The introduction of a vaccine for
people aged 70 years (routine cohort)
and 79 years (catch up cohort) to
protect against shingles
(Herpes Zoster)
An Update for Healthcare Professionals
Public Health Protection Unit, NHSGGC
August/September 2013
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
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
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
Clinical presentation of shingles
Initial prodromal stage
The first signs of shingles may include
•Headache
•Feeling generally unwell
•Myalgia
•Malaise
•High Temperature (38°C) (although this is less common)
A prodromal illness is experienced by 80% of individuals with shingles
and can last up to 72 hours before the rash appears
Clinical presentation of shingles (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
Transmission
• The varicella virus that causes
shingles (HZ) is the same virus
that causes chickenpox (VZ)
• Exposure to shingles is
through direct contact with
the fluid filled blisters only
• Shingles can not be
transmitted from one person
to another
• Shingles is not spread through
coughing, sneezing or casual
contacts
• A person exposed to
chickenpox or shingles will not
develop shingles but can
develop chickenpox if no
previous immunity
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
Possible complications of shingles
Complications are more likely in adults aged over 50 years,
with the severity of the illness increasing with age
The most common complications are
• Post herpetic neuralgia (PHN)
• Secondary bacterial skin infections
Other less common complications can include
• Ophthalmic Zoster
• Peripheral motor neuropathy
• In severe cases shingles can lead to hospitalisation and death
Possible complications of shingles: 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
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
Incidence rate
RCGP (1991-1992)
MSGP4 (1991-1992)
Hope-Simpson (1947-1972)
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%
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
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
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
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 prefilled syringe is a clear
colourless liquid
• When mixed together,
Zostavax should appear
as a semi-hazy to
translucent, off white to
pale yellow liquid
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)
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
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).
Contraindications and Precautions
Contraindications
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
Contraindications and Precautions
Precautions
• Acute illness- defer immunisation until recovered
• Immunosuppressed patients who require protection against
shingles should seek advice from a specialist
• Transmission of vaccine virus may rarely occur between
recently vaccinated individuals and susceptible contacts
• 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
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
Reporting suspected adverse reactions
Yellow card scheme
• Voluntary reporting system for suspected adverse reaction
to medicines/vaccines
• Success depends on early, complete and accurate
reporting
• Report even if uncertain about whether vaccine caused
condition
• http://yellowcard.mhra.gov.uk/
• See chapter 8 of Green Book for details
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
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
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