COMMISSION STAFF WORKING DOCUMENT Synopsis Report Accompanying the document Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and The Committee of Regions and Proposal for a Council Recommendation on Strengthened Cooperation against Vaccine Preventable Diseases
Date: 2018-04-26
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, access to information, cross-border cooperation, epidemic, infectious disease, information system, public health, research and development, vaccination, vaccine

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  EN 

   EUROPEAN COMMISSION  Brussels, 26.4.2018 SWD(2018) 149 final  COMMISSION STAFF WORKING DOCUMENT Synopsis Report Accompanying the document Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and The Committee of Regions  and  Proposal for a Council Recommendation on Strengthened Cooperation against Vaccine Preventable Diseases {COM(2018) 245 final} - {COM(2018) 244 final}  
 
 
SYNOPSIS REPORT 

1.  INTRODUCTION 

This  report  covers  input  from  citizens  and  from  administrations,  associations  and  other 
organisations  (‘stakeholders’)  on  a  Commission  initiative  developed  by  the  Directorate-
General  for  Health  and  Food  Safety  (DG  SANTE)  as  a  Council  Recommendation  on 
strengthened cooperation against vaccine-preventable diseases (‘the Recommendation’).  

Citizens and stakeholders had four weeks to provide feedback on the Commission's roadmap 
on the Recommendation1 that was published on the Better Regulation Portal2. 
An  online  public  consultation3  via  EU  Survey,  available  in  23  EU  languages4  ran  from  21 
December 2017 to 15 March 2018. The analysis of the results was made via DORIS Public 
Consultation Dashboard and through qualitative analysis. 
In  addition,  two  targeted  consultations  with  stakeholders  took  place.  Selected  stakeholders5 
were invited to respond to a questionnaire via EU-Survey between 17 January 2018 and 14 
February 2018. The questionnaire featured more open questions than the public consultation, 
and was also analysed through DORIS and qualitative analysis.  

Face-to-face stakeholder meetings took place between 18 January and 9 February 2018 with 
groups representing the healthcare and clinical professionals, medical students, international 
organisations, non-governmental organisations, civil society and the vaccine industry. 

Overall,  355  responses were  submitted  on  the Commission’s  roadmap,  with  90%  of replies 
being vaccine hesitant.  

The  public  consultation  received  8894  replies;  of  which  8  688  from  citizens  and  206  from 
stakeholders. On 14 March, one day before closure, the public consultation received almost       
6 000 responses from France (60% of total answers). Most of these answered using the ‘no 
opinion’ option to all questions. These responses may be linked to an online message by the 
Institut  pour  la  protection  de  la  santé  naturelle6  suggesting  that  this  option  was  the  only 
possible answer to a perceived pro-vaccine bias in the questionnaire.  

33 stakeholders responded to the online targeted consultation and 20 took part in the face-to-
face meetings. 

A  total  of  33  participants  (14  citizens  and  19  stakeholders)  uploaded  additional  PDF 
documents to the roadmap, and 3 stakeholders did the same for the public consultation. These 
additional documents will be taken into account in the analysis. 

13 responses to the roadmap and 127 responses to the public consultation were not taken into 
account, due to duplication, anonymity, non-relevance or inadequate language. 

Over 25% of stakeholders were NGOs, followed by health administrations and professional 

1 http://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-5925775_en 
2 From 4 December 2017 to 1 January 2018. 
3 https://ec.europa.eu/info/consultations/open-public-consultation-strengthened-cooperation-against-vaccine-
preventable-diseases_en#how_to_submit 
4 The questionnaire was not available in Gaelic. 
5 Members of the Health Policy Platform; applicants to the EU Health NGO Award contest on vaccination; 
stakeholders representing the appointed national contact points involved in the EU Joint Action on Vaccination; 
Member State representatives in the Advisory Forum and the Network for Vaccine-preventable Diseases of the 
European Centre for Disease Prevention and Control (ECDC)’s. 
6 https://www.ipsn.eu/vaccins-commission-europeenne-demande-avis-15-mars 

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associations.  As  for  the  citizens,  8  769  came  from  the  EU,  the  vast  majority  from  France 
(78.3%), followed by Italy (4.4%) and Belgium (3.9%). There were 200 responses from non-
EU countries.  

This report summarises all the responses received from the 4 consultations. They are grouped 
along  the  initiative’s  3  main  pillars:  (1)  tackling  vaccine  hesitancy;  (2)  sustainable  vaccine 
policies  in  the  EU;  and  (3)  EU  coordination,  including  the  promotion  of  stakeholders’ 
dialogue and contribution to global health.  

1.  PILLAR I: TACKLING VACCINE HESITANCY 

Over  50%  of  the  respondents  to  the  public  consultation  considered  that  the  fear  of  side 
effects,  lack  of  information  on  risks,  introduction  of  mandatory  vaccination  and  levels  of 
confidence in the effectiveness of vaccines have the highest impact on vaccine hesitancy. 

1.1. BETTER COMMUNICATION ON SAFETY AND EFFECTIVENESS OF VACCINES 

Respondents highlighted the need for face-to-face interaction at the local level, including: 

  providing a patient-centred approach in the dialogue with healthcare professionals; 
  developing local awareness-raising programmes and events; 
  communicating directly with parents, including during pre-natal courses; 
 
 

introducing trusted mediators in vulnerable groups (e.g. Roma communities, refugees); 
improving  the  comprehension  of  vaccine  safety  studies  (e.g.  info-graphics,  videos, 
leaflets); 

  opening the debate for supporters and opponents to give a balance of benefits and risks; 

and 

  checking facts on fake news and conflicts of interest on a proactive basis. 

The  feedback  on  the  roadmap  also  supported  better  access  to  information.  Training  at  the 
workplace and at university was almost unanimously accepted7 as the most effective methods 
of communication to healthcare workers. 
On the EU’s communication on vaccine safety and effectiveness, over 60% of citizens8 and 
stakeholders believe that it is inadequate. Healthcare professionals noted that9: 

  online  data  from  the  European  Medicines  Agency  (EMA)  and  the  European  Centre  for 

Disease Control (ECDC) are fragmented, insufficiently circulated and accessible; 

  updated  information  on  a  single  platform  should  be  set  up  by  the  ECDC  (as  the  US 

Centers for Disease Control and Prevention); 

  EU  should  encourage  national  websites  on  vaccine  hesitancy  EU  should  promote  an 

interactive campaign on vaccination. 

Feedback  on  the  roadmap  suggested  that  the  Commission  should  improve  its  engagement 
with vaccine hesitant groups. 

7 By the respondents to the public consultation and the targeted consultation. 
8 Not including those who provided no opinion on the matter. 
9 Answering the targeted consultation only. 

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1.2. BETTER COOPERATION BETWEEN ACTORS IN TACKLING VACCINE HESITANCY 

Respondents10 suggested to promote recommended vaccinations and to provide the scientific 
evidence backing those recommendations.  

Other suggestions focused on educating the public: 

involve women as the main carers of children and the elderly and celebrities in advocacy; 

  distinguish essential vaccines (e.g. polio) from voluntary ones (e.g. influenza); 
 
  display images of vaccine-preventable diseases, on the model of cigarette packs; and 
 

raise awareness of herd immunity and individual responsibility. 

Stakeholders11 also highlighted the role of the vaccine industry in: 

  providing transparent information on vaccines, prices and ingredients; 
  prioritising public health over commercial gains; and 
 

improving the quality and supply of vaccines  through more R&D. 

1.3. BETTER SUPPORT TO HEALTHCARE PROFESSIONALS 

81.33%  of  citizens  believed  that  healthcare  professionals  should  be  better  supported  in 
advocating  vaccination and be provided with material to inform the public.  
Stakeholders12 consider that the EU should support healthcare professionals through training 
on  communication  (82%),  online  information  (79%),  scientific  material  (70%)  and 
developing EU campaigns on vaccination (66%). They also suggested: 

  developing hard mandates (e.g. mandatory vaccination for high-risk groups); 
  ensuring all healthcare professionals receive relevant vaccination themselves; 
 
improving working hours conditions to enable more patient communication; 
 
increasing education standards; and 
  creating common EU recommendations, with fees for rule breaches. 

Stakeholders  that  responded  to  the  targeted  consultation  believe  in  need  to  promote 
continuous  education  on  vaccination  to  pharmacists.  Feedback  on  the  roadmap  supported 
improving education programmes and health promotion through digital tools.  

PILLAR II: SUSTAINABLE VACCINE POLICIES IN THE EU 

To  overcome  national  differences  in  the  sustainability  of  vaccination  programmes, 
stakeholders13 (81%) suggested harmonising vaccination schedules in the EU. 

1.4. INVESTMENT IN E-HEALTH AND DIGITALIZATION 

Developing an electronic vaccination record was the most endorsed e-health investment with 
almost unanimous consensus14. Potential benefits include sending notifications on recalls and 
tracking coverage rates.  

10 Answering the OPC and the targeted consultation. 
11 Answering the targeted consultation only. 
12 Answering the targeted consultation only. 
13 Answering the targeted consultation only 
14 The OPC respondents were not involved on this topic. 

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1.5. BETTER COMMUNICATION WITH THE VACCINE INDUSTRY 

Citizens supported obliging industries to supply the required vaccines (24.55%). In contrast, 
stakeholders15  supported  mapping  vaccine  demand  (70.87%)  and  establishing  national 
systematic forecasts of vaccines (65.53%). Stakeholders16 also suggested:  

  creating an EU alert and planning mechanisms; 
  simplifying EU legislation on marketing authorisation to increase capacity; 
  promoting cooperation between vaccine industry and WHO; and 
  creating national and EU vaccine producers' federations. 

1.6. BETTER ENGAGEMENT IN FUNCTIONING AND SUSTAINABLE VACCINATION PROGRAMMES 

Stakeholders17  suggested  new  EU  actions  to  address  the  sustainability  of  vaccination 
programmes: 

  exchanging information with authorities outside the EU on vaccine quality; 
 
improving EU legislation with new binding commitments for vaccine manufacturers; 
  establishing an EU platform with guidance on national implementation programmes; and 
  performing pharma-economic evaluations. 

Grassroots level organisations could support sustainable vaccination policies by:  

forming a stakeholders' alliance to align work and hear patients’ voices; 
researching barriers to vaccination access; and 

 
 
  establishing an EU "Vaccination Ambassador" programme.  

Other targeted  consultation  proposals include shifting tasks from doctors  to  nurses,  seeking 
cooperation  from  employers  to  ensure  suitable  leave  for  vaccinations,  and  reviewing  co-
payments, out-of-pocket contributions and vaccine injury compensation rights. 

One response suggested implementing an EU Technical Advisory Group based on the model 
of the US Advisory Committee on Immunization Practices. 

To ensure effective information flow and monitoring of the impacts at EU level, respondents 
suggest:  

  circulating ECDC data more effectively; 
  setting  up  a  fund  (with  mandatory  contributions  from  the  vaccine  industry)  for  vaccine 

impact studies; and 

  setting up an information and monitoring system at EU level to consolidate vaccine data. 

1.7. BETTER PROMOTION OF VACCINATION TO INCREASE COVERAGE RATES 

To promote vaccination, stakeholders propose: 

  developing information campaigns; 
 

formulating robust legal regulation of vaccination, with clear accountability for all actors 
involved; and 

15 Answering the open consultation only. 
16 Answering the targeted consultation only. 
17 Answering the targeted consultation only. 

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 

improving  vaccination  coverage  of  healthcare  professionals, 
encouragement/incentives or mandatory requirement. 

through  voluntary 

82%  of  other  stakeholders18  believe  that  the  EU  should  develop  a  common  approach  to 
vaccination schedules.  They also propose: 

  aligning vaccination schedules and policies;  
  providing surveillance methods for specific groups; 
  developing an EU interoperable immunisation information system; 
  ensuring  citizens have adequate and free access to vaccination programmes;  
  allowing pharmacists and nurses to prescribe and administer vaccines; and 
 
improving coordination between Health Ministries and ECDC/WHO.   

Stakeholders that responded to the targeted consultation called for greater focus on adolescent 
and adult vaccinations. 

Stakeholders  rejected  almost  unanimously  a  ‘one-size-fits-all’  strategy.  Feedback  on  the 
roadmap  called  for  more  focus  on  vaccine  injuries,  including  setting  up  independent 
European vaccine adverse effect reporting (VAER) systems. 

1.8. REDUCTION OF VACCINE SHORTAGES AND IMPROVEMENT OF PRODUCTION CAPACITIES 

Stakeholders that responded to the public consultation and the targeted consultation believe 
the  key  policy  interventions  to  mitigate  vaccine  shortages  are  forecasting  and  joint 
procurements. 36.8% of citizens considered the availability of individual vaccines to be most 
important. 
Stakeholders19 suggest that EU coordination on vaccine shortages could be improved by: 

  creating an industry flag to highlight that a manufacturing problem is anticipated; 
  standardising packaging; and 
  providing transparent price and volume. 

To increase vaccine production and reduce lead times, stakeholders20 suggest: 

increasing surveillance and investment in production/research; 

 
  amending EU legislation (e.g. simplification of marketing authorisations); 
  using new technologies and financial incentives for industry; 
  enhancing  the  joint  procurement  system  and  improving  coordination  of  EU  vaccination 

schedules; and 

  harmonising vaccine information, including packaging and language. 

To enable a sufficient production capacity in the EU, stakeholders propose: 

regulating and prioritising vaccine production; 

 
  coordinating planning, forecasting, joint procurement and funding mechanisms; 

18 Answering the targeted consultation only. 
19 Answering the targeted consultation only. 
20 Answering the targeted consultation only. 

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  establishing  multiannual  budgets  for  national  immunisation  schedules  and  vaccine-dose 
planning based on epidemiological studies at least 3 years before manufacturing orders; 
and 

  R&D  funding  mechanisms  (based  on  the  US  Biomedical  Advance  Research  and 
Development Authority model - BARDA) for vaccines that are health security priorities. 

Feedback also proposed developing European guidelines on vaccines planning.  

1.9. BOLSTER RESEARCH AND DEVELOPMENT 

Stakeholders21 also suggest speeding up R&D by: 

  aligning with the GLOPID and the CEPI for developing new vaccines; 
  ensuring industry's support for public health-led, independent vaccine studies; and 
  establishing joint scientific advice groups and regulators at EU level. 

Proposals for the EU to better support the scientific evaluation of new vaccines include: 

  closer collaboration with WHO and UN; 
  complementing central authorisation procedures with independent vaccine testing; 
  creating a network of National Immunisation Technical Advisory Groups, EU regulators, 

Health Technology Agencies to share strategies and evidence; and 

  supporting  the  development  of  post-marketing  studies  based  on  an  EU  immunisation 

information system. 

2.  PILLAR III: EU COORDINATION, INCLUDING PROMOTION OF STAKEHOLDERS’ DIALOGUE AND 

CONTRIBUTION TO GLOBAL HEALTH 

Stakeholders22 identified new EU cooperation areas for vaccination: 

  common regulatory framework and digital record system; 
  communication and media; 
  cross-border public health campaigns; 
  EU funding platform for vaccine studies and research; and 
  EU immunisation platform for exchanging information and best practice. 

The most important funding instruments for R&D were the EU Horizon 2020 grants (42%) 
and the EU-funded public-public partnerships (33%). 

2.1. PROMOTION OF CROSS-BORDER EXCHANGES IN THE EU 

In the targeted consultation, stakeholders23 (97%) call on the Commission to coordinate the 
exchange of best practice and vaccine products among Member States.  
Citizens24 (55%) call for an exchange of best practice on vaccine injury compensation. 

21 Answering the targeted consultation only. 
22 Answering the targeted consultation only. 
23 Answering the targeted consultation only. 
24 Those citizens not providing any opinion were not considered on this matter. 

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STRENGTHENING EU COOPERATION IN PUBLIC HEALTH PREPAREDNESS 

Respondents  to  the  public  consultation  and  the  targeted  consultation  consider  that  Member 
States  should  collaborate  with  industry  on  a  crisis  management  plan to  forecast  and  reduce 
risks during vaccine manufacturing.  

2.2. MAKING RESEARCH MORE GLOBAL AND EFFECTIVE 

Respondents  to  the  public  consultation  and  the  targeted  consultation  almost  unanimously 
agree that EU action on vaccine research take place within and outside the EU.  

To  enable  collaboration  between  public  health  authorities,  civil  society  and  the  vaccine 
industry on implementing research, stakeholders suggest: 

  setting up expert networks or platforms; 
  establishing a regulatory framework, focusing on anticipating shortages; 
  establishing a dedicated EU agency to design actions and define funding; and 
  developing joint actions and public-private partnerships to build trust and generate/collect 

new data. 

3.  CONCLUSION 

Overall, the results of the consultation called for a more coordinated effort in vaccination at 
national  and  EU  level.  Equal  access  to  vaccination  programmes  and  vaccine  hesitancy  was 
identified  as  the  main  challenges.  Citizens  expressed  more  concern  over  the  safety  and 
effectiveness  of  immunisation  programmes,  emphasising  the  need  for  more  transparent 
research and information. 

The  main  concerns  for  vaccine  hesitant  respondents  were  (i)  side  effects  and  vaccine 
ingredients,    (ii)  perceived  lack  of  safety  and  effectiveness  of  vaccines,  (iii)  imposition  of 
mandatory  vaccination,  (iv)  lack  of  vaccine  injury  compensation  schemes,  (v)  financial 
interests  of  the  pharmaceutical  industry,  (vi)  lack  of  transparent  and  industry-independent 
scientific  research,    (vii)  perceived  unilateral  information  on  benefits,  but  not  on  risks,  and  
(viii) mistrust in public authorities. 

Although  these  groups  represent  the  vast  majority  of  respondents  (over  70%),  the  other 
respondents endorsed the initiative. 

Key  suggestions  arising  from  the  targeted  consultation  were  to  (i)  involve  pharmacists  in 
vaccine  administration,  (ii)  include  immunisation  in  a  wider  preventive  healthcare  concept, 
(iii) focus more on adult vaccination, and (iv) upgrade access to information and data by the 
ECDC and EMA. 

Feedback from the roadmap focused on the need for dialogue, cooperation and the exchange 
of best practice, while respecting national specificities and competences.  

Respondents to the public consultation and the targeted consultation also called for healthcare 
professionals  to  be  more  involved  in  promoting  vaccination  by  providing  training  and 
information material. Educating and informing the public on vaccination using a local, face-
to-face approach was emphasised. The introduction of an electronic vaccination record was 
strongly supported.  

Overall, the  role of the Commission as a facilitator in the exchange of information and best 
practice on vaccines and immunisation among countries was supported. 

Due to the high geographical imbalance of contributions, the questionnaire is not statistically 

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representative as a consultation instrument. However, the high number of responses received 
compared to other consultations is an indication of the importance of the issue. 

8