EUROPE & VACCINES For effective vaccination policies in Europe - November 2019 - n 60 - The European Files
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November 2019 - n°60 EUROPE & VAC C I N E S For effective vaccination policies in Europe
PROTECTING HEALTH, SAVING LIVES
EU cooperation against vaccine-preventable diseases
V
million
2.7 MEASLES
Worldwide
vaccines million
2 NEONATAL
prevent TETANUS
every year
1 million
PERTUSSIS
VACCINATION IN THE EU INFECTIOUS DISEASES ON THE RISE
Influenza vaccination coverage rates More than 14 000 measles &
among people aged 65+ 696 rubella cases in 2017
UK 71% RO - 5 608 measles
NL 67% IT - 5 098 measles
EU 34% DE - 929 measles
Sources: ECDC; Eurostat; WHO; The Vaccine Confidence Project
BG 2% GR - 967 measles
EE 2%
EU ACTION
DISTRUST IN VACCINES
Ensure ACCESS to vaccines for all
0% Control all vaccines to ensure HIGHEST
SAFETY STANDARDS
Share CLEAR, INDEPENDENT
45.5% and TRANSPARENT information
“ I think vaccines More RESEARCH to develop new vaccines
are not safe”
European Commission: ec.europa.eu/health/vaccination/overview_en
European Centre for Disease Prevention and Control: ecdc.europa.eu
@EU_Health #EUvaccines
Health and
Food Safety
Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe | The European Files | 3
E D I T O R I A L
V
EUROPE & VACCINES
V accination is the primary instrument
for prevention in public health. Thanks
to vaccination programmes, life
expectancy in the world is one of humanity’s
greatest achievements. According to the
interest of vaccination should be more clearly
highlighted. Providing reliable information
to the general public and dispelling myths
about vaccines and vaccination through the
exchange of good practices is key to ensure
vaccination programmes. The Commission is
considering the creation of a European virtual
data warehouse on vaccine needs, which
could facilitate the voluntary exchange of
information on available supplies. This would
WHO, vaccination can prevent between 2 and effective public health. ensure that the necessary measures are in
3 million deaths per year worldwide. place in the event of a pandemic.
For several years now, the sub-optimal
Nowadays, several European and neigh- vaccination coverage observed in Europe Vaccination policies fall within the purview
bouring countries are facing the return of has led the European Commission to step of national authorities. However, the EU
some epidemics thought to be long forgotten, up its vaccination efforts by working closely must ensure fair access to vaccines for all EU
the resurgence of which is mainly due to a lack with Member States. In December 2018, citizens through free distribution in order to
of vaccination coverage. the Council adopted a recommendation to remove major financial barriers, combat dis-
strengthen EU cooperation against vaccine- information and build confidence in vaccines,
In an increasingly digitalized and intro- preventable diseases. Subsequently, it estab- facilitating a vaccination pathway from an
verted society, misinformation is on the rise, lished a roadmap to ensure better cooperation early age.
social media pose a new challenge when it between Member States. A feasibility study on
comes to maintaining confidence in immu- the development of a common EU vaccination Vaccination is first and foremost about
nization. However, the use of digital tools map was launched this year. A draft common education for all of us. In this issue of The
would facilitate and improve vaccination vaccination document, which could help EU European Files, we capture the responses of
programmes throughout Europe, using citizens to continue their vaccination in the our institutions and hope to encourage a
interoperability of systems, monitoring data, Member States, is expected to be completed public discussion faithful to the greater good.
procurement and a real-time supply status, in 2022.
preventing waste, all as a way of fighting fire Editor-in-Chief
with fire. Europe plays an important role in the pro- LAURENT ULMANN
duction of these vaccines. Several European
Our policies and scientists must have a clear countries have experienced a shortage of
and unambiguous narrative about the need vaccine production and supply which has
for vaccination and its coverage. The collective hampered the implementation of their
Management: The European Files / Les Dossiers Européens - 19 rue Lincoln, 1180 Brussels
www.europeanfiles.eu - ISSN 1636-6085 - email: ulmann@europeanfiles.eu
Publication Director and Editor-in-Chief: Laurent ULMANN
Layout & printing: VAN RUYS PRINTING
Copyright: Shutterstock, European Commission
4 | The European Files | Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe
TABLE OF CONTENTS
The benefits of digital tools for improving Sustain vaccination programmes through a healthier
immunisation programmes 6 vaccine ecosystem in an interconnected Europe 16
Krista Kiuru, Finnish Minister for Family Affairs and Social Corinne Bardone, Pharm D, Head of Global Vaccines Public
Services Affairs, for Polio, Pertussis and Hib containing Vaccines, Sanofi
Pasteur
To eliminate measles in Germany: The Measles Protection Christina Klein, Manager, Global Vaccine Public Affairs,
Act. Requirement for all children entering school or Sanofi Pasteur
kindergarten to have both measles vaccinations 7
Jens Spahn, Germany’s Federal Health Minister Florence Baron-Papillon, Pharm D, Head of Public Affairs
Europe for Vaccines, Sanofi Pasteur
Place vaccination at the forefront of the public space 8
Agnès Buzyn, French Minister for Solidarity and Health, Looking ahead to the next decade for
Extract from the article in European immunisation week immunization in Europe 19
Dr. Siddhartha Datta, Programme Manager, Vaccine-
Dedicated supra-structural vaccination organizations: preventable Diseases and Immunization programme, WHO
the driver of a successful vaccination schemes 10 Regional Office for Europe
Maggie De Block, Belgian Minister of Social Affairs and Public Ms. Catharina de Kat, Communications, Web and
Health and Asylum Policy and Migration Information Officer, Vaccine-preventable Diseases and
Immunization programme, WHO Regional Office for Europe
Promote vaccination, particularly the childhood
immunisation programme and the HPV vaccine Securing a robust vaccine sector in Europe 20
for both girls and boys 11 Magdalena Rodriguez de Azero, Executive Director,
Simon Harris, Irish Minister for Health Vaccines Europe
European Commission roadmap on vaccination 12 Harnessing the power of partnerships to
Anne Bucher, Director-General DG SANTE, European develop life-saving vaccines 22
Commission Dr. Pierre Meulien, Executive Director, Innovative Medicines
Initiative (IMI)
A cancer vaccine: how to eradicate virus-related
cancers in Europe? 13 Vaccination, Population Health, and
Véronique Trillet-Lenoir, Oncologist and MEP, Renew European Leadership 24
Europe, France, Member of the ENVI Committee David E. Bloom, Harvard T.H. Chan School of Public Health
Boston, Massachusetts USA
Clinical Evaluation of vaccines 14 Daniel Cadarette, Harvard T.H. Chan School of Public Health
Prof. Guido Rasi, Director Executif of EMA Boston, Massachusetts USA
Improving pan-european collaboration in tackling Raising awareness about the importance of
vaccine-preventable diseases 15 vaccination in Europe for public health 25
Andrea Ammon, ECDC Director Monika Beňová, MEP (S&D Group),
Member of the ENVI Committee
Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe | The European Files | 5
Europe & Vaccines
For effective vaccination
policies in Europe
Is Europe Prepared for the Future of Vaccines - The educational and preventive role 37
Vaccines Innovation? 26 Sara Cerdas, MEP (S&D Group), Member of the ENVI
Dr. Emmanuel Hanon, Senior Vice President, Head of R&D, Committee
GSK Vaccines
Dr. Rino Rappuoli, Chief Scientist, GSK Vaccines The EU research programmes in support to vaccine
Research & Innovation 38
Dr. Philippe Denoel, Head of External R&D, GSK Vaccines Irene Norstedt, Acting Director, People Directorate,
Directorate-General for Research and Innovation, European
Vaccination for patients with chronic conditions 28 Commission
Marco Greco, President of European Patients’ Forum (EPF)
Alessandra Martini, Policy officer, Directorate-General for
Research and Innovation, European Commission
Vaccine hesitancy: public health emergency 29
Rory Palmer, MEP (S&D Group), Member of the ENVI Julia Molto Lopez, Programme assistant EU policies,
Committee Directorate-General for Research and Innovation, European
Commission
Resilient immunisation systems: looking Barbara Kerstiëns, Head of Unit Combatting diseases,
beyond high vaccination rates 30 Directorate-General for Research and Innovation, European
Sibilia Quilici, Public Policy Director, MSD Commission
Raising awareness about the key role of health Vaccination in Europe – the crucial role of
professionals - The role of physicians in vaccination 32 the health care provider 40
Prof. Dr Frank Ulrich Montgomery, President of the Pierre Van Damme, MD, PhD, vice-dean faculty of Medicine
Standing Committee of European Doctors (CPME) and Health Sciences, director Centre for the Evaluation of
Vaccination, University of Antwerp, Belgium.
Vaccination in Pharmacies 33
Michał Byliniak, President of PGEU (The Pharmaceutical Maternal vaccination: A new and highly
Group of the European Union) effective policy to improve European pertussis
immunisation programmes 42
Independent control contributes to Benoit Soubeyrand Md, Blossom Vaccinology, Lyon, France
ensuring vaccine quality 34
Susanne Keitel, Director of the EDQM, Council of Europe
Healthcare distribution: facilitating optimal
access and uptake of vaccines in Europe 35
Monika Derecque-Pois, Director General of GIRP
AIM calls for European Action with
regard to Vaccination Hesitancy 36
Christian Zahn, President of AIM (International Association
of Mutual Benefit Societies)
visu
6 | The European Files | Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe
A B
The benefits of digital
tools for improving Logo s.4
immunisation programmes
Logo ja tarkenne s.5
Logon erottuminen s.6 Tun
Kuv
Eläv
Comprehensive immunisation information tools could correct the trend by
information systems are essential using different context-based strategies to
Suunnittelu: deSignal / Timo Kuoppala
Electronic vaccination registries or immu- counter the spread of misinformation and
nisation information systems (IIS) can show create partnerships with civil society and other
up-to-date vaccination coverage across all relevant stakeholders.
age groups and sub-populations, as well as in Modern website algorithms seek to
different geographic or healthcare-providing determine which information a user would
areas. Full interoperability of different elec- like to see, based on their previous internet
tronic systems and registries is essential. For activity. This might be harmful to both indi-
example, the IIS data can be analysed together viduals and society if it leads to increasing
with the disease-surveillance data to monitor hesitancy and mistrust concerning vaccines
the real-time impact of vaccines, both in or information provided by health authorities.
terms of effectiveness and safety. The IIS data On the other hand, sophisticated search algo-
Krista KIURU combined with vaccine procurement data rithms could also play an important role in
can show the supply situation in real time addressing vaccine hesitancy. Health systems
Finnish Minister for Family Affairs
and reduce vaccine wastage. The IIS can also could be developed to individually tailor
and Social Services
provide new opportunities to inform those at messages most likely to resonate with citizens.
risk that they should be vaccinated. This can The real-time analysis of internet and social-
be achieved through automated reminders via media discussions and networks could also be
email, SMS alerts and dedicated health apps. utilised in vaccine confidence monitoring and
When integrated with electronic healthcare to identify possible safety concerns.
records, the reminders can also target
healthcare professionals, so that every time a Sustainable EU-level collabo-
patient visits any healthcare facility, the visit ration to improve vaccination
can be utilised as an opportunity to administer programmes
I mmunisation programmes are one of the
most cost-effective public health inter-
ventions, saving millions of lives every year.
In addition to protecting individuals, vaccines
can also protect the whole population against
vaccine doses missed during previous visits.
All individuals should have easy access to
the data on vaccines they have received. The
IIS can generate individual electronic vacci-
nation cards that can be accessed online —
Immunisation programmes are the respon-
sibility of the Member States. However, it is
clear that we should also enhance EU-level
collaboration. Pursuant to Article 168 of the
Treaty on the Functioning of the European
epidemics as well as significantly reduce while respecting data protection and privacy Union (TFEU), a high level of human health
healthcare and societal costs. A unique benefit requirements, naturally. protection is to be ensured in the definition
of high vaccination coverage is herd immunity Some EU countries already have an opera- and implementation of all Union policies and
– population-level protection for individuals tional IIS. However, more effort is still needed activities. Union action, which complements
who cannot be vaccinated because they both at EU and Member State level to develop national policies, is to be directed towards
are too young or have pre-existing medical operational guidelines and remove infra- improving public health, preventing physical
conditions. structural, legal and standardisation barriers and mental illness and disease, and obviating
While many new effective and safe vaccines in order to facilitate interoperability and elec- sources of danger to physical and mental
have been introduced in national immuni- tronic immunisation-data-sharing. The feasi- health. The EU Joint Action on Vaccines and
sation programmes in recent years, vaccines bility of developing a common EU vaccination other initiatives provide important platforms
are still underused and vaccine hesitancy card should also be explored as a matter of for the creation of EU-level added value
is posing a threat to the high vaccination priority. for immunisation programmes. In addition
coverage needed to stop the spread of com- to initiatives and networks, we should also
municable diseases in communities and Internet and social media as tools strengthen the role of the European Centre for
internationally. to improve vaccination coverage Disease Prevention and Control (ECDC) as an
Council Recommendation (2018/C 466/01) Never before has the creation, distribution, EU agency responsible for providing scientific
on strengthened cooperation against vaccine- use and, unfortunately, manipulation of infor- advice and support to Member States on the
preventable diseases is a comprehensive and mation been this easy. Ideally, the internet development and adaption of new tools to
ambitious commitment from the Member should provide fast and easy access to reliable improve vaccination programmes.
States and the Commission to jointly ensure information on vaccination to the public.
that European citizens have the full benefit However, the experience so far has been that
of existing and new vaccines. The recommen- misinformation from anti-vaccine groups may
dation highlights eHealth and digital inno- spread even faster than science-based infor-
vations as important new tools for improving mation provided by healthcare professionals
immunisation programmes. and public-health authorities. New digital
Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe | The European Files | 7
To eliminate measles in Germany: The Measles Protection
Act. Requirement for all children entering school or
kindergarten to have both measles vaccinations
in these settings will also have to be vaccinated With all of that, the second shot is easily for-
against this dangerous infectious disease. The gotten. We can therefore assume that our new
same applies to staff working in healthcare regulation will provide a welcome reminder in
facilities. Exempted from mandatory vac- these cases. And I trust that it will result in more
cinations are persons for whom the vaccine children getting both measles vaccinations.
would not be safe on medical grounds and The case might be different for people who
persons born before 1970. In the absence of this are against mandatory immunisation for other
proof, the child can be barred from attending reasons. In such cases, reference is often made
school or day care. Parents of school children to the question of proportionality and the
will face a fine. After all, it is the same as in road right to “free choice regarding vaccination”.
traffic: if you put others at risk and get caught, My counterargument is that any person who
you have to pay a fine. sits in a paediatrician’s waiting room with their
Between August 2018 and late July 2019, baby, who is still too young to be vaccinated,
Jens SPAHN more than 13,000 measles cases were reported must be able to rely on the older children in
across Europe. In Germany, as many as 485 the waiting room not having measles. That too
Germany’s Federal Health Minister cases were registered by early September of is a precondition of freedom – and it applies
this year. In 2018, a total of 544 cases were particularly to those entrusted to our care who
reported nationally for the entire year. Measles are children. And even more so to children
commonly involve complications and lead to who cannot be vaccinated for medical reasons.
secondary conditions. One in 1,000 children Naturally, it also becomes the State’s business if
who contract measles will develop a brain unvaccinated children attend day care facilities
M easles are among the most con-
tagious infectious diseases and –
contrary to the widespread narrative
– they are not a ‘harmless children’s disease’!
In fact, globally, measles cases even doubled in
inflammation known as measles encephalitis.
Children under five, and adults over 20 years
of age, are at an increased risk of experiencing
serious complications. This clearly debunks
the argument put forward by many vaccine
and schools. This is especially the case if, as in
Germany, school attendance is mandatory.
Being unvaccinated not only poses a con-
siderable threat to the physical well-being
of the affected person themselves but also
2018. In Germany, a large number of children, deniers that measles usually takes a mild course constitutes a risk to other persons who, for
young people and adults are still not vaccinated therefore rendering vaccination unnecessary. example, because of their age or specific health
against measles. This means that they can shed However, according to current evaluations limitations cannot be vaccinated. That is why
and spread the pathogen, causing repeated done by the Berlin-based Robert Koch Institute mandatory vaccination must begin as early
outbreaks. We cannot let this go unchallenged. (RKI), despite all of the campaigns to educate as possible and must begin in those places
The best protection against measles is vac- the population, the measles vaccination gaps where people come into daily contact with one
cination. Vaccines afford immunity for life. in Germany are still too large. While it is true another.
Therefore, I most strongly believe that not that 97.1 per cent of all children starting school Vaccination is one of humanity’s greatest
only do people who fail to have themselves have had their first shot, there are large regional achievements. We have almost eradicated
or their children vaccinated put their own life differences in the numbers of those getting infectious diseases that in earlier generations
and health at risk, but, as we live in an open the second, decisive shot. This means that, at took the life of many millions of people. I
society, they do the same to others. My goal Federal level, we still fall short of the target therefore have the utmost confidence that
is to protect all children in Germany, if at all immunisation coverage of 95 per cent. Only through this piece of legislation vaccination will
possible, from measles infection – at day care this coverage rate can afford what is known as become the norm and vaccination myths will
facilities, at their day care mother’s home and ‘herd immunity’. be exposed. Mandatory vaccination for children
at school. This is why we seek to make measles According to new data from the RKI, a good should also cause parents to reflect and to ask
vaccination mandatory in all of these settings. 93 per cent of children who started primary themselves: why am I not vaccinated? In short,
We want to do this by introducing the “Measles school in 2017 have had two measles shots. mandatory vaccination is health education!
Protection Act”. With the approval of the Here, it must be said that not all of the parents In a free country, I must be able to bank on
German Bundestag, it will become effective in who failed to get the second shot for their child the fact that the person sitting opposite me
spring of next year. on schedule are out and out ‘vaccine deniers’. does not pose a danger to me. That too is a pre-
What specific regulations do we have in This can be seen from the fact that the children condition of freedom. We have an obligation
mind? Going forward, all children entering already had their first shot. Apparently, there to protect our children, so that they do not
school or kindergarten will need to provide are those parents who just lose sight of the become infected and infect others. If parents
evidence of the two measles shots recom- second shot and its importance for long-term do not do it, then the State must take action!
mended by the German Standing Committee immunity. It may be that the family is growing No child in Germany should ever again become
on Vaccinations (STIKO). This proof will also or that the demands of work, the children infected with measles or die as a consequence
have to be furnished if the child is being looked starting school and going about their hobbies of this disease.
after by a day care mother. Persons who work sometimes make it hard to organise daily life.
8 | The European Files | Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe
Place vaccination at the
forefront of the public space
Extending the immunisation obligations to Actions to inform and promote vaccination
infants or simplifying the vaccination process have been stepped up.
for seasonal influenza vaccination are all
measures that redefine and revitalise the vac- With the launch of the vaccination info
cination policy in France. service website for the general public and
access of this vaccination info service website
The European Immunisation Week was first to professionals;
launched back in 2005 at the behest of the
World Health Organisation. Also with, – and this is the key –, the com-
mitment of all professionals. I should like
Many events, coordinated by Regional to thank in particular the associations of
Health Agencies, such as the “vaccination info health-care professionals that support the
villages”, take place in the regions during that government vaccination policy. Their signing
Agnès BUZYN Week every year. the charter last fall reflects their commitment
French Minister for Solidarity and Health, to promoting the vaccination of these
Extract from the article in European These actions bring together a wide panel professionals.
immunisation week of field operators: health and education pro-
fessionals, the civil society, health insurance We are right to wager on a proactive policy:
funds, supplementary mutual insurances, our actions are starting to bear fruit.
scientific societies and professional asso-
A
ciations, whom I sincerely thank for their work As I had announced and as prescribed by
s you know, vaccination is a topic dear throughout the year towards improving the law, I will present a review of the reform of the
to me. I am committed to it because
health of our fellow citizens. immunisation obligations at the end of 2019.
vaccination is the great exponent of
Indeed, in order to take stock, we need to give
our history and a symbol of the progress in I would like to start with a brief overview of children born after January 1 time to grow up
medicine and the fight against obscurantism. the actions and steps taken since 2018. a little and benefit from the vaccines.
Pasteur has blazed the trail that we are
all walking on. Everyone can see that the I have proposed reforms that affect the daily The results are already noticeable, and the
fight against vaccination is never safe from lives of our fellow citizens in a spirit of col- first immunisation coverage data for children
opposing, still very dangerous, forces. lective and solidarity-based protection. born between January and May 2018, at the
age of 7 months, is proceeding as expected.
As soon as I took office, I made vaccination I am referring, of course, to the extension
one of my top priorities. The choices and of the immunisation obligations to infants, For hexavalent vaccination, which, may I
decisions I made were dictated by the context which was implemented as early as 1 January remind you, includes vaccinations against DTP,
of vaccine hesitation and the resurgence of 2018, alongside a whole series of support tools whooping cough and Heamophilus influenzae
the epidemics we are facing. for the health professionals, parents and com- type B infections and hepatitis B, we have gone
munities, including assistance in monitoring from 93.1% (compared with the same period
It was also vital to place vaccination at the these obligations before children enter the in 2017) to 98.6%.
forefront of the public space and to have a community;
clear, strong and responsible public narrative. Vaccination coverage against meningo-
I am also thinking of simplifying the vacci- coccal C infections with one dose is now
It is therefore with the greatest pleasure nation process for people eligible for seasonal estimated at 75.7%, compared with only 39.3%
that I am here with you today for a new flu vaccination since, from now on, anyone over the same period in 2017. We have clearly
phase, the launch of European Immunisation going for their first vaccination will have the made significant progress here, too.
Week 2019. choice to go to a nurse’s or pharmacist’s, in
addition to a doctor’s or midwife’s practice; Vaccination coverage for the MMR vaccine
2018 and 2019 are two pivotal years in for children born in 2018 is not yet available
which many milestones have been set for By the upcoming 2019-2020 season, because this vaccination begins at the child’s
vaccination. Influenza vaccination by pharmacists will first birthday. But the vaccination rate also
have been generalized. As everyone knows, progressed in 2018, from 85 to 87.2% for the
Including vaccination as one of the priority increasing vaccination opportunities by sim- first dose, which was hoped for in the face of
issues of the Priority Prevention Plan pre- plifying the process it is the best way to trigger the tragedies caused by the epidemic we expe-
sented in March 2018 by Edouard Philippe is this collective effort on the part of our fellow rienced then and are still seeing with the 2019
a decisive support to this proactive policy. citizens. outbreaks.
Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe | The European Files | 9
The movement brought about by the reform With this new approach, a reference › › An experiment is being conducted to
of the immunisation obligations benefits vac- framework for pharmacovigilance is a nec- bring the professionals closer to the young
cination in the broadest sense. essary prerequisite. This inventory will be with the aim of promoting and improving
accompanied by data on the first 6 months the HPV vaccination coverage.
The rate for the first dose of HPV vaccine of the implementation of the reform of the Finally, this year, Santé publique France will
among 15-year-old girls, albeit still far too low, extension of immunisation obligations from conduct a nationwide survey in a number of
has improved, rising from 26.2% for girls born January to June 2018. health facilities and EHPADs (residential estab-
in 2002 to 29.4% for girls born in 2003. lishments for dependant elderly people) to
While our first actions are already taking assess the vaccination coverage of the health
In terms of parents’ participation, Santé shape, and in a positive way, many challenges professionals, and identify the obstacles to
publique France has also carried out surveys still await us and we must restore confidence their vaccination against influenza. On this
among parents of children under two years of and keep being vigilant. basis, we will launch in 2020 trial cooperation
age. actions between professionals to promote the
We face recurring clustered cases of measles; vaccination of health professionals.
Parents’ opinions about the importance of and the latest outbreak has attracted the
vaccination for children’s health is increasing interest of the media. These situations, which And I will conclude with a more compre-
by +5 points (compared with June 2018). The mark the return to times and epidemics we hensive objective, to which the European
perception of collective vaccination protection believed were over, are due to the inadequacy Immunisation Week is contributing: restoring
is making progress in the same direction. of measles vaccination coverage, particularly confidence.
among young adults.
A slightly less positive figure: 47% of the Restoring confidence by talking about vacci-
parents admit to being unfamiliar with the That is why the current measles epidemic, nation, restoring confidence by having a clear,
immunisation obligations for infants. We, although less intense than in 2018 but still strong and responsible narrative.
institutions and health professionals alike, worrying, needs to raise our awareness about
must therefore keep up our collective efforts, the potential seriousness of this disease: it was Restoring confidence also by being there
in terms of communication with and infor- responsible for one death early in 2019, and I where the French citizens get their infor-
mation to the parents. would like to remind you that in 2018 three mation and by combatting misinformation
deaths were linked to this disease. or disinformation. Fake news is a scourge, as
Finally, the Collège de la médecine générale, rampant and dangerous as ever.
in partnership with Santé publique France, This epidemic must also make us aware of
interviewed a number of general practitioners. the need to protect ourselves against measles Health-wise, the European Union is also a
in order to protect the most vulnerable. major field of action. Health is our common
99% say they are in favour of vaccination good, and Europe has a role to play.
in general, and 75% of them perceive the Similarly, despite our efforts, the rate of
extension of the immunisation obligations seasonal influenza vaccination among the Since September 2018, France has been
as a positive step. I do not know whether the target population is 50%, a figure that remains coordinating a joint European action on vac-
latter figure will increase, or whether it reflects well below the WHO target of 75%. cination. This action, which is planned over 3
the bitterness of having to exercise pressure in years, will strengthen cooperation and com-
order to increase the immunisation coverage. I am also thinking of the vaccination against munication between all Member States in
HPV. Initial activity data show an increase, order to have common tools at their disposal
We are well on our way to achieve the col- but we are still a long way from achieving our and to fight, for example, against vaccine hesi-
lective protection of the new generations, and goal. Preventing cervical cancer is yet a major tation or fake news.
I cannot help but think that every point gained challenge.
in vaccination coverage means fewer tragedies. Coming back to the European Immuni-
We must therefore build upon this dynamic sation Week, I would like to stress that this
I know that there are still parents out there and consolidate our foundations: event of general mobilisation extends beyond
who fear the adverse effects of vaccination, our boundaries and gets the same message
but the risks of not vaccinating a child are I have asked the Haute Autorité de Santé across everywhere to rally around the same
infinitely higher. (HAS or High Authority for Health) to propose objective.
changes for even simpler vaccine pathways,
As I was committed to this for the sake and expanding the vaccination skills of the Our common objective of promoting vac-
of transparency, to which I am very much health professionals will do just that; cination will have a new and very concrete
attached, I will also present a pharmacovig- translation this year.
ilance report at the end of the year. I also asked the HAS to extend the HPV vac-
cination programme to young boys;
The National Agency for the Safety of Med-
icines and Health Products (ANSM) is working Experiments will also be conducted between
with stakeholders and will present in June 2019 and 2020 to identify new means for
2019 a first progress report on the safety of action to promote vaccination.
mandatory vaccines for children under 2 years ›› A project is underway to make vac-
of age vaccinated during the years 2012-2017 cines available in doctors’ and midwives’
(i.e. before the implementation of the reform). practices,
10 | The European Files | Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe
Dedicated supra-structural vaccination
organizations: the driver of a
successful vaccination schemes
5% by hospital services. (Groupe de réflexion Today, with a coverage of 97,2% Belgium is at
scientifique Vaccinations, 2016) In Flanders the point of eradication. An obvious question
a totality of 85.4% of the children were vac- is: why not make all vaccinations obligatory?
cinated by Kind & Gezin, 9.5% by the pedia-
trician, 4.4% by the general practitioner and An advice on the matter by the Belgian
0.7% by other authorities, for example vacci- Advisory Committee on Bioethics expresses
nation programs overseas. (Vandermeulen C, a pragmatic and valuable approach regarding
e.a., 2017) this question: “It is ethically unacceptable for
a parent to deny his / her child a vaccine that
In Flanders, Wallonia and Ostbelgien a is effective against a serious and preventable
supra-structure of medical supervision works disease such as poliomyelitis or tetanus. On
in schools themselves (CLB, PSE and Kaleido- the other hand, it is ethically acceptable to
DG). Every two or three years each pupil refuse the vaccination of his / her child if the
Maggie DE BLOCK visits this medical service. The visit of school balance of vaccination / disease risks is not sci-
children to these facilities gives a unique entifically decisive. Parents must always make
Belgian Minister of Social Affairs and Public
access to vaccination. Flanders started with their decisions in the best interest of the child,
Health and Asylum Policy and Migration
HPV vaccination for girls through this medical and it is legally and ethically unacceptable for
school supervision supra-structure in 2010, them to make decisions that are manifestly
which led to a vaccination coverage of 90%. In to the detriment of their child.” (Belgian
Wallonia this supra-structure was not offering Advisory Committee on Bioethics, 2015) This
this possibility. Only approximately 35% of the conclusion undoubtfully will be used as a
S uccess and high participation in vac-
cination schemes by the population
is a multi-layered issue. A solid reim-
bursement regulation and the mere availability
of vaccines will not guarantee that there will
eligible female target population is vaccinated.
Luckily since 2019 with new HPV-vaccines on
the market, both in Flanders and Wallonia
this supra-structure will now offer HPV-
vaccination to all boys and girls. The coverage
benchmark in the debate should the anti-vax
movement keep growing.
Summing up, making vaccination com-
plementary by law, should be a last resort.
be a high uptake or vaccination coverage. Two of vaccination against measles, is different However, when the public health is at stake,
other equally important drivers to success are in the two parts of our country: in Wallonia such drastic measures need to be considered.
the supra-structural organization responsible and Brussels, 75% of the adolescents are vac- The priority is to invest in common sense of the
for vaccination and the legal framework cinated, while in Flanders 93% is vaccinated. A citizens and to ensure supra-structural organi-
regarding vaccination. recent rapport (Devos C, 2019) on the Belgian zations that can facilitate and contribute to
health system, showed however the necessity pro-actively vaccinate the population. Espe-
First lets highlight how supra-structural that not only actions are needed to attain a cially in adult and older populations, there is
organizations for vaccination can contribute high level of vaccination in children, but also a gap to fill.
to a high coverage. By this we mean all facilities for the detection and vaccination of non-vac-
that assure the successful functioning of a vac- cinated adults in order to prevent outbreaks. Bibliography
cination program. In Belgium, the government
guarantees access to vaccination for all Reaching the elderly is a challenge. How Belgian Advisory Committee on Bioethics.
children. Three supra-structural organizations can we establish a dedicated supra-structure (2015). Opinion no. 64 of 14 December 2015 on
oversee the administering of vaccines: Kind & to reach the elderly population easily in terms the ethical aspects of mandatory vaccination.
Gezin in Flanders, ONE in Wallonia and Kaleido of pro-active vaccination? In contrary to the Brussels: BACB; https://www.health.belgium.
DG in Ostbelgien. Working in close collabo- maternity wards and the schools where the be/en/opinion-no-64-mandatory-vaccination
ration with the maternity department in the eligible target population flocks together, Devos C, C. A. (2019). De performantie van
hospitals, these organizations assure basic vac- the major part of the elderly population is het Belgische gezondheidssysteem - rapport
cination and the follow-up according to the scattered all over the geographical area, except 2019 Health Service Research (HRS). Brussels:
vaccination scheme for young children set by for elderly homes. An interesting option to Belgian Health Care Knowledge Centre (KCE)
the government. The presence on the field of study is whether a dedicated team in a home
KCE Reports 313A. D/2019/10.273/32.
this supra-structural organizations leads to a nursing service could take up this role similar
Groupe de réflexion scientifique Vaccinations.
vaccination coverage among newborn babies to the supra-structural organizations to ensure
of over 93% in both Flanders and Wallonia for pro-active vaccination in this population. (2016). Enquête de couverture vaccinale en
the most essential recommended vaccination. Wallonie. online: https://www.vaxinfopro.be/
A second driver for vaccination might be spip.php?article2000&lang=fr.
In Wallonia nearly 55% of these vaccines are to make it compulsory by law. In 1966 the Vandermeulen C, e.a. (2017). Vaccinatiegraad
given to children by the ONE, 35% by private Belgium government made poliomyelitis vac- in Vlaanderen in 2016. Vlaams Infectiebulletin,
pediatricians, 5% by general practitioners, cination obligatory for each newborn child. 6-17.Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe | The European Files | 11
Promote vaccination, particularly the
childhood immunisation programme and
the HPV vaccine for both girls and boys
hpvalliance.ie), led by the Irish Cancer Society, to platforms. Information about vaccines on social
promote the vaccine and regain parental trust. media can be misleading. I welcome efforts to
The role of patient advocates in the Alliance direct parents to trusted sources of information
was vital in connecting with the public. I would with the appropriate scientific advice which can
particularly like to remember the contribution enable them to make the right choice to vac-
of one such advocate, Laura Brennan, who sadly cinate their children. From an Irish perspective,
passed away at the age of 26 in March this year I look forward to engaging with social media
as a result of cervical cancer. Her legacy will be companies in the coming weeks and months
the lives saved through her inspirational efforts to discuss what further measures can be put in
to encourage girls to get vaccinated. Her work place to combat vaccine misinformation.
and the work of everyone involved in the HPV
Vaccination Alliance has seen uptake rates dra- The Role of the European Union
matically improve to over 70%. In addition, from Cooperation between member states plays
Simon HARRIS this academic year, boys in secondary school an important role in protecting the health of all
are now able to avail of HPV vaccination which Europeans as infectious diseases do not respect
Irish Minister for Health
will further reduce HPV related cancer deaths in national boundaries. We have seen evidence of
years to come. this with the rise in outbreaks of measles across
“Misinformation about vaccines is Europe in over the past couple of years.
as contagious and dangerous as the The Vaccine Alliance Within the European Union I would like to
diseases it helps to spread.” Dr Tedros Regrettably, Ireland has experienced a drop especially commend the ongoing collaborative
Adhanom, Director-General of the in the uptake of many of our other routine research on Vaccine Hesitancy. “The State of
World Health Organisation, September childhood vaccinations over the past five years. Vaccine Confidence in the EU 2018” report
2019 This has been associated with recent national highlights the need to maintain high levels
outbreaks of vaccine preventable diseases such of confidence in vaccination programmes to
G lobal life expectancy gains resulting
from universal immunisation pro-
grammes represent one of the greatest
achievements of humanity. The irony is that this
success can lead to complacency as we forget the
as measles and pertussis and has highlighted
the need for on-going vigilance regarding our
childhood immunisation programmes.
In September this year I launched the Vaccine
Alliance which includes members from a wide
achieve herd immunity but also underlines the
complexities involved, including both individual
and environment factors that can influence
confidence.
At an international level I think it is important
morbidity and mortality caused by diseases such range of health and civil society organisations. to recognise the role that transnational agencies
as smallpox and polio in the past. In recent years The alliance will look to replicate and build on play in protecting us all. The work of the GAVI
in Ireland we have had to face new challenges the good work done by the HPV Vaccination Alliance has seen huge strides being made in
to vaccination confidence. Much work has gone Alliance. Their vison is to ensure all children in countries that would otherwise not be able to
into restoring that confidence but undoubtedly Ireland are protected from vaccine preventable financially support and organise national immu-
this work is not over. diseases and I will support them in whatever way nisation programmes. Similarly, the work of the
I can to achieve this goal. WHO and of representative member states in
HPV Vaccine Uptake Under Threat reacting to Public Health Emergencies of Inter-
Chronic infection with Human Papilloma Social Media national Concern and preparing for future pan-
Virus (HPV) infection causes cervical cancer, Although the absolute effect on vaccine demics is vital and I hope this work continues
along with other cancers of the vulva, vagina, uptake is difficult to measure, I have no doubt and strengthens into the future.
penis, anus, and oropharynx. A school-based that social media has played a role in under-
programme of HPV vaccination for teenage mining confidence in vaccination. The dynamic Vaccinations save lives
girls began in Ireland in 2010. It was initially nature of social media presents a new challenge Vaccinations have saved millions of lives since
well received with an 87% uptake in the for maintaining confidence in immunisation they were first introduced towards the end of
2014-15 academic year. However, following a programmes worldwide. Misinformation on the 18th century, and we continue to improve
coordinated anti-vaccination campaign this social media has the potential to spread and and strengthen our vaccination programmes
plummeted to an estimated 50% in 2016-17. amplify in manner not seen before. However, with the introduction of more vaccines, like
Anti-vaccine campaigners managed to utilise it also provides an opportunity to disseminate those against HPV and rotavirus, as they
both traditional media and social media to information regarding the benefits of vaccines to become available. It would be a travesty to see
spread misinformation about the HPV vaccine a wide audience especially younger generations this progress stall or regress, however there are
with devastating effect. who are less inclined to use traditional media. worrying signs both in Ireland and in Europe. I
The response to the drop in HPV vaccination It has been heartening to see that social therefore call on all member states to redouble
uptake required a co-ordinated effort from a media companies have begun to recognise their efforts in maintaining robust childhood
wide range of stakeholders. This included the the important role they can play in preventing immunisation programmes to protect the
formation of an HPV Vaccination Alliance (www. the spread of vaccine misinformation on their futures of all children in Europe.12 | The European Files | Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe
European Commission
roadmap on vaccination
extensive vaccination campaigns. These cam- sources of information for the public, as well
paigns save lives. In 2019 three EU Member as a European vaccination information portal
States lost their measles-free status. There is to be launched next year.
still work to be done.
The Commission will support countering
Vaccination is a safe and cost-effective online vaccine disinformation and develop
way to protect people – especially infants evidence-based information tools and
and young children – from certain infectious guidance for Member States in responding to
diseases. Despite this, many children in Europe vaccine hesitancy. Communication on vacci-
go unvaccinated and remain vulnerable to nation, explaining the myths, misconceptions
potentially life-threatening diseases. The and skepticism that surround this issue will be
key to preventing serious consequences as a priority for the next College.
a result is to ensure that every community is
Anne BUCHER not only prepared but also well informed that In the field of vaccine reserves, the Com-
vaccinations protect the individual and those mission is considering a virtual European data
Director-General DG SANTE, European
around them. warehouse on vaccine needs, which could
Commission
facilitate the voluntary exchange of infor-
At the EU level, our role is to assist countries mation on available supplies, possible surpluses
in coordinating their policies and programmes. and global shortages of essential vaccines. This
The European Commission has stepped up its would ensure that necessary measures are in
action on vaccination, working closely with EU place in the event of a pandemic.
L ast September, during the Global Vacci-
nation Summit in Brussels - co-organized
with the World Health Organization
(WHO), I was particularly moved by the pres-
entations of two of our participants: Ethan
Member States and key partners in the global
community. In December 2018, the Council
adopted a Recommendation to strengthen EU
cooperation on vaccine-preventable diseases.
Moving forward, the European Commission
We also want to ensure, along with industry,
that a steady supply of vaccines is available,
while ensuring a diversity of suppliers, and to
exploit the possibilities of joint vaccine pro-
Lindenberger, at the age of 18, went against his has set out a roadmap to ensure better coop- curement. Measures such as these are already
mother’s anti-vaccine stance and inoculated eration among Member States. being rolled out. 15 Member States and the
himself; and Kevin Brennan, whose sister Laura Commission have signed framework contracts
Brennan died of cervical cancer this year aged Firstly, a feasibility study on the devel- for the production and supply of pandemic
26 after dedicating her last two years of life to opment of a common EU vaccination card influenza vaccines guaranteeing access to
advocate for the HPV vaccine - which she had began this year, with a proposal for a common vaccines in the case of a pandemic.
not received1 . What struck me most about vaccination document that could help EU
both of these cases, was that they could – and citizens continue their vaccination across Recent years have shown us that the spread
should - have been unnecessary. Member States, is expected in 2022. of contagious diseases do not respect borders.
Europe has not only a responsibility to its
Yet, these testimonies are crucial. According The Commission will continue the devel- citizens but to the global community as well,
to a 2018 WHO/UNICEF report, vaccine opment of safe and effective new vaccines as evidenced by its work this year in central
hesitancy has been reported in more than through Research programmes Horizon 2020 Africa. Thanks to close cooperation of Member
90% of countries worldwide, while according and the upcoming Horizon Europe. States and the European Medicines Agency
to a recent Eurobarometer, 38% of Europeans (EMA), more than 1.5 million doses of a new
believe that vaccines could cause the illnesses The bi-annual Report on the State of Ebola vaccine in the Democratic Republic of
from which they protect2. Vaccine Confidence in the EU started in 2018. Congo have now been stocked.
Its role is to monitor attitudes to vaccination
Let us be clear - vaccines work. In 1980, the on a regular basis. Based on this, guidance that Together in the EU, we have built solid foun-
World Health Organization declared smallpox, can support Member States in countering dations that will serve us well for success in the
which once killed 400,000 in Europe each year, vaccine hesitancy will be presented by 2021. future. Let us keep up the fight to relegate
to be eradicated. This was as a direct result of further diseases to history, and ensure that
Information is key, in particular to coun- following generations no longer die from pre-
teract the increasing trend on hesitancy in ventable causes, and avoid further speeches
1 https://ec.europa.eu/health/vaccination/
some of our countries. The European Centre like those of Ethan Lindenberger and Kevin
ev_20190912_en for Disease Prevention and Control (ECDC) Brennan.
2 https://ec.europa.eu/health/
will establish a European Vaccination Infor-
sites/health/files/vaccination/ mation Sharing system and provide guidance
docs/20190426_special-eurobarometer-sp488_en.pdf for developing relevant and trustworthyEurope & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe | The European Files | 13
A cancer vaccine: how to eradicate
virus-related cancers in Europe?
by 99%. These studies do not show any side phenomenon of mistrust of vaccines, largely
effects that can be attributed to the vaccine. fuelled by significant disinformation about
their risks and leading to a strong hesitation
The European Centre for Disease Prevention from citizens regarding vaccination, in par-
and Control (ECDC) therefore recommends ticular parents for their children.
that Member States vaccinate girls aged 10-14
years with 3 doses. What can the European Union do?
However, the vaccination schedule remains In order to respect gender equality regarding
an exclusive competence of the Member diseases, and given the proven efficacy of vac-
States. cination for male cancers, it is important to
review ECDC’s recommendations for gender-
The recommendations vary greatly from neutral programmes to include young boys.
Véronique TRILLET-LENOIR country to country in the European Union:
vaccination is recommended at different ages The European Union should also encourage
Oncologist and MEP, Renew Europe, France,
(from 9 to 26 years), most of the time only for an increase in the number of teenagers vac-
Member of the ENVI Committee
girls, at different doses (2 or 3 doses), and since cinated (ideally 90%) and guarantee fair
2017 it has been extended to boys in Italy, access to vaccination by preventing the risk of
offered at school in Hungary and Ireland, free shortages.
or partially reimbursed (France), etc.
Last but not least, informing and educating
S ome cancers are virus-induced. Among
them, human papillomavirus (HPV),
responsible for sexually transmitted
cancers of the cervix, anus, penis, vulva and
the ENT region.
Vaccination coverage is also very uneven:
above 70% in Sweden, the United Kingdom,
Northern Ireland, Spain, Portugal, Italy,
Malta, Hungary, Belgium, 50-60% in Finland,
the Netherlands, Denmark, Latvia, 30-50%
people is key in order to raise citizen awareness
about the issues at stake.
Updating European guidelines, working on
hesitation regarding vaccination and setting
in Germany, Slovenia, below 30% in France, up surveillance records for vaccine coverage
The vaccine against the virus is effective: Luxembourg, Greece, Cyprus, Poland, Slovakia, should be part of a future European Cancer
26 studies conducted on 73,000 women and Romania and unknown in Estonia, Lithuania, Plan.
which compare the risk of cervical cancer the Czech Republic, Austria, Croatia, Bulgaria.
depending on whether or not they had been
vaccinated with a follow-up of up to 8 years The gaps in coverage are due to a lesser
have been compiled: the risk of developing extent to discrepancies in Member States’
lesions leading to cancer has been reduced recommendations than to a growing14 | The European Files | Europe & Vaccines - For effe c t i ve v a c c i n a t i o n p o l i c i e s i n Europe
Clinical Evaluation
of vaccines
In early clinical studies, the aim is usually pregnant women, to be included in the safety
to determine safety and immunogenicity of database.
the vaccine in a limited number of vaccinees, After approval, there is a need to make sure
according to different doses and schedules, so that, vaccines are continuously monitored so
to define the posology to be progressed into that emerging information on their benefit risk
later clinical studies. Research geared towards balance is rapidly evaluated. To facilitate this,
gaining more insight into the immune response risk management plans are put in place at time
that confers protection after vaccination or of approval summarising, among other aspects,
natural exposure would help in streamlining the the activities needed to gather additional
development of new vaccines. In addition, new information on the safety of the vaccine. Effec-
generation assays for both humoral and cell tiveness studies, that reflect real-world efficacy
mediated immune responses could facilitate in terms of both the direct and indirect effect
antigen(s) and regimen selection, and support of the vaccine, are in certain cases required as
Prof. Guido RASI definition of correlates of protection with post-approval commitments. The existence of
major impact on the development process. networks that can rapidly conduct safety and
Director Executif of EMA
In case there is no immune marker that effectiveness studies in the post-authorisation
can be accepted as surrogate endpoint for phase would be instrumental for a timely and
protection, and whenever possible, studies to efficient collection of these data. Collaboration
determine the efficacy of the vaccine in pre- with public health authorities is often necessary
venting the disease in the target population is to allow the conduct of these studies, which
required. Depending on the incidence of the calls for a structured and transparent col-
V accines are arguably among the most
cost-effective and successful inter-
ventions in public health. Regulatory
authorities are responsible for evaluating
infectious disease to be prevented, often these
randomised studies require large sample sizes,
in the order of the thousands, to meet the
study objectives.
For several diseases and pathogens, the
laboration among the different stakeholders.
A platform that would enable the conduct of
these studies across the EU would be of major
public health relevance as it would support
more rapid and better-informed public health
vaccines prior to marketing authorisation
and continually monitor vaccines that are conduct of field efficacy trials is hampered by policy decisions on vaccination in Europe
placed on the market to ensure requirements the relative rarity of cases that can be recruited through knowledge sharing and utilisation of
for quality, safety and effectiveness are met. in a reasonable timeframe. In such instances, common methodologies. At the same time,
Robust and established criteria for evidence provided feasible and scientifically adequate, it would also facilitate rapid and robust regu-
to be generated during vaccine development approaches such as human challenge studies, latory decisions on individual vaccines.
are in place and illustrated in dedicated up to or inferring protection from animal models of Overall, provision of greater assurance on
date guidance documents issued by EMA. EMA disease, have been proposed. More in-depth the robust evaluation of vaccine safety and
also offers the possibility of scientific advice to understanding of these models and their sur- vaccine effectiveness, would improve public
discuss elements related to a specific vaccine, rogacy is needed to help regulators in deter- confidence in vaccines and vaccination moni-
that cannot be addressed by guidelines. mining their value across the different devel- toring programmes.
opment phases. Indeed, the growing phenomenon of
Several new vaccines are currently under
Late stage clinical trials usually provide vaccines hesitancy is negatively affecting vac-
development. These cover pathogens for which
major contribution to the safety database of cination campaigns in many countries in the
a vaccine is not yet available or pathogens for
the vaccine. Besides standard requirement for EU and elsewhere in the world, with detri-
which current options may provide further
the safety evaluation of medicinal products, mental consequences on the ability to protect
improvements. In order to efficiently advance
adverse events of special interest following citizens and save lives due to the spread of
the development of these vaccines, it has been immunisation are proactively collected in vaccine preventable diseases. Regulators have
advocated for a more conducive environment the clinical trials. The actual size of the safety a major role to play in improving transparency
to foster vaccines research and development in database at time of approval may vary for each and providing easily accessible way infor-
the EU and retain the current vaccines expertise vaccine depending on the identified potential mation on vaccine product ingredients and
and infrastructure. risks. However, in principle the database should the assessment of quality, safety and efficacy,
Innovative technologies such as nucleic be sufficiently large to estimate the frequency including safeguarding their scientific integrity.
acids and viral vectored vaccines, including of uncommon adverse events (occurring in- The collaboration with ECDC, health care
heterologous prime-boost strategies, or alter- between 1/100 and 1/1000 vaccinated persons). professionals and other authorities around
native routes of administration such as needle- Depending on the vaccine and the target popu- the world, to raise awareness on safety and
free mucosal administration, are emerging lation, there is a need to consider the number effectiveness of vaccines, and the creation of
approaches requiring where an understanding of subjects in the target population within a an EU vaccination portal to proactively share
of the underlining science is needed to establish certain age range or belonging to any special information on vaccines and vaccination in the
regulatory requirements. population, e.g. immunodeficient subjects or EU, are important steps forward in that regard.You can also read
