Transcript Shingles vaccination: training slideset for healthcare

Vaccination against shingles
(Herpes Zoster)
An update for healthcare professionals
July 2016
Key messages
• shingles can lead to a severe painful illness in older people that 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
• over 50,000 cases of shingles occur in people aged 70 years and
over each year in England and Wales with approximately 50 cases
resulting in death
• shingles vaccine is now offered routinely to individuals aged 70
years to reduce the incidence and severity of shingles and shingles
related complications in older people
It is important that healthcare professionals encourage and offer
vaccination to all eligible patients
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Vaccination against shingles (Herpes Zoster)
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 78 years
• identify sources of additional information
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Vaccination against shingles (Herpes Zoster)
Contents
• what is shingles?
• why vaccinate adults aged 70 and 78 years against shingles?
• vaccination against shingles and the use of Zostavax®
• the national shingles programme
• resources
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Vaccination against shingles (Herpes Zoster)
What is shingles?
•shingles is a viral infection of the nerve cells and
surrounding skin
•after a person recovers from chickenpox
infection (caused by the varicella zoster virus),
the virus remains dormant in the nerve cells and
can reactivate at a later stage when the immune
system is weakened
•reactivation of the dormant virus leads to the
clinical manifestation of shingles
•reactivation can be associated with older age,
malignancy, immunosuppressant therapy or HIV
infection
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Vaccination against shingles (Herpes Zoster)
Image courtesy of PHE/SPL
Clinical presentation of shingles
Prodromal phase
The first signs of shingles may include
• abnormal skin sensations and pain in the affected area of skin
• headache
• feeling generally unwell
• photophobia
• malaise
• fever (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
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Vaccination against shingles (Herpes Zoster)
Clinical presentation of shingles (cont’d)
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 (an area of skin that is
supplied by a single nerve)
• the rash often causes intense pain and itching and a tingling,
pricking or numb 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
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Vaccination against shingles (Herpes Zoster)
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 (leading to keratitis, corneal ulceration,
conjunctivitis, retinitis, optic neuritis and/or glaucoma)
• peripheral motor neuropathy
In severe cases, shingles can lead to hospitalisation and death
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Vaccination against shingles (Herpes Zoster)
Possible complications of shingles (cont’d)
Post herpetic neuralgia (PHN) is a common complication of shingles in
older adults:
9
•
PHN is a pain at the rash site that persists for, or appears more than
90 days after the onset of the shingles rash
•
on average, PHN lasts from 3 to 6 months but can persist for longer
•
severity of pain can vary and may be constant, intermittent or
triggered by stimulation of affected area, eg wind on the face
•
the pain may be a burning, itching, stabbing or aching pain, which is
extremely sensitive to touch and is not generally relieved by common
painkillers
•
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
Vaccination against shingles (Herpes Zoster)
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.
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Vaccination against shingles (Herpes Zoster)
Transmission
• shingles can not be transmitted from one person to another
• a person exposed to shingles will not develop shingles
• a person exposed to chickenpox 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
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Vaccination against shingles (Herpes Zoster)
Why vaccinate older adults
against shingles?
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Vaccination against shingles (Herpes Zoster)
Incidence of shingles
•over 50,000 cases of shingles occur in people aged 70 years and above
each year in England and Wales
•of these,14,000 develop a very painful and long lasting condition called
post herpetic neuralgia (PHN)
•1,400 cases of shingles result in hospitalisation
•1 in 1,000 cases of shingles in people aged 70 years and over are
estimated to result in death
•risk of shingles higher in individuals with lupus, rheumatoid arthritis,
diabetes and granulomatosis with polyangiitis
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Vaccination against shingles (Herpes Zoster)
Epidemiology of shingles in England and Wales
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Vaccination against shingles (Herpes Zoster)
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).
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Vaccination against shingles (Herpes Zoster)
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.
Vaccination for individuals over the age of 80 years is not recommended
due to the decreased efficacy of the vaccine in this age group.
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Vaccination against shingles (Herpes Zoster)
Shingles vaccine coverage data: England
•
following the successful introduction of shingles vaccination in September
2013 in England, there has been a year on year decline in coverage in
both the routine (70-year-old) and catch-up (78-year-old) cohorts
*
•
it is important that general practices consider how they can optimise the
uptake of shingles vaccine in eligible patients in order to reduce the
significant burden of disease associated with shingles among older adults
* To end Feb 2016
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Vaccination against shingles (Herpes Zoster)
Vaccination against shingles
(Herpes Zoster)
The use of Zostavax®
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Vaccination against shingles (Herpes Zoster)
The recommended vaccine: Zostavax®
Brand name: Zostavax®
Generic name: Varicella Zoster Virus
Marketed by Sanofi Pasteur MSD
• Live attenuated (ie a weakened live organism)
• Licensed for use from age of 50 years and above
• Recommended for adults aged 70 (with a catch-up programme
for 78 and 79-year-olds)
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Vaccination against shingles (Herpes Zoster)
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 at least 5 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%
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Vaccination against shingles (Herpes Zoster)
The recommended vaccine: Zostavax®
•Zostavax® is the only market
authorised shingles vaccine
available in the UK
•it is important immunisers
familiarise themselves with the
vaccine and its product information
to avoid administration errors
Image courtesy of Sanofi Pasteur MSD
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Vaccination against shingles (Herpes Zoster)
Presentation of Zostavax®
•the vial contains a powder as an
off-white, compact crystalline plug
Zostavax® contains:
•the diluent in the pre-filled syringe
is a clear colourless liquid
•x1 pre-filled syringe
•when mixed together, Zostavax®
should appear as a semi-hazy to
translucent, off white to pale
yellow liquid
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Vaccination against shingles (Herpes Zoster)
•x1 Zostavax® vial
•x2 separate needles in secondary
packaging
Composition of Zostavax®
Composition
Varicella-zoster virus, Oka/Merck
strain (live, attenuated)not less than
19400 PFU
produced in human diploid (MRC-5)
cells
PFU = Plaque-forming units
Residual substances
This vaccine may contain traces
of neomycin
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Vaccination against shingles (Herpes Zoster)
Excipients
Powder:
Sucrose
Hydrolysed gelatin
Sodium chloride
Potassium dihydrogen phosphate
Potassium chloride
Monosodium L-glutamate monohydrate
Disodium phosphate
Sodium hydroxide (to adjust pH)
Urea
Solvent:
Water for injection
Zostavax® reconstitution instructions
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•
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 of the reconstituted vaccine into a syringe for injection
•
change the needle and push the new needle into the extremity of the syringe and
rotate a quarter of a turn (90⁰) 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
in the SPC (a semi-hazy to translucent, off white to pale yellow liquid)
Vaccination against shingles (Herpes Zoster)
Administration of Zostavax®
Marketing authorisation:
The Green Book states:
“While 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 aged 50-69 years
when compared with older ages.
Furthermore, given that the duration
of protection is not known to last for
more than ten years and the need for
a second dose is not known, the
vaccine is not recommended to be
offered routinely below 70 years of
age”
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Vaccination against shingles (Herpes Zoster)
•the Zostavax® summary of product
characteristics (SPC) states that the
vaccine is licensed for immunisation of
individuals 50 years of age or older
•while 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
Administration of Zostavax®
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•
a single dose of 0.65ml should be given by intramuscular or subcutaneous
injection, preferably in the deltoid region of the upper arm
•
intramuscular injection is the preferred route of administration as
injection-site reactions were significantly less frequent in those who received
the vaccine via this route of administration
•
for individuals with a bleeding disorder, Zostavax® should be given by deep
subcutaneous injection to reduce the risk of bleeding
•
if more than one vaccine is given at the same appointment, they should be
given at separate sites, preferably in different limbs. If given in the same limb,
they should be given at least 2.5cm apart
•
the site at which each vaccine was given should be noted in the individual’s
records
Vaccination against shingles (Herpes Zoster)
Administration of Zostavax® (cont)
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•
Zostavax® can be administered at the same time as inactivated vaccines such
as influenza and 23-valent pneumococcal polysaccharide vaccine (PPV)
•
Zostavax® can also be administered at the same time as, or before or after
other live vaccines except MMR and Yellow Fever
•
where MMR and Zostavax® are not administered at the same time, a four
week minimum interval should be observed between vaccines
•
a four-week interval should be left between administration of Yellow Fever
vaccine and Zostavax® – do not give at same appointment
•
Zostavax should not be administered to patients currently receiving oral or
intravenous antiviral agents such as aciclovir or who are within 48 hours after
cessation of treatment as the therapy may reduce the response to the vaccine
Vaccination against shingles (Herpes Zoster)
Administration of Zostavax®
Zostavax® should only be administered using a:
• prescription written manually or electronically by a registered medical
practitioner or other authorised prescriber
• patient specific direction (PSD)
• patient group direction (PGD)
A PGD template to support the national shingles (Zostavax®) vaccination
programme for eligible adults is available on the PHE website.
www.gov.uk/government/collections/immunisation-patient-group-direction-pgd
NB: Local authorisation is required before PHE PGD templates can be used
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Vaccination against shingles (Herpes Zoster)
Contraindications and precautions
Zostavax® is a live vaccine – it is critically important to check that the
recipient has no contraindications to receiving a live vaccine
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•
the decision to administer Zostavax® to immunosuppressed individuals
should be based on a clinical risk assessment
•
if the individual is under highly specialist care and it is not possible to obtain
full information on that individual’s treatment history, then vaccination
should not proceed until the advice of the specialist or a local immunologist
has been sought
•
if primary healthcare professionals administering Zostavax® have
concerns about the nature of therapies (including biologicals) or the
degree of immunosuppression, they should contact the relevant
specialist for advice
Vaccination against shingles (Herpes Zoster)
Contraindications
The shingles vaccine should not be given to a person who:
1. Has primary or acquired immunodeficiency states due to conditions including:
•
acute and chronic leukaemias, lymphoma (including Hodgkin’s lymphoma)
•
immunosuppression due to HIV/AIDS (see later)
•
cellular immune deficiencies
•
those remaining under follow up for a chronic lymphoproliferative disorder including
haematological malignancies such as indolent lymphoma, chronic lymphoid leukaemia, myeloma
and other plasma cell dyscrasias (NB: this list not exhaustive)
•
those who have received an allogenic stem cell transplant (cells from a donor) in the past 24
months and only then if they are demonstrated not to have ongoing immunosuppression or graft
versus host disease (GVHD)
•
those who have received an autologous (using their own stem cells) haematopoietic stem cell
transplant in the past 24 months and only then if they are in remission
Humoral deficiencies affecting IgG or IgA antibodies are not of themselves a contraindication unless
associated with T cell deficiencies. If there is any doubt (eg common variable immune deficiency),
immunological advice should be sought prior to administration.
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Vaccination against shingles (Herpes Zoster)
Contraindications (cont’d)
The shingles vaccine should not be given to a person who:
2. Is on immunosuppressive or immunomodulating therapy including:
•
those who are receiving or have received in the past 6 months immunosuppressive
chemotherapy or radiotherapy for malignant disease or non-malignant disorders
•
those who are receiving or have received in the past 6 months immunosuppressive
therapy for a solid organ transplant (depending upon the type of transplant and the
immune status of the patient)
•
those who are receiving or have received in the past 12 months biological therapy (eg
anti-TNF therapy such as alemtuzumab, ofatumumab and rituximab) unless otherwise
directed by a specialist
•
those who are receiving or have received in the past 3 months immunosuppressive
therapy including
i) short term high-dose corticosteroids (>40mg prednisolone per day for more than 1 week)
ii) long term lower dose corticosteroids (>20mg prednisolone per day for more than 14 days)
iii) non-biological oral immune modulating drugs e.g. methotrexate >25mg per week, azathioprine
>3.0mg/kg/day or 6-mercaptopurine >1.5mg/kg/day
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Vaccination against shingles (Herpes Zoster)
Contraindications (cont’d)
32
•
Many adults with chronic inflammatory diseases (eg rheumatoid arthritis,
inflammatory bowel disease, psoriasis, glomerulonephritis) may be on stable
long term low dose corticosteroid therapy (defined as ≤20mg prednisolone per
day for more than 14 days) either alone or in combination with other
immunosuppressive drugs including biological and non-biological therapies
•
Long term stable low dose corticosteroid therapy (defined as ≤20mg
prednisolone per day for more than 14 days) either alone or in combination with
low dose non-biological oral immune modulating drugs (eg methotrexate ≤25mg
per week, azathioprine ≤3.0mg/kg/ day or 6-mercaptopurine ≤1.5mg/kg/day)
are not considered sufficiently immunosuppressive and these patients
can receive the vaccine
•
specialist advice should be sought for other treatment regimes
•
Zostavax® is not contraindicated for use in individuals who are receiving
topical/inhaled corticosteroids or corticosteroid replacement therapy
Vaccination against shingles (Herpes Zoster)
Contraindications (cont’d)
Zostavax vaccine should not be given to a person who:
• is pregnant
• has had a confirmed anaphylactic reaction to a previous dose of
varicella-containing 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 antivirals (such as
aciclovir) until 48 hours after cessation of treatment
(the use of topical aciclovir is not a contraindication to vaccination)
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Vaccination against shingles (Herpes Zoster)
Patients anticipating immunosuppressive therapy
• the risk and severity of shingles is considerably higher among
immunosuppressed individuals
• therefore eligible individuals anticipating immunosuppressive
therapy should ideally be assessed for vaccine eligibility before
starting treatment that may contraindicate future vaccination
• eligible individuals who have not received Zostavax® should receive
a single dose of vaccine at the earliest opportunity and at least 14
days before starting immunosuppressive therapy, although leaving
one month would be preferable if a delay is possible
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Vaccination against shingles (Herpes Zoster)
HIV infection
• the safety and efficacy of Zostavax® have not been conclusively
established in adults who are known to be infected with HIV with or
without evidence of immunosuppression
• a CD4 count of 200 cells/μl may be a suitable cut-off value below
which vaccination should not be given
• seek advice from patient’s specialist
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Vaccination against shingles (Herpes Zoster)
Current or recent shingles infection
36
•
any acute illness – defer immunisation until fully recovered
•
Zostavax® not recommended for 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 natural boosting that occurs following an episode of shingles makes the
benefit of offering zoster vaccine immediately following recovery limited
•
immunocompetent individuals who develop shingles should have their
shingles vaccination delayed for one year
•
patients who have two or more episodes of shingles in one year should
have immunological investigation prior to vaccination
Vaccination against shingles (Herpes Zoster)
Transmission of vaccine virus
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•
transmission of vaccine virus may occur rarely between recently vaccinated
individuals who develop a varicella-like rash and susceptible contacts
•
any person who develops a vesicular rash after receiving Zostavax® should
ensure the rash area is kept covered when in contact with a susceptible
(chickenpox naïve) person until the rash is dry and crusted
•
if the person who received the vaccine is themselves immunosuppressed,
they should avoid contact with susceptible people until the rash is dry and
crusted, due to the higher risk of virus shedding
•
prophylactic aciclovir can be considered in vulnerable patients exposed to a
varicella like rash in a recent vaccinee
•
if a varicella (widespread) or shingles-like (dermatomal) rash develops postZostavax®, a vesicle fluid sample should also be sent for analysis to
determine whether the rash is vaccine associated or wild type
Vaccination against shingles (Herpes Zoster)
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, headache
Very rarely reported (1:10,000 of people vaccinated)
• varicella (chickenpox) like-illness
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Vaccination against shingles (Herpes Zoster)
Reporting suspected adverse reactions
Serious suspected adverse reactions to Zostavax® should be reported
to the Medical and Healthcare products Regulatory Agency (MHRA)
using the Yellow Card reporting scheme
Yellow Card scheme
• voluntary reporting system for suspected adverse reaction to
medicines/vaccines
• success depends on early, complete and accurate reporting
• report even if uncertain about whether vaccine caused condition
• http://mhra.gov.uk/yellowcard
• see chapter 8 of Green Book for details
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Vaccination against shingles (Herpes Zoster)
The national shingles
immunisation programme
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Vaccination against shingles (Herpes Zoster)
The national shingles immunisation programme
• the national shingles immunisation programme began on
1 September 2013
• shingles vaccine is now routinely offered to adults aged 70 years
• a catch-up programme for adults aged 71-79 years is being rolled
out gradually with those aged 78 on 1 September each year being
eligible for immunisation
• in addition, patients who have been or have become eligible for
immunisation since the programme began but have not yet been
vaccinated against shingles remain eligible until their 80th birthday
• any individual who reaches their 80th birthday is no longer eligible
for the vaccination due to the reducing efficacy of the vaccine as
age increases
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Vaccination against shingles (Herpes Zoster)
The national shingles immunisation programme
From 1 September 2016 shingles vaccine should be offered to:
• patients aged 70 years on 1 September 2016
• patients aged 78 years on 1 September 2016
In addition, patients who were eligible for immunisation in the first three
years of the programme but have not been vaccinated against shingles
remain eligible until their 80th birthday. These cohorts are:
• patients aged 71 to 73 on 1 September 2016
• patients aged 79 on 1 September 2016
Until 31 August 2016, GPs should continue to offer shingles vaccine to
all those who were aged 70 or 78 on 1 September 2015
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Vaccination against shingles (Herpes Zoster)
The national shingles
vaccine programme how do you know
who is eligible?
Look at PHE Immunisation website
Shingles: guidance and
vaccination programme page for
PHE/NHS England letters and
eligibility chart
www.gov.uk/government/collections/
shingles-vaccination-programme
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Vaccination against shingles (Herpes Zoster)
Maximising uptake
• every effort should be made by healthcare professionals to
maximise the uptake of the shingles vaccine
• be able to provide clear, concise and accurate information to
individuals eligible to receive shingles vaccine
• as Zostavax® can be administered concomitantly with flu vaccine,
the appointment for administration of flu vaccine is an appropriate
opportunity to also provide Zostavax®
• however, any opportunity to offer the vaccine should be used
Think of checking shingles vaccine status when an eligible patient
presents for another reason
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Vaccination against shingles (Herpes Zoster)
Maximising uptake (cont’d)
• for the 2015/16 programme, by the end of March 2016 just under
half of eligible 70 and 78-year-olds had been vaccinated against
shingles
• this represents a significant achievement but one that can be
improved on
• ongoing efforts to identify and vaccinate all eligible individuals are
needed to achieve a continuing reduction in the number of cases of
this debilitating and painful condition
• take every opportunity to offer shingles vaccination to eligible
patients to help to protect as many elderly people as possible from
this serious illness
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Vaccination against shingles (Herpes Zoster)
Resources
• PHE and NHS England Letter (2016) Shingles immunisation
programme from 1 September 2016
https://www.gov.uk/government/collections/shingles-vaccinationprogramme
• PHE Immunisation against infectious disease (the Green Book)
Shingles (herpes zoster) chapter 28a
https://www.gov.uk/government/collections/immunisation-againstinfectious-disease-the-green-book
• PHE Shingles: questions and answers for healthcare professionals,
patient information leaflets, eligibility chart and other resources
https://www.gov.uk/government/collections/shingles-vaccinationprogramme
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Vaccination against shingles (Herpes Zoster)
Key messages
• shingles can lead to a severe painful illness in older people that 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
• over 50,000 cases of shingles occur in people aged 70 years and
over each year in England and Wales with approximately 50 cases
resulting in death
• shingles vaccine is now offered routinely to individuals aged 70
years to reduce the incidence and severity of shingles and shingles
related complications in older people
It is important that healthcare professionals encourage and offer
vaccination to all eligible patients
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Vaccination against shingles (Herpes Zoster)
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Published July 2016
PHE publications gateway number: 2016154
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Vaccination against shingles (Herpes Zoster)