Influenza and Shingles Vaccines August 2013

Influenza and Shingles Vaccines August 2013
DRAFT ONLY - Please see the disclaimer text on slide 1 Influenza and Shingles Vaccines August 2013 Richard Smithson Sinead McGuinness Mary Loughrey Maureen McCartney As most of you will be aware this year is seeing 4 major changes to the vaccination programme. The introduction of rotavirus vaccine and significant changes to the Men C programme have already been introduced and were covered by training in April/May. We are now approaching the next 2 changes – the introduction of flu vaccine for all 2 – 16 year olds inclusive, and the introduction of a shingles vaccine for people in their 70s. This training programme is to help prepare for these changes.

DRAFT ONLY - Please see the disclaimer text on slide 1
Outline of Talk Extension of Flu vaccine to 2 – 16 year olds Important aspects of routine seasonal flu vaccine campaign Shingles vaccine. Today we will be particularly covering the two new programmes but we will also briefly cover some important aspects of the normal seasonal flu campaign that we need to remind ourselves about.

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 1st October 2013 the seasonal flu vaccination programme will be extended to all two and three year old children in Primary Care and to P6 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. Background Following a recommendation in 2012 by the Joint Committee on Vaccination and Immunisation (JCVI) 1 that the programme should be extended to all children aged 2 to 16 years of age inclusive, the phased introduction of this extension will begin in 2013. From 1st, October 2013 the seasonal influenza (flu) 2 vaccination programme will be extended to all two and three year old children to be vaccinated in primary care, and P6 children to be vaccinated in schools by school health teams.

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. Complications of flu are more likely to occur in the risk groups limited, however they can also occur in previously healthy individuals.

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. Since the year 2000 Northern Ireland has had a routine annual immunisation programme of vaccination with the seasonal influenza vaccine of all individuals who are at increased risk of complications (clinical risk groups) from Influenza virus. Until season 2012/13 this has relied exclusively on vaccination with an inactivated vaccine (i.e. not a live vaccine) which has had to be administered by injection. Last year Northern Ireland introduced the live attenuated vaccine for “at risk” children aged 2 to 17 years inclusive.

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. The function of partial implementation is to test the delivery mechanisms to ensure successful implementation of the programme and not to test the vaccine itself - which has been extensively tested prior to it’s launch in the Unites States market. Since then there has been extensive post launch surveillance in the USA, involving millions of doses in children with no evidence found of any safety concerns. As with all vaccines and medicines, MHRA will closely monitor the safety of Fluenz® as it is used. JCVI (the Joint Committee for Vaccination and Immunisation) is an independent panel of experts who make recommendation to the UK government on vaccination issues.

Details for 2013 - In schools
DRAFT ONLY - Please see the disclaimer text on slide 1 Details for In schools All P6 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”) All P6 children will be offered the vaccine in school including those in risk groups as it is thought that offering it in school will improve uptake. Whilst Fluenz will be the main vaccine offered in schools, those children who can’t receive it will be offered the injected vaccine assuming they have no contraindications to it. Due to time pressures schools will be visited once only by school health teams, therefore if a child does not receive the vaccine on that day, because it is absent or there is no consent form etc. then they will not be vaccinated in school. Parents of such children will receive a note stating that they have not had the vaccine and that they should contact the GP surgery should they want their child to have it. It will emphasise that this is particularly important for any “at risk” children. GPs are asked to facilitate this, the normal fee will be payable for any such children vaccinated in the GPs surgery whether “at risk” or “healthy”.

Details for 2013 - General Practice
DRAFT ONLY - Please see the disclaimer text on slide 1 Details for 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 P6 who will be offered vaccine in school DOB: 02/07/03 – 01/07/04 Children in P6 who miss vaccination in school, to be offered it if parents contact surgery requesting it.

Extension of seasonal flu vaccination programme to children (2 to16 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. The aim of the new programme is to both directly protect children and give them the benefits of being vaccinated and because children play a big role in spreading flu to reduce the overall level of flu in the community. This effect will be particularly seen as the programme is rolled out over the next couple of years. The JCVI position statement on the extension of the annual flu vaccination programme to children can be found at: And / or

Extension of seasonal flu vaccination programme to children (2 to16 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;

Recent observation/studies relating to flu and children
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 Evidence from clinical trials on the effectiveness of one and two dose schedules of live attenuated Influenza vaccine (LAIV) in Influenza vaccine-naïve young children shows a second dose of LAIV doesn’t provide much additional protection against Influenza infection. A single dose of LAIV provides similar protection to children as two doses of inactivated influenza vaccine 4, 5 A recent meta-analysis suggested an efficacy against confirmed disease of 83% Analysis of the difference in the population health impact and the cost effectiveness of one and two dose schedules of LAIV for influenza vaccine-naïve children aged up to nine years when extending the programme to all pre-school children from two years of age and primary school-aged children and an analysis of the direct health impact only of either two doses of LAIV to two year old children or one dose to two and three year old children suggests that the greater health impact would be obtained if the available quantity of vaccine was provided through a one dose schedule to the larger number of children with two doses reserved for those children under the age of nine who are in a clinical group at increased risk of complications.

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) /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 days to reach protective levels. Protection lasts for one season. Due to the changing nature of Influenza viruses in February of each year the World Health Organisation recommends the viruses that should be in the vaccine for the forthcoming winter. Most current flu vaccines are trivalent, containing two subtypes of Influenza A and one type B virus. Although quadrivalent vaccines with an additional type of B virus are being developed and maybe available in future years but are not available this year in Northern Ireland. For many years only inactivated flu vaccines given by intramuscular injection have been available in the UK. These give 70 to 80% protection when the vaccine strains are well matched to those circulating but tend to give less protection to children. They are also less protective in the elderly but still significantly reduces bronchopnemumonia, hospitalisations and mortality. Trivalent live attenuated Influenza vaccine has been shown to provide a higher level of protection for children than trivalent inactivated flu vaccine 18; a recent meta-analysis suggested an efficacy against confirmed disease of 83% 17,21,23 After immunisation, protective immune responses may be achieved within 14 days. Protection afforded by the vaccine is thought to last for one flu season, with the level of protection provided in subsequent seasons reducing, in addition the subtypes of virus often change between seasons, hence the importance of re-vaccination.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz® 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: x x 36mm; Provides greater protection for children than inactivated influenza vaccine. Fluenz® is a live attenuated vaccine (a weakened form of flu virus which cannot cause disease but which protects against flu). It is a cold adapted virus which means it cannot replicate at body temperature. This is a nasal vaccine and must not be injected. It is supplied in a box containing 10 prefilled nasal applicators. Live attenuated Influenza vaccine (Fluenz®) has been shown to provide greater protection for children than inactivated Influenza vaccine. This vaccine is the preferred vaccine for children aged two to less than 18 years. It became available in the UK for the 2012/13 Influenza season. It has been used in USA for many years and millions of doses have been given.

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 Although this is a live vaccine there are 2 mechanisms to prevent it causing disease in recipients – first, as with other live vaccines it has been attenuated or weakened, in addition it has been cold adapted, this means it cannot replicate at body temperature – it replicates in the mucosa of the nose where the temperature is slightly lower, producing antibodies that provide protection, but without causing disease.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz® Fluenz® composition: Active ingredient: A/California/7/2009 (H1N1)pdm09-like virus 107.0±0.5 FFU; A/Texas/50/ ±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. The vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2013/14 season. Fluenz® protects against the same strains of Influenza in the trivalent inactivated Influenza vaccine. The virus strains were produced in Vero Cells (monkey cell line) and grown in fertilised hens’ eggs from healthy chicken flocks. Fluenz® does not contain any preservatives such as thiomersal. 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.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz® Fluenz® presentation: Prefilled nasal applicator-ready to use, no reconstitution or dilution required; Nasal spray (suspension); Each applicator contains 0.2ml. Colourless to pale yellow, clear to opalescent. Small white particles may be present Fluenz® is supplied as a single use prefilled nasal applicator. 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.

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 25C. 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. Fluenz® must be stored in accordance with the manufacturers instructions. As with most vaccines Fluenz® should be stored between +2°C and +8°C. The vaccine should be stored in the original packaging. This makes it easy to identify in the vaccine fridge and to check batch numbers and expiry dates. The original packaging also provides some protection against fluctuation of temperature and protection from light. The manufacturer has stated the vaccine can be kept up to 12 hours out of a fridge, however at the end of this time it must be disposed of, therefore it is important to avoid taking more than is likely to be used out of the fridge or validated cool box. Vaccine are expensive and it is important to minimise wastage through inappropriate storage.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) – use of Fluenz® 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 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. The dose of Fluenz® is 0.2ml, administered as a divided dose (0.1ml) in both nostrils. After administering half of the dose in one nostril, administer the other half in the other nostril immediately or shortly thereafter. Children who are not in a clinical at risk group require a single dose (0.2ml). The marketing authorisation holder’s Summary of Product Characteristics (SmPC) 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® 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 SPC 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. However children aged under nine years of age in clinical at risk groups and who are receiving flu vaccine for the first time will require the two dose schedule. If the first dose is given in school the second dose will be given by the individuals GP.

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. Fluenz® can be given at the same time as other vaccines including live vaccines. On this basis, it is normally recommended that, where vaccines cannot be given simultaneously, a four week interval should be observed between live vaccines. There are no data on whether this applies to Fluenz®. If protection against flu is needed before the start of the seasonal increase in flu activity, Fluenz® administration should not be delayed because of an administration of a recent live vaccine, or vaccination with inactivated Influenza vaccine could also be considered.

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: Against a Patient Specific Direction; Against a Patient Group Direction. This is a prescription only medicine and the usual rules apply.

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. Advice in Standard Infection Control Precautions (SCIPs) would suggest no additional infection control precautions are required when administering Fluenz® vaccine. Comprehensive infection control advice is available on HPS website at To ensure the correct disposal of Fluenz® vaccine applicators contact should be made with local NHS Board Waste Management Officer for advice. ##Note: GBC advice may alter- awaiting final version##

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. There are very few individuals who cannot receive any influenza vaccine. When there is any doubt, appropriate advice should be sought from the Public Health Agency Duty Room rather than withholding vaccination.

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. In cases of contraindication as result of immunosuppression, severe asthma, wheezing at time of immunisation, pregnancy or salicylate therapy, consider use of the inactivated (i.e. injectable) influenza vaccine. Chapter 6 of Green Book on contraindications and special precautions contains gives further advice on the use of live vaccines in individuals who are severely immunosuppressed. Chapter 6 of Green Book suggests systemic high doses steroids (and until at least three months after treatment has stopped) would include children who receive prednisolone, orally or rectally, at a daily dose (or its equivalent) of 2mg/ kg/day for at least one week, or 1mg/kg/day for one month. Fluenz® 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. 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.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - Administration of Fluenz® Precautions Acute severe febrile illness: defer until recovered. Heavy nasal congestion or severe rhinitis; defer until resolved or consider inactivated influenza vaccine. Please note: Minor illnesses without fever or systemic upset are not valid reasons to postpone vaccination. Minor illnesses without fever of systemic upset are not valid reasons to postpone vaccination. If the individual is acutely unwell the vaccination may be deferred until they have recovered - this is to avoid confusing the differential diagnosis of acute illness by wrongly attributing the signs or symptoms as adverse effects of the vaccine. There are no data on the effectiveness of Fluenz® when given to children with 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 should be considered or an appropriate alternative intramuscularly administered Influenza vaccine should be considered.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - Administration of Fluenz® Precautions 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. Situations such as this are likely to be extremely rare as we are talking about much more severe immunosuppression than would contraindicate vaccination in the child. These contacts are so immunosuppressed they are likely to be in isolation and therefore the child is unlikely to have contact with them anyway. With regard to classmates, whilst some children may not themselves be able to receive Fluenz because of immunosuppression, if they are able to attend school and be exposed to the viruses and bacteria that normally circulate, then there is no reason why they should not attend whilst the rest of the class is being given Fluenz. Most of these children will probably themselves be offered injected flu vaccine as immunosuppression is an indication for flu vaccination.

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.

- use of inactivated flu 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. Some children will not be able to receive Fluenz, but will be able to be given the injected inactivated flu vaccine. This includes those who are immunosuppressed, those with severe asthma and those who are allergic to egg. Whilst some flu vaccines are only suitable for certain ages, all the CENTRALLY purchased and supplied vaccines in Northern Ireland, 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. There are very few individuals who cannot receive any flu vaccine. When there is any doubt, appropriate advice should be sought from the PHA Duty Room rather than withholding vaccination. Inactivated flu vaccine should be considered when the patient cannot receive Fluenz® due to immunosuppression, severe asthma, wheezing at time of immunisation, pregnancy or salicylate therapy. Inactivated flu vaccine has a very similar adverse reaction profile as Fluenz® - the main difference is that with inactivated flu virus is that the most common adverse reaction is a local injection site reaction. This usually disappears after 1-2 days.

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. Very few children will require 2 doses of vaccine. Of the new groups being added only those 2 & 3 year olds who cannot receive Fluenz will need 2 doses if this is the first year they are being vaccinated. At risk children need 2 doses if they are under 9 years old and this is the first year they are being vaccinated for the first time, whichever vaccine they are receiving. This is because at risk children need the higher level of protection of 2 doses. Previous flu vaccine includes any flu vaccine, injected or intranasal received at any time in the past, including having received swine flu vaccine. No one in P6 will require a second dose as they are all over 9 years of age.

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 P6 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. It is very difficult to know what the uptake for this vaccine is going to be, as nothing like this has been attempted before. Planning has been undertaken on the assumption of a 75% uptake. If uptake is significantly below this it is important to have contingency plans so that an expensive vaccine is not wasted. Vaccine usage will therefore be monitored very closely and if necessary the programme will be rolled out to older age groups. This would start from 4 years and work upwards depending on uptake. It would be based in primary care and the normal fee would apply to whichever groups it was rolled out to.

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 See chapter 8 of Green Book for details. 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. 36

Extension of the seasonal flu programme to children (2 to 16 years of age inclusive) Resources
Green Book available at: Patient Group Directions Leaflets for 2&3 year olds and for P6s Q&A briefing Publications will be available at: CMO letters available at: Any registered healthcare practitioner who administers vaccines should be familiar with the Green Book available at: Part 1 includes 12 chapters, the content of which is generic. 37

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) References JVCI minutes [last accessed 11th 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 and Wales: Results from a dynamic transmission model. Vaccine 31(6):927-42 4. Rhorer et al. (2009) Efficacy of live attenuated influenza vaccine in children: a meta-analysis of nine randomized clinical trials. Vaccine. 27, 5 Jefferson et al. (2012) Vaccines for preventing influenza in healthy children. Cochrane database of Systematic Reviews. Issue 8, Art. No. CD004879 6. Ruf B.R., Knuf M. (2013) The burden of seasonal and pandemic influenza in infants and children. European Journal of Pediatrics May 10. [Epub ahead of print] 38

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): 8. 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. N Engl J Med 342(4): 9. Mullooly J.P., Barker W.H. (1982) Impact of type A influenza on children: a retrospective study. Am J Public Health 72(9): 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): 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): 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): 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): 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):

(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 season. J Pediatr 149: 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): 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): 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, 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, 21. 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. Pediatr Infect Dis J 25(10): 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):

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 (1. 1), 36-44 24. Ritzwoller DP, Bridges CB, Shetterly S et al. (2005) Effectiveness of the influenza vaccine among children 6 months to 8 years of age, with 1 vs 2 doses. Pediatrics 116: 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, Pediatrics 119: e 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): S731–41.

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. This presentation has had to be prepared before the final version of the Green Book Flu Vaccine chapter is available. It is not anticipated that there will be any major changes, if there are we will ensure we communicate these in writing to those involved in the programme. It will be important to read any such communication and not assume that because you have been to the training everything has been covered. Once the final version of the Green Book Chapter has been published and everything has been cross-checked against it then we will make this presentation available online, unfortunately until then we cannot make it available as we do not wish to cause potential confusion by having different versions circulating.

Routine Flu vaccine programme – important reminders
DRAFT ONLY - Please see the disclaimer text on slide 1 Routine Flu vaccine programme – important reminders As we don’t have much time we will just look very quickly at some important points about the routine programme.

Start of programme 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. As usual once you know you have vaccine it is ok to start running clinics. We are encouraging people to try and vaccinate 2 & 3 year olds early so that we can start getting an idea of uptake.

Target Groups 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. Apart from the role out to children already discussed there are no changes to the target groups from last year.

Flu vaccine and pregnancy
DRAFT ONLY - Please see the disclaimer text on slide 1 Flu vaccine and pregnancy 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 It is important to remind ourselves that pregnant women are a high priority for vaccination. This programme has gone well in Northern Ireland with over 60% uptake last year. Unlike other groups women are obviously becoming pregnant all the time and it is important to identify them as they do so and offer them vaccine as soon as possible.

WHO – Strategic Advisory Group of Experts on Immunisation
DRAFT ONLY - Please see the disclaimer text on slide 1 WHO – Strategic Advisory Group of Experts on Immunisation 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 Not only are pregnant women now considered a group for vaccination they are actually considered the highest priority because of benefits both for them and their babies.

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 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, PLEASE Don’t Over Order
DRAFT ONLY - Please see the disclaimer text on slide 1 Please, Please, PLEASE Don’t Over Order Movianto will deliver next working day Will deliver as often as needed Only order what you need for next week This avoids: Vaccine being left over at end of campaign Vaccine can’t be taken back once it has been delivered Large losses if fridge breaks down Over ordering causes us problems. Last year some Practices ran out of Fluenz, whilst others had a considerable excess – 100 or more doses in some cases – that had to be thrown away and wasted. There was enough Fluenz, the problem was entirely due to over ordering. Vaccine cannot be taken back once delivered. There is PLENTY of vaccine this year if everyone orders sensibly. There is NO need or justification for ordering too much.

Audit of vaccine usage 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 We are going to start looking much more carefully at vaccine usage and those practices that order large amounts more than they need will be held to account. We know there will be some stock left over, and that is acceptable, but having a lot of doses left over is certainly not.

Egg Anaphylaxis 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 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 of Product Vaccine Type Route of administration Age Suitable for Egg Allergy Patients Sanofi Pasteur MSD Inactivated Influenza Vaccine Inactivated Intramuscular injection From 6 months Yes GlaxoSmithKline UK Ltd Fluarix® From 6 months AstraZeneca UK Ltd Fluenz® Live Attenuated Nasal spray From months to less than 18 yrs of age No Novartis Vaccines Optaflu® From yrs Reserve for egg anaphylactic patients

Vaccination against shingles (Herpes Zoster)
Richard Smithson Sinead McGuinness Mary Loughrey Maureen McCartney July 2013 Background The Joint Committee of Vaccination and Immunisation (JCVI)1 reviewed all the available medical, epidemiological and economic evidence as well as vaccine safety and efficacy relevant to offering a universal vaccination programme for shingles. As part of the review, age-specific incidence of shingles and associated disease burden were taken into account. Disease burden was measured in terms of those that developed secondary complications as a result of shingles infection, those that required hospitalisation and those that eventually resulted in or contributed to an individual’s death. The JCVI concluded that the incidence of shingles is closely associated with older age groups, with the severity and disease burden increasing as the individual gets older. As a result, the four UK Departments of Health are introducing a routine shingles vaccination programme for people aged 70 years old with a catch-up immunisation programme, in 2013, for people aged 79 years. Rationale for resource This resource is designed to support healthcare professionals involved in raising the issue of vaccination against shingles with individuals aged 70 and 79 years, with evidence based information about vaccination against shingles. Note: shingles is also known as herpes zoster. For the purpose of this resource shingles is used throughout this document.

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 and Wales with approximately 50 cases resulting in death. This equates to an estimated cases in Northern Ireland per year in people in their 70s Shingles vaccine will be offered to individuals aged 70 (routine cohort) and 79 years (catch-up cohort for ) to reduce the incidence of shingles and shingles-related complications. It is important that healthcare professionals encourage vaccination in this age group The vaccine will be offered routinely to adults aged 70 years on 1 September In conjunction with the routine vaccination of adults aged 70 years, a catch-up programme will also be offered to adults aged 79 years on 1 September 2013 for the 2013/14 year. Please refer to CMO letter “Introduction of shingles vaccine for people aged 70 years (routine cohort) and 79 years (catch up cohort)” for further details.

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 Key roles of immunisers in relation to vaccination against shingles in older people Advise older people eligible for shingles vaccination (those aged 70 and 79 years of age) that it is strongly recommended that they are vaccinated against shingles by their General Practitioner (GP) Explain the risks and complications of shingles in older people and in particular explain that disease severity is associated with increased age Explain how a single dose of vaccine given from the age of 70 can provide protection against shingles and associated post-herpetic neuralgia (PHN) Explain what vaccine will be used, the contraindications and possible side effects of vaccination and the evidence for this new vaccination programme how they can arrange for vaccination General Practitioners should routinely offer the shingles vaccination to eligible patients when they are called for the annual influenza vaccine and/or pneumococcal vaccine. These vaccines can be administered at the same time.

Contents 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 Infection with varicella zoster (chickenpox) is a pre-requisite for the development of shingles You do not develop shingles from being in contact with chickenpox Increasing incidence of shingles infection amongst older age groups is thought to be associated with a decline in cell mediated immunity to varicella zoster virus2 shingles can not be transmitted from one person to another, although it can cause chickenpox in individuals who have not previously had the disease and who have direct contact with the fluid from the shingles vesicles Although rare, it is possible to have shingles more than once Shingles is not caused by the same virus that causes genital herpes 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 cases of shingles in people in their 70s and 250 cases of PHN JCVI statement on varicella and herpes zoster vaccines 1

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 Shingles can affect any part of the body, although most commonly affected areas include face (including eyes) chest and abdomen. Individuals may also experience pain in the arms and legs and may feel exhausted. A dermatome can be defined as an area of skin that is supplied by a single nerve. Shingles can affect one or more isolated dermatomes.

Shingles is not spread through coughing, sneezing or casual contact
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 Shingles can cause a number of secondary complications and the severity of these can be dependent on how weak the individual’s immune system is. Most commonly reported complications in the older age groups include secondary bacterial infections at the site of the rash (that may require antibiotic therapy) and post herpetic neuralgia. Other less common complications can include ophthalmic shingles and peripheral motor neuropathy. Ophthalmic shingles affects the facial nerve (trigeminal) and can cause ulceration and scarring of the eye4 and uveitis (inflammation of the inner eye). Ophthalmic shingles can also cause loss of vision if untreated and is often associated with long term pain. Estimates show between 10-20% of shingles cases result in ophthalmic zoster5 with approximately 4% of these cases resulting in long term sequelae6 Peripheral motor neuropathy is more common in the elderly population and results in temporary nerve damage(peripheral motor nerve) that controls movement (peripheral motor nerve) of limbs such as the arm or leg, causing paralysis in the associated limb4 . This affect is temporary and individuals can make a good recovery.

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 PHN is defined as an intense pain that persists for, or develops after 90 days following the onset of the shingles rash and can persist between 3 and 6 months in 50% of those affected7. This pain can last longer and is dependent on the individuals immune system. As the pain can be intense and is not generally relieved by common pain killers, PHN can have a negative impact on the individuals quality of life. PHN can contribute to fatigue, insomnia, depression, anxiety and can impair the basic activities of daily living for the individual8 .

Why vaccinate older adults against shingles?

Epidemiology of shingles in England and Wales
The above graph shows the estimated annual age-specific incidence of shingles per 100, 000 per year in the immunocompetent population (Y- axis) against the age quinqennia (x-axis). The graph shows a continued increase in age related shingles, outlining that the incidence of shingles is largely associated with older age who are more at risk of developing the disease. Age-specific incidence rates of shingles have been estimated using a number of different primary care derived data sources3 including: the Royal College of General Practitioners (RCGP) Weekly Returns Service9 ; the fourth Morbidity Survey in General Practice (MSGP-4)10 , and the General Practice Research Database11 These are estimates (based on available data sources) as shingles is only clinically diagnosed, thus no lab confirmation of this is available - so actual figures may be much higher2.

Epidemiology of shingles in England and Wales
Estimated annual age-specific incidence, hospitalisation rate, length of inpatient stay, Burden of disease in the immunocompetent population England and Wales. (Data taken from van Hoek et al, 2009). This table again shows the estimated annual age specific incidence per 100,000 with the associated burden of disease for each of the age quinquennia. The burden of disease is measured in this table as the percentage developing post herpetic neuralgia (PHN) after 90 days, proportion of those hospitalised after the first diagnosis and the mean number of days spent in hospital. The table shows the association between the incidence of age related shingles and the burden of disease. In particular, those individuals within the age quinquennia of 75-79, and 85+ years account for a higher percentage of those developing PHN after 90 days, show a continued increase in those hospitalised as a result of the disease and contribute to the highest mean number of days when admitted to hospital. As outlined in the table, the burden of disease is closely related to age with those in the older age groups experiencing severe forms of the illness. The severity of the disease burden is markedly increased in those individuals aged years. Individuals aged 85 years and over account for 4.4% of hospital admissions after the first diagnosis and 8.1% of hospital admissions within the first three diagnoses. They account for 52% of individuals developing PHN after 90 days and as a result of the disease, require a minimum of 22 days in hospital. This highlights the severity and impact of the disease in this age group and outlines the importance of offering vaccination to older individuals.

National shingles vaccination programme
JCVI has recommended that everyone aged 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 Vaccination for individuals over the age of 80 years is not recommended due to the decreased efficacy of the vaccine in this age group. Economic analysis suggested that the vaccine would not be cost effective in individuals over the age of 80 years

Routine cohort For 2013/14 All those aged 70 on 1 September 2013 ie DOB – 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 1st September 2013 ie
DOB between – 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. 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 to 79 years. If offered outside the specified age-cohorts, vaccine must be prescribed separately and programme vaccine must not be used. Vaccine may or may not be available from a high street chemist, because so much has been bought for the campaign – this reflects the overall tight supply, however if a GP wishes a patient to have it they should at least try prescribing it. Remember shingles vaccine has only just recently become available on prescription anyway, so patients are no worse off than before.

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. Vaccine supply from the manufacturer is at present limited, and between 1 September 2013 and 31 August 2014, there will only be enough vaccine to fully vaccinate two birth cohorts – the routine cohort, and one catch-up cohort (those aged 79 on 1 September 2013). The catch-up cohort has been chosen because 79year-olds will be too old to be eligible for vaccination in 2014/15, when more vaccine becomes available. Because of the limited supply of vaccine, vaccinating patients earlier than indicated could result in those aged 79 being unable to receive vaccine while eligible. If all Practices adhere to the guidance there should be sufficient vaccine for the eligible cohorts, however not doing so will result in a shortage. Vaccine stock will therefore be carefully monitored. This situation should be explained to patients and they should be reassured that they will be offered the vaccine in the future. Details of future catch up campaigns will be issued in due course.

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 This is the only exception to those aged 80 being offered the vaccine and will only apply to those very slightly over this age. Offering of the vaccine is based on birth date cohorts, if someone turns 71 or 80 just before they are due the vaccine they should still be offered it. Nothing specific happens on the 80th birthday to make the vaccine effective the day before but not the day after. It is important that we stick to these birth cohorts.

What if someone was aged 69 (or 78) years on 1 September but by the time they attend for vaccination they have turned 70 (or79) years? They should NOT be offered the vaccine – eligibility is determined by their age on 1 September 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. It is recognised that apply these rules strictly may cause some problems with patients for example a patient who has just turned 70 when they attend for flu vaccine, request shingles vaccine, because they have seen it is for 70 year olds, but are told they will have to wait until next year. However it is the only way to manage a very tight vaccine supply, and it is always best to be consistent in such situations.

Prescribing of Zostavax®
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 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 JCVI (2010) recommendations to offer the vaccine to individuals aged 70 and 79 years were based on all the available evidence. After carefully considering the epidemiological evidence, it was clear that people in this age group are more at risk of severe complications of the disease, resulting in an increased disease burden compared to individuals aged 50 years. Currently, the vaccine manufacturers do not know whether a second dose is required or what the timing of a second dose. Current recommendations are based on a one dose schedule of the vaccine with no plans for a second/booster dose. Healthcare professionals are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary of Product Characteristics (SPC) 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 DHSSPS should be reflected in PGDs.

Vaccination against shingles (Herpes Zoster)
The use of Zostavax ® In 2010, the Joint Committee on Vaccination and Immunisation (JCVI) reviewed all the available epidemiological and economic evidence as well as vaccine safety and efficacy relevant to a shingles vaccination programme for adults aged 60 years and above. This age group was specifically reviewed in light of the disease burden that they are likely to experience as they get older. Offering the vaccination from the age of 70 years may result in boosting immunity against the disease; thus providing protection to the individual in later years. The aim is to prevent the development of the disease in the first instance and secondly to reduce the severity of the complications such as post herpetic neuralgia (PHN). Based on the available evidence, the JCVI recommended a universal herpes zoster (shingles) vaccination programme for adults aged 70 with a catch up programme for those aged 79 years of age to help prevent the development of the shingles and shingles related PHN. The JCVI decision to offer this vaccine to individuals aged 70 (routine) and 79 (catch up cohort) years, was based on the economic analysis that suggested that the vaccine would be most cost effective in this age group. The decision was based on the incidence of shingles, the severity and risk of complications, the efficacy of the vaccine and estimated duration of protection provided by the vaccine.

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 aim of the national shingles immunisation programme is to lower the incidence and severity of shingles in older people. It is recommended that it be routinely offered to people aged 70 with a catch up for individuals aged 79 years.

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 efficacy of the vaccine in this age group is estimated to be as low as 38%7 and may not fully prevent the development of shingles infection. However, vaccinating adults aged 70 years and over can help to significantly reduce the severity of the illness by 55% and associated PHN by 66.8%12 The vaccine is expected to provide protection against shingles for a minimum period of 7 years3 and at this time, a one dose schedule of the vaccine is recommended with no requirement for a second/booster 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 Zostavax® is recommended for the prevention of shingles infection and shingles related PHN only. Zostavax® should not be used for the treatment of PHN. Zostavax® contains a significantly higher antigen level of varicella zoster virus than the routine varicella (chickenpox) vaccine and is not recommended for the prevention of chickenpox infection

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: x1 Zostavax® vial x1 pre-filled syringe x2 separate needles in secondary packaging

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

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 Pasteur13) It is recommended that the vaccine be administered immediately after reconstitution. Discard reconstituted vaccine if it is not used within 30 minutes

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)- 0.65ml (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 It is important to note that Zostavax® should be administered subcutaneously (SC) into the upper arm (deltoid region)and not intramuscularly (IM). Zostavax® vaccine can be given at same time as other vaccines such as inactivated influenza vaccine and 23- valent pneumococcal polysaccharide vaccine (PPV) and other live vaccines, such as MMR. Ideally, live vaccines should be administered at the same time. If this is not possible, a four week interval is recommended between the two. Zostavax® can be given at the same time as 23-valent pneumococcal polysaccharide vaccine for those who are eligible for both vaccines. Although a manufacturer conducted trial showed inferior VZV antibody responses in those receiving zoster vaccine and PPV-23 concomitantly than those receiving the vaccines 4 weeks apart, there is no established correlation between antibody titres to VZV and protection from herpes zoster. Furthermore a more recent observational study showed that herpes zoster vaccine was equally effective at preventing herpes zoster whether it was administered simultaneously or 4 weeks apart14. General Practitioners are encouraged to offer the shingles vaccination to this age group when they are called for the annual influenza vaccine. However, scheduling of the appointment should not delay the administration of the vaccines and the shingles vaccine can be administered outside of the influenza vaccine season where the two vaccines have not been given together. The vaccines should be given at a separate site, preferably in a different limb. If more than one vaccine is given in the same limb, they should be given at least 2.5cm apart. The sites at which each vaccine was given should be noted in the individual’s health records. More information on immunisation by nurses and other health professionals is available in chapter 5 of the Green Book (Immunisation against infectious disease)

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®
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 high-dose corticosteroids) Zostavax® is contraindicated in individuals receiving high dose corticosteroids (please refer to the Green Book, chapter 6, contraindications and special considerations for further information). Individuals receiving low doses of corticosteroids should be considered for the vaccine and this should be discussed with the clinical specialist. Zostavax® is not contraindicated for use in individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e.g., for adrenal insufficiency. Zostavax is not indicated in women of childbearing age. Women who are pregnant should not receive Zostavax® and pregnancy should be avoided for three months following the last dose. It is not known whether VZV is secreted in human milk. Caution should be exercised in administration to a breast-feeding woman. Please refer to the Green Book shingles chapter for more detailed information on contraindications and precautions. Further information on contraindications and special considerations for vaccination can be found in Chapter 6 of the Green Book.

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 6mercaptopurine (<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 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. Immunisation of individuals who are acutely unwell should be postponed until they have recovered fully. This is to avoid confusing the diagnosis of any acute illness by wrongly attributing any sign or symptoms to the adverse effects of the vaccine. The safety and efficacy of Zostavax® have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see contraindications). Immunosuppressed patients who require protection against shingles should seek advice from a specialist. Post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between those vaccinated who develop a varicella-like rash and susceptible contacts. Transmission of vaccine virus from varicella vaccine recipients who do not develop a varicella-like rash has also been reported (Zostavax® SPC).

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. Although an individual may present without a clinical history of chickenpox, many such patients would have had a subclinical infection without being aware. Therefore, the vaccine should still be offered to individuals without a clinical history of chickenpox to ensure protection against zoster

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 Healthcare workers should refer to the vaccine manufacturers authorisation holders summary of product characteristics (SPC).

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 See chapter 8 of Green Book for details Healthcare professionals and patients are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the yellow card reporting scheme Please note: To open hyperlinks from the slide set, right click on your mouse and select open hyperlink

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 CMO Letter - Introduction of a shingles vaccine for people aged 70 years (routine) and 79 years (catch up) to protect against herpes zoster Green Book (Immunisation against infectious disease) Ch. 28a PHE Q&A - Vaccination against shingles for adults aged 70 and 79 years of age Shingles Support Society Shingles Aware Please note: To open hyperlinks from the slide set, right click on your mouse on the link and select ‘open hyperlink’

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 [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 cost-effectiveness of vaccination against herpes zoster in England and Wales. Vaccine 27(9): Cited in Joint Committee on Vaccination and Immunisation (2010) Statement on varicella and herpes zoster vaccines 29 March NHS Choices (2012). Shingles. [internet] accessed 14 May 2013[link] Please note: To open hyperlinks from the slide set, right click on your mouse and select open hyperlink

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): 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): 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): 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. Please note: To open hyperlinks from the slide set, right click on your mouse and select open hyperlink

References (cont’d) 9. Fleming DM (1999) Weekly Returns Service of the Royal College of General Practitioners. Commun Dis Public Health 2(2): McCormick 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): 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): Oxman MN and Levin MJ (2008) Vaccination against Herpes Zoster and Postherpetic Neuralgia. J Infect Dis 197 Suppl 2 S Sanofi Pastuer MSD Limited (2013) Zostavax SPC. [internet] accessed on 14 May 2013 [link] Please note: To open hyperlinks from the slide set, right click on your mouse and select open hyperlink

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

Influenza and Shingles Vaccines August 2013

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Influenza and Shingles Vaccines August 2013

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