Proposal for a Council recommendation on seasonal influenza vaccination
Date: 2009-07-08
Institutions: European Commission
Subjects: epidemiology, health risk, infectious disease, vaccination, vaccine

EN 

EN 

   EN 

 
 
COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.7.2009 
COM(2009) 353 final 

Proposal for a 

COUNCIL RECOMMENDATION 

On seasonal influenza vaccination 

EN 

   EN 

 
 
 
  
EXPLANATORY MEMORANDUM 

INTRODUCTION 

Influenza  is  a  highly  contagious  respiratory  infection  of  viral  origin,  which  occurs 
epidemically  most  frequently  during  winter  months.  Influenza  disease  usually  presents  as 
rapid onset of a typical pattern of combined symptoms, in particular very prominent headache. 
Mild and asymptomatic cases also occur while recovery from the typical infection normally 
takes  a  week.  However,  many  other  respiratory  infections  of  viral  or  bacterial  origin  will 
cause similar but rarely all combined symptoms. 

Extensive  disease  often  presents  with  severe  or  even  fatal  pneumonia.  While  these 
complications can occur in anyone they are far more common among the elderly or in people 
with chronic underlying medical conditions inducing higher rates of morbidity and mortality. 
These persons are considered as ‘risk groups’ (ECDC 20081).  

This paper is based on two interlinked objectives:  

(1) 

(2) 

to combat the burden of seasonal flu, and  

to adjust the production capacity of flu vaccines in the EU in order that, in the event 
of a pandemic, the vaccine manufacturers can provide the amount of vaccines needed 
to cope with such a situation.  

OVERALL DISEASE BURDEN  

The  burden  from  influenza  is  manifold.  Firstly,  there  is  severe  disease  that  may  be  fatal. 
Secondly, there are large numbers of mild to moderate cases, which result in a multiplication 
of days called off sick and loss of productivity in the working population. Both effects are of 
great economic impact. The burden varies from year to year, which makes it hard to estimate 
the  annual  number  of  deaths.  One  estimate  looking  at  excess  deaths  attributed  to  influenza 
found that, in milder influenza seasons, there were around 8 deaths per 100,000 population, 
while in more severe but non-pandemic years, the figure would be 44 per 100,000. Another 
independent estimate established similar data with average estimated excess deaths of 25 per 
100,000 between 1989 and 1998. Extrapolating this data to an EU population of around 500 
million in 2008 would result in between 40,000 deaths in a moderate year and 220,000 in a 
particularly severe influenza season, which however has not been seen recently.  

These crude figures are not taking into account the variable levels of influenza vaccine use in 
vulnerable groups, or the rising proportion of the very old and vulnerable people in European 
countries.  While  much  attention  is  paid  to  the  potential  impact  of  a  pandemic  many  more 
people  will  regrettably  die  in  the  intervening  years  between  two  pandemics  because  of 
seasonal  influenza  epidemics  than  during  a  pandemic  itself.  Of  additional  and  growing 
importance  are  large  epidemics  causing  overflow  of  emergency  medical  services  and  high 
intake  of  hospital  admissions,  which  together  with  flu-induced  staff  shortages  in  hospitals 
create extensive dysfunctions in the health care sector. 

Estimates of disease associated costs 

The  costs  caused  by  an  illness  are  mostly  calculated  by  computing  the  sum  of  all  direct, 
indirect  and  intangible  costs.  Direct  costs  result  from  the  use  of  medical  and  non  medical 

1 

http://ecdc.europa.eu/en/files/pdf/Publications/priority_risk_groups_forinfluenza_vaccination.pdf 

EN 

2 

   EN 

 
                                                 
resources.  Indirect  costs  are  due  to  productivity  loss  and  absenteeism  from  work;  and 
intangible costs relate to impaired performance and quality of life. 

Direct costs are influenced by chronic underlying conditions and other risk factors (e.g. age), 
which  may  lead  to  increases  in  hospital  admissions  and  prolonged  treatments.  Influenza 
constitutes  a  substantial  socioeconomic  burden  for  society  in  terms  of  medical  treatments 
(increase  in  consultations,  hospitalisations,  clinical  complications,  drug  use)  and  work 
absenteeism.  There  are  different  estimates  on  the  total  economic  impact  of  an  influenza 
epidemic. For example, the total impact of an influenza epidemic (total estimated direct and 
indirect costs) in industrialised countries may reach 56.7 million € per million people. 

Several studies have estimated costs using a variety of methods. A WHO paper reported that 
for  Germany,  the  estimated  total  costs  of  the  1996-1997  influenza  epidemic  amounted  to 
approximately  987.8  million  €;  a  French  study  estim ated  the  total  cost  of  influenza  at  more 
than  1,796  million  €.  In  the  United  States,  the  y early  total  costs  have  been  calculated  at 
approximately  10,000–17,000  million  €.  Extrapola ting  these  costs  to  a  standard  EU 
population of around 495 million would give a level of costs shown in Table 1 with variations 
explained above. 

Table 1: Estimated annual costs of influenza epidemics (million €) 

Country 

Population 
(million) 

Annual costs 
(million €) 

Extrapolated to EU 
population (495 million) 

France 

Germany 

63.4 (2007) 

82.3 (2007) 

1,796

988

United States 

303.8 (2008) 

10,000 – 17, 000

14,022 

5,942 

27,699 

Nevertheless, the precise cost/benefit relationship of a targeted vaccination of risk groups is 
difficult to evaluate. 

An  overall,  comprehensive  study  has  been  established  by  the  ECDC  listing  the  different 
elements of the burden of disease of seasonal influenza in Europe and promoting the basis of 
cost/benefit evaluations in different risk groups classified according to their conditions.  

VACCINE EFFICACY AND EFFECTIVENESS 

Estimates of vaccine efficacy and effectiveness vary depending on the match between vaccine 
and  the  circulating  viral  strain,  the  age  group  and  the  clinical  category.  Generally,  seasonal 
influenza  vaccines  tend  to  work  less  well  in  the  elderly  and  those  with  underlying  chronic 
disease.  In  trials,  influenza  vaccines  have  consistently  been  shown  to  prevent  laboratory-
confirmed illness in 70% to 90% of healthy adults. Despite the on average benign course of 
the disease, reduction in hospital admissions and deaths is still highly significant: 21 to 27% 
reduction in risk of hospitalisations attributable to influenza vaccination in the elderly and 12 
to 48% reduction in risk of death attributable to influenza vaccination. 

While for example cost benefit effectiveness for groups above 65 of age is well established in 
nearly  all  locations,  this  may  vary  from  demographic  and  economic  setting  to  setting.  For 
example, cost benefit effectiveness is well established also for groups from 60-64 years of age 
in the Netherlands but might be less so in other countries.  

EN 

3 

   EN 

 
 
RATIONALE FOR THIS PROPOSAL 

Health benefits for seasonal influenza and the link to pandemic influenza preparedness  

Every  year,  seasonal  influenza  causes  considerable  morbidity  and  mortality.  Currently 
available  antivirals  are  of  limited  use  if  any  in  the  prevention  or  treatment  of  influenza,  as 
they  need  to  be  administered  in  a  very  timely  fashion  after  the  onset  of  the  first  clinical 
symptoms. Furthermore, there are significant concerns about the development of resistance in 
influenza  viruses  that  tend  to  limit  their  use  with  the  view  to  preserving  their  value  in  the 
event  of  a  pandemic.  The  best  way  therefore  to  mitigate  seasonal  influenza  is  vaccination. 
Since the genome l of the influenza virus is prone to frequent mutations and re-assortments, 
WHO  expert  panels  recommend  for  each  season  the  three  most  appropriate  antigens  for 
inclusion  in  the  formulations  for  industrial  vaccine  production.  Although  the  immune 
response elicited by a single shot could last and protect longer, the antigenic variations impose 
that vaccinations need to be renewed every year. 

Despite the well recognized merits of seasonal flu vaccination, actual vaccination coverage is 
low:  twenty  countries  measured  influenza  vaccine  uptake  among  those  aged  above  65 
years,findings range from 1.8%-82.1%. Only seven countries assessed the coverage in persons 
with  underlying  medical  conditions  and  found  a  range  between  27.6%  and  75.2%.  Studies 
point  at  several  reasons  for  this  low  coverage.  The  disease  or  condition  associated  with  the 
risk  (e.g.  heavy  smoking,  asthma)  is  not  always  perceived  as  severe  enough  to  justify 
vaccination, or vaccines are not considered as effective enough (mainly due to the confusion 
between influenza and other "influenza  like"  illnesses that might affect a person even when 
vaccinated).  

Persons at risk could possibly be brought to accept a vaccination if their physicians or nurses 
tried  to  convince  them  harder.  Lack  of  training  on  the  disease  and  vaccines  in  the  general 
public has also been pointed out. Evidently, stronger commitment of public health authorities 
and better organisation of vaccination campaigns and reimbursement of costs incurred would 
entail  higher  coverage  rates.  On  the  other  hand,  measurements  of  precise  coverage  rates  of 
specific risks groups  has  its problem since the correct size of risk groups in Member  States 
might be difficult to establish. This is the reason why in turn increasing coverage rates of risk 
groups  has  proven  to  be  elusive.  However,  efforts  by  the  ECDC  on  developing  a  robust 
monitoring  tool  are  ongoing  and  have  provided  initial  consensus  on  the  identity  of  these 
groups (Eurosurveillance, October 20082). 

The need for action from Member States has already been emphasized in several documents 
adopted by the World Health Assembly, the Commission and the European Parliament. 
In  2003,  the  World  Health  Assembly  recommended  in  its  resolution  56.193  to  increase 
seasonal influenza vaccination coverage of all people at high risk with the goal of attaining a 
vaccination coverage of the elderly population of at least 50% by 2006 and 75% by 2010. As 
this  deadline  is  more  and  more  elusive,  we  propose,  following  consultation  with  the  WHO, 
2015 or the best possible target by default4 

2 
3 

4 

http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19018 
World Health Assembly. Prevention and control of influenza pandemics and annual epidemics. Fifty-
sixth World Health Assembly; Resolution WHA56.19. 28 May 2003 
The WHO recommendation was adopted in 2003 and seven years were given to countries worldwide to 
reach the 75% coverage objective. This objective has not been reached in the EU so far and the increase 
of coverage remains modest. Based on this recommendation a similar time-frame has to be envisioned 
to  meet  a  similar  target,  however  taking  into  account  the  specificity  of  the  EU  in  terms  of  both 
demography and economic development.  

EN 

4 

   EN 

 
                                                 
While  the  seasonal  influenza  virus  is  different  from  the  pandemic  influenza  virus,  the 
initiatives for both cases are closely linked. In the case of an influenza pandemic one of the 
main tools to fight the pandemic will be – in addition to the use of antivirals, masks and the 
implementation of social distancing measures – vaccination of the population with the strain 
responsible  for  the  pandemic.  Pandemic  vaccines  will  be  produced  using  the  same 
manufacturing  facilities  as  for  seasonal  flu  vaccines.  Regarding  pandemic  preparedness,  we 
can note the following initiatives at the EU level: 

On 22 April 2005 the Commission published a paper called ‘Towards sufficiency of pandemic 
influenza  vaccines  in  the  EU’5.  This  paper  sets  out  recommendations  for  a  strategy  for 
creating  conditions  of  sufficiency  in  such  vaccines  and  outlines  a  public-private  partnership 
(PPP)  between  public  bodies  and  the  vaccine  industry.  One  of  the  proposed  public  sector 
contributions  is  a  firm  commitment  ('pull')  by  all  EU  Member  States  to  increase  inter-
pandemic  influenza  vaccine  uptake  in  line  with  the  World  Health  Assembly  (WHA) 
Resolution 56.19. On the other hand, the significance of linking increase of seasonal vaccine 
coverage, i.e. use of inter-pandemic vaccines to current vaccine production capacity that is not 
deemed sufficient to meet the demands of the Community in the event of a pandemic ('push') 
has  already  been  reiterated  by  the  Commission  in  the  reviewed  version  of  the  Community 
Pandemic Influenza Preparedness and Response Plan adopted on 28 November 20056.  

On 26 October 2005 the European Parliament adopted a resolution on the strategy against an 
influenza pandemic7 stating that: 

•  the  potential  threat  of  the  avian  influenza  virus  recombining  with  seasonal 
influenza would be reduced by ensuring that all those at high risk of exposure to 
the avian influenza virus are immunized against seasonal influenza; 

•  there  is  a  substantial  risk  of  inadequate,  inequitable  and  delayed  supply  of 

vaccines in countries, which do not produce them; 

•  Member States are responsible for taking the necessary measures to prevent and 
prepare for an influenza pandemic but the Commission plays a coordinating role; 

Furthermore, the European Parliament 

•  urges  Member  States  to  take  all  necessary  steps  to  prevent  recombination  of 
H5N1 into a virus that can be transmitted from person to person, and, therefore, 
insists  that  workers  in  and  connected  to  the  poultry  sector  be  vaccinated  as  a 
matter of priority; 

•  urges Member States to increase vaccination coverage during the inter-pandemic 
period  in  accordance  with  WHO  recommendations,  which  will  also  encourage 
industry to expand production capacity to meet the expected pandemic demand for 
vaccines; 

•  calls  on  Member  States  to  target  poultry  farmers  as  a  high  priority  group  for 
vaccination in order to reduce the chances of recombination of human and avian 

5 
6 

7 

http://ec.europa.eu/health/ph_threats/com/Influenza/influenza_key03_en.pdf 
Communication  from  the  Commission  to  the  Council,  the  European  Parliament,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  on  Pandemic  Influenza 
Preparedness  and  Response  Planning  in  the  European  Community,  COM(2005)  607  final:  http://eur-
lex.europa.eu/LexUriServ/site/en/com/2005/com2005_0607en01.pdf,  
European  Parliament.  Strategy  against  an  influenza  pandemic.  European  Parliament  resolution 
P6_TA(2005)0406. 26 October 2005 

EN 

5 

   EN 

 
                                                 
influenza  viruses  at  one  of  the  most  important  potential  interfaces.  While  this 
point is reaching less and less scientific  consensus  (many  species can  serve  as a 
mixing vessel, not only humans) it should be kept under scrutiny in respect of the 
principle of precaution.  

In  addition,  on  14  June  2006,  the  European  Parliament  adopted  another  Resolution  on 
pandemic  influenza  preparedness  and  response  planning  in  the  European  Community8, 
recalling that: 

•  particular  attention  should  be  paid  to  developing  further  the  capacity  to  produce 

pandemic vaccines; 

•  the Commission should take steps to ensure that sufficient antivirals and vaccines 

are available; 

•  Member States should increase orders of seasonal influenza vaccines in line with 
WHO  recommendations  to  assist  the  pharmaceutical  industry  in  increasing  the 
production  capacity  of  influenza  vaccines,  in  order  to  cope  with  the  substantial 
increase in demand in the event of a pandemic. 

In  the  event  of  a  pandemic  the  EU27  would  need  at  least  495  million  doses  of  pandemic 
vaccine (monovalent). The annual seasonal flu vaccine production in the EU is estimated to 
be  223  million  doses,  of  which  about  105  million  doses  are  marketed  in  the  EU.  Seasonal 
vaccines are, however, trivalent (i.e. contain three different seasonal vaccine strains). In terms 
of vaccine production capacity this means that each seasonal vaccine dose requires as much 
capacity  as  three  pandemic  vaccine  doses  and  that  the  amount  of  vaccine  necessary  to 
vaccinate one person for seasonal flu is the same as that which is needed to vaccinate three 
persons  for  pandemic  flu.  Accordingly,  in  order  to  cover  the  whole  EU  population,  we  will 
need  to  increase  the  production  of  trivalent  seasonal  flu  vaccine  for  the  EU  to  165  million 
doses, to reach the capacity of 495 million monovalent pandemic vaccine doses. This increase 
from 105 million to 165 million doses represents a 57% increase (i.e. 60 million doses) in the 
use of trivalent seasonal flu vaccines. Such an increase would enable the industry to have the 
capacity  to  produce  enough  pandemic  vaccines  for  the  entire  EU  population.  The  target  of 
increased seasonal vaccination coverage for high risk groups, as mentioned above, will help 
the EU attain this objective regarding pandemic vaccines. 

In  addition,  the  logistics  of  vaccinating  rapidly  the  entire  EU  population  are  not  to  be 
underestimated:  the  higher  the  coverage  rate,  the  higher  the  vaccine  dispensing  capacity  in 
case of emergency needs to be. Member States have already taken measures to increase the 
dispensing  capacity,  for  example  by  allowing  nurses  to  give  flu  shots.  Nevertheless,  this 
capacity increase cannot be planned but has to be tested incrementally. Indeed, doubling the 
current level of coverage of flu vaccines in the general population would mean reaching about 
30 % overall coverage. This means that in most cases the vaccination workload would double 
in the time window foreseen between the release of the season's vaccine and the start of the 
caseloads.  At  the  level  of  an  individual  General  Practitioner,  this  would  mean  that  flu 
vaccination could take up the entire week. Logistical problems of bringing vaccines to point 
of care delivery are already encountered year after year.  

8 

European  Parliament.  Pandemic  influenza  preparedness  and  response  planning  in  the  European 
Community. European Parliament resolution P6_TA(2006)0259. 14 June 2006 

EN 

6 

   EN 

 
                                                 
It is estimated that the present insufficient capacity to produce and dispense vaccines will lead 
to  difficult  choices  in  terms  of  vaccination  targets  and  will  create  discrepancies  among  the 
Member States. 

NEED FOR BEHAVIOURAL AND ORGANISATIONAL CHANGES AND RESEARCH NEEDS 

Some  Member  States  have  already  high  vaccination  coverage  and  a  good  organisation  to 
achieve high coverage levels (communication, reimbursement, administration of the vaccine). 
But for some other Member States the target is still very far to reach and they step up efforts 
to  address  health  professionals  and  at  risk  groups  in  order  to  ensure  better  vaccination 
coverage. 

Member states as well as successive Commission Framework Programmes (FP) for Research 
have  made  significant  investments  into  influenza  research  and  have  funded  a  number  of 
vaccine development projects. While the majority of these projects were focused on pandemic 
vaccines,  they  also  include  novel  concepts  like  intranasal  delivery,  cell-based  vaccine 
production  methods  and  the  testing  of  new  adjuvants,  which  are  relevant  for  seasonal 
vaccines. However, more social and behavioural sciences research, epidemiological studies of 
vaccine  effectiveness  and  efficacy  as  well  as  continued  research  into  the  above  mentioned 
biological  and  technological  innovations  is  necessary  in  order  to  reach  the  goal  of  a  better 
protection  of  the  population.  Funding  for  these  needs  should  come  from  vaccine 
manufacturers as well as from public sources. 

WORKING TOGETHER IN EUROPE 

The health of EU citizens depends on having an agreed approach to the mitigation of seasonal 
influenza,  a  disease  responsible  in  recent  times  for  several  severe  pandemics.  The  1918 
"Spanish" Flu pandemic, for instance was responsible for more deaths than the WW I military 
operations.  Given  the  large  scale  of  movements  of  people  in  the  EU  a  pandemic  influenza 
virus  can  spread  very  rapidly  through  the  population  and  take  advantage  of  weaknesses  in 
vaccination  preparedness.  The  great  discrepancies  among  Member  States  in  vaccination 
coverage against seasonal influenza indicates that there is an important potential for reducing 
the burden of the disease in Europe in at risk groups that would be most beneficial to those 
Member  States  with  lower  vaccination  coverage.  In  addition,  the  well  being  of  the  EU  as  a 
whole would benefit by ensuring that spread of disease is reduced, with significant savings in 
health terms but also in terms of economic loss avoided. 

In case of a pandemic access to sufficient doses of pandemic vaccine will be difficult. This 
will lead to difficult choices to determine the target population to be vaccinated. 

DEFINITION OF RISK GROUPS 

The  European  Centre  for  Disease  Prevention  and  Control  (ECDC)  has  provided  a  scientific 
opinion on the at risk groups, which most benefit from vaccination. The analysis of literature 
indicates that there are two at risk groups where routine annual immunisation with seasonal 
influenza vaccine is justifiable on scientific and public health grounds in Europe: 

(1) 

(2) 

older age groups, usually 65 years and older; and 

people  with  chronic  medical  conditions,  particularly  diseases  of  the  following 
categories: 

–  chronic respiratory diseases; 

EN 

7 

   EN 

 
–  chronic cardiovascular diseases; 

–  chronic metabolic disorders; 

–  chronic renal and hepatic diseases; 

–  persons with deficient immunity (congenital or acquired); 

–  young people taking long-term salicylate therapy; and 

–  persons with conditions, which compromise respiratory function. 

Calculations made by ECDC suggest that on average about 25% of the EU population belongs 
to the two major risk groups. 

Furthermore,  the  ECDC  should  be  able  to  assist  the  Member  States  in  developing  standard 
operating  procedures  and  surveillance  methodologies  to  allow  for  better  comparability  of 
seasonal 
the 
in  monitoring 
implementation of recommendation proposals and action undertaken by Member States. 

influenza  vaccination  uptake.  The  ECDC  could  help 

AIM OF THIS PROPOSAL 

In order to help Member States to reach a vaccination coverage of 75% of the "at risk groups" 
(elderly over 65 and people with specific health conditions/disease), the Commission hereby 
proposes  to  Council  to  adopt  a  Recommendation  on  seasonal  influenza  vaccination.  This 
Recommendation  proposes  a  set  of  specific  measures  to  be  implemented  by  the  Member 
States to reach the target as early as possible, however, no later than by winter 2014/2015. 

•  Ensuring that a national action plan exists aimed at improving vaccination coverage in at 

risk groups. It should incorporate all the aspects of the policy. 

•  Description  of  the  actions  to  be  implemented  to  reach  the  75%  target  by  the  winter  of 

2014/2015, which should cover the following: 

•  Ways  to  improve  vaccination  coverage  in  at  risk  groups  (e.g.:  vaccination 

campaigns, reimbursement, etc.);9 

•  Methodology used to measure coverage; 

•  Training and information of health care professionals; 

•  Communication targeting at the risk groups. 

•  Forecast of coverage to be reached from 2011 till 2012. 

•  Reporting  to  the  Commission  on  the  implementation  of  their  national  action  plans  every 
year  before  the  31st  May  after  the  adoption  of  this  Recommendation.  The  report  will 
include accurate data on the percentage of vaccination coverage achieved in at risk groups 
by means of uptake surveys and other methods developed by ECDC. 

The  lack  of  easily  up-scalable  manufacturing  technology  (such  as  cell-based  production)  is 
also  a  cause  for  insufficient  (surge)  capacity  in  manufacturing.  Research  on  more  efficient 
adjuvants  would  help  immunize  more  people  with  less  amount  of  antigen.  Vaccine 
manufacturers should invest more on research in order to reach the target production capacity. 

9 

For the purpose of this Recommendation this set of risk groups will be used to benchmark the coverage 
of  75%.  However,  obviously  nothing  prevents  the  Member  States  from  extending  the  benefit  of 
vaccination to further groups. 

EN 

8 

   EN 

 
                                                 
Proposal for a 

COUNCIL RECOMMENDATION 

On seasonal influenza vaccination 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular  its 
Article 152(4), 
Having regard to the proposal from the Commission10, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

10 
11 

12 

13 

Seasonal  influenza  is  a  highly  contagious  viral  disease,  which  typically  occurs  as  an 
epidemic  during  the  cold  months.  It  is  one  of  the  most  significant  and  commonly 
occurring communicable diseases and is a frequent source of morbidity and mortality 
in all Member States of the European Union. 

In some cases, complications go beyond a benign respiratory infection and encompass 
severe pneumonia with often fatal or debilitating outcome. These complications occur 
far more commonly among the older aged groups and in people with chronic medical 
conditions. 

Seasonal  influenza  can  be  mitigated  through  vaccination  but  the  virus  changes 
frequently  its  antigenic  composition  and,  therefore,  vaccine  composition  need  to  be 
regularly updated.  

The  World  Health  Organisation  (WHO)  recommended,  in  2003,  in  its  resolution 
56.1911 to increase influenza vaccination coverage of all people at high risk with the 
goal of attaining vaccination coverage of at least 50% of the older aged groups of the 
population by 2006 and 75% by 2010. 
In  October  200512  and  June  200613  the  European  Parliament  adopted  Resolutions 
calling on the Member States to increase influenza vaccination in line with the WHO 
recommendations.  These  Resolutions  also  urged  Member  States 
increase 
vaccination  coverage  during  the  inter-pandemic  period  in  accordance  with  WHO 
recommendations,  pointing  out  that  it  would  also  provide  an  incentive  to  the 
pharmaceutical  industry  to  expand  the  production  capacity  in  order  to  meet  the 
expected  demand  for  vaccines  in  case  of  a  pandemic  influenza  as  well  as  allow  to 
increment the dispensing capacity of the health systems. 

to 

J.O. 
World Health Assembly. Prevention and control of influenza pandemics and annual epidemics. Fifty-
sixth World Health Assembly; Resolution WHA56.19. 28 May 2003 
European  Parliament.  Strategy  against  an  influenza  pandemic.  European  Parliament  resolution 
P6_TA(2005)0406. 26 October 2005 
European  Parliament.  Pandemic  influenza  preparedness  and  response  planning  in  the  European 
Community. European Parliament resolution P6_TA(2006)0259. 14 June 2006 

EN 

9 

   EN 

 
                                                 
(6) 

(7) 

(8) 

Therefore,  concerted  action  at  the  Community  level  should  be  taken  to  contain 
seasonal influenza by encouraging vaccination among at risk groups. The purpose of 
this Recommendation is to reach the target of 75% vaccination coverage of the older 
aged  groups  recommended  by  the  WHO  as  far  as  possible  by  2015  or  the  earliest 
possible  target  beyond  2010.  This  target  of  75%  should  be  extended  to  the  at  risk 
group  of  people  with  chronic  conditions,  in  line  with  the  guidance  issued  by  the 
European Centre for Disease Prevention and Control (ECDC) in August and October 
2008. 

Increased  vaccination  rates  among  at  risk  groups  would  also  contribute  to  higher 
vaccination  rates  in  general  and  therefore  to  the  expansion  of  the  strategically 
important production capacity of vaccines within the European Union. 

To bring about the changes a necessary first step is that all participants of the health 
care  environment,  at  risk  groups,  health  care  workers,  physicians,  health  care 
managers  and  policy  makers  need  to  be  informed  about  the  problem  of  seasonal 
influenza through public and professional awareness campaigns. 

(9)  Measures  taken  by  the  Member  States  in  this  area  and  the  way  they  have  taken  into 
account this Recommendation should be the subject of annual reports at the national 
level.  It  is  notably  essential  to  gather  specific  and  comparable  data  as  to  the  uptake 
rates in at risk groups in order to properly assess the situation in all the Member States. 
Such  data  was  not  always  available  before  the  adoption  of  this  Recommendation. 
Based  on  this  data  the  Commission  and  the  Member  States  will  be  able  to  share 
information  and  best  practices  with  third  countries  through  the  existing  channels  of 
international cooperation in the field of health. 

(10)  Regulation  N°  (EC)  851/2004  of  the  European  Parliament  and  the  Council14  of  21 
April  2004  establishing  a  European  Centre  for  Disease  Prevention  and  Control 
(ECDC)  notably  entrusted  the  ECDC  with  the  mission  to  provide  technical  and 
scientific  expertise  to  the  Commission  and  to  the  Member  States.  The  ECDC  also 
operates the dedicated network established for the surveillance of seasonal influenza in 
accordance with Commission Decision N° 2000/96/EC15 of 22 December 1999 on the 
communicable diseases to be progressively covered by the Community network under 
Decision No 2119/98/EC of the European Parliament and of the Council. The ECDC 
should therefore assist the Member States in developing guidelines in order to improve 
the comparability of seasonal influenza vaccination uptake.  

(11) 

In accordance with the principles of subsidiarity set out in Article 5 of the Treaty, any 
new measure taken in an area which does not fall within the exclusive competence of 
the  Community,  such  as  seasonal  influenza  vaccination,  may  be  taken  up  by  the 
Community  only  if,  by  reason  of  the  scale  or  effects  of  the  proposed  action,  the 
objectives proposed can be better achieved by the Community than by Member States. 
Seasonal influenza can lead to a pandemic and cannot be confined to a geographical 
region or Member State. Coordinated action at Community level is therefore required. 

HAS ADOPTED THE FOLLOWING RECOMMENDATION: 

1. 

14 
15 

EN 

Member  States  should  adopt  and  implement  a  national  action  plan  aimed  at 
improving vaccination coverage, in order to reach, as early as possible, however, no 

OJ L 142 of 30.4.2004, p. 1–11 
OJ L 028 of 3.2.2000, p. 50 - 53 

10 

   EN 

 
                                                 
later than by the winter season 2014/2015, a vaccination coverage rate of 75% in all 
at risk groups referred to in point 2(a).  

The  action  plan  should  take  into  account  the  gaps  identified  at  national  level  and 
should allocate necessary resources to reach the target and to organise the activities 
referred to in point 2 (b) and (c). 

2. 

In  the  framework  of  the  national  action  plan  referred  to  in  point  1  Member  States 
should : 

(a).  adopt  and  implement  the  following  common  definitions  of  "at  risk  groups" 

according to the guidance issued by the ECDC in August 200816: 

(i) 

"Older Age Groups" means population of 65 years and older; 

(ii) 

"People with underlying  Medical Conditions" means people with health 
conditions of the following categories: 

- 

- 

- 

- 

- 

chronic respiratory system diseases and dysfunctions ; 

chronic cardiovascular diseases; 

chronic metabolic disorders; 

chronic renal and hepatic diseases; 

immune system dysfunctions (congenital or acquired); 

(b).  organise  annual  uptake  surveys  in  all  at  risk  groups  in  accordance  with 
guidelines to be issued by the ECDC, and to analyse the reasons why persons 
do not benefit from vaccinations; 

(c). 

foster education, training, and information exchange on seasonal influenza by 
organising: 

(i) 

information for health care workers; 

(ii) 

information for persons at risk groups and their families about risks and 
prevention.  

3. 

4. 

Member  States  should  report  to  the  Commission  on  the  implementation  of  this 
Recommendation,  notably  on  the  coverage  achieved  among  at  risk  groups,  every 
year  (before  the  31st  May)  following  the  adoption  of  this  Recommendation  with  a 
view to contributing to the follow-up of this Recommendation at Community level.  

The  Commission  is  invited  to  report  to  the  Council  on  the  implementation  of  this 
Recommendation, on the basis of the annual reports provided by the Member States, 
on an annual basis until 2015, and then every 3 years.  

Done at Brussels, 

For the Council 
The President 

16

http://ecdc.europa.eu/en/files/pdf/Publications/priority_risk_groups_forinfluenza_vaccination.pdf 

EN 

11 

   EN