COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL AND THE EUROPEAN INVESTMENT BANK EU Strategy for COVID-19 vaccines
Date: 2020-06-17
Institutions: European Commission, Secretariat-General
Subjects: EU aid, EU strategy, European Medicines Agency, emergency aid, epidemic, infectious disease, international cooperation, medical research, organisation of health care, vaccine

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 17.6.2020  COM(2020) 245 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL AND THE EUROPEAN INVESTMENT BANK EU Strategy for COVID-19 vaccines  
 
 
1.  AN URGENT NEED FOR ACTION 

The  COVID-19  pandemic  is  inflicting  huge  human  and  economic  costs  on  the  European 
Union and the world. A permanent solution to this crisis is most likely to be brought about by 
the development and deployment of an effective and safe vaccine against the virus.  

The scale of the crisis means that time pressure is unprecedented: every month gained in the 
deployment of a vaccine will save many lives, many jobs and many billions of euros.  

However,  the  quest  for  a  vaccine  against  COVID-19  is  particularly  challenging  due  to  the 
urgency. Vaccine development usually takes more than 10 years. 

This is because developing a safe and effective vaccine is a highly complex process. A large 
share of vaccine candidates fail during clinical trials. Under normal circumstances, companies 
make  investments  in  production  capacity  dependent  on  the  probability  of  obtaining  a 
successful vaccine from the development phase that will meet the strict standards of quality, 
safety and efficacy needed to be authorised, and that will be viable according to the demand 
projections available. This results in long development and production timelines. 

However,  a  vaccine  against  COVID-19  is  needed  more  urgently  than  this.  In  the  current 
crisis,  teams  around  the  world  are  working  with  the  ambition  of  delivering  a  successful 
vaccine  within  a  timeframe  of  12  -  18  months.  In  addition,  once  a  successful  COVID-19 
vaccine is available, hundreds of millions, or even billions, of doses will need to be produced 
in  order  to  cover  global  needs,  without  compromising  the  production  of  other  essential 
vaccines. 

Delivering such an undertaking within such a compressed timeframe requires running clinical 
trials  in  parallel  with  investing  in  production  capacity  and  securing  raw  materials  so  that 
production can start as soon as those trials are concluded, or even earlier. The need to deliver 
quickly,  the  high  upfront  costs,  and  the  high  failure  rate  make  investing  in  a  COVID-19 
vaccine a high-risk decision for vaccine developers.  

This  is  not  only  a  European  challenge,  it  is  also  a  global  one.  All  regions  of  the  world  are 
affected.  The  spread  of  the  virus  has  shown  that  no  region  is  safe  until  the  virus  is  under 
control  everywhere.  In  addition  to  it  being  in  their  clear  self-interest  to  do  so,  high-income 
countries  have  a  responsibility  to  accelerate  the  development  and  production  of  a  safe  and 
effective vaccine and make it accessible for all the regions of the world. The EU recognises 
this task as its responsibility. 

To this end, the EU is leading the global effort for universal testing, treatment and vaccination 
by  mobilising  resources  through  international  pledging  and  by  joining  forces  with  countries 
and  global  health  organisations  through  the  Access  to  Covid-19  Tools  (ACT)  Accelerator 
collaborative framework1. The Commission will continue to support this global mobilisation 
and collaboration. 

As  part  of  the  effort  to  help  protect  people  everywhere  and  EU  citizens  in  particular,  the 
Commission is proposing an EU strategy to accelerate the development, manufacturing, and 
deployment of vaccines against COVID-19.  

1 

https://www.who.int/who-documents-detail/access-to-covid-19-tools-(act)-accelerator 

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The strategy has the following objectives: 

  Ensuring the quality, safety and efficacy of vaccines. 
  Securing  timely  access  to  vaccines  for  Member  States  and  their  population  while 

leading the global solidarity effort. 

  Ensuring  equitable  access  for  all  in  the  EU  to  an  affordable  vaccine  as  early  as 

possible. 

The strategy rests on two pillars:  

  Securing  sufficient  production  of  vaccines  in  the  EU  and  thereby  sufficient 
supplies for its Member States through Advance Purchase Agreements (APAs) with 
vaccine producers via the Emergency Support Instrument (ESI2). Additional financing 
and other forms of support can be made available on top of such agreements. 

  Adapting the EU’s regulatory framework to the current urgency and making use 
of  existing  regulatory  flexibility  to  accelerate  the  development,  authorisation  and 
availability of vaccines while maintaining the standards for vaccine quality, safety and 
efficacy. 

2.  SUPPORT FOR VACCINE DEVELOPMENT AND PRODUCTION IN THE EU 

Only very swift and unified action by the EU and its Member States will ensure sufficient and 
speedy supplies of a safe and effective vaccine. In order to maximise the chances of success, 
the most promising candidates should be supported in their development and in the building-
up of manufacturing capacity. At the same time, EU citizens will want  assurances that they 
will have access to any successful vaccine. 

In order to clearly understand the scale of the vaccine needs in  the EU, the Health Security 
Committee  is  advancing  its  work  on  an  EU  immunisation  framework,  as  requested  by  the 
Health Council on 7 May. This immunisation framework draws on the expertise of Member 
States,  the  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  and  the  World 
Health Organization (WHO). 

2.1.  An EU approach for efficiency and solidarity 

The  EU  Member  States  are  closely  interlinked.  The  Single  Market,  allowing  the  free 
movement of goods and people, has allowed economies to integrate closely and has increased 
the  interdependence  of  all  our  economies  and  societies.  As  the  pandemic  moves  across 
borders,  so  its  socio-economic  impact  on  each  of  the  Member  States  spreads  to  the  others. 
Against that background, it is essential that all 27 EU Member States have access to a vaccine 
as early as possible. The same applies to the Member States of the European Economic Area 
(EEA). 

Joint  action  at  EU  level  is  the  surest,  quickest  and  most  efficient  way  of  achieving  that 
objective.  No  Member  State  on  its  own  has  the  capacity  to  secure  the  investment  in 

2   Council  Regulation  (EU)  2016/369  of  15  March  2016  on  the  provision  of  emergency  support  within  the 
Union as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support 
under  Regulation  (EU)  2016/369,  and  amending  its  provisions  taking  into  account  the  COVID-19 
outbreak.(OJ L 117, 15.4.2020, p.3). 

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developing and producing a sufficient number of vaccines. A common strategy allows better 
hedging  of  bets,  sharing  of  risks  and  pooling  investments  to  achieve  economies  of  scale, 
scope and speed.  

An important step towards joint action between Member States has already been taken in the 
formation  of an inclusive vaccine Alliance by  France, Germany,  Italy, and the Netherlands. 
This  alliance  was  formed  to  pool  the  national  resources  of  those  countries  and  secure  fair 
access  to  vaccine  supplies  for  the  European  population.  The  current  proposal  builds  on  the 
important groundwork undertaken by that Alliance. 

In order to scale this approach up to cover the whole EU, the Commission proposes to run a 
central procurement process, which creates a number of important advantages. In particular, 
all EU Member States will be able to benefit from an option to purchase vaccines via a single 
procurement  action.  This  process  also  offers  vaccine  producers  a  significantly  simplified 
negotiation  process  with  a  single  point  of  contact,  thus  reducing  costs  for  all.  Centralising 
vaccine procurement at EU level has the merit of speed and efficiency by comparison with 27 
separate  processes.  A  truly  European  approach  would  avoid  competition  between  Member 
States.  It  creates  solidarity  between  all  Member  States,  irrespective  of  the  size  of  their 
population and their purchasing power. A pan-EU approach will increase the EU’s leverage 
when negotiating with industry. It will also enable us to combine the scientific and regulatory 
expertise of the Commission and the Member States. 

A common EU approach will always respect the principle of subsidiarity and Member States’ 
competences in health policy: vaccination policies remain in the hands of Member States. 

2.2.  Advance Purchase Agreements via the Emergency Support Instrument 

In  order  to  support  companies  in  the  swift  development  and  production  of  a  vaccine,  the 
Commission  will  enter  into  agreements  with  individual  vaccine  producers  on  behalf  of 
Member States. In return for the right to buy a specified number of vaccine doses in a given 
timeframe and at a given price, part of the upfront costs faced by vaccines producers will be 
financed  from  the  ESI.  This  will  be  done  in  the  form  of  advance  purchase  agreements 
(APAs). 

These  agreements  will  be  negotiated  with  individual  companies  according  to  their  specific 
needs and with the aim of supporting and securing an adequate supply of vaccines. They will 
de-risk the necessary investments related to both vaccine development and clinical trials, and 
the preparation of the at-scale production capacity along the entire vaccine production chain 
which is required for a rapid deployment of sufficient doses of an eventual vaccine in the EU 
and globally. The conditions of the contract will reflect the balance between the prospect of 
the  producer  providing  a  safe  and  effective  vaccine  quickly  and  the  investment  needed  to 
deploy the vaccine on the European market. 

The  contracts  with  companies  may  be  concluded  through  a  procurement  process  run  by  the 
Commission on behalf of all participating Member States. The related funding will come from 
the ESI. The budgetary authorities, the European Parliament and the Council, have made EUR 
2.7  billion  available  under  the  ESI.  The  Commission  stands  ready  to  commit  a  significant 
proportion  of  those  funds  to  the  activities  described  here  in  order  to  maximise  chances  of 
arriving  at  a  viable  vaccine  for  the  EU  and  the  world  in  the  shortest  time  possible.  If 
additional  funds  are  needed,  Member  States  will  have  the  possibility  to  top-up  the  ESI  to 
make up any financing gap in order to finance more offers. 

Once any of the vaccines supported proves successful, Member States will be able to acquire 
that vaccine directly from the producer on the basis of the conditions laid down in the APA. 

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Allocation  of  access  to  vaccine  doses  between  Member  States  would  be  according  to  a 
population-based distribution key.  

As the ultimate acquirers of the vaccines, Member States will participate in the process from 
the start. They will be invited to contribute their expertise on potential vaccine candidates as 
well as provide additional financing (should financing under ESI be insufficient), and will be 
closely  associated  with  the  negotiations.  The  Commission  proposes  to  enter  into  an 
Agreement with participating Member States to formalise their reciprocal commitments. All 
participating  Member  States  will  be  represented  in  a  steering  board,  which  will  assist  the 
Commission  on  all  aspects  of  the  APA  contract  before  signature.  A  joint  negotiation  team 
composed of the Commission and a small number of Member State experts will negotiate the 
APAs. The APAs will be concluded on behalf of all participating Member States.  

The  aim  of  the  negotiations  is  to  conclude  Advance  Purchase  Agreements  with  individual 
companies  under the best  possible conditions.  These APAs will specify a number of details 
with  respect  to  expected  payments  (such  as  payment  amounts,  schedule  and  financial 
structure),  delivery  details  of  the  vaccine  if  and  when  successful  (such  as  price  per  person 
vaccinated, quantity of vaccines and delivery timeline after approval) and any other relevant 
conditions  (such  as  production  capacity  in  the  EU,  possible  availability  of  production 
facilities for the manufacturing of other vaccines or medicines in case of failure, or liability 
arrangements). 

As per the requirements of the ESI Regulation, the Member States and the Commission would 
agree in the above-mentioned agreement that the Commission carries out the procurement on 
behalf  of  the  Member  States  including  the  terms  applicable  to  such  procurement.  As 
stipulated in the ESI Regulation, the procurement procedure is carried out in conformity with 
the  requirements  of  the  Financial  Regulation3,  which  contains  rules  which  are  equivalent  to 
those of the Procurement Directives of the Union and therefore also to national procurement 
rules. When any of the vaccines becomes available, Member States can use the results of the 
procurement  carried out  by the Commission  to  acquire vaccines directly  from  the producer, 
without the need to carry out an additional national procurement procedure. 

While the Commission will be responsible for the procurement process and the APA contracts 
concluded,  the  liability  for  the  deployment  and  use  of  the  vaccine,  including  any  specific 
indemnification  required  by    a  given  APA  will  remain  with  the  purchasing  Member  States. 
For this reason, the assistance of the steering board on any liability issues will be essential. 

The  unprecedented  circumstances  in  which  the  EU  finds  itself  requires  a  bold  response. 
Though steps will be taken to mitigate the risk  – for example, by investing in a portfolio of 
companies covering different technologies - the failure rate of vaccine development is high. 
There is  a very real risk that none of the supported candidates will be successful. However, 
the  value  of  earlier  access  to  a  vaccine  is  enormous,  in  terms  of  lives  saved  and  economic 
damage avoided. This makes the risk worth taking. 

3 

Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on 
the  financial  rules  applicable  to  the  general  budget  of  the  Union,  amending  Regulations  (EU)  No 
1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 
1316/2013,  (EU)  No  223/2014,  (EU)  No  283/2014,  and  Decision  No  541/2014/EU  and  repealing 
Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1) 

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This  proposed  framework is  therefore an insurance policy, which transfers some of the  risk 
from  industry  to  the  public  authorities  in  return  for  assuring  Member  States  equitable  and 
affordable access to a vaccine, should one become available.  

The strategy will seek synergies with other Union instruments to ensure full consistency and 
complementarity of Union actions. 

2.3.  Selection criteria for vaccine candidates 

The  Commission  stands  ready  to  enter  into  negotiations  with  all  vaccine  producers,  which 
have either started or have firm plans to start clinical trials still in 2020 and which have the 
potential to deliver doses at the necessary scale and within the necessary timelines. While an 
initial list of candidates would need to be established quickly to start negotiations, the list will 
be updated as additional information becomes available, in particular from the clinical trials. 

When taking the financing decision, the following non-exhaustive criteria will be taken into 
account:  

-  Soundness  of  scientific  approach  and  technology  used,  including  drawing  on  any 
evidence  related  to  quality,  safety  and  efficacy  already  generated  from  the  development 
phases, where available. 

-  Speed of delivery at scale: progress in clinical trials and the ability to deliver sufficient 

quantities of the vaccine in 2020 and 2021.  

-  Cost: amount of financing requested, the schedule and conditions of the related payments. 

-  Risk sharing: benefits offered in return for the financing provided in the two cases where 
there either (a) is a successful vaccine or (b) no vaccine (e.g. potential flexibilities in the 
use of manufacturing capacity). Funding provided will be considered as a down-payment 
on  the  vaccines  that  will  actually  be  purchased  by  the  Member  States,  and  will  be 
reflected in the conditions for final purchase of the vaccines. 

-  Liability: what special liability coverage, if any, companies would require. 

-  Coverage  of  different  technologies:  vaccines  are  being  developed  using  a  number  of 
different  types  of  platforms/production  methods4.  In  order  to  maximise  the  chances  of 
having  an  effective  and  safe  vaccine,  the  portfolio  of  APAs  should  cover  different 
technologies. 

-  Capacity to supply  through development of production  capacity within the EU:  the 
COVID-19  crisis  has  demonstrated  the  advantage  of  diversified  sources  of  supply  and 
having parts of the supply chains of essential goods within the EU. While the EU remains 
fully committed to international trade and to the development of global supply chains, it 
should  also  aim  to  attract  production  capacity  for  vaccines  to  its  territory  in  order  to 
mitigate disruptions to such supply chains. The output of such production sites will not be 
reserved for the EU. 

4   Such  as  nucleic-acid  vaccines,  viral-vector  and  protein-based  vaccines.:  https://www.who.int/who-

documents-detail/draft-landscape-of-covid-19-candidate-vaccines 

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-  Global solidarity: a commitment to making future doses of vaccines available for partner 

countries to end the global pandemic. 

-  Engagement at an early stage with EU regulators with the intention to apply for an EU 

marketing authorisation for the candidate vaccine(s). 

2.4.  Additional support through loans from the European Investment Bank 

Significant  levels  of EU support have already been made available to  vaccine producers.  In 
particular,  the  Commission  is  currently  providing  guarantees  to  the  European  Investment 
Bank  (EIB)  under  its  financial  instruments,  such  as  Horizon  2020  InnovFin,  the  European 
Fund for Strategic Investments (EFSI) and the forthcoming InvestEU5. This allows the EIB to 
offer highly attractive conditions on financial products offered for vaccine development  and 
related manufacturing activities. These products, ranging from debt to equity-type financing, 
are already supporting key players developing innovative COVID-19 vaccine candidates. This 
is  particularly  the  case  for  the  Horizon  2020  InnovFin  Infectious  Disease  Finance  Facility 
(H2020  InnovFin  IDFF),  a  debt  facility  guaranteed  at  100%  by  the  Commission,  which 
provides  support  from  clinical  studies  to  scaled-up  manufacturing.  As  announced  in  the 
context of the Coronavirus Global Response Pledge Conference hosted by President von der 
Leyen, the Commission has allocated an additional budget of EUR 400 million in 2020 to this 
facility, which now covers COVID-19 projects exclusively.  

Among the frontrunners of vaccine candidates having already entered the clinical trial stage, 
an  EU  based  biotechnology  company  which  is  a  leader  in  mRNA  technology  is  receiving 
support through these financial products for the development and upscaling of manufacturing 
capacities: on 11 June, BioNTech SE signed an agreement with the EIB for EUR 100 million 
financing guaranteed jointly by EFSI and Horizon 2020 InnovFin. 

3.  A FLEXIBLE AND ROBUST REGULATORY PROCESS 

Whilst the need for a vaccine is urgent, it is essential that any regulatory decision concerning 
its  authorisation  is  underpinned  by  sufficiently  robust  data  to  ensure  patient  safety  and 
vaccine efficacy. The EU’s regulatory framework, which offers a high degree of protection, 
contains regulatory flexibilities to cater for urgency. Together with the Member States and the 
European  Medicines  Agency  (EMA),  the  Commission  will  make  the  greatest  use  of  these 
existing  flexibilities  to  accelerate  the  authorisation  and  availability  of  successful  vaccines 
against COVID-19. 

In addition, the Commission has adopted alongside the present Communication a proposal for 
a  Regulation  to  adjust  and  clarify  certain  legal  requirements  for  the  environmental  risk 
assessment for COVID-19 vaccines that contain or consist of genetically modified organisms 
that could  otherwise slow down the conduct of  clinical  trials with  these  vaccines in  the EU 
and  their  administration,  where  appropriate,  to  specific  populations  that  could  benefit  from 
early access. 

5   Notably  under  its  Research,  Digitisation  and  Innovation  window,  as  well  as  its  European  Strategic 

Investments window. 

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3.1.  Early engagement with EMA and international cooperation 

The  development  of  a  vaccine  within  short  deadlines  creates  a  particular  challenge  for  the 
authorisation  process.  Usually,  the  authorisation  procedure  starts  when  the  applicant  is  in  a 
position  to  present  the  relevant  data  package  in  the  form  of  an  application  for  marketing 
authorisation. 

EMA has set up a Task Force (ETF) to interact with developers of COVID-19 vaccines and 
offer  scientific  support  from  the  early  stages  of  development.  Through  the  ETF,  it  provides 
rapid  scientific  advice  and  feedback  on  development  plans,  offers  scientific  support  to 
facilitate clinical trials conducted in the EU and a rolling review of incoming scientific data 
from clinical trials to allow for an accelerated assessment of the final data after completion of 
the clinical trials. This will facilitate and ultimately accelerate the development, assessment, 
authorisation and safety monitoring of vaccines.  

EMA also  ensures close cooperation with  relevant  European  and  international organisations 
and third countries regulators, including with the World Health Organization on clinical trial 
protocols for vaccines. 

3.2.  Accelerated procedure for authorisation 

The  EU  regulatory  system  contains  significant  flexibility  when  it  comes  to  authorisation 
procedures,  which  will  facilitate  access  to  a  vaccine.  In  a  pandemic  situation,  clinical  trials 
will be carried out within a remarkably compressed timeframe, thus limiting the data available 
for  reviewing  the  market  authorisation  request.  The  EU  regulatory  system  is  designed  to 
accommodate this situation by providing for a conditional authorisation system. This means 
that the initial authorisation is based on less comprehensive data than would normally be the 
case  (though  nonetheless  with  a  positive  benefit-risk  balance),  and  with  obligations  on  the 
marketing authorisation holders for the data to be completed afterwards. Member States can 
also provide earlier access, based on their assessment of risk and need and taking into account 
harmonised advice by EMA.  

In  addition,  the  Commission  will  reduce  the  time  needed  to  complete  the  authorisation 
procedure, by shortening the period for consulting Member States, and allowing translation of 
the  documents  into the  full  set  of  languages  after  the  authorisation,  rather  than  before.  This 
will reduce the Commission’s authorisation procedures from nine weeks to one. 

3.3.  Flexibility in relation to labelling and packaging requirements 

Under  normal  circumstances,  packaging  and  labelling  of  authorised  medicinal  products, 
including  vaccines,  should  be  provided  in  all  EU  languages.  However,  requirements  in 
relation  to  labelling and  packaging may slow down the rapid  deployment  of the COVID-19 
vaccines.  The  Commission  will  propose  to  Member  States  to  alleviate  the  language 
requirements  and  to  ensure  the  acceptability  of  multi-dose  presentations  for  COVID-19 
vaccines to facilitate more rapid deployment of a new vaccine and more even distribution of 
the doses between Member States. 

3.4.  Legislation on genetically modified organisms 

A common approach to the development of vaccines is based on attenuated viruses and viral 
vectors. that, whilst conferring immunity to the vaccines’ recipients, are not pathogenic. This 
is also the case for some of the vaccines in development against COVID-19.  

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These products may fall under the definition of genetically modified organisms (GMOs) and 
are thus covered by the relevant EU legislation. There is considerable variety across Member 
States in the national requirements and procedures implementing the GMO Directives used to 
assess  environmental  risks  of  clinical  trials  of  medicinal  products  that  contain  or  consist  of 
GMOs. This is likely to cause significant delay, particularly for multi-centre clinical trials in 
several  Member  States.  These  are  precisely  the  kind  of  clinical  trials  needed  to  ensure 
representativeness  of  the  populations  for  whom  the  vaccines  are  intended  and  to  generate 
robust and conclusive data on COVID-19 vaccines. 

The  Commission  is  therefore  proposing  a  Regulation  to  derogate  temporarily  -  only  for  the 
period  during  which  COVID-19  is  regarded  as  a  public  health  emergency  -  from  certain 
provisions  of  the  GMO  Directive  for  clinical  trials  with  COVID-19  vaccines  (and  also 
COVID-19 treatments) that contain or consist of GMOs. This proposed derogation will apply 
to  the  operations  necessary  for  the  clinical  trial  phase  and  for  compassionate  or  emergency 
use  in  the  context  of  COVID-19.  Compliance  with  good  manufacturing  practice  in  the 
manufacture or importation of investigational medicinal products containing or consisting of 
GMOs  for  use  in  clinical  trials  will  continue  to  be  mandatory,  and  an  environmental  risk 
assessment of the products will be carried out before a marketing authorisation is granted in 
the EU. 

The Commission invites the European Parliament and Council to adopt the proposal swiftly in 
order to enable clinical trials to take place in Europe as soon as possible. 

4.  GLOBAL CONTEXT  

The  Commission  is  committed  to  universal,  equitable  and  affordable  access  to  COVID-19 
vaccines, and has taken a number of steps to promote this. 

In  response  to  the  WHO’s  call  for  global  action  on  24  April,  the  Commission  launched  a 
Global  Coronavirus  Response  to  mobilise  resources  and  join  forces  among  countries  and 
global  health  organisations  to  accelerate  the  development  and  deployment  of  diagnostics, 
therapeutics and vaccines wherever they are needed.  

By the end of May 2020, the pledging campaign the Commission initiated had raised EUR 9.8 
billion euro, to which it had contributed EUR 1.4 billion (of which 1 billion from its Horizon 
2020  research  and  innovation  framework  programme),  with  the  aim  of  providing  universal 
access  to  affordable  coronavirus  vaccination,  treatment  and  testing.  A  second  step  is 
underway in partnership with Global Citizen and other governmental and non-governmental 
partners.  The mobilised funds serve to empower and resource existing organisations such as 
CEPI (the Coalition for Epidemic Preparedness Innovation) and GAVI, the vaccine alliance, 
to  work together in  partnership with  industry, science, regulators and foundations as part of 
the ACT-Accelerator. The ACT-Accelerator is a dedicated framework the Commission helped 
establish  for  enhancing  global  collaboration  in  speeding  up  the  development  and  universal 
deployment of the tools required to fight COVID-19.  

As  part  of  the  ACT-Accelerator,  the  WHO  is  leading  work  with  many  other  actors  on 
developing  a  global  immunisation  strategy  and  a  policy  on  product  allocation,  which  will 
enable vaccines to reach priority groups as quickly as possible.  

The actions set out in this Communication contribute to this global response. Supporting and 
accelerating  clinical  trials  and  de-risking  simultaneous  investments  in  production  capacity 
will significantly increase the potential for the world to have access to an affordable vaccine 
sooner than would otherwise be the case. 

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This  Communication  has  noted  the  benefits  of  a  joined-up  EU  approach  in  speeding  up 
vaccine  development,  de-risking  investment,  ensuring  access  to  a  broader  portfolio  of 
candidates,  and  avoiding  competition  between  countries.  These  benefits  will  be  increased  if 
more countries were to join the common effort. In the light of the experience it will gain with 
the  present  strategy,  and  building  on  existing  international  procurement  initiatives,  the 
Commission is ready to support the development and operation of an inclusive international 
COVID-19  procurement  mechanism  that  facilitates  early  and  affordable  access  to  vaccines 
and  other  tools  for  all  who  need  it  across  the  world.  With  sufficient  scale  and  scope,  such 
international mechanism could become the world’s insurance policy against pandemics.  

The  EU  can  also  promote  global  access  through  a  scientific  review  provided  by  EMA 
combined  with  the  epidemiology  and  disease  expertise  of  WHO,  and  experts  and  national 
regulators in the target countries, to promote the development of high-priority medicines for 
markets outside the EU. This can greatly facilitate early availability of vaccines in low- and 
middle-income  countries.  The  Commission  and  EMA  will  encourage  vaccine  producers  to 
consider this possibility. 

The Commission also supports voluntary pooling and licensing of intellectual property related 
to COVID-19 therapeutics and vaccines, in line with the recent resolution of the World Health 
Assembly6, to promote equitable global access as well as a fair return on investments. 

In this way, the Commission will ensure that the EU continues to play its part in resolving the 
COVID-19 crisis for the world. The EU will only be safe if the rest of the world is safe. 

5.  CONCLUSION AND NEXT STEPS 

There  is  no  guarantee  that  a  safe  and  effective  vaccine  will  be  available  soon.  The 
development  and  deployment  of  tests  and  treatments  therefore  remain  important.  But  an 
effective and safe vaccine against COVID-19 is generally considered the most likely lasting 
solution  to  the  ongoing  pandemic.  Joint  EU  action  within  a  global  framework  greatly 
enhances  the  potential  for  universal  vaccination  against  COVID-19  and  returning  economic 
and social life to normality across the world.  

The Commission  will implement  the EU strategy  for COVID-19 vaccines together with  the 
Member States, thus increasing the likelihood that all who need vaccines will have equitable 
and affordable access to the supplies of these vaccines in the shortest possible time frame. To 
this effect, it will deploy the regulatory, financial, advisory and other tools at its disposal. 

Companies with a promising vaccine candidate, already in or close to starting clinical trials, 
are 
following  email  address:  EC-
VACCINES@ec.europa.eu  

the  Commission  via 

to  contact 

invited 

the 

6   World Health Assembly Resolution 73.1 

9