The national flu immunisation programme 2015/16 Training for healthcare practitioners

The national flu immunisation programme 2015/16

Training for healthcare practitioners

Key messages

• Flu immunisation is one of the most effective interventions immunisers can provide to reduce harm from flu and pressures on health and social care services during the winter

• Increasing flu vaccine uptake in clinical risk groups is important because of increased risk of death and serious illness if people in these groups catch flu

• For a number of years only around half of patients aged six months to under 65 years in clinical risk groups have been vaccinated

• Influenza during pregnancy may be associated with perinatal mortality, prematurity, smaller neonatal size, lower birth weight and increased risk of complications for the mother

• Vaccination of health and social care workers protects them & reduces risk of spreading flu to their patients, service users, colleagues and family members

2 The national flu immunisation programme 2015/16

Aims of resource

The purpose of this training resource is to:

• Develop the knowledge base of healthcare practitioners regarding the 2015/16 seasonal flu vaccination programme

• Support healthcare practitioners involved in discussing flu vaccination with those eligible by providing evidence based information

• Promote high uptake of flu vaccination in those eligible by increasing the knowledge of those involved in delivering the vaccination programme

• Provide information on the administration of flu vaccines


Learning Outcomes

On completion of this resource, healthcare practitioners will be able to:

• Describe the cause of flu

• Understand how flu is transmitted and the possible effects of flu

• Understand the evidence base for the administration of flu vaccination to those aged 65 years and over and those in clinical risk groups

• Explain which vaccines will be used and the precautions and contraindications to the administration of flu vaccines

• Explain the sequence of steps in flu vaccine administration

• Explain the possible side effects from flu vaccines

• Understand the importance of their role in promoting and providing evidence based information about flu vaccination to patients

• Identify sources of additional information


What is flu?

• Flu is an acute viral infection of the respiratory tract (nose, mouth, throat, bronchial tubes and lungs)

• Highly infectious illness which spreads rapidly in closed communities

• Even people with mild or no symptoms can infect others

• Most cases in the UK occur during an 8-10 week period during the winter

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Influenza viruses

There are 3 types of influenza viruses:

A viruses• Cause outbreaks most years and are the usual cause of epidemics

• Animal reservoir – wildfowl, also carried by other mammals

B viruses• Tend to cause less severe disease and smaller outbreaks

• Burden of disease mostly in children

• Predominantly found in humans

C viruses• Minor respiratory illness only


Flu A virus

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The blue protuberances represent haemagglutinin and the red spikes neuraminidase

Two surface antigens:

•Haemagglutinin (H)

•Neuraminidase (N)

Genetic material (RNA) in the centre

There are 16 different types of H and 9 different types of N


Genetic changes in the flu virus – what this means

Changes in the surface antigens (H & N) result in the flu virus constantly changing

• Antigenic drift: refers to minor changes (natural mutations) in the genes of flu viruses that occur gradually over time

• Antigenic shift: when two different strains combine. This abrupt major change results in a new subtype. Immunity from previous flu infections/vaccinations may not protect against the new subtype, potentially leading to a widespread epidemic or pandemic

Because of the changing nature of flu viruses, WHO monitors their epidemiology throughout the world

Each year WHO makes recommendations about the strains of influenza A and B which are predicted to be circulating in the forthcoming winter

These strains are then included in the influenza vaccine developed each year


Flu vaccine effectiveness• Efficacy calculated at between 50-60% for adults aged 18-65yrs,

• Lower efficacy in elderly although immunisation shown to reduce incidence of severe disease including bronchopneumonia, hospital admissions and mortality

• In 2014/15 the flu vaccine only provided limited protection against infection caused by one particular strain of flu A (H3N2)

• Caused by a mismatch between the A(H3N2) strain selected for the vaccine and the main A(H3N2) strain that circulated

• Throughout the last decade, there has generally been a good match between the strains of flu in the vaccine and those that subsequently circulated

Flu vaccination remains the best way to protect people from flu

It is crucial the mismatch in winter 2014/15 does not discourage at-risk groups from having flu vaccination in future flu seasons


Features of flu• Easily transmitted by large droplets, small-particle aerosols and by hand to

mouth/eye contamination from an infected surface or respiratory secretions of infected person

• People with mild or no symptoms can still infect others

• Incubation period 1-5 days (average 2-3 days) though may be longer especially in people with immune deficiency

Common symptoms include:

• Sudden onset of fever, chills, headache, muscle and joint pain and extreme fatigue

• Dry cough, sore throat and stuffy nose

• In young children gastrointestinal symptoms such as vomiting and diarrhoea may be seen


Possible complications of flu

Common:

• Bronchitis• Otitis media (children), sinusitis• Secondary bacterial pneumonia

Less common:

• Meningitis, encephalitis, meningoencephalitis• Primary influenza pneumonia

Risk of most serious illness higher in children under 6 months, pregnant women, older people and those with underlying health conditions such as respiratory disease, cardiac disease, chronic neurological conditions or immunosuppression

Flu during pregnancy may be associated with perinatal mortality, prematurity, smaller neonatal size and lower birth weight


Flu epidemiology

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Rate of influenza/influenza-like illness episodes in England (weekly returns to Royal College of General Practitioners), 2008–09 to 2014–15

• Flu activity usually between September to March (weeks 37 and 15)

• Impact of flu varies from year to year

• Moderate levels of influenza activity seen in 2014/15 season

• ICU/HDU admissions in 2014/15 higher than seen in the previous few seasons


UK flu vaccination programme • Late 1960s: annual flu immunisation recommended to directly protect those in

clinical risk groups who are at a higher risk of influenza associated morbidity and mortality

• 2000: flu vaccine policy extended to include all people aged 65 years or over

• 2010: pregnancy added as a clinical risk category for routine influenza immunisation

• 2013: phased introduction of an annual childhood flu vaccination programme

for all children aged 2-16y began with vaccine offered to all children aged 2 and 3 years and seven geographical pilots in primary school aged children

• 2014: phased introduction of childhood flu vaccination programme continued with vaccine offered to all children aged 2, 3 and 4 years and geographical pilots in primary and secondary school aged children

• 2015: offer to all 2, 3 & 4 year old children and children of school year 1 & 2 age


Flu vaccine eligibility: 2015/16 flu season

• those aged 65 years and over on or before 31 March 2016

• those aged six months to under 65 years with a serious medical condition

• all pregnant women (including those who become pregnant during flu season)

• all children aged two, three and four years on 31 Aug 2015

• all children of school years 1 and 2 age

• primary school-aged children in areas that participated in primary school pilots in 2014/15

• those in long-stay residential care homes or other long-stay care facilities

• carers and household contacts of immunocompromised individuals

Health and social care workers who are in direct contact with patients or service users should be offered flu vaccination by their employer


Morbidly obese patients• JCVI has advised morbidly obese patients (BMI 40+) could benefit from flu

vaccination

• Those with morbid obesity (BMI>40) found to be at higher risk of hospitalisation and death following pandemic influenza infection

• Many in this patient group already eligible due to complications of obesity that place them in another risk category

• Practices need to use clinical judgement to decide whether to vaccinate this group of patients

• However, flu vaccinations for morbidly obese patients with no other recognised risk factor will not attract a payment in 2015/16

• The inclusion of this patient group into the flu programme from 2016/17 is currently under consideration


Clinical risk groups who should receive flu vaccine (1)

Clinical risk category Examples (this list is not exhaustive and decisions should be based on clinical judgement)

Chronic respiratory disease Asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission.

Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema; bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD).

Children who have previously been admitted to hospital for lower respiratory tract disease.

see precautions section on live attenuated influenza vaccineChronic heart disease Congenital heart disease, hypertension with cardiac complications, chronic heart failure,

individuals requiring regular medication and/or follow-up for ischaemic heart disease.

Chronic kidney disease Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic syndrome, kidney transplantation.

Chronic liver disease Cirrhosis, biliary atresia, chronic hepatitisChronic neurological disease (included in the DES directions for Wales)

Stroke, transient ischaemic attack (TIA). Conditions in which respiratory function may be compromised due to neurological disease (e.g. polio syndrome sufferers).

Clinicians should offer immunisation, based on individual assessment, to clinically vulnerable individuals including those with cerebral palsy, learning difficulties, multiple sclerosis and related or similar conditions; or hereditary and degenerative disease of the nervous system or muscles; or severe neurological disability

Diabetes Type 1 diabetes, type 2 diabetes requiring insulin or oral hypoglycaemic drugs, diet controlled diabetes.


Clinical risk groups who should receive flu vaccine (2)Clinical risk category Examples (this list is not exhaustive and decisions should be based on

clinical judgement)Immunosuppression (see contraindications and precautions section on live attenuated influenza vaccine)

Immunosuppression due to disease or treatment, including patients undergoing chemotherapy leading to immunosuppression, bone marrow transplant, HIV infection at all stages, multiple myeloma or genetic disorders affecting the immune system (e.g. IRAK-4, NEMO, complement disorders)

Individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day (any age), or for children under 20kg, a dose of 1mg or more per kg per day.

It is difficult to define at what level of immunosuppression a patient could be considered to be at a greater risk of the serious consequences of influenza and should be offered influenza vaccination. This decision is best made on an individual basis and left to the patient’s clinician.

Some immunocompromised patients may have a suboptimal immunological response to the vaccine.

Asplenia or dysfunction of the spleen

This also includes conditions such as homozygous sickle cell disease and coeliac syndrome that may lead to splenic dysfunction.

Pregnant women Pregnant women at any stage of pregnancy (first, second or third trimesters).

(see precautions section on live attenuated influenza vaccine)


Flu immunisation should also be offered to:

• Those living in long-stay residential care homes or other long-stay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality (this does not include prisons, young offender institutions, university halls of residence etc.)

• Those who are in receipt of a carer’s allowance, or those who are the main carer of an elderly or disabled person whose welfare may be at risk if the carer falls ill

• Household contacts of immunocompromised individuals, specifically those who expect to share living accommodation on most days over the winter and therefore for whom continuing close contact is unavoidable.

• Health and social care staff in direct contact with patients/service users (they should be vaccinated by their employer as part of an OH programme)


Other groups who should receive flu vaccine

• The list of clinical risk groups is not exhaustive

• Healthcare practitioners should apply clinical judgement to take into account the risk of flu exacerbating any underlying disease as well as the risk of serious illness from flu itself

• Flu vaccine should be offered to such patients even if the individual is not in the clinical risk groups specified in the risk groups list

• Child contacts of very severely immunocompromised individuals should be given inactivated vaccine


Why vaccinate these risk groups?

Number of fatal flu cases (%)

Mortality rate per 100,000 population

Age-adjusted relative risk

In a risk group 213 (59.8) 4.0 11.3 (9.1-14.0)

Not in any risk group 143 (40.2) 0.4 Baseline

Chronic renal disease 19 (5.3) 4.8 18.5

Chronic heart disease 32 (9.0) 3.7 10.7 (7.3-15.7)

Chronic respiratory disease 59 (16.6) 2.4 7.4 (5.5-10.0)

Chronic liver disease 32 (9.0) 15.8 48.2 (32.8-70.6)

Diabetes 26 (7.3) 2.2 5.8 (3.8-8.9)

Immunosuppression 71 (19.9) 20.0 47.3 (35.5-63.1)

Chronic neurological disease (excluding stroke/transient ischaemic attack)

42 (11.8) 14.7 40.4 (28.7-56.8)

Total 378 0.8

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Influenza-related population mortality rates and relative risk of death among those aged six months to under 65 years by clinical risk group in England, September 2010 – May 2011


Vaccination of clinical risk groups• Increasing flu vaccine uptake in clinical risk groups important because of

increased risk of death and serious illness if people in these groups catch flu

• For a number of years only around half of patients aged six months to under 65 in clinical risk groups have been vaccinated

• Despite those with liver disease and chronic neurological disease having some of the highest mortality rates, they have the lowest flu vaccine uptake rate amongst those in clinical risk groups

• Vaccine uptake for all those in clinical risk groups needs to improve, but particularly in those with chronic liver and neurological disease, and people with learning disabilities.


Flu vaccine uptake by clinical risk group in 2014/15


Flu vaccine uptake rates 2012/13 – 2014/15


2014/15 2013/14 2012/2013

Patients aged 65 years or older 72.7% 73.2% 73.4%

Patients aged six months to under 65 years in risk groups (excluding pregnant women without other risk factors)

50.3% 52.3% 51.3%

Pregnant women 44.1% 39.8% 40.3%

Health care workers 54.9% 54.8% 45.6%

Carers 45.1% 44.8% 46.3%

Children aged two years old (including those in risk groups) 38.5% 42.6% N/A

Children aged three years old ( including those in risk groups) 41.3% 39.5% N/A

Children aged four years old ( including those in risk groups) 32.9% N/A N/A

Pregnant womenAll pregnant women are recommended to receive the inactivated flu vaccine

irrespective of their stage of pregnancy

• Pregnant women at increased risk from complications if they contract flu

• Having flu during pregnancy may be associated with premature birth and smaller birth size and weight

• Flu vaccination during pregnancy provides passive immunity against flu to infants in the first few months of life

• Studies on safety of flu vaccine in pregnancy show that inactivated flu vaccine can be safely and effectively administered during any trimester of pregnancy

• No study to date has demonstrated an increased risk of either maternal complications or adverse fetal outcomes associated with inactivated flu vaccine

• Women should be offered the vaccine every time they are pregnant


Why vaccinate children against flu?Extension of the seasonal flu vaccination programme to all children aims to appreciably lower the public health impact of flu by:

• Providing direct protection thus preventing a large number of cases of flu in children

• Providing indirect protection by lowering flu transmission from children: • to other children• to adults• to those in the clinical risk groups of any age

Reducing flu transmission in the community will avert many cases of severe flu and flu-related deaths in older adults and people with clinical risk factors

Annual administration of flu vaccine to children is expected to substantially reduce flu-related illness, GP consultations, hospital admissions and deaths


Health and social care workers• Frontline health and social care workers have a duty of care to protect their

patients and service users from infection.


• Evidence vaccination significantly lowers rates of flu-like illness, hospitalisation and mortality in elderly in long-term healthcare settings

• Reduces transmission of flu to vulnerable patients, some of whom may have impaired immunity that may not respond well to immunisation

• Vaccination of frontline workers also helps reduce sickness absences and contributes to keeping the NHS and care services running through winter pressures


Health and social care workers (cont)• NHS and social care bodies have responsibility to ensure, as far as is

reasonably practicable, that health and social care workers are free of, and are protected from exposure to infections that can be caught at work

• Responsibility for funding and administering seasonal flu vaccine to staff lies with employers

• Trusts/ employers must ensure that health and social care staff directly involved in delivering care are encouraged to be immunised and that processes are in place to facilitate this

• Overall level of flu vaccine uptake in health care workers is still below the 75% aspiration

• See NHS Employers flu fighter campaign www.nhsemployers.org/flu


Key messages to health and social care workers • Duty of care as professionals to patients or residents to do everything in your power to

protect them against infection, including being immunised against flu

• Getting vaccinated against flu can help protect you, your patients and family

• Everyone is susceptible to flu, even if you are in good health and eat well

• You can be infected with the virus and have no symptoms but can still pass flu virus to others including patients or residents

• Good infection control measures reduce spread of flu and other acute respiratory infections in healthcare settings but are not sufficient alone to prevent them

• Impact of flu on frail and vulnerable patients can be fatal and outbreaks can cause severe disruption in communities, care homes and hospitals

• Flu vaccine has a good safety record and will help protect you. It cannot give you flu. Having the vaccination can encourage your colleagues to do likewise

• Throughout the last ten years there has generally been a good to moderate match between the strains of flu virus in the vaccine and those that subsequently circulated

• Staff act as positive role models for patients aged 65 and over, those with long-term health conditions and pregnant women to take up the offer too


When to vaccinate• As early as possible between September and early November before flu

starts circulating in the community

• Flu can circulate considerably later than this however so clinical judgement should be applied to assess needs of individual patients for vaccination beyond this time period

• This should take into account level of flu-like illness in community and fact that the immune response following flu vaccination takes about two weeks to develop fully

• Protection afforded by the vaccine thought to last at least one influenza season

• However, as antibody levels likely to reduce in subsequent seasons and may be changes to circulating strains from one season to next, annual revaccination is important


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Which flu vaccine should be used?


Types of flu vaccinesTwo main types of vaccine available:

• Inactivated – by injection • Live - by nasal application

None of the flu vaccines can cause clinical influenza in those that can be vaccinated

Trivalent: flu vaccines contain two subtypes of Influenza A and one type B virus

Quadrivalent vaccines contain two subtypes of Influenza A and both B virus types*

As quadrivalent vaccines may be better matched and therefore may provide better protection against the circulating B strain(s) than trivalent flu vaccines, the live intranasal vaccine offered to children aged 2yrs and over is a quadrivalent vaccine

*Quadrivalent inactivated flu vaccine only authorised for children aged 3 years and older


Live attenuated influenza vaccine (LAIV)

• A live attenuated intranasal spray called Fluenz Tetra® is the recommended vaccine for the childhood flu programme

• The live attenuated influenza vaccine (LAIV) has been shown to be more effective in children compared with inactivated influenza vaccines

• It may offer some protection against strains not contained in the vaccine as well as to those that are

• Since this vaccine is comprised of weakened whole live virus, it replicates natural infection which induces better immune memory (thereby offering better long-term protection to children than from the inactivated vaccines)

• In addition to being attenuated (weakened), the live viruses in Fluenz Tetra® have been adapted to cold so that they cannot replicate efficiently at body temperature

• Fluenz Tetra® has a good safety profile in children aged two years and older


Inactivated flu vaccines• A number of different manufacturers produce flu

vaccines. Those available for 2015/16 season are listed in the June 2015 Vaccine Update

• Most of the inactivated vaccines are administered by intramuscular injection, although one vaccine (Intanza®) is administered by the intradermal route

• Most flu vaccines are prepared from viruses grown in embryonated hens eggs – details of ovalbumin content available in Vaccine Update June 2015 and product SPC

• Some flu vaccines are restricted for use in particular age groups. The SPC for individual products should always be referred to when ordering vaccines for particular patients


Vaccine Update Issue 230 June 2015

Storage of flu vaccine

Efficacy, safety and quality may be adversely affected if vaccines are not stored at the temperatures specified in the licence

Flu vaccines must be stored in accordance with manufacturer’s instructions:• Store between +2°C and +8°C • Do not freeze• Store in original packaging• Protect from light

Check expiry dates regularly:

• Fluenz Tetra® has an expiry date 18 weeks after manufacture – this is much shorter than inactivated flu vaccines


Flu vaccines for patients in clinical risk groups

Age Which vaccine? How many doses?

Children aged six months to less than two years of age in clinical risk groups

These children should be offered inactivated trivalent influenza vaccine

Those who have not received flu vaccine before should receive a second dose of vaccine at least four weeks later.

Children aged two to less than 18 years of age in clinical risk groups

These children should be offered the live intranasal vaccine Fluenz Tetra® unless it is medically contraindicated

For those children for whom Fluenz Tetra® is medically contraindicated, a suitable inactivated flu vaccine should be offered.

The quadrivalent inactivated influenza vaccine (Fluarix™ Tetra) is authorised for children from the age of three years and is preferred because of the additional protection offered. The quadrivalent vaccine has both lineages of influenza B and may therefore provide better protection against the circulating B strain(s) than trivalent inactivated influenza vaccines.

Children aged two years should be given an inactivated trivalent vaccine.

Those aged two to less than nine years who have not received flu vaccine before should receive a second dose of vaccine at least four weeks later

Over 18 years Any of the inactivated vaccines A single dose


Which vaccine and how many doses?Vaccine type Authorised age indication Dose

Live attenuated intranasal vaccine - Fluenz Tetra®

Children aged two to under 18 years (if no contraindications)

Single application in each nostril of 0.1ml

Children NOT in clinical risk groups only require one dose of this vaccine.

Children in clinical risk groups aged two to under nine years who have not received influenza vaccine before should receive a second dose of vaccine at least four weeks later.

N.B Follow Green Book not SPC

Inactivated intramuscular vaccine (number of different brands)

Children aged six months and older and adults

(N.B some of the vaccines are not authorised for young children)

Single injection of 0.5ml

Children aged six months to under nine years who have not received influenza vaccine before should receive a second dose of vaccine at least four weeks later.

Inactivated intradermal vaccine - Intanza® 15µg

Adults aged 60 years and older Single injection of 0.1ml


Trivalent vaccines will contain the following three viruses:

• an A/California/7/2009 (H1N1)pdm09-like virus

• an A/Switzerland/9715293/2013 (H3N2)-like virus

• a B/Phuket/3073/2013-like virus

In addition to the above, the quadrivalent vaccine will also contain:

B/Brisbane/60/2008-like virus

None of the influenza vaccines for the 2015/16 season contain thiomersal as an added preservative

More detailed information on the characteristics of the available vaccines, including age indications can be found in the Influenza chapter of the Green Book

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Flu vaccine composition 2015/16


Flu vaccine presentation and dosage

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• Inactivated flu vaccines for intramuscular (IM) administration supplied as suspensions in pre-filled syringes containing a 0.5ml dose

• If SPC for IM inactivated flu vaccine states young children can be given either a 0.25ml or a 0.5ml dose, give 0.5ml dose

• Intanza®, the intradermal vaccine, is supplied in a micro-needle injection system

• Fluenz Tetra®, the intranasal vaccine, is supplied as a nasal spray suspension in a special single use, pre-filled, nasal applicator. No reconstitution or dilution required. Each applicator contains 0.2ml (administered as 0.1 ml per nostril)


Vaccine administrationIntramuscular flu vaccines should be given into the upper arm (or anterolateral

thigh in infants)

Individuals with a bleeding disorder should be given vaccine by deep subcutaneous injection to reduce the risk of bleeding

Intradermal: Intanza® is supplied in a micro-needle injection system that should be held at right-angles to the skin. The device allows intradermal vaccination to be performed without the need for additional training

• Both inactivated and live flu vaccines can be given at the same time as, or at any interval before or after, other live and inactivated vaccines

• Different vaccines should be given at separate sites, preferably in a different limb. If given in the same limb, they should be given at least 2.5cm apart


Administration of Fluenz Tetra®

• Fluenz Tetra® is a live nasal vaccine and must not be injected

• Fluenz Tetra® can be administered at the same time as, or at any interval from other vaccines including live vaccines

• Patient should breathe normally - no need to actively inhale or sniff

• The vaccine is rapidly absorbed so no need to repeat either half of dose if patient sneezes, blows their nose or their nose drips following administration


Image courtesy of AstraZeneca

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Supply and administration of flu vaccines

A range of mechanisms can be used for the supply and administration of vaccines, including :

• Patient specific prescription written manually or electronically by a registered medical practitioner or other authorised prescriber

• Patient Specific Direction

• Patient Group Direction

Where PGDs are developed, they must comply with the legal requirements specified in the Human Medicines Regulations 2012, and should reflect NICE good practice guidance on PGDs: (http://publications.nice.org.uk/patient-group-directions-mpg2)


There are very few individuals who cannot receive any flu vaccine

Where there is doubt, expert advice should be sought promptly so that the period the individual is left unvaccinated is minimised

For children aged 2-18 years, where live flu vaccine cannot be given, it is likely that inactivated vaccine could be given instead


Contraindications

None of the influenza vaccines should be given to those who have had:

• Confirmed anaphylactic reaction to a previous dose of the vaccine

• Confirmed anaphylactic reaction to any component of the vaccine

The live attenuated flu vaccine should not be given to children who are:• Clinically severely immunodeficient due to conditions or

immunosuppressive therapy: Acute and chronic leukaemias Lymphoma HIV infection not on highly active antiretroviral therapy Cellular immune deficiencies High dose corticosteroids

• Receiving salicylate therapy • Known to be pregnant


Contraindications to flu vaccines


Acutely unwell:• defer until recovered

Heavy nasal congestion:• defer live intranasal vaccine until resolved or consider inactivated flu vaccine

Use with antiviral agents against flu:

• The live intranasal vaccine (Fluenz Tetra®) should not be administered at the same time or within 48 hours of cessation of treatment with flu antiviral agents

• Administration of flu antiviral agents within two weeks of administration of Fluenz Tetra® may adversely affect the effectiveness of the vaccine


Precautions to flu vaccines

Severe asthma or active wheezing

• Live flu vaccine is not recommended for children who are currently taking or have been prescribed oral steroids in the last 14 days

• Children currently taking a high dose inhaled steroid - Budesonide >800 mcg/day or equivalent (e.g. Fluticasone > 500 mcgs/day) should only be given live flu vaccine on the advice of their specialist

As these children are a defined flu risk group, those who cannot receive LAIV should receive an inactivated flu vaccine

• Vaccination with Fluenz Tetra® should be deferred in children with a history of active wheezing in the past 72 hours or those who have increased use of bronchodilators in the previous 72 hours. If condition not improved after a further 72 hours then inactivated flu vaccine should be offered to avoid delaying protection in this high risk group


Egg allergy - adults• Most flu vaccines are prepared from flu viruses grown in embryonated hens

eggs- the final vaccine products contains varying amounts of egg (as ovalbumin)

• Adults with egg allergy can be immunised in any setting using either an ovalubumin-free flu vaccine (Optaflu® - licensed from 18yrs of age)

or an inactivated flu vaccine with an ovalbumin content less than 0.12

µg/ml (equivalent to <0.06 µg for 0.5 ml dose)

• Adults with either severe anaphylaxis to egg which has previously required intensive care, or with both egg allergy and severe uncontrolled asthma should be referred to specialists for immunisation in hospital


Egg allergy - children• Children with an egg allergy can be safely vaccinated with Fluenz Tetra® in

any setting (including primary care and schools)

• Those with both egg allergy and clinical risk factors* that contraindicate Fluenz Tetra® (e.g. immunosuppression) should be offered an inactivated flu vaccine with a very low ovalbumin content (less than 0.12 μg/ml)

• Children with a history of severe anaphylaxis to egg which has previously required intensive care, should be referred to specialists for immunisation in hospital

• For children with egg allergy and asthma, follow recommendations for severe asthma (previous slide)

*Children in a clinical risk group and aged under nine years who have not been previously vaccinated against influenza will require a second dose whether given LAIV or inactivated vaccine


• Theoretical potential for transmission of live attenuated virus to immunocompromised contacts

• Risk is for one to two weeks following vaccination

• Extensive use of the live attenuated influenza vaccine in United States - no reported instances of illness or infections from the vaccine virus among immunocompromised patients inadvertently exposed to vaccinated children

• However, where close contact with very severely immunocompromised patients (e.g. bone marrow transplant patients requiring isolation) is likely or unavoidable (e.g. household members) consider an appropriate inactivated flu vaccine instead


Risk of transmission of vaccine virus

• Theoretical potential for transmission of live attenuated virus to immunocompromised contacts

• Risk is for one to two weeks following vaccination

• Extensive use of LAIV in United States - no reported instances of illness or infections from the vaccine virus among immunocompromised patients inadvertently exposed to vaccinated children

• However, where close contact with very severely immunocompromised patients (e.g. bone marrow transplant patients requiring isolation) is likely or unavoidable (e.g. household members) consider an appropriate inactivated flu vaccine instead


Risk of transmission of vaccine virus

Exposure of healthcare workers to live attenuated influenza vaccine viruses

• There may be some low level exposure to the vaccine viruses for those administering LAIV and/or from recently vaccinated patients

• In the US, where there has been extensive use of LAIV, no reported instances of illness or infections from the vaccine virus among HCWs inadvertently exposed

• Risk of acquiring vaccine viruses from the environment is unknown but probably low

• The vaccine viruses are cold-adapted and attenuated and therefore unlikely to cause symptomatic influenza

• As a precaution, very severely immunosuppressed individuals should not administer LAIV

• Other healthcare workers who have less severe immunosuppression or are pregnant, should follow normal clinical practice to avoid inhaling the vaccine and ensure that they themselves are appropriately vaccinated


Inadvertent administration of Fluenz Tetra®

• If an immunocompromised individual receives LAIV, the degree of immunosuppression should be assessed

• If patient is severely immunocompromised, antiviral prophylaxis should be considered

• Otherwise they should be advised to seek medical advice if they develop flu-like symptoms in the 4 days following administration of the vaccine

• If antivirals are used for prophylaxis or treatment, patient should also be offered inactivated flu vaccine in order to maximise their protection in the forthcoming flu season (this can be given straight away)


Commonly reported adverse reactionsFollowing inactivated flu vaccine:

• Pain, swelling or redness at the injection site, low grade fever, malaise, shivering, fatigue, headache, myalgia and arthralgia

• A small painless nodule (induration) may also form at the injection site

• These symptoms usually disappear within one to two days without treatment

Following live attenuated flu vaccine:

• Nasal congestion/rhinorrhoea, reduced appetite, weakness and headache

Rarely, after live or inactivated vaccine, immediate reactions such as urticaria, angio-oedema, bronchospasm and anaphylaxis can occur



Reporting suspected adverse reactions

All serious suspected reactions following flu vaccination should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card scheme at http://yellowcard.mhra.gov.uk/

Fluenz Tetra® and Fluarix™ Tetra carry a black triangle symbol (▼) (as do all vaccines during the earlier stages of their introduction)

This is to encourage reporting of all suspected adverse reactions

http://yellowcard.mhra.gov.uk/

http://yellowcard.mhra.gov.uk/

Vaccine ordering• All flu vaccines for children (both live and inactivated) are purchased

centrally by PHE • All children aged 2, 3 and 4yrs, and in school years 1 & 2 and • All children in clinical risk groups aged 6 months to 18 years

i.e. PHE will supply Fluenz Tetra® for those who can receive it and inactivated flu vaccine for those children for whom Fluenz Tetra® is contraindicated

• Flu vaccines for children can be ordered through the ImmForm website as for other centrally purchased vaccines (www.immform.dh.gov.uk)

• Providers are responsible for ordering sufficient flu vaccine for all other eligible patients aged 18 years and older directly from manufacturers

• Ordering from more than one supplier is recommended in case of supplier delays or difficulties in the manufacture or delivery of the vaccine


Inactivated Influenza Vaccine for children contraindicated to receive Fluenz Tetra®

• Children for whom Fluenz Tetra® is contraindicated should be offered a suitable alternative inactivated flu vaccine

• Some inactivated flu vaccines have been associated with high rates of febrile convulsions in children

• Some inactivated flu vaccines contain too much ovalbumin for egg allergic children

• Check SPC for vaccine suitability before administration

Guidance on which vaccines to use for those children who cannot receive Fluenz Tetra ® can be found in the Green Book influenza chapter

• Fluarix Tetra® is the preferred vaccine for children aged ≥ 3years who cannot receive Fluenz Tetra®

• Children 6m to <3yrs should be given inactivated influenza vaccine (Split Virion) BP®


Beware of product confusion!Fluarix Tetra® is an inactivated vaccine licensed from three years of age

that can be given to children who cannot receive the live intranasal flu vaccine, the 65 and overs, the under 65s at risk, pregnant women and healthcare workers

Care must be taken not to confuse the two ‘Tetra’ brands

One way of remembering which vaccine is which is:

• Fluenz is the nazal flu vaccine

• Fluarix is the arm injected vaccine


Recording of flu vaccine given

As a wide variety of influenza vaccines are on the UK market each year, it is especially important that the following information be recorded:

● vaccine name, product name, batch number and expiry date

● dose administered ● date immunisation given

● route/site used ● name and signature of vaccinator

This information should be recorded in:

• Patient's GP record (or other patient record, depending on location)

• Personal Child Health Record (the ‘Red Book’) if a child

• Practice computer system

• Child Health Information System


Data collection• Flu vaccine uptake data is collected via the web-based ImmForm system (

www.immform.dh.gov.uk) where it is managed and published by PHE

• Over 90% 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 antenatal clinics, pharmacies etc. are reported to the patient’s GP

• Uptake data for school years 1 & 2 and pilot areas will be manually submitted by Area Teams onto ImmForm

• Uptake data for HCWs is manually submitted by Trusts and Area Teams via ImmForm

• 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


http://www.immform.dh.gov.uk/

Achieving high uptake (GP Practice checklist)

In order to obtain high vaccine uptake, it is recommended that GP practices:

1. Should have a named individual within the practice who is responsible for the flu vaccination programme

2. Have a register that can identify all pregnant women, patients in the under 65 years at risk groups, those aged 65 years and over and those aged 2 to 4 years

3. Update patient registers throughout the flu season paying particular attention to the inclusion of women who become pregnant during the flu season

4. Submit accurate data on the number of its patients eligible to receive flu vaccine and the flu vaccinations given to its patients on ImmForm

5. Order sufficient flu vaccine taking into account past and planned performance, expected demographic increase, and to ensure that everyone at risk is offered the flu vaccine


Achieving high uptake (GP Practice checklist cont’d)

6. Patients recommended to receive the flu vaccine should be directly contacted (e.g. letter, e-mail, phone call, text or other) inviting them to a flu vaccination clinic or to make an appointment

7. The practice should follow-up patients who do not respond or fail to attend scheduled clinics or appointments

8. Flu vaccination should start as soon as practicable after receipt of the vaccine so maximum number of patients are vaccinated as early as possible to ensure they are protected before flu starts to circulate

9. The GP practice should collaborate with midwives to offer and provide flu vaccination to pregnant women and to identify, offer and provide to newly pregnant women as the flu season progresses


Achieving high uptake (GP Practice checklist cont’d )

10.The GP practice should offer flu vaccination in clinics and opportunistically.

11.The GP practice and/ or CCG should collaborate with other providers such as community or health and social care trusts to identify and offer flu vaccination to residents in care homes, nursing homes and house-bound patients

The GP practice checklist highlights good practice

• It is based upon the findings from a study examining the factors associated with higher vaccine uptake in general practicei

• GP practices are encouraged to review their systems in the light of the checklist

• Most recommendations will apply to other areas where flu vaccine is giveniDexter LJ et al (2012) Strategies to increase influenza vaccination rates: outcomes of a nationwide cross-sectional survey of UK general

practice. bmjopen.bmj.com/content/2/3/e000851.full


Key messages• Flu immunisation is one of the most effective interventions immunisers can

provide to reduce harm from flu and pressures on health and social care services during the winter

• Increasing flu vaccine uptake in clinical risk groups is important because of increased risk of death and serious illness if people in these groups catch flu

• For a number of years only around half of patients aged six months to under 65 years in clinical risk groups have been vaccinated

• Influenza during pregnancy may be associated with perinatal mortality, prematurity, smaller neonatal size, lower birth weight and increased risk of complications for mother




Resources

• Flu Plan and Supporting Letter detailing 2015/16 flu programme: Department of Health, Public Health England, NHS England. Published 27 March 2015. Available at: https://www.gov.uk/government/publications/flu-plan-2015-to-2016

• Green Book Influenza chapter updated May 2015. Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

• Leaflets, posters, Q&As and other resources to support the annual flu programme Available at: https://www.gov.uk/government/collections/annual-flu-programme

• A video for health professionals on how to administer the Fluenz Tetra® vaccine produced by NHS Education for Scotland is available at http://www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/public-health/health-protection/seasonal-flu.aspx

• Summary of Product Characteristics (SPC) for flu vaccines are available at http://www.medicines.org.uk/emc/

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



https://www.gov.uk/government/collections/annual-flu-programme

https://www.gov.uk/government/collections/annual-flu-programme

http://www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/public-health/health-protection/seasonal-flu.aspx



http://www.medicines.org.uk/emc/

http://www.medicines.org.uk/emc/

Documents

The national flu immunisation programme 2015/16 Training for healthcare practitioners