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Extension of the seasonal flu vaccination programme to include children (2 to under 17 years) Phase 1 - 2013/14 Training for healthcare practitioners. Key messages.

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  1. Extension of the seasonal flu vaccination programme to include children (2 to under 17 years)Phase 1 - 2013/14Training for healthcare practitioners

  2. 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 will begin in 2013 and the ambition is to roll out from 2014 including to secondary school aged children • From 1st September 2013, the seasonal flu vaccination programme will be extended to all two and three year old children, with a pilot to include some primary school aged children this season • All those involved in immunisation have a key role in promoting high uptake of flu vaccination in children through increasing awareness of the programme • There will be key roles for nurses as the programme is rolled out including the school nurse’s leadership role, staff nurse’s clinical role for children and young people in the school setting and for health care assistants providing support in school nurse teams • PHE will learn from the pilots and work with local leaders and coordinators, professionals and professional bodies to develop further guidance, training and support as is required to enable a successful implementation of the programme Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  3. 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® Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  4. Learning Outcomes • On completion of this resource 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 will be used and the precautions and contraindications to the administration of this vaccine • Explain the possible side effects from the live attenuated flu vaccine (Fluenz®) • Explain the sequence of steps in Fluenz® 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  5. Contents • What is flu? • Why extend the seasonal flu immunisation programme to all children • (2 to under 17 years of age)? • Vaccination of children against flu • Resources Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  6. What is flu? • Flu is an acute viral infection of the respiratory tract • It is a highly infectious illness which spreads rapidly in closed communities • Most cases in the UK occur during an 8-10 week period during the winter Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  7. Influenza (flu) viruses • There 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  8. Flu A virus • 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 The blue protuberances represent haemagglutinin and the red spikes neuraminidase. Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  9. 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  10. 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  11. 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 disease Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  12. 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 begins with the inclusion of children aged 2 and 3 years in the routine programme Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  13. Proposed extension to 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 will be rolled out over a number of seasons and will include pilots • The pilots will allow Public Health England and NHS England opportunity to ascertain the most effective way of implementing it • In 2013/14: • All two and three year olds (but not four years or older) on the 1 September 2013 will be offered flu vaccine • And • In a small number of geographical pilots, flu vaccine will be offered to four to ten year olds (up to and including pupils in school year 6) Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  14. Why extend the seasonal flu vaccination programme to children (2 to 17 years of age)? Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  15. 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 protectionthus preventing a large number of cases of influenza disease in children • Providing indirect protection by lowering influenza transmission from: • Child to child • Child to adult • Child to those in the clinical risk groups of any age • Annual administration of flu vaccine to children is expected to substantially reduce flu-related illness, GP consultations, hospital admissions and deaths Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  16. 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 <6 months) • - 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  17. 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 low risk 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  18. Which flu vaccine should be used? Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  19. Types of flu vaccines • Two main types of vaccine available: • Inactivated - by intramuscular injection • Live - by nasal application • Most current flu vaccines are trivalent,containing two subtypes of Influenza A and one type B virus • Quadrivalentvaccines with an additional type of B virus have been developed and will be available for use for the first time this year (2013)* • *Quadrivalentinactivated influenza vaccine is only authorised for children aged three years and older • 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  20. Live attenuated influenza vaccine (LAIV) • A live attenuated intranasal spray called Fluenz® 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) • Fluenz® has a good safety profile in children aged two years and older and has an established history of use in the United States. Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  21. How many doses? • Two doses of the inactivated influenza vaccines are required to achieve adequate antibody levels in younger children • A single dose of LAIV should provide protection to previously unvaccinated healthy children however • 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 less than nine years who are in clinical risk groups and have not received influenza vaccine previously should be offered a second dose of LAIV Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  22. Fluenz® • Generic name: influenza vaccine (live attenuated, nasal) • Brand name: Fluenz® • 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 • Container dimensions: 117.5 x 115.5 x36mm Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  23. Fluenz® composition 2013/14 • Active ingredient: • A/California/7/2009 (H1N1)pdm09-like virus 107.0±0.5 FFU • A/Texas/50/2012 107.0±0.5 FFU* • B/Massachusetts/2/2012-like virus 107.0±0.5 FFU • Excipients: • Sucrose • Dibasic potassium phosphate • Monobasic potassium phosphate • Gelatin (porcine type A) • Arginine hydrochloride • Monosodium glutamate monohydrate • Water for injection • Residues: • Egg proteins (e.g. ovalbumin) • Gentamicin * A/Texas/50/2012 is an A/Victoria/361/2011 (H3N2)-like strain Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  24. Fluenz® presentation • Single use prefilled nasal applicator • Ready to use • Nasal spray (suspension) • Each applicator contains 0.2ml Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  25. Storage of Fluenz® • Fluenz® must be stored in accordance with manufacturer’s instructions: • Store between +2°C and +8°C • Store in original packaging • Protect from light • Check expiry dates regularly: • Fluenz® has an expiry date 18 weeks after manufacture – this is much shorter than inactivated flu vaccines Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  26. Fluenz® dosage and schedule • 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 less than nine years who are in clinical at risk groupsand who have not received flu vaccine before should receive two doses of Fluenz® (if not immunocompromised) with the second dose at least four weeks after the first • NB: This advice differs from that given in the Fluenz® SPC • Where Green Book advice differs from SPC, Green Book should be followed Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  27. Administration of Fluenz® • Fluenz® is different from other influenza vaccines - it is a live nasal vaccine and must not be injected • Fluenz® can be administered at the same time as 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  28. Administration of Fluenz® 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  29. Fluenz® Applicator Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  30. Administration of Fluenz® Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  31. Administration of Fluenz® Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  32. Administration of Fluenz® Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  33. Contraindications to Fluenz® • 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®: • Confirmed anaphylactic reaction to a previous dose of influenza vaccine • Confirmed anaphylactic reaction to any component of the vaccine including gentamicin and gelatin • Egg allergy Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  34. Contraindications to Fluenz® (cont’d) • Severe immunosuppression 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 • Individuals with severe asthma (BTS/SIGN step 4 or above) * • * BTS SIGN step 4 is defined as “poor control on moderate dose of inhaled steroids + add on therapy: addition of fourth dose” • Active wheezing at the time of vaccination • Known to be pregnant The childhood influenza programme 2013 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  35. Egg allergy • Fluenz® 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 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 with severe uncontrolled asthma (BTS SIGN step 4 or above) should be referred to specialists for immunisation in hospital • The ovalbumin content of influenza vaccines is given in the Green Book influenza chapter Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  36. Precautions to Fluenz® • 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® 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® may adversely affect the effectiveness of the vaccine Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  37. Risk of transmission of vaccine virus • Potential for transmission of live attenuated virus to severely immunocompromised contacts (e.g. bone marrow transplant patients requiring isolation) • Risk is for one to two weeks following vaccination • Where close contact is likely or unavoidable (e.g. household members) consider an appropriate inactivated flu vaccine instead Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  38. Exposure of healthcare professionals to live attenuated influenza vaccine (LAIV) • There may be some inadvertent low level exposure of those administering LAIV to the vaccine viruses • 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 attenuatedand 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  39. Infection control issues • There are no specific infection control precautions required when administering Fluenz® • 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® applicators should be disposed of in accordance with local procedures for disposal of clinical waste Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  40. Adverse reactions to Fluenz® • Common adverse reactions (affects more than 1 in 10 Fluenz® recipients) • Blocked or runny nose • Headache • Fever • Malaise • Myalgia • Decreased appetite • Hypersensitivity reactions (including oedema, urticaria and bronchospasm) can occur but are very rare Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  41. Reporting suspected adverse reactions • As with all vaccines during the earlier stages of their introduction, Fluenz® 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  42. Vaccine ordering • Fluenz® has been procured centrally to cover the pilots and for the two and three year old cohorts, including children in at risk groups • Vaccine ordering for two and three year olds: • Fluenz® is available for GPs to order through ImmForm in the normal manner. The vaccine is on the ImmForm vaccine ordering pages alongside the other vaccines available in the childhood programme • Vaccine ordering for the four to ten year old pilots: • Fluenz® will be available to be ordered through ImmForm. Only the organisations participating in the pilots will be able to place orders • ImmForm is available via https://www.immform.dh.gov.uk/ • ImmForm Helpdesk: 0844 376 0040 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  43. Inactivated Influenza Vaccine (TIV) for children contraindicated to receive Fluenz® • Guidance on which vaccines to use for those children who cannot receive Fluenz® can be found in the Green Book influenza chapter • For those 2 and 3 year olds who are contraindicated to receive Fluenz® • Inactivated flu vaccines already ordered by GPs for 2and 3 year olds in clinical risk groups can be used for the contraindicated 2 and 3 year olds • GPs will be reimbursed for this as per children in clinical risk groups • For the 4 to 10 year old pilots • Inactivated flu vaccine for children contraindicated for Fluenz® can be ordered via ImmForm • To order this for children in the pilots please call the ImmFormHelpdesk Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  44. Recording of flu vaccine given to children • The 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 Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  45. 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 will begin in 2013 and the ambition is to roll out from 2014 including to secondary school aged children • From 1st September 2013, the seasonal flu vaccination programme will be extended to all two and three year old children, with a pilot to include some primary school aged children this season • All those involved in immunisation have a key role in promoting high uptake of flu vaccination in children through increasing awareness of the programme • There will be key roles for nurses as the programme is rolled out including the school nurse’s leadership role, staff nurse’s clinical role for children and young people in the school setting and for health care assistants providing support in school nurse teams • PHE will learn from the pilots and work with local leaders and coordinators, professionals and professional bodies to develop further guidance, training and support as is required to enable a successful implementation of the programme Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  46. Resources • Letter detailing childhood programme: Department of Health, Public Health England, NHS England. The flu immunisation programme 2013/14 – extension to children. 26 July 2013. Available at: https://www.gov.uk/government/publications/childrens-flu-immunisation-programme-2013-to-2014 • Green Book updated Influenza chapter August 2013. Will be 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. Will be available from https://www.gov.uk/government/organisations/public-health-england/series/annual-flu-programme • British guidelines on the management of asthma (BTS SIGN) http://www.brit-thoracic.org.uk/guidelines-and-quality-standards/asthma-guideline/ Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

  47. Acknowledgement • This training slide set was adapted for use in England from one developed by NHS Education for Scotland • Their permission to adapt it is gratefully acknowledged Extension of seasonal flu vaccination programme to children (aged 2 to under 17 years of age)

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