Quarterly Newsletter:

April 2023

Issue #7

Editorial

Over the last three years, we’ve experienced multiple crises affecting the whole world, from the COVID-19 pandemic to the war in Ukraine. Whether in a small or large way, they have all impacted people’s lives. Time and time again, we’re witnessing the proof that health system resilience and a strong innovative life science sector are paramount for tackling the challenges of today and tomorrow. 

We cannot let our guard down now – health must continue to be high on the political agenda. Vaccination is a very effective and cost-efficient prevention tool that saves and improves millions of lives every year. A lot of work still needs to be done to ensure the ecosystem for vaccine research, development and manufacturing is resilient in its day-to-day functioning and in crisis, for the overall European health security. Strong political leadership and collaboration between all stakeholders – public and private – are crucial to strengthen a European Health Union that protects its citizens while bringing significant innovation to patients.  

The European elections in 2024 present an opportunity to prioritise health across the EU Member States. The COVID-19 pandemic has taught us valuable lessons, including how much adult’s health can be affected by infectious diseases. We need to strengthen adult immunisation programmes across Europe, to the level of the successful childhood immunisation schedules we have today. This would require prioritising sustainable immunisation financing in every EU Member State, as a smart spending associated with significant socioeconomic, clinical and environmental gains. 

COVID-19 also demonstrated that sustainable investments in research, development, innovation (R&D&I) and manufacturing are essential to tackle the health challenges of today and tomorrow. We need to ensure Europe fosters an attractive environment where immunisation innovation can thrive. Europe’s science and R&D base remain a strength that should be preserved at all costs, and strengthened so that vaccines can continue to be developed in the EU, with diverse technology platforms. A key focus for a European strategy must be to accelerate R&D&I with the relevant push and pull incentives to move fast and far. 

At Vaccines Europe, we are committed to continue our work within these areas, together with all stakeholders of the EU vaccine ecosystem. Representing its 15 member companies, Vaccines Europe is the only organisation solely focused on prevention of vaccine-preventable diseases and immunisation policies.  

We won’t rest until we bring our science to people everywhere to protect them from vaccine-preventable diseases.  

Key Figures

Vaccines Europe External Engagement

National AMR action plans and immunisation programmes: key policy priorities in the fight against AMR

On the 29th of March, Vaccines Europe, together with LiF, the trade association representing innovative pharmaceutical companies in Sweden, organised a webinar on AMR and vaccination.

Focusing on national AMR action plans and immunisation programmes, the event offered the opportunity to discuss strategies to best implement vaccination into national AMR plans to help in the fight against AMR.

Opening the debate, John Paget, Senior Researcher at NIVEL, presented a study he led analysing national AMR plans from WHO countries, demonstrating that whilst a great part of the countries surveyed (87%) included vaccination into their national AMR action plans, vaccination is recognised as a main objective only in a minority of them (34%).

The last speaker, Jaime Jesús Pérez Martín, President of the Spanish Society of Vaccinology, echoed the calls to include concrete objectives into AMR plans, and recommended the inclusion as well of NITAGs, and of the value of vaccines against AMR in their assessment process.

Sibilia Quilici, Executive Director Vaccines Europe, then introduced the industry’s perspective, highlighting how vaccines can be directly and indirectly efficient in the fight against AMR by reducing antibiotic use, overuse and misuse. Presenting the recent Vaccines Europe review of its members’ pipelines, showing that, from the vaccines candidates in clinical trials, 11 are targeting antibiotic-resistant bacteria, Sibilia called for strategies to stimulate R&D on vaccines with AMR impact.

The Council Recommendation on AMR under the Swedish Presidency of the Council of the EU represents an opportunity to:

• Acknowledge and implement the WHO Immunisation Agenda 2030 and its Goals, Objectives and Priority Actions on “Leveraging Vaccines to Reduce Antibiotic Use and Prevent Antimicrobial Resistance”
• Call upon Member States to: 
  • Include immunisation strategies into AMR national plans, with defined vaccination coverage rates (VCR) targets and objectives by pathogens.
  • Ensure national monitoring of VCR and implement appropriate public health measures to reach national targets for vaccine-preventable infections.
  • Organise awareness campaigns towards HCPs and citizens on the additional benefit of vaccines in avoiding antibiotic use responsible for AMR.

  • Establish sustainable immunisation financing for their immunisation policies.

• Call upon Member States and the European Commission to:
  • Invest in research into new vaccines against antibiotic-resistant bacteria.
  • Investigate on innovative funding mechanisms and incentives dedicated to boost R&D of new vaccines against antibiotic-resistant bacteria.

The resilience of (international) supply chains of vaccines and critical medical goods, and the question of health-related EU strategic autonomy

Public Hearing, Special Committee on COVID-19 pandemic, European Parliament, 6 February

Supply chain resilience on the agenda for the COVI Committee's work on lessons learned from the pandemic

On 6 February 2023, the European Parliament’s Special Committee on the COVID-19 Pandemic (COVI) held an exchange of views on the resilience of (international) supply chains of vaccines and critical medical goods, and the question of health-related 'EU strategic autonomy', to feed into its report on lessons learned from the pandemic.

Sibilia Quilici, Executive Director Vaccines Europe, represented the voice of vaccines industry expressing its commitment to ensure supply of vaccines for European citizens, while supporting the work done by the EU in ensuring resilient supply chains.

She highlighted the importance of vaccine manufacturing and explained that Europe is now considered the 'powerhouse' of vaccines in terms of the capacity and its ability to respond to the needs of the EU citizens, as well as delivering vaccines beyond Europe. That is why, nowadays, vaccine manufacturing in Europe is strong enough not to heavily depend on China’s supply chains.

She also noted that forecasting an accurate demand for vaccines guarantees the right level of supply and at the right time, and data collected from such monitoring needs to be shared with the industry in a timely manner.

Based on the experiences that proved successful during the pandemic, Vaccines Europe calls for continued and further strengthened collaboration between the public and private sector, as well as between vaccine developers and manufacturers on a voluntary basis. Additionally, a strong IP framework and regulatory flexibilities were vital in ensuring fast development and manufacturing of COVID-19 vaccines.

Read the statements from the debate in the minutes of the COVI Committee meeting or re-watch it on the European Parliament’s webpage. To read more about the position and the recommendations of the vaccines industry on supply challenges in Europe, please click here.

Other events we participated in

• Greece’s agenda to combat cancer: Third annual summit, The Economist Impact – 7 March (Greece)
• Strengthening the EU vaccine ecosystem: managing the digital transformation – webinar by the European Health Management Association (EHMA) – 26 January

DIA Outstanding Contribution to Global Health Award

On 21 March, Sibilia Quilici accepted the DIA Award for Outstanding Contribution to Global Health on behalf of Vaccines Europe. 

Communications Highlights

World Cancer Day

World Cancer Day (4th February) presents an opportunity to raise awareness of cancer and its implications. Immunisation plays a key role in that global conversation. Vaccination against Hepatitis B and HPV could prevent 1.1 million cancer cases worldwide every year.  In our communications around World Cancer Day, we focussed on the value of vaccination in the fight against cancer, and drew attention to the ambition of the European Beating Cancer Plan to eliminate vaccine-preventable cancers in Europe.

Revisiting our flagship initiatives from the end of 2022

In November and December 2022, we published three central papers, focussing on different parts of the vaccine ecosystem: from innovation in vaccine research and development, to the importance of prioritising adult immunisation, to improving access to vaccines in Europe. In the first few months of 2023, we continued to share key information from these publications on our social channels. We also launched an interactive webpage, allowing people to explore the pipeline review in more detail. 

Health Policy Highlights

Commission’s revision of the EU General Pharmaceutical Legislation

The European Commission announced that the publication of the proposal for the revision of the EU General Pharmaceutical Legislation is further postponed until 26 April. The revision represents a unique opportunity to implement learnings from COVID-19. This will help ensure future-proof and resilient healthcare systems in Europe, building on a strong, efficient and flexible regulatory framework.

Although the date for official publication remains a moving target, the European Commission’s working draft proposals leaked at the end of January. It introduces criteria for what constitutes Unmet Medical Need (UMN) and High Unmet Medical Need (HUMN). Incentives such as Regulatory Data Protection (RDP) and extended market exclusivity can be modulated based on the concepts of UMN and HUMN. In addition, the proposal links RDP with access, allowing only those who launch in all EU27 markets to benefit from extended RDP.

The draft also proposes to define vaccines in a broader sense as “any medical product that is intended to elicit an immune response for prevention, including post-exposure prophylaxis, and for treatment of diseases caused by an infections agent”.

The proposal further provides Member States with the opportunity to introduce e-leaflets in parallel to paper leaflets, with the Commission having the possibility to make e-leaflets mandatory as of 2035.

Europe’s current innovation ecosystem for vaccines has been successful, as shown by Vaccines Europe’s pipeline review. This presented 100 promising vaccine candidates as of July 2022. In the context of the legislative revision, the specificities of vaccines and vaccination should clearly be considered to ensure that the European environment for the development of new vaccines remains attractive.

European Parliament Special Committee on the COVID-19 pandemic

Which lessons can we learn from the COVID-19 pandemic? How can the EU be better prepared in case another pandemic hits us?

Two important questions to which the Members of the European Parliament Special Committee on COVID-19 pandemic (COVI) have been trying to gather insights and answers to for the past months. The draft report of the COVI Committee is now public and has been distributed to its members for amendments. A vote on the final report is expected to happen in July in Strasbourg.

Vaccines Europe believes the COVI Committee has represented a unique opportunity to draw guidelines for better prepared, more resilient healthcare systems in the EU. To make the EU, as a whole, better equipped to face the next pandemic, we call for:

• Strengthening healthcare system capacities, through the rollout of COVID-19 and routine vaccination campaigns, and adequate monitoring systems across Europe;
• Addressing vaccine hesitancy, as well as public education, via robust and transparent communication plans;
• The research ecosystem that has provided the major solutions to health threats such as COVID-19, is built on intellectual property (IP) rights. To enable medical innovation, Europe needs a dynamic and well-funded research ecosystem and a supportive IP framework;
• Medical countermeasures, and especially vaccines, are complex products using novel technologies and ingredients. We need to strengthen global supply chains to support the production and free flow of such technologies;
• A range of regulatory flexibilities (e.g. on rolling review) provided during the pandemic, can add value beyond emergency situations;
• The creation of a European Health Emergency Preparedness and Response Authority (HERA) is a first step to putting Europe on the front foot in addressing global health threats. Should we wish HERA to live up to its ambitions, it will be critical to provide funding at scale.

President Emmanuel Macron recently confirmed that the vaccination against Human Papillomavirus (HPV) will be offered by 2024 to each 11-year-old child, girl or boy, with easier accessibility in schools and retail pharmacies and no upfront costs. The stated ambition for his 2022-2027 five-year term is clear: to reaffirm the central position that prevention must have in the French health system and, with it, the vaccination policy. This must become a priority, and its reinforcement an emergency in the face of insufficient vaccination coverage rates.

HPV is responsible for more than 6,300 cancers each year, with eight different cancer sites: cervix, anus, oropharynx, vulva, vagina, oral cavity, larynx and penis.

Last December in France, the National Institute of Cancer (INCa) published its strategy to fight cancers for the next decade (2021-2030). The government set ambitious objectives and, in particular, to improve prevention in order to reduce avoidable cancers by 60,000 per year by 2040 (currently estimated around 153,000 per year).

Today, vaccination against HPV is recognised to be a real tool for prevention and public health. Although it has been widely extended by many countries around the world, the level of integration of HPV vaccination into national immunisation programmes is still low.

In France, we have known for many years a vaccination coverage rate which was below the public health objectives. In the context of the pandemic, some vaccinations have experienced significant slowdowns. This is specifically the case for vaccination against papillomavirus (about 37% of 16-year-old girls vaccinated) and adult boosters of routine vaccinations.

Through that ten-year cancer control strategy presented by INCa, prevention and detection of infectious risks is one of the pillars of the action plan and it should permit to achieve an HPV vaccination coverage rate of 80% by 2030.

This is a major step forward for France in terms of prevention.

What We Are Reading & Watching

Pneumococcal vaccination atlas - an online tool by the Coalition for Life Course Immunisation and International Longevity Centre UK

Protocol for a COVID-19 vaccine effectiveness study using health data registries - a report by the European Centre for Disease Prevention and Control (ECDC)

Study on global disease surveillance and pathogen sharing - a research project by Covington

Life-course immunization: Country landscape report - a report by IFPMA