virtual database to exchange information on vaccine surpluses or shortages.  

Vaccines Europe congratulates the Czech Presidency on the important work done raising the importance of vaccination on the agenda, looking ahead to strengthen Europe’s approach beyond pandemic preparedness. This is an encouraging step towards realising the full value of vaccination in the EU, and we hope that the Swedish Presidency will continue and carry the political initiative forward.

President von der Leyen highlights “miracle” of vaccines at the Grand Challenges Annual Meeting 2022 

In her keynote remarks during the Grand Challenges Annual Meeting 2022, Commission President von der Leyen reflected on her experience of the pandemic and lessons learned. Europe’s leadership on global health and its decision to take the path of solidarity and openness during the pandemic was hailed when discussing the importance of solidarity and cooperation. 

“My third lesson is about the miracle of vaccines themselves. As a medical doctor by training, the importance of research and development is not news to me. But the pandemic made it very real for all of us. As you know, the outstanding mRNA vaccines did not come out of the blue. Their discovery, like all innovation, relies on long-term investment in scientists and their research”, highlighted the President in her speech.

Vaccines Europe strongly welcomes this reflection, as well as the emphasis on supporting science and research in its many forms – from education to the protection of intellectual property rights. All of these factors are of fundamental importance to ensuring that the European Union is prepared for future pandemics.

She stressed the importance of global cooperation in research and development and the need for long-term investments. However, having these safe and effective vaccines alone is not enough. Europe will therefore invest in strengthening supply chains and increasing manufacturing capacity on the continent.  

Building strong global health systems is crucial in overcoming future health threats, and the creation of HERA is a first step to putting Europe on the front foot in addressing global health threats in a spirit of cooperation and solidarity. 

The first-ever State of Preparedness Report signals the European Commission’s strong commitment to improving crisis preparedness in the EU 

Vaccines Europe and its members welcomes the State of Preparedness report from DG HERA, reflecting the state of preparedness and the overall changing risk landscape in Europe that we might face in the near future.  

This report, first of its kind, focuses on preparedness capabilities related to medical countermeasures. It presents an overview of the progress made throughout the past three years to reinforce preparedness in the EU, and outlines the state of play and actions that are planned to fill the gaps in relation to ensuring sufficient availability and supply of medical countermeasures. Future editions will focus on different aspects of preparedness, beyond medical countermeasures, and should also present preparedness indicators based on reporting from Member States.  

Tied to the launch of this report, HERA’s 2023 Work Programme was published with a budget of EUR 1.267,75 billion from EU4Health, Horizon Europe and UCPM/rescEU. HERA’s activities in 2023 will support Member States’ preparedness with a focus on the availability and accessibility of medical countermeasures. Based on the findings of the State of Preparedness report, the Work Programme includes several important flagship initiatives, including the establishment of a state-of-art IT system for intelligence gathering and threat assessment; ensuring further development of medical countermeasures for epidemic and pandemic preparedness such as innovative vaccines; and reservation of manufacturing capabilities for vaccines.   

As Vaccines Europe, we believe that Europe’s ability to apply lessons learned from COVID-19 will be central to the better preparedness of the EU for the next crisis. At the outset of the pandemic, a number of factors contributed to a less-than-optimal response to the pandemic. These include unilateral trade restrictions and national mandatory stockpiling requirements; a lack of real-time surveillance and monitoring data; delays in pathogen access; as well as pressure on and erosion of IP to enable medical innovation. 

There are a number of short- and long-term priorities to prepare for the next crisis. In the short term, maintaining the EMA’s regulatory flexibilities, accelerated pathways and structured multi-stakeholder dialogues will be key. Additionally, a focus on enabling the supply of critical raw materials via global supply chains should be maintained. In light of a vaccination “plateau” across the EU despite surging COVID-19 cases, Member States need to drive booster vaccination campaigns. 

Long-term work should be focused on ensuring a robust and predictable IP framework in Europe, delivered through the revision of the pharmaceutical legislation. The pandemic has also demonstrated that global health security starts with pathogen surveillance and sharing. By engaging in the Pandemic Treaty discussion in relation to Pathogen Access & Pandemic Influenza Preparedness (PIP) Framework, the EU can play a leading role in ensuring an effective and coherent international approach to sharing of pathogens and associated information.

Important steps towards improving immunisation coverage rates

Association of International Medicines Manufacturers (ARPIM)

2022 marked an impressive moment for vaccination in Romania: for the first time the possibility of vaccine reimbursement was introduced in the legislation and the bases for immunisation happening in pharmacy was established. The awareness and public affairs projects implemented and
developed by ARPIM had significant contribution towards shaping the legislation and framework in Romania, and paving the way for vaccination prioritisation and for a better approach to life-long vaccination.

ARPIM achieves two historic milestones this year in order to improve vaccination coverage rates: the launch of a pharmacy-based immunisation pilot-project and the introduction of the possibility to reimburse vaccines in the Health Law.

Vaccination at the pharmacy premises brings vaccines and vaccination services closer to the citizens who are not included in the risk groups, don’t have time to go to their General Practitioner (GP), but have the possibility to pay out-of-pocket both the vaccine and the administration fee. The pharmacy-based immunisation has proven its effectiveness in all the countries where it has been introduced, providing many benefits to citizens, authorities and GPs. In Romania, this pilot-project allows adults and minors (legally represented) to get their flu shots in pharmacy, after an anamnesis performed by the pharmacists trained accordingly.

Vaccines reimbursement represents another important step forward, contributing to the increase of the vaccination coverage rates in Romania.

At the end of November, following the consistent advocacy efforts conducted by the members of the Romanian Pro-Vaccination Forum, one of them being the ARPIM Vaccines Working Group (WG), the Romanian Parliament adopted, and the Romanian President promulgated the primary legislation for permitting the reimbursement of vaccines in Romania. This opens a new path for increased access to vaccines,
aimed to contribute to the increase of the vaccination coverage rates in this country.

This is a success not only for the Romanian Pro-Vaccination Forum and its members – patient associations, medical societies, Key Opinion Leaders (KOLs), and pharmaceutical industry representatives, but it also represents a success for everyone in Romania, and especially for the patients with chronic diseases who will have access to reimbursed vaccines now.

Based on this primary legislation, ARPIM and the rest of the members of the Romanian Pro-Vaccination Forum will continue to shape the environment for convincing also the authorities to draft and publish
the secondary legislation, a necessary step for implementing the reimbursement of vaccines.

For visible results in the long term, on top of increased access to vaccines and vaccination, we need to educate the population with regards to prevention, mainly to prevention through vaccination. Therefore, another important step that ARPIM Vaccines WG members and the Romanian Pro-Vaccination Forum propose to develop soon is the implementation of some educational campaigns and workshops for GPs, specialised doctors and other healthcare professionals that could have attributions in vaccination and prevention at large. The medical community representatives can become important vectors in promoting the benefits of vaccination towards all the levels of the society, including mass-media, authorities, and public. The key for reaching our objective of lifelong vaccination is to work together, to combine our efforts, knowledge, and good will, for the benefit of the Romanian population.

What We Are Reading & Watching

EU Global Health Strategy to improve global health security and deliver better health for all by the European Commission

One year of HERA conference by the Health Emergency Preparedness and Response Authority (HERA)

State of vaccine confidence in the EU (2022) - a report by the European Commission and the Vaccine Confidence Project

Towards the next Council conclusions: are we doing enough for adult immunisation? - an article by Health Europa