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•	Chronic diseases affect more than 80% of people aged over 65 in Europe and they account for up to 80% of healthcare costs in terms of premature deaths, healthy life years lost, and lost productivity.  It is estimated that almost 50 million people live with multiple chronic diseases ,and the main challenge facing Europe’s healthcare systems is to provide equitable access to high-quality care that is patient/person-centred and meets people’s changing needs.

•	Vaccination is one of the public health’s biggest achievements. It is the most cost-effective, safe methods to prevent and control infectious diseases.   Vaccines used in national immunisation programmes are considered safe and effective when correctly administered, however, they are not risk-free. Mild adverse effects can be expected to develop, including fever, as the body is building immunity.

•	While vaccination programmes continue to be the best method for controlling infectious diseases, the trend in some areas of Europe towards lower vaccination uptake has been concerning specifically, as patients with chronic diseases can have weaker immune systems and are more likely to develop complications of the condition which may involve long-term illness, hospitalisation, and even death.

Addressing public trust in vaccine safety is, thus, key to the success of vaccination programmes.

Introduction: information is key

•	Vaccination can protect us against more than 20 serious life-threatening infectious diseases, helping people of all ages live longer, healthier lives saving millions of lives every year: the World Health Organization (WHO) reports that immunisation currently prevents 2-3 million deaths / year, making it one of the most effective health interventions available.  It is particularly important for patients with chronic diseases and long-term conditions because their immune system can be weaker and, accordingly, they are more likely to develop complications of the condition which may involve long-term illness, hospitalisation, and even death.  

•	For society and governments, there may be significant savings for health and social systems from reducing the burden of chronic as well as vaccine-preventable diseases. For example, many hospital admissions could be avoided with better management of chronic conditions in the community. Potentially avoidable admissions for conditions such as asthma and diabetes account for over 37 million bed days each year across the EU.  

•	Although remarkable progress has been made in treating various chronic conditions, wide disparities in access to treatment and health outcomes persist, both between and within EU Member States. A life-course approach to vaccination as part of universal health coverage can enhance people’s quality of life, including that of people living with chronic diseases.

Importance of vaccination

•	People living with chronic diseases or long-term health conditions can benefit from a life-course approach to vaccination because their immune system is weaker, and they are more vulnerable to vaccine preventable diseases.   The approach focuses on a healthy start to life targeting the needs of people at critical periods throughout their lifetime with regular opportunities for vaccination as part of routine healthcare checks.

•	The main challenge facing Europe’s healthcare systems is to provide equitable access to high-quality care that is patient-centred and the changing needs for the estimated 50 million that people live with multiple chronic diseases.   A life-course approach to vaccination promotes timely investments with a high rate of return for public health and the economy by addressing the causes, not the consequences, of ill health.  

•	The vaccination rate needed for effective community immunity varies depending on the disease and how contagious it is. It is vital for patients who cannot be vaccinated that other around them are. In the case of measles, diphtheria, tetanus and pertussis, a 95% coverage rate is required to protect the whole community. 

•	The European Patients Forum background report on Vaccinations and Patients with Chronic Conditions, based on input from patients and patient organisations across the EU, calls for vaccination as an explicit part of disease management plans and treatment guidelines for chronic diseases.  

•	Bearing in mind that Universal Health Coverage (UHC) is among the objectives under the UN Sustainable Development Goals – which the EU and its Member States have individually and collectively committed themselves to – and includes timely access to affordable preventive as well as curative healthcare and health promotion services.  The integration of a life-course approach to vaccination as part of universal health coverage can in fact enhance people’s quality of life, including that of people living with chronic diseases.



Vaccination and chronic diseases

•	Only 70 years after the introduction of antibiotics, an increase in diseases caused by resistant-bacteria due to antibiotics overuse and/or misuse has become a major public health concern. The European Center for Disease Prevention and Control (ECDC) reports 33 000 people die from infections related to bacteria resistant antibiotics every year. In fact, we may be facing a future without effective antibiotics for treatment and patients having very limited treatment options.  

•	Vaccines can help limit the spread of antibiotic resistance by preventing infectious diseases and, therefore reducing the need for using antibiotics. Improving the use of existing vaccines, together with development of new ones, is therefore an important action to reduce preventable illness and deaths.   

•	People living with chronic diseases are particularly vulnerable to antibiotic resistance because they spend longer periods in healthcare environments, and in undergoing many routine healthcare procedures that may require antibiotics to prevent or deal with infections. Understanding the links between antibiotic resistance and vaccination is, therefore, essential in reducing the impact of antimicrobial resistance and, thus, costs associated to it.   


Vaccination and antibiotic resistance

Below are 3 key messages on vaccination, coupled with essential tools for healthcare professionals to address patients’ needs:

•	Prevention of communicable diseases through vaccination is effective. Vaccination is regarded as one of the most powerful public health interventions. 
Before routine vaccination was introduced, infectious diseases were the principal cause of child death globally. Vaccinations against diseases like influenza, measles, pertussis, diphtheria, and tetanus avert 2-3 million deaths globally each year, with another 1.5 million avoidable deaths if vaccination coverage rates would be higher.

•	Vaccination is safe. 
Any new vaccine must go through careful testing before it can be used. As with any medicinal product, there is an occasional risk of adverse events. It is vital to highlight that these are expected to develop since the body is building immunity against the pathogen. However, the medical and public health advantages of vaccines outweigh the risk of adverse effects. Healthcare professionals are best suited to communicate this to patients, their families, and carers.

Keep in mind: Trusted healthcare professionals provide patients with vaccination information well-ahead of the scheduled immunisation visit and addresses any resulting concerns during the medical appointment!

•	Vaccination is beneficial to individuals, communities, and entire populations: vaccines protect us against diseases that could have serious consequences for our health. Vaccination programmes can eliminate infectious diseases or reduce the number of new cases significantly. If enough people in a population being immunised against an infectious disease makes the disease unlikely to spread from person to person. This is known as ‘herd immunity’ (also referred to as community or population immunity).


Summary – vaccination key messages

Vaccines contain the following: 

1.	Active Ingredients (antigens)
These are the part of the vaccine made from viruses or bacteria: either live attenuated (weakened), or inactivated (killed) viruses and bacteria. More recently, messenger-ribonucleic acid (mRNA) vaccines have been developed. These do not contain an antigen, but instead genetic instructions for our own cells to temporarily make a viral protein, or even a part of the protein, triggering an immune response. From the COVID-19 vaccines authorised in the EU as of September 2021, Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) are mRNA vaccines.

2.	Added Ingredients (adjuvants, stabilisers, emulsifiers, and taste improvers) These are products that help to improve the immune response to vaccines, examples include aluminium and gelatine (adjuvants), sorbitol and glycerol (stabilisers), polysorbate 80 (emulsifier), sugar and flavours (taste improvers). 

3.	Products used in vaccine manufacture (excipients)
Products used in the manufacture of vaccines, also referred to as excipients, are present in trace amounts examples include neomycin and gentamycin (antibiotics), milk, ovalbumin (egg proteins), yeast proteins, formaldehyde and glutaraldehyde, sodium borate and salts based on potassium phosphate and sodium phosphate (acidity regulators). Whenever these substances are present at a level that might trigger a reaction in a sensitive or allergic individual, their presence is declared in the information leaflet provided.  

4.	Human cell strains, animal cell strains and GMOS
These are used to grow viruses for some vaccines in laboratories on cultures that contain human or animal cells that will later undergo purification to remove the cell culture material. Some do not need to be grown on human or animal cells, example, nasal flu vaccines can be made by genetically modifying flu virus strains to make new strains. More recently, modified viral-vector vaccines have been developed. From the COVID-19 vaccines authorised in the EU as of September 2021, Vaxzevria (AstraZeneca) and Janssen are viral-vector vaccines. The vaccine uses a harmless virus (adenovirus) that had been genetically modified to include coronavirus genes, which when injected into human cells makes coronavirus spike proteins that stimulate the immune system to fight any future coronavirus infections. The adenovirus simply serves as the vehicle to get the genetic sequence into your cells. 

Reminder: All vaccine components are consistently controlled to ensure they are present at levels that have been shown to be safe. Regulators check that their benefits are weighed against the risk of any reactions to them.  



What are vaccines made of?

There are several different types of vaccines. Their characteristics differ, determining how they are used.

•	Live attenuated vaccines are produced by modifying a virus or a bacterium in a laboratory, making them harmless. With most of the live attenuated vaccines, only 1 or 2 doses can give a lifetime protection against a germ and the disease. As an example, they are used to protect against measles, mumps, and rubella (the MMR combined vaccine).

•	Inactivated vaccines use an inactivated version of a germ causing a disease. Due to the modified, inactive version, the bacteria/virus can no longer cause an infection. They can be composed of either whole viruses or bacteria or fractions of either. 
Generally, they do not provide as strong immunity as the live attenuated vaccines. Therefore, several doses may be needed over time. As an example, inactivated vaccines are used to protect against Hepatitis A, the flu (influenza) and polio.

•	Subunit, recombinant, polysaccharide, and conjugate vaccines use only specific pieces of the germ giving a strong immune response targeted to its key parts. They can be used also on people with weakened immune systems and long-term health problems. However, booster shots may be needed. As an example, these vaccines are used to protect against HPV (Human papillomavirus), whooping cough (as part of the DTaP combined vaccine), Hepatitis B and pneumococcal disease.

•	Toxoid vaccines use a toxin made by the germ that causes a disease triggering the immunity to the parts of the bacteria/virus that cause a disease. Booster shots may be needed with toxoid vaccines. As an example, they are used to protect against diphtheria and tetanus (as part of the DTaP vaccine)

•	Messenger-ribonucleic acid (mRNA) vaccines work by synthetically producing an RNA copy of a desired pathogen’s gene code (e.g., coronavirus). Once introduced into human cells, this can act as an mRNA where it is translated to produce a desired protein, or part of the protein (e.g., coronavirus spike protein) tricking the body to produce antigens targeting the specific infectious pathogen it was encoded for. It is important to highlight that mRNA vaccines do not affect or interact with your DNA and the body quickly gets rid of both the encoded protein and initially introduced mRNA.

Keep in mind: Researchers have been studying diverse approaches to utilising mRNA for decades including targeted cancer research, but it had not been optimised until COVID-19 vaccines were developed.  The process of mRNA vaccine development is faster than traditional methods as it uses readily available materials that could be easily scaled up. 

•	Viral-vector vaccines use a modified version of a harmless virus (e.g., adenovirus) as a vector to deliver protection against another infectious pathogen (e.g., coronavirus). The virus had been genetically modified to include instructions in the form of genetic code for our own cells to temporarily make a viral protein, or even a part of the protein (e.g., coronavirus spike protein). When injected into body, the vaccine stimulates the immune system to fight any future infections. The virus simply serves as the vehicle to get the genetic sequence into human cells. It is also important to highlight that viral-vector vaccines do not affect or interact with your DNA and the body quickly gets rid of both the encoded protein and initially introduced adenovirus.

•	Keep in mind: Viral-vector technology has previously been used in a number of studies including vaccination against Zika, flu (influenza), and HIV.

Reminder: Certain vaccines are not recommended for people with compromised immune systems. This should be addressed on a case-by-case basis. It is essential to also note that though some patients may develop minor symptoms after vaccination, these are normal signs that the body is building protection. Symptoms, if any, should subside in a few days.

Types of vaccination

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•	Edward Jenner is considered the founder of western vaccinology: in 1796, the English physician found that dairy maids with cowpox were relatively immune to smallpox, accordingly, he inoculated 8-year-old James Phipps with exudates and secretions from a cowpox pustule to demonstrate immunity against smallpox. 

•	The vaccination was effective since the boy did not catch smallpox even when he was infected with smallpox virus six weeks after the vaccination. Jenner published his findings in 1798 and the first smallpox vaccine was developed. Jenner's method underwent medical and technological changes over the 18th and 19th centuries which eventually resulted in the in global eradication of smallpox by1979. However, evidence suggest that smallpox inoculation practiced over 2000 years ago in China and India.  

•	By 1900, two virus vaccines were developed and three bacterial vaccines. The 20th century was an active time for vaccination research and development leading to rapid discoveries and innovations of new vaccines including the development of hepatitis B, rotavirus, and pneumococcal vaccines, as well as techniques for seasonal influenza vaccine manufacture.

•	Below is an illustration of vaccine development timeline based on the European Patient's Forum (EPF) the Art of Conversation - Let’s Talk about Vaccination: 

•	As demonstrated, there are currently over 20 vaccine-preventable diseases, yet advances in science and technology are helping us design more effective vaccines: ones with a better immune response, or that can be easier or quicker to manufacture.

History of vaccination

A novel vaccine candidate undergoes an elaborate development process. This takes on average 12-15 years with public and private involvement. Vaccines are tested thoroughly for safety following the highest standards and involving trials in large numbers of people. The aim of the of testing is to make sure the vaccine is safe, of high quality, and that it works.  

•	In general, this includes the following five stages of the development cycle:

1.	 The Exploratory stage involves small scale laboratory studies on pharmaceutical quality to identify natural or synthetic antigens that might help prevent or treat a disease. This stage often lasts 2-4 years. 

2.	Non-/Pre-clinical development involves in vitro lab testing and in vivo animal testing to assess the safety of the candidate vaccine, its immunogenicity, or its ability to provoke an immune response.

3.	Clinical development involves clinical trials in humans’ subjects and is divided into 3 phases: phase I (20-100 healthy volunteers), phase II (several hundred volunteers) and phase III (thousands of volunteers) vaccine trials. Studies are designed to answer two questions: is the vaccine safe? and does it induce an immune response? If the vaccine is determined to be unsafe, or does not consistently induce an immune response, it will not be developed further. Phase III Studies can be undertaken across large geographic areas to test it in wider, more diverse groups of people. Phase IV trial are optional studies that may be conducted by the manufacturer after a vaccine is released to continue testing for safety, efficacy, and other potential uses.  

4.	Regulatory review is a rigorous approval process, just like other medicinal products, where a vaccine is evaluated against a number of product properties, such as quality, safety and efficacy. The European Medicines Agency (EMA) is the EU agency in charge of the evaluation and supervision of medicinal products, including vaccines. Registration or licensing can be done centrally for the whole of the EU, via the EMA, or nationally.

5.	Manufacturing provides the infrastructure, personnel, and equipment necessary to create mass quantities of vaccines. This usually takes 1-3 years (70% of manufacturing time is spent on quality control by the manufacturer, the exporting and importing countries, and an official European control laboratory).   The Good Manufacturing Practices (GMP) for Pharmaceutical and Biological Products are applied in producing candidate vaccine for clinical studies and Standard Operating Procedures covering all aspects of production, quality control, storage and distribution are also documented.



Vaccination development

•	In the European Union, the Treaty of Lisbon has enhanced the importance of health policy, stipulating that ‘a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities. Accordingly, the primary responsibility for health protection and, in particular, healthcare systems lie with the Member States; however, the EU still plays an important role in improving public health, preventing and managing diseases, mitigating sources of danger to human health, and harmonising health strategies across Europe.

•	European citizens have access to vaccination through their national vaccination programs, but the landscape varies by country in terms of the range of vaccines that are offered and funded, who and where the vaccines are administered, and the number and the schedule of the doses. Moreover, the vaccination schemes can be either mandatory or recommended based on local conditions, such as how common the disease is.

Healthcare professionals have a role in ensuring that patients in their care receive the recommended vaccines at the right time.

•	Communicable diseases do not know borders so they can spread fast if actions are not taken. In response to growing concerns about falling rates of vaccination coverage in Europe, the spread of vaccination hesitancy, and the emergence of epidemics of contagious disease in different parts of Europe, the European Commission published in April 2018, a Communication on strengthened cooperation against vaccine preventable diseases, which recognised vaccine preventable diseases as a cross-border health threat.

Quick tip: The European Centre for Disease Prevention and Control (ECDC) is an EU agency aiming to strengthen Europe's defences against infectious diseases. One of its tasks is to give scientific advice, collect, analyse, and disseminate surveillance data on vaccine-preventable diseases and immunisation.

Vaccination within a European context

•	On-going work with patient representatives across Europe suggests vaccine scepticism may not be the only driver of low uptake of vaccination recommendations among patients with chronic conditions. Other barriers to vaccination include:

1.	affordability of vaccination to patients (some vaccines in some countries are offered free to all, others are free for at-risk groups only, and others are not reimbursed and available only out-of-pocket)
2.	ease of access to vaccination (e.g., whether a patient is required to make multiple appointments and trips to purchase and administer one vaccine)
3.	availability of vaccines (e.g., in case of national shortages)

•	Several European countries are currently facing outbreaks of vaccine-preventable diseases due to insufficient vaccination coverage rates. The reasons behind low vaccination coverage vary from difficulties to access vaccine providers and price barriers to the rise of disinformation and vaccine hesitancy.     

•	Poor access and misconceptions around the impact of vaccination are problematic. Many people believe that communicable diseases do not pose a threat to them anymore and are no longer getting vaccinated.

•	In Europe, the coverage rates vary widely between and within countries. Inequalities in access to immunisation services are growing between the eastern and western parts of the continent. Moreover, people with lower socio-economic status, some ethnic groups and migrant populations are often disadvantaged in relation to vaccination and other health services. 



Current challenges

•	Attitudes towards vaccination have changed over time, but hesitancy or scepticism is not a recent phenomenon: it was already present in the early 1800s. However, since the 1970s the problem has grown as people started thinking of their health less in terms of society and more as an individual issue.

•	Vaccine hesitancy is defined as a delay in the acceptance or refusal of vaccines despite the availability of vaccine services. It is context-specific varying across time, place, type of vaccines, and depends public perceptions which can change rapidly.

•	In Europe, key determinants of hesitancy relate to concerns about the safety of vaccines, both when it comes to the public and healthcare professionals. Contributing factors include a lack of perceived risk from vaccine preventable diseases, following their near eradication through effective vaccination programmes; rapid spread of disinformation particularly online and through social media, and increasing distrust in authorities.

•	According to the World Health Organization (WHO) SAGE Group’s Three Cs model, vaccine hesitancy is based on the following 3 key factors: complacency, convenience, and confidence.  

1.	Complacency exists where perceived risks of vaccine-preventable diseases are low, and vaccination is not deemed necessary. It is influenced by many factors, including other life and/or health responsibilities that may be more important at the time.

2.	Convenience is a significant factor when physical availability, affordability, and willingness to pay, geographical accessibility, language and health literacy, and appeal of immunization services affect vaccination uptake.

3.	Confidence is defined as trust in the effectiveness and safety of vaccines, the system that delivers them including the reliability and competence of the health services and health professionals, and the motivations of policymakers who decide on the needed vaccines.

•	The second WHO SAGE model of vaccine hesitancy determinants is the Vaccine Hesitancy Matrix. This has determinants arranged in 3 categories: contextual influences, individual and group influences, vaccines, and vaccination-specific influences.


Vaccine hesitancy

The body of research relating to patients with chronic diseases is not extensive. The Vaccination Confidence - Patients’ and Professionals’ Awareness, Communication and Trust (VAC-PACT) review, fills a gap in the literature, and provides for the first time a review of the diverse body of literature on the determinates of vaccine uptake among the population of patients with chronic diseases.

•	Research questions addressed include:
1) Documented factors contributing to vaccine hesitancy or reasons advanced for refusing vaccination in patients with chronic conditions, families, and communities
2) Documented interventions to reduce vaccine hesitancy or increase acceptability and uptake of vaccines in patients with chronic conditions
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•	VAC-PACT Literature Review results maps the determinants for vaccine hesitancy, according to the WHO Vaccine Hesitancy Matrix, and brings to light individual and group influences related to previous experience with vaccination as the main factor for vaccine hesitancy.

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•	The review also reported significant factors that do not fit into the WHO SAGE model of determinants including socio-demographic (such as age, education, socio-professional category and migration status) and clinical variables (such as diseases characteristics, time since diagnosis, treatment, and comorbidities).

•	Negative beliefs around vaccination were found to be directly related to having a chronic disease. These included the patients' fear that the vaccine might add excess “strain” on their immune system.


VAC-PACT Literature review

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•	We are all being exposed to a huge amount of information on a daily basis, and unfortunately not all of it is reliable. Information is, in fact, knowledge obtained from investigation/ study, and/or current shared intelligence. The communication may be to the best to our knowledge at the time and, thus, could be uncertain.

•	Misinformation is false information spread and/or shared by well-intentioned individuals who are genuinely interested in a specific topic but lack the background knowledge to dissect the information correctly. This shared knowledge can, unfortunately, turn out to be quite harmful to the public. While disinformation is false information created and/or shared with the intention of causing harm and/or directly or indirectly profiting. Disinformation generally serves a hidden agenda and can be very dangerous.

•	Mis- and disinformation on vaccination is heavily shared online and via social media channels by vloggers, bloggers, podcasters, and other social media influencers. The COVID19 pandemic, specifically, has exposed us to a large amount of health-related information. The World Health Organization (WHO) is, accordingly, addressing this flood of information on the COVID-19 pandemic head on, by what is now termed as a global "Infodemic".

•	Official communications from governments, national health agencies, and European institutions are the go-to source of trusted information on peer-reviewed scientific studies, fact-based news articles, accurate data, and related messages. Make sure they are your primarily source of shared information!

Information, misinformation, and disinformation

•	A total of 65 semi-structured interviews were conducted by the European Centre of Disease Control (ECDC) in Croatia, France, Greece, and Romania to investigate vaccine hesitancy among healthcare workers and their patients. Concerns relating to vaccines were reported as country- and context-specific with some healthcare workers expressing concerns relating to the risks of vaccination and a lack of trust in health authorities. While others, were against vaccination in general. Studies have shown that the attitudes and knowledge of health professionals may not only influence their own and their children’s vaccine uptake but also their intention to recommend vaccination.  

•	Communication is key: Healthcare professionals’ attitude towards vaccination is vital as they often represent a trusted source of information for patients, contributing to a change of perceptions surrounding vaccination.   It is, thus, crucial that healthcare professionals are equipped to discuss with vaccine-hesitant individuals, have more effective conversations about vaccination, and support patients in making informed choices by delivering evidence-based factual information about vaccination and the benefits of immunisation.

•	Furthermore, information and education for patients and health professionals should aim to facilitate shared decision-making: “a process in which clinicians and patients work together to select tests, treatments, management or support packages, based on clinical evidence and the patient’s informed preferences. It involves the provision of evidence-based information about options, outcomes and uncertainties, together with decision support counselling and a system for recording and implementing patients’ informed preferences.”  

Improving vaccination uptake

Section 1: KEY FACTS ON VACCINATION

•	Diabetes is a chronic condition characterised by elevated blood glucouse that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. 

•	Insulin is a hormone that regulates glucose in the blood. Hyperglycaemia, or raised blood sugar, is a common consequence of uncontrolled diabetes and over time leads to serious damage to the heart, blood vessels, eyes, kidneys, and nerves over time.

•	There are three main types of diabetes – type 1, type 2 and gestational. 

         Type 1 diabetes is defined by an autoimmune reaction resulting in the destruction of pancreatic beta cells by T cells of the immune system. This can appear at any age but occurs most frequently in children and adolescents. Neither the cause of Type 1 diabetes nor the means to prevent it are known, however research has linked it to a combination of genetic and environmental conditions. 

         Type 2 diabetes is the most common, accounting for ~90% of cases, mostly in adults. This is generally characterised by insulin resistance. This develops as a result of a combination of unmodifiable, genetic, physiological, and environmental factors, as well as modifiable and behavioural risk factors, including excess body weight and lack of physical activity.

         Gestational diabetes (GDM) can develop during pregnancy and is associated with complications to both mother and child. Women affected and their children are at increased risk of developing type 2 diabetes.

•	The IDF Diabetes Atlas estimates 463 million people, aged 20 -79 years, live with diabetes worldwide. In 2019, a study on the mortality attributable to Diabetes in adults reports 11.3% of deaths worldwide are attributed to diabetes, with about 46.2% of these occurring in people under 60 years of age. 

•	Diabetes is associated with reduced life expectancy, significant morbidity due to specific diabetes related microvascular complications, increased risk of macrovascular complications (ischaemic heart disease, stroke, and peripheral vascular disease), and diminished quality of life. 

•	There is, currently, no cure for diabetes but with treatment, preventative care, and lifestyle modifications, people with diabetes can live a long, healthy life. ,  

DIABETES - Diabetes Overview

•	Thousands of adults around the world get sick from diseases that could be prevented by vaccines every year. The World Health Organization (WHO) estimates, 422 million people worldwide have diabetes, and about 1.6 million deaths are directly attributed to diabetes / year.  

•	Diabetes, specifically if not adequately compensated, can make it harder for the immune system to fight infections rendering them more susceptible to health risks related to vaccine-preventable diseases.  

•	Remember: routine medical visits are an opportune time for providing diabetes care, follow-up, and continuous patient education.

•	Vaccination protects those vaccinated, the people around them, and the overall community. When enough people in a population are immune to an infectious disease, the disease is then unlikely to spread from person to person. This is known as community immunity (also referred to as herd immunity). 

•	Herd immunity is especially beneficial for subgroups of the population who cannot be vaccinated, or in which the effect of vaccination could be sub-optimum (e.g., people with compromised immune systems due to autoimmune diseases, recent organ transplant, cancer treatment, and/or allergies).

•	Some patients underestimate the risk of getting a disease and do not realise that their lack of being vaccinated can result in a serious risk to their health and to the health of others. You can refer back to VAC-PACT e-Learning Module Section 1 Herd immunity.

•	Getting vaccinated is an important step in staying healthy. Talk to your patient, and make sure you discuss their individual situation and/or health needs. It is crucial to address each situation on a case-by-case basis as certain vaccines are not recommended for people with compromised immune systems and/or allergies.

Here are 5 key vaccines that help to mitigate these risks based on recommendations from the Centers for Disease Control and Prevention (CDC):

•	Influenza (flu) vaccine protects against flu infections every year. Flu-associated illnesses include various types of lungs infections that can trigger the worsening of associated chronic conditions. Getting a flu vaccine is now more important than ever as patients are at higher risk for serious COVID-19 health outcomes.

•	Hepatitis B vaccine protects against hepatitis B virus (HBV) a virus that attacks the liver, cause lifelong infection, cirrhosis (scarring), liver cancer, liver failure, and death. Heavy alcohol use, toxins, drugs, and certain medical conditions can cause hepatitis. Vaccination is recommended for adults under 60 years.

•	DTaP / DTwP vaccine protects against tetanus, diphtheria, and pertussis which can be a serious disease for people of all ages. Lockjaw, croup, and whooping cough are some of the unwanted symptoms of these infections. The frequency of the vaccine dose is recommended based on age: usually a booster dose is given every 10 years.

•	Zoster vaccine protects against shingles (also known as herpes zoster) and the related painful rushes and blisters that accompany it on one side of the body, often the face or torso. The blisters typically scab in 7 - 10 days and fully clear up within 2 - 4 weeks. However, for some, the pain can last months or even years after the rash subsides. It is recommended for adults 50 and older, including adults who have had shingles or got the previous shingles vaccines.

•	The pneumococcal vaccine protects against pneumococcus bacteria that can cause pneumonia, blood infections and meningitis. Pneumococcal disease is common in young children, but older adults are at greatest risk of serious illness and death. The risk to contract these infections increases with flu. It is, recommended for all adults 65 years or older to take the vaccine. Some groups may need multiple or booster doses.

There are still considerable variations between national immunisation schedules across the EU. You can get an insight about vaccine schedule variations in EU/EEA countries, by using the Vaccine Scheduler provided by the European Centre for Disease Prevention and Control (ECDC).


Key vaccines 

•	On 11 March 2020, the WHO characterised COVID-19, an infectious respiratory disease, caused by a newly discovered Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) as a global pandemic affecting people of all ages. Symptoms usually start within 3-7 days of exposure to the virus, but in some cases, it has taken up to 14 days for symptoms to appear.

•	Common symptoms include fever, breathing difficulties, cough, muscle aches, and tiredness

•	Rare and severe complications can include lung infection, kidney disease, and even death.

•	Severity of COVID-19 is associated with increased age (> 60 years), and the presence of multiple underlying health conditions including hypertension, diabetes, cardiovascular diseases, chronic respiratory diseases, and immune suppression. Recent data also points towards male groups at slightly higher risk rates.

•	People with diabetes are considered as high-risk groups for COVID-19 and are more likely of developing severe symptoms. In view of their increased risk of poor health outcomes as a consequence of COVID-19, it is important that people with diabetes are included among priority groups for vaccination programmes.

•	By September 2021, the European Medicines Agency (EMA) has authorised the following COVID-19 vaccines for use in the European Union: Comirnaty (Pfizer BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca), and Janssen. 

•	It is essential to also note that though some patients may develop minor symptoms after vaccination, these are normal signs that the body is building protection. Symptoms, if any, should subside in a few days. 

•	The safety of all vaccines in the EU is carefully monitored by EMA.


COVID-19 Outbreak

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•	The topic of vaccination is becoming an emotionally charged debate, but it is vital that lack of vaccination uptake and hesitancy must be addressed through open dialogue, backed with scientific evidence.

•	Patient empowerment is one of the key elements of patient-centred healthcare. This is defined as a multi-dimensional, process that helps patients gain control over their own lives and increases their capacity to act on issues that they themselves define as important. The messenger may be more important than the message itself for people to accept health interventions. 

•	Patient empowerment encompasses of 3 overlapping and mutually reinforcing aspects: health literacy, shared decision-making, and self-management. Empowerment is a two-way process. The patient needs a counterpart in the “empowered health professional” who welcomes the patient’s involvement and knows how to create an enabling healthcare environment. 


Informed Decision

•	Chronic respiratory diseases are chronic diseases of the airways and other structures of the lung. These can be grouped into obstructive lung diseases (e.g., asthma, chronic obstructive pulmonary disease (COPD)) and restrictive lung diseases (e.g., pulmonary fibrosis, chronic sinusitis).
  
•	Among the most common respiratory diseases are asthma and chronic obstructive pulmonary disease (COPD).  The World Health Organization (WHO) estimates that 262 million people in the world have asthma , 65 million people have COPD, and millions other have allergic rhinitis and other often-underdiagnosed chronic respiratory diseases.

1)  Obstructive lung diseases cause more difficulty while exhaling air, such as asthma, chronic obstructive pulmonary disease (COPD), and bronchiectasis. 

2)  Restrictive lung diseases are diseases that can cause problems by restricting the ability to inhale air, such as pulmonary fibrosis, chronic sinusitis, and occupational lung diseases.

•	There is a remarkable amount of people with asthma, COPD or other respiratory diseases who are not yet diagnosed and/or treated.

•	The causes of the chronic respiratory diseases are well known and include exposure to indoor and outdoor air pollutants, allergens, and occupational chemicals. Most modifiable risks include tobacco use and, to a lesser extent than for other chronic diseases, unhealthy diet, obesity, and physical inactivity. Moreover, ageing is associated with an increase in chronic and disabling diseases. Chronic respiratory diseases are among the most frequent and severe of all.

•	Major symptoms include wheezing, shortness of breath, chest tightness and cough. There is currently no cure for chronic respiratory diseases but with treatment, preventative care, and lifestyle modifications, people with respiratory disease can live a long, healthy life.



RESPIRATORY DISEASES - Overview of the disease

•	Thousands of adults around the world get sick from diseases that could be prevented by vaccines every year. The World health Organization estimates 3.23 million deaths attributed to Chronic Obstructive Pulmonary Disease (COPD) in 2019, placing it as the third leading cause of death worldwide. 
 
•	People with respiratory diseases are often at higher-risk of complications from vaccine-preventable diseases as the lung is the internal organ most vulnerable to infection and injury from the external environment because of its constant exposure to particles, chemicals and infectious organisms in ambient air. Moreover, certain vaccine-preventable diseases can increase the swelling of your airways and lungs. The combination of the two can lead to pneumonia and other serious respiratory illnesses. 

•	Remember: routine medical visits are an opportune time for providing respiratory diseases related-healthcare, follow-up, and continuous patient education.

•	Vaccination protects those vaccinated, the people around them, and the overall community. When enough people in a population are immune to an infectious disease, the disease is then unlikely to spread from person to person. This is known as community immunity (also referred to as herd immunity). 

•	Herd immunity is especially beneficial for subgroups of the population who cannot be vaccinated, or in which the effect of vaccination could be sub-optimum (e.g., people with compromised immune systems due to autoimmune diseases, recent organ transplant, cancer treatment, and/or allergies).

•	Some patients underestimate the risk of getting a disease and do not realise that their lack of being vaccinated can result in a serious risk to their health and to the health of others. You can refer back to VAC-PACT e-Learning Module Section 1 Herd immunity.

•	Getting vaccinated is an important step in staying healthy. Talk to your patient, and make sure you discuss their individual situation and/or health needs. It is crucial to address each situation on a case-by-case basis as certain vaccines are not recommended for people with compromised immune systems and/or allergies.


Importance of vaccination for people with respiratory diseases

Here are 5 key vaccines that help to mitigate these risks based on recommendations from the Centers for Disease Control and Prevention (CDC):

•	Influenza (flu) vaccine protects against flu infections every year. Flu-associated illnesses include various types of lungs infections that can trigger the worsening of associated chronic conditions. Getting a flu vaccine is now more important than ever as patients are at higher-risk for serious COVID-19 health outcomes.

•	DTaP / DTwP vaccine protects against tetanus, diphtheria, and pertussis which can be a serious disease for people of all ages. Lockjaw, croup, and whooping cough are some of the unwanted symptoms of these infections. The frequency of the vaccine dose is recommended based on age: usually a booster dose is given every 10 years.

•	Zoster vaccine protects against shingles (also known as herpes zoster) and the related painful rushes and blisters that accompany it on one side of the body, often the face or torso. The blisters typically scab in 7 - 10 days and fully clear up within 2 - 4 weeks. However, for some, the pain can last months or even years after the rash subsides. It is recommended for adults 50 and older, including adults who have had shingles or got the previous shingles vaccines.

•	The pneumococcal vaccine protects against pneumococcus bacteria that can cause pneumonia, blood infections and meningitis. Pneumococcal disease is common in young children, but older adults are at greatest risk of serious illness and death. The risk to contract these infections increases with flu. It is, recommended for all adults 65 years or older to take the vaccine. Some groups may need multiple or booster doses.

There are still considerable variations between national immunisation schedules across the EU. You can get an insight about vaccine schedule variations in EU/EEA countries, by using the Vaccine Scheduler provided by the European Centre for Disease Prevention and Control (ECDC).

Key vaccines

•	On 11 March 2020, the WHO characterised COVID-19, an infectious respiratory disease, caused by a newly discovered Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) as a global pandemic affecting people of all ages. Symptoms usually start within 3-7 days of exposure to the virus, but in some cases, it has taken up to 14 days for symptoms to appear.

•	Common symptoms include fever, breathing difficulties, cough, muscle aches, and tiredness

•	Rare and severe complications can include lung infection, kidney disease, and even death.

•	Severity of COVID-19 is associated with increased age (> 60 years), and the presence of multiple underlying health conditions including hypertension, diabetes, cardiovascular diseases, chronic respiratory diseases, and immune suppression. Recent data also points towards male groups at slightly higher risk rates.

•	People with respiratory diseases are considered as high-risk groups for COVID-19 and are more likely of developing severe symptoms. In view of their increased risk of poor health outcomes as a consequence of COVID-19, it is important that people with respiratory diseases are included among priority groups for vaccination programmes.

•	By September 2021, the European Medicines Agency (EMA) has authorised the following COVID-19 vaccines for use in the European Union: Comirnaty (Pfizer BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca), and Janssen. 

•	It is essential to also note that though some patients may develop minor symptoms after vaccination, these are normal signs that the body is building protection. Symptoms, if any, should subside in a few days. 

•	The safety of all vaccines in the EU is carefully monitored by EMA.


Section2: DISEASE-SPECIFIC INFORMATION 

•	Most people regard vaccination positively as an important aspect of healthcare. They do trust science and facts. The presence of misinformation in the news, online and on social media is making it trickier to distinguish between trustworthy and not so trustworthy information. 

•	This is not an indication that people are unintelligent but simply a consequence of misinformation being very good at masquerading as “scientific”. 

•	The media sometimes engage in “false balance”, presenting “two sides of the debate” even when the two opinions do not have equal value or credibility. This may give the impression that there is a genuine scientific controversy when the vast majority of scientists agree. 


Introduction

•	Patients perceive healthcare professionals as trusted sources of medical advice. Professionals, including nurses, medical doctors, dentists, and pharmacists, are key providers of information on vaccination. Thus, the way they communicate about vaccination, and their attitudes towards it, are a strong influence on patients’ attitudes towards vaccination.  

•	Healthcare professionals should be well equipped to have conversations with their patients about vaccination. Increasingly, patients ask questions – perhaps about vaccines and vaccinations in general, or about the specific vaccinations that they may need. 

•	If professionals do not have the time to discuss vaccination, patients may be more likely to look for information elsewhere. Some studies show that many physicians feel there is not enough support from governments, health authorities, or other professionals in developing consistent and clear communication strategies on vaccination. The Vaccine Confidence project has showed that whilst some professionals are comfortable responding to patients and believe they have sufficient information and tools to do so, others do not. 

•	For patients with some chronic conditions, there may be additional benefits from vaccines compared with routine immunisation of the population. This is because patients with chronic conditions may be more vulnerable to vaccine-preventable diseases, and complications from those diseases may be more dangerous to them. This makes having conversations about vaccines and identifying immunisation needs even more important. 


Healthcare professionals are trusted sources of information 

•	Health literacy is of a vital impact on public health: low Health Literacy is associated with poorer health conditions and more frequent use of health services, longer hospitalisations, and higher mortality rates.  

•	According to the European Centre for Disease Prevention and Control (ECDC), health literacy can be defined as “the capacity that an individual has to access and effectively use health-related information, in order to promote and maintain good health”.  

•	This knowledge, motivation, and competence to access, understand, appraise, and apply health information is critical when it comes to making decisions in terms of healthcare, disease prevention, and health promotion.

•	In Europe there are widely varying levels of health literacy. Most non-specialists are not able to critically appraise scientific studies, especially when they are written for a specialist audience. Whilst people increasingly search for information online, many feel unable to appraise the trustworthiness of the information they find. 

•	According to a paper written by a group of experts form the European Parliament, European Commission, universities and local health policy makers, health literacy remains a European public health challenge: recent research shows that health literacy advancement is still in its infancy with only 15 % of first authors of scientific literature on health literacy coming from Europe.  

•	There is a need for systematic and sustainable integration of health literacy in healthcare services, outcomes, and management. Moreover, there is a need to improve the health literacy material user-friendliness, providing citizens with the necessary skills and competence to be able to manage their own health. 

•	In this current digital world where information is available everywhere at any time, the World Health Organization (WHO) defines an infodemic as too much information including false or misleading information in digital and physical environments during a disease outbreak which causes confusion and risk-taking behaviours that can harm health. 

•	Consumers of health information are, accordingly, overwhelmed in an increasingly digital world. Where should we look for reliable information and how do we appraise and apply it to prevent illness and promote self-care? How can we become more health literate and navigate the digital healthcare landscape?  

•	The EU and its Member States need to work together in order to establish best practices for accessible and reliable online communication of health information including implementing novel policies to improve the availability of reliable health information via digital sources, education of health professionals on health literacy in the including a digital era, and meaningful patient involvement in developing health literacy tools and methods. 

•	An infodemic leads to mistrust in health authorities and undermines the public health response. With growing digitisation information can spread more rapidly, infodemic management is now necessary and is the next step towards reducing the impact of false or misleading information in digital and physical environments.


Health literacy 

- The Manifesto on the importance of vaccination for patients with chronic conditions calls for the recognition of vaccination as part of the regular management of a chronic health condition.  Patients should be assessed for their vaccination needs during routine encounters and offered vaccination where appropriate.  
- This is consistent with the recommendation by the World Health Organization (WHO) that healthcare professionals should initiate conversations about vaccination confidently, presenting vaccination as a normal and routine part of healthcare provision.  
- Background research provided by the European Patients Forum (EPF) has showed that whilst there is plenty of information available on vaccination, patients perceive some information gaps:

    1. &nbsp;&nbsp;&nbsp;Vaccination recommendations for their specific chronic condition
    2. &nbsp;&nbsp;&nbsp;The implications of vaccination for patients with specific chronic diseases, such as autoimmune diseases 
    3. &nbsp;&nbsp;&nbsp;Benefits and risks set in context and explained in lay-friendly language from trustworthy sources 
    4. &nbsp;&nbsp;&nbsp;Information on the risk of not being vaccinated  

- Patient feedback also indicates that it is important to find information that can be trusted; and those patients often get different information from different sources, including from different healthcare professionals. Some respondents said they thought that benefits of vaccines were well covered while risks were not, raising questions around whether information given on the latter was fully transparent. 

- Patients would like to know the recommendations for vaccination for their condition, and to be given recommendations for trustworthy websites where to look for further information. Information on specific vaccines should be validated and based on scientific literature and should include the composition of the vaccine.

- Some patients have very specific concerns about the risks of vaccines for someone with their condition. They may also be concerned to know which vaccines they may or may not be able to take. This is a positive thing: patients should be encouraged to ask such questions before deciding about any healthcare intervention, including vaccination.

Benefits and risks of vaccines 

- Research on how people perceive risks has shown that people tend to worry much more about involuntary risks compared with voluntary risks; and unfamiliar risks compared to familiar ones. People also to accept more easily risks they feel in control of compared to those they feel not in control of – driving a car versus being in an aeroplane. 

- In terms of health, key drivers of risk perception include whether a disease has high or low prevalence; perceived risk frequencies; the availability and comprehensiveness of information; perceived ambiguities regarding how to interpret information; and the consequences of decisions. Emotional factors, such as altruism or freeloading also factor, and personal views may be influenced by levels of confidence and trust in institutions, complacency, and convenience. 

- Because vaccination is a preventative measure, its benefit is seen in terms of a negative (not contracting a disease). If the intervention is successful, nothing happens. All this can make the risk of possibly having a disease in future seem too remote compared to the much more immediate risk of having a vaccination.

- It is important to be able to communicate benefits and risks in context and in a way the patient can easily understand and relate to their own situation. Many people no longer grasp the risk of infectious diseases because we are so far removed from the period when they were part of everyday life. 

When communicating risk:
- Explain the risks of the vaccine-preventable disease and the impact of the underlying health condition 
- Explain the risks of the specific vaccine, putting them in context
- Explain relative vs absolute risk where relevant
- Include a visual tool where possible

Risks of vaccine-preventable disease

- For people with a chronic disease or health condition, it is very important to clearly understand the risks of vaccine-preventable disease that may be increased by having the underlying chronic condition. 
- Refer back to VAC-PACT e-Learning Module Section

Side effects 

- Most people who report doubts about vaccination refer to the fear of side effects. In any decision-making process, it is important to discuss potential side effects. (See also: “The hesitant patient”, below). 

- People sometimes make connections between events that happen close to one another in time, when in reality they are not related. It is important to be able to explain the difference between correlation and causation in lay-friendly, non-patronising terms. It is also useful to clarify that the risk of serious side effects is very small, putting it into context of other risks if possible. Finally, it is good to let the patient know that if they suspect a side effect they should report it, preferably to a healthcare professional. Other ways exist also. (see “How vaccines are developed, approved and monitored”, below)
- Refer to VAC-PACT e-Learning Module Section 1 on Summary – vaccination key messages

Herd immunity 
- It is important that the healthcare professional is able to explain how herd immunity works. Especially for patients who may not be able to take some, or any, vaccines, it is important for their supporting persons (family, potentially friends) to understand the importance of being vaccinated to support the person with weak immunity who is vulnerable to infection. 
- Some people dislike the term “herd immunity”. For those, it may be better to use the term “community immunity” or “community protection”. 
- A visual representation can also be helpful to illustrate the concept.
- Refer to VAC-PACT e-Learning Module Section 1 on Importance of vaccination

![0001.jpg](https://vac-pact.fra1.digitaloceanspaces.com/a9a5de7018c4c3183e5b0051df640820.jpg)
![0002.jpg](https://vac-pact.fra1.digitaloceanspaces.com/eb0748f634826734bda2732726726864.jpg)


How vaccines are developed, approval and monitored 
- Patients with chronic conditions are sometimes – though not always – quite knowledgeable about the approval process for new medicines. They may or may not know that the same process applies to vaccines. Some patients are keen to have information on this.
- Healthcare professionals may wish to share summary information on how vaccines are developed, the different phases of clinical trials, the EU authorisation process, safety standards and pharmacovigilance monitoring. 
- It is important for patients to know that vaccines undergo exactly the same rigorous scientific evaluation and approval process at EU level as any other medicinal product. It is also a good idea to explain that vaccines, just like other medicines, undergo continuous monitoring of their safety (pharmacovigilance), and in case there are reports of important side effects, the EU system will take action. 
- Refer to VAC-PACT e-Learning Module Section 1 Vaccination development


What information do patients with chronic disease need about vaccination? 

EN_trust_matrix.png

•	A conversation is a mutual exchange. It is part and parcel of the process of shared decision-making. Having meaningful conversations implies that the two parties are exchanging views on the same footing – even if the views held by one may not have the same scientific validity as the others. It is vital that healthcare professionals “listen more and develop a communication style that is trust-based and science-informed.” 

•	For patients and healthcare professionals to make shared, informed decisions, it is important that there is full information based on the latest available scientific evidence. The information needs to be conveyed in a way that the patient can readily understand, and the patient’s personal views and preferences need to be equally considered in the decision. 

•	Healthcare professionals can reinforce trust by explaining transparently what is known based on scientific evidence and being open about areas of uncertainty in the evidence-base. 
Thus, shared decision-making is an important aspect of building a trustful relationship between patient and professional. 


Paternalism to partnership: direction to dialogue

•	Some patients may express hesitation when it comes to vaccination. They may, in some cases, have read or heard something that worried them, or may simply have questions relating to their health condition. 

•	Dismissing a patient’s views is not effective, and facts alone are not necessarily effective in changing behaviour.

•	The World Health Organization (WHO) recommends motivational interviewing for hesitant patients (who do not outright reject vaccination). This is a technique of interaction that can be used to explore the patient’s reasons for hesitating and move them towards acceptance on the spectrum (figure, above). The same basic principles can be applied to interactions with patients who have chronic diseases, though the specific questions they have may be different. 

•	Motivational interviewing involves 5 steps:

     1.      Open (why…? what…?) rather than closed (yes/no) questions 

     2.      Reflecting on and responding to what the patient says, repeating back what you think they meant.  This is a way of acknowledging their concerns!

    3.     Affirming strengths (“Good that you are thinking about vaccination”) and validating concerns (“Protecting yourself from illness is important to you.”)

     4.      Ask – provide – verify 

             •	Ask about what the patient knows about vaccines
             •	Provide information 
             •	Verify that the patient has understood, check what they will do with the information 

     5.	Summarise the conversation and determine the action. If the patient still hesitates, suggest revisiting the issue at another (specific) time. If they refuse, do not reject but leave the door open for re-engagement.  

•	A conversation is a two-way process, a give and take. The patient should feel free to express their views. You as a healthcare professional should also feel free to express your views. It may be difficult to do this if you feel the patient is wrong or misguided, but it is important not to patronise or talk down to a patient. 

•	Being respectful is important. Respecting their need (and your own) to have the space to reflect on what is being said and come back to the conversation is also important.

•	Some people are not used to being asked how they feel. Maybe no-one ever asked about their feelings and needs, especially if they are used to having to “fight to be heard” because of their “alternative” perspective on an issue.

•	Refer to VAC-PACT e-Learning Module Section 1 Vaccine Hesitancy


The hesitant patient

Source: Adapted from the WHO conversation guide

•	I understand you wish to make the best possible choice for yourself. What are your concerns?
•	What side effects are you concerned about? 
•	What do you already know about the importance of vaccination for your health condition?
•	Can I offer you some information about why vaccination is important for people with your health condition? 
•	What do you know about how the immune system works? 
•	What is your concern about your immune system and this vaccine?  
•	Given our discussion, how do you view the decision now?
•	Remember, I am here to help talk through any concerns you may have.


Possible questions and statements in response to a patient’s expressed concerns

Healthcare professionals should engage with patients who wish to discuss information they found online, rather than dismissing it. How can one you know if information is reliable?

•	Is it from an official source? Check the URL – Is it official, such as a governmental website (e.g,. .gov.uk, who.int)?

•	Look at the context – who is publishing the information, and why? Is it a university, funding body or peer-reviewed journal? 

•	Check references – do the claims come with sources? Can you trace them back to reliable information?

•	Search for specific terms (example: “vaccination recommendations for diabetes”) rather than simply “vaccination”. The latter may be more likely to bring up unreliable results. 


How to help patients interpret online information 

The FAQs are based on questions received from patients with various chronic diseases after consultation of EPF’s membership, during the Shot Callers webinars over the cross of 2021, with representatives from the World Health Organization (WHO) Global Advisory Committee on vaccine safety and the European Medicines Agency (EMA).

Below we present some of the patients’ some of the most frequently asked questions that they would like healthcare professionals to be able to answer.  

•	Q: Some people are concerned that mRNA is an untested and risky technology to be used so quickly for the mass public. How new is this technology?

A: The use of mRNA vaccines goes back to the early ‘90s where it has been studied in clinical trials and tested. mRNA vaccines for human use have been developed to treat diseases such as rabies and influenza. In December 2020, UK’s Medicines and Healthcare products Regulatory Agency MHRA became the first global medicine regulator in history to approve an mRNA vaccine for human use, the Pfizer/BioNTech vaccine based on world data on efficacy and safety under highly scrutinized clinical trials.


•	Q: Are mRNA vaccines considered safe for everyone?

A: Yes, mRNA vaccines are classically associated with iatrogenic reactions: the most common is pain at the injection site. Fatigue and headache are others relatively common adverse events. High fever, however, is less common. These events are generally resolved within a couple of days and are more common between younger vaccines recipients. Second doses are associated with more adverse events. Reports on vaccine recipients experiencing severe allergic reactions shortly after receiving the first dose are rare. 


•	Q: Are there any precautions, for example, for certain people with chronic conditions and/or people who are immunocompromised?

A: Presently, hypersensitivity is only absolute contraindication to the vaccine which is known. While there is limited data on how immunocompromised people may respond to the vaccine, there are no safety concerns to expect from this population specifically as they are at increased risk for severe COVID-19 complications.


•	Q: What can we do to better protect particular groups who cannot be vaccinated, because of their condition?

A: Protect yourself, avoid crowds, avoid poorly ventilated spaces, wash your hands often, and get vaccinated. The aim is to achieve the herd immunity through vaccination, lowering the overall amount of virus able to spread within the population and, therefore, keep the vulnerable population safe.


•	Q: Normally, the development of a vaccine takes several years. Can you explain how the EMA has been able to approve COVID-19 vaccines to quickly?

A: The first and most important reason has been the availability of volunteers to be recruited in the clinical trials: generally, the recruitment takes months. The COVID-19 pandemic had made it possible to easily collect the data and allocate an incredible number of resources worldwide for this initiative. 


•	Q: Did EMA have different safety and efficacy requirements for COVID-19vaccines compared to other vaccines and medicines? 

A: No, the main body of evidence for vaccine safety and efficacy comes from large controlled, randomised clinical trials where selected volunteers are randomly allocated to receive the vaccine being tested under controlled conditions and strict protocols. In terms of numbers and magnitude, COVID-19 studies were much higher than previously approved vaccines within the last 25 years. 


•	Q: What can we know about the long-term effects of the vaccines?

A: Vaccines can cause side effects just like any medication would. It is essential to also note that though some patients may develop minor symptoms after vaccination, these are normal signs that the body is building protection. Symptoms, if any, should subside in a few days. Remember, the safety of all vaccines in the EU is carefully monitored by the European Medicines Agency (EMA).


•	Q: What should one do if one suspects an adverse reaction to a vaccine?

A: Patients should report side effects directly to their healthcare professional. Suspected side effects should then be directly to the respective national authority, contact details available here, or to the manufacturer of the medicines using the instructions in the patient leaflet


Model FAQ

This vignette is the summary of an interview with a patient undertaken within the EPF’s work on vaccination in 2018. The patient’s name has been changed and some other details omitted. How could a healthcare professional approach vaccination with John? 

John’s story 

•	John is a middle-aged man who was diagnosed with an autoimmune disorder in his twenties. John has since his youth approached his overall health and well-being not only through medication or “Western” medicines, but also by considering and even testing some complementary/alternative medicines.

•	When his chronic condition revealed itself, a doctor told him it may have been caused by a vaccine he received as a child. John received all the childhood vaccines.

•	Since then, John’s attitude to vaccination is one of a “careful doubter”: he does not reject all vaccines nor denies their efficacy or benefits in general, but he thinks they should not be widely generalised. 

•	John believes personalised medicine should be fully applied in the case of vaccination: each person should be tested prior to being vaccinated to assess whether they run a risk of an adverse reaction. If John needed to go to a country with high risk of yellow fever, for instance, we would seriously consider getting the yellow fever jab before his visit, he said. 

•	However, John says he did not vaccinate his very young daughter and left her the choice of doing so herself. His daughter decided later to get all the most common vaccines. Fortunately, says John, she did not develop any bad reactions. John was scared that he might have transmitted to his daughter a possible genetic defect that would have made her more sensitive to vaccines. 

•	John has consulted CAM specialists for his condition and explored acupuncture, homeopathy, and other practices. He likes to manage his health holistically. John’s thinking is: “my immune system is already compromised, why would I attack it with chemicals I am not sure my body can cope with?” John was never vaccinated against influenza. He believes living a healthy life overall would help him fight it should he catch it – and that his lifestyle does not expose him to high risks of being affected by influenza. 

•	John supports the principle of homeopathy. When told that scientific studies did not find any more clinical efficacy to homeopathy than placebos, he underlined that the latter should be given as much attention as a treatment as other options – “it has shown it worked”, he added.

•	John recommends that in the future, when we understand DNA better, the health services should offer personalised vaccination taking into consideration the genetic specifications of the person. Tests could be even run pre-birth. He also suggested the possibility of “conscious objection”, such as in the army, to oppose mandatory vaccination. 

•	John stressed that risks and benefits are not communicated well in his country. The health system puts a great emphasis on benefits, but he read and heard about risks of autism due to vaccination and of people who get ill after a flu jab. John believes that science does not always get it right and that people’s environment – for example high risk of exposure or not – should be taken into consideration when taking the decision to vaccinate or not. 


Case study of a hesitant patient: John’s story 

•	Approach vaccination as a normal part of healthcare. The confidence of a healthcare professional can be a strong influence on a patient’s confidence. 
•	If the patient has questions, answer them with evidence-based information in a lay-friendly way. 
•	Listen attentively and really hear what the patient is saying. 
•	Acknowledge their concerns a legitimate. 
•	Understand that there may be strong emotions involved. 
•	Do not patronise. 
•	Provide science-based information to respond to their concerns.
•	Avoid using scary images with needles in visual materials.
•	Have the relevant facts at your fingertips. 
•	Have a conversation in an environment that is suitably private. Take time. 
•	Share personal stories if appropriate. 
•	Give the patient information materials to take away with them, or point them to online information sources
•	Be prepared for situations where a patient may get different messages from a doctor, nurse, pharmacist, or other healthcare professional.
•	If appropriate, refer the patient to a patient organisation for information and support. 


Summary: how to have a good conversation about vaccination 

•	A vaccine is a product that improves immunity to a certain disease and protects the person from that disease. It typically contains an agent that resembles a disease-causing micro-organism. Vaccines are normally administered by using needle injections, but they can also be given by mouth or sprayed into the nose.

•	Vaccination is the administration of a vaccine to help the immune system develop protection against a communicable disease. It is an effective, safe, and simple way to protect people before they come into contact with diseases.

•	Immunity means the condition of being immune against infectious disease conferred either by the immune response generated by immunisation or previous infection or by other nonimmunologic factors. 

•	Herd immunity, also known as community or population immunity, is reached when enough people in a population being immunised against an infectious disease makes the disease unlikely to spread from person to person.

•	Immunisation is the process where a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine.

•	Vaccine hesitancy is defined as a delay in the acceptance or refusal of vaccines despite the availability of vaccine services.

•	Vaccine confidence is defined as trust in the effectiveness and safety of vaccines but also in the system that delivers them, including healthcare professionals, and in the processes that lead to vaccination policies and immunisation schedules.

•	Complacency occurs where perceived risks of vaccine-preventable diseases are low and vaccination is not considered a necessary preventive action.

•	Convenience is a factor when availability, affordability, geographical accessibility, ability to understand (language and health literacy) and appeal of immunisation services affect uptake.

•	Health literacy is the capacity to make sound health decisions in the context of everyday life at home, in the community, at the workplace, in the health-care system, in the marketplace, and in the political arena. This mean also understanding healthcare professionals advise and information about vaccination.

•	Misinformation means false information that is communicated regardless of an intention to mislead. It is often started by someone who wants to understand the topic and cares for example about vaccination. This false information is then shared by others believing that it is correct.

•	Disinformation means false information that is spread intentionally to mislead and cause harm. That harm could be to people, organisations or even countries.

•	Patient empowerment is a multi-dimensional process that helps people gain control over their own lives and increases their capacity to act on issues that they themselves define as important. It comprises of three overlapping and mutually reinforcing aspects: information/education (health literacy), shared decision-making, and self-management.

•	Patient involvement at individual level is the extent to which patients (and their families/caregivers as appropriate) participate in decisions related to their condition, for example through shared decision-making and self-management, or contribute to improvements in healthcare quality through bringing their specific experience and perspective as patients. At collective level, patient involvement is the extent to which patients’ representative organisations contribute the patient perspective and voice to shaping healthcare systems through their involvement in healthcare policymaking, organisation, design, and delivery.


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