Conclusions on vaccination as one of the most effective tools for preventing disease and improving public health - Approval - Hoofdinhoud

Document­datum	29-11-2022
Publicatie­datum	30-11-2022
Kenmerk	14771/22
Externe link	origineel bericht
Originele document in PDF

Council of the European Union Brussels, 29 November 2022 (OR. en)

14771/22

SAN 609 PHARM 177 MI 877 SOC 656 RECH 632 EDUC 410 DIGIT 226

NOTE

From: General Secretariat of the Council

To: Council

Subject: Conclusions on vaccination as one of the most effective tools for preventing disease and improving public health

• - 

  Approval

• 1. 

  On 14 September 2022, the Presidency submitted to the Working Party on Public Health a set of draft Council conclusions on vaccination as one of the most effective tools for preventing

  disease and improving public health 1 .

• 2. 

  The COVID-19 pandemic has highlighted once again the issue of vaccine hesitancy and has demonstrated the value of EU cooperation in preventing and limiting the spread of vaccinepreventable diseases. These two aspects of vaccination policy were a priority for the Czech Presidency. Among several events on these topics, the videoconference of the members of the Working Party on Public Health (High Level) on 26 July 2022 and the informal meeting of Ministers of Health on 7 September 2022 provided input for the proposal for Council conclusions.

1 12396/22

• 3. 

  The Working Party on Public Health examined the draft Council conclusions in three meetings and reached a tentative agreement on 31 October 2022 following further informal consultations.

• 4. 

  On 25 November, the Permanent Representatives Committee endorsed the draft conclusions

tentatively agreed by the Working Party 2 and decided to submit them to the Council (EPSCO)

for approval at its session on 9 December 2022.

• 5. 

  The Council is invited to:

  • - 

    approve the Conclusions as set out in the Annex to this note, and - decide to have them published in the Official Journal of the European Union.

ANNEX

Conclusions on vaccination as one of the most effective tools for preventing disease and

improving public health

Introduction

Vaccination is considered to be one of the most effective public health tools in the prevention of infectious diseases and the mitigation of their most damaging effects. Vaccination is not only important for children, but also in a life-course perspective. The development of vaccines represents a shift in medical history and has had a significant impact on public health. Many diseases have been prevented by vaccination, thereby reducing the burden on health systems and preventing an

3

estimated 3,5 - 5 million deaths annually . In the case of smallpox, this disease has even been eradicated thanks to vaccination.

However, today, vaccination is a victim of its own success. Some people no longer see the impacts of infectious diseases that are no longer present due to vaccination schemes and a considerable number may even therefore question the importance of vaccination. Vaccination coverage rates in many regions across the EU are falling well below the recommended levels. Infectious diseases can easily return under such circumstances. An example of this is the measles epidemic that has broken out in recent years in a number of European countries.

People’s willingness to receive safe, effective, recommended and available vaccines has been challenged over the last few decades. Vaccine hesitancy is ranked by the World Health

Organization (WHO) among the 10 biggest threats to global health. It is also a problem that varies depending on the context, country and type of vaccine concerned, and for this reason it is particularly challenging. There is no one-size-fits-all solution, and a sustainable effort in improving dialogue with citizens, understanding their concerns and developing tailored vaccination strategies, alongside targeted communication campaigns, is required.

3 https://www.who.int/health-topics/vaccines-and-immunization#tab=tab_

The COVID-19 pandemic has further highlighted the size and scope of this issue. COVID-19 vaccine hesitancy was substantially influenced by diverse factors, among which concerns about the perceived safety and effectiveness of the vaccine have been predominant. Although in some EU

Member States COVID-19 vaccination campaigns did not result in very high vaccination rates, in some parts of the European Union the results were impressive.

On the positive side, the pandemic has also brought forward the development of a number of important solutions and tools which we can already make use of today. Significant developments have been made, for example, in digitalisation, with the collection and exchange of data at EU level as well as establishment of the EU Digital COVID Certificate, an important milestone setting a global standard as part of the public health measures to contain the spread of the pandemic. The EU Strategy for COVID-19 vaccines 4 followed by the launch of the Health Emergency Preparedness and Response Authority (HERA) also represents a major step forward in ensuring the development, procurement, purchase and distribution of medical countermeasures at EU level, such as of vaccines and therapeutics. Another equally important achievement is putting in place the European Health Union, which aims at reinforcing the crisis preparedness and response of key agencies.

We need to learn from the COVID-19 pandemic to ensure adequate preparedness for future public health crises. In this regard, flows of displaced persons to the EU may pose a public health challenge, first and foremost for displaced group itself, and also for the Member States, that should include all such persons in their vaccination strategies, according to national legislation.

Additionally, we should focus on the impact of climate change on public health, which may be farreaching, with potential shifts in the transmission ranges of infectious diseases, in particular vectorborne diseases such as hantavirus, tick-borne encephalitis, Lyme disease and malaria.

With this in mind, Member States should step up their joint efforts, building on the Council

Recommendation on strengthened cooperation against vaccine-preventable diseases from 2018 5 and lessons learned during last years of COVID-19 pandemic.

4 COM/2020/245 final

5 COM/2018/244 final

While vaccination services, programmes and policies are a responsibility of Member States, given the cross-border nature of infectious diseases and the common challenges faced by national immunisation programmes, particularly in the light of COVID-19 pandemic, migration, or the monkeypox outbreak, Member States could benefit from an even more coordinated EU approach to preventing and limiting the spread of epidemics and vaccine-preventable diseases.

Combating vaccine hesitancy: the risk of mis- and disinformation and the need to increase public confidence in vaccination

THE COUNCIL OF THE EUROPEAN UNION

• 1. 

  RECALLS that, pursuant to Article 168 of the Treaty of Functioning of the European Union (TFEU), Union action, which is to complement national policies, is to be directed towards

  improving public health, preventing physical and mental illness and disease, and preventing sources of danger to physical and mental health.

• 2. 

  RECOGNISES that while vaccination programmes are the responsibility of the Member

  States, a better coordinated EU approach can generally have an added value, given the crossborder nature of vaccine-preventable diseases.

• 3. 

  NOTES that vaccine hesitancy has different root causes. Different situations such as routine vaccination with well-known vaccines or vaccination during health crises, such as the

  COVID-19 pandemic, where newly developed vaccines are deployed, require different solutions.

• 4. 

  ACKNOWLEDGES that the COVID-19 pandemic clearly demonstrated the threats and challenges that mis- and disinformation pose to our societies. ‘Infodemics’ – too much information, including false or misleading information, in digital and physical environments during a disease outbreak 6 – was one of the crucial factors, which increased the risks to human health, health systems and effective crisis management.

• 5. 

  RECALLS the joint Communication of the Commission and the High Representative adopted on 5 December 2018 launching the Action Plan against Disinformation 7 , the Commission

  Communication on ‘Tackling online disinformation’ 8 adopted on 26 April 2018, the Commission Communication on ‘Guidance on Strengthening the Code of Practice on Disinformation’ 9 adopted on 26 May 2021, the Commission Communication on ‘Strengthened Cooperation against Vaccine Preventable Diseases’ 10 adopted on 26 April 2018 and joint Communication of the Commission and the High Representative adopted on 10 June 2020 on Tackling COVID-19 disinformation - Getting the facts right 11 .

• 6. 

  RECALLS the Council Conclusions on strengthening resilience and countering hybrid threats, including disinformation in the context of the COVID-19 pandemic 12 , the Council

  Recommendation on strengthened cooperation against vaccine-preventable diseases 13 , which pays particular attention to the issue of vaccine hesitancy and disinformation shifting the public focus away from the benefits of vaccination and towards a distrust in science and fear of possible side effects, and TAKES NOTE OF the Roadmap 14 of the European Commission for the implementation of actions called for by the Recommendation together with the activities of the Joint Action on Vaccination 15 , delivering recommendations and concrete tools for stronger responses to vaccination challenges, including promoting vaccine acceptance.

• 7. 

  RECALLS the report for the Commission on the ‘State of Vaccine Confidence in the

  EU+UK’ published on 11 December 2020. 16

7 JOIN/2018/36 final

8 COM/2018/236 final

9 COM/2021/262 final

10 COM/2018/245 final

11 JOIN/2020/ 8 final

12 ST 13626/20

13 COM/2018/244 final

14 https://health.ec.europa.eu/system/files/2022-07/2019-2022_roadmap_en.pdf

15 https://eu-jav.com/

16 https://ec.europa.eu/health/system/files/2020-12/2020_confidence_rep_en_0.pdf

• 8. 

  RECALLS the report on ‘Countering online vaccine misinformation in the EU’, published by the European Centre for Disease Prevention and Control on 29 June 2021 17 , examining the evidence base for how to counter online vaccine misinformation in the EU and HIGHLIGHTS the European Vaccination Information Portal 18 , hosted by the ECDC, which provides accurate and up-to-date evidence on vaccination together with an overview of the EU mechanisms to ensure vaccine safety and effectiveness.

• 9. 

  RECALLS the Regulation of the European Parliament and of the Council amending

  Regulation (EC) No 851/2004 i establishing a European Centre for disease prevention and control 19 and also WELCOMES ECDC’s overall role and contribution, including in facilitating the fight against mis- and disinformation regarding vaccination and increasing vaccine confidence such as e-learning courses on how to address online vaccination misinformation 20 .

• 10. 

  WELCOMES the EU4Health Programme, which ambitiously fosters Union-wide and crosssectoral crisis prevention, with a particular emphasis on improving vaccination coverage rates in the Member States, specifically by providing funding available for awareness-raising

  campaigns and communications activities targeting both the general public and specific groups, with the aim of preventing and addressing vaccine hesitancy, misinformation and disinformation.

• 11. 

  WELCOMES the HORIZON 2020 actions tackling vaccine misinformation and the development of tools to improve vaccine uptake and the HORIZON Europe actions aimed at providing evidence to better counter mis- and disinformation.

• 12. 

  WELCOMES the Immunization Agenda 2030 21 , published by WHO on 1 April 2020, which seeks to address vaccine hesitancy by developing robust, innovative strategies to mitigate vaccine misinformation and reduce its propagation and negative impact.

17 https://www.ecdc.europa.eu/en/news-events/ecdc-launches-report-countering-online-vaccine-misinformation-eueea

18 https://vaccination-info.eu/en

19 2020/0320(COD) i

20 Misinformation (europa.eu)

21 https://www.who.int/publications/m/item/immunization-agenda-2030-a-global-strategy-to-leave-no-one-behind

• 13. 

  EMPHASISES the need for constant analysis and public communication of individual risks and benefits of vaccinations in various risk groups and among those with insufficient sources of information, for example due to social, cultural or linguistic challenges.

• 14. 

  INVITES THE MEMBER STATES TO:

  • - 

    Use interdisciplinary expertise (including public health experts, digital health experts, communication specialists, social media experts and behavioural experts) to amplify efforts to counter vaccine mis- and disinformation and apply a stronger, evidence-based and more strategic approach to vaccine communications, with harmonised messaging between the parties involved.

• 15. 

  INVITES THE COMMISSION TO:

  • - 

    Without duplication with existing initiatives and minimising the administrative burden on Member States, establish an expert forum on Vaccine Hesitancy to provide a

    platform to bring together experts from all relevant fields in order to discuss, exchange best practice, follow up on the Joint Action on Vaccination’s activities beyond the project itself and, in particular, facilitate and accelerate the communication with EU agencies to provide guidance on how to increase vaccination coverage rates across the European Union;

  • - 

    Strengthen, where appropriate, the coordination between EU policies on vaccination and on fighting disinformation in order to support a more effective holistic approach,

    including by issuing a Commission Communication on combating vaccine hesitancy;

  • - 

    Together with ECDC provide Member States, upon request with non-binding tailormade

  recommendations and guidelines on how to tackle vaccine hesitancy taking into

  account national specificities;

  • - 

    Provide advice, upon Member State´s request, to those responsible for national

  immunisation programmes within Member States, on the use of all relevant EU

  programmes and instruments for targeted vaccination campaigns and how to evaluate

  these campaigns.

• 16. 

  INVITES THE MEMBER STATES AND THE COMMISSION TO:

  • - 

    Develop training opportunities (communications and social media training) to allow

  health professionals and health communication experts to become more versed in

  effective techniques and tools for countering vaccine mis- and disinformation, including

  online, for developing communication strategies or ensuring effective communication

  between health professionals and citizens about the benefits of vaccination (shared

  decision-making), involving the Coalition for Vaccination and health professionals’ and

  students associations at national level;

  • - 

    Promote awareness-raising activities on the benefits of vaccination, including through partnerships with the education sector, social partners and action targeting the media, while putting particular focus on the responsibilities and role of social media platforms;

  • - 

    Support national policies that will ensure provision of equitable, accessible and appealing vaccination services to all eligible people, ensuring that vaccination does not become a missed opportunity.

Strengthening EU cooperation to prepare for upcoming challenges: building on best practice and lessons learnt

• 17. 

  NOTES that the COVID-19 pandemic has affected vaccination policies at European and national level in a significant and unprecedented way. Although in some Member States,

  COVID-19 vaccine acceptance has been high, in many it has not been sufficient. It has also accelerated the development of new tools and solutions that the EU can build on to encourage cooperation on vaccination strategies and immunisation programmes.

• 18. 

  UNDERLINES the benefits of strengthened EU cooperation in terms of countering vaccine mistrust and encouraging vaccine uptake; realizing that significantly different approaches though based on the same scientific data, may in some cases negatively influence public confidence in vaccination.

• 19. 

  RECALLS Regulation (EU) 2021/953 of the European Parliament and of the Council of

  14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate), which has been a great success for the EU.

• 20. 

  RECALLS the EU Vaccines Strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19, presented by the Commission on 17 June 2020, which enabled Member States to jointly procure and secure timely access to COVID-19 vaccines.

• 21. 

  WELCOMES the creation of the Health Emergency Preparedness and Response Authority

  (HERA), which should work to improve preparedness and response to serious cross-border threats in the area of medical countermeasures and, in doing so, should closely cooperate with Member States. Attention should be paid to tackling challenges related to the supply of medical countermeasures.

• 22. 

  NOTES that international mobility and migration have been accelerated therefore cooperation in the field of vaccination should always have a global dimension.

• 23. 

  RECALLS the Commission Communication on ‘Welcoming those fleeing war in Ukraine:

  Readying Europe to meet the needs’, adopted on 23 March 2022, which emphasises the need to increase vaccination coverage among displaced Ukrainians, with a particular focus on childhood vaccination programmes.

• 24. 

  RECALLS the ECDC guidelines on ‘Operational public health considerations for the prevention and control of infectious diseases in the context of Russia’s aggression towards Ukraine’, published on 8 March 2022.

• 25. 

  POINTS OUT that also other global issues and crises are expected to affect infectious disease occurrence within the EU, particularly climate change, which is likely to

  increase transmission of tick-borne encephalitis and other vector-borne diseases, such as West

  Nile fever or dengue.

• 26. 

  RECOGNISES the work carried out by the European Medicines Regulatory Network related to vaccines, ensuring the quality, efficacy and safety of medicines in the European Union.

  The work of the regulatory network implies scientific networking, benchmarking and strong collaboration between national competent authorities which contributes to an in-depth scientific knowledge on vaccines and increases reliability among the European population.

27 INVITES THE MEMBER STATES TO:

‒ Promote adult vaccination campaigns to provide protection against transmissible

infectious diseases that may be associated with serious outcomes, such as measles, diphtheria, tetanus or poliomyelitis;

‒ Maintain childhood vaccination campaigns and provide protection against transmissible

infectious diseases to children who are not yet protected by vaccination, i.e. to carry out vaccination catch-up campaigns;

‒ Support the digitisation of the healthcare system and explore the possibility of

developing medical facilities’ capacity to store electronic information on citizens’ vaccination status;

‒ Build and maintain an adequate health sector workforce capable of providing a rapid

and effective response to health threats, as well as improve vaccination coverage among health care professionals as a good health practice for the general public;

‒ Promote health education and health literacy in a life-course perspective.

• 28. 

  INVITES THE COMMISSION TO:

  • - 

    While ensuring the protection of health data, explore the added value and possibilities of overcoming the legal and technical barriers to the interoperability of (sub-) national

    immunization information systems, where they exist, through the opportunities offered by the existing or future cross border health data exchange mechanisms, and explore the added value of a digital version of vaccination certificates, taking into consideration the experiences with European digital infrastructures and other existing tools, such as the International Certificate of Vaccination or Prophylaxis.

  • - 

    Put particular focus on research and innovation and examine possibilities for supporting the development of new vaccines against (re)emerging infectious threats, with particular attention to vector-borne diseases.

  • - 

    To invite ECDC to update its public health guidance on screening and vaccination for infectious diseases in newly arrived migrants within the EU/EEA, taking into account existing national public health guidelines .

• 29. 

  INVITES THE MEMBER STATES AND THE COMMISSION TO:

  • - 

    Develop, based on the good practice and experience gained from the “Bazaar tool”

  developed for the needs of the Steering Board for Covid-19 vaccines procurement,

  a virtual database to facilitate, on voluntary basis, exchange of information on possible

  surpluses and shortages of essential vaccines, thus enabling possible resell or donation

  among Member States.

  • - 

    Make use of possibilities for the joint procurement of vaccines where appropriate, while taking into account the serious cross border health threats recognized at Union level and the actual needs of the Member States.

  • - 

    Support the European Medicines Regulatory Network through a well-resourced and

  flexible mechanism to consolidate its work and ensure the sustainability of the network

  contribution in the long term.