COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Addressing together current and new COVID-19 challenges
Date: 2021-12-01
Institutions: European Commission, Secretariat-General
Subjects: EU Member State, coronavirus disease, epidemic, health care, health certificate, security of supply, travel, vaccination, vaccine

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 1.12.2021  COM(2021) 764 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS  Addressing together current and new COVID-19 challenges  
 
 
ADDRESSING TOGETHER CURRENT AND NEW COVID-19 CHALLENGES 

I 

INTRODUCTION 

This autumn has seen a resurgence of COVID-19 in many Member States, with rapidly rising 
case numbers and renewed pressure on hospitals and health workers. Governments are again 
having to balance the need for restrictions to limit the spread of the virus with the cost to social 
and  economic  life.  The  return  to  a  critical  situation  after  a  period  of  respite  has  sparked 
frustration  and  fatigue  in  many  citizens.  The  new  threat  from  the  Omicron  variant  has 
accentuated concerns still further. 

Urgent and determined action is required. The common efforts of the EU, Member States, and 
citizens mean that we are now much better equipped to act than at the start of the pandemic. 
We know far more about how to limit transmission of COVID-19 through hygiene measures 
and  targeted  restrictions.  Therapeutics  allowing  COVID-19  to  be  treated  are  increasingly 
becoming available. Above all, vaccination is massively reducing the risks for most Europeans. 
It has allowed much of daily life to resume, economies to start their recovery and opened the 
door  to  initiatives  to  restore  freedoms  such  as  the  EU  Digital  COVID  Certificate.  EU  joint 
efforts to build up the production and supply of vaccines have substantially increased access to 
vaccination, and there is now no question about the availability of vaccines: a clear example of 
the added value of an EU-level approach. Vaccination means that responses to the pandemic 
can be more tailored to the situation of the individual.  

Nevertheless, the renewed risk of new variants serves as a reminder that we must continue to 
be determined in action and swift in response. We now have a much wider range of tools and 
the experience to deploy them to best effect: but the success of vaccination has also meant that 
new measures to anticipate the current phase in the pandemic were not always taken in time. 
We are learning again that the more we delay in using these tools, the more drastic the action 
required. 

This  urgency  also  applies  to  global  action.  Only  by  working  together  we  can  tackle  the 
pandemic  effectively  and  progress  towards  long-term  health  security.  The  Omicron  variant 
shows again the importance of real-time transparency and global coordination, as well as of 
sharing the tools needed to combat the pandemic. It also underlines that international efforts to 
support all countries in tackling the pandemic have not gone far enough. Accelerating this work 
must be a major priority. 

The experience of the last 18 months shows that a coordinated EU response is the most effective 
and persuasive approach to the pandemic. It maximises the scale and impact of our actions, it 
ensures predictability for citizens and it provides a framework within which Member States 
can tailor their responses. It shows our citizens that policy continues to be driven by a strong 
scientific consensus. It is now urgent to draw on this approach once again. The EU needs to 
show its continued determination by taking swift, clear and coordinated steps to address the 
resurgence in the virus.  

II 

THE NEW WAVE OF COVID-19 INFECTIONS  

The EU today faces a double challenge. Member States are already in the midst of rapidly-
rising cases serious enough to once again put health systems under the severest of challenge. 
To this is now added the threat of the Omicron variant: and although the detailed impact of this 

1 

 
 
 
 
variant is still under assessment, the rapidity of its spread and the extent of the mutation make 
it a clear variant of concern. The fact that it comes at a time when vaccination still falls short, 
when boosters are only now being deployed, and when health services have faced almost two 
years of intense pressure,  means this demands urgent action. 

The recent spread of the virus 
COVID-19  cases  have  been  rising  steeply  since  October1.  This  has  led  to  week-by-week 
increases in  serious illness,  hospitalisations, and deaths,  particularly in  Member States with 
low vaccination rates. However, the rollout of vaccines also means that the proportion of people 
who are getting seriously ill or dying is significantly lower than in the initial waves. 

One reason  behind  this resurgence  is  the dominance of the Delta variant, which is  twice as 
transmissible as  the original  virus, even if the vaccines  remain  effective  against  the disease 
caused by this variant. In addition, immunity may have started to wane in those who received 
the vaccine first (in general, the most vulnerable and older age groups). The change in season 
caused much of social and economic life to move indoors, where the virus can be more easily 
transmitted. And the speed at  which restrictions  and precautions  are  relaxed or imposed by 
governments also has a clear impact on the ability of the virus to spread.  

However, of critical importance to the current situation is that a substantial share of Europeans 
remains unvaccinated. Overall, 23.5% of adults across the EU are still not fully vaccinated, 2 
and in some Member States this figure is as high as 70.8%. Perhaps most worryingly, in some 
Member States up to 65 % of people over 65 years are still not fully vaccinated.  

It is clear that vaccination reduces the likelihood of infection, and is very effective in reducing 
severe disease and death. Vaccination does not offer a complete protection against infection 
and vaccinated people, if infected, can still transmit the disease. But infection in vaccinated 
people is far more likely to result in a relatively mild case of COVID-19. A first analysis of 
data from three Member States confirms that the hospitalisation rate is substantially higher in 
unvaccinated  people  compared  to  those  vaccinated.  In  other  words,  vaccination  very 
significantly reduces someone’s chances of becoming seriously ill with COVID-19. 

1  

2  

The overall COVID-19 case notification rate in week 45 (08-14 November 2021) for the EU/EEA was 485.5 
per 100 000 population from 8-14 November, and 612.2 from 15-21 November (ECDC 17th update of the 
rapid risk assessment). 
This equates to 34.3% of the total population. 

2 

 
                                                           
Figure: Rate of hospitalisation for COVID-19 by vaccination in three Member States 

While still offering solid protection, the effectiveness of vaccines naturally declines over time. 
On 24 November, the European Centre for Disease prevention and Control (ECDC) issued a 
rapid risk assessment indicating the need to urgently consider a booster dose for those 40 years 
and over, targeting first the most vulnerable and the elderly. ECDC also indicated that countries 
could  consider a booster dose for all adults  from six months  after completing their primary 
vaccination. This would increase protection against infection in the face of waning immunity3. 
All Member States have already started delivering booster doses to the most at-risk groups and 
a number of Member States are already offering population-wide booster campaigns.   

In addition to adult vaccination, the approval of two vaccines for use in the 12+ age group has 
allowed Member States to extend vaccination still further.  In addition to this, a vaccine has 
now been approved for use in the 5 to 11 age group..  

The effectiveness of vaccination allowed much of social and economic life to resume over the 
summer. However, with the relaxation of constraints contributing to a renewed spread of the 
virus,  basic  hygiene  measures  such  as  mask-wearing  were  no  longer  enough.  This  left 
authorities with the challenge of identifying the most effective targeted measures to use as the 
number of cases started to increase. 

The upsurge in cases of severe illness, especially among the unvaccinated, has resulted in an 
enormous strain on hospitals and healthcare staff already stretched by the events of the past 18 
months. This overburdening of health care systems is also having a direct impact on the health 
of non-COVID patients, as once again access to healthcare for other conditions is put under 
pressure by the need to treat COVID-19 patients. The result is a burden on healthcare systems 
comparable  to  or  higher  than  last  winter.  This  is  making  the  imposition  of  new  measures 
inevitable, with governments faced with difficult decisions about when and what measures to 
apply. 

Action to tackle the Omicron variant 

The identification of the Omicron variant (B.1.1.529) by South Africa illustrates the importance 
of acting swiftly and decisively to reduce and slow down the transmission of the virus and to 
manage the risk of possible further mutations. South Africa’s work in carrying out analysis and 

3  

https://www.ecdc.europa.eu/en/publications-data/rapid-risk-assessment-sars-cov-2-situation-november-
2021 

3 

 
 
 
                                                           
its  transparency  in  sharing  the  results  has  been  indispensable  in  allowing  a  swift  global 
response and is a model of how international cooperation should work. 

As the World Health Organization4 concluded on 26 November 2021, a global effort is needed 
to ensure that variants are identified and tracked. This means: 

  enhanced surveillance and rapidly expanded global genomic sequencing efforts; 
  submitting complete genome sequences to a publicly available database;  
 

reporting  initial  cases  and  clusters  associated  with  variants  of  concern  infection  to 
WHO and ECDC; 

  performing field investigations and laboratory assessments to improve understanding 

of the potential impacts of the variants of concern. 

As well as this global effort, the EU and Member States must act now. While urgent steps are 
taken to gather key data on the Omicron variant, precautionary measures are essential. Member 
States need to put contingency plans into action as soon as cases emerge. Increased vaccination, 
including the rapid rollout of booster campaigns, and the quick introduction of precautions and 
restrictions limiting social contacts should slow down the transmission of the Omicron, and 
any other, variant. Member States must take swift and decisive action whenever a cluster of 
cases is identified. 

In this respect the EU can draw on key initiatives put in place over the past year. First,  with 
the HERA Incubator, launched in February 2021, the Commission prepared for the detection 
of variants, the development, regulatory approval and production of adapted vaccines. The EU 
has made a major effort to strengthen its capacity to rapidly detect and characterise variants of 
concern.  In  February  2021,  €200  million  was  made  available  to  reinforce  Member  States’ 
sequencing capacities. A whole genome sequencing service contract has helped 11 Member 
States and three Western Balkan countries to have more than 100,000 samples analysed. A new 
€77 million programme is building up long-term genome sequencing and testing infrastructure 
in 24 EU/EEA countries, with an extension proposed for 2022. This not only means a better 
response to the current pandemic, but also a permanent step up in capacity. The EU has also 
developed its capacity for the testing of wastewater to identify the location of new cases. As a 
result,  the  EU  is  now  better  prepared  for  variants:  the  investment  in  increased  genetic 
sequencing capacity and effective data sharing will enable the real time identification of any 
further mutant strains, such that immediate responses can be put in place. Adapting vaccines 
to new strains when needed is now factored into contracts with vaccine manufacturers. 

Second, with the launch of the EU Health Emergency Preparedness and Response Authority 
(HERA) in September 2021, the Commission has brought together both strategic direction and 
expertise at both national and EU level in the HERA Board and provides for joined up action. 
It is already deploying and networking modelling and foresight capabilities so that the right 
responses can be quickly identified and deployed. Its strong industrial dimension is leveraging 
industrial partnerships and expanding industrial capacity for vaccines and therapeutics. 

Third, travel related restrictions can slow down further entry points of this variant from outside 
the EU. The common framework put in place to coordinate measures to restrict travel to the 
EU (see below) allowed an “emergency brake” to be applied within a matter of hours of the 
recognition of the Omicron variant by the WHO. The result was agreement on 26 November 
to apply targeted travel measures for those countries most affected by the  Omicron variant. 
These arrangements also allow the situation to be constantly monitored to either expand the list 

4 

https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.1.529)-sars-cov-2-variant-of-
concern 

4 

 
                                                           
of affected third countries, to introduce possible measures within the EU or to lift precautionary 
measures as further scientific evidence becomes available.  

The EU and Member States need to take immediate action: 

  Member States need to have contingency plans in place to take rapid and decisive to 

control outbreaks of the variant wherever they are identified; 

  Member  States  need  to  have  booster  campaigns  immediately  in  place  as  an 

indispensable step towards increased protection against variants; 

  Member States, supported by the Commission, should closely coordinate to apply real-
time changes to border and travel measures in line with the Council Recommendations 
on  travel  to  the  EU  and  on  free  movement  within  the  EU,  including  on  testing  and 
quarantine measures. Based on the latest available scientific evidence and in line with 
the precautionary principle, to answer to the current risk from the omicron variant, the 
requirement of a PCR test prior to arrival can be a suitable means for Member States to 
consider, in particular for travel to the EU, as well as for travel within the EU, as part 
of  an  emergency  brake.  Such  steps  should  be  for  the  shortest  time  necessary, 
proportionate, non-discriminatory and subject to constant review; 

  Member States should increase genomic sequencing capacity and surveillance of the 
Omicron and any other variants of concern, including through widespread wastewater 
testing. The Commission will help to ensure that samples and results are shared swiftly;  
  The Commission will support sampling for countries with low sequencing data as well 

as the rollout of antigen tests; 

  Support should be provided at both EU and Member State level to countries in Southern 
Africa,  and  any  other  relevant  countries,  on  gathering  and  studying  clinical  data 
associated with infections by this new variant;  

  HERA will continue to use the potential it offers to tackle Omicron to the full: 

  The HERA expert group on variants acts as the focal point for situational analysis; 
  HERA works with vaccine manufacturers to ensure the swift adaptation of vaccines 
to  the  new  variant  if  necessary  and  guarantee  sufficient  vaccine  production 
capacity; 

  The HERA Board, also in coordination with the WHO, brings together the strategic 

direction of EU and national action. 

III  

STAYING THE COURSE: COORDINATED ACTION TO COMBAT COVID-
19 

The virus has proved both durable and adaptable, with the Delta variant currently the dominant 
strain in the EU and with the new threat of the Omicron variant. Only sustained and determined 
action  will  allow  the  pandemic  to  be  brought  and  maintained  under  control.  This  makes  it 
particularly important that measures are taken not only in response to surges in infection and 
the arrival of new variants, but also when infection rates are low. This has been the guiding 
principle  of  EU  action  against  the  pandemic:  to  ensure  the  availability,  supply  and 
administration of vaccines; to improve the treatment of those infected; and to act together to 
ensure that restrictions are effective, but remain proportionate and fair.  

One  of  the  main  lessons  from  the  last  eighteen  months  is  the  importance  of  agreeing  on  a 
common  and  coordinated  EU  approach  and  communicating  that  approach  as  clearly  as 
possible.  Discrepancies  between  national  approaches  to  vaccination  which  are  not  clearly 
explained have undermined efforts to tackle vaccine hesitancy. Major differences in the public 

5 

 
 
health  measures  applied,  which  could  not  be  explained  by  equally  large  differences  in 
epidemiological situations, undermined public confidence. 

Continuing to build effective vaccination 

Vaccination efforts must be continued. Supply and production capacity is now assured through 
the EU Vaccines Strategy. By the end of this year, the EU will have an installed manufacturing 
capacity of over 300 million doses a month. The contracts put in place under the EU Vaccines 
Strategy give Member States access to as many doses of vaccines (including adapted vaccines 
if they prove necessary) as they need in 2022 and 2023. The EU will need to continue to invest 
in  developing  and  producing  better,  more  advanced  vaccines  against  COVID-19  and  its 
variants. HERA will allow the development of a powerful strategic capacity to perform exactly 
that  function  in  order  to  combat  both  current  and  future  threats  through  improving  the 
development,  manufacturing,  procurement  and  distribution  of  vaccines.  This  will  include 
identifying and addressing vulnerabilities in critical supplies and materials for the production 
of vaccines, building on the work of the Commission’s Task Force for industrial scale-up. The 
existing  Joint  Procurement  for  syringes  should  be  taken  up  by  Member  States  to  address 
potential  shortages.  Also  key  is  improving  access  to  vaccines,  so  that  the  administration  of 
vaccines  by  health  services  can  takes  place  in  local  communities  and  with  easy  access  for 
citizens.  

A primary challenge today is to persuade those who are not yet vaccinated to get the vaccine. 
Member States are starting to use a greater variety of measures to reflect the reality that the 
unvaccinated pose more of a threat to the health of society at large and the sustainability of 
healthcare systems than the vaccinated. Vaccine hesitancy has a variety of causes. They often 
need tailor-made, local solutions with trust in local health professionals playing a key factor. 
Nevertheless, there are certain common elements which the EU and its Member States  – as 
well as global partners such as NATO – could continue to work on together, not least the huge 
amount  of  misinformation  and  disinformation  about  vaccines  which  has  been  put  into  the 
public sphere. The Commission has set up a dedicated process to facilitate a swift response to 
disinformation. A Rapid Alert System allows for effective cooperation with Member States, 
with  a  dedicated  COVID-19  Cooperation  Space  bringing  together  pandemic-related 
disinformation  analysis  and  responses.  The  Commission  has  also  offered  direct  bilateral 
support  to  those  Member  States  with  the  lowest  vaccine  uptake  rates,  also  reaching  out  to 
healthcare  professionals  in  those  countries5.  This  could  now  be  expanded  to  mobilise  other 
community  leaders  (such  as  business,  trade  union,  religious,  and  sporting  leaders).  The 
Commission  is  also  engaging  with  online  platforms  to  motivate  them  to  offer  space  for 
communication campaigns and promotion of expert views, as well as to monitor disinformation 
and to share data. 

More data is now emerging about the rate at which immunity wanes. Booster doses are the key 
response to address this waning. They are also essential tools in protection against variants. At 
the moment, all EU Member States are offering boosters or additional doses to the most at-risk 
groups, such as the elderly, the immunocompromised and immunosuppressed, long-term care 
facility residents and healthcare workers. In view of the ECDC guidance above, all Member 
States need to ensure that the most vulnerable have a booster shot as a matter of priority, and 
to  deploy  the  right  equipment  and  resources  for  mass  booster  campaigns.  The  onset  of  the 
Omicron  variant  adds  extra  urgency  to  the  need  to  roll  out  mass  booster  campaigns  in  all 
Member States. 

5  

The EU Coalition for Vaccination brings together European health professionals’ and students’ associations 
to advocate for vaccination in their daily work with patients and fellow health professionals. 

6 

 
                                                           
Treating people with COVID-19 

Better  treatment  of  those  who  do  contract  COVID-19  has  also  been  a  key  development  in 
combatting  the  virus.  This  is  one  consequence  of  better  diagnostics  to  understand  the 
prevalence of the virus and how to address it. Member States will increasingly be able to use 
therapeutic medicines in the fight against COVID. The EU COVID-19 Therapeutics Strategy 
is now up and running with a portfolio of the ten most promising candidate therapeutics, with 
several joint procurements with Member States now concluded to ensure equitable access to 
such therapeutics. Three treatments  have now been authorised.  This  will play a particularly 
important part in limiting the risks of COVID-19 for the most vulnerable, and could also help 
address the challenges of post-COVID complications for recovered patients. Communication 
will be key to explain the benefits of authorised treatments and the risks of misinformation. 
These therapeutics will help individuals to recover faster and mitigate the impact of the virus 
on individuals and on health systems: however, they are a complement to vaccination, not a 
replacement for it. This will also be an important part of the work of HERA in the medium and 
long term. 

At the same time, the rise in cases in some Member States risks taking their health systems 
back into crisis mode. The Union Civil Protection Mechanism remains available to galvanise 
support from less affected Member States to those under most pressure. Since the beginning of 
October,  the  Emergency  Response  Coordination  Centre  has  facilitated  the  delivery  of 
immediate life-saving assistance from several Member States6 to Romania and Latvia. 

Prevention measures 

Daily behaviour is an essential component in combatting the virus and should remain the norm. 
This includes most obviously the use of mouth masks in closed and at risk settings, avoidance 
of high risk gatherings, social distancing, and proper ventilation of closed settings.  

The reality is that with increased spread of the virus and the risk that this will extend still further 
with the Omicron variant, further preventive measures will also be needed to limit the risks of 
contact and infection. Vaccination is not enough to hold back the virus on its own. Experience 
since  the  start  of  the  pandemic  shows  that  such  measures  are  an  essential  part  of  action  to 
combat  the  spread  of  the  virus.  Success  factors  include  decisive  decision-making,  good 
communication, and community engagement. As has been the case throughout the pandemic, 
authorities  will  need  to  find  the  right  point  of  balance  so  that  such  restrictions  are  timely, 
effective but also proportionate: individuals should not have their liberties restricted if doing 
so does not make a significant contribution to reducing the impact of the virus. Lessons must 
also be learned from previous experiences in applying these restrictions – for example, the high 
impact  of  closing  schools,  universities  and  colleges  on  the  mental  health  and  educational 
performance  of  children  and  young  people.  But  equally,  waiting  too  long  before  applying 
essential  steps  means  that  that  more  radical  measures  are  then  needed.  Measures  such  as 
improved hygiene or staying at home when showing symptoms may become norms for society 
over the longer term. 

With  a  growing  share  of  the  population  being  vaccinated  and  now  receiving  boosters, 
restrictions are increasingly shifting away from measures for the whole population to measures 
that take into account both individual circumstances and the risk that a given individual could 

6      11 Member States (Austria, Czech Republic, Denmark, Finland, France, Germany, Italy, Lithuania, Poland, 
Slovakia  and  Sweden)  as  well  as  Serbia  provided  medicines,  medical  equipment,  personal  protection 
equipment and vaccines. Poland and Denmark sent medical teams to Romania. Support was provided from 
the EU-financed rescEU strategic reserve hosted by Hungary, the Netherlands and Sweden. 

7 

 
                                                           
make  the  situation  worse.  Measures  such  as  requiring  those  working  in  environments  with 
vulnerable people to get vaccinated are a logical response to the current reality. 

The toolbox to monitor and manage the situation 

Alongside these requirements, Member States should continue to use the tools at their disposal 
to facilitate everyday life. Available and accessible testing will remain an indispensable tool to 
manage and control the pandemic and respond swiftly to outbreaks. Member States need to 
look  ahead  to  ensure  that  sufficient  testing  will  be  available  to  manage  surges  in  the  virus. 
Testing strategies should be targeted, for example on settings with high-risk groups such as 
long-term care facilities and hospitals, as well as on areas of high transmission such as schools. 
This could also be combined with testing for other circulating viruses such as influenza. Work 
should also continue on ensuring the accuracy of testing, such as whether the effectiveness of 
tests is influenced by vaccination.  

Contact tracing remains part of the toolbox to contain a resurgence of COVID-19 and Member 
States  should  maintain  a  sufficient  capacity.  By  complementing  existing  manual  contact 
tracing,  contact  and  warning  tracing  apps  can  also  continue  to  play  an  important  role  in 
breaking  the  chain  of  infections,  nationally  and  across  borders,  thus  contributing  to  saving 
lives. To date, 21 EU/EEA countries have a contact and warning tracing app, with 18 connected 
through the European Federated Gateway Service, allowing people to continue using their app 
even when cross borders: all Member States are encouraged to participate.  

The EU Digital COVID Certificate, designed, adopted and implemented with unprecedented 
speed, is a key enabler of recovery and has proved an invaluable tool for Member States and 
citizens,  enabling  cross-border  movement  of  EU  citizens  and  helping  social  and  economic 
activity to continue with the minimum of disruption. Member States have now issued over 650 
million EU Digital Covid Certificates.7  

The  successful  and  widespread  implementation  of  the  EU  Digital  COVID  Certificate  also 
makes  possible  a  revised  approach  to  free  movement  within  the  EU.  The  Commission  has 
therefore made a proposal for a new Council Recommendation on a coordinated approach to 
facilitate safe free movement during the COVID-19 pandemic.8 This sets out a new approach 
based on the Certificate, so that travellers with a valid EU Digital Covid Certificate should in 
principle not be subject to additional restrictions to free movement, such as quarantine or tests. 
It also takes account of the situation where the virus is circulating at very high levels in some 
areas of the EU, where  Member States  should advise against all non-essential travel  to  and 
from such areas. Travellers without a vaccination or recovery certificate arriving from such 
high-risk areas should  have  a test  prior to  departure,  as  well as  post-arrival  quarantine/self-
isolation. Finally, the proposal also adapts the methodology and factors vaccine uptake into the 
regional map prepared by the ECDC. 

Requirements to control the virus such as testing and quarantine within the EU are foreseen 
under the emergency brake procedure of the Council Recommendation in the face of a high 
prevalence of a variant of concern such as omicron. Member States should consider applying 
measures  as  part  of  precautionary  steps  to  limit  the  risks  of  spread  whilst  first  analysis  of 

7 

8  

See Report from the Commission on the issuance, verification and acceptance of interoperable COVID-19 
vaccination,  test  and  recovery  certificates  to  facilitate  free  movement  during  the  COVID-19  pandemic 
(COM(2021) 649). 
Proposal for a Council Recommendations on a coordinated approach to facilitate safe free movement during 
the  COVID-19  pandemic  (replacing  Recommendation  (EU)  2020/1475,  COM  (2021)  749)  and  on  a 
coordinated  approach  to  facilitate  safe  travel  during  the  COVID-19  pandemic  in  the  Schengen  area 
(amending Recommendation 2020/1632, COM (2021) 755). 

8 

 
                                                           
omicron is under way. Such steps should be proportionate, non-discriminatory, transparent and 
fully coordinated. 

A key issue is to ensure the right length for the validity of vaccination certificates under the 
EU  Digital  COVID  Certificate,  recognising  that  in  time,  the  reassurance  provided  by  the 
certificates  wanes  alongside  the  effectiveness  of  the  vaccine.  The  length  of  validity  of 
certificates therefore needs to be compatible both with this waning effect, as well as with the 
need for a reasonable time to allow booster campaigns to be implemented, so that the constraint 
on  free  movement  from  validity  coming  to  an  end  is  fully  proportionate.  The  Commission 
considers that, with effect from 10 January 2022, certificates which are more than nine months 
from the initial vaccination course should no longer be accepted by Member States.  This is 
reflected in the Commission’s proposal which takes into account the guidance of the ECDC 
regarding the administration of booster doses as of six months, and provides for an additional 
period of three months to ensure that national vaccination campaigns can adjust and citizens 
can have access to boosters. In addition, the Commission is considering whether to provide for 
such validity in a binding manner.9 Finally, the Regulation currently applies until 30 June 2022. 
As it appears unlikely that the pandemic will have ceased by then, the Commission is therefore 
preparing a legislative proposal to extend its applicability for a limited period of time..  

The  EU  Digital  COVID  Certificate  is  the  only  large-scale  COVID-19  certificate  system  in 
force, addressing the impact of COVID-19 on daily life and also facilitating the travel of non-
EU residents to and from the EU. The linking of the Certificate to third country systems has 
already allowed connections to 51 countries, and will continue to be further extended, including 
to Africa. 

The Commission has also proposed to amend the rules for travel to the EU, establishing a link 
with the EU Digital COVID Certificate and the third-country certificates deemed equivalent to 
it. This revision would, from 10 January until March 2022, allow for a fresh review of the list 
of eligible third countries from which non-essential travellers are allowed on the basis of the 
epidemiological situation. For most other countries, travel would be limited to essential travel, 
the  vaccinated  and  the  recovered,10  with  Member  States  also  able  to  apply  quarantine  and 
additional testing. Member States would accept not only COVID-19 vaccines authorised in the 
EU,  but  also  those  having  completed  the  emergency  listing  procedure  of  the  World  Health 
Organisation  (WHO),  if  travellers  also  have  a  valid  proof  of  a  negative  PCR  test  before 
departure.  From  March  2022,  the  Commission  proposes  to  shift  from  the  current  hybrid 
country/person-based to a purely person-based approach, privileging vaccinated and recovered 
travellers. A coordinated approach to travel restrictions from particularly high-risk areas will 
continue to be vital to slow or limit the arrival and transmission of new variants in the EU.  

Member  States  and  Schengen  Associated  Countries  must  follow  this  Recommendation  and 
coordinate restrictions for all types of travel into the EU+. As set out above, the key need for 
this effective coordinated approach is now being demonstrated in the case of Omicron variant. 
The swift application of the emergency brake procedure rules showed that the EU framework 
for a coordinated approach works and will help to limit the spread of the new variant. A day-
to-day assessment is needed in order to assess whether further countries should be added to the 
measures, as well as the nature of testing and quarantine for essential travellers still allowed to 
come to the EU. However, the reality is that the variant has already spread, and travellers may 
have contracted the variant before the final point of departure to the EU. It is therefore essential 
to have the 14-day travel history of all arrivals into the EU, as well as the ability to identify 

9  
10  

Through a Delegated Act under the Digital COVID Certificate Regulation. 
Persons who have recovered from COVID within 180 days before the travel, with a negative PCR test before 
travel. 

9 

 
                                                           
those in close contact with an infected passenger on the trip, so that they can be effectively 
traced, including across borders. This underlines the need for all Member States to put in place 
effective passenger locator forms. Without clear information about the countries visited by all 
travellers in  the 14 days before arrival  in  the EU, a deteriorating situation is  more likely to 
require  a  complete  travel  ban  from  outside  the  EU  for  non-essential  travellers,  and  more 
stringent quarantine requirements for essential travellers. The Commission will propose an EU 
legal framework for a coordinated approach to passenger locator forms to the extent necessary 
to  stem the spread of COVID-19.11  Transport operators  can  also  play  a key  role helping to 
ensure this critical information is available. 

Structural resilience and coordination 

Close  coordination  between  Member  States  will  play  a  particularly  important  part  in 
maximising the ability of the EU to harness its tools to address the current resurgence of the 
virus. This implies a high level of information flow on planned national measures, a constant 
monitoring and consistent use of the guidance from ECDC and EMA. Key fora such as the 
Health Security Committee and the Integrated Political Crisis Response (IPCR)12 need to be 
used to the full.  

A  swift  adoption  of  the  full  package  of  the  European  Health  Union  proposals  and  the 
emergency  framework  to  allow  the  EU  and  its  Member  States  to  use  the  new  possibilities 
offered by HERA to act decisively on future serious cross-border health threats is a necessity 
to tackle the challenges of the pandemic in 2022. In parallel, HERA should reach its goal of 
giving a full voice to all key stakeholders in defining an operational EU approach. 

IV 

THE IMPERATIVE OF GLOBAL ACTION 

The  EU  should  continue  to  lead  efforts  to  ensure  that  the  whole  world  is  protected  against 
COVID-19. No one is safe until everyone is safe.  

From the beginning, the EU has been leading the global response to the pandemic by supporting 
neighbours and partner countries in facing its health and socio-economic consequences. It has 
also  been  a  driver  of  vaccine  research,  the  world’s  biggest  exporter  of  vaccines,  and  at  the 
forefront  of  vaccine  sharing.    It  has  also  been  leading  support  to  countries  facing  the 
combination of severe health impacts and economic slump. This work now needs to be further 
intensified. 

Openness and fairness are Europe's trademark. Over 1 billion vaccines produced in the EU 
have been shipped to more than 150 countries on all continents. The EU has exported as much 
as it has delivered to its citizens. At least every second vaccine produced in Europe is and has 
been exported. A proposal for a new export transparency mechanism will ensure that the EU 
can continue to track exports of vaccines and active substances. 

Ensuring access to safe and affordable COVID-19 vaccines around the world, notably for low 
and middle-income countries, is a priority for the EU. With only 2% of the population in low-
income countries and 19% of the population of lower-middle income countries vaccinated, the 
priority must be to speed up global vaccination if the pandemic is to be effectively addressed. 

11   Existing platforms linking national systems provide valuable experience. 
12   Council Implementing Decision (EU) 2018/1993 of 11 December 2018 on the EU Integrated Political Crisis 

Response Arrangements. 

10 

 
 
                                                           
Africa is a particular focus13 and a support package will be identified ahead of the EU-Africa 
summit in February 2022.  

The Commission is constantly working with manufacturers to ensure a continued regular and 
predictable  supply  of  vaccines.  Member  States  can  have  confidence  that  they  will  have  the 
doses  to  meet  their  vaccination  needs,  including  for  boosters  or  adapted  vaccines.  Member 
States  should  therefore  also  feel  confident  in  continuing  to  redirect  significant  numbers  of 
planned deliveries of vaccines to low and middle-income countries. 

On top of exports, the EU is delivering on commitments made on vaccine sharing. 250 million 
doses will be shared by Team Europe before the end of 2021, with a total of 700 million to be 
shared by the middle of 2022, 200 million of these funded through the EU budget. Through an 
EU  Vaccine  Sharing  Mechanism  and  supported  by  a  task  force  set  up  by  the  Commission, 
Member States have already delivered over 100 million vaccine doses worldwide: donations 
and delivery of vaccine sharing can and must now be accelerated. This is work which will need 
to  be  maintained  for  the  foreseeable  future,  and  will  be  more  effective  the  quicker  it  is 
delivered. 

These commitments are in addition to Team Europe’s existing and leading support to ACT-A 
and  its  vaccine  pillar  COVAX,  including  deliveries  to  humanitarian  settings  through  its 
Humanitarian Buffer. The Commission will follow up on the commitment made by industrial 
partners at the Global Health Summit in Rome to make 1.5 billion vaccine doses available to 
low income countries at no profit, and to middle income countries at lower prices. Also key is 
to stimulate production worldwide: Team Europe is also investing €1 billion to ramp up mRNA 
production capacity in Africa. 

However, dose supply is not enough. Member States, manufacturers and COVAX need to work 
together to ensure that vaccines can be distributed more predictably in the places of greatest 
need,  and  with  the  logistics  in  place  to  minimise  the  risk  of  wastage.  The  availability  of 
equipment  such  as  vials  and  syringes,  as  well  as  clear  and  effective  logistical  planning,  is 
indispensable  to  effective  delivery  by  donating  countries  and  absorption  of  supplies  by 
recipient  countries.  Also  key  is  support  to  health  services  such  as  personal  protective 
equipment, tests, treatments, and key supplies such as oxygen. The EU will work with partner 
countries and COVAX to ensure that this is in place.  

Team Europe programmes are also under way to help set up vaccine manufacturing capacity 
and  develop  conducive  regulatory  frameworks  in  partner  countries  such  as  South  Africa, 
Senegal  and  Rwanda,  which  can  act  as  regional  vaccine  hubs.  HERA  will  also  provide  an 
important new dimension to the EU’s work.  

By November 2021, 44 third countries had directly requested vaccines and ancillary material 
from the EU via the Union Civil Protection Mechanism. This led to support and co-financing 
for the delivery of almost 24 million doses to 37 countries, meeting 22 requests in full. More 
recently, the donations of vaccines has been accompanied with the syringes needed for their 
administration. The Commission will continue to support operationally and financially further 
needs in the future. 

The EU is also actively pursuing agreements in the World Trade Organisation to ensure the 
continuing  availability  of  necessary  materials  through  open  supply  chains  and  trade,  and 
existing flexibilities in the intellectual property system. 

13   For example, the EU is currently supporting the vaccination rollout in seven Southern African countries with 

up to €13 million in support to national health systems and vaccination campaigns.. 

11 

 
                                                           
Cooperation with the US will be a driving force for global solidarity and health security. The 
EU  -  US  Agenda  for  Beating  the  Global  Pandemic  in  September  included  the  goal  of 
vaccinating 70% of the world population by mid-2022 and the establishment of a joint EU-US 
Covid-19 Manufacturing and Supply Chain Taskforce.14 The EU–US partnership is supporting 
the efforts at the World Health Organisation towards an improved global health architecture 
and  instruments  to  improve  preparedness  for  and  response  to  future  pandemics  and  to 
strengthen the International Health Regulations (IHR).  

Enhancing global pandemic preparedness and response, and strengthening the international 
framework for global health is now more urgent than ever. The G20 Declaration adopted at 
the  Global  Health  Summit  in  Rome  provides  a  compass  for  developing  multilateral 
cooperation, with principles emphasising the political commitment to act, using a One Health 
approach and underlining the need for sustainable financing. The EU should continue to take a 
leading  role  in  turning  these  principles  into  action,  identifying  shortcomings  and  finding 
solutions, working in particular through the G7 and G20. It will work through the G20 Joint 
Finance-Health Task Force to develop coordination arrangements between Finance and Health 
Ministries,  thus  promoting  collective  action  and  effective  stewardship  of  resources  for 
pandemic preparedness and response. In doing so, it will follow up on the recommendations of 
independent panels to establish a global health and finance body and a financial intermediary 
fund.  
At the 74th World Health Assembly, held in May 2021,1 the EU advocated for the start of a 
WHO  process  towards  a  new  Framework  Convention  on  Pandemic  Preparedness  and 
Response.15 A few months later, at the Special Session of the World Health Assembly of 29 
November-1 December 2021, WHO members agreed by consensus to start negotiations in 2022 
on  an  international  agreement  or  other  international  instrument  on  pandemic  prevention, 
preparedness and response. This is of primary importance in emerging from the present crisis 
with a stronger global health architecture able to prevent, manage, and significantly reduce the 
impact of the next pandemic. The EU’s participation in the negotiating process is essential. A 
key  element  in  the  work  of  this  global  intergovernmental  process  must  be  to  strengthen 
transparency. 

V 

CONCLUSION 

The EU again faces a serious threat from COVID-19, with the combination of a rise in cases 
and the Omicron variant. This is again a global threat which needs global action. In tackling 
this threat, the lesson of the last two years is clear: that whatever the policy area, a coordinated 
approach by the EU and its Member States has worked better than an uncoordinated approach; 
and that delayed action comes with higher risk. A collective approach to vaccine production, 
development  and  procurement  delivered  safe  and  effective  vaccines  at  the  earliest  possible 
opportunity and at the scale needed. It now means that there is no obstacle to a swift rollout of 
boosters,  and  is  also  now  being  applied  to  ensure  timely  and  equal  access  to  therapeutics. 
Adoption  of  the  complete  Health  Union  package  and  the  full  rollout  of  HERA  will  further 
consolidate  this  approach,  reinforcing  preparedness  and  structural  resilience.  A  coordinated 
approach to the EU Digital COVID Certificate has delivered a key tool that helped Europe to 
re-open and is in constant use throughout the EU. Team Europe continues to take a lead in the 
global fight against the pandemic, as well as efforts to improve global security for the future. 

14   Statement of 22 September 2021. 
15  

The Council adopted the position to be taken on the Union’s behalf in the World Health Assembly on 20 
May 2021 (OJ L 238, 6.7.2021, p. 79). 

12 

 
 
                                                           
 
 
All these are steps which have made the EU increasingly capable to deal with the pandemic 
and to help build recovery, with EU action helping national health systems to cope with the 
huge pressures they face.  

We now need to should fast to these principles as the EU tackles the twin challenge of rapidly 
rising cases and the risk of the Omicron variant. The EU and Member States need to show our 
readiness to react quickly need to put in place action to address the upsurge in the virus and to 
maintain the drive for a strong and sustainable long-term response to this threat. This calls for 
a determined and urgent response: 

  The EU  and Member States should  commit to implementing a  joined-up  strategy to 
limit the spread of the Omicron variant, with a day-by-day review of essential travel 
restrictions and a readiness to impose all necessary controls; 

  Member States should make a renewed campaign to target unvaccinated people in all 
eligible age groups, with targeted national strategies to address vaccine hesitancy; 

  Member  States  should  rapidly  deploy  booster  doses  to  maintain  a  strong  level  of 
protection against the virus and the Omicron variant, starting with the more vulnerable; 

  EU agencies should ensure that the necessary scientific guidance is rapidly available; 

  The Commission will step up efforts to produce, authorise and jointly procure COVID-

19 therapeutics; 

  The European Parliament and the Council should adopt the full European Health Union 

package and the Council the HERA crisis regulation as a matter of urgency; 

  Member  States  should  put  in  place  targeted  and  proportionate  precautions  and 
restrictions to limit the spread of the virus, saving lives and reducing the pressure on 
healthcare systems. Full EU coordination should be assured. The onset of the Omicron 
variant means that particular attention should be paid to applying and communicating 
specific measures on contacts during the end-of-year period; 

  Member States should agree on and implement the revised approach for free movement 
with a standard 9-month validity period for vaccination under the EU Digital COVID 
certificate; 

  The EU and Member States should accelerate Team Europe efforts on vaccine sharing 
to achieve the global vaccination target of 70% in 2022 agreed at the G20 summit in 
October 2021. Work to support capacity building for sequencing, testing, treatment and 
vaccination logistics must also be stepped up; 

  The EU must be a driving force towards a renewed global health architecture which 
mobilises the resources needed to deliver stronger, more equitable and more transparent 
cooperation and solidarity. 

13