The national childhood flu immunisation programme 2014/15 Training for healthcare practitioners

The national childhood flu immunisation programme 2014/15

Training for healthcare practitioners

Key messages• In 2012 the Joint Committee on Vaccination and Immunisation (JCVI)

recommended that the seasonal influenza (flu) programme should be extended to all children aged 2 to under 17 years of age

• This extension to the flu vaccination programme should reduce the impact of seasonal flu on children and reduce transmission of flu within the community

• The phased introduction of this programme began in 2013 with flu vaccine being offered to all two and three year olds and to some primary school aged children in pilot areas

• From 1st September 2014, the seasonal flu vaccination programme will be extended to all two, three and four year old children, with pilots in some primary and secondary school aged children

• All those involved in immunisation have a key role in promoting high uptake of flu vaccination in children through increasing awareness of the programme

2 The national childhood flu immunisation programme 2014/15

Aims of resource

This training resource aims to:

• Develop the knowledge base of healthcare practitioners regarding the extension of the flu vaccination programme to children

• Support healthcare practitioners involved in discussing flu vaccination for children with parents and carers by providing evidence based information

• Promote high uptake of flu vaccination in children through increasing the knowledge of those involved in delivering the vaccination programme

• Provide information on the administration of Fluenz Tetra®


Learning OutcomesFollowing training, healthcare practitioners will be able to:

• Understand the evidence base for the administration of flu vaccination to children

• Describe the aetiology of flu

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

• Explain which vaccine should be used and the precautions and contraindications to this vaccine

• Explain the possible side effects from the live attenuated flu vaccine (Fluenz Tetra®)

• Explain the sequence of steps in Fluenz Tetra® administration

• Identify sources of additional information

• Understand the importance of their role in raising the issue of vaccination with parents and carers of children and providing evidence based information about flu vaccination


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 (flu) virusesThere are 3 types of influenza (flu) 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

Two surface antigens:

•Haemagglutinin (H)

•Neuraminidase (N)

The blue protuberances represent haemagglutinin and the red spikes neuraminidase.

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: minor changes which tend to occur from season to season

• Antigenic shift: major changes and the emergence of new subtype. Immunity from previous virus may not protect against new subtype thus leading to widespread epidemic or pandemic in a non-immune population

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


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

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

• 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, myalgia & severe 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• 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 or immunosuppression


Flu vaccination programme • Late 1960s: annual flu immunisation recommended in the UK with the aim

of directly protecting 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 extension to offer annual flu vaccination to

all children aged 2-17y began with the inclusion of children aged 2 and 3 years in the routine programme and pilots in some primary schools

• 2014: phased introduction of childhood flu vaccination programme continues with the vaccine to be offered to all children aged 2, 3 and 4 years and pilots in some primary and secondary schools


Rollout of the childhood flu vaccination programme in England• Extending flu programme to all children involves considerable planning and work

in order to obtain a high level of uptake

• For this reason, programme is being rolled out over a number of seasons and includes geographical piloting in different age groups

• The pilots will allow Public Health England and NHS England opportunity to ascertain the most effective way of implementing it

In 2014/15, flu vaccination will be offered to • All those aged two, three and four years old (but not five years or older) on 1

September 2014 (i.e. date of birth on or after 2 Sept 2009 and on or before 1 Sept 2012)

• Primary school aged children in the geographical pilots started in 2013/14 • Secondary school aged children in Years 7 and 8 (11-13 years old) in different

geographical locations


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Why has the seasonal flu vaccination programme been extended to include children (2 to 17 years of age)?


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: • Child to child• Child to adult• Child 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


Recent review of burden of flu in children• Average influenza season: estimated 0.3% to 9.8% of 0-14 year old

children present to a GP with influenza

• Incidence rates can be markedly higher in the younger age groups

• Influenza associated hospitalisation rates:

- 83-1,038/ 100,000 children 0-59 months old (highest in <6m) - 16-210/100,000 children 5-17 years

• Children more vulnerable to infection than adults when exposed

• Children with influenza contribute to the burden of influenza in all age groups because they are more likely to pass on the infection than adults


Cost effectiveness of extending seasonal flu vaccination programme to children

Studies commissioned by the JCVI suggest that despite the high cost, extending the flu vaccination programme to children is:

•Highly likely to be cost-effective

•Well below the established cost-effectiveness threshold when indirect protection to the whole population is taken into account, particularly over the longer-term


2013/14 childhood flu uptake and pilots2013/14: all 2 and 3 year olds offered vaccination through GP surgeries

National uptake was 42.6% for two year olds and 39.6% for three year olds

A pilot programme began for children of primary school age, with children in school years 1 to 6 being offered vaccination through pilot programmes in 7 areas

Uptake rates in the pilot areas varied from 35.8% in the pharmacy/GP based model to 71.5% in the most successful school based pilot

The pilots tested a variety of delivery methods:

-school nursing teams and specialist immunisation teams (both working in schools)

-one model delivered vaccine through community pharmacy and GPs


Impact of 2013/14 childhood flu pilotsIn 7 pilots areas, a total of 104,792 primary age children received at least

1 dose of flu vaccine (overall uptake of 52.5% in the target group)

Despite low flu activity in 2013/14, early results suggest a positive impact

In pilot areas compared to non-pilot areas:

• There were fewer GP consultations and A&E attendances for ‘influenza like’ and respiratory illness

• Fewer people tested positive for flu in primary care


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Which flu vaccine should be used?


Types of flu vaccinesTwo main types of vaccine available:

• Inactivated - by intramuscular injection• Live - by nasal application

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

Most inactivated flu vaccines are trivalent, containing two subtypes of Influenza A and one type B virus

An inactivated quadrivalent vaccine containing both B virus types was made available for the first time in 2013*. As quadrivalent vaccines may be better matched and therefore may provide better protection against the circulating B strain(s) than trivalent influenza vaccines, a quadrivalent live intranasal vaccine will be offered to children aged 2yrs and over in the 2014/15 flu season

*Quadrivalent inactivated influenza vaccine is only authorised for children aged three 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 in lungs efficiently at body temperature

• Fluenz Tetra® has a good safety profile in children aged two years and older and a very similar trivalent vaccine has an established history of use in the United States


How many doses?• Two doses of the inactivated influenza vaccines are required to achieve

adequate antibody levels in younger children

• However a single dose of LAIV should provide protection to previously unvaccinated healthy children

• Only modest additional protection provided by a second dose of LAIV

• JCVI advise greater population health impact can be achieved if the limited quantity of LAIV available is given as one dose schedule to larger number of children

• Only children who are in clinical risk groups aged two to less than nine years who have not received influenza vaccine previously should be offered a second dose of LAIV (given at least 4 weeks apart)

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Fluenz Tetra®• Generic name: influenza vaccine (live attenuated, nasal)

• Brand name: Fluenz Tetra®

• Marketed by AstraZeneca

• Licensed from 24 months to less than 18 years of age

• Nasal spray (suspension) in a prefilled nasal applicator

• Supplied as pack containing 10 doses


Image courtesy of AstraZenica

Active ingredient:

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

A/Texas/50/2012 (H3N2)-like virus

B/Massachusetts/2/2012-like virus

B/Brisbane/60/2008-like virus

Excipients:

SucroseDibasic potassium phosphateMonobasic potassium phosphateGelatin (porcine type A)Arginine hydrochlorideMonosodium glutamate monohydrateWater for injection

Residues:Egg proteins (e.g. ovalbumin)Gentamicin

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Fluenz Tetra® composition 2014/15


Fluenz Tetra® presentation


• Single use prefilled nasal applicator

• Ready to use (no reconstitution or dilution required)

• Nasal spray (suspension)

• The suspension is colourless to pale yellow, clear to opalescent. Small white particles may be present

• Each applicator contains 0.2ml (administered as 0.1 ml per nostril)

Storage of Fluenz Tetra®Fluenz Tetra® 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

• It is important that the expiry date on the nasal spray applicator is checked before use

• It is highly likely that all the Fluenz Tetra® supplied centrally will have expired by February 2015. It is therefore important to ensure that efforts are made to vaccinate children before the Christmas holidays


Fluenz Tetra® dosage and schedule reminder

• A single dose is 0.2ml (administered as 0.1ml per nostril)

• A single dose for all children not in clinical at risk group

• Children aged 2 years to less than 9 years who are in clinical at risk groups and who have not received flu vaccine before should receive two doses of Fluenz Tetra® (if not immunocompromised) with the second dose at least four weeks after the first

NB: This advice differs from that given in the Fluenz Tetra® SPC

Where Green Book advice differs from SPC, Green Book should be followed


Administration of Fluenz Tetra®

• Fluenz Tetra® is different from other influenza vaccines - it 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


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The vaccine may only be administered:

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

• Against a Patient Specific Direction

• Against a Patient Group Direction


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Fluenz Tetra® Applicator


Image taken from Fluenz Tetra® SPC 2014

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Images taken from Fluenz Tetra® SPC 2014

Administration videoA video for health professionals

on how to administer the Fluenz Tetra® vaccine has been produced by NHS Education for Scotland

It is available to view on the NES website at: http://www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/public-health/health-protection/seasonal-flu.aspx


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




There are very few children who cannot receive any influenza vaccine

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

Where live flu vaccine cannot be given, it is likely that inactivated vaccine could be given instead


Contraindications to Fluenz Tetra®

• Confirmed anaphylactic reaction to a previous dose of influenza vaccine

• Confirmed anaphylactic reaction to any component of the vaccine including gentamicin and gelatin

• Severely immunodeficient due to conditions or immunosuppressive therapy:

Acute and chronic leukaemias Lymphoma HIV positive patient not on highly active antiretroviral therapy Cellular immune deficiencies High dose steroids

• Individuals receiving salicylate therapy • Egg allergy• Known to be pregnant


Contraindications to Fluenz Tetra®


Severe asthma or active wheezing

The live attenuated influenza vaccine (Fluenz Tetra®) is not recommended for children with:

• a history of active wheezing at the time of vaccination (until at least 7 days after wheezing has stopped) or

• who are currently taking or have been prescribed oral steroids in the last 14 days or

• who are currently taking a high dose inhaled steroid - Budesonide >800 mcg/day or equivalent* (e.g. Fluticasone > 500 mcgs/day) because of limited safety data in these groups

* In children aged 5-12 years, the definition of severe asthma corresponds to the British Thoracic Society BTS Sign Step 5

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Egg allergy• Fluenz Tetra® contains traces of egg (ovalbumin content

≤0.24ug/0.2ml dose) and is therefore not suitable for egg-allergic children

• Children with egg allergy should be immunised in primary care using either an egg-free influenza vaccine or, if not available, an inactivated influenza vaccine with an ovalbumin content less than 0.12 µg/ml (equivalent to 0.06 µg for 0.5 mL dose)

• Only children who have either confirmed anaphylaxis to egg or egg allergy and severe uncontrolled asthma should be referred to specialists for immunisation in hospital

• The ovalbumin content of influenza vaccines is given in the Green Book Influenza chapter

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Acute severe febrile illness:• defer until recovered

Heavy nasal congestion:• defer until resolved or consider inactivated influenza vaccine

Use with antiviral agents against flu:

• 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 Fluenz Tetra®

Inadvertent administration of Fluenz Tetra®

• If an immunocompromised individual receives LAIV in error, 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 four days following administration of the vaccine

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


• Theoretical potential for transmission of live attenuated virus to very severely immunocompromised contacts (e.g. bone marrow transplant patients requiring isolation)

• 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 individuals is likely or unavoidable (e.g. household members) consider an appropriate inactivated flu vaccine instead


Risk of transmission of vaccine virus

Exposure of healthcare professionals to live attenuated influenza vaccine (LAIV)

• There may be some low level exposure to the vaccine viruses for those administering LAIV

• In the US, where there has been extensive use of LAIV, no reported instances of illness or infections from the vaccine virus among HCPs or immunocompromised patients 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

• However, others in clinical risk groups for influenza, including those with asthma and pregnant women can administer this vaccine

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The national flu immunisation programme 2014/15


Infection control issues There are no specific infection control precautions required when

administering Fluenz Tetra®

Routine hand hygiene procedures should be performed before and after each child contact

Gloves and aprons are not required

Disposal of clinical waste:

Empty Fluenz Tetra® applicators should be disposed of in accordance with local procedures for disposal of clinical waste


Adverse reactions to Fluenz Tetra®Common adverse reactions (affects more than 1 in 10 Fluenz Tetra® recipients)

• Blocked or runny nose

• Headache

• Fever

• Malaise

• Myalgia

• Decreased appetite

Hypersensitivity reactions (including oedema, urticaria and bronchospasm) can occur but are very rare

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Reporting suspected adverse reactions

As with all vaccines during the earlier stages of their introduction, Fluenz Tetra® carries a black triangle symbol (▼)

This is to encourage reporting of all suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card scheme

Yellow card scheme: http://mhra.gov.uk/yellowcard;

• Voluntary reporting system for suspected adverse reaction to medicine/vaccines

• Success depends on early, complete and accurate reporting

• Report even if uncertain about whether vaccine caused condition

• See chapter 8 of Green Book for details

http://mhra.gov.uk/yellowcard

http://mhra.gov.uk/yellowcard

Vaccine ordering• PHE has centrally procured both live and inactivated flu vaccine for all

children aged from 6 months to less than 18 years old

• This is for those children who are part of the extension of the programme (2,3,4yrs and pilots) and those children in clinical risk groups who are not part of the extension

i.e. PHE will supply LAIV (Fluenz Tetra®) for those who can receive it and inactivated flu vaccine for those children for whom Fluenz Tetra® is not suitable or contraindicated

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


Vaccine ordering

Eligible cohort Vaccine available

6 months to less than 2 years old in clinical risk group

Offer trivalent inactivated flu vaccine

2 year olds to less than 17 years old in roll-out cohort and pilots

Offer LAIV (Fluenz®). If Fluenz® unsuitable, then offer suitable inactivated flu vaccine.

2 year olds to less than 18 years old clinical risk groups (not in roll-out cohort and pilots)

Offer LAIV (Fluenz®). If Fluenz® unsuitable, then offer suitable inactivated flu vaccine.

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Centrally purchased flu vaccines available for each eligible cohort in the children’s programme in 2014/15 are as follows (order through ImmForm website):

Inactivated Influenza Vaccine (TIV) for children contraindicated to receive Fluenz Tetra®

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

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

• Check SPC for vaccine suitability before administration

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

• Fluarix Tetra® is the preferred vaccine for those children aged three years and over who cannot receive Fluenz Tetra®

(N.B This quadrivalent inactivated influenza vaccine (Fluarix Tetra®) is only authorised for children aged three years and older)

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The national flu immunisation programme 2014/15


Beware of product confusion!Fluarix Tetra® is an inactivated vaccine being supplied for children aged

three and over who cannot receive the live Fluenz Tetra® vaccine

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


Porcine gelatine• Fluenz Tetra® contains porcine gelatine

• Gelatine is used to stabilise live viral vaccines and is contained in many pharmaceutical products, not just Fluenz Tetra®

• There is currently no alternative vaccine of equivalent efficacy that does not include porcine gelatine

• Anyone who does not wish to be vaccinated with Fluenz Tetra® can refuse vaccination. However, current policy is that only those who are in clinical risk groups or have clinical contra-indications are offered an inactivated injectable vaccine as an alternative to Fluenz Tetra®

• See PHE’s website (www.gov.uk/government/news/vaccines-and-gelatine-phe-response) for Q&As, responses from different faith groups and more information on vaccines and gelatine


http://www.gov.uk/government/news/vaccines-and-gelatine-phe-response

Recording of flu vaccine given to childrenThe following information should 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:

● Personal Child Health Record (the ‘Red Book’)

● Child’s GP record (or other patient record, depending on location)

● Child Health Information System

● Practice computer system


Key messages• In 2012 the Joint Committee on Vaccination and Immunisation (JCVI)

recommended that the seasonal influenza (flu) programme should be extended to all children aged 2 to under 17 years of age

• This extension to the flu vaccination programme should reduce the impact of seasonal flu on children and reduce transmission of flu within the community

• The phased introduction of this programme began in 2013 with flu vaccine being offered to all two and three year olds and to some primary school aged children in pilot areas

• From 1st September 2014, the seasonal flu vaccination programme will be extended to all two, three and four year old children, with pilots in some primary and secondary school aged children

• All those involved in immunisation have a key role in promoting high uptake of flu vaccination in children through increasing awareness of the programme



Resources• Letter detailing childhood programme: Department of Health, Public Health England,

NHS England. The national flu immunisation programme 2014/15. 28 April 2014. Available at: https://www.gov.uk/government/publications/flu-immunisation-programme-2014-to-2015

• Green Book updated Influenza chapter July 2014. Available at: https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book

• A leaflet and a poster have been prepared specifically for the childhood influenza programme. Available at: https://www.gov.uk/government/organisations/public-health-england/series/annual-flu-programme

• A video for health professionals on how to administer the 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

• Fluenz Tetra® Summary of Product Characteristics (SPC) available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002617/WC500158412.pdf

https://www.gov.uk/government/publications/flu-immunisation-programme-2014-to-2015

https://www.gov.uk/government/publications/flu-immunisation-programme-2014-to-2015

https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book




https://www.gov.uk/government/organisations/public-health-england/series/annual-flu-programme







http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002617/WC500158412.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002617/WC500158412.pdf

Acknowledgement

This training slide set has been adapted for use in England from one originally developed by NHS Education for Scotland

Their permission to adapt it is gratefully acknowledged


Documents

The national childhood flu immunisation programme 2014/15 Training for healthcare practitioners