Influenza and respiratoryFind ways to improve development ofuniversal influenza, respiratory syncytial virus,Middle East respiratory syndrome andpneumococcal vaccines.

Key reasons why you must join uson 10-12 October in Barcelona1) The strongest agenda yet: Governed by

our 13-strong Scientific Advisory Board,which includes Dr Rino Rappuoli, Dr JeraldSadoff, Professor Albert Osterhaus, DrJeffrey Almond, Dr Antu Dey, Dr NathalieGarcon, Dr Cyril Gay, Dr Mahesh Kumar, DrJan Poolman, Dr Konrad Stradler, Dr RoyBaynes and Dr Bernard Vallat, these leadingexperts will ensure the agenda, topics andspeakers are relevant and cutting edge;

2) More CEOs, CSOs and decision makers:Hear from over 150 senior speakers including Richard Hatchett, CEO of theCoalition for Epidemic PreparednessInnovations (CEPI), Dr Martin Friede from theWHO, Dr Steve Reed, the founder of theInfectious Disease Research Institute (IDRI),Dr Annaliesa Anderson, the vice-presidentand CSO bacterial vaccines at Pfizer, andmany more;

3) Six tracks and two co-locatedconferences: Attend focused sessionsacross multiple tracks and two co-locatedcongresses. Take this unique opportunity toattend not only the sessions at the WorldVaccine Congress but also the 3rd WorldVeterinary Vaccines Congress and 2ndImmune Profiling World Congress; and

4) Keynote plenary sessions you cannotmiss: Join CEPI, WHO and the Ministry ofScience and Technology India on how tocreate a new strategy in our current globaloutbreak response system on Day 1.

Make sure you are at the forefront of the vaccines industry. Nomatter where your interest lies, at the 18th annual WorldVaccine Congress, 3rd World Veterinary Vaccine Congress

and 2nd Immune Profiling World Congress, we have content, networkingand potential partners for you. By bringing experts from the whole valuechain under one roof, you get to choose the sessions which are the mostapplicable to help your business plan for the future of vaccine research,development and manufacture.

Take just three days out of the office to meet with 450+ potentialcustomers who need to find solutions to challenges around thecommercial and scientific issues in manufacturing, trials, strategy,regulation, veterinary, immune profiling, respiratory, therapeutic andemerging diseases vaccines.

Download the brochure to find out more and book your ticket.

2

World Vaccine Congress

The World Vaccine Congress Europe 2017 in Barcelona, Spain, on 10-12 October is theplatform for research, development and strategic partnering for the global vaccine industry

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Bioprocessing, delivery and manufacturingOptimise early formulation through to clinical manufacturing by

embracing new techniques and technologies.

Emerging and re-emerging diseasesUnderstand the opportunities for your business in reacting to global

threats like malaria, dengue and Ebola.

Preclinical validation to clinical trialsAssess how to improve your clinical trial performance, from developing

novel immunological assays to creating clinical efficacy.

VeterinaryFrom livestock to companion, gain crucial insights into the emerging

infections and new technologies changing the landscape.

TherapeuticFrom new adjuvant technologies to novel immunotherapies, better

understand the latest developments in the fast-evolving landscape,

whether you are interested in cancer and immunotherapy, allergy or

chronic infectious diseases.

Immune profilingDiscuss how profiling of the immune system using high-throughput

technologies can aid therapeutic design and treatment strategies in

infectious and non-infectious diseases, including cancer.

No matter where your interest lies we have content, networking and

potential partners for you.

Download the brochure to find out more and book your ticket.

Learn. Discover. Network

Day 2 focuses on new vaccine

collaborations in emerging markets –

companies include Serum Institute of

India, YISHENG Biopharma, Bharat

Biotech, Sanofi Pasteur, the European &

Developing Countries Clinical Trials

Partnership (EDCTP) and Takeda.

Vaccine Congress World Series of EventsScience, technology and strategy for theglobal veterinary vaccine market

3

World Vaccine Congress Europe

www.terrapinn.com/conference/world-vaccine-congress-europe/

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The 3rd Annual World Veterinary VaccineCongress 2017 is the place where the globalvaccine industry meets to discusscommercial and scientific issues aroundregulation, strategy, manufacturing, trials andemerging diseases.

This event will provide a platform for you toshowcase how you are moving veterinaryvaccine development methods forward, fromtechnology to regulation and manufacture.

Download the brochure to find out more andbook your ticket.

Integrating the technologies revolutionisingimmunotherapy and its impact on vaccines development

The World Vaccine & Immunotherapy Congress

2017 in San Diego, US, on 30 November to 1

December will offer learning and business

development opportunities taking advantage of

the rich biotech and funding environment that

the west coast of the US offers.

The focus will be on the vaccines industry in

general, but also more specifically on integrating

the technologies revolutionising immunotherapy

and its impact on vaccine development.

This is the congress for top decision makers of

the vaccine and immunotherapy industry with

both scientific and commercial interests,

specifically interested in both learning

and/or partnering.

With the development of newer and more advanced immune profiling

technologies, we are getting to better understand the complexities of the

human immune system. This includes infection and vaccination as well

as how diseases or pathogens alter immune cell repertoires and their

functional activities.

Following the successful meeting last October, the Immune Profiling

Congress 2017 in Barcelona will again focus on bringing together experts

to discuss how profiling of the immune system using high-throughput

technologies can aid therapeutic design and treatment strategies in

infectious and non-infectious diseases, including cancer.

Download the brochure to find out more and book your ticket.

Research, development and strategic partnering for the globalvaccine industry

By bringing ten conferences together under one roof, at the World

Vaccine Congress Washington 2018 meeting on 3-5 April you get to

choose the sessions which are the most applicable to help your business

plan for the future of vaccine research, development and manufacture.

Take just three days out of the office to meet over 800+ potential

customers who need to find solutions to their challenges. Build three

days of totally tailored content and attendees where the ten conferences

include: Bioprocessing & Manufacturing Conference; Cancer &

Immunotherapy Conference; Influenza & Respiratory Conference; Clinical

Trials & Development Conference; Veterinary Vaccine Conference;

Vaccine Safety Conference; Vaccine Supply & Logistics Conference;

Emerging & Re-Emerging Diseases; Immune Profiling Conference; and

Partnerships Conference.

Download the brochure to find out more and book your ticket.

Reproduced by kind permission of Pan European Networks Ltd, www.paneuropeannetworks.com © Pan European Networks 2017

Vaccines are an important arrow in the quiver of theveterinarian and are arguably one of the most powerful toolsin keeping animals healthy and well. Recent advances in

technologies and our improved understanding of pathogenicity,immunology and epidemiology have opened new opportunities forpreventing infectious diseases at an unprecedented level. In this articlewe want to outline some of the advances that we consider amongstthe most impactful, including advances in delivering and presentingantigens to the immune system, platforms enabling an improvedresponse to emerging diseases and progress in manufacturing.

Current vaccines in veterinary medicinesubstantially contribute to animal welfare andhealthy food, but many have their limitationsInfectious diseases remain a major challenge in veterinary andhuman medicine, and the interaction and interdependencebetween both is increasingly being recognised through the conceptof ‘One Health’. Vaccines based on inactivated and conventionallyattenuated pathogens have made substantial contributions tokeeping animals and humans healthy. However, in many instancesvaccines based on conventional technologies also have theirlimitations. For example, the immunogenicity of many bacterialpathogens is complex and can frequently only incompletely beimitated in inactivated vaccines (so-called ‘bacterins’). Often it isnot fully understood what triggers a protective immune responsein the host, but the ability of many bacterial species to express alarge number of genes and their capability to evolve in ‘serovars’ isthought to play an important role. Viral pathogens evade theimmune system through different mechanisms, including theshutdown of the cellular interferon response and high mutationrates (especially in RNA viruses). Generating attenuated livebacterial vaccines (so-called attenuated live cultures or ALCs) hasproven to be a successful strategy in some of those cases and thevaccine against Lawsonia intracellularis (Enterisol Ileitis®) is oneexample. But the conventional attenuation method throughrepeated passaging in vitro is a time-consuming, cumbersome andsomewhat unpredictable process and defining the right balancebetween attenuation and immunity is challenging.

As a consequence, for a number of the clinically relevant diseasesmore or less satisfactory vaccine solutions are available; however,there are still many diseases where vaccines are either not availableat all, have substantial weaknesses or a very narrow spectrum ofprotection, necessitating the application of different technologies tofill the gaps.

Innovation drives the quest for new and better solutionsOver the last decade progress in biomedical research, virology andmicrobiology has also fuelled the innovation of vaccine research,including better understanding of the interaction between pathogensand the host immune system, the continuous improvement in thedeciphering of the immune response and its components indomestic animals.

Subunit and virus-like particle (VLP)-based vaccinesImproved understanding of the immunogenic and protectiveantigens of pathogens as well as the ability to produce recombinantproteins cost-effectively and at high quality have opened the doorto vaccines that are based on relevant antigens only. Conceptuallythe advantages of this approach over conventional inactivatedpathogens are: 1) that the immune system can focus its responseto the most ‘relevant’ antigen(s) rather than producing antibodiesagainst a large number of different and potentially irrelevant proteins;2) subunit proteins can be modified from the wild type structure toincrease immunogenicity and thus, potentially broaden thespectrum of protection; 3) reduction of unwanted or unnecessaryproteins can improve tolerability of the vaccine; and 4) the exclusionof potentially immune suppressive proteins can improve the efficacyof the vaccine.

Some viral proteins can spontaneously assemble into biologicalnanoparticles, so-called ‘virus-like particles’. VLPs mimic viralstructures but cannot cause a productive infection and are readilyrecognised by the immune system, triggering an enhanced B and Tcell immune response. Prominent examples of VLP-based vaccinesare some baculovirus/insect cell-expressed vaccines against Porcinecircovirus 2 (PCV2), for example Ingelvac CircoFLEX®. The immune

Boehringer Ingelheim Vetmedica’s Dr Randolph Seidler discusses the emergingtrends in veterinary vaccines

The future of veterinary vaccines

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responses to those vaccines can be further boosted by the use ofimmune stimulators or adjuvants. With the more frequent usage ofrecombinant vaccine antigens and the increasing emphasis on safetyand tolerability of vaccines for the sake of animal welfare, thosecompounds are predicted to gain more importance in the future.

Vaccines using targeted deletions and modificationsLive vaccines maintain beneficial features for veterinary medicinedue to their powerful stimulation of the immune system in relevanttissues, typically alleviating the need for ‘boosting’ of vaccinationand leading to robust immune responses especially in cases, whereinactivated vaccines show limited protection. Conventional modifiedlive vaccines (MLVs) are typically attenuated through multiplepassages in culture, followed by selection of a clone thatdemonstrates the desired properties. While multiple examples existthat this can lead to very good or at least acceptable vaccines, onedownside of this approach is that the underlying mechanism forattenuation is often poorly understood. Recent improvements in theunderstanding of virulence and pathogenicity combined witheffective molecular biological methods have given way to rationaldesign of vaccines, where virulence factors have selectively beeneliminated or functionally silenced. This has led to vaccines thatmaintain the beneficial properties of live vaccines, while reducingthe risk for a potential reversion of virulence. An example of thistechnology is a vaccine against Bovine viral diarrhoea virus (BVDV)recently introduced in the EU (Bovela®), where deletion andmodification of two non-structural proteins allowed combining safetyof an inactivated vaccine with the efficacy of a MLV.

Vector-based vaccinesInsertion of protective antigens into a live but apathogenic vectororganism is a strategy that has been successfully applied toexperimental and commercial vaccines. However, while vector-basedvaccines are ‘coming of age’ for viral diseases, they are still onlyemerging for bacterial diseases. Besides conceptually combiningthe advantages of a live vaccine with its potent immune systemstimulation with the high degree of safety of an avirulent carrier, theyalso allow for a potentially faster regulatory review. Additionaladvantages of some vector systems is their limited or even abortivereplication competence in the host animal, substantially reducingthe risk for shedding and recombination. Finally, vector-basedvaccines are typically excellent candidates for so-called ‘DIVA’(differentiation of vaccinated from naturally infected animals)vaccines a key tool for the eradication of infectious diseases.

Merial has been a pioneer in this field and has introduced some ofthe earliest vector-based vaccines in veterinary medicine, inducinga canarypox-vectored rabies vaccine for cats (Purevax®) and aherpes-based infectious bursal disease virus (vHVT-IBD) vaccine forchickens (Vaxxitek®). Much current research focuses on theidentification and optimisation of additional vector systemsoptimally suited for different species and applications as well as onidentification of optimised antigens potentially allowing for fasterand longer lasting immune responses or for broader protectionacross different clades or serotypes.

Emerging technologiesUsing DNA for vaccination represents a relatively new technologyand its swift accessibility and well controlled production makes it apotentially interesting solution for the future. DNA vaccines currentlysuffer from some drawbacks, including: 1) relatively high costs; 2)strict requirements for intramuscular administration, which is alimitation in many domestic animal species; and 3) incompatibilitywith other classical vaccines leading to a barrier for the easydevelopment of combination vaccines.

Even higher expectations are on the use of RNA for vaccination;however, there are still technical hurdles to overcome before it willbe widely used as vaccine, including the development ofcommercially viable formulations of mRNA. Both, DNA and RNAvaccines are able to broadly stimulate the immune system and areaddressing the humoral and cellular immunity.

In addition, nanotechnology has found its way into vaccinology;particles either produced by protein expression systems or madesynthetically are used as carriers for vaccine antigens which can belinked to the surface of the support particle. These systems havethe potential to be used as a platform technology for vaccineproduction. The first DNA/RNA-based vaccines have recently beenapproved for the use in veterinary medicine. The veterinary vaccineindustry has been at the forefront in developing commercial DNAvaccines including a vaccine against Salmon Pancreas Disease(Clynav®), a currently not commercialised West Nile virus (WNV)vaccine for horses or a canine melanoma vaccine (Oncept®).

Shortening the response time to emerging diseaseswill be key to protect livestock and humansRecent emerging viral disease events in livestock in Europe (i.e.Bluetongue virus and Schmallenberg virus diseases) as well as inhumans in Africa (i.e. Ebola virus) have shown that response timesto develop a vaccine is of essence for an effective response, butthat current development and marketing authorisation models arestill too slow for a swift response, especially when diseases areinsect-borne as they can spread very fast over long distances.

Currently, the extensive work packages and review time required to arriveat a marketing authorisation limit the response time. A solution couldbe platform technologies e.g. in vitro systems for antigen expression.

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The development of a vaccine against a new infectious disease, usingthe well-established pathways for inactivated vaccines, or well-knownviral vectored vaccine platforms, such as the non-replicativecanarypox virus, still takes a minimum of four years if a full marketingauthorisation is required. Consequently, there is a need to rethink theway we design ‘optimal vaccines’ for these unexpected (re-)emergingdiseases. The first objective is to deliver a vaccine product in theshortest time possible and to scale up production in order to supplyvery large populations of either animals or humans. Forzoo(anthropo)notic viruses, it is more efficient to block the outbreakfirst in animals in order to control the virus reservoir and consequentlythe transmission to humans by contact.

The EU-supported Innovative Medicines Initiative (IMI) ZoonosesAnticipation and Preparedness Initiative (ZAPI) project was launchedtwo years ago with the intention of designing a methodology that willsupport the very rapid and large scale manufacturing of key controltools (both vaccines and therapeutic neutralising antibodies) againstnew or existing zoonotic pathogens. This unique One Health projectbrings together representatives of the animal health industry, thehuman health industry and key academic centres for developingcompletely new approaches to define, manufacture and releasevaccine batches. An important additional objective for ZAPI is to avoidthe need for using animals for the quality control of vaccines, sincethe in vivo phase can significantly impact the manufacturing cycletime before release and a key target for reduction of animal use (3R).

The ZAPI ambition is to achieve a cycle time of a few weeks insteadof several months. The final achievements of ZAPI will be known inapproximately three years’ time. It is expected that key learnings willbe applicable at multiple levels in our industry and will thuscontribute to the faster development of animal health vaccines inemergency situations.

The role of modern vaccines in the effort forprudent use of antibioticsThe growing prevalence of bacterial strains resistant against a broadspectrum of antibiotics poses a substantial problem in the treatmentof bacterial diseases. While the prudent use of antibiotics is a sharedresponsibility between the medical and veterinary community, the

use of antibiotics in livestock husbandry has received substantialcriticism in the public debate. Bacterial diseases remain a keychallenge in veterinary practice and responsible use of antibioticsis presently an important tool to overcome these diseases, preventsuffering of animals and thus improve animal welfare. However, thereis a growing understanding that – while antibiotics use cannot fullybe avoided – increased efforts are needed to prevent diseasethrough better hygiene measurements and vaccines.

Many bacterial diseases can be found in different serotypes andcross-protection between serotypes is often poor. The consequenceis that vaccination against a certain serotype will not sufficientlyprotect the animal from infection of other serotypes. At the sametime a combination of different serotypes can be limited byinterference in the immune response between different strains,tolerability issues due to increased side effects, and/or productioncosts. In addition, for many bacterial diseases inactivated vaccinesthemselves are not sufficiently protective. Research into the functionof individual genes within bacteria and their role in the pathology ofbacterial disease in order to identify cross-protective immunogensubunits is now progressing faster through the combined use oflarge scale (deep) sequencing, bioinformatics and predictivesoftware. However, targeted changes to arrive at effective and safevaccines is still a mid- to long-term objective for many bacterialdiseases requiring substantial additional basic research.

Innovation in manufacturing will drive quality,supply, and cost effectivenessCapital investment into manufacturing facilities continues to be alimiting factor in the expansion of commercial manufacturing ofveterinary vaccines and is a key driver of cost of goods. While theintrinsic properties of newly developed vaccines such as productionyields and minimum immunising dose (MID) play a key role for thecapacity requirements and cost in commercial manufacturing,technology advances in manufacturing technologies and processeshave increased flexibility, lowered cost and increased response timeto changing market demands.

Such advances include: 1) the use of modular facilities, for examplethrough utilisation of a ‘ballroom’ concept and of single-use

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technology, which can lower initial investment cost and decreasechangeover time, therefore increasing flexibility, response time andoverhead cost; 2) the use of high-density cell banking systems canshorten the seed-train and therefore the overall production cycle; 3) inline measurement of key process parameters allow for a bettercontrolled manufacturing process, optimisation of yields, reductionin batch-by-batch variability and product quality attributes andtherefore optimised cost and improved quality; 4) advancements inthe formulation of vaccines have enabled the manufacturing of morestable vaccines with the ultimate goal of thermostable and liquidvaccine presentations; and 5) the development of in vitro productrelease assays can reduce assay variability, reduce the number ofanimals used in commercial manufacturing, thereby serving the ‘3R’ambition, reduce cost and shorten production cycle times.

Innovation is driven through collaboration,partnering, and strategic alliancesAs outlined in this article, technological advances have enabled the(veterinary) medical community to tackle vaccines against infectiousdisease at an unprecedented level. It can be expected that a numberof these advances will translate into products that will improveprevention of disease and enable veterinarians and animal ownersin their effort to keep animals healthy, improve their wellbeing andreduce the use of antibiotics in livestock. At the same time the needfor breakthrough innovations often requires pursuing multipleapproaches in parallel, makes identification of the best approachmore unpredictable, and requires a plethora of skills and scientificdisciplines that are unlikely to be found in one place.

Academic research in universities and government researchinstitutions provide the optimal environment to develop anunderstanding of the basic mechanisms of infectious diseases,host-pathogen interactions and novel vaccine concepts. Small andmid-sized companies dedicated to the identification anddevelopment of veterinary medicines have recently emerged andhave shown significant progress and agility. Finally, large animalhealth companies possess a unique institutional knowledge aboutthe successful development of vaccines for all major regions,regulatory authority requirements and access to global markets.

Different models of collaboration have successfully been deployedin the past and have proven their effectiveness. Among those,sponsored research collaborations and licensing of technology havebeen most common. A special case has been consortial researchendeavours that have proven to provide a good basis for scientificprogress in specific areas and to de-risk early approaches. Forexample, the Horizon 2020 framework programme and its InnovativeMedicines Initiative, supported by the European Union, have set ahigh standard. However, a number of collaboration models such asopen innovation, crowd-sourcing of technology and pre-competitivecollaborations have just recently emerged and are not yet utilisedto their potential as research tools by companies and academia.

The changes in innovation models have led to the realisation thatbuilding alliances between partners of complementary skills andcapabilities will become a key success factor in effectively identifyinginnovation and implementing it in well-defined applications for ourend users in the market. Most large companies, including one of

the authors, have implemented dedicated resources for alliancemanagement, ensuring the maximisation of value for all involvedpartners of mid- and long-term alliances. For the control of zoonoticdiseases a closer collaboration between the human and the animalhealth sector in the development of vaccines seems prudent.Examples of such diseases including Hepatitis E, MERS, Rift ValleyFever, etc. However, for some of those vaccines the economic rewardis low and shared financing between the private and the publicsector appears rational.

ConclusionIn summary, we predict that – driven by new technology andapproaches – veterinary vaccines will see a wave of innovation inthe coming years to the benefit of veterinarians, animals, animalowners and ultimately the research-driven manufacturingcompanies. New models of better working collaboratively betweendifferent stakeholders in this area will be a key driver for innovation.

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Dr Randolph SeidlerGlobal Business Development & LicensingBoehringer Ingelheim Vetmedica GmbH

+49 (6132) 77-3203

randolph.seidler@boehringer-ingelheim.comhttps://boehringer-ingelheim.com/animal-health/animal-health

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Co-authorsKonrad Stadler, Boehringer Ingelheim Veterinary Research Center

GmbH & Co. KGJean-Christophe Audonnet, Merial S.A.S.

Randolph Seidler, Boehringer Ingelheim Vetmedica GmbH

Reproduced by kind permission of Pan European Networks Ltd, www.paneuropeannetworks.com © Pan European Networks 2017

Developing new and innovative vaccinesAgainst the backdrop of an ageing population,new vaccines with, for example, adjuvants thattarget specifically the aged immune systemcould help to overcome the impact ofimmunosenescence and ensure a betterprotection of vulnerable, elderly individuals.

While existing vaccines reduce the use ofantibiotics for the infections that they prevent,new vaccines could play a critical role inpreventing multidrug-resistant infections, such as from Staphylococcus aureus and extra-intestinal pathogenic Escherichia coli.6

However, there is a real risk that the much-needed innovative vaccines will not bedeveloped and made available to all citizens inthe EU and the rest of the world. The non-conducive environment in the EU andelsewhere, with increasing regulatoryrequirements, pressure on healthcare spendingand the tendency towards vaccinescommoditisation, has made it increasinglydifficult for companies to engage in the long-term investments needed to enable newvaccines to be developed and made accessibleto populations in need. Importantly, in a contextcharacterised by a relatively limited number ofvaccine manufacturers addressing global publichealth needs, the non-conducive environmentin the EU hampers the development of vaccinesfor the rest of the world. As a matter of fact, theEU today still occupies a leading position in thedevelopment of vaccines for global use and isseen by many countries as a reference model.7

The European Commission’s Horizon 2020initiative definitely demonstrated the EU’scommitment to research and development, andthe Innovative Medicines Initiative (IMI) representswith no doubt a way forward to bring together allstakeholders to collaborate on different vaccineresearch projects. Unfortunately, experienceshows us that these actions alone are unable to

ITis an indisputable fact that vaccination constitutes one of themost cost-effective public health interventions implementedworldwide to prevent morbidity and mortality associated with

several deadly diseases.1 Vaccination has, however, become a victim ofits own success. Today, increasing hesitant behaviour and mountingcomplacency towards disease are putting at risk the properimplementation of national immunisation programmes across EUmember states.2

As a result, over the past few years, Europe has been experiencing aworrying surge in cases of vaccine-preventable diseases.3 This situationhas placed avertable strain on healthcare systems. While the necessaryvaccines and infrastructure to deliver the programmes are often in place,their use remains suboptimal. This represents a gap, as the investmentin cost-effective vaccination programmes must be seen on the one handas instrumental in protecting individual health, and on the other ascontributing to healthcare systems’ sustainability, societal welfare andeconomic growth.

Extending access and overcoming vaccine hesitancy This phenomenon of growing vaccine hesitancy is complex and context-specific, varying across time and place and applying to differentvaccines. It incorporates factors such as complacency, convenience andeven confidence in vaccines.4 There is no single solution to all theseissues, but healthcare professionals have proved to be an importantdeterminant in their own vaccine uptake, their intention to recommendvaccines to people, and the vaccine uptake within at-risk populations.Additionally, access is, in some cases, a barrier to getting vaccinated,and some countries have extended their access points for vaccinationby considering alternative channels, i.e. vaccination by pharmacists andonsite vaccination in hospital wards.

Ending fragmentationWhile immunisation is a fundamental national public health competence,the adopted EU Council Conclusions on vaccinations as an effective toolin public health in December 20145 highlighted the need to join forcesin Europe to address the common challenges that EU member statesare facing. The EU Council Conclusions identified the major issue that afragmented approach to vaccination directly affects the successfulimplementation of existing immunisation programmes in Europe. As thechallenges we face are multifaceted in nature, a strong politicalleadership is needed to move forward beyond the status quo. This iseven more essential in a phase of increasing uncertainties, posed byrisks of supply shortages, the increase of antimicrobial resistance, andan ageing population that requires innovative vaccines to be developedtargeting these populations.

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Boosting the EU approach

Andrea Rappagliosi, the president of Vaccines Europe, suggests how the EU canstrengthen its approach to communicable diseases via more effective vaccination

development and programmes

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Andrea Rappagliosi

© V

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objectives in accordance with their national immunisation strategiesand programmes.

The EU Joint Action on Vaccination should aim to build an EUimmunisation roadmap through the development of effective guidancefor the establishment, and implementation of well-functioning nationalimmunisation programmes in the member states, with clearimmunisation targets throughout the life of the individual. These mustinclude the necessary capability and capacity to implement theprogrammes, with input from all actors concerned.

Key areas to consider Vaccines Europe has identified a number of key areas that couldsignificantly strengthen vaccination in Europe, such as improvingEuropean surveillance capabilities to provide the data required to supportthe national immunisation strategies; engaging physicians, nurses andpharmacists in actively increasing vaccination coverage; addressing theroot causes of vaccine shortages and ensuring a continuous interactionwith all stakeholders to overcome barriers/blocking factors to thediscovery and development of the next generation of vaccine. Last butnot least, the role of the European Centre for Disease Prevention andControl (ECDC) should be strengthened to play a more active role inproviding guidelines to member states to inform on future nationalimmunisation policies.10

Communicable diseases know no borders. In Europe we need to set acommon roadmap involving governments, health authorities, scientificsocieties, healthcare workers, civil society and industry with the aim ofimplementing a coherent EU strategy for vaccination to protect Europeancitizens of all ages against infectious diseases. We need to shift ourmindset and think ‘protection first, prevention, immunisation’ to helphealthy people to stay healthy.

References1 Plotkin SL, Plotkin SA. A short history of vaccination. In: Plotkin SA, Orenstein WA, eds.

Vaccines, 4th edn. Philadelphia: WB Saunders; 2004: 1-15

2 Larson, HJ et al. (2016). The State of Vaccine Confidence 2016: Global Insights Througha 67-Country Survey. EBioMedicine. 2016; Volume 12, 295-301

3 https://ecdc.europa.eu/en/news-events/epidemiological-update-measles-monitoring-european-outbreaks-22-june-2017

4 http://www.who.int/immunization/programmes_systems/vaccine_hesitancy/en/

5 http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/145973.pdf

6 https://ec.europa.eu/health/amr/sites/amr/files/amr_action_plan_2017_en.pdf

7 http://www.vaccineseurope.eu/about-vaccines/vaccines-europe-in-figures/

8 http://ec.europa.eu/dgs/health_food-safety/docs/amr_factsheet_en.pdf

9 http://ec.europa.eu/chafea/health/actions.html

10 http://www.vaccineseurope.eu/wp-content/uploads/2017/06/VE-paper_priorities_vaccination_policy-22-05-2017.pdf

solve all the challenges faced today. This is whywe need to promote an open, multi-stakeholderdiscussion on how to overcome barriers/blockingfactors to the discovery and development of thenext generation of vaccines. Such a dialogue isalso needed to more clearly define vaccineresearch priorities and to implement policies thatreward innovation and ensure that vaccines areappropriately valued from public health andaccess perspectives. This is vital in the context ofthe changing demographic structure of the EUpopulation and rising threats of emerging medicalneeds, including antimicrobial resistance, whichhas been identified as a major public healthpriority at European and worldwide levels.8

Meeting supply and demandIn this context, a major concern is thesustainability of the industrial investmentsneeded to continue to innovate and secure thecontinued supply of vaccines in Europe. Themanufacturing of biological medicines is highlycomplex with long lead times. Vaccinemanufacturers strive to anticipate and respondto production issues and to continuouslyimprove production processes in order to meetdemand. Supply and demand sides need to bebalanced to ensure a healthy vaccineecosystem. This should: 1) recognise thestrategic value of the EU vaccine industry inproviding prevention in the fight againstinfectious diseases; 2) ensure the long-termfunding of vaccination programmes; 3)measure the public health outcomes resultingfrom vaccination programmes; and 4) fostersustainable supply.

The EU Joint Action on VaccinationThe EU Joint Action on Vaccination9 recentlylaunched by the European Commission shouldprovide the needed political leadership to moveforward the current status quo in the years tocome (2018-2020). This would enablemember states to work together in identifyingand developing the appropriate actions thatcan help them meet their public health

9

Andrea RappagliosiPresidentVaccines Europe

www.vaccineseurope.eu

V A C C I N E D E V E L O P M E N T

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Vaccine developmenttakes on average 12-15 years

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