Influenza and Shingles Vaccines August 2013 Richard Smithson

Influenza and Shingles Vaccines August 2013 Richard Smithson Sinead Mc. Guinness Mary Loughrey Maureen Mc. Cartney

Outline of Talk Extension of Flu vaccine to 2 – 16 year olds Important aspects of routine seasonal flu vaccine campaign Shingles vaccine.

Key message - Extension of the seasonal flu programme to children (2 to 16 years of age inclusive) • 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 16 years of age inclusive, the phased introduction of this will begin in 2013. • From 1 st October 2013 the seasonal flu vaccination programme will be extended to all two and three year old children in Primary Care and to P 6 children in school by school health service. • The purpose of this extension to the flu vaccination programme is to reduce the impact of seasonal flu on children and reduce transmission of flu within the community. • Registered healthcare practitioners have a key role in promoting increased uptake of flu vaccination in children through increasing awareness.

Possible Complications of flu Common: • Bronchitis; • Otitis media (children), sinusitis; • Secondary bacterial pneumonia. Less common: • Meningitis, encephalitis; • Primary influenza pneumonia; • Most serious illness in neonates, pregnant women, older people and those with underlying disease.

Current Flu Vaccination Programme in Northern Ireland • In Northern Ireland, there is an annual vaccination programme which aims to reduce the impact (morbidity and mortality) of flu particularly in high-risk groups e. g. those over 65 years old, in clinical risk groups and in pregnant women.

Proposed extension to flu vaccination programme in Northern Ireland • A live flu vaccine rather than the current injectable inactivated flu vaccine has been in use for many years in children in the USA; • JCVI has recommended that our programme be extended to include annual vaccination of all children aged 2 to 16 years of age inclusive, primarily using Fluenz® (A live flu vaccine); • Partial implementation will take place in 2013 and it is anticipated that in 2014/5 the programme will roll out to all pre-school and primary school children; • The aim is that in autumn 2015 it will be rolled out to all children aged 2 to 16 years inclusive.

Details for 2013 - In schools All P 6 children will be offered the vaccine in school; Includes “at risk” children as well as healthy children; Fluenz will be offered to most children – those for whom contraindicated but who can receive injected vaccine will be offered injected vaccine in school; School health teams will visit each school once only – no mop-up of those absent on day of visit; Parents will be advised to contact GP if require vaccine – particularly important for “at risk” children; Normal fee payable for all such children vaccinated by GP (Both “healthy” and “at risk”)

Details for 2013 - General Practice All children aged 2 & 3 years on 1 September 2013 should be invited for flu vaccination. (DOB range: on and after 2 September 2009 and on or before 1 September 2011) Children of all ages in risk groups – invited as normal – except those in P 6 who will be offered vaccine in school DOB: 02/07/03 – 01/07/04 Children in P 6 who miss vaccination in school, to be offered it if parents contact surgery requesting it.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) Why vaccinate children? Extension of the seasonal flu vaccination programme to all children aims to appreciably lower the public health impact of flu by: • • providing direct protection to children thus averting a large number of cases of influenza disease; lowering influenza transmission from: – Child to child; – Child to adult; – Child to those in the clinical risk groups of any age The expected effect of the vaccination of children will then be a reduction in both the morbidity and mortality associated with flu.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) Cost effectiveness Studies commissioned by the JCVI 3 suggest that despite the high cost, extending the flu vaccination programme to all children is: • • highly likely to be cost-effective; is 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 (2 to 16 years of age inclusive) Recent observation/studies relating to flu and children - Clinical trials on effectiveness of live attenuated influenza vaccine (LAIV) - single dose of LAIV provides similar protection to children as two doses of inactivated influenza vaccine 4, 5 - most of the protection is gained from the first dose - Limited amount of LAIV available for season 2013/14 – compare impact: - either two doses of LAIV to two year old children OR - one dose of LAIV to two and three year old children => greater health impact expected if the available quantity of LAIV is provided through a one dose schedule to the larger number of children => two dose LAIV schedule reserved for those children under nine years who are in a clinical risk group and are vaccine naive

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - Recent review of burden of influenza in children • average influenza season: estimated 0. 3% to 9. 8% of 0 -14 year old children present to a GP with influenza; 7 • incidence rates can be markedly higher in the younger age groups; • influenza associated hospitalisation rates; 8, 9, 10, 11, 12 - 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; 13, 14 • 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. 15, 14 (Ruf & Knuf, 2013)6

Extension of the seasonal flu programme to children (2 to 16 years of age inclusive) What is the additional evidence to support the offer of vaccination? • • • trivalent inactivated vaccine (TIV) shown to be effective in eliciting a protective antibody response /averting influenza like illness, when a two dose schedule is used for vaccine naïve children; 16, 22, 24, 25 live attenuated influenza vaccine (LAIV) ~ 50% more effective than TIV in averting laboratory confirmed influenza; 17, 18 meta-anlaysis of six LAIV studies showed median VE of 78% (range: 57 -93) in children 6 months to 7 years; 23 one dose of LAIV provides clinically significant protection against influenza in young influenza vaccine naïve children, with a second dose providing additional protection. Up to 90% of protection are conferred by the first dose; 19, 20. LAIV is well tolerated in children and adolescents with asthma. 21, 26

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) – types of vaccines Two main types of vaccine: • inactivated - by intramuscular injection; • live - by nasal application. Antibody levels may take 10 -14 days to reach protective levels. Protection lasts for one season.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz®: • Generic name: influenza vaccine (live attenuated, nasal); • Brand name: Fluenz®; • Marketed by Astra. Zeneca; • 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 x 36 mm; • Provides greater protection for children than inactivated influenza vaccine.

Live Attenuated Vaccine has been attenuated, or weakened, so that cannot cause disease. Also “cold adapted” – can’t replicate at body temperature Replicates in nose – produces antibodies which then protect against infection

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz® composition: Active ingredient: A/California/7/2009 (H 1 N 1)pdm 09 -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 injections. Residues: Egg proteins (e. g. ovalbumin); Gentamicin.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz® presentation: • Prefilled nasal applicator-ready to use, no reconstitution or dilution required; • Nasal spray (suspension); • Each applicator contains 0. 2 ml. • Colourless to pale yellow, clear to opalescent. Small white particles may be present

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) – use of Fluenz® 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. Using Fluenz May be taken out of fridge, for maximum 12 hours not above 25 C. If not used should then be disposed of Whilst may make running school clinics easier need to take care to avoid wastage. 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 (2 to 16 years of age inclusive) – use of Fluenz® dosage and schedule • A single dose is 0. 2 ml (administered as 0. 1 ml 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 groups who have not received influenza vaccine before should receive two doses of Fluenz® with the second dose at least four weeks after the first.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) Administration of Fluenz® • Fluenz® is different from other influenza vaccine, 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; • If not given at same time as another live vaccine normally leave 4 week gap – but do not delay Fluenz because of this – more important to give protection before start of flu season; • Patient should breathe normally - no need to actively inhale or sniff; • 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 (2 to 16 years of age inclusive) 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: o Against a Patient Specific Direction; o Against a Patient Group Direction.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) Administration of Fluenz® Video clip showing administration

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - the use of Fluenz® 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. Disposal of clinical waste: • Empty Fluenz® vaccines should be disposed of in accordance with local procedures for disposal of clinical waste.

Extension of seasonal flu vaccination programme to children ( 2 to 16 years of age inclusive) - use of Fluenz® Contraindications • Age under 2 years; • Age 18 years or above – routine programme will be up to and including 16 but “at risk” is up to and including 17; • Confirmed anaphylactic reaction to a previous dose of influenza vaccine; • Confirmed anaphylactic reaction to any component of the vaccine; • including gentamicin and gelatin; • Allergy to egg – use injected vaccine with low ovalbumin content.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz® Contraindications (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); Active wheezing at the time of vaccination; Known to be pregnant. Injected vaccine should be actively considered for the above.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - Administration of Fluenz® Precautions • Acute severe febrile illness: o defer until recovered. • Heavy nasal congestion or severe rhinitis; o defer until resolved or consider inactivated influenza vaccine. Please note: Minor illnesses without fever or systemic upset are not valid reasons to postpone vaccination.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - Administration of Fluenz® Precautions Cont’d: • Use with antiviral agents against flu; • Fluenz® should not be administered at the same time; • Fluenz® should not be administered 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 (2 to 16 years of age inclusive) - Administration of Fluenz® Risk of transmission • 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; • Where close contact is likely or unavoidable (e. g. household members) consider inactivated flu vaccine.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of inactivated flu vaccine In many cases where Fluenz cannot be given, an injected inactivated vaccine should be considered. This includes both “at risk” and “healthy” children. “At risk” examples: immunosuppression, severe asthma, wheezing at time of immunisation, pregnancy or salicylate therapy “Healthy” example: egg allergy Very few children cannot have any vaccine.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of inactivated flu vaccine Presentation: • Inactivated flu vaccines are supplied as prefilled syringes; • Must be shaken well before they are administered. Storage: • Store between +2°C and +8°C, in original packaging, protected from light. Age restrictions: • Some flu vaccines (inactivated) are restricted to use in particular age groups. Practitioners must be familiar with and refer to the summary of product characteristics for the particular brand when administering vaccines. All CENTRALLY supplied vaccines in NI, apart from the egg free vaccine, are suitable for all ages from 6 months upwards.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of inactivated flu vaccine Contraindications, precautions and adverse reactions Contraindications: • Confirmed anaphylactic reaction to a previous dose of influenza vaccine; • Confirmed anaphylactic reaction to any component of the vaccine; • Confirmed anaphylactic reaction to egg proteins – refer to hospital Precautions: • Acute severe febrile illness defer until recovered. Adverse Reactions: • Pain, swelling, redness at injection site; • Low grade fever, malaise, shivering, fatigue, headache, muscle pain and joint pain.

One or Two doses? Healthy children of any age receiving Fluenz require only 1 dose even if never vaccinated before i. e. new group being added only need 1 dose if getting Fluenz Healthy children who need injected vaccine, are being vaccinated for the first time and are under 9 years old require 2 doses “At risk” children, being vaccinated for the first time and under 9 years old require 2 doses, whichever vaccine they receive.

Extension of seasonal flu vaccination programme to children ( 2 to 16 years of age inclusive) - Data Collection • Very important to closely monitor uptake from start; • Weekly collection of total number of doses given to 2&3 year olds from each practice; • Weekly collection of uptake for P 6 children in schools; • Will allow early action to be taken if uptake is significantly different from that predicted; • End of season vaccination uptake data will be provided in a more detailed analysis.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - Reporting suspected adverse reactions Yellow card scheme: • Voluntary reporting system for suspected adverse reaction to medicines/vaccines; • • Success depends on early, complete and accurate reporting; Report even if uncertain about whether vaccine caused condition • http: //mhra. gov. uk/yellowcard; • See chapter 8 of Green Book for details.

Extension of the seasonal flu programme to children (2 to 16 years of age inclusive) Resources • • • Green Book available at: http: //www. dh. gov. uk/greenbook Patient Group Directions Leaflets for 2&3 year olds and for P 6 s Q&A briefing Publications will be available at: http: //www. publichealth. hscni. net/ CMO letters available at: http: //www. dhsspsni. gov. uk/index/phealth/professional/cmo_com munications. htm

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) References 1. JVCI minutes. 2013. http: //media. dh. gov. uk/network/261/files/2012/07/JCVI-minutes-13 -June-2012 revised. pdf [last accessed 11 th July 2013]. 2. CMO letter- to be added when available 3. Pitman R. J. , Nagy L. D. and Sculpher M. J. (2013) Cost-effectiveness of childhood influenza vaccination in England Wales: Results from a dynamic transmission model. Vaccine 31(6): 927 -42 http: //www. ncbi. nlm. nih. gov/pubmed/23246550 4. Rhorer et al. (2009) Efficacy of live attenuated influenza vaccine in children: a meta-analysis of nine randomized clinical trials. Vaccine. 27, 1101 -1110. 5 Jefferson et al. (2012) Vaccines for preventing influenza in healthy children. Cochrane database of Systematic Reviews. Issue 8, Art. No. CD 004879 6. Ruf B. R. , Knuf M. (2013) The burden of seasonal and pandemic influenza in infants and children. European Journal of Pediatrics. 2013 May 10. [Epub ahead of print]

References (continued) 7. 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 8. Izurieta H. S. , Thompson W. W. , Kramarz P. , Shay D. K. , Davis R. L. , De. Stefano F. , Black S. , Shinefield H. , Fukuda K. (2000) Influenza and the rates of hospitalisation for respiratory disease amongst infants and young children. N Engl J Med 342(4): 232 -239 9. Mullooly J. P. , Barker W. H. (1982) Impact of type A influenza on children: a retrospective study. Am J Public Health 72(9): 1008 -1016 10. 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. N Engl J Med 342(4): 225 -231 11. 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 underrecognised burden of influenza in young children. N Engl J Med 355(1): 31 -40 12. Weigl J. A. , Puppe W. , Schmitt H. J. (2002) The incidence of influenza-associated hospitalisations in children in Germany. Epidemiol Infect 129(3): 525 -533 13. 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 postexposure prophylaxis. J Infect Dis 189(3): 440 -449 14. Viboud C. , Boelle P-Y, Cauchemez S. , Lavenu A. , Valleron A. J. , Flahault A. , Carrat F. (2004) Risk factors of influenza transmission in households Br J Gen Pract 54(506): 684 -689 15. Neuzil K. M. , Hohlbein C. , Zhu Y. (2002) Illness among schoolchildren during influenza season: effect on school absenteism, parental absenteism and secondary illness in families. Arch Pediatr Adolesc Med 156(10): 986991

(References continued) 16. Allison MA Daley MF, Crane LA et al. (2006) Influenza vaccine effectiveness in healthy 6 to 21 month-old children during the 2003 --2004 season. J Pediatr 149: 755 -62. 17. 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. Pediatr Infect Dis J 25(10): 870 -9. http: //www. ncbi. nlm. nih. gov/sites/entrez/17006279 18. Belshe RB, Edwards KM, Vesikari T et al. (2007) Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med 356(7): 685 -96. http: //www. ncbi. nlm. nih. gov/sites/entrez/17301299 19. 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. Clin Ther. 31, 2140 -7. 20. Bracco Neto H, Farhat CK, Tregnaghi MW, et al. (2009) Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children. Pediatr Infect Dis J. 28, 365 -71. 21. Fleming DM, Crovari P, Wahn U et al. (2006) Comparison of the efficacy and safety of live attenuated coldadapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J 25(10): 860 -9. http: //www. ncbi. nlm. nih. gov/sites/entrez/17006278 22. 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. J Infect Dis 194(8): 1032 -9. http: //www. ncbi. nlm. nih. gov/sites/entrez/16991077

References continued 23. 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. Lancet Infect Dis. 12(1. 1), 36 -44 24. Ritzwoller DP, Bridges CB, Shetterly S et al. (2005) Effectiveness of the 2003 -- 2004 influenza vaccine among children 6 months to 8 years of age, with 1 vs 2 doses. Pediatrics 116: 153 -9. 25. Shuler CM, Iwamoto M, Bridges CB, et al. (2007) Vaccine effectiveness against medically attended, laboratory -confirmed influenza among children aged 6 to 59 months, 2003 -2004. Pediatrics 119: e 587 -95. 26. Wright PF, Thompson J, Vaughn WK et al. (1977) Trials of influenza A/New Jersey/76 virus vaccine in normal children: an overview of age-related antigenicity and reactogenicity. J Infect Dis 136 (suppl): S 731– 41.

Disclaimer We very gratefully acknowledge the assistance of Scottish colleagues in sharing draft materials with us and for all their hard work in preparing them. However we take full responsibility for using them and the following disclaimed should be noted: These ‘draft’ training resources have been prepared with reference to the version of Public Health England’s “Immunisation against infectious disease: the green book’ available at the time of publication. The resources have been made available at this time, to allow the training to commence in line with the requirements of and at the request of the Scottish Immunisation Service Delivery Group, the Scottish Immunisation Coordinating Group and other UK partners. It should be noted that whilst every effort has been made to ensure the accuracy of this training material and information at the time of publication, additions, updates, alterations and changes to the “Green Book” are likely to occur between the time of publication and the time the user views the training material. NHS Education for Scotland (NES) advises users to verify the accuracy and completeness of the information before any future use of the materials or committing to any related course of action. Under no circumstances will NES be liable for damages arising from use of this information or training material.

ROUTINE FLU VACCINE PROGRAMME – IMPORTANT REMINDERS

Start of programme Ø Ø Ø Official launch late September/early October Expecting vaccine supplies into NI by early September – on schedule All Practices should have received initial deliveries before end September Can start clinics once have received vaccine Once Fluenz received encouraged to do 2 & 3 year olds early.

Target Groups Ø Ø No additions to last year Remember ALL pregnant women to be vaccinated by GP Importance of children & young people with chronic neurological disease and complex health problems again emphasised People living in same house as immunocompromised patients should be considered for vaccination – as well as the immunocompromised patient themselves.

Flu vaccine and pregnancy Ø Ø Ø Flu vaccine recommended at all stages of pregnancy “Pregnancy” is now a “risk group” and pregnant women will be vaccinated every year from now. Vaccination will just take place during normal flu vaccination period. Responsibility for vaccinating all pregnant women now lies with GP. Important to identify women as they become pregnant and vaccinate early

WHO – Strategic Advisory Group of Experts on Immunisation Ø Ø Ø Met in April 2012 to review all up to date evidence Recommended pregnant women as the most important group for flu vaccine. Was based on compelling evidence of substantial risk of disease. Evidence that vaccine is safe and effective in pregnant women Also protect their babies in whom disease burden is also high

Fluenz As well as being used for the new programme for healthy children Fluenz is the vaccine of choice for at risk children aged 2 to 17 years inclusive – except where contraindicated. Sufficient vaccine has been ordered to easily provide for all such children.

Supply & Ordering Ø Ø Ø Doses ordered this year will be able to meet all demands Need to avoid wastage – last year Fluenz problems caused by overordering. Don’t over order Look after cold chain Destroy any remaining vaccine from last year before ordering this year’s

Please, PLEASE Don’t Over Order Movianto will deliver next working day Ø Will deliver as often as needed Ø Only order what you need for next week This avoids: Ø Vaccine being left over at end of campaign Ø Vaccine can’t be taken back once it has been delivered Ø Large losses if fridge breaks down Ø

Audit of vaccine usage Ø Ø Ø Vaccine supply will be compared with vaccine usage Practices with significant differences will be asked to account for difference New data collection forms will cover all legitimate usage of vaccine

Egg Anaphylaxis Ø Ø Ø Patients with confirmed ANAPHYLAXIS to egg or egg allergy and uncontrolled asthma (BTS SIGN 4 or above) Adults – give egg free vaccine – Optaflu – in primary care Children – Optaflu not licensed for use – refer to paediatric unit for vaccination as day case in controlled conditions.

Egg allergy Ø Ø Other egg allergic patients (adults and children) – vaccinate as normal with low ovalbumin vaccine The main centrally purchased vaccines in NI are low ovalbumin Do NOT use Optaflu for these patients – limited supplies Supply of Optaflu to practices will be closely monitored and controlled.

Manufacturer Name Product Sanofi Pasteur MSD Glaxo. Smith. Kline Ltd UK Astra. Zeneca UK Ltd of Vaccine Type Route of administration Age Suitable for Egg Allergy Patients Inactivated Influenza Vaccine Intramuscular injection From 6 months Yes Fluarix® Inactivated Intramuscular injection From 6 months Yes Fluenz® Live Attenuated Nasal spray From 24 No months to less than 18 yrs of age Intramuscular injection From 18 yrs Reserve for egg anaphylactic patients Novartis Vaccines Optaflu® Inactivated

Vaccination against shingles (Herpes Zoster) Richard Smithson Sinead Mc. Guinness Mary Loughrey Maureen Mc. Cartney July 2013

ACKNOWLEDGEMENTS Thanks to Public Health England for producing this slide set, which has been amended for use in Northern Ireland.

Key Messages • • • Shingles can lead to a severe painful illness in older people which can persist for several months or even years. The severity of the illness increases with age and older people aged 70 years and over are at an increased risk An estimated 50, 000 cases of shingles occur in people aged 70 years and above each year in England Wales with approximately 50 cases resulting in death. This equates to an estimated 900 - 1000 cases in Northern Ireland per year in people in their 70 s Shingles vaccine will be offered to individuals aged 70 (routine cohort) and 79 years (catch-up cohort for 2013 -14) to reduce the incidence of shingles and shingles-related complications. It is important that healthcare professionals encourage vaccination in this age group

Learning Outcomes After completing this training, immunisers will be able to: • Describe the aetiology and epidemiology of shingles • Describe the relationship between shingles and chickenpox (varicella zoster) and the severity of the disease in older people • Discuss the important role of vaccination against shingles with people aged 70 and 79 years • Explain their role in raising the issue of vaccination against shingles with people aged 70 and 79 years with evidence based information about the vaccine • Identify sources of additional information

Contents 1. 2. 3. 4. 5. What is shingles? Why vaccinate adults aged 70 and 79 years against shingles? Vaccination against shingles and the use of Zostavax® The role of healthcare professionals Resources

What is shingles? • • • Shingles is a viral infection of the nerve cells and surrounding skin. It is caused by the (herpes) varicella zoster virus that also causes chickenpox After a person recovers from chickenpox infection, the virus remains dormant in the nerve cells and can reactivate at a later stage when the immune system is weakened Reactivation can be associated with older age, immunosuppressant therapy or HIV infection Image Courtesy of PHE/SPL

Epidemiology of shingles • • • An estimated 50, 000 cases of shingles occur in people aged over 70 years each year in E&W Of these, 14, 000 develop a very painful and long lasting condition called Post Herpetic Neuralgia 1, 400 cases of shingles result in hospitalisation 1 in 1, 000 cases of shingles are estimated to result in death In Northern Ireland this corresponds to 900 -1000 cases of shingles in people in their 70 s and 250 cases of PHN

Clinical presentation of shingles Initial prodromal stage The first signs of shingles may include • Headache • Feeling generally unwell • Myalgia • Malaise • High Temperature (38°C) (although this is less common) A prodromal illness is experienced by 80% of individuals with shingles and can last up to 72 hours before the rash appears

Clinical presentation of shingles 2 Acute stage • A rash of fluid filled blisters develops after a few days and commonly occurs either on one side of the face or body, usually within the distribution of a dermatome • The rash often causes pain, itching or a tingling sensation in the area of the affected nerve • The blisters typically scab over in 7 -10 days and the rash eventually clears within 2 -4 weeks • In individuals with weakened immune systems, a more disseminated rash covering multiple dermatomes may occur and this may appear similar to the chickenpox rash

Transmission • • Shingles can not be transmitted from one person to another A person exposed to shingles will not develop shingles However, a person who has not had chickenpox previously may develop chickenpox as a result of exposure to the shingles virus through direct contact with the fluid filled blisters The varicella virus that causes shingles (herpes zoster) is the same virus that causes chickenpox (varicella zoster) Shingles is not spread through coughing, sneezing or casual contact

Infectious period • A person with shingles is only infectious when the rash is present and fluid filled • A person is not infectious - before the rash is present OR - when the rash has crusted • Shingles is less infectious than chickenpox and covering the rash will greatly reduce the risk of exposure to those non immune to chickenpox

Possible complications of shingles Complications are more likely in adults aged over 50 years, with the severity of the illness increasing with age The most common complications are • Post herpetic neuralgia (PHN) • Secondary bacterial skin infections Other less common complications can include • Ophthalmic Zoster • Peripheral motor neuropathy • In severe cases shingles can lead to hospitalisation and death

Possible complications of shingles 2 Post herpetic neuralgia (PHN) • is a common complication of shingles in older adults • PHN is defined as pain that persists for, or appears, more than 90 days after the onset of the shingles rash • In 50% of those affected it can persist for 3 to 6 months • PHN is specifically focused in the area affected by shingles • PHN is more likely to develop, and is more severe, in people over the age of 50, with one third of sufferers over the age of 80 experiencing intense pain • The pain may be a constant burning, itching, stabbing or aching pain which is extremely sensitive to touch and is not well-relieved by common pain killers

Why vaccinate older adults against shingles?

Epidemiology of shingles in England Wales

Epidemiology of shingles in England Wales Estimated annual age-specific incidence, hospitalisation rate, length of inpatient stay, Burden of disease in the immunocompetent population England Wales. (Data taken from van Hoek et al, 2009).

National shingles vaccination programme JCVI has recommended that everyone aged 70 79 is offered shingles vaccination Routine vaccination at 70 years (defined as 70 years on 1 September) Catch-up of people aged up to and including 79 over the next few years In 2013/14, catch-up will be those aged 79 years on 1 September 2013

Why vaccinate older adults aged 70 and 79 against shingles this year? The epidemiology shows that individuals over 70 years of age are not only at an increased risk of developing shingles, but they also suffer a more severe form of the illness resulting in complications such as PHN and an increased rate of hospital admissions Duration of protection is unknown; follow-up is continuing Analytical studies show that the most cost-effective age for offering vaccination to prevent and/ or reduce the disease burden is for those aged 70 to 79 Catch-up cohort chosen as age 79 because insufficient vaccine to do more than 1 year and next year this age-group will be over 80 so would miss out

Routine cohort For 2013/14 All those aged 70 on 1 September 2013 ie DOB 02. 09. 1942 – 01. 09. 1943 Routinely immunise with seasonal flu vaccination but can immunise patients in cohort at any time of year Routine cohort expected to be those aged 70 on 1 September 2014 for 2014 season

Catch-up cohort For 2013/14 All those aged 79 on 1 st September 2013 ie DOB between 02. 09. 1933 – 01. 09. 1934 • some of this cohort will be aged 80 when they are immunised • if not in this DOB range do not immunise as part of the programme

Vaccine availability Vaccine is in very short supply therefore it is vital that programme stocks are only used for the routine and catch-up cohorts Ordering will be restricted to a total maximum of 75% of registered patients in cohort age-ranges. Based on uptake for flu vaccine. Any additional will require a special request and may not be available If demand exceeds supply then vaccination may need to be delayed

Can the vaccine be offered to individuals below the age of 70 years or over 80 years? Licensed from 50 years of age, but most cost effective from 70 to 79 years. If GP wishes to give to patient outside this range, must be prescribed, dispensed from high street chemist but NOT taken from centrally supplied stock. Availability from high street chemist cannot be guaranteed because stock has been bought up for campaign.

What if someone 71 to 78 years of age requests vaccination in 2013/14? Vaccine supply is very limited – only sufficient for the recommended cohorts. Those outside these cohorts should be told that they cannot receive it this year but will be offered it in the future. If a GP decides there is an urgent clinical need this year, then it must be prescribed, NOT taken from centrally supplied stock etc.

What if someone was aged 70 (or 79) years on 1 September but by the time they attend for vaccination they have turned 71 (or 80) years? They should still be offered the vaccine – eligibility is determined by their age on 1 September 2013. This is the only exception to those aged 80 being offered the vaccine and will only apply to those very slightly over this age.

What if someone was aged 69 (or 78) years on 1 September but by the time they attend for vaccination they have turned 70 (or 79) years? They should NOT be offered the vaccine – eligibility is determined by their age on 1 September 2013. It should be explained to them that they will be offered the vaccine next year. These rules have to be strict and consistently applied to ensure we have enough vaccine.

Prescribing of Zostavax® Marketing authorisation: The Green Book states: “Whilst the vaccine is authorised for use from age 50 years and is effective in this age group, the burden of shingles disease is generally not as severe compared with older ages, the duration of protection and need for reinforcing doses of vaccine are not known and the most cost effective age to offer the vaccine therefore is to individuals aged 70 and 79 years” • The vaccine marketing authorisation holder’s Summary of Product Characteristics (SPC) for Zostavax® states that the vaccine is licensed for immunisation of individuals 50 years of age or older • Clinical decision to prescribe to other individuals but such use is not part of the routine shingles programme and must be prescribed and sourced separately from programme stocks ie through commercial pharmacy • Availability may be limited

Vaccination against shingles (Herpes Zoster) The use of Zostavax ®

The recommended vaccine: Zostavax® Brand name: Zostavax® Generic Name: Varicella Zoster Virus Marketed by Sanofi Pasteur MSD • • • Live Attenuated (i. e. a weakened live organism) Licensed for use from age of 50 years and above Recommended by JCVI for adults aged 70 (with a catch up programme for 79 year olds)

The recommended vaccine: Zostavax® A one dose schedule of Zostavax® was assessed in clinical trials using 17, 775 adults aged 70 years and over The vaccine reduced the incidence of shingles by 38% and provided protection for a minimum of 7 years For those vaccinated but who later developed shingles, the vaccine significantly reduced the burden of illness by 55% significantly reduced the incidence of PHN by 66. 8%

The recommended vaccine: Zostavax® is the only vaccine recommended for the prevention of shingles and shingles-related PHN It is important immunisers familiarise themselves with the vaccine and its product information to avoid administration errors Image courtesy of Sanofi Pasteur MSD

Presentation of Zostavax® • The vial is a freeze dried preparation that appears as an off-white, crystalline plug • The diluent in the pre-filled syringe is a clear colourless liquid • When mixed together, Zostavax® should appear as a semi-hazy to translucent, off white to pale yellow liquid Zostavax® contains: • x 1 Zostavax® vial • x 1 pre-filled syringe • x 2 separate needles in secondary packaging

Composition of Zostavax® Composition Varicella-zoster virus, Oka/Merck strain (live, attenuated)not less than 19400 PFU produced in human diploid (MRC-5) cells PFU = Plaque-forming units Residual substances This vaccine may contain traces of neomycin Excipients Powder: Sucrose Hydrolysed gelatin Sodium chloride Potassium dihydrogen phosphate Potassium chloride Monosodium L-glutamate Anhydrous disodium phosphate Sodium hydroxide (to adjust p. H) Urea Solvent: Water for injection

Zostavax® - reconstitution • • Separate needles should be used for the reconstitution and administration of the vaccine To reconstitute the vaccine, inject all the solvent in the pre-filled syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly Withdraw the entire contents into the syringe for injection Two separate needles are available with the pre-filled syringe The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90°) to secure the connection It is recommended that the vaccine be administered immediately after reconstitution Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or of the reconstituted vaccine differs from that described above (Sanofi Pasteur 13)

Administration of Zostavax® • • The vaccine comes as a vial and pre-filled syringe for reconstitution– mix before use to form a semi-hazy to translucent, off white to pale yellow liquid Give by subcutaneous injection into the upper arm (deltoid region)- 0. 65 ml (1 dose) Zostavax® is safe to be administered concomitantly with both inactivated vaccines such as influenza and 23 -valent pneumococcal polysaccharide vaccine (PPV) and live vaccines such as MMR and Yellow Fever Zostavax® should ideally be given at the same time as other live vaccines. If live vaccines cannot be administered simultaneously, a four-week interval is recommended

Techniques for subcutaneous and intramuscular injections Subcutaneous administration Intramuscular Administration Deep SC injections should be given with the needle at a 45º angle to the skin and the skin should be bunched, not stretched. IM injections should be given with the needle at a 90º angle to the skin and the skin should be stretched, not bunched.

Subcutaneous injection Intramuscular injection

Administration of Zostavax® should 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

Contraindications The vaccine should not be given to a person who: • has a primary or acquired immunodeficiency state due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS; cellular immune deficiencies • is receiving immunosuppressive therapy (including highdose corticosteroids)

Contraindications 2 The vaccine should not be given to a person who: • has had a confirmed anaphylactic reaction to a previous dose of varicella vaccine • has had a confirmed anaphylactic reaction to any component of the vaccine, including neomycin or gelatin Zostavax® is not recommended for the treatment of shingles or post herpetic neuralgia (PHN). Individuals who have shingles or PHN should wait until symptoms have ceased before being considered for shingles immunisation

Not contraindications Zostavax® is not contraindicated for use in individuals on topical/inhaled corticosteroids or low-dose systemic corticosteroids or in patients receiving corticosteroids as replacement therapy, e. g. , for adrenal insufficiency Zostavax® is not contraindicated for use in individuals receiving therapy with low-doses of methotrexate (<0. 4 mg/Kg/week), azathioprine (<3. 0 mg/Kg/day), or 6 mercaptopurine (<1. 5 mg/Kg/day) for treatment of rheumatoid arthritis, psoriasis, polymyositis, sarcoidosis, inflammatory bowel disease, and other conditions as not considered sufficiently immunosuppressive

Precautions • Acute illness - defer immunisation until recovered • Immunosuppressed patients who require protection against shingles should seek advice from a specialist • Transmission of vaccine virus may rarely occur between recently vaccinated individuals and susceptible contacts particularly if vaccinee develops a rash. As a precaution any person who develops a rash should avoid contact with a susceptible person. • Oral antivirals such as acyclovir are likely to attenuate response. The use of topical acyclovir is not a contraindication to vaccination.

What if an individual does not have a previous history of chickenpox; should they still be offered the vaccine? Yes, a previous clinical history of chickenpox infection is not a pre-requisite for receiving Zostavax® Many people who think they haven’t had chickenpox have in fact had a sub-clinical infection. These people should be vaccinated.

What if an individual presents with a previous history of shingles infection; should they still be offered the vaccine? Yes, the individual should still be offered the vaccine despite presenting with a previous history of shingles infection. People can get shingles more than once and the vaccine will reduce the risk of further attacks.

Possible adverse reactions Most commonly reported (1: 10 of people vaccinated) • Erythema (redness), pain, swelling and pruritis (itching) at the injection site Less commonly reported (1: 100 of people vaccinated) • Haematoma, induration and warmth at the injection site Very rarely reported (1: 10, 000 of people vaccinated) • Varicella (chickenpox) infection

Reporting suspected adverse reactions Yellow card scheme • Voluntary reporting system for suspected adverse reaction to medicines/vaccines • Success depends on early, complete and accurate reporting • Report even if uncertain about whether vaccine caused condition • http: //mhra. gov. uk/yellowcard • See chapter 8 of Green Book for details

The role of healthcare professionals To provide clear, concise and accurate information to individuals aged 70 and 79 years regarding vaccination against shingles Every effort should be made by healthcare professionals to maximise the uptake of the shingles vaccine

Resources • • • NHS Choices www. nhs. uk/conditions/Shingles/Pages/Introduction. aspx CMO Letter - Introduction of a shingles vaccine for people aged 70 years (routine) and 79 years (catch up) to protect against herpes zoster http: //www. dhsspsni. gov. uk/hssmd 272013. pdf Green Book (Immunisation against infectious disease) Ch. 28 a https: //www. gov. uk/government/organisations/public-healthengland/series/immunisation-against-infectious-disease-the-greenbook PHE Q&A - Vaccination against shingles for adults aged 70 and 79 years of age Shingles Support Society www. shinglessupport. org Shingles Aware www. shinglesaware. co. uk

Key Message Shingles can lead to post herpetic neuralgia (PHN) in older people which can persist for several months or even years. The severity of the illness increases with age and older people are at an increased risk Offering the shingles vaccine to individuals aged 70 and 79 years of age may help prevent shingles from developing in some cases. Severity of the illness and PHN is significantly reduced in those who receive the vaccine but who later develop shingles

References 1. Joint Committee on Vaccination and Immunisation (2010) Statement on varicella and herpes zoster vaccines 29 March 2013. [internet] accessed 14 May 2013 [link]. 2. Department of Health, 2013 Immunisation against infectious diseases: Shingles Chapter, TSO Publishing, Crown Copyright [link]. 3. van Hoek AJ, Gay N, Melegaro A et al. (2009) Estimating the costeffectiveness of vaccination against herpes zoster in England Wales. Vaccine 27(9): 1454 -67. Cited in Joint Committee on Vaccination and Immunisation (2010) Statement on varicella and herpes zoster vaccines 29 March 2013. 4. NHS Choices (2012). Shingles. [internet] accessed 14 May 2013[link]

References (cont’d) 5. Opstelten W, Mauritz JW, de Wit NJ et al. (2002) Herpes zoster and postherpetic neuralgia: incidence and risk indicators using a general practice research database. Fam Pract 19(5): 471 -5. 6. Bowsher D (1999) The lifetime occurrence of Herpes zoster and prevalence of post-herpetic neuralgia: A retrospective survey in an elderly population. Eur J Pain 3(4): 335 -42. 7. Oxman MN, Levin MJ, Johnson GR et al. (2005) A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 352(22): 2271 -84. 8. Schamder, K. E. (2002) Epidemiology and impact on quality of life of post herpetic neuralgia and painful diabetic neuropathy. Journal of Clinical Pain. Nov-Dec; 18(6): 350 -4.

References (cont’d) 9. Fleming DM (1999) Weekly Returns Service of the Royal College of General Practitioners. Commun Dis Public Health 2(2): 96 -100. 10. Mc. Cormick A, Charlton J and Fleming D (1995) Assessing health needs in primary care. Morbidity study from general practice provides another source of information. BMJ 310(6993): 1534. 11. Gauthier A, Breuer J, Carrington D et al. (2009) Epidemiology and cost of herpes zoster and post-herpetic neuralgia in the United Kingdom. Epidemiol Infect 137(1): 38 -47. 12. Oxman MN and Levin MJ (2008) Vaccination against Herpes Zoster and Postherpetic Neuralgia. J Infect Dis 197 Suppl 2 S 22836. 13. Sanofi Pastuer MSD Limited (2013) Zostavax SPC. [internet] accessed on 14 May 2013 [link]

References (cont’d) 14. Tseng HF, Smith N, Sy LS, Jacobsen SJ. Evaluation of the incidence of herpes zoster after concomitant administration of zoster vaccine and polysaccharide pneumococcal vaccine. Vaccine 2011; 29(20): 3628– 32