1. The introduction of a vaccine for people aged 70 years (routine cohort) and 79 years (catch up cohort) to protect against shingles (Herpes Zoster)
Background
The Joint Committee on Vaccination and Immunisation (JCVI, 2010) 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-related 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 JCVI recommended a universal herpes zoster (shingles) vaccination programme for adults aged years (up to the 80th Birthday) to commence in September 2013, for the prevention of shingles infection and shingles related post herpetic neuralgia.
Rationale for resource
This resource is designed to support healthcare professionals involved in raising the issue of vaccination against shingles with individuals aged years, with evidence based information about vaccination against shingles.
This resource does not cover the actual administration techniques involved in vaccinating against shingles. If staff are required to deliver vaccinations they should refer to their line manager for alternative training.
Note: shingles is also known as herpes zoster. For the purpose of this resource shingles is used throughout this document.
An Update for Healthcare Professionals
Public Health Protection Unit, NHSGGC
August/September 2013

2. Contents Shingles and it’s epidemiology
Why vaccinate older adults aged 70 and 79 years against shingles
Vaccination against shingles and the use of Zostavax®
Safety and efficacy of the vaccine
Indication and contraindications
Vaccine supply, administration and call/recall

3. What is shingles?
Shingles is a viral infection of the nerve cells and surrounding skin. It is caused by the 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 or immunosuppression due to various reasons
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 (Department of Health, 2013)
Shingles can not be transmitted from one person to another, although it can cause chickenpox in individuals who have not previously had the disease
Although rare, it is possible to have shingles more than once
Shingles is not caused by the same virus that causes genital herpes

4. What is shingles (cond)
An estimated 7,000 cases of shingles occur in people aged 70 years and above each year in Scotland
Of these, 700 to 14,00 develop a very painful and long lasting condition called Post Herpetic Neuralgia (PHN)
Approximately 1 in 4 adults will experience shingles in their lifetime
Around 600 hospitalisation episodes recorded each year
1 in 1,000 cases of shingles are estimated to result in death
JCVI (2010) Statement on varicella and herpes zoster vaccines 29 March 2010.

5. 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

6. Clinical presentation of shingles (contd)
Acute stage
Usually within a dermatome, a rash will begin to develop, often causing a pain, itching or tingling sensation in the area of the affected nerve
A fluid filled painful rash then develops a few days after and commonly occurs either on one side of the face or body
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
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

8. Transmission
The varicella virus that causes shingles (HZ) is the same virus that causes chickenpox (VZ)
Shingles can not be transmitted from one person to another
A person exposed to chickenpox or shingles will not develop shingles but can develop chickenpox if no previous immunity
Exposure to shingles is through direct contact with the fluid filled blisters only
Shingles is not spread through coughing, sneezing or casual contacts

9. 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

10. 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 eye (NHS Choices, 2012) 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 (Opstelten et al, 2002) with approximately 4% of these cases resulting in long term sequelae (Bowsher, 1999).
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 (NHS Choices, 2012). This affect is temporary and individuals can make a good recovery.

11. Possible complications of shingles: PHN
PHN is a common complication of shingles in older adults
it is defined as an intense pain that persists for or develops after 90 days following the onset of the shingles
PHN pain can persist between 3 to 6 months in 50% of those affected and is focused in the area affected by shingles
PHN is more likely to develop and is more severe in people over 50 years with one third of sufferers over 80 years experiencing intense pain
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
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 (Oxman et al, 2005) 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 (Schmader, 2002)

12. Why vaccinate older adults aged 70 and 79 years 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
Studies undertaken on behalf of the JCVI 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
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 cost effective in individuals over the age of 80 years

13. Incidence rate
RCGP ( )
MSGP4 ( )
Hope-Simpson ( )

16. The recommended vaccine: Zostavax®
A one dose schedule of Zostavax® was assessed in clinical trials using 17,775 adults aged 70 years and over
The vaccine
reduced the incidence of shingles by 38% and
provided protection for a minimum of 7 years
For those vaccinated but who later developed shingles, the vaccine
significantly reduced the burden of illness by 55%
significantly reduced the incidence of PHN by 66.8%
The efficacy of the vaccine in this age group is estimated to be as low as 38% (Oxman et al, 2005) 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% (Oxman et al, 2008).
The vaccine is expected to provide protection against shingles for a minimum period of 7 years (van Hoek et al., 2009) and at this time, a one dose schedule of the vaccine is recommended with no requirement for a second/booster vaccine.

17. Zostavax Recommendation
SPC states that the vaccine is licensed from the age of 50 years
JCVI recommended routine vaccination of those aged 70 years based on available medical, epidemiological, economic and vaccine efficacy data in 2009
JCVI also recommended a catch up for those aged 71 years to 79 years but no vaccination in those age 80 years and over

18. Vaccination against shingles: implementation phases
Routine Programme: all those aged 70 years on 1st Sept 2013 (born between 02/09/1942 and 01/09/1943)
Catch up programme: all those aged 79 years on 1st Sept 2013 (born between 02/09/1933 and 01/09/1934)
Further catch up programme: for those aged 71 to 78 years on 1st Sept 2013 yet to be decided

19. The recommended vaccine: Zostavax®
Live attenuated vaccine
Zostavax® is the only vaccine currently recommended by the DH for the prevention of shingles and shingles related PHN
Other vaccines may become available in future years
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.

20. Presentation of Zostavax®
Zostavax contains:
x1 Zostavax vial
x1 pre-filled syringe
x2 separate needles in secondary packaging
The vial is a lyophilised 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

21. Administration of Zostavax®- reconstitution instructions
The vaccine comes as a vial and pre-filled syringe for 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 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
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
(Sanofi Pasteur MSD SPC, 2013)
It is recommended that the vaccine be administered immediately after reconstitution. Discard reconstituted vaccine if it is not used within 30 minutes

22. Administration of Zostavax®
The reconstituted vaccine form a semi-hazy to translucent, off white to pale yellow liquid
Given by subcutaneous injection into the deltoid- 0.65ml as insufficient immunogenicity data for intra-muscular injection
Given as a single dose and no booster recommended
Zostavax® can safely be administered concomitantly with other vaccines such as inactivated influenza
Zostavax can also be given concomitantly with 23-valent pneumococcal polysaccharide vaccine (pneumovax) although this is contrary to the SPC advice
Zostavax® vaccine can be given at same time as other vaccines such as inactivated influenza vaccine and 23- valent pneumococcal polysaccharide vaccine (PPV).
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 apart (Tseng et al, Vaccine 2011).
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 and should 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)

23. Subcutaneous Injection Technique
Skin is bunched up, not stretched
Ensures insertion into fatty tissue just below skin and not intra-dermal, using a blue needle
Inserted at 45 angle
Source: Diggle L. Injection technique for immunisation. Practice Nurse 2007; 33 (1).

24. Contraindications and Precautions
The vaccine should not be given to a person who:
has 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 disease or treatment
is receiving immunosuppressive therapy (including high-dose corticosteroids); has an active untreated TB infection
is pregnant
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 contraindicated in individuals receiving high dose corticosteroids. 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.
Although pregnancy in this age group is unlikely, healthcare professionals should be aware that this is a live attenuated vaccine that therefore should not be administered in pregnancy.
Please refer to the Green Book shingles chapter for more detailed information on contraindications and precautions.

25. Contraindications and 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
Ideally Zostavax should be delayed until therapy with anti-viral drugs are completed
Delay giving vaccine to someone recovering from shingles
Therapy with low-doses methotrexate , azathioprine etc for treatment of rheumatoid arthritis is not a contraindication
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 post herpetic neuralgia (PHN). Individuals who have shingles or PHN should wait until symptoms have ceased before being considered for shingles immunisation
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).

26. Possible adverse reactions
Most commonly reported (1:10)
Erythema (redness), pain, swelling and pruritis (itching) at the injection site
Less commonly reported (1:100)
Haematoma, induration and warmth at the injection site
Very rarely reported (1:10,000)
Varicella (chickenpox) infection
Healthcare workers should refer to the Vaccine Manufacturers Authorisation Holders Summary of Product Characteristics (SPC) for the full list of side effects. (updated by manufacturer on 27/2/2013).

27. 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

28. Vaccine supply and call/recall
Practices responsible for their own call/recall
Template letter available from NHS Health Scotland
Can be given with flu vaccine or any time between September to August next year
Vaccine supplied by the PDC but liaise closely with the PDC before arranging clinics
Limited supply of vaccine so need to adhere to the age groups strictly
Each practice would receive a maximum of 75% of its cohort allocation in total

29. Monitoring uptake and data collection
GP practices to submit number of eligible people in the practice
GP practices also to submit number not eligible due to contraindications or have not responded or refused vaccine by August 2014
HPS to extract data from GP system for interim monthly uptake
Final uptake figure to reconcile interim data and practice submitted data

30. Key Message
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 7,000 cases of shingles occur in people aged 70 years and above each year in Scotland with approximately 5 cases resulting in death
To reduce the incidence of shingles and shingles related complications, vaccination will be offered routinely to adults aged 70 years on 1 September every year from 2013
A catch up programme for those aged 79 years on 1 Sept 2013 from September this year
The vaccination programme will initially be offered to individuals aged years of age.
An estimated 50,000 cases of shingles occur in people aged 70 years and above each year in England and Wales (E&W) with over 50 cases resulting in death (van Hoek AJ et al, 2009).