THEORY OF

VACCINATIONS –

DELEGATE

HANDOUT

ABSTRACT The course covers the background of

vaccines; current issues and

controversies; legal aspects of

vaccines; communication with patients

and parents; the correct handling and

storage of vaccines

© ECG

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Contents Objectives ............................................................................................................................................... 2

Principle aim of immunisations............................................................................................................... 2

History of Immunisation ......................................................................................................................... 2

Aims of immunisation programmes ....................................................................................................... 4

Immunisation programmes are designed to protect individuals .................................................... 4

Implementing UK vaccine policy ............................................................................................................. 5

Vaccine Trials .......................................................................................................................................... 6

Introduction to the immune system ....................................................................................................... 6

Immune response ................................................................................................................................... 8

Herd immunity ........................................................................................................................................ 9

Uncertain or incomplete vaccination status ........................................................................................... 9

Different types of vaccine ....................................................................................................................... 9

Response to vaccines ............................................................................................................................ 10

Combination vaccines ........................................................................................................................... 11

Immunoglobulin and the timing of doses ............................................................................................. 11

Efficacy .................................................................................................................................................. 11

Current Issues and Controversies ......................................................................................................... 12

Dealing with issues and controversies .................................................................................................. 12

Some of the myths about vaccination .................................................................................................. 13

Communicating with patients and parents .......................................................................................... 14

Factors affecting immunisation rates ................................................................................................... 16

Strategies for improving immunisation rates ....................................................................................... 16

Consent ................................................................................................................................................. 16

Capacity to consent ............................................................................................................................... 17

Who can consent .................................................................................................................................. 17

Consent on behalf of another ............................................................................................................... 18

Consent for young children ................................................................................................................... 18

Other Legal Points ................................................................................................................................. 18

Storage of vaccines ............................................................................................................................... 19

Managing the cold chain ....................................................................................................................... 20

Ordering and disposal of vaccines ........................................................................................................ 21

Reconstitution of vaccines .................................................................................................................... 22

Safe use of sharps ................................................................................................................................. 24

Handling of spillages ............................................................................................................................. 24

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Objectives

By the end of reading this course booklet, you will be able to:

• Know the aims of immunisation

• Know the immune system and how vaccines work

• Know the different types of vaccines used and their composition

• Know the vaccine preventable diseases - influenza

• Know the current issues and controversies regarding immunisation

• Communicate with patients and parents/guardians

• Understand the legal aspects of vaccines

• Know the storage and handling of vaccines

• Know the correct administration of vaccines

• Know the adverse events including faint, anaphylaxis and panic attacks

The practical elements of the vaccination course will be completed within face to face training. Please

also ensure that you speak with your employer after completing this training course so that you are

aware of any local policies or procedures that you may need to follow to ensure compliance.

Principle aim of immunisations

Immunisation prevents illness, disability and death from vaccine preventable diseases.

The principal aims of immunisation are to:

• Protect the individual who receives the vaccine

• Prevent outbreaks of disease

• Eradicate infectious diseases world-wide

The two public health interventions with the greatest impact are clean water and vaccination

History of Immunisation

FACT: Over the last 50 years, immunisation has saved more lives worldwide than any other medical

product or procedure, and it's estimated that immunisation currently averts 2 to 3 million deaths every

year.

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1796: Edward Jenner discovers vaccination

Dr Edward Jenner, British physician, discovered vaccination

and proved to the scientific community that it worked.

1803: Royal Jennerian Institute founded

Jenner was awarded government funding, and the Royal Jennerian Institute was founded. Support for

vaccination grew with it becoming popular throughout Europe and the US.

1870s: Opposition to vaccination

Despite vaccination being taken up enthusiastically by many, there was also violent opposition as it

became widespread. People found it difficult to believe that it really worked, and felt it took away

people's civil liberties when it was made compulsory.

1880s: Rabies vaccine

Louis Pasteur improved vaccination even more and developed a vaccine for rabies. The science of

immunology developed and more vaccines were created as scientists began to understand more about

how diseases worked.

1890: Diphtheria and tetanus vaccines developed

Scientists discovered the antitoxins of diphtheria and tetanus and demonstrated that animals injected

with small amounts of the tetanus toxin became immune to the disease.

1920s: Vaccines become widely available

By the end of the 1920s, diphtheria, tetanus, whooping cough and tuberculosis (TB) vaccines were all

available. Vaccination spread across the world and although crude, these early vaccines worked. The

first programmes dramatically reduced the number of deaths from disease.

1955: Polio vaccination begins

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Polio vaccination was introduced in the UK, dramatically reducing the incidence of the disease. Polio is

now extremely rare and is close to being completely eliminated world-wide.

1956-1980: WHO fights to eradicate smallpox

In 1956 the World Health Organization (WHO) decided to try to eradicate smallpox across the world by

using the smallpox vaccine on a global scale. By 1980 it was declared as being eradicated.

2008: Cervical cancer scientist awarded Nobel Prize

It was discovered that cervical cancer was caused by a virus, Human Papillomavirus (HPV) making it

possible to develop a vaccine for the disease. The NHS cervical cancer vaccination programme began,

in which all girls aged 12 to 13 are offered HPV vaccination. HPV vaccination is the first routine universal

vaccine that has been given to prevent a type of cancer.

2013: NHS vaccinates against shingles, rotavirus and children's flu

The NHS vaccination programme introduced the rotavirus vaccination for babies and a shingles vaccine

for over-70s. The intranasal flu vaccine for children was also launched.

2015: NHS vaccinates babies against meningitis B

The NHS vaccination programme saw the introduction of Men B vaccination for babies - the first

national, routine, universal and publicly funded Meningitis B vaccination programme in the world.

Aims of immunisation programmes

Immunisation programmes are designed to protect individuals Immunisation programmes are designed to protect individuals at highest risk or to control or eliminate

disease:

Selective immunisation strategy:

Implemented to protect those at highest risk of a particular disease, for example, clinical, travel or

occupational risk

Universal immunisation:

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Implemented to control, eliminate and eradicate disease (e.g. all routine immunisations offered in

childhood)

Designing and monitoring immunisation programmes

The role of surveillance in designing and monitoring immunisation programmes:

Surveillance refers to monitoring the occurrence and spread of a disease, along with the efficacy and

safety of vaccines

It is an ongoing process that is undertaken before and after a vaccine programme is introduced

Before a vaccine programme is designed the burden of the disease is surveyed, which informs the

vaccination strategy

Epidemiological data and surveillance

Using epidemiological data and surveillance the following questions are answered:

• Is there a need for the vaccination programme?

• Is there a safe and effective vaccine available?

• What other issues need to be considered? For example cost, cultural attitudes

Monitoring following implementation of a

vaccine programme

Once a vaccine programme is implemented the

following are monitored:

• Incidence of the disease

• Vaccine coverage

• Adverse Events Following Immunisation

(AEFIs)

• Adverse Drug Reactions (ADRs)

• Vaccine safety

Implementing UK vaccine policy The following bodies are responsible for implementing UK vaccine policy:

• Joint Committee on Vaccination and Immunisation (JCVI) - Reviews evidence and

advises the Department of Health

• Department of Health (DH) - Sets national policy and leads the national programmes

• Regular guidance is issued through the Green Book, CMO and other guidance letters

• Medicines and Healthcare products Regulatory Agency (MHRA) Responsible for the

licensing of vaccines and the Yellow Card reporting system

• National Institute for Biological Standards and Control (NIBSC) Responsible for the

quality and safety of vaccines

• The Green Book Guidance from The Green Book plus manufacturer's instructions should be

used to define local policies and PGDs.

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Vaccine Trials

In the UK, vaccines are tested for safety, efficacy, quality, and immunogenicity before they are licensed

for use. Click on the circles to the right to find out more about each phase.

Ongoing monitoring

Once marketed, the Medicines and Healthcare Regulatory Agency (MHRA) is responsible for monitoring

all medicines and medical devices including adverse reactions.

Yellow Card scheme

Any suspected adverse drug reactions (ADR) following the use of a medicine, vaccine or medical device

should be reported to the MHRA using the Yellow Card scheme.

Once reported the data is entered onto a database and reviewed regularly. Appropriate investigation

and action is initiated if a possible problem is identified.

Phase 1

The safety and tolerability of the vaccine is tested on

a small number of healthy adult volunteers.

Phase 2

Involves proving that the vaccine is safe and effective

at preventing the disease.

The dose, age ranges and schedules for the vaccine

are also devised.

Phase 3

The vaccine is trialled on the population it is designed

to protect.

Introduction to the immune system

Innate, passive and active immunity

Immunity is the ability of the human body to protect itself from infectious diseases. The complex

mechanism of defending the body can be either innate or acquired.

Innate immunity

Innate immunity refers to immunity present from birth, which includes:

• physical barriers (such as the skin and mucous membranes) and

• chemical barriers (such as digestive enzymes)

Acquired immunity

There are two mechanisms for acquiring immunity, passive and active

• Passive immunity - This is protection provided from the transfer of antibodies from immune

people:

o Commonly across the placenta

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o The protection from transfer of antibodies across the placenta differs in effectiveness

depending on the infection and is temporary - often for a few weeks or months

o Immunity can also occur from the transfusion of blood or blood products such as

immunoglobulin

• Active immunity - Immunisation is the induction of artificial immunity through the

administration of a vaccine or immunoglobulin. Vaccines tend to provide immunity

comparable to the natural disease without the risk from the disease or it's complications.

Active immunity can be either cell mediated, or antibody mediated. This type of protection is

produced by an individual's own immune system:

o It is normally long lasting

o It can be acquired by vaccination or natural disease

o This type of immunity can be either

- antibody-mediated or

- cell-mediate

An antigen - any substance capable of eliciting an immune response. Antibodies -

proteins that are produced by the immune system in response to infection or

vaccination.

Active immunity

Lymphocytes

The cells responsible for immune specificity are lymphocytes, which are found in large numbers in the

blood, lymph and lymphoid organs. There are two major classes of lymphocytes - T cells and B cells:

• T cells are responsible for cell mediated immunity

• B cells produce antibodies and act as memory cells

Antibody Mediated Immunity

Antibody mediated responses are produced by B cells:

• When a B cell encounters an antigen, the B cell is stimulated to proliferate and produce large

numbers of antibody to the antigen

• These antibodies circulate in the bloodstream, where they bind specifically to the antigen that

induced them

• This binding inactivates viruses and bacterial toxins by blocking their ability to bind to receptors

on target cells

• Antibody binding also labels invading microorganisms, making it easier for phagocytic cells to

ingest them, or activates complement mediated killing

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Cell Mediated Immunity

Cell mediated immunity relies on a system of antigen recognition and cytokine production rather than

antibody production and is controlled by T cells:

• The T cells recognise antigens present on the surface of cells which generates their effect

• Once activated T cells produce cytotoxic cells

• These destroy infected cells, and stimulate the release of cytokines which prevent

microorganisms from replicating within cells

Types of T cells

There are several types of T cells:

• T helper cells stimulate the immune response of other cells, including the release of cytokines

• T suppressor cells play an inhibitory role and control the level and quality of the immune

response

• Cytotoxic T cells recognise and destroy infected cells and activate phagocytes to destroy

pathogens

Immune response The immune response to a vaccine

• A vaccine is a biological preparation that improves immunity to a certain disease

• A vaccine typically contains an agent that resembles a disease-causing microorganism • It is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins

How it works The agent stimulates the body's immune system in order to:

This means that the immune system can more easily recognise and destroy any of these microorganisms

that it later encounters.

Vaccines produce their protective effect by inducing active immunity and immunological memory

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This memory means that the immune system is able to recognise and respond quickly to an exposure to

natural infection, and prevent or modify the disease.

Conditions that might affect the immune response to vaccines:

• Immunosuppression by disease or treatment

• Impaired immunological mechanism

• Malnutrition and chronic disease

• Sickle cell disease and other causes of hyposplenism

• Simultaneous administration of immunoglobulin

Herd immunity The primary aim of vaccination is to protect the person who receives the vaccine. Those vaccinated are

also less likely to be a source of infection to others, thus reducing the risk of an un-vaccinated

individual's exposure to infection. This means that those unable to be vaccinated, or for whom

vaccination has failed, will also benefit from the vaccine programme - This is known as herd immunity.

When high levels of population immunity exist, infection may be eliminated.

High vaccine coverage is required to be maintained to prevent the disease from returning.

Uncertain or incomplete vaccination status If children or adults present with unknown vaccination history, every effort needs to be made to

ascertain which vaccines they may have had. If this is not possible, the assumption that they are

unimmunised should be made and a full course of the immunisation given. If any course of

immunisation is interrupted, The Green Book guidance advises to resume and complete it as soon as

possible.

NOTE: There would be no need to re-commence the whole course again, as the immunological

memory from the previous doses is likely to be maintained

Different types of vaccine There are two types of vaccine, inactivated and attenuated.

Inactivated Vaccines

• Inactivated bacteria or viruses - e.g. pertussis

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• Inactivated toxins (toxoids), only the antigens that are needed for protection - e.g. tetanus and

diphtheria

• A surface protein (hemagglutinin) - e.g. influenza

• A polysaccharide from the bacteria capsule - e.g. pneumococcal

Conjugate Vaccines

Polysaccharide vaccines do not stimulate the immune system as broadly as protein antigens. Therefore

the protection from these vaccines is short lived, and the response is poor in infants and young

children. Some polysaccharide vaccines have been enhanced whereby the polysaccharide antigen is

attached to a protein carrier. This enables the immune system to respond more effectively to the

antigen and provide an immunological memory (e.g. Hib and Men C vaccines).

This is known as a conjugate vaccine.

Adjuvants

Some inactivated vaccines contain adjuvants such as aluminium phosphate or aluminium hydroxide,

in order to enhance the antibody response to the antigen.

Response to vaccines The body’s response to inactivated vaccines

The first injection results in a primary

antibody response - Where an inactivated

vaccine or toxoid is given to someone without

previous exposure to the antigen.

Further injections may be needed to elicit

such a response in young infants - This is

known as the primary course.

Further injections will lead to an accelerated

response dominated by IgG - Depending on

the potency of the product and the time

interval. This is known as the secondary

response.

Following a primary course of vaccination, antibodies may persist for months or years - Even if the

level of detectable antibody subsequently falls, the immune system has been primed. Therefore an

individual may be protected.

Further reinforcing doses of vaccine are used to boost immunity and to provide longer-term

protection Inactivated vaccines cannot cause the disease that they are designed to prevent.

The body’s response to live attenuated vaccines

• Live attenuated virus vaccines, such as MMR, usually promote a full, long-lasting antibody

response after one or two doses

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• To produce an immune response, the live organism must replicate (grow) in the vaccinated

individual over a period of time (days or weeks)

• The immune system responds in the same way as it does to natural infection

• It usually does this without causing the disease itself (because the vaccine virus is weakened or

'attenuated'), but for some vaccines, a mild form of the disease may rarely occur (e.g. a rash

following measles-containing vaccines)

Combination vaccines Vaccines are either monovalent or combination:

• Monovalent vaccines immunise against a single antigen or microorganism

• Combination vaccines immunise against two or more strains of the same microorganism or two

or more microorganisms

Before combination vaccines are licensed, studies are carried out to ensure that:

• The immune response to any of the combined antigens is just as good as the response to the

individual vaccines

• The rates of adverse reactions are the same as they would be if the vaccines were administered

separately

Immunoglobulin and the timing of doses Immunoglobulin

Injecting human immunoglobulin can provide passive immunity:

• It contains the antibodies to target the infection thus temporarily increasing the antibody levels

to the specific infection

• It may be recommended when protection is required quicker than it takes for the vaccine to

provide protective antibody response, (e.g. after exposure to the disease)

Advice on the use of immunoglobulins is given in The Green Book

Timing of doses

Intervals are necessary between vaccine doses to enable the vaccine response to develop properly:

• After a primary response to a vaccine, subsequent doses may be needed to ensure a longer

lasting response (secondary response)

• The interval between doses will depend on the vaccine given

Live vaccines should be deferred until 3 months after receiving any blood products. This is because the

human normal immunoglobulin found in blood products could prevent vaccine virus replication.

Efficacy Vaccines do not offer 100% protection from the disease, with a small percentage of individuals getting

infected in spite of vaccination.

Vaccines can fail in two ways:

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• Primary Failure - When someone fails to make an immunological response to the vaccine.

• Secondary Failure - When an individual initially responds but protection wanes over time.

Those who acquire infection despite vaccination may have a milder form of the disease. They

are also less likely to suffer severe complications than if not previously vaccinated.

Current Issues and Controversies Healthcare professionals are the primary point of contact for the general public regarding

immunisation.

By accessing up-to-date information about vaccines and vaccine programmes, practitioners can deliver

programmes effectively and actively address concerns that patients and parents may have. Being well

informed and communicating effectively can have a significant impact on vaccine uptake rates.

Dealing with issues and controversies All healthcare professionals involved in immunisations should have access to The Green Book and be

able to access relevant immunisation guidance e.g.

• Department of Health (DH)

• World Health Organisation (WHO)

• Public Health England (PHE)

Those performing vaccinations can subscribe to regular email vaccine updates which describe the latest

developments in vaccines, policies and procedures.

Points to consider when critically evaluating vaccine research

• The background and expertise of the author

• Where it was published

• Any author bias - i.e. do they have a vested interest in presenting a particular viewpoint

• The intended audience

• Is the source peer-reviewed - i.e. is it agreed upon by multiple credentialed members of the

same field?

• Make sure the study quoted followed all research protocols and resulted in statistically

significant findings that are conclusive - These findings should also be peer-reviewed

• Is the connection noted "causal" or "correlated"?

• Was the sample large enough to be statistically sound?

• Correlated findings are only suggestive, and further research is necessary to determine if the

two factors under investigation are truly related

• Causal findings suggest the factors under study are actually related

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It is important to use information that is reliable and

valid

Misconceptions and beliefs can have an effect on

vaccine update rates

Some of the myths about vaccination Read each fact below and decide if it is true or false and then click on the button to find out more.

• Better hygiene and sanitation means vaccines are not necessary

o FALSE. If vaccination programmes are stopped, the diseases that are vaccinated

against will return. Whilst improved hygiene, hand washing and clean water help

protect people from infectious diseases, many infections can spread regardless of

cleanliness. If people are not vaccinated, diseases that have become less common,

such as polio and measles, will quickly reappear.

• Vaccines have damaging and long-term side-effects that are not known

o FALSE. Vaccines are very safe. Most vaccine reactions are minor and temporary, such

as an achy arm or mild fever. Serious health events are extremely rare and are carefully

monitored and investigated. The combined vaccine can cause sudden infant death

syndrome.

• The combined vaccine against diphtheria, tetanus and pertussis (whooping cough) and the

vaccine against poliomyelitis cause sudden infant death syndrome.

o FALSE. There is no causal link between vaccines and sudden infant death. However,

these vaccines are administered at a time when babies can suffer sudden infant death

syndrome (SIDS). In other words, the SIDS deaths are co-incidental and would have

occurred without vaccinations being given. It is important to remember that these

four diseases are life-threatening and babies who are not vaccinated against them

are at serious risk of death or serious disability.

• Vaccine-preventable diseases are almost eradicated, so vaccination is unnecessary

o FALSE. Although vaccine preventable diseases have become uncommon in many

countries, the infectious agents that cause them continue to circulate in some parts of

the world. In our highly inter-connected world, these agents can travel across

geographical borders and infect anyone who is not protected. Successful vaccination

programmes depend on the cooperation of every individual.

• Giving somebody more than one vaccine at a time can increase the risk of side-effects

o FALSE. Evidence shows that giving several vaccines at the same time has no adverse

effect on someone's immune system. People are exposed to several hundred foreign

substances every day that trigger an immune response. The simple act of eating food

introduces new antigens into the body, and numerous bacteria live in the mouth and

nose. An individual is exposed to far more antigens from a common cold or sore

throat than they are from vaccines.

• Influenza isn’t serious, and the vaccine isn’t very effective

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o FALSE - Influenza is a serious disease that kills 300,000 - 500,000 people worldwide

every year. Pregnant women,

small children, elderly people and

anyone with a chronic condition,

such as asthma or heart disease,

are at higher risk for severe

infection and death. Most of the

influenza vaccines offer immunity

to the three most prevalent

strains circulating in any given

season. It's the best way to reduce

the chance of severe flu and of

spreading it to others.

• It is better to be immunised through disease than through vaccines

o FALSE - Vaccines stimulate the immune system to produce an immune response similar

to that produced by the natural infection - However they do not cause the disease or

put the immunised person at risk of its potential complications. In contrast, the risk

from getting immunity through natural infection can be high and can result in, e.g.

o Mental retardation from Haemophilus influenzae type b (Hib)

o Birth defects from rubella

o Liver cancer from hepatitis B virus

o Death from measles

• Vaccines contain mercury, which is dangerous

o FALSE - Thiomersal (an organic compound that contains mercury) is added to some

vaccines as a preservative. It is the most widely-used preservative for vaccines that are

provided in multi-dose vials. There is no evidence to suggest that the amount of

thiomersal used in vaccines poses a risk to health.

Communicating with patients and parents Decision Making

Factors affecting people's decision-making around vaccines can include:

o Religious beliefs

o Medical reasons - sometimes people believe a vaccine is contraindicated or have been mal-

advised by a healthcare professional

o That healthy living conditions make immunisation unnecessary

o That the risks of the vaccine are greater than the risk of the disease

o That herd immunity will protect them, so vaccination is unnecessary

o That their/their child's immune system will be overloaded

o Belief that as they have already had the disease, there is no need to have the vaccine

o Concerns about vaccine production/material

o That the vaccine will not protect them

o That the vaccine isn't safe

o Emotional distress at prospect of pain from the injection

Questions and Misconceptions

Addressing questions and correcting misconceptions about vaccines:

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Those giving vaccines need to be well informed with the facts about individual vaccines, particularly

when the media have raised fears about the safety of vaccination:

o Reassure patients (or parents) that vaccine safety is taken extremely seriously, that vaccines go

through rigorous trials and are strictly regulated and monitored

o Be aware of any current controversies and misconceptions surrounding immunisations, using

reliable and official sources to keep up to date (e.g. Public Health England) so you can discuss

them with patients

o Provide patients with up to date immunisation information leaflets (in the patient's language)

o Be aware of advertisement campaigns and documentaries and be able to discuss them

Risks

To effectively communicate about risks associated with vaccination:

o Communicate openly

o Be open and honest about known adverse effects of vaccines

o Keep vaccine related risks in context - i.e. the minimal risk of vaccination reactions compared

with the potential of the disease and its complications

o Emphasize the benefits of vaccines

o Ensure you can take time to answer any questions

o Be confident and empathic

o Acknowledge factors affecting an individual's decision‐making

o Explore any specific concerns

o Take into account the individual's level of knowledge

o Give written information and signpost to reliable sources of information

Anxious Patients

People of all ages can become anxious about having injections. Consider the following when dealing

with anxious patients:

o Adopt a calm approach

o Use distraction techniques, for example, engage them in conversation unrelated to the

vaccination

o Explain the procedure to ensure that the patient knows what to expect

o Reassure that it is a quick and simple process

o Prepare the vaccine and administer out of sight of the patient where possible

Other Factors

Other factors affecting immunisation rates are:

o Socioeconomic - such as living in deprived areas, living in lone parent families or being part of

a travelling community

o Attitudes - including personal beliefs and experiences, media portrayal, family and friends'

beliefs

o Health service issues - misconceptions regarding contraindications, lack of knowledge on

current policies, inadequate immunisation services

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Factors affecting immunisation rates Flu vaccine uptake data is collected via the web-based ImmForm system where it is managed and

published by Public Health England. Over 90% of GP practices are able to make automated data returns

where the number of their patients vaccinated is directly extracted from their IT system and put into

ImmForm. For data to be accurate and complete, it is critical that vaccines given outside the surgery

e.g. in pharmacies are reported to the patient's GP. Data is collected and published monthly on all the

groups for whom flu vaccine is indicated at national level and local NHS England team level, to enable

performance to be reviewed and time to take action if needed.

Public Health England set annual targets for uptake of the vaccine and these are as follows:

o Actively offering flu vaccination to 100% of all those in eligible groups

o Vaccinating at least 75% of those aged 65 years and over

o Vaccinating at least 75% of healthcare workers with direct patient contact

o Improving uptake for those in clinical risk groups, particularly for those who are at the highest

risk of mortality from flu but have the lowest rates of vaccine uptake e.g. those with long-term

liver and neurological disease, including people with learning disabilities

o For children, a minimum uptake of 40% has been shown to be achievable in pilots conducted

to date

As a minimum we would expect uptake levels between 40% and 60% to be attained.

Strategies for improving immunisation rates All healthcare professionals who immunise need to be knowledgeable and confident about the subject:

Providing a flexible and accessible service

o Are your clinics held at convenient times for patients?

o Do you hold evening or weekend immunisation clinics?

o Are you flexible in when you offer immunisations? Not just at 'baby' or 'child health' clinics?

o Are clinics adequately staffed with sufficient administrative support?

o Are clinic appointments long enough to allow discussion with parents / patients?

If you can't currently say yes to all the above, consider what more you could do to maximise uptake.

Consent It is a general legal and ethical principle that valid consent must be obtained before starting any

treatment, investigation, or providing personal care for a person. This includes administering a vaccine.

The principle reflects the right of patients and is a fundamental part of good practice. To gain informed

consent, health professionals should ensure that the individual (or those giving consent on their behalf)

fully understands the consent process. The consent process should include discussion on:

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o What immunisation(s) are to be given

o Which disease(s) will be prevented

o Benefits and risks of immunisation versus risks of

disease(s)

o Possible side effects and how these should be dealt

with

o With any follow-up/action required

o Information flows necessary for the appropriate

recording in the patient's GP practice record

o In the case of vaccinations administered under the

NHS, it also covers the sharing of information with NHS

England and the NHS Business Service Authority for the purpose of administration and

evaluation of the care provided

The individual must be informed about the process and be able to communicate their decision.

Further points on consent

o Consent must be given voluntarily and freely

o Information given should be relevant to the individual patient, explained properly and

questions answered fully

o The Community Pharmacy Seasonal Influenza Vaccination Advanced Service Specification

requires each patient to complete a consent form before the vaccine is administered

Any healthcare professional who does not respect this principle may be liable to legal action by the

patient and to action by their professional body.

Capacity to consent For consent to be valid it must be given by an appropriately informed person who has the capacity to

consent. The Mental Capacity Act defines someone who lacks capacity as "someone who is unable to

make a decision for themselves due to impairment or disturbance in the functioning in their mind or

brain."

Capacity

A person's mental capacity may be impaired either temporarily or permanently:

o Temporary impairment may be due to sedative medications or acute confusion.

o Longer term impairment may be as a result of dementia, brain injury or a learning disability.

To be deemed to have capacity an individual must be able to make a decision and therefore, be able

to do the following:

o Understand the information relevant to that decision, including understanding the likely

consequences of making, or not making the decision

o Retain that information

o Use or weigh that information as part of the decision-making process

o Communicate their decision

Who can consent o An adult is considered as a person over the age of 18

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o People of 16-17 years of age are presumed to give consent for their own medical treatment.

o Children under 16 years who have sufficient understanding and intelligence to enable them to

understand fully what is involved in a proposed intervention will also have the capacity to

consent to that intervention. This is described as being Gillick Competent

o If a person aged 16 or 17 or a person that is Gillick Competent consents to treatment, a parent

is unable to override that decision

o Where a young person of 16 or 17 or a child under 16 but Gillick Competent refuses treatment,

it is possible that this refusal could be over-ruled, if in all probability it could lead to the death

of the child or severe permanent injury.

Consent on behalf of another Individuals who are able to give consent on behalf of another individual are:

Those with parental responsibility (for a patient under the age of 18)

o Someone authorised under a Lasting Power of Attorney

o Someone who has the authority to make decisions about their treatment as a court appointed

deputy

Consent for young children For young children, not competent to give or withhold consent, such consent can be given by a person

with parental responsibility, provided that person is capable of consenting to the immunisation in

question and is able to communicate their decision."

See Chapter 2 of The Green Book for further details on "Who has parental responsibility?"

The child should be given an explanation (age appropriate) of the vaccination process. Evidence shows

that children appear to be less traumatised when parents value vaccinations and the child has been

prepared for what is going to happen.

For more information see Department of Health Reference Guide to consent for examination and

treatment

Other Legal Points

Data Protection

From the 25th May 2018 GDPR set standards which must be satisfied when obtaining, holding, using

or disposing of personal data. In adherence with current data protection legislation, individuals should

be informed about:

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o How data about immunisations will

be stored

o Who can access that information

o How the data may be used,

emphasising that it would be used to

monitor the safety and efficacy of

vaccination programmes

Patient Group Directions (PGDs)

PGDs are written instructions for the supply or administration of medicines to patients who may not

be individually identified before the presentation for treatment. They provide a legal framework for

supplying and administrating medications by a range of qualified healthcare professionals.

Organisations must ensure that individual users of PGDs are fully competent and trained in their use.

PGDs should be reserved for situations where they provide an advantage for patient care whilst not

compromising patient safety.

o Healthcare professionals using the PGD must

o Be individually named

o Have signed the PGD

o Act within their code of professional conduct

Documentation

Accurate, accessible records of vaccinations given are important for keeping individual clinical records,

monitoring immunisation uptake and potentially facilitating the recall of recipients of vaccines or

reporting Adverse Drug Reactions (ADRs).

The following information should be accurately recorded:

o Vaccine name, product name, batch number and expiry date

o Dose administered

o Site(s) used - including clear description of which injection was administered in each site,

especially where two injections were administered in the same limb

o Date given

o Name and signature of vaccinator

Professional Accountability

Healthcare professionals involved in the administration of immunisations are not normally negligent

if they are acting within their own competencies and within practice that conforms to that of a

responsible body of medical opinion held by practitioners skilled in the particular field.

Storage of vaccines There are a number of best practice principles governing the storage and handling of vaccines:

Store on delivery

• Store immediately

• Use a locked designated vaccine fridge

• Maximum/minimum thermometer

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• Allow room for air to circulate - This enables temperature to remain constant

Storing vaccines

• Specialised pharmaceutical fridges must be used for vaccines

and diluents

• The fridge must be lockable or in a locked room

• The temperature of the fridge must be monitored with a

maximum-minimum thermometer and recorded at least once

a day on a chart specifically designed for recording

temperatures.

• Sufficient space around the vaccine packages must be left

allowing air to circulate

• Vaccines should be store away from the side and back of the

fridge to prevent them from freezing

• To maintain a constant temperature of the fridge, keep the

opening of the fridge door to a minimum

• Ensure electricity to the fridge is safeguarded against inadvertent breaks by the use of a

switchless electric socket or a plug clearly marked "pharmacy fridge - do not switch off"

Daily monitoring

• Monitor and record maximum/minimum and current temperature

• Reset max and min thermometer readings daily

• Record at least daily in log books

• If any variations, take action accordingly

Ensure good practice

Reset fridge temp after clinics, re-stocking etc.

• Rotate stock

• Records to be kept for a minimum of 5 years

• Regular audit of current practice

• Training around the cold chain

• Local multidisciplinary support

Defined local policies should be in place. Written in accordance with PGDs, SPCs, The Green Book.

Managing the cold chain The cold chain refers to the cold conditions that certain products require to be kept at during storage and distribution. Vaccines should be stored according to the manufacturers Summary of Product Characteristics (SPC), usually between +2 and +8 degrees centigrade, in their original packaging. They must also be protected from light. Efficacy, quality and safety of vaccines may be affected if they are not stored at the temperatures stipulated in the SPC. Storage outside of the recommended temperature range speeds up irreversible loss of potency which may result in the vaccine being less effective at creating the desired immune response and subsequently reducing protection. Heat speeds up the decline in potency of most vaccines, therefore reducing their shelf life.

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Storage

IMPORTANT: Vaccines must never be frozen This causes deterioration of vaccines and may give rise to a loss of potency and an increase in reactogenicity by:

• Irreversibly denaturing the proteins in the vaccine • Causing the emulsions in the vaccines to become unstable • Producing hairline cracks in the ampoule/vial/pre-filled syringe, potentially contaminating the contents • The glass spicules (small sharp pointed fragments) produced may also cause serious local adverse

reactions Persons involved in the handling of vaccines should follow appropriate policies to ensure the cold chain is maintained until the point of administration.

Breaks in the cold chain

Management of breaks in the cold chain Any vaccine that has not been stored or transported according to the requirements, stated in the SPC, should not be used without a risk assessment of the likely impact of the temperature variation on the vaccine. Guidance on how to manage breaks in the cold chain can be found in the Health Protection Agency (HPA) document "Vaccine Incidence guidance". NOTE: Ensure you are familiar with your local policy in the event of a failure in the cold chain, and who to contact, if necessary.

Cool boxes

Setting up and using cool boxes

• Validated cool boxes and cool packs should be used (from a recognised medical supply company) • As well as a maximum minimum thermometer • The temperature should be recorded at the beginning and end of each session • Using a validated cool box ensures that the cold chain will be maintained for several hours

NOTE: Vaccines must be kept in their original packaging, wrapped in bubble wrap (or similar insulation material) to protect them from any contact with the cool packs and placed in the cold box as per manufacturer's instructions.

Ordering and disposal of vaccines Ordering stock

Stocks of vaccines should be monitored regularly by nominated staff members to avoid over-ordering or shortages. Vaccination providers should have no more than two to four weeks' supply of vaccines at any one time. Best practice is to order small quantities on a regular, scheduled basis.

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Disposal of vaccines

• Vaccines must never be used if they have passed their expiry date • Any out of date stock should be labelled, immediately removed from the fridge and disposed of as per

local policy • There should be locally written policy and procedures for the disposal of vaccines by incineration, these

must be followed • Equipment including any vials, ampoules, needles and syringes should be disposed of by placing into a

suitable sharps box (they come in varying sizes) • Sharps boxes should be sealed and replaced once they are two-thirds full or at the level indicated on

the box

Reconstitution of vaccines Some vaccines are supplied in a pre-filled syringe, others need to be reconstituted before use. Vaccines should be reconstituted when required, not in advance of an immunisation session, to avoid errors and maintain vaccine efficacy and stability. To reconstitute:

• Only use the diluent supplied and note the time scale in which it must be used after dilution (often 1-4 hours).

• Ensure correct diluent is used • Carry out away from direct sunlight to protect the vaccine • A green needle (21G x 38mm (11/2 inch)) should be used to draw up the diluent and to inject it slowly

into the ampoule containing the vaccine. • Injecting diluent rapidly into the vaccine may cause frothing, which can affect the dilution and

consequent potency of the vaccine; shaking the ampoule may have a similar effect. • If the freeze-dried powder does not instantly dissolve in the diluent, gently rotate the ampoule until it

dissolves. • Draw up the appropriate dose. • Unless the vaccine is supplied in a pre-filled syringe with an attached needle, a new needle should be

used to inject the vaccine. • The needle should be selected according to the patient's size

When removing liquid from a vacuum-sealed ampoule, in order to break the vacuum first inject the equivalent measure of air to the volume of liquid to be removed. When drawing up from a glass ampoule, use a needle gauge no larger than 21G to eliminate the possibility of drawing up glass fragments

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Vaccines are usually supplied as a vial of powder and a solvent in a prefilled syringe.

Add the entire contents of the prefilled syringe into the vial.

If the powder does not dissolve immediately, gently rotate the ampoule

until it dissolves.

After reconstitution, the mixture should be drawn up in full and used in accordance

to the manufacturers recommendation

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Safe use of sharps There are some key points to remember when handling sharps in order to reduce the risk of injury.

• Consider the use of needle-less and safer needle systems whenever available and appropriate • Sharps should not be passed directly from hand to hand, and handling should be kept to a minimum • Used standard needles:

- Must not be bent or broken before disposal - Must not be recapped

• Remove the sheath just before you intend to administer the vaccine

• Used sharps must be discarded immediately by the person generating the sharps waste into a sharps container conforming to current standards Always dispose of the sharp prior to placing cotton wool on the patient's arm

• Some vaccine sheaths are tight to get off, so point the needle and syringe down and away from you and gently twist to remove sheath

Sharps containers:

• Must be located in a safe position that avoids spillage, are at a height that allows the safe disposal of sharps within an arm's distance from the site of injection, are away from public access areas and are out of the reach of children

• Must not be used for any other purpose than the disposal of sharps • Must not be filled above the fill line and must be disposed of when the fill line is reached • Should be temporarily closed when not in use • Should be disposed of every 3 months even if not full, by the licensed route in accordance with local

policy

Handling of spillages

• There should be locally written procedures on how to clean the area, this may include the use of a spill kit

• You should also refer to the manufacturers' Control of Substances Hazardous to Health (COSHH) safety data sheets

• Spillages should be cleared up quickly and gloves worn • Care should be taken to avoid skin puncture from glass or needles • If a vaccine is splashed in the eyes, they should be washed with sterile 0.9% sodium chloride

solution and medical advice sought

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References British National Formulary British National Formulary (BNF) November 2016

Department of Health, 2006

Department of Health, 2006. A review of services to allergy: The epidemiology, demand for and the provision of treatment and effectiveness of clinical interventions.

EMC www.medicines.org.uk

Immform https://portal.immform.dh.gov.uk/Logon.aspx?returnurl=%2f

JCVI https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation

MHRA https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

NHS Patient Group Direction for Adrenaline

NHS Patient Group Direction for Adrenaline 1 in 1000 Nov 2014 March Review 2016

NIBSC http://www.nibsc.org/

Resuscitation Council Guidelines

Resuscitation Council Guidelines 2015

The Green Book https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Update of the Evidence Base: World Allergy Organization Anaphylaxis Guidelines

Simons F, Ebisawa M, Sanchez-Borges M et al. (2015) 2015 Update of the Evidence Base: World Allergy Organization Anaphylaxis Guidelines. World Allergy Organization Journal. 8:32

WHO http://www.who.int/en/