COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL AND THE COUNCIL HERA Incubator: Anticipating together the threat of COVID-19 variants
Date: 2021-02-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU action, coronavirus disease, disease surveillance, emergency aid, epidemic, epidemiology, medical research, public health, vaccination, vaccine

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 17.2.2021  COM(2021) 78 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL AND THE COUNCIL HERA Incubator: Anticipating together the threat of COVID-19 variants  
 
 
INTRODUCTION 

As the people, societies and economies of Europe and the rest of the world continue to battle 
the  COVID-19  pandemic,  new  challenges  and  threats  continue  to  emerge,  ranging  from 
variants  to  vaccine  adaptation  or  mass  production.  These  have  the  potential  to  disrupt  or 
complicate our sustained and united efforts to  overcome the virus and start our recovery in 
earnest.  Europe  must  now  be  ready  to  anticipate  challenges,  to  proactively  counter  and 
mitigate threats and to work together as Team Europe and with global partners, on all fronts 
with unity and solidarity to ensure the well-being of our citizens. 

As  we  set  about  doing this, we  have  a  lot  to  build  on  and  a  lot  to  learn  from.  The  EU 
Vaccine Strategy has secured access to 2.3 billion vaccine doses as part of the broadest global 
portfolio of safe and secure COVID-19 vaccines. This is our principal line of defence for the 
long-term. Less than a year since the virus appeared for the first time in Europe, vaccination 
has  started  across  all  Member  States.  This  is  a  remarkable  achievement  of  European  and 
global  advanced  research  and  vaccine  development,  condensing  what  usually  takes  5-10 
years in just over 10 months.  

At  the  same  time,  the  past  weeks  have  shown  how  challenging  it  is  for  the  scale-up  of 
industrial vaccine production to keep pace. In order to boost production capacity in Europe, 
we need a much closer, more integrated and more strategic public-private partnership with 
industry.  In  this  spirit,  the  Commission  has  set-up  a  Task  Force  for  Industrial  Scale-up  of 
COVID-19 vaccines to detect and help respond to issues in real-time. 

Europe now also needs to stay ahead of the curve as new and  emerging threats  continue to 
appear  in  the  present  or  on  the  horizon.  The  most  immediate  of  these  are  emerging  and 
multiplying  variants  already  spreading  and  developing  in  Europe  and  across  the  world.  As 
things  stand,  presently  authorised  vaccines  are  considered  effective  against  the  variants  we 
are aware of. However, Europe must be ready and prepared for the possibility of future 
variants being more or fully resistant to existing vaccines.  

This  very  real  threat  of  variants  requires  determined,  collective  and  immediate  action.  Our 
response should build on our experience since the emergency of the initial virus, learning the 
lessons from where there were delays, disruptions and bottlenecks. To bring this together, the 
Commission  will  establish  and  operate  a  new  bio-defence  preparedness  plan  called  HERA 
Incubator, to access and mobilise all means and resources necessary to prevent, mitigate and 
respond to the potential impact of variants.  

To  this  end,  it  will  act  immediately  and  as  a  matter  of  urgency  on  a  number  of  different 
fronts: 

(1) 

(2) 

(3) 

(4) 

Rapid detection of variants; 

Swift adaptation of vaccines; 

Setting up a European Clinical Trials Network; 

Fast-tracking  regulatory  approval  of  updated  vaccines  and  new  or  repurposed 
manufacturing infrastructures; and 

(5) 

Enable upscaling of production of existing, adapted or novel COVID-19 vaccines. 

1 

 
This emergency plan will tackle the short to medium-term threat and simultaneously prepare 
for  the  future.  It  will  serve  as  the  vanguard  for  the  European  Health  Emergency 
Preparedness and Response Authority (HERA)1. 

Time is of the essence. Europe needs a common understanding of the threat we face, a new 
mind-set  to  act  urgently  on  different  fronts  and  an  adapted  governance  to  take  decisions  in 
real time.  

1.  WHAT NEEDS TO BE DONE? 

1.1.  Rapid detection of new variants  

The increased spread of  new SARS-CoV-2 variants  first  identified in the United Kingdom, 
South Africa and Brazil are a potential paradigm shift in the global fight against COVID-19.  
They  exhibit  higher transmissibility  and  in  some cases they have been linked to  potentially 
increased severity of the disease.  

Whole genome sequencing, which maps out the unique genetic blueprints of different strains 
of the virus, is an essential tool to make informed public health decisions. It is key to identify 
variants, both in humans and animals, as well as to monitor their spread in communities and 
populations. It enables the investigation of viral genomes and the screening for mutations that 
potentially  have  an  impact  on  transmissibility  or  pathogenicity.  The  data  that  comes  from 
whole  genome  sequencing  improves  our  understanding  of  outbreak  transmission  dynamics 
and spill-over events both in humans and animals and helps identify variants of concern.  

the  virus  circulating  on 

It is essential that Member States have sufficient sequencing capacity in place to monitor 
the  strains  of 
territories.  Genome  sequencing  and 
epidemiological  data  need  be  shared  between  Member  States  -  in  quick  time  and  in 
comparable  formats  -  to  ensure  that  trends  and  areas  of  concern  can  be  identified  and 
responded  to  rapidly.  This  requires  systematic  sampling  and  data  sharing,  which  should  be 
done according to the FAIR principles2 and made openly available for research purposes. 

their 

In  this  spirit,  HERA  Incubator  will  work  closely  with  the  European  Centre  for  Disease 
Prevention  and  Control  (ECDC)  to  ensure  that  Member  States  have  sufficient  sequencing 
capacities  and  access  to  sequencing  support  services.  HERA  Incubator  and  ECDC  will 
standardise sequencing procedures so that the data is comparable. 

In addition to ramping up sequencing capacities to the required levels, HERA Incubator and 
ECDC will support the increased use of specialised tests to detect samples that are likely 
to contain variants of concern (‘RT-PCR tests’). For each new emerging variant, new RT-
PCR assays may need to be developed, evaluated and adjusted before they can be rolled out. 
HERA Incubator will carefully monitor the situation and make resources available as needed. 
Ensuring sufficient testing capacity in Member States remains essential.  

1  As announced by President von der Leyen in the State of the Union Speech and subsequently included in 
the  Communication  of  11  November  2020  on  ‘Building  a  European  Health  Union:  Reinforcing  the  EU’s 
resilience for cross-border health threats’. 
Findable, 
accessible, 
content/EN/TXT/?uri=CELEX%3A52020PC0767  

https://eur-lex.europa.eu/legal-

interoperable 

re-usable 

and 

2 

2 

 
                                                 
Genome sequencing efforts are also needed to detect variants of concern beyond the EU. 
Reflecting  the  common  global  interest  of  sequencing  and  sample  and  data  sharing,  HERA 
Incubator will work with ECDC and the World Health Organization to build on and increase 
synergies  with  key  facilities.  These  include  GISAID3,  as  well  as  the  Horizon  2020  VEO 
project4  and  EU  COVID-19  data  portal5  both  launched  last  year  to  share,  analyse  and 
understand  genomic  sequences  information  and  identify  new  variants.  The  available  data 
must also be standardised in order to facilitate global communication and response to variants 
of concern. The EU will engage with partners to discuss the possibilities of supporting low-
income countries for developing their genome sequencing capacities in order to ensure global 
coverage and early detection of variants. 

Some  Member  States  have  demonstrated  the  added  value  of  regular  surveillance  of  waste 
waters in combination with other indicators for the management of the pandemic. This allows 
screening among large population groups to identify where more detailed analysis is needed. 
This can help ultimately help speed up the detection of variants6 and be a valuable part of an 
increased  genomic  and  epidemiological  surveillance.  The  Commission  will  intensify  work 
with EU Member States and other actors concerned and present a recommendation on waste 
water surveillance and set up a permanent EU public database.  

KEY ACTIONS 

  Member States should mobilise resources to ensure that a sequencing capacity of at least 

5% of positive test results can be reached.  

  ECDC will develop guidance on standardisation of sequencing procedures across the EU 

for comparability and to facilitate swift data exchange. 

  The EU will support the deployment of other PCR-based assays, through EU level 
procurement if necessary and by joint procurement if requested by Member States.  

  At least €75 million in EU funding will be made available for these activities. 

  The Commission will present a recommendation to the Member States on the use of waste 

water monitoring to track Covid-19 and its variants. 

1.2.  Research, assessment, and analysis 

HERA  Incubator  will  join  up  research,  assessment  and  analysis  carried  out  in  the  EU  and 
beyond  with  a  view  to  responding  to  emerging  variants.  Greater  access  to  comprehensive 
datasets,  research  outcomes  and  reinforced  data  analysis  coupled  with  genomic, 
epidemiologic and clinical data will inform the development of effective measures, vaccines 
and treatments. It will also pinpoint gaps where further research efforts are required.  

Research will focus on key questions for an effective public health response to the variants. 
These  include  risk  factors  for  the  transmission  and  development  variants  and  the  potential 

https://www.gisaid.org/  
https://www.veo-europe.eu/  
https://www.covid19dataportal.org/ 

3 
4 
5 
6   Further  details  on  how  waste  water  sampling  can  be  used  to  track  COVID-19  can  be  found  at:  

https://ec.europa.eu/environment/water/water-
urbanwaste/info/pdf/Waste%20Waters%20and%20Covid%2019%20MEMO.pdf  

3 

 
 
                                                 
protection of vaccines against them. It will also address issues such as whether the vaccines 
currently  available  protect  against  transmission  and  whether  refresher  boosters  at  regular 
intervals could change protection levels.  

Research  activities  will  align  with  the  most  recently  approved  vaccines,  as  well  as  future 
vaccine  candidates  and  their  corresponding  technologies.  They  will  take  a  flexible  and 
diversified approach, including the testing of prime-boost vaccine strategies, the development 
of multivalent vaccines, as well as testing combinations of different vaccines  – the mix and 
match  approach.  They  may  leverage  High  Performance  Computing  to  help  speed  up  data 
related to new variants. 

The Commission will immediately boost research on variants by providing an additional  € 
30 million  to  several  projects  running under Horizon 2020.  It  intends to swiftly  allocate  an 
additional €120 million for new actions responding to latest challenges of the pandemic under 
the new Horizon Europe programme.  

In  all  research,  assessment  and  analysis  activities,  HERA  Incubator  will  ensure  early 
coordination  with  producers  and  regulators  to  enable  a  swift  transition  from  research  and 
development to the clinical phase, with approval and production at scale. 

Access to high quality data, in coordination with relevant international systems and networks, 
will enable the identification of new variants and the appropriate response measures. This 
will ensure that the development of new vaccines and treatments targets the variants of 
high  concern.  This  work  should  also  leverage  existing  systems  and  networks,  such  as  the 
Global Influenza Surveillance and Response System (GISRS)7. 

KEY ACTIONS 

  The Commission will swiftly make available €30 million under Horizon 2020 and €120 

million under Horizon Europe to support the above actions. 

  Member States should share data more swiftly on relevant research projects.  

  The Commission, in consultation with the WHO, will leverage all scientific knowledge to 
provide guidance on the identification of strains for which research should be pursued. 

1.3.  Adaptation to variants: The European clinical trial network  

The clinical  trials phase, during which the safety, efficacy and immunogenicity of vaccines 
candidates  is  studied  in  humans,  is  a  key  step  in  vaccine  development.  As  we  have  learnt 
during this pandemic, clinical trials can face challenges linked to size, speed and scope. This 
is  why  HERA  Incubator  will  work  closely  with  the  research,  regulatory  and  industry 
communities  to  facilitate  access  to  clinical  trial  networks  in  Europe  and  globally  to  further 
support and expand these activities. 

7 

https://www.who.int/influenza/gisrs_laboratory/en/  

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As  part  of  this  a  new  EU-wide  and  EU-funded  vaccine  trial  network  called 
VACCELERATE8 is being launched in parallel with this Communication. All Member States 
are  encouraged  to  participate.  The  network  will  ensure  that  vaccine  trial  sites  –  commonly 
hospitals - are available across Europe to test vaccines. It will cover clinical trials of modified 
and/or  novel  COVID-19  vaccine  candidates,  including  targeted  trials  and  with  a  focus  on 
candidates  adjusted  to  new  variants.  The  European  Medicines  Agency  (EMA)  is  fully 
involved, helping to streamline the regulatory approval process.  

KEY ACTIONS 

  Member States are strongly encouraged to join the new VACCELERATE vaccine trial 

network or other similar clinical trial networks. 

  The EMA and the Commission will support this process and streamline the regulatory 

approval process. 

1.4.  Advanced Purchase Agreements for the next generation of vaccines 

Companies  that  successfully  developed  COVID-19  vaccines  are  already  closely  monitoring 
the efficacy of their vaccines against the emerging variants of concern. They are looking into 
the  possibilities  of  adapting  their  vaccines  to  emerging  variants.    The  Commission  will 
continue  to  use  the  instrument  of  Advanced  Purchase  Agreements  and,  building  on  its 
successful track-record, it will continue to ensure the rapid access to and delivery of the next 
generation of vaccines. 

This  approach  to  help  de-risk  private  investments  in  the  early  development  of  production 
capacity  for  vaccine  candidates  still  in  early  clinical  trial  stages  has  shown  its  worth  and 
offers a ready-made structure on which to build. 

Existing agreements may have to be updated to  cover protection against variants.  Based on 
the lessons learned, a detailed and credible plan showing capability to produce vaccines 
in the EU and deliver on a reliable timescale will be a prerequisite. This should not prevent 
the EU from considering sources from outside the EU if needed, provided they meet the EU 
safety requirements.  

Capacity support will be considered, notably for smaller firms, to facilitate the production of 
vaccines  and  ensure  the  availability  of  intermediary  inputs  and  infrastructures,  such  as 
laboratories. 

KEY ACTIONS 

  The Commission, Member States and vaccine developers will continuously review which 

vaccines should be adapted to new variants of concern. 

  Where necessary, the Commission, with the Member States, will update current or sign 
new Advance Purchase Agreements as soon as possible, to be financed through the 
Emergency Support Instrument.  

8  The network includes already 16 EU Member States and 5 Associated Countries (including Switzerland and 

Israel), and more countries have expressed interest to participate in a later stage.  

5 

 
 
                                                 
  The Commission is ready to mobilise all necessary funding for the purpose of these 

agreements. 

  Additional resources will be made available by teaming up with the European Investment 
Bank via the Horizon 2020 InnovFin Infectious Diseases Finance Facility (IDFF) and 
under InvestEU. 

2.  ENABLING CONDITIONS FOR DELIVERY 

2.1.  An accelerated regulatory framework 

A  predictable  and  streamlined  regulatory  framework  which  guarantees  safety  is 
essential to ensuring citizens’ trust and is a cornerstone of protecting public health. As part of 
this, there is scope to adapt procedures to reflect the particular circumstances of the variants. 
While the EMA will continue to support vaccine developers, all proposed changes will fully 
safeguard the scientific independence and excellence of the Agency. 

The Commission,  together with  EMA and the  Member States,  will  continue  to  make the 
greatest  use  of  regulatory  flexibilities  to  accelerate  the  authorisation  of  vaccines  against 
COVID-19.  In  addition,  the  regulatory  procedure  will  be  amended  to  accelerate  the 
approval  of  COVID-19  vaccines  to  the  new  variants9,  as  is  currently  done  with  human 
influenza vaccines. This will enable the approval of an adapted vaccine with a smaller set of 
additional data10 submitted to EMA on a rolling basis, also using the rolling review concept 
for  post-authorisation  changes.  It  will  guarantee  an  EU  tailor-made  system  for  adapted 
vaccines and complement efforts by vaccine manufacturers. 

The EMA is developing guidance on clear scientific requirements for developers, so that the 
requirements for variants are known in advance. The EMA will also continue to work closely 
on  monitoring  and  assessing  the  possibilities  for  vaccine  development  for  children  and 
adolescents, in accordance with the agreed paediatric investigation plans. It is essential that 
paediatric patients of all ages are included in clinical trials11 and the new VACCELERATE 
network is ready to enable this where possible. 

Early involvement of regulatory authorities for the certification of the new production 
lines is also essential. This applies for the preparation of new or repurposed manufacturing 
sites and/or for transferring technology between sites. The early and rapid development of the 
necessary process control, validation and stability data by companies is key in order to enable 
the review by EMA on a rolling basis and rapid authorisation of the new production facilities. 
To  achieve  this  objective,  the  Commission  counts  on  the  full  cooperation  of  manufacturers 
and Member States. 

9  EMA  will  also  coordinate  with  other  regulatory  authorities  at  national  level  and  in  third  party  countries, 
such  as  the  US  Food  and  Drug  Administration.  Aligning  regulatory  pathways  will  help  to  streamline  the 
process for concerned industry stakeholders and increase supply security. 

10  https://www.ema.europa.eu/en/news/ema-preparing-guidance-tackle-covid-19-variants 
11  https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu; 

https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-moderna-authorisation-eu; 
https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu  

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The Commission is also ready to propose a targeted amendment of pharmaceutical legislation 
to introduce an emergency authorisation of vaccines at EU level with shared liability among 
Member States.  

KEY ACTIONS 

  The Commission will put forward a proposal to adapt the regulatory framework for the 

authorisation of new vaccines adapted for already authorised ones. 

  EMA and national regulatory authorities will reinforce their support to research and 

manufacturers to reduce by a maximum the necessary time for approving new vaccines 
and new production lines. 

  The Commission will mobilise research projects, notably VACCELERATE, to include 

paediatric patients in clinical trials.  

2.2.  Ramping up industrial production of vaccines 

To successfully and rapidly manufacture at scale new or modified vaccines against variants, 
the EU cannot afford problems in the supply chain or insufficient manufacturing capacities.  

Many non-COVID-19 vaccines today are produced in integrated sites that cover various parts 
of the production process. Producers face or will face bottlenecks in many parts of the supply 
chain.  This  includes  access  to  raw  and  packaging  materials,  including  lipid  nanoparticles 
supply  for  mRNA  vaccines,  expert  personnel,  production  equipment  as  well  as  vials  and 
needles. A more distributed, synchronised and flexible model of production can help address 
these  bottlenecks  in  the  short  run.  Europe  has  a  large  and  innovative  pharmaceutical  and 
chemical industry that can step up further to address these challenges. We have already seen 
positive examples where companies are partnering to increase production capacity. 

The  Commission  will  also  continue  to  address  potential  bottlenecks  in  production  and 
supply  of  raw  materials  and  other  essential  input  required  for  vaccines  manufacturing.  It 
will build on the ongoing mapping of existing industrial capacities for vaccine production in 
Europe,  as  well  as  facilities  which  can  be  potentially  repurposed  to  produce  vaccines.  For 
example, these could include pharmaceutical companies not producing vaccines or veterinary 
medicine  manufacturers.  To  support  this,  one  of  the  responsibilities  of  the  Task  Force  for 
Industrial  Scale-up  is  to  act  as  a  one  stop  shop  helpdesk  for  any  queries  and  operational 
support. 

The vaccine development and production require highly specialised and skilled professionals. 
To that end, the Commission will continue building strong skills partnerships under its Pact 
for Skills. 

One of the fastest ways to increase production is to engage those European facilities that have 
relevant  capacities  available.  Increasing  manufacturing  and  ‘fill  and  finish’  capacities  can 
mean sharing the technological know-how and intellectual property behind the vaccines and 
their corresponding technology, with a view to shortening the time necessary for technology 
transfer.  The  Commission  will  foster  the  creation,  if  need  be,  of  a  voluntary  dedicated 
licensing  mechanism,  which  would  allow  technology  owners  to  retain  a  continued  control 
over  their  rights  whilst  guaranteeing  that  technology,  know-how  and  data  are  effectively 
shared with a wider group of manufacturers. 

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The  Commission  will  support  the  pre-production  cooperation  between  undertakings  for 
building-up manufacturing capacities12. The cooperation should be limited to what is strictly 
necessary to achieve the specific objective in terms of research and development, production 
or  supply,  which  the  companies  acting  alone  would  not  be  in  a  position  to  do.  The 
Commission  stands  ready  to  provide  pro-competition  legal  guidance  in  relation  to  the 
production of vaccines or treatments, including in light of the criteria set out in the Antitrust 
Temporary Framework. 

The  EU’s  investment  into  creating  state-of-the-art  vaccine  and  drug  research,  development 
and  manufacturing  capacities  will  be  one  of  the  cornerstones  of  any  future  pandemic 
preparedness  and  response.  It  will  also  strengthen  open  strategic  autonomy  in  the  area  of 
health and the strategic positioning of the European healthcare industry. 

The  above  actions  will  contribute  to  the  creation  of  an  “EU  Fab”  project,  a  network  of 
‘ever-warm’,  single  and/or  multi-user,  single  and/or  multi-technology  production  capacities 
for vaccine and medicine manufacturing at European level, thus becoming over time an asset 
of the future HERA. 

KEY ACTIONS 

The Commission will: 

  Work closely with manufacturers to help monitoring supply chains and addressing 

identified production bottlenecks.  

  Support the manufacturing of additional vaccines addressing new variants. 

  Develop a dedicated voluntary licensing mechanism to facilitate technology transfer. 

  Support pre-production cooperation between undertakings. 

  Ensure EU’s manufacturing capacity by building up the “EU Fab” project. 

CONCLUSION 

This  virus  is  adapting  fast  and  Europe’s  response  must  do  the  same.  Europe  will  continue 
ramping  up  the  production  and  roll  out  of  authorised  vaccines,  whilst  in  parallel  getting 
prepared for addressing the urgent and emergent threats of variants. In order to stay ahead of 
the curve, Europe can rely on the experience, knowledge and lessons of the crisis to date. It 
must  anticipate  problems  earlier,  detect  issues  faster  and  respond  together  –  pooling  our 
strengths  in  a  public-private  approach  and  response.  This  is  the  concept  and  action  of  the 
HERA Incubator launched today by the Commission.   

HERA  Incubator  will  ensure  continuous  exchanges  and  operational  cooperation  between 
regulators, public authorities and industry involved in the value and supply chain. It will be 

12https://ec.europa.eu/info/sites/info/files/framework_communication_antitrust_issues_related_to_cooperation_b
etween_competitors_in_covid-19.pdf  

8 

 
 
 
 
 
                                                 
operated  and  driven  by  the  Commission  and  form  the  backbone  of  a  cooperation  between 
researchers,  technological  companies,  developers,  manufacturers  and  regulators  and  public 
authorities. 

A primary objective of HERA Incubator is to ensure the EU can swiftly secure access the 
volume of vaccines needed to face the variant threats. Given the uncertainty of success to 
find  a  suitable  new  or  adapted  vaccines,  HERA  Incubator  should  initially  facilitate  and 
encourage  several  concurrent  projects  to  identify  and  develop  the  most  promising  vaccine 
candidates.  It  should  then  ensure  the  availability  of  manufacturing  capacity  to  allow 
production and supply at scale of new or adapted vaccines. A well-functioning Single Market 
with undisrupted supply chains and free movement will remain essential in that respect. 

In  operating  HERA  Incubator,  the  Commission  will  act  on  behalf  of  the  EU,  in  a  public-
private cooperation  with  Member States, regulators, business  and the scientific community, 
ensuring  transparent  reporting  to  Member  States  and  the  European  Parliament,  subject  to 
contractual confidentiality rules needed for the success of this operation. 

Since EU vaccine production is critical for global supply this initiative will be of benefit far 
beyond the EU’s borders. HERA Incubator’s activity will entail outreach to and cooperation 
with the EU’s external and global partners such as CEPI, GAVI and WHO on the challenge 
of variants. In the medium and long-term, the EU should cooperate with lower and middle-
income countries, in particular in Africa to help scale up local manufacturing and production 
capacities.  

Given the race against time, sufficient funding will need to be made quickly available, 
and the Commission is ready to mobilise all means at its disposal, including through the 
Emergency  Support  Instrument.  The  HERA  Incubator  will  start  rolling  out  its  activities 
immediately. 

The  Commission  invites  the  European  Heads  of  State  and  Government  meeting  on  25 
February to endorse and properly mandate the HERA Incubator and to mobilise the relevant 
national actors and capacities in this coordinated effort. 

9