COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Preparedness for COVID-19 vaccination strategies and vaccine deployment
Date: 2020-10-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, EU strategy, coronavirus disease, epidemic, vaccination, vaccine

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 15.10.2020  COM(2020) 680 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Preparedness for COVID-19 vaccination strategies and vaccine deployment  
 
 
1. 

THE JOURNEY TOWARDS SAFE COVID-19 VACCINES 

The coronavirus crisis has turned upside down the way we live our lives, how we interact with 
each  other,  how  we  use  public  spaces,  and  the  way  we  work.  No  part  of  our  lives  has 
remained  unaffected.  Europe  has  made  massive  strides  towards  overcoming  the 
coronavirus  pandemic,  safeguarding  the  internal  market  and  providing  cross  border 
solutions. 

But  now is  not  the  moment  to  let  down  our  guard.  After  a  period  of  lower  transmission 
rates,  during  which  countries  were  able  to  progressively  start  lifting  the  public  health 
measures  that  were  put  in  place,  infection  rates  have  been  increasing  again  across  the  EU 
since August1.  

While the upsurge initially correlated to increased testing rates in countries and transmission 
among younger people showing no or mild symptoms, the majority of EU countries is now 
observing a worrying rise in the rate of infections across the whole population, as well as 
increasing  hospitalisations,  severe  cases,  and  fatalities.  As  the  number  of  COVID-19  cases 
rise sharply in parts of Europe, fuelled largely by young adults, health authorities from many 
Member States are calling on  all citizens, and particularly on  young people, to do more to 
halt the spread of the virus. 

As of 11 October2, more than 4 million COVID-19 cases have been reported in the EU/EEA 
and  the  UK.  Furthermore,  nearly  all  countries  belonging  to  this  area  are  experiencing  high 
levels or sustained increases of their 14-day COVID-19 case notification rate. More than half 
of the countries are observing high levels or sustained increases among people over 65 years 
of age, and hospital, intensive care unit occupancy and/or new admissions due to COVID-19 
are  high  or  are  increasing  in  half  of  the  countries.  The  14-day  mortality  rate  has  been 
increasing for more than two weeks, with  nearly half of the countries having high levels  or 
sustained increases. 

While non-pharmaceutical interventions3 are crucial in slowing down the spread of the 
coronavirus, they are not able to control it sustainably. The practical limits of such measures 
have  been  demonstrated  as  citizens  are  experiencing  ‘pandemic  fatigue’  and  are  tired  of 
taking the necessary precautionary actions,  including physical  distancing  and reduced social 
interactions.  Even  so,  these  exceptional  measures  have  saved  lives  and  continue  to  be 

1 https://www.ecdc.europa.eu/en/publications-data/covid-19-risk-assessment-increased-transmission-twelfth-
update  
2 Since 31 December 2019 and as of 11 October 2020, 4 051 387 cases of COVID-19 (in accordance with the 
applied case definitions and testing strategies in the affected countries) have been reported in the EU/EEA and 
the UK, including 195 217 deaths (Source: European Centre for Disease Control (ECDC) daily situation update, 
https://www.ecdc.europa.eu/en/cases-2019-ncov-eueea).  
3 These include use of masks, stay-at-home orders and recommendations, closure of public places, limitations of 
the number of people allowed at indoor and outdoor gatherings, teleworking and adaptation of workplaces (for 
the latter, the EU-OSHA guidance available under the following link: https://osha.europa.eu/en/highlights/covid-
19-guidance-workplace).  

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necessary. As stressed by President von der Leyen in the State of the Union 2020 Address4, 
Europe  needs  to  continue  to  handle  the  COVID-19  pandemic  with  extreme  care, 
responsibility  and  unity,  and  use  the  lessons  learnt  to  strengthen  the  EU’s  crisis 
preparedness and management of cross-border health threats. 

The development and swift global deployment of safe and effective vaccines against COVID-
19  remains  an  essential  element  in  the  management  of  and  eventual  solution  to  the  public 
health  crisis5.  Vaccination,  once  a  safe  and  efficient  vaccine  is  available,  will  play  a 
central  role  in  saving  lives,  containing  the  pandemic,  protecting  health  care  systems,  and 
helping  restore  our  economy.  While  the  development  of  a  vaccine  is  highly  complex  and 
usually  takes  around  10  years,  efforts  focus  on  achieving  it  within  a  timeframe  of  12  -  18 
months,  if  not  earlier,  without  compromising  on  safety,  quality  or  efficacy.  Ensuring  the 
availability of a safe vaccine for all Europeans remains a top priority of the European 
Commission.  

As  Europe  learns  to  live  with  the  pandemic,  it  is  imperative  that  the  Member  States 
follow a common vaccination strategy for vaccine deployment and apply evidence-based 
and proportionate non-pharmaceutical measures to stem infection rates to manageable levels. 
Both tracks should be adapted to local and regional needs. At the same time, coordination at 
EU level is required to align our efforts, to ensure and to show solidarity, and to best ensure 
the  full  functioning  of  the  internal  market,  good  public  health  management  for  COVID-19 
matters and beyond, and the protection of all  EU citizens no matter where they live.  At the 
Special  European  Council  meeting  of  2  October,  Member  States  called  on  the  Council  and 
European Commission to further step up the overall coordination effort and the work on the 
development and distribution of vaccines at EU level6. 

To  support  Europe  in  preparing  for  and  containing  further  potential  COVID-19  outbreaks, 
save lives and livelihoods, and to bridge the period until a safe and effective vaccine becomes 
available for broad use, the Commission adopted a Communication on short-term EU health 
preparedness7  in  July.  It  sets  out  key  measures  in  six  specific  areas.  The  effective 
implementation  of  these measures  requires  coordination  and  effective  information  exchange 
between Member States. One of the main action points necessary for Europe to overcome the 
coronavirus  pandemic  is  accelerating  the  development,  manufacturing,  and  deployment  of 
vaccines  against  COVID-19.  The  EU  Strategy  for  COVID-19  vaccines8,  published  in 
June, charts the way forward. Its recommendations are still relevant and all Member States 
are encouraged to follow them. 

4 https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_20_1655  
5 The development of COVID-19 vaccines is supported by the EU through the direct funding of research 
projects, through the provision of debt financing agreements of the European Investment Bank to vaccine 
developers and through providing support to the Coalition for Epidemic Preparedness Innovations (CEPI). 
6 https://www.consilium.europa.eu/media/45910/021020-euco-final-conclusions.pdf  
7 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1602083349633&uri=CELEX:52020DC0318  
8 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1597339415327&uri=CELEX:52020DC0245  

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The  Strategy  proposed  a  way  to  provide  pre-financing  to  vaccines  producers  to  speed  up 
development and manufacturing of promising vaccine candidates, and to ensure that Member 
States had access to those vaccines on the best possible terms and conditions. In this spirit, the 
Commission has entered into agreements with individual vaccine producers on behalf of the 
Member  States,  purchasing  and/or  reserving  the  right  to  purchase  vaccine  doses  under 
Advance  Purchase  Agreements9.  As  of  the  time  of  publication,  there  are  three  contracts10 
that allow the purchase of a vaccine once  it has  proven safe and  effective, namely  with 
Astra  Zeneca,  Sanofi-GSK  and  Johnson&Johnson.  As  of  October  2020,  the  Commission 
continues  discussing  similar  agreements  with  other  vaccine  manufacturers  (CureVac, 
Moderna  and  BioNTech/Pfizer)  with  which  it  has  concluded  exploratory  talks.  All  three 
contracts approved with vaccine producers include provisions through which Member States 
may donate or resell vaccine doses to third countries, striving for global solidarity.  

The Commission has so far secured access to potential COVID-19 vaccines: 

  AstraZeneca: 300 million doses.  
  Sanofi-GSK: a purchase option for 300 million doses. 
  Johnson & Johnson: 200 million doses. 

Currently,  it  is  unknown  which  potential  vaccine,  if  any,  will  successfully  complete  the 
development and authorisation process and thus meet efficacy and safety criteria to be placed 
on  the  EU  market.  To  overcome  the  crisis,  Europe  needs  to  obtain  a  broad  portfolio  of 
vaccine  candidates  as  to  maximise  the  chances  of  quickly  developing,  manufacturing  and 
deploying a vaccine for all Europeans.  

Such a portfolio will contain vaccines with different technological approaches in order to 
achieve  the  highest  possible  chances  of  finding  a  successful  COVID-19  vaccine.  It  is 
important  that  all  Member  States  participate  in  the  full  portfolio.  The  Advance  Purchase 
Agreements contain a provision on the equal distribution of vaccine doses to Member States, 
which  will  ensure  that  each  country  receives  doses  based  on  a  pro  rata  population 
distribution  key,  unless  otherwise  agreed  between  the  participating  Member  States  in  the 
course of implementation of the Advance Purchase Agreements. A broader vaccine portfolio 
will offer Member States the best chance of benefiting from effective and safe vaccines in the 
quantities needed and in the timeliest manner, but this will require additional funding. That is 
why all Member States are invited to top-up the budget of the Emergency Support Instrument.  

To prepare the European Union and its citizens for when and if a safe and effective vaccine is 
available, the Commission has set out key elements to be taken into consideration by Member 

9 Financed by the Emergency Support Instrument (ESI), 2016 legal base: https://eur-
lex.europa.eu/eli/reg/2016/369/oj; 2020 activation. 
10 On 14 August,  the Commission reached a  first agreement  with the pharmaceutical company  AstraZeneca to 
purchase 300 million doses of a potential vaccine against COVID-19. On 18 September, a second contract with 
Sanofi-GSK was signed, for an option that will allow all Member States to purchase up to 300 million doses of 
the  Sanofi-GSK  vaccine.  On  8  October,  the  Commission  approved  an  advance  purchase  agreement  with 
Pharmaceutica  NV,  one  of  the  Janssen  Pharmaceutical  Companies  of  Johnson  &  Johnson,  allowing  Member 
States to purchase vaccines for 200 million people. 

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States  for their COVID-19 vaccination  strategies, in  line with  the competences as set  out  in 
the  EU  Treaties.  These  key  considerations  will  support  Member  States  in  identifying  and 
addressing  possible  challenges  and  gaps  for  effective  deployment  and  acceptance  of  a  safe 
COVID-19 vaccine. Technically aligned and politically agreed vaccination strategies should 
ultimately  lead  to  a  high  uptake  of  COVID-19  vaccines  in  the  EU.  Notably,  effective, 
consistent  and  transparent  wide-reaching  communication  on  vaccines  and  their 
availability will be crucial.  

Furthermore,  the  Commission  is  putting  in  place  a  coordinated  approach  to  the 
distribution  of  vaccines  across  EU  Member  States.  An  allocation  methodology,  agreed 
between  the  Commission  and  Member  States11,  ensures  that  all  Member  States  will  have 
equal access to the available doses based on their population size. 

Once available and authorised at EU level, all Member States will have access to COVID-
19 vaccines at the same time. The overall number of vaccine doses will be limited during the 
initial stages of deployment and before production can be ramped up. Meanwhile, high on the 
list of actions is a decision on which groups should have priority access to vaccines. 

While  ensuring  Europe  is  prepared,  supporting  the  equal  and  global  access  to  a  safe  and 
efficient vaccine for everyone and making the vaccine a global public good is a priority for 
the Commission. The EU Strategy for COVID-19 vaccines goes hand in hand with the EU's 
commitment  to  global  solidarity.  In  order  to  work  with  international  partners  for  equitable 
access  to  universal  and  affordable  COVID-19  vaccines  everywhere  and  for  everyone  who 
needs  them,  on  18  September,  the  Commission  confirmed  its  participation  in  the  global 
COVAX Facility, which aims to accelerate the development, manufacture and deployment of 
COVID-19 vaccines and to guarantee fair and equitable access globally12. The Commission, 
in  collaboration  with  its  Member  States,  the  COVAX  Facility,  Gavi  and  the  World  Health 
Organization, will facilitate early access to vaccines and the capacity to authorise and deploy 
them in an effective manner to partner countries around the world. The Commission has also 
raised almost €16 billion since May 2020 under the Coronavirus Global Response, the global 
action  for  universal  access  to  tests,  treatments  and  vaccines  against  coronavirus  and  for  the 
global  recovery.  It  contributed  so  far  €  400  million  to  the  COVAX  facility  specifically.  As 
part  of  the  EU's  global  coronavirus  response,  the  EU  Humanitarian  Air  Bridge  can  help 
bringing  vaccines  and  other  medical  equipment  to  the  most  vulnerable  populations  in  the 
world. 

2. 

THE IMPORTANCE OF SAFE AND EFFECTIVE COVID-19 VACCINES  

While  the  urgency  for  a  vaccine  against  COVID-19  is  growing  each  day,  and  experts  and 
scientists  around  the  world  are  working  around  the  clock  on  delivering  successful 

11  Agreed  by  the  Commission  and  Member  States  in  the  Agreement  on  the  joint  EU  approach  to  COVID-19 
vaccines procurement adopted by the Commission on 17 June and endorsed by all Member States.  
12 https://ec.europa.eu/commission/presscorner/detail/en/IP_20_1694  

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vaccines, standards for vaccine quality, safety and efficacy will not be jeopardised. The safety 
of  citizens  is,  and  will  always  be  the  top  priority  of  the  European  Commission.  Safety, 
quality  and  effectiveness  are  fundamental  requirements  for  any  vaccine,  or  medicinal 
product, to reach the EU market. The safety requirements for COVID-19 vaccines remain 
as  high  as  for  any  other  vaccine  in  the  EU,  and  the  context  or  urgency  brought  on  by  the 
pandemic will not change this. 

One of the main pillars of the EU Strategy for COVID-19 vaccines addresses this exact point. 
The  EU’s  regulatory  framework,  which  set  out  high-standards  and  strict  requirements, 
contains  regulatory  flexibilities  to  cater  for  urgencies.  In  this  way,  the  development, 
authorisation and availability of vaccines can be accelerated while standards for vaccine 
quality, safety and efficacy remain strict. This is key to citizens’ confidence. 

Vaccine  safety,  quality  and  efficacy  are  the  cornerstones  of  any  vaccine  development  and 
authorisation process, and vaccine developers are required to submit extensive documentation 
and  data  to  the  European  Medicines  Agency  through  the  EU  Marketing  Authorisation 
procedure.  This  includes  robust  evidence  from  clinical  trials.  A  comprehensive, 
independent  and  scientific  assessment  is  then  conducted  by  the  Agency  and  based  on  this 
evaluation, the European Commission can grant the necessary marketing authorisation.  

For  COVID-19,  the  European  Medicines  Agency  has  put  rapid  review  procedures  in 
place  to  quickly  deliver  assessments  of  applications  while  ensuring  robust  scientific 
opinions  and  the  same  high  standards  for  quality,  safety  and  efficacy  as  for  all  medicinal 
products.  A  dedicated  group  -  the  COVID-19  European  Medicines  Agency  pandemic  Task 
Force  -  has  been  created  and  provides  scientific  advice  on  clinical  trials  and  product 
development  and  a  “rolling  review”  of  incoming  evidence  to  speed  up  the  assessment  of  a 
promising vaccine. Normally, all data on a medicine’s effectiveness, safety and quality and all 
required documents must be submitted at the start of the evaluation in a formal application for 
marketing  authorisation.  In  the  case  of  a  rolling  review,  data  is  reviewed  as  they  become 
available from ongoing studies, before a formal application is submitted.  That significantly 
shortens  the  normal  assessment  times,  as  most  of  the  data  is  quickly  reviewed,  while 
maintaining the principles of quality, safety and efficacy. Normally, once the data package 
is complete, the developer submits a formal marketing authorisation application13.  

After authorisation, EU law requires that the safety of the vaccine as well as its effectiveness 
is  monitored.  As  part  of  the  monitoring,  studies  will  be  conducted  by  public  authorities 
responsible for vaccination programmes. Such studies may also be requested to companies 
as part of the conditions for maintaining their marketing authorisation. Further evidence will 
need to be centrally collected to assess the impact and effectiveness of COVID-19 vaccines 

13 In duly justified cases, to meet unmet medical needs of patients, a marketing authorisation may, for medicinal 
products intended for the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening 
diseases,  be  granted  prior  to  the  submission  of  comprehensive  clinical  data  provided  that  the  benefit  of  the 
immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact 
that  additional  data  are  still  required.  In  emergency  situations,  a  marketing  authorisation  for  such  medicinal 
products may be granted also, where comprehensive pre-clinical or pharmaceutical data have not been supplied. 

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once  rolled  out  in  the  population  from  a  public  health  perspective.  This  will  be  key  to 
overcoming the pandemic and instilling confidence in Europeans.  

The  European  Medicines  Agency,  in  close  collaboration  with  the  Member  States,  the 
Commission,  European  and  international  partners,  is  establishing  enhanced  safety 
monitoring activities specifically for COVID-19 vaccines. Member States will be invited to 
share  their  national  surveillance  data  on  unintended  side-effects,  if  relevant,  with  other 
Member States and the European Authorities. These activities aim to make sure that any new 
post-marketing  information  is  centrally  collected,  identified  and  evaluated  as  quickly  as 
possible, and appropriate regulatory  actions are taken in  a timely manner to  protect  patients 
and  safeguard  public  health.  This  calls  for  a  European  network  of  vaccine  clinical  trials, 
focusing  on  phase  3  (efficacy  and  safety)  and  phase  4  (continuing  assessing  safety  and 
efficacy post introduction) trials.  

In  addition  to  safety,  the  monitoring  and  control  of  COVID-19  will  require  strengthened 
surveillance systems at EU level, integrating both data on the epidemiology of the disease as 
well as on vaccination coverage rates among target groups. Any surveillance system, in case 
they  involve  the  processing  of  personal  data,  will  have  to  comply  with  the  General  Data 
Protection  Regulation.  The  European  Data  Protection  Board  (EDPB)  should  play  an  active 
coordinating role between the EU's data protection authorities to contribute to the consistent 
application  of  data  protection  rules  throughout  the  European  Union  in  times  of  crisis.  High 
levels  of  vaccination  coverages  will  also  be  a  key  indicator  of  vaccine  acceptance  and 
accessibility.  The  European  Centre  for  Disease  Prevention  and  Control  and  European 
Medicines  Agency,  in  close  collaboration  with  the  Commission,  Member  States,  European 
and  international  partners  are  establishing  enhanced  vaccine  effectiveness,  coverage,  safety 
and  impact  monitoring  activities  specifically  for  COVID-19  vaccines.  This  includes  the 
development  of  a  structured  post  marketing  monitoring  platform  for  vaccines,  including 
COVID-19 vaccines. 

3. 

ELEMENTS FOR EFFECTIVE COVID-19 VACCINATION STRATEGIES  

The Commission is securing access to safe, efficient and high quality COVID-19 vaccines for 
EU citizens. However, the successful deployment and a sufficient uptake of such vaccines 
is equally important. Member States should take a number of preparatory steps in order to 
enable  an  as  efficient  and  targeted  rollout  as  possible,  once  an  effective  vaccine  become 
available.  

Preparations by each Member State for the next crucial phase are of utmost importance. 
In this context, the World Health Organization has produced relevant guidance for the World 
Health Organization European Region to support ministries of health, bodies thereof, national 

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immunisation technical advisory groups or committees, and relevant public and private sector 
authorities in preparing for deployment of COVID-19 vaccines and vaccination14.  

Once one or more COVID-19 vaccines have become available, it is important to ensure that 
vaccination services are able to deliver and distribute vaccines in an ordered manner, within a 
given  timeframe  and  in  line  with  a  rapidly  changing  epidemiological  situation.  Member 
States should ensure that vaccination services have sufficient resources to carry out their 
task,  both  in  terms  of  skilled  workforce  for  the  administration  of  COVID-19  vaccines  and 
supply  of  the  necessary  medical  and  protective  equipment.  Concerning  the  necessary 
workforce,  Member  States  should  already  consider  new  recruitments  and 
training 
programmes, potentially involving students or retired staff. As for the supplies of medical and 
protective equipment needed, attention should be paid to potential manufacturing bottlenecks. 
Member States should make use of the joint public procurement framework contracts signed 
by the Commission on behalf of participating Member States, allowing those to order items 
required 
for  COVID-19  vaccination.  Moreover,  emergency  stockpiles  of  medical 
countermeasures hosted by Member States will continue to be developed under rescEU as part 
of the Union Civil Protection Mechanism. 

Building  on  this,  vaccination  services  should  be  made  easily  accessible  for  target 
populations,  both  in  terms  of  affordability  –  Member  States  are  encouraged  to  consider 
providing  COVID-19  vaccines  free  of  charge  –  and  with  physical  proximity.  The  practical 
steps for getting access to vaccines – including via centralised structures, where possible, and 
central  points  of  contact  –  should  be  clearly  communicated  to  citizens.  Clear  and  timely 
access  through  relevant  media  to  information  is  key.  The  required  infrastructures  and 
communication activities should be planned now and be ready for rollout at the end of 2020. 

The  planning  of  infrastructure  should  take  into  account  that  COVID-19  vaccines  will  have 
different  characteristics,  storage and transport requirements, and that  “one fits  all” solutions 
will  most  likely  not  work  in  practise.  Some  vaccines  will  have  specific  temperature 
requirements  (as  low  as  -70  º  C)  and  differences  in  vaccine  characteristics  are  likely  to 
translate into different sizes of packages and specific transport needs. Member States should 
therefore review arrangements, bearing in mind that cold chains, cooled transport options and 
both  peripheral  and  central  storage  capacity  may  need  to  be  increased.  A  deployment  of  a 
portfolio of vaccines with different characteristics and requirements is thus very likely.  The 
Commission can support Member States in this process, putting all Union instruments 
with logistical and transport capabilities, such as the Union Civil Protection Mechanism, 
at their disposal. 

To  facilitate  an  accelerated  deployment  of  COVID-19  vaccines,  once  authorised,  the 
Commission  has  discussed  labelling  and  packaging  flexibilities  with  Member  States  and 
European Medicines Agency, which may be used where possible and for a temporary period. 
As outlined in the EU Strategy for COVID-19 vaccines, such flexibilities can support a more 

14 WHO Europe, Strategic considerations in preparing for deployment of COVID-19 vaccine and vaccination in 
the WHO European Region, 21 September 2020.  

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rapid deployment of the vaccine by increasing production capacity, reducing transport costs, 
optimising  storage  spaces,  improving  the  distribution  of  the  doses  between  Member  States 
and limiting the possible impacts on the production of other, routine, vaccines. Examples of 
the  flexibilities  put  forward  are  multi-dose  presentations  for  COVID-19  vaccines,  the 
possibility to limit the packaging and labelling information to one EU official language and 
the option of separate distribution of a print out  of the package leaflets to accommodate for 
one patient leaflet per dose. So as to more quickly distribute the vaccine, the Commission may 
use those flexibilities when specifying the conditions for labelling and packaging for COVID-
19  vaccines,  and  countries  should  communicate  such  information  to  citizens  clearly  and 
effectively.  

To monitor the performance of the vaccination strategies, it is essential for Member States 
to  have  suitable  registries  in  place.  This  will  ensure  that  vaccination  data  is  appropriately 
collected and enables the subsequent post-marketing surveillance and ‘real time’ monitoring 
activities. Member States should ensure that Electronic Immunisation Information Systems or 
other vaccination registries are up-to-date and fully compliant with data protection legislation. 

As  it  can  be  expected  that  several  COVID-19  vaccines  will  require  two  doses,  it  will  be 
important for Member States to institute an effective recall system. It will also be important 
to clearly communicate risks and the benefits to the population through relevant media as well 
as the popular communication channels (online platforms), and to collect the necessary data in 
order to remind and track those that fail to receive the second dose within the necessary time 
frame. Actions such as these are key to the effective rollout of a safe vaccine.  

Concerning the sufficient uptake of safe COVID-19 vaccines, it is already important to start 
building public confidence in vaccines. The lack of confidence has in the recent past led to 
an  insufficient  uptake  of,  for  example,  key  childhood  vaccines  and  consequently,  new 
outbreaks of vaccine-preventable diseases, such as measles, have occurred. The problems 
associated  with  waning  confidence  in  vaccines  has  been  described,  for  example,  in  the  EC 
Communication on strengthened cooperation against vaccine preventable disease15, the 2018 
State of Vaccine Confidence in  the EU report16 as  well as  in  the Wellcome Global  Monitor 
report on confidence in vaccines from that same year17. This is not a new phenomenon.  

As  underlined  in  the  Commission  Communication  on  tackling  COVID-19  disinformation18, 
misinformation and disinformation around a possible COVID-19 vaccine has not slowed 
down  and  will  likely  make  the  eventual  deployment  and  uptake  of  vaccines  more  difficult. 
Coordination  and  collaboration  with  actors  at  both  EU  and  global  levels,  together  with  the 
World Health Organization and online platforms, will be essential for monitoring and tackling 
COVID-19 disinformation and for effectively responding to misinformation challenges. Clear 

15 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2018%3A245%3AFIN  
16https://static1.squarespace.com/static/5d4d746d648a4e0001186e38/t/5da9a66cda5d5c5fdd6d5816/1571399327
071/2018_vaccine_confidence_en.pdf  
17https://static1.squarespace.com/static/5d4d746d648a4e0001186e38/t/5da9a9ee57ce312451325890/157140017
8293/wellcome-global-monitor-2018.pdf  
18 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020JC0008  

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and timely information and a proactive approach on false and misleading information is 
key.  The  Commission  will  further  address  the  disinformation  phenomenon  in  the  European 
Democracy Action Plan by end of 2020. 

In addition, whilst fully respecting high quality, safety and effectiveness standards, the very 
speed at which COVID-19 vaccines are currently being developed, is likely to make the 
build-up of trust in such vaccines particularly challenging, with citizens raising concerns 
about  the  safety  of  vaccines  developed  in  such  a  short  timeframe.  It  is  important  that 
Member  States  already  start  providing  citizens  with  objective,  accurate,  factual  and 
targeted information about the importance of COVID-19 vaccines.  It must be explained 
that such vaccines are likely to be our only real exit from the ongoing pandemic and that, due 
to the strict EU market authorisation procedure, no corners will be cut in terms of safety or 
effectiveness.  Timely,  continuous  and  consistent 
the  vaccine 
development,  approval,  launch,  rollout  and  safety  monitoring  processes,  will  help  reassure 
citizens that all mechanisms are in place to ensure safety and vaccine effectiveness.  

information  around 

The  parallel  market  launch  of  several  vaccines,  once  proven  safe  and  effective,  and  their 
distribution  will  be  a  considerable  challenge  requiring  a  strong  collaboration  and 
concerted  action  across  all  Member  States.  There  would  be  substantial  benefits  in 
establishing  coordinated  and  EU-wide  effectiveness  and  safety  monitoring  studies  for 
COVID-19  vaccines.  Discussions  at  national  level  can  be  supported  by  data  and 
information sharing within the existing EU/EEA National Immunisation Technical Advisory 
Groups collaboration19. The European Centre for Disease Prevention and Control (ECDC) can 
help address topics such as vaccination policies, assist in systematically reviewing reports of 
available evidence and to establish relevant indicators to measure performance and coverage.  

It is key for Member States to share knowledge and their experiences during this global 
health crisis. The Commission is helping Member States coordinate the efforts and responses 
to  the  pandemic  via  the  Health  Security  Committee.  While  the  responsibility  for  health 
policy  lies  with  Member  States,  and  national  strategies  may  differ  due  to  several 
contributing  factors  such  as  different  healthcare  system  capacities,  population  structure  or 
epidemiological situation, it is nevertheless important to ensure the coordination of national 
responses  to  the  pandemic.  This  includes  the  distribution  and  deployment  of  COVID-19 
vaccines  once  authorised.  In  this  context,  it  is  important  to  ensure  cooperation  between  the 
health  authorities  of  Member  States  and  the  civil  protection  authorities.  The  Emergency 
Response Coordination Centre could support Member States in this regard as well as through 
monitoring and information sharing. The Commission has been working closely with Member 
States to define needs,  explore strategies and to exchange information and best practices. In 
addition,  modernising  public  administration  and  services,  including  health,  is  one  of  the 
proposed flagships of the Recovery and Resilience Facility.  

19 https://www.ecdc.europa.eu/en/about-us/partnerships-and-networks/national-immunisation-technical-advisory-
groups-nitag  

9 

 
 
                                                           
PROPOSED ACTIONS  

  Member  States  should  ensure  the  capacity  of  vaccination 
services  to  deliver  COVID-19  vaccines,  including  a  skilled 
workforce, and medical and personal protective equipment. 
  Member States should ensure easy access to vaccines for target 
terms  of  affordability  and  physical 

in 

populations,  both 
proximity.  

  Member States should prepare for deployment of vaccines with 
different  characteristics  and  storage  and  transport  needs,  and 
review  the  required  vaccination  infrastructure,  in  particular  in 
terms of cold chain, cooled transport and storage capacities.  
  Member  States  should  ensure  that  Immunisation  Information 
Systems  and  other  vaccination  registries  are  updated  and  ready 
to process vaccination data. 

  Member States should ensure clear communication on the 
benefits, risks and importance of COVID-19 vaccines, thus 
promoting public trust.  
-  Member States should identify and share best practices on 

effective ways to address vaccine hesitancy 

-  Member States should work with health professionals as 

trusted sources on vaccination matters 

  Member  States  should  coordinate  efforts  in  tackling  the 
misinformation and disinformation around a possible COVID-19 
vaccine,  in  coordination  and  collaboration  with  international 
bodies  and  online  platforms.  The  Commission  should  facilitate 
these efforts. 

  Member  States  and  public  health  authorities  should  prepare  to 
undertake  studies,  independent  of  industry  interests,  of  vaccine 
effectiveness and safety: 
- 

establishing the necessary networks to collect data and 
analyse evidence, including if possible, in a statistically 
representative way, different target populations, such as 
workers 
ensure mechanisms to detect, review and respond to vaccine 
safety events 
ensure mechanisms for continuous assessment of 
risk/benefits 

- 

- 

Timeline 
October to 
November 2020 

October to December 
2020 

October onwards 

October onwards 

October onwards 

October onwards 

October to 2022 

-  via coordination by the European Medicines Agency and 

the European Centre for Disease Prevention and Control, 
prepare the participation in large-scale EU-wide 
effectiveness and safety monitoring studies 

  EU/EEA National Immunisation Technical Advisory Groups 

Ongoing 

collaboration, with European Centre for Disease Prevention 
and Control coordination, to support national efforts via data 
and information sharing 

  Member States and public health authorities, with technical 

Ongoing 

10 

 
 
 
 
support from the European Centre for Disease Prevention and 
Control, should set up systems for the collection of data on 
vaccination coverage in target populations and monitor coverage 
in real-time through individual-based data, incl. through the 
electronic immunisation register and in accordance with the 
rules on the protection of personal data. 

  Member  States  should  coordinate  efforts  and  responses  to  the 
pandemic  through  the  Health  Security  Committee,  coordinated 
by  the  European  Commission.  Cooperation  between  health 
authorities and civil protection authorities should be ensured. 

Ongoing 

4. 

POSSIBLE PRIORITY GROUPS FOR THE INITIAL PHASES OF VACCINE 
DEPLOYMENT  

When  effective  and  safe  vaccines  against  COVID-19  will  become  available,  the 
immediate  stages  of  the  delivery  will  depend  on  the  available  production  capacities. 
Member States will need to  make decisions on which groups should have priority access  to 
the  COVID-19  vaccines  so  as  to  save  as  many  lives  as  possible.  These  decisions  should  be 
driven  by  two  criteria:  to  protect  the  most  vulnerable  groups  and  individuals,  and  to  slow 
down and eventually stop the spread of the disease. 

Member  States  and  expert  organisations  have  started  to  define  action  plans  and 
prioritisation lists, based on what the first phase of the pandemic has shown us in terms of 
impact  on  different  population  groups  and  communities.  For  example,  the  World  Health 
Organization  Strategic  Advisory  Group  of  Experts  on  Immunisation  has  published  a 
framework  for  the  allocation  and  prioritisation  of  COVID-19  vaccination,  based  on  core 
principles  and  built  around  different  objectives20.  Moreover,  the  National  Academies  of 
Sciences,  Engineering,  and  Medicine  has  recently  released  its  final  report  recommending  a 
four-phased allocation framework for the US21.  

Building  on  such  approaches  as  well  as  the  currently  available  knowledge  on  the 
characteristics  of  the  coronavirus  and  the  disease  it  causes,  the  following  table  provides 
examples of unranked priority groups to be considered by countries when the deployment 
of  COVID-19  vaccines  becomes  a  reality.  Further  prioritisation  and  specific  vaccine 
recommendations will become possible once product-specific details are known, such as 
vaccine  specificities  and  characteristics,  its  efficiency  and  benefit  assessment  for  specific 
groups, as well as storage and supply chain requirements.  

These unknowns on expected performance profiles of different vaccines and across different 
target  groups  make  it  even  more  important  to  work  with  vaccine  portfolios.  For  example,  a 
vaccine  effective  against  the  severity  of  the  disease  should  be  administered  to  vulnerable 

20 https://apps.who.int/iris/bitstream/handle/10665/334299/WHO-2019-nCoV-SAGE_Framework-
Allocation_and_prioritization-2020.1-eng.pdf?sequence=1&isAllowed=y  
21 https://www.nap.edu/catalog/25917/framework-for-equitable-allocation-of-covid-19-vaccine  

11 

 
 
 
 
                                                           
groups  while  a  vaccine  effective  in  cutting  the  transmission  of  the  virus  should  be 
administered to  groups  more susceptible of spreading the disease.  This  should  be addressed 
by vaccination strategies and their corresponding objectives. This is essential to ensuring the 
availability  of,  and  access  to  a  wide  array  of  different  vaccines,  particularly  when  targeting 
and  prioritising  different  groups.  Some  groups  may  require  specific  strategies,  for  example, 
young  people  that  have  recently  increasingly  been  tested  positive  and  are  thus  likely  to 
contribute  to  spread  the  coronavirus.  Member  States  are  encouraged  to  reach  out  to  young 
people and ensure they understand the seriousness of the situation 

Moreover,  country-specific  epidemiological  situations  at  the  time  of  vaccine  deployment, 
demographics,  vaccine  delivery  systems  and  healthcare  requirements  and  capacities  are 
examples of other elements that will determine and influence country-level decision making. 
Additionally, as availability of the vaccines improves, vaccines strategies and their objectives 
will need to be adjusted accordingly. For example, while strategies are likely to focus in the 
beginning  on  decreasing  death  rates  and  disease  burden  from  the  COVID-19  pandemic  and 
ensuring  the  continuation  of  essential  services,  later  in  the  vaccination  deployment  process 
this may shift to the reduction of wider societal and economic restrictions and impact. Such 
flexibility in terms of changing objectives should be envisaged by countries when preparing 
their  vaccination  strategies.  Similarly,  it  is  imperative  to  have  an  adaptable  and  flexible 
vaccination  approach  to  respond  to  rapid  changes  in  the  epidemiological  situation  at  local, 
regional and national level. 

PRIORITY GROUPS TO 
CONSIDER BY MEMBER 
STATES (in no particular order) 

Health care and long-term care 
facility workers  

People above 60 years of age 

CONSIDERATIONS 

Essential workers with significantly elevated risk of 
being infected  
Carry out essential functions to combat the pandemic 

Age-based elevated risk of severe disease or death  
In particular those living in high risk situations such as 
long-term care facilities 

Vulnerable population due to 
chronic diseases, co-morbidities 
and other underlying conditions 

Elevated risk of severe disease or death 
Examples of risk factors: obesity, hypertension, asthma, 
heart conditions, pregnancy 

Essential workers outside the 
health sector  

Communities unable to 
physically distance  

Workers unable to physically 
distance  

Vulnerable socioeconomic 
groups and other groups at 
higher risk 

E.g. teachers, child care providers, agriculture and food 
sector workers, transportation workers, police officers 
and emergency responders  

E.g. dormitories, prisons, refugee camps 

E.g. factories, meat cutting plants and slaughterhouses  

E.g. socially deprived communities to be defined 
according to national circumstances 

12 

 
 
It  is thus  likely  that,  at  the beginning of vaccination  programmes, a tiered approach  will be 
required.  Once  vaccine  production  will  be  scaled  up  and  the  amount  and  pace  of  vaccine 
supply will start to meet demands, it will be important to start assessing population immunity 
and the possible protection that may be provided because of it. As of today, it remains unclear 
if population-wide immunity will be provided once vaccination programmes will kick off, and 
this  will  depend  on  the  specific  vaccines  that  will  be  authorised  in  the  EU  and  the  level  of 
population coverage that can be achieved. 

PROPOSED ACTIONS 

and 

  Member  States  should  define  a  priority  list  for  vaccination, 
targeting  key  population  groups  and 
identifying 
communities,  ideally  in  a  tiered/phased  approach.  Such  a  list 
should  be  flexible  to  allow  for  adaptions  and  updates  once 
details  about  the  vaccine  become  available  and  to  address 
epidemiological developments. 

  Member  States  should  develop  and  carry  out  modelling 
exercises  (e.g.  for  demand  planning  and  vaccine  intervention 
exercises) preferably in a context that allows for cross-European 
learning  and  exchange  of  experiences.  The  European  Centre 
for  Disease  Prevention  and  Control 
is  working  on  a 
mathematical model that will support Member States in decision 
making for planning deployment of COVID-19 vaccines 

  Member  States  should  regularly  review  critical  factors,  such  as 
the epidemiological situation at national and subnational levels, 
new  evidence  about  the  virus  and  its  impact  on  human  health, 
actual vaccine uptake and by whom, vaccine storage and supply 
chain capacities and (human) resources required for vaccination 
of  the  population,  and  define,  reassess  and  adapt  COVID-19 
strategies 
vaccination  objectives, 
accordingly. 

targets,  priorities  and 

  Member  States  should  share  knowledge  and  experiences 
regarding  the  development  and  implementation  of  vaccination 
strategies, particularly concerning the definition and coverage of 
priority  groups, 
the  Health  Security  Committee, 
coordinated by the European Commission 

through 

Timeline 
Ongoing 

October to December 
2020 

Ongoing  

Ongoing 

5.  

BRIDGING STEPS: TOWARDS WIDESPREAD VACCINE AVAILABILITY 

While awaiting the arrival of approved, safe and effective vaccines against COVID-19, and in 
parallel  to  safeguarding  the  continuation  of  other  essential  healthcare  and  public  health 
services and programmes, the EU must continue ensuring that the transmission of the virus is 
mitigated.  This  primarily  takes  the  form  of  public  health  measures,  the  protection  of 
vulnerable  groups,  and  that  citizens  are  actively  engaged  with  to  adhere  to  public  health 
measures.  

13 

 
 
 
 
 
Until  a  safe  and  effective  vaccine  against  COVID-19  is  available,  and  most  likely  also 
throughout the initial vaccination rollout phases, non-pharmaceutical measures will continue 
to serve as the main public health tool to control and manage COVID-19 outbreaks.  

Additionally,  it  is  crucial  to  ensure  that  the  European  health  systems  are  able  to  respond 
appropriately  to  potentially  worsening  epidemiological  developments.  In  this  regard,  the 
Commission  recalls  the  actions  underlined  in  the  Communication  on  short-term  EU  health 
preparedness  for  COVID-19  outbreaks,  which  remain  essential  as  bridging  steps  until  a 
vaccine has arrived and is available at sufficient scale for widespread vaccination.  

While the area of public health is first and foremost the competence of Member States, 
the Commission and EU Agencies have implemented a number of actions to support Member 
States’ responses to COVID-19. Testing, contact tracing and surveillance remain integral 
to  managing  the  transmission  of  the  coronavirus  and  breaking  infection  chains.  The 
Commission  and  Member  States  recently  agreed  on  aligned  testing  strategies  and 
methodologies22. This is a good example of a flexible and coordinated approach, which now 
only  requires  being  implemented  by  Member  States.  Other  examples  of  EU-coordinated 
actions that are currently being developed include an EU platform for digitalised Passenger 
Location  Forms  as  well  as  initiatives  for  ensuring  interoperability  between  contact 
tracing and warning apps. Together, this will be essential in ensuring the safe mobility of all 
EU citizens.  

Medical  countermeasures,  covering,  for  example,  personal  protective  equipment  and 
therapeutics, will also remain crucial. Member States and the Commission must ensure that 
challenges in supply, availability and access of these products are overcome, across the EU as 
well  as  in  neighbouring  countries.  The  Commission  will  work  with  Member  States  and 
industry to  build on  the work done by the Clearing House for medical  equipment  and to 
gather intelligence on the needs for and on the availability of essential medical equipment.  

Simultaneously,  Member  States  and  the  other  Joint  Procurement  Agreement  (JPA) 
signatories  already  have  access  to  ongoing  joint  public  procurements  covering  personal 
protective equipment, ventilators and laboratory supplies, with additional public procurements 
coming up for intensive care unit medicines and vaccination supplies, also supporting large-
scale  vaccination  campaigns.  Transport  and  logistical  support  to  ensure  a  proper  and 
adequate  distribution  of  vaccines  should  also  remain  a  high  priority.  The  Commission 
should  continue  supporting  Member  States  as  necessary  in  this  area,  making  full  use  of  the 
tools at  its disposal.  While the EU’s approach to supporting Member States with  healthcare 
surge capacity has primarily focused on bolstering solidarity mechanisms, the importance of 
non-pharmaceutical interventions cannot be underrated as they save lives.  

As COVID-19 hit Europe, gaps  in  EU health preparedness  were highlighted. Structures and 
mechanisms  under  the  EU’s  framework  for  health  security  on  serious  cross-border  health 

22 https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/common_testingapproach_covid-
19_en.pdf  

14 

 
 
                                                           
threats facilitated the exchange of information on the evolution of the pandemic and supported 
specific  national  measures  taken.  However,  they  were  limited  in  their  ability  to  trigger  a 
timely  common  EU  level  response,  to  coordinate  the  crucial  aspects  of  risk  communication 
and to ensure solidarity among Member States. As a result, the Commission intends to shortly 
be putting forward legislative proposals  - allowing concrete and tangible actions - to ensure 
the functioning of the internal market as well as to bolster the health security framework, the 
European  Centre  for  Disease  Prevention  and  Control  and  the  European  Medicines  Agency. 
Moreover,  the  Commission  is  also  working  on  a  proposal  for  the  creation  of  an  EU 
‘BARDA’23, to work on biomedical research, preparation and response, as announced by 
President von der Leyen in the State of the Union Speech. This should be an important step 
towards  reaching  a  higher  level  of  open  strategic  autonomy  for  the  development  and 
deployment of pharmaceutical products and health threat countermeasures more generally.  

In  conclusion,  during  and  beyond  the  period  that  will  need  to  be  bridged  until  safe  and 
effective  COVID-19  vaccines  become  widely  available,  efforts  should  continue  and  be 
reinforced  in  line  with  epidemiological  developments  and  to  ensure  that  the  spread  of 
the  coronavirus  is  contained  as  much  as  possible.  Better  diagnostics  will  support  the 
detection  and  contact  tracing  efforts,  the  timely  and  specific  reaction  to  localised  outbreaks 
and  clusters,  as  well  as  the  prevention  of  exposure  of  larger  groups,  e.g.  at  airports  or  in 
airplanes. Better and improved treatments will help to reduce the mortality rate, in particular 
among the current risk  groups and thus  reduce the pressure on health systems and therefore 
improve the capacities to deal with other diseases and save lives.  

Once safe, effective and high-quality COVID-19 vaccines have been authorised and enter the 
European market, solidarity in the public procurement and deployment of a large COVID-19 
vaccines  portfolio  will  contribute  to  getting  Europe,  and  the  world,  out  of  the  ‘emergency 
the 
phase’  of 
implementation  of  vaccination  strategies  that  currently  are  being  developed  by  the 
Member States. The strategies should be aligned along the key parameters described in this 
Communication.  Preparedness  and  coordination  remain  key  to  overcome  the  pandemic 
and saving lives.  

the  pandemic.  Once  available,  vaccine  portfolios  should  guide 

23 Biomedical Advanced Research and Development Authority 

15