The introduction of a vaccine to protect against shingles

Transcription

1 The introduction of a vaccine to protect An update for registered healthcare practitioners October 2014 Quality Education for a Healthier Scotland 1 Background The Joint Committee on Vaccination and Immunisation 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, in Scotland, the vaccine was introduced and offered routinely to adults aged 70 years from 1 September In conjunction with the routine vaccination of adults aged 70 years, a catch-up programme was commenced from September Rationale for resource This resource is designed to support registered healthcare practitioners involved in discussing the issue of vaccination and providing them with evidence based information. This resource does not cover the actual administration techniques involved in vaccinating. If administration technique training is required staff should access this through their line manager. The resource does not cover the clinical management of acute shingles or post-herpetic neuralgia (PHN). Note: Shingles is also known as herpes zoster. For the purpose of this resource the term shingles is used throughout this document.

2 Acknowledgments This resource was based on work prepared by Public Health England to support vaccination (herpes zoster). Amended for use in Scotland by NHS Education for Scotland and Health Protection Scotland. Title slide image source: Centers for Disease Control and Prevention (CDC). Quality Education for a Healthier Scotland 2

3 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 7000 cases of shingles occur in people aged 70 years and over each year in Scotland with approximately five cases resulting in death To reduce the incidence of shingles and shingles related complications in Scotland, the shingles vaccination programme was introduced to adults aged 70 years from 1 September 2013 Quality Education for a Healthier Scotland 3 An estimated 7000 cases of shingles occur in people aged 70 years and above each year in Scotland with approximately five cases resulting in death.

4 Key Messages (cont.) In conjunction with the routine vaccination of adults aged 70 years, a catch-up programme was commenced It is important that registered healthcare practitioners encourage vaccination in this age group Quality Education for a Healthier Scotland 4

5 Aims of Resource To support registered healthcare practitioners involved in discussing vaccination with individuals To raise awareness of shingles aetiology, current epidemiology and the impact of shingles on older people To provide guidance on the administration of this vaccine, including how to administer the vaccine, contraindications, precautions and potential adverse reactions To promote uptake of the shingles vaccine through increasing awareness amongst registered healthcare practitioners Quality Education for a Healthier Scotland 5 Key roles of registered health care practitioners in relation to vaccination in older people: To advise eligible individuals and their carers that it is strongly recommended that older people are vaccinated. To explain the risks and complications of shingles in older people and in particular explain that disease severity is associated with increased age. To explain how a single dose of vaccine given from the age of 70 can provide protection and associated post-herpetic neuralgia (PHN). To explain what vaccine will be used, the contraindications and possible side effects of vaccination and the evidence for this new vaccination programme. To safely administer this new vaccine in accordance with the vaccine schedule. To ensure any adverse effects are managed and reported appropriately. To advise older people eligible for shingles vaccination how they can arrange for vaccination and, where appropriate, the registered healthcare practitioner should facilitate the arrangements for the appointment to be vaccinated.

6 Learning Outcomes On completion of this programme, registered healthcare practitioners 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 in older people Explain their role in raising the issue of vaccination with older people with evidence based information about the vaccine Know the contraindications for vaccination Quality Education for a Healthier Scotland 6

7 Learning Outcomes (cont.) Safely administer the vaccine Recognise the potential adverse reactions and how to report these Identify sources of additional information Quality Education for a Healthier Scotland 7

8 Contents 1. Shingles vaccination programme 2. What is shingles? 3. Why vaccinate older adults? 4. Vaccination and the use of Zostavax 5. Resources Quality Education for a Healthier Scotland 8

9 Who is eligible in year two 2014/15 (from September 2014) Routine Programme Those who are 70 years of age on 1 September 2014 (those born between 02/09/1943 and 01/09/1944) Catch-up programme Those who are 78 years of age on 1 September 2014 (those born between 02/09/1935 and 01/09/1936) Those who are 79 years of age on 1 September 2014 (those born between 02/09/1934 and 01/09/1935) Those individuals who were 70 years of age on 1 September 2013 (those born between 02/09/1942 and 01/09/1943) who were not vaccinated in year one of programme. Quality Education for a Healthier Scotland 9 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 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 shingles vaccination programme or adults aged 70 with a catch-up programme for those up to 79 years of age (up to the 80 th birthday) to help prevent the development of shingles and shingles related PHN. The JCVI decision to offer this vaccine to individuals aged 70 to 79 years, was based on the economic analysis that suggested 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. In the first year (from September 2013) of the shingles vaccination programme the vaccine was offered to all those aged 70 years on 1 September In conjunction with the routine vaccination of adults aged 70 years a catch-up programme was commenced. In 2013, the vaccine was offered to adults aged 79 years on 1 September continued overleaf

10 Who is eligible in year two 2014/15 (from September 2014) Routine Programme Those who are 70 years of age on 1 September 2014 (those born between 02/09/1943 and 01/09/1944) Catch-up programme Those who are 78 years of age on 1 September 2014 (those born between 02/09/1935 and 01/09/1936) Those who are 79 years of age on 1 September 2014 (those born between 02/09/1934 and 01/09/1935) Those individuals who were 70 years of age on 1 September 2013 (those born between 02/09/1942 and 01/09/1943) who were not vaccinated in year one of programme. Quality Education for a Healthier Scotland 9 (cont.) In the second year of the programme (from 1 September 2014) all adults aged 70 years on 1 September i.e. those born between 02/09/43 and 01/09/44 will be offered vaccine. In year two of the programme, the catch up programme will be extended to include a further two birth cohorts. Those who are 78 or 79 years on 1 September 2014 will be offered vaccine. These were the groups who were 77 or 78 years of age when the vaccine was introduced in September Individuals who were 70 years of age on 1 September 2013 who did not take up their offer of vaccination in year one of the programme remain eligible for vaccination in year two. This decision is a one-off (for ) and will be subject to review for future years. Individuals who were 79 years of age on 1 September 2013 who did not take up their offer of vaccination in year one of the programme are not eligible in year two because of the decreased efficacy of the vaccine in persons in this age group. The economic analysis suggested the vaccine would not be cost effective in individuals over the age of 80 years.

11 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 Quality Education for a Healthier Scotland 10 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 virus. 3 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.

12 What is shingles? (cont.) An estimated 7000 cases of shingles occur in people aged 70 years and above each year in Scotland Of these, between develop a very painful and long lasting condition called post-herpetic neuralgia (PHN) Around 600 hospitalisation episodes are recorded per year 1 in 1000 cases of shingles are estimated to result in death Source: CDC / Dr. Erskine Palmer Quality Education for a Healthier Scotland 11 Data available from PTI data to 2011/12, ISD.

13 Clinical presentation of shingles Initial prodromal stage The first signs of shingles may include: Headache Feeling generally unwell Myalgia Malaise High temperature (38 o 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. Quality Education for a Healthier Scotland 12

14 Clinical presentation of shingles (cont.) 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 tingling sensation in the area of the affected nerve The rash forms blisters that typically scab over in 7-10 days and this 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 Quality Education for a Healthier Scotland 13 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.

15 Transmission of shingles 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. Quality Education for a Healthier Scotland 14

16 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 Source: CDC Quality Education for a Healthier Scotland 15

17 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: Other less common complications include: Post-herpetic neuralgia (PHN) Ophthalmic Zoster Secondary bacterial skin infections Peripheral motor neuropathy In severe cases shingles can lead to hospitalisation and death Quality Education for a Healthier Scotland 16 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 PHN. 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 eye 3 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 zoster 4 with approximately 4% of these cases resulting in long term sequelae. 5 Peripheral motor neuropathy is more common in the elderly population and results in temporary nerve damage (peripheral motor nerve) that controls movement of limbs such as the arm or leg, causing paralysis in the associated limb. 3 This affect is temporary and individuals can make a good recovery.

18 Possible complications of shingles (cont.) Post herpetic neuralgia (PHN) Is a common complication of shingles in older adults Defined as a pain that persists for, or appears more than 90 days after the onset of the shingles rash Specifically focused in the area affected by shingles 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 In 50% of those affected it can persist for 3 to 6 months The pain may be a constant burning, itching, stabbing or aching pain which is extremely sensitive to touch and is not routinely relieved by common pain killers Quality Education for a Healthier Scotland 17 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 affected. 6 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 individual. 7

19 Why vaccinate older adults? Quality Education for a Healthier Scotland 18

20 Why vaccinate older adults? Epidemiology of shingles in Scotland in Consultation rate (per 1000 patients) Males Females Age group (years) Data source: ISD Quality Education for a Healthier Scotland 19 The above graph shows the estimated number of patients consulting their GP per 1000 registered. 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. These are estimates (based on available Practice Team Information data sources from ISD) as shingles is only clinically diagnosed, thus no lab confirmation of this is available - so actual figures may be much higher.

21 Epidemiology of shingles in Scotland Rate of hospitalisation in 2011 by age group Rate of hospitalisation (per ) Males Females Age group (years) Data source: ISD Quality Education for a Healthier Scotland 20 The data show that the burden of disease is disproportionately higher in those aged 70 or older. It is important to recognise that rate of hospitalisation per does not refer to individual patients since many patients will have several episodes of shingles, which may require frequent stays in hospital. Data were derived from SMR01 data, derived from ISD.

22 Why vaccinate older adults against shingles? The epidemiology of the disease shows that individuals over 70 years of age are not only at an increased risk of developing the disease, but they also suffer a more severe form of the illness resulting in complications such as PHN and an increase in hospital admissions 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 years Quality Education for a Healthier Scotland 21 Vaccination for individuals over the age of 80 years is not recommended due to the decreased efficacy of the vaccine in this age group and the economic analysis suggested that the vaccine would not be costeffective in individuals over the age of 80 years.

23 The use of Zostavax Quality Education for a Healthier Scotland 22

24 The recommended vaccine: Zostavax Zostavax is the only vaccine recommended for the prevention of shingles and shingles related PHN It is important to familiarise yourself with the vaccine and its product information to avoid administration errors Image courtesy of Sanofi Pasteur MSD Quality Education for a Healthier Scotland 23 Zostavax is recommended for the prevention of shingles infection and shingles related PHN. 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.

25 The recommended vaccine: Zostavax Brand name: Zostavax Generic Name: Shingles (herpes zoster) vaccine live 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 up to 79 years) Administered by subcutaneous injection. It should not be given by intramuscular injection Powder and solvent for suspension for injection in a prefilled syringe Container dimensions 47 x 23 x 150mm Quality Education for a Healthier Scotland 24 The aim of the national shingles immunisation programme is to lower the incidence and severity of shingles in older people. 2 Administration after 80 years is less cost-effective due to the limited effectiveness of the vaccine beyond this age. Zostavax is a live attenuated vaccine (a weakened form of virus which cannot cause disease but which protects ). Zostavax should be given by subcutaneous injection. It should not be given by intramuscular injection. The packaging is similar in size to many currently used childhood vaccines. The vaccine was procured following a tendering exercise undertaken by the Department of Health on behalf of UK nations and ensured the vaccine was available at a cost-effective price.

26 Composition of Zostavax Composition Varicella-zoster virus, Oka/ Merck strain (live, attenuated) not less than 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 Solvent: Water for injection Monosodium L-glutamate Anhydrous disodium phosphate Sodium hydroxide (to adjust ph) Urea Quality Education for a Healthier Scotland 25 Zostavax does not contain any thiomersal. Zostavax does not contain any latex.

27 Storage of Zostavax Zostavax must be stored in accordance with manufacturer s instructions Cold chain must be maintained - Store between +2 C and +8 C - Store in the original packaging - Protect from light Image courtesy of Sanofi Pasteur MSD Quality Education for a Healthier Scotland 26 Zostavax must be stored in accordance with the manufacturer s instructions. As with most vaccines Zostavax 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, provides some protection against fluctuation of temperature and will protect from light. Vaccines are expensive and it is important to minimise wastage through inappropriate storage.

28 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 Quality Education for a Healthier Scotland 27 Zostavax is supplied as a vial and a pre-filled syringe of diluent, with two separate needles in the secondary packaging. Zostavax is only available in single packs.

29 Zostavax reconstitution instructions 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 a syringe for injection Two separate needles are available with the pre-filled syringe Select the needle required for injection The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90 ) to secure the connection Quality Education for a Healthier Scotland 28 A 21G green needle should be used to reconstitute vaccine (21G needles are not included with the vaccine). It is recommended that the vaccine be administered immediately after reconstitution. Discard reconstituted vaccine if it is not used within 30 minutes. 8

30 Zostavax reconstitution instructions (cont.) It is recommended that the vaccine be administered immediately after reconstitution Discard reconstituted vaccine if it is not used within 30 minutes 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 (Zostavax reconstitution instructions courtesy of Sanofi Pasteur 8 ) Image courtesy of Sanofi Pasteur MSD Quality Education for a Healthier Scotland 29

31 Zostavax dosage and schedule Adults should receive a single dose of 0.65ml Image courtesy of Sanofi Pasteur MSD Quality Education for a Healthier Scotland 30 The vaccine is expected to provide protection for at least seven years 9 and at this time, a one dose schedule of the vaccine is recommended with no requirement for a second/booster vaccine.

32 The recommended vaccine: Zostavax A one dose schedule of Zostavax was assessed in clinical trials using adults aged 70 years and over. The vaccine: Reduced the incidence of shingles by 38% and provided protection for a minimum of seven 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% Quality Education for a Healthier Scotland 31 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%. 7 The vaccine is expected to provide protection for a minimum period of 7 years 9 and at this time, a one dose schedule of the vaccine is recommended with no requirement for a second/booster vaccine.

33 Administration of Zostavax Given by subcutaneous injection into the upper arm (deltoid region) ml (1 dose) Further information on vaccinations given by subcutaneous injection can be found in chapter 4 of the Green Book Image courtesy of Sanofi Pasteur MSD Quality Education for a Healthier Scotland 32 Zostavax must be administered by subcutaneous injection preferably in the deltoid region of the upper arm. It should not be given by intramuscular injection as there are few data on the effectiveness of the vaccine given by this route. The vaccine must not be given intravascularly. Further information on vaccinations given by subcutaneous injection can be found in chapter 4 of the Green Book. 10

34 Licensing of Zostavax 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 in those ages years when compared with older ages. Furthermore, given that the duration of protection is not known, offering vaccination routinely below 70 years of age may not confer protection during the period where the burden of disease is highest. Administration after 80 years is less costeffective due to the limited effectiveness of the vaccine beyond this age. Quality Education for a Healthier Scotland 33 The JCVI (2010) recommendations to offer the vaccine to individuals aged 70 to 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. 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 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 the Department of Health should be reflected in PGDs.

35 Licensing of Zostavax (cont.) 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 Whilst the SPC indication allows for use from 50 years of age, JCVI recommendation is that it should be used from 70 to 79 years The recommendations for use of the vaccine detailed within the Green Book are based upon JCVI s expert opinion after reviewing all the available evidence and these recommendations should be followed Quality Education for a Healthier Scotland 34

36 Administration of Zostavax with other vaccines Zostavax can be given at the same time as inactivated influenza vaccination. If given at the same time as influenza vaccination, care should be taken to ensure that the appropriate route of injection is used for all the vaccinations Given that individuals eligible for seasonal influenza vaccination may be immunosuppressed, it is important to check that there are no contraindications to administering a live vaccine to these at risk groups Zostavax can be administered at the same time as 23-valent pneumococcal polysaccharide vaccine (PPV) Quality Education for a Healthier Scotland 35 Zostavax vaccine can be given at same time as other vaccines such as inactivated influenza vaccine and 23- valent pneumococcal polysaccharide vaccine (PPV) Given that individuals eligible for seasonal influenza vaccination may be immunosuppressed, it is important to check that there are no contraindications to administering a live vaccine to these at risk groups. 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 four 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 four weeks apart. 11 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 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 the Department of Health should be reflected in PGDs. 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. Zostavax can be given at the same time as live vaccines. In the case of Zostavax and MMR or Zostavax and Yellow Fever vaccine if these vaccines cannot be administered on the same day, then four-week minimum interval period should be observed.

37 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 Quality Education for a Healthier Scotland 36

38 Administration of Zostavax and pork gelatin Zostavax contains pork (porcine) gelatin which is an essential ingredient in many medicines, including some vaccines Many faith groups have approved the use of gelatincontaining vaccines. It is, however, an individual choice whether or not to receive this vaccine and we recognise there will be diversity of thought within different communities There is no alternative shingles vaccine available that does not contain porcine gelatin Image courtesy of Sanofi Pasteur MSD Quality Education for a Healthier Scotland 37 The following statements from representatives of the Jewish and Muslim communities may help individuals reach a decision about having this vaccine. Rabbi Abraham Adler from the Kashrus and Medicines Information Service, said: It should be noted that according to Jewish laws, there is no problem with porcine or other animal derived ingredients in non-oral products. This includes vaccines, including those administered via the nose, injections, suppositories, creams and ointments. In 2001, The World Health Organization published a letter reporting the findings of a seminar involving more than 100 Islamic legal scholars to clarify Islamic purity laws on the use of medicinal products containing gelatin which stated that: Transformation which means the conversion of a substance into another substance, different in characteristics, changes substances that are judicially impure into pure substances, and changes substances that are prohibited into lawful and permissible substances. This means that gelatin made of unclean animal s bones, skin and tendons is clean and permissible for consumption. Vegetarians should also note that pork gelatin is an ingredient in the vaccine.

39 Administration of Zostavax Contraindications and Precautions Contraindications The vaccine should not be given to an individual who: Has primary or acquired immunodeficiency state due to conditions such as: - acute and chronic leukaemias - lymphoma - immunosuppression due to HIV/AIDS - cellular immune deficiencies Quality Education for a Healthier Scotland 38 Please refer to the Green Book shingles chapter for more detailed information on contraindications and precautions. Unless stated differently here, the information on contraindications and special considerations for vaccination found in Chapter 6 of the Green Book apply to Zostavax. Department of Health (2013) Immunisation against infectious diseases: Contraindications and special considerations chapter. TSO publishing, Crown Copyright. contraindications-and-special-considerations-the-green-book-chapter-6. In individuals with chronic lymphoid neoplasms, the degree of immunosuppression should be assessed before considering vaccination. If there is any doubt over the functional integrity of the immune system, immunological advice should be sought.

40 Administration of Zostavax Contraindications and Precautions Contraindications (cont.) The vaccine should not be given to an individual who: is receiving immunosuppressive therapy. This includes highdose corticosteroids, biological therapies or combination therapies. Quality Education for a Healthier Scotland 39 Please refer to the Green Book shingles chapter for more detailed information on contraindications and precautions. Unless stated differently here, the information on contraindications and special considerations for vaccination found in Chapter 6 of the Green Book apply to Zostavax. Department of Health (2013) Immunisation against infectious diseases: Contraindications and special considerations chapter. TSO publishing, Crown Copyright. contraindications-and-special-considerations-the-green-book-chapter-6. People who have undergone immunosuppressive chemotherapy or radiotherapy for malignancy should not receive the vaccine until 6 months after the end of treatment, and they are demonstrated to be in remission. Clinicians may wish to discuss with the specialist caring for the patient prior to administration. People receiving 40mg Prednisolone per day for more than one week should not receive the vaccine until at least 3 months after cessation of therapy. A longer delay, up to 6 months, may be appropriate for the age cohorts included in the national vaccination programme. The vaccine is not contraindicated for use in individuals who are receiving topical / inhaled corticosteroids and in people who are receiving corticosteroids as replacement therapy (e.g. for adrenal insufficiency). Therapy with a single low-dose non-biological oral immune modulating drug, either alone or with low dose steroids, for treatment of rheumatoid arthritis, psoriasis, polymyositis, sarcoidosis, inflammatory bowel disease, and other conditions, are not necessarily sufficiently immunosuppressive and may not be contraindications for administration of zoster vaccine. The degree of immunosuppression should be assessed on a case by case basis. Specialists with responsibility for patients in the vaccine eligible age cohorts should include a statement of their opinion on the patient s suitability for Zostavax in their correspondence with primary care. If the clinician administering the vaccine has concerns about the nature of therapies (including biologics) or degree of immunosuppression they should contact the relevant specialist.

41 Administration of Zostavax Contraindications and Precautions Contraindications (cont.) The vaccine should not be given to an individual 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 is being treated with either oral or intravenous aciclovir or is within 48 hours of cessation of treatment due to the potential to lower effectiveness of the vaccine is pregnant Quality Education for a Healthier Scotland 40 Please refer to the Green Book shingles chapter for more detailed information on contraindications and precautions. Unless stated differently here, the information on contraindications and special considerations for vaccination found in Chapter 6 of the Green Book apply to Zostavax. Department of Health (2013) Immunisation against infectious diseases: Contraindications and special considerations chapter. TSO publishing, Crown Copyright. contraindications-and-special-considerations-the-green-book-chapter-6. The use of topical aciclovir is not a contraindication to vaccination. Asplenia/splenectomy is not of itself a contraindication, though the underlying cause may be (such as leukaemia or lymphoma infiltration). Humoral deficiencies affecting IgG or IgA antibodies are not of themselves a contraindication unless associated with T cell deficiencies. If there is any doubt (e.g. common variable immune deficiency), immunological advice should be sought.

42 Administration of Zostavax Contraindications and Precautions Precautions Acute illness - defer immunisation until recovered Immunosuppressed patients who require protection should seek advice from a specialist Transmission of vaccine virus may rarely occur between those vaccinated who develop a varicella like rash and susceptible contacts. Zostavax is not recommended for the treatment of shingles or post-herpetic neuralgia (PHN) Quality Education for a Healthier Scotland 41 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. Zostavax is not recommended for the treatment of shingles or PHN. The natural boosting that occurs following an episode of shingles makes the benefit of offering the zoster vaccine immediately following recover limited. Individuals with PHN should wait until symptoms have ceased before being considered for shingles vaccination. In immunocomplent individuals who develop shingles, vaccination should be delayed for one year. 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 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. As a precautionary measure, any person who develops a vesicular rash after receiving Zostavax should avoid direct contact with a susceptible (chickenpox naïve) person until the rash is dry and crusted.

43 Administration of Zostavax 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, pain in arm or leg and headache Very rarely reported (1:10,000 of people vaccinated) Varicella (chickenpox) infection Quality Education for a Healthier Scotland 42 The full list of adverse reactions associated with Zostavax is available in manufacturers authorisation holder s summary of product characteristics (SPC). Anaphylaxis is a very rare adverse effect of most vaccines and facilities for its recognition and management must be available.

44 Administration of Zostavax 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 See chapter 8 of Green Book for details Quality Education for a Healthier Scotland 43 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.

45 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 7000 cases of shingles occur in people aged 70 years and over each year in Scotland with approximately five cases resulting in death To reduce the incidence of shingles and shingles related complications in Scotland, was introduced to adults aged 70 years from September 2013 Quality Education for a Healthier Scotland 44 An estimated 7000 cases of shingles occur in people aged 70 years and above each year in Scotland with approximately five cases resulting in death.

46 Key Messages (cont.) In conjunction with the routine vaccination of adults aged 70 years, a catch-up programme was commenced It is important that registered healthcare practitioners encourage vaccination in this age group Quality Education for a Healthier Scotland 45

47 Resources NHS Choices pages/introduction.aspx CMO Letter CMO(2014)21.pdf Green Book organisations/public-health-england/ series/immunisation-against-infectiousdisease-the-green-book NHS Education for Scotland and Health Protection Scotland training resources shingles.aspx Shingles Support Society Quality Education for a Healthier Scotland 46

48 References 1. Joint Committee on Vaccination and Immunisation (2010) Statement on varicella and herpes zoster vaccines 29 March [accessed 01 March 2013] 2. Chief Medical Officer for Scotland (2013) Important changes to the Scottish Immunisation Programme in 2013/14 - The introduction of a vaccine for people aged 70 years (routine cohort) and 79 years (catch up cohort) to protect. Available at: Direct link: 3. NHS Choices (2012). Shingles. [accessed 14 April 2013] 4. 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): Oxman MN and Levin MJ (2008) Vaccination against Herpes Zoster and Postherpetic Neuralgia. J Infect Dis 197 Suppl 2 S Sanofi Pasteur MSD Limited (2013). Zostavax SPC. [accessed on 14 April 2013] 9. Public Health England, 2013, Immunisation against infectious disease: the Green Book. [accessed on 29 July 2013] Available at: series/immunisation-against-infectious-disease-the-green-book 10. 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): 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)