Extension of the seasonal - NHS Education for Scotland of Fluenz™ Tetra 4 ... Extension of the seasonal influenza vaccination programme to children: Phase 2-2014/14 Frequently asked

Extension of the seasonal influenza vaccination programme to children: Phase 2 - 2014/15An update for registered healthcare practitioners

Frequently asked questions

Version 3.0 August 2014

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Extension of the seasonal influenza vaccination programme to children: Phase 2-2014/14 Frequently asked questions

Table of ContentsExtension of the seasonal influenza vaccination programme to children: Phase 2-2014/15 1

Background 1

Why vaccinate children? 1

Role of Registered Healthcare Practitioners 2

Flu 3What is Flu? 3Who does it affect? 3What are the features of Flu? 3Possible complications of Flu 3

Extension of seasonal flu vaccination programme to children 4Types of vaccines 4Use of Fluenz™ Tetra 4The virus within the Fluenz™ Tetra vaccine is cold adapted, what does this mean? 4Is Fluenz™ Tetra effective? 4Is Fluenz™ Tetra safe? 4How should Fluenz™ Tetra be stored? 5What is the shelf life of Fluenz™ Tetra? 5How is Fluenz™ Tetra ordered? 5How is Fluenz™ Tetra presented? 5How many doses are required? 5How is the vaccine given? 6What happens if the child sneezes, blows their nose or has nasal dripping following administration? 6Does Fluenz™ Tetra contain latex? 6Does Fluenz™ Tetra contain any preservatives such as thiomersal? 6My child is allergic to raw eggs but not eggs products that have been cooked. Can my child receive Fluenz™ Tetra vaccine? 6Once a child has received Fluenz™ Tetra do I need to wait four weeks before I administer another live vaccine e.g. MMR? 6Can Fluenz™ Tetra be administered with antiviral agents against flu? 6What are the contraindications to Fluenz™ Tetra? 7


Should Fluenz™ Tetra vaccination be administered to children who are very severely immunocompromised (e.g. bone marrow transplant recipients requiring protective isolation) and should they be excluded from school? 8Should children who are less severely immunocompromised (e.g. a leukaemic child not in protective isolation) receive Fluenz™ Tetra? 8Should Fluenz™ Tetra vaccination be administered to household contacts of severely immunocompromised individuals? 8What if a child has a heavy runny nose with no fever? 9Can Fluenz™ Tetra be given in pregnancy? 9What if the child is unwell on the day of vaccination? 9As Fluenz™ Tetra is a live vaccine, can it be passed on to others? 9Can healthcare staff in clinical risk groups administer the vaccine? 9What does the term ‘follow normal clinical practice’ mean in managing exposure of healthcare professionals to live attenuated influenza vaccine viruses? 10What should I do if Fluenz™ Tetra is given to individuals who are clinically immunocompromised by mistake? 10How will the practice/ school nurse recognise if someone is severely immunocompromised? 10What are the potential side effects of Fluenz™ Tetra? 10What should be done if an individual experiences a side effect? 11I have read that there is some concern that Bell’s palsy may be associated with receipt of Fluenz™ Tetra vaccine. Is this correct? 11Can a child with cystic fibrosis receive Fluenz™ Tetra? 11If Fluenz™ Tetra is contraindicated which inactivated flu vaccine should be considered? 11How many doses of inactivated flu vaccine are required? 12Does Fluenz™ Tetra contain pork (porcine) gelatin? 12Fluenz™ Tetra contains a genetically modified organism (GMO). Does this pose a potential risk to the environment? 13

Flu vaccination for winter 2014/2015 13

Why are all of the potential side effects of the vaccine not listed on the patient information leaflet? 13

Have Health Scotland leaflets been translated into other languages? 13

Where can I get further information? 13

Supporting Evidence 14

Appendix A 16


1

Extension of the seasonal influenza vaccination programme to children: Phase 2-2014/15

Note: For the purposes of this resource the term ‘influenza’ will be replaced by the term ‘Flu’ unless it relates to a specific virus/strain.

BackgroundIn 2012 the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the seasonal flu programme should be extended to all children aged 2 to less than 17 years.i In Scotland, there is currently an annual vaccination programme that aims to reduce the impact (morbidity and mortality) of flu particularly in high risk groups e.g. those over 65 and in clinical risk groups. This programme is being extended to include all children from 2 to 17 years of age.ii From 1 October 2013, the extension of the seasonal flu vaccination programme in children was started. In phase one during 2013/14 flu vaccine was offered to all two and three year old children and there were pilots that included some primary school aged children.

In phase two, from 1 October 2014 the vaccine will be offered to all preschool children from age two years and all primary school aged children in Scotland.

Why vaccinate children?Extending the current flu vaccination programme to low risk children aims to lower the public health impact of flu by:

• providing direct protection to children thus averting a large number of cases of flu in children

• lowering flu transmission from children to other children, adults and those in the clinical risk groups of any age, thus averting many cases of severe flu disease and flu-related deaths, that mostly occur in older adults and those of any age with clinical risk factors.

Studies commissioned by JCVIiii suggested that, despite the high cost, extending the flu vaccination programme to low risk children is highly likely to be cost effective and well below the established cost effectiveness threshold when indirect protection to the whole population is taken into account, particularly over the longer-term.

The cost effectiveness study also suggested that extending flu vaccination to children remained cost effective in circumstances where vaccine uptake by clinical risk groups was substantially increased.

i Joint Committee on Vaccination and Immunisation - minutes. (2013) http://media.dh.gov.uk/network/261/files/2012/07/JCVI-minutes-13-June-2012-revised.pdf [last accessed 11 July 2013].

ii Scottish Government (SGHD/CMO(2013)17) Important changes to the Scottish immunisation programme in 2013-14-extension of the seasonal influenza vaccination programme to children (2-17 years). Edinburgh. Scottish Government.

iii Pitman R.J., Nagy L.D. and Sculpher M.J. (2013) Cost-effectiveness of childhood influenza vaccination in England and Wales: Results from a dynamic transmission model. Vaccine 31(6):927-42.

http://media.dh.gov.uk/network/261/files/2012/07/JCVI-minutes-13-June-2012-revised.pdf



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Role of Registered Healthcare Practitioners Registered healthcare practitioners have a key role in promoting increased uptake of flu vaccination in children through:

• Understanding the evidence base for the administration of the vaccination against flu.

• Advising parents/carers of children who are eligible to receive the flu vaccination that it is strongly recommended that children are vaccinated against flu.

• Safely administering flu vaccines including Fluenz™ Tetra in accordance with the vaccine schedule.

• Ensuring any adverse effects are managed and reported appropriately.


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Flu

What is Flu?Flu is a highly infectious acute viral infection of the respiratory tract. It is transmitted by large droplets and small-particle aerosols and by hand to mouth / eye contamination from an infected surface. The incubation period is 1-5 days (average 2-3 days) though it may be longer especially in children and immunocompromised people.

There are three types of influenza viruses:

A Causes epidemics and pandemics. This virus is also found in many different animals and may spread between them i.e. there is an animal reservoir. This is mainly in wildfowl and pigs but it also carried by other mammals.

B May cause epidemics - Predominantly found in humans.

C Minor respiratory illness only.

Who does it affect?Flu can affect anyone but is a more serious illness in neonates, pregnant women, older people and those with underlying disease.

What are the features of Flu?• In healthy individuals it is usually unpleasant but self limiting with recovery within 5-7 days.

• Common symptoms include sudden onset of fever, chills, headache, myalgia (muscle aches) and severe fatigue.

• Sufferers can also experience a dry cough, sore throat and stuffy nose.

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

Possible complications of FluCommon complications may include bronchitis, otitis media/middle ear infection (especially in children) and sinusitis.

Less common complications include secondary bacterial pneumonia, meningitis, encephalitis, and primary influenza pneumonia.


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Extension of seasonal flu vaccination programme to children

Types of vaccinesThere are two main types of vaccine which will be used:

• Live - by nasal application.

• Inactivated - by intramuscular (or in the case of Intanza® vaccine intradermal) injection.

Use of Fluenz™ TetraThe flu vaccine being used for most children in the UK is Fluenz™ Tetra, a live attenuated (a weakened form of the virus which cannot cause disease but which protects against flu) intranasal vaccine. This is different to the vaccine used in phase one in 2013/14 – Fluenz® which contained only three strains of flu virus. Fluenz™ Tetra contains two influenza B strains and may be better matched and therefore may provide better protection against the circulating B strain(s) than trivalent flu vaccines.

Fluenz™ Tetra is marketed by Astra Zeneca and is licensed from 24 months to less than 18 years of age.

As Fluenz™ Tetra is a live vaccine not all children are able to receive it, this is covered later in this resource (under contraindications).

Where Fluenz™ Tetra is contraindicated, children will be offered inactivated flu vaccine. You should check the local agreed arrangements for this group.

The virus within the Fluenz™ Tetra vaccine is cold adapted, what does this mean? A cold adapted virus is designed not to replicate at body temperatures but will replicate at the cooler temperatures found within the nose. This allows the child to produce antibodies which then protect against infection. By limiting the replication of the virus to the nose the worst symptoms of flu are avoided.

Is Fluenz™ Tetra effective?Fluenz™ Tetra provides greater protection for children than inactivated flu vaccine.

Is Fluenz™ Tetra safe?Fluenz® has been used in US for many years, millions of doses have been given and it has a good safety profile in children aged two years and older. Fluenz® was used in phase one of the programme extension throughout the UK and confirmed the good safety profile.


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How should Fluenz™ Tetra be stored?Fluenz™ Tetra must be stored in accordance with manufacturer’s instructions. The cold chain must be maintained. Store between +2°C and +8°C in original packaging. Do not freeze and protect from light.

Before use, Fluenz™ Tetra may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above +25°C. If the vaccine has not been used after this 12-hour period, it should be disposed of.

What is the shelf life of Fluenz™ Tetra?Fluenz™ Tetra has an expiry date 18 weeks after manufacture – this is much shorter than inactivated flu vaccines. Expiry dates should be checked regularly.

How is Fluenz™ Tetra ordered?Fluenz™ Tetra has been procured following a UK tendering exercise. It should be ordered from NHS board vaccine holding centres.

How is Fluenz™ Tetra presented?Fluenz™ Tetra is supplied as a box containing 10 single use, prefilled nasal applicators.

Each applicator contains 0.2ml nasal suspension. The nasal applicator is ready to use. No reconstitution or dilution is required. The nasal suspension is colourless to pale yellow, clear to opalescent. Small white particles may be present.

How many doses are required?The marketing authorisation holder’s Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) states that all children under nine years old receiving flu vaccine for the first time require two doses, with second at least four weeks after the first. The JCVI have considered this issue and have advised that in children who are not in a clinical at risk group, a single dose of Fluenz™ Tetra is recommended.

Registered healthcare practitioners are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the SmPC for a particular vaccine. When this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and this advice should be followed. The Green Book recommendations and/or further advice from the Department of Health should be reflected in PGDs.

Children NOT in clinical risk groups only require one dose of this vaccine. A single dose of Fluenz™ Tetra is 0.2ml (administered as 0.1ml per nostril).

Children aged less than nine years who are in clinical at risk groups who have not received flu vaccine before should receive two doses of Fluenz™ Tetra with the second dose at least four weeks after the first.


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How is the vaccine given?Fluenz™ Tetra is administered by the intranasal route and is supplied in an applicator that allows a divided dose to be administered in both nostrils (total dose of 0.2ml) with 0.1ml in each nostril.

What happens if the child sneezes, blows their nose or has nasal dripping following administration?Administration of either dose does not need to be repeated. Reassurance should be given that the vaccine will still be effective if any of these occur.

Does Fluenz™ Tetra contain latex?The vaccine is supplied in a single use nasal applicator (type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector (synthetic rubber), plunger rod, plunger stopper (butyl rubber) and dose divider clip which should not affect latex sensitive individuals.

Does Fluenz™ Tetra contain any preservatives such as thiomersal?No - Fluenz™ Tetra does not contain any thiomersal.

My child is allergic to raw eggs but not eggs products that have been cooked. Can my child receive Fluenz™ Tetra vaccine?No. There are insufficient data on the use of live attenuated vaccine (Fluenz™ Tetra) in children with egg allergy and at the current time Fluenz™ Tetra should not be given to children with an egg allergy.

Once a child has received Fluenz™ Tetra do I need to wait four weeks before I administer another live vaccine e.g. MMR?No, Fluenz™ Tetra can be given at the same time as other vaccines, including live vaccines. Although it was previously recommended that, where vaccines cannot be administered simultaneously; a four-week interval should be observed between live viral vaccines, JVCI have advised that no specific intervals need to be observed between Fluenz™ Tetra and other live vaccines.

Can Fluenz™ Tetra be administered with antiviral agents against flu?There is a potential for flu antiviral agents to lower the effectiveness of Fluenz™ Tetra. Therefore flu antiviral agents and Fluenz™ Tetra should not be administered concomitantly. Fluenz™ Tetra should not be administered within 48 hours following the 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.


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What are the contraindications to Fluenz™ Tetra?There are very few individuals who cannot receive any flu vaccine. When there is any doubt, appropriate advice should be sought from an immunisation coordinator or other appropriate person e.g. consultant in public health medicine (CPHM) rather than withholding vaccination. Fluenz™ Tetra should not given to a person who:

• Is under 24 months or 18 years or older.

• Has had a confirmed anaphylactic reaction to a previous dose of flu vaccine.

• Has had a confirmed anaphylactic reaction to any component of the vaccine.

• Is allergic to eggs.

• Is clinically severely immunocompromised due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; HIV infection not on highly active antiretroviral therapy (HAART); cellular immune deficiencies; and high dose corticosteroids.

• Has severe asthma or active wheezing:

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

- currently taking or have been prescribed oral steroids in the last 14 days; or

- currently taking a high dose inhaled steroid – Budesonide greater than 800mcg/day or equivalent because there is limited safety data in those groups. In children aged 5-12 years, the definition of severe asthma corresponds to British Thoracic Society BTS / SIGN step 5.

• Is receiving salicylate therapy (other than for topical treatment of localised conditions).

• Is pregnant.

Chapter 6 of Green Booki on “contraindications and special considerations” gives further advice on the use of live vaccines in individuals who are severely immunosuppressed. In cases of contraindication such as immunosuppression, severe asthma, wheezing at time of immunisation, pregnancy or salicylate therapy, consideration should be given to the use of inactivated (i.e. injectable) flu vaccine.

Fluenz™ Tetra is not contraindicated for use in children or adolescents with HIV infection receiving stable antiretroviral therapy; or who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.

i Public Health England (2013) Immunisation against infectious disease: the Green Book. Contraindications and Special Considerations V2_0 Gov.UK.


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Should Fluenz™ Tetra vaccination be administered to children who are very severely immunocompromised (e.g. bone marrow transplant recipients requiring protective isolation) and should they be excluded from school?No, they should not receive the live nasal vaccine. They should receive the injectable flu vaccine instead.

Using the example of bone marrow transplant patients in protective isolation as an illustration, such individuals would not be at school or in the community so there is no need to exclude them from school.

There may be clinical circumstances in which other severely immunocompromised child or adolescent should not be given the live attenuated influenza vaccine (Fluenz™ Tetra) e.g. HIV infection not on highly active antiretroviral therapy (HAART) or specific cellular immune deficiencies.

In situations where doubt remains the prescriber can further discuss with the hospital clinician caring for the child.

Should children who are less severely immunocompromised (e.g. a leukaemic child not in protective isolation) receive Fluenz™ Tetra? In general, a rule of thumb to assist clinicians, is that if a child is well enough to attend school (i.e. not in protective isolation) that the child can receive Fluenz™ Tetra vaccine. Note, Fluenz™ Tetra is not contraindicated for use in children or adolescents with stable HIV infection receiving antiretroviral therapy.

In situations where doubt remains, the prescriber can further discuss with the hospital clinician caring for the child.

Should Fluenz™ Tetra vaccination be administered to household contacts of severely immunocompromised individuals? No, the close contacts of very severely immunosuppressed patients should be offered inactivated influenza vaccine as an alternative to Fluenz™ Tetra. This is not necessary for people with lesser degrees of immunosuppression such as a teacher who is taking immunosuppressants for a transplant, grandchildren of a person receiving chemotherapy or children receiving chemotherapy who are at school. In these situations there is absolutely no reason for Fluenz™ Tetra to be withheld as healthy contacts of these individuals.

The only situation where Fluenz™ Tetra should not be given to healthy children would be the situation where they are close contacts of someone who is very severely immunosuppressed (requiring a protective environment - for example following bone marrow transplant).


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What if a child has a heavy runny nose with no fever? There are no data on the effectiveness of Fluenz™ Tetra when given to children with a heavily blocked or runny nose (rhinitis) attributable to infection or allergy. As heavy nasal congestion might impede delivery of the vaccine to the nasopharyngeal mucosa, deferral of administration until resolution of the nasal congestion or an appropriate alternative intramuscularly administered influenza vaccine should be considered. The practical solution we would advocate is that heavy nasal congestion equates with both nostrils being blocked. If the child can sniff through at least one side of their nose then their nasal passage is patent and this would allow sufficient airflow to allow administration of the vaccine. The vaccine should still be administered into both nostrils but we recognise that there may be clinical situations where this may not be possible and administration of alternative inactivated vaccine should then be considered.

Can Fluenz™ Tetra be given in pregnancy?Inactivated flu vaccines are preferred for those aged under 18 years who are pregnant. There is no need to specifically test girls for pregnancy or to avoid pregnancy in those who have been recently vaccinated.

What if the child is unwell on the day of vaccination?If the child has an acute severe febrile illness, Fluenz™ Tetra administration should be deferred until recovered. Minor illnesses without fever or systemic upset are not valid reasons to postpone vaccination.

As Fluenz™ Tetra is a live vaccine, can it be passed on to others?There is the potential for transmission of live attenuated virus to very severely immunocompromised contacts (e.g. bone marrow transplant patients requiring isolation). The risk is for the period of one to two weeks following vaccination. Where close contact is likely or unavoidable (e.g. household members) consideration should be given to using inactivated flu vaccine.

Can healthcare staff in clinical risk groups administer the vaccine?There may be some inadvertent low level exposure of those administering live attenuated flu vaccine, to the vaccine viruses. In the US, where there has been extensive use of the live attenuated flu vaccine, there have been no reported instances of illness or infections from the vaccine virus among those registered healthcare practitioners or immunocompromised patients inadvertently exposed. Thus, the Centers for Disease Control and Prevention have considered that the risk of acquiring vaccine viruses from the environment is unknown but is probably low.

As the vaccine viruses are cold adapted and attenuated, there are unlikely to cause symptomatic flu. Nevertheless, as a precaution, very severely immunosuppressed individuals should not administer live attenuated flu vaccine. Other healthcare workers who are immunosuppressed or pregnant, should follow normal clinical practice to avoid inhaling the vaccine and ensure that they themselves are appropriately vaccinated.


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What does the term ‘follow normal clinical practice’ mean in managing exposure of healthcare professionals to live attenuated influenza vaccine viruses? Public Health Practitioners have asked for clarification of the statement in the section of the flu GB chapter “regarding pregnant women and those who are immunosuppressed follow ‘normal clinical practice’ to avoid inhaling the vaccine”. The answer is that a common sense approach should apply in this situation and that there is no need to wear a mask as the risk of colonisation is thought to be minimal. (Some practical suggestions may include don’t give vaccine too close-up, don’t inhale whilst vaccinating, arms length administration of the vaccine, well ventilated room if possible etc.)

What should I do if Fluenz™ Tetra is given to individuals who are clinically immunocompromised by mistake?The current Green Book advice is if an immunocompromised individual receives LAIV by mistake then the degree of immunosuppression should be assessed. If the patient is severely immunocompromised (e.g. bone marrow transplant recipients requiring protective isolation) antiviral treatment should be considered, otherwise they should be advised to seek medical advice if they develop flu-like symptoms in the four days (the usual incubation period) following administration of the vaccine. If antivirals are used, then in order to maximise their protection in the forthcoming flu season, the patient should be offered inactivated flu vaccine. This can be given straight away.

How will the practice/ school nurse recognise if someone is severely immunocompromised?An individual may be considered severely immunocompromised if they fall into the following:

• Severely immunocompromised 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.

What are the potential side effects of Fluenz™ Tetra?Fluenz™ Tetra has a similar adverse reaction profile to inactivated flu vaccines. Nasal congestion/runny nose (rhinorrhoea), reduced appetite, weakness and headache are common adverse reactions following administration of the live attenuated intranasal vaccine Fluenz™ Tetra. Although uncommon some children may experience a nosebleed after administration of Fluenz™ Tetra.

Immediate reactions such as urticaria, angio-oedema, bronchospasm and anaphylaxis can occur.


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What should be done if an individual experiences a side effect?As with all vaccines and other medicines registered healthcare practitioners and patients are encouraged to report suspected adverse reactions using the yellow card reporting scheme at http://mhra.gov.uk/yellowcard.

I have read that there is some concern that Bell’s palsy may be associated with receipt of Fluenz™ Tetra vaccine. Is this correct?Bell’s palsy is a condition affecting the facial nerve (the VII cranial nerve) in which individuals may experience drooping of one side of their face. Bells’ palsy is often associated with a variety of different infections as its trigger, particularly infection with Herpes Simplex (the virus that causes cold sores). As with other seasonal flu vaccines, Bells’ palsy been rarely reported following flu and pandemic vaccination. A review of the data submitted to the Centre for Disease Control Vaccine Adverse Event Reporting System (VAERS) reveals two reports of Bell’s palsy in children aged 5 or under and a further 16 instances in those between the ages of 6 and 17 during a period in which millions of doses of Fluenz™ Tetra have been administered. The EU Fluenz™ Tetra SPC does not mention any association between Fluenz™ Tetra and Bell’s palsy.

(Please note that following the introduction of newly licensed intranasal inactivated adjuvanted flu vaccine in Switzerland in October 2000, 46 cases of Bell’s palsy were noted among people who received the vaccine - Nasalflu, Berna Biotech was available for the 2000–2001 flu season; it contained Escherichia coli heat-labile toxin as a mucosal adjuvant [http://www.nejm.org/doi/full/10.1056/NEJMoa030595]. This vaccine was withdrawn from use and is not like the vaccine being used in the UK for the childhood vaccination programme.)

Can a child with cystic fibrosis receive Fluenz™ Tetra?Assuming a child has not other contraindications to flu vaccination, cystic fibrosis is not a reason not to immunise a child with Fluenz™ Tetra. Whilst it is recognised that in some children, the available effective surface area in the nose for absorption may theoretically be affected/could impede delivery of the nasal vaccine this has not translated into a clinical concern limiting the use of the Fluenz™ Tetra vaccine in this group. Fluenz™ Tetra should still be the recommended vaccine for this group.

Can anaphylaxis occur with Fluenz™ Tetra?

As with all vaccines, there is a very rare possibility of this vaccine causing severe allergic reaction called anaphylaxis. All registered healthcare practitioners responsible for vaccination should be trained to recognise and treat anaphylaxis.

If Fluenz™ Tetra is contraindicated which inactivated flu vaccine should be considered?As Fluenz™ Tetra is a live vaccine not all children are able to receive it. Where Fluenz™ Tetra is contraindicated, inactivated flu vaccine should be considered. Inactivated flu vaccines are presented as prefilled syringes for intramuscular injection. The preferred site for injection is the deltoid region of the upper arm.

http://mhra.gov.uk/yellowcard

http://www.nejm.org/doi/full/10.1056/NEJMoa030595

http://www.nejm.org/doi/full/10.1056/NEJMoa030595


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Children aged from three years for whom Fluenz™ Tetra is not suitable should be offered quadrivalent inactivated vaccine (Fluarix™ Tetra). The quadrivalent vaccine has both influenza B strains and may be better matched and therefore may provide better protection against the circulating B strain(s) than trivalent inactivated influenza vaccines.

The quadrivalent inactivated flu vaccine is not recommended in children under three years of age. So children from age two years to under three years for whom Fluenz™ Tetra is not suitable should be offered a trivalent inactivated flu vaccine licensed for their age. Some trivalent inactivated flu vaccines are restricted to use in particular age groups. Practitioners must be familiar with and refer to the SmPC for individual brands when administering trivalent inactivated flu vaccine.

Inactivated flu vaccine has a similar adverse reaction profile to Fluenz™ Tetra. The most common adverse reaction for inactivated flu vaccines are injection site reactions. These usually disappear after one or two days.

How many doses of inactivated flu vaccine are required?When children cannot receive Fluenz™ Tetra due to a contraindication where the child is aged less than nine years and have not received flu vaccine before should receive two doses of inactivated flu vaccine with the second dose at least four weeks after the first.

Does Fluenz™ Tetra contain pork (porcine) gelatin?Yes. Gelatin is an essential ingredient in many medicines, including some vaccines. Many faith groups have approved the use of gelatin-containing vaccines. It is, however, an individual choice whether or not to receive this vaccine and we recognise there will be diversity of thought within different communities. The following statements from representatives of the Jewish and Muslim communities may help individuals reach a decision about having this vaccine.

Rabbi Abraham Adler from the Kashrus and Medicines Information Service, said: “It should be noted that according to Jewish laws, there is no problem with porcine or other animal derived ingredients in non-oral products. This includes vaccines, including those administered via the nose, injections, suppositories, creams and ointments.”

In 2001, The World Health Organization published a letter reporting the findings of a seminar involving more than 100 Islamic legal scholars to clarify Islamic purity laws on the use of medicinal products containing gelatin which stated that: “Transformation which means the conversion of a substance into another substance, different in characteristics, changes substances that are judicially impure into pure substances, and changes substances that are prohibited into lawful and permissible substances”. This means that gelatin made of unclean animal’s bones, skin and tendons is clean and permissible for consumption.

Vegetarians should also note that pork gelatin is an ingredient in the vaccine.

NHS boards will make local arrangements for provision of alternative injectable vaccine that does not contain gelatin where necessary.


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Fluenz™ Tetra contains a genetically modified organism (GMO). Does this pose a potential risk to the environment?The overall risk of Fluenz™ Tetra to human health and the environment has been evaluated and is concluded by the Commission for Human Medicines and Products to be low. Fluenz™ Tetra does not replicate in the environment, does not carry a toxic transgene, is specific to humans, does not integrate and therefore is very unlikely to transfer genes to any other species, and is well tolerated in vaccinated individuals at recommended administration doses.

Flu vaccination for winter 2014/2015 An algorithm showing this vaccination programme can be found in Appendix A on page 16.

Why are all of the potential side effects of the vaccine not listed on the patient information leaflet?Patient information leaflets (PILs) are a well accepted mechanism to provide a short factual document to highlight key points/common adverse effects that have been assessed as the most important information to cover for each vaccine. None of these patient information leaflets can provide all of the details that are covered within the Summary Product Characteristics (SPC) produced for each medicinal product by each manufacturer – these PILs are available as the insert within the manufacturer packaging for each dispensed item. The SPC’s document the range of adverse events that may have been reported for any individual medicinal product. Additional information on adverse events may also be available for a range of questions and answers on the Immunisation Scotland website - http://www.immunisationscotland.org.uk/vaccines-and-diseases/seasonalflu/index.aspx.

Have Health Scotland leaflets been translated into other languages?Consent forms for the flu vaccine have not been translated into alternative languages. However, for vaccination of primary school children, translations from the Health Scotland leaflet ‘Protect your child against flu: Information for parents of primary school aged children’ are available a http://www.healthscotland.com/documents/22023.aspx.

Where can I get further information?Public Health England (2013) Immunisation against infectious disease: the Green book: Chapter 19 v5_2. Influenza. Available from: http://www.gov.uk/government/publications/influenza-the-green-book-chapter-19.

Scottish Government (SGHD/CMO(2014)13). Scottish Immunisation Programme Childhood Flu Programme - Year 2 Implementation 2014-15. Edinburgh. Scottish Government. Available from: http://www.sehd.scot.nhs.uk/cmo/CMO(2014)13.pdf

http://www.immunisationscotland.org.uk/vaccines-and-diseases/seasonalflu/index.aspx

http://www.immunisationscotland.org.uk/vaccines-and-diseases/seasonalflu/index.aspx

http://www.healthscotland.com/documents/22023.aspx

http://www.healthscotland.com/documents/22023.aspx

https://www.gov.uk/government/publications/influenza-the-green-book-chapter-19

https://www.gov.uk/government/publications/influenza-the-green-book-chapter-19

http://www.sehd.scot.nhs.uk/cmo/CMO%25282014%252913.pdf


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Supporting EvidenceAllison MA, Daley MF, Crane LA et al. (2006) Influenza vaccine effectiveness in healthy 6 to 21 month-old children during the 2003--2004 season. The Journal of Pediatrics 149: 755-62.

Ashkenazi S, Vertruyen A, Aristegui J et al. (2006) Superior relative efficacy of live

attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. The Pediatric Infectious Disease Journal 25(10): 870-9.

Belshe RB, Edwards KM, Vesikari T et al. (2007) Live attenuated versus inactivated influenza vaccine in infants and young children. New England Journal of Medicine 356(7): 685-96. http://www.ncbi.nlm.nih.gov/sites/entrez/17301299

Block S L, Toback SL, Yi T et al. (2009) Efficacy of a single dose of live attenuated influenza vaccine in previously unvaccinated children: a post hoc analysis of three studies of children aged 2 to 6 years.Clinical Therapies Journal. 31, 2140-7.

Bracco Neto H, Farhat CK, Tregnaghi MW, et al. (2009) Efficacy and safety of 1 and 2 doses of liveattenuated influenza vaccine in vaccine-naive children. The Pediatric Infectious Disease Journal. 28, 365-71.

Fleming DM, Crovari P, Wahn U et al. (2006) Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. The Pediatric Infectious Disease Journal 25(10): 860-9. http://www.ncbi.nlm.nih.gov/sites/entrez/17006278

Hayden F.G., Belshe R., Villanueva C., Lanno R., Hughes C., Small I., Dutkowski R., Ward P., Carr J. (2004) Management of influenza in households: a prospective, randomised comparison of oseltamivir treatment with or without post exposure prophylaxis. The Journal of Infectious Diseases 189(3):440-449 http://www.ncbi.nlm.nih.gov/sites/entrez/17006279

Izurieta H.S., Thompson W.W., Kramarz P., Shay D.K.., Davis R.L., DeStefano F., Black S., Shinefield H., Fukuda K. (2000) Influenza and the rates of hospitalisation for respiratory disease amongst infants and young children. New England Journal of Medicine 342(4):232-239.

Jefferson et al. (2012) Vaccines for preventing influenza in healthy children. Cochrane database of Systematic Reviews. Issue 8, Art. No. CD004879.

Joint Committee onVaccination and Immunisation - minutes. (2013) http://media.dh.gov.uk/network/261/files/2012/07/JCVI-minutes-13-June-2012-revised.pdf [last accessed 11 July 2013].

Mullooly J.P., Barker W.H. (1982) Impact of type A influenza on children: a retrospective study. American journal of public health 72(9): 1008-101.

Neuzil K.M., Hohlbein C., Zhu Y. (2002) Illness among schoolchildren during influenza season: effect on school absenteeism, parental absenteeism and secondary illness in families. Archives of Pediatric Adolescent Medicine 156(10):986-991.

Neuzil K.M., Mellen B.G., Wright P.F., Mitchel E.F. Jr, Griffin M.R. (2000) The effect of influenza on hospitalisations, outpatient visits and courses of antibiotics in children. New England Journal of Medicine 342(4):225-231.

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Neuzil KM, Jackson LA, Nelson J et al. (2006) Immunogenicity and reactogenicity of 1 versus 2 doses of trivalent inactivated influenza vaccine in vaccine-naive 5-8-year-old children. Journal of Infectious diseases 194(8): 1032-9. http://www.ncbi.nlm.nih.gov/sites/entrez/16991077

Osterholm, M. T., Kelley, N. S., Sommer, A., and Belongia, E. A. (2012) Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis.. 12. 12(1. 1), 36-44The Lancet Infectious Diseases.

Paget W.J., Balderston C., Casas I., Donker G., Edelman L., Fleming D., Larrauri A., Meijer A., Puzelli S., Rizzo C., Simonsen L., EPIA collaborators (2010) Assessing the burden of paediatric influenza in Europe: the European Paediatric Influenza Analysis (EPIA) project. European Journal of pediatrics 169(8):997-1008.

Pitman R.J., Nagy L.D. and Sculpher M.J. (2013) Cost-effectiveness of childhood influenza vaccination in England and Wales: Results from a dynamic transmission model. Vaccine 31(6):927-42.

Poehling K.A., Edwards K.M., Weinberg G.A., Szilagyi P., Staat M.A., Iwane M.K., Bridges C.B., Grijalva C.G., Zhu Y., Bernstein D.I., Herrera G., Erdman D., Hall C.B., Seither R., Griffin M.R., Network NVS (2006) The under recognised burden of influenza in young children. New England Journal of Medicine 31-40 355(1).

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16

Appendix A

If never had flu vaccine before give a second dose at least four weeks later



One dose of trivalentinactivated vaccine

One dose of quadrivalentinactivated vaccine(Fluarix™ Tetra)

One dose ofFluenz™ Tetra


Aged three years or above?

NOYES NO YES

NO YES

If never had fluvaccine before give asecond dose at least

four weeks later

Administration of Childhood Flu Immunisation (birth to pre-school age groups)

Suitable for Fluenz™ Tetra? Suitable for Fluenz™ Tetra?Vaccinationnot required


NO YES NO YES

Vaccinationnot required

In Clinical Risk Group?(See table 19.5 Green Book flu

chapter for further details)



Birth to undersix months

Six months tounder two years

Pre-school aged two - five years

Be careful with TetrasFluenz™ Tetra(Live vaccine given by nasal administration)

Fluarix™ Tetra(Inactivated vaccine given by intramuscularinjection)








Aged nine years or above? Aged nine years or above?

NOYES NO YES

Administration of Childhood Flu Immunisation (primary school age group)

Suitable for Fluenz™ Tetra? Suitable for Fluenz™ Tetra?

NO YES



Primary school children

NO YES NO YES

Be careful with TetrasFluenz™ Tetra(Live vaccine given by nasal administration)

Fluarix™ Tetra(Inactivated vaccine given by intramuscularinjection)


17



NO YES

Suitable forFluenz™ Tetra?

Administration of Childhood Flu Immunisation (secondary school to over 65 years age groups, pregnant women and other special groups)

One dose of trivalentinactivated

vaccine


NO YES



Aged 18 years tounder 65 years


NO YES



Secondary schoolchildren (up to 18 years)


All pregnant women(at any stage of

pregnancy)


All people 65 yearsand over


Others*

* Health and social care workers People in long stay residential care homes or other long stay facilities Carers Household contacts of immunocompromised patients

A poster version of the algorithms is available from: 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

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

Documents

Extension of the seasonal - NHS Education for Scotland of Fluenz™ Tetra 4 ... Extension of the seasonal influenza vaccination programme to children: Phase 2-2014/14 Frequently asked