Transcript PHE Flu Training 2016 to 2017

The national flu immunisation
programme 2016/17
Viv Cleary, Consultant in Health Protection, London PHE
Training for healthcare practitioners
Introduction
Training for healthcare practitioners
What is flu?
•
flu is an acute viral infection of the respiratory tract (nose,
mouth, throat, bronchial tubes and lungs)
•
it is a highly infectious illness which spreads rapidly in
closed communities
•
even people with mild or no symptoms can infect others
•
most cases in the UK occur during an 8 to 10 week period
during the winter
The national flu immunisation programme 2014/15
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The national flu immunisation programme 2016/17
Influenza viruses
There are three types of influenza viruses:
A viruses
• cause outbreaks most years and are the usual cause of epidemics
• live and multiply in wildfowl from where they can be transmitted to humans.
Also carried by other mammals
B viruses
• tend to cause less severe disease and smaller outbreaks
• burden of disease mostly in children
• predominantly found in humans
C viruses
• minor respiratory illness only
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The national flu immunisation programme 2016/17
5
Influenza Virus
Single stranded RNA virus
3 types (A, B, C)
Subtypes of A
Haemaglutinin (H) antigen (H1-16)
HA - for attachment of virus to receptors
on cell membrane.
Neuraminidase (N) antigen (N1-9)
for viruses to be released from infected
cell after replication - new viruses infect
other cells and spread infection
- major change (shift), A type
- minor change (drift)
Genetic changes in the flu virus – what this means
Changes in the surface antigens (H and N) result in the flu virus constantly changing
•
antigenic drift: minor changes (natural mutations) in the genes of flu viruses that
occur gradually over time
•
antigenic shift: when two or more different strains combine. This abrupt major change
results in a new subtype. Immunity from previous flu infections/vaccinations may not
protect against the new subtype, potentially leading to a widespread epidemic or
pandemic
Because of the changing nature of flu viruses, WHO monitors their epidemiology
throughout the world. Each year WHO makes recommendations about the strains of
influenza A and B which are predicted to be circulating in the forthcoming winter.
These strains are then included in the flu vaccine developed each year
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The national flu immunisation programme 2016/17
Flu vaccine effectiveness
•
efficacy calculated at between 50-60% for adults aged 18 to 65 years
•
lower efficacy in elderly although immunisation shown to reduce incidence of
severe disease including bronchopneumonia, hospital admissions and mortality
•
in 2014/15 the flu vaccine only provided limited protection against infection as the
main A(H3N2) strain that circulated differed from the A(H3N2) strain selected for
the vaccine
•
however, throughout the last decade, there has generally been a good match
between the strains of flu in the vaccine and those that subsequently circulated
In 2015/16 , the A(H1N1) strain was the predominant circulating virus for the majority of
the season and was well matched to the vaccine strain. The UK provisional vaccine
effectiveness was 52.4% (for all ages) and 57.6% for the live attenuated vaccine in
children aged 2 to 17 years
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The national flu immunisation programme 2016/17
Features of flu
•
easily transmitted by large droplets, small-particle aerosols and by hand to
mouth/eye contamination from a contaminated surface or respiratory
secretions of infected person
•
people with mild or no symptoms can still infect others
•
incubation period 1-5 days (average 2-3 days) though may be longer
especially in people with immune deficiency
Common symptoms include:
10
•
sudden onset of fever, chills, headache, muscle and joint pain and extreme
fatigue
•
dry cough, sore throat and stuffy nose
•
in young children gastrointestinal symptoms such as vomiting and diarrhoea
may be seen
The national flu immunisation programme 2016/17
Possible complications of flu
Common:
• bronchitis
• otitis media (children), sinusitis
• secondary bacterial pneumonia
Less common:
• meningitis, encephalitis, meningoencephalitis
• primary influenza pneumonia
Risk of most serious illness is higher in children under six months, pregnant women,
older people and those with underlying health conditions such as respiratory
disease, cardiac disease, long-term neurological conditions or immunosuppression.
Flu during pregnancy may be associated with perinatal mortality, prematurity, smaller
neonatal size and lower birth weight
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The national flu immunisation programme 2016/17
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Influenza – transmission of infection
Non-porous
surfaces
 transmission
24 hours
Porous surfaces
 transmission
up to 8 hours
www.cdc.gov/
Flu epidemiology
Weekly all age GP influenza-like illness rates for 2015 to 2016 and past seasons, England (RCGP)
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The national flu immunisation programme 2016/17
•
flu activity usually between
September to March (weeks
37 and 15)
•
impact of flu varies from
year to year
•
moderate levels of influenza
activity seen in 2015/16
season – long and late
season
•
biggest impact in young
adults
•
high number admissions to
hospital and ICU/HDU
admissions – higher than
seen in the previous few
seasons
South East London situations by LA
Bexley
Bromley
Greenwich
Lambeth
Lewisham
Southwark
Total
2013
0
1
1
1
0
1
4
2014
1
2
1
0
0
1
5
2015
1
1
0
1
0
1
4
2016
1
2
1
2
7
2
15
Total
3
6
3
4
7
5
28
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Presentation title - edit in Header and Footer
SE London situations by setting
Care Home
Community
Hospital
Nursery
School
Total
2013
0
1
2
0
1
4
2014
0
0
1
1
3
5
2015
4
0
0
0
0
4
2016*
0
0
4
1
10
15
Total
4
1
7
2
14
28
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UK flu vaccination programme
• late 1960s: annual flu immunisation recommended to directly protect those in clinical risk
groups who are at a higher risk of influenza associated morbidity and mortality
• 2000: flu vaccine policy extended to include all people aged 65 years or over
• 2010: pregnancy added as a clinical risk category for routine flu immunisation
• 2013: phased introduction of an annual childhood flu vaccination programme for all children
aged 2 to 16 years began with vaccine offered to all children aged 2 and 3 years and seven
geographical pilots in primary school aged children
• 2014: phased introduction of childhood flu vaccination programme continued with vaccine
offered to all children aged 2, 3 and 4 years and geographical pilots in primary and
secondary school aged children
• 2015: offer to all 2, 3 and 4 year old children and children of school years 1 and 2 age
• 2016: offer to all 2, 3 and 4 year old children and children of school years 1, 2 and 3 age
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The national flu immunisation programme 2016/17
2016/17 Influenza Season
Flu vaccine eligibility: 2016/17 flu season
•
all children aged two, three and four years on 31 August 2016
•
all children of school years 1, 2 and 3 age
•
all primary school-aged children in former primary school pilot areas
•
those aged six months to under 65 years in clinical risk groups
•
all pregnant women (including those who become pregnant during flu season)
•
those aged 65 years and over (including those becoming 65 years by 31 March 2017
•
those living in long-stay residential care homes or other long-stay care facilities
•
carers and household contacts of immunocompromised individuals
Frontline health and social care workers should be provided flu vaccination by their employer.
This includes general practice staff.
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The national flu immunisation programme 2016/17
Morbidly obese patients
17
•
JCVI has advised morbidly obese patients (BMI 40+) could benefit from flu
vaccination
•
those with morbid obesity (BMI>40) found to be at higher risk of hospitalisation and
death following pandemic influenza infection
•
many in this patient group already eligible due to complications of obesity that place
them in another risk category
•
practices need to use clinical judgement to decide whether to vaccinate this group of
patients
•
however, flu vaccinations for morbidly obese patients with no other recognised risk
factor will not attract a payment in 2016/17
The national flu immunisation programme 2016/17
Clinical risk groups who should receive flu vaccine (1)
Clinical risk category
Chronic respiratory disease
Examples (this list is not exhaustive and decisions should be based on clinical
judgement)
Asthma that requires continuous or repeated use of inhaled or systemic steroids or with
previous exacerbations requiring hospital admission.
Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and
emphysema; bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and
bronchopulmonary dysplasia (BPD).
Children who have previously been admitted to hospital for lower respiratory tract
disease.
Chronic heart disease
Chronic kidney disease
Chronic liver disease
Chronic neurological disease
(included in the DES directions for
Wales)
Diabetes
18
see precautions section on live attenuated influenza vaccine
Congenital heart disease, hypertension with cardiac complications, chronic heart failure,
individuals requiring regular medication and/or follow-up for ischaemic heart disease.
Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic syndrome,
kidney transplantation.
Cirrhosis, biliary atresia, chronic hepatitis
Stroke, transient ischaemic attack (TIA). Conditions in which respiratory function may be
compromised due to neurological disease (eg polio syndrome sufferers).
Clinicians should offer immunisation, based on individual assessment, to clinically
vulnerable individuals including those with cerebral palsy, learning difficulties, multiple
sclerosis and related or similar conditions; or hereditary and degenerative disease of the
nervous system or muscles; or severe neurological disability
Type 1 diabetes, type 2 diabetes requiring insulin or oral hypoglycaemic drugs, diet
controlled diabetes.
The national flu immunisation programme 2016/17
Clinical risk groups who should receive flu vaccine (2)
Clinical risk category
Immunosuppression (see
contraindications and
precautions section on live
attenuated influenza
vaccine)
Examples (this list is not exhaustive and decisions should be based on
clinical judgement)
Immunosuppression due to disease or treatment, including patients
undergoing chemotherapy leading to immunosuppression, bone marrow
transplant, HIV infection at all stages, multiple myeloma or genetic
disorders affecting the immune system (eg IRAK-4, NEMO, complement
disorders)
Individuals treated with or likely to be treated with systemic steroids for
more than a month at a dose equivalent to prednisolone at 20mg or more
per day (any age), or for children under 20kg, a dose of 1mg or more per kg
per day.
It is difficult to define at what level of immunosuppression a patient could
be considered to be at a greater risk of the serious consequences of
influenza and should be offered influenza vaccination. This decision is best
made on an individual basis and left to the patient’s clinician.
Some immunocompromised patients may have a suboptimal immunological
response to the vaccine.
Asplenia or dysfunction of the This also includes conditions such as homozygous sickle cell disease and
spleen
coeliac syndrome that may lead to splenic dysfunction.
Pregnant women
Pregnant women at anystage of pregnancy (first, second or third trimesters).
(see precautions section on live attenuated influenza vaccine)
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The national flu immunisation programme 2016/17
Flu immunisation should also be offered to:
20
•
those living in long-stay residential care homes or other long-stay care
facilities where rapid spread is likely to follow introduction of infection and
cause high morbidity and mortality (this does not include prisons, young
offender institutions, university halls of residence etc)
•
those who are in receipt of a carer’s allowance, or those who are the main
carer of an elderly or disabled person whose welfare may be at risk if the carer
falls ill
•
household contacts of immunocompromised individuals, specifically those
who expect to share living accommodation on most days over the winter and
therefore for whom continuing close contact is unavoidable.
•
health and social care staff in direct contact with patients/service users
should be vaccinated as part of an employer’s occupational health obligation
The national flu immunisation programme 2016/17
Other groups who should receive flu vaccine
21
•
the list of clinical risk groups is not exhaustive
•
healthcare practitioners should apply clinical judgement to take into account
the risk of flu exacerbating any underlying disease as well as the risk of
serious illness from flu itself
•
flu vaccine should be offered to such patients even if the individual is not in
the clinical risk groups specified in the risk groups list
•
child contacts of very severely immunocompromised individuals should be
given inactivated vaccine
The national flu immunisation programme 2016/17
Why vaccinate these risk groups?
Influenza-related population mortality rates and relative risk of death among those aged six months to
under 65 years by clinical risk group in England, September 2010 – May 2011
Number of fatal flu cases
(%)
22
Age-adjusted relative risk
In a risk group
213 (59.8)
Mortality rate per 100,000
population
4.0
Not in any risk group
143 (40.2)
0.4
Baseline
Chronic renal disease
19 (5.3)
4.8
18.5
Chronic heart disease
32 (9.0)
3.7
10.7 (7.3-15.7)
Chronic respiratory disease
59 (16.6)
2.4
7.4 (5.5-10.0)
Chronic liver disease
32 (9.0)
15.8
48.2 (32.8-70.6)
Diabetes
26 (7.3)
2.2
5.8 (3.8-8.9)
Immunosuppression
71 (19.9)
20.0
47.3 (35.5-63.1)
Chronic neurological disease
(excluding stroke/transient
ischaemic attack)
42 (11.8)
14.7
40.4 (28.7-56.8)
Total
378
0.8
The national flu immunisation programme 2016/17
11.3 (9.1-14.0)
Vaccination of clinical risk groups
23
•
increasing flu vaccine uptake in clinical risk groups important because of
increased risk of death and serious illness if people in these groups catch flu
•
for a number of years only around half of patients aged six months to under 65 in
clinical risk groups have been vaccinated
•
despite those with liver disease and chronic neurological disease having some of
the highest mortality rates, they have low flu vaccine uptake rate compared with
those in other clinical risk groups
•
vaccine uptake for all those in clinical risk groups needs to improve, but
particularly in those with chronic liver and neurological disease, and people with
learning disabilities
The national flu immunisation programme 2016/17
Flu vaccine uptake by age and clinical risk group in
2015/16 (Patients aged 6 months to under 65 years)
6months
to under
2 years
Age:
2years to
under 5
years
Risk group:
24
5 years
to under
16 years
16 years
to under
65
Total
under
65years
% Vaccine uptake
Patients with chronic heart disease
19.0
44.0
30.8
50.2
48.6
Patients with chronic respiratory disease
23.4
52.4
42.3
48.2
47.4
Patients with chronic kidney disease
35.4
46.7
33.8
53.8
53.5
Patients with chronic liver disease
29.5
48.8
37.2
42.6
42.5
Patients with diabetes
28.2
58.0
55.0
65.7
65.5
Patients with immunosuppression
26.4
53.9
43.3
53.2
52.9
Patients with Chronic Neurological Disease (including Stroke/TIA,
Cerebral Palsy or MS)
17.7
43.4
32.9
50.1
49.0
Patients with Asplenia or dysfunction of the spleen
27.0
47.3
30.0
37.0
36.4
Patients with morbid obesity (BMI>=40)
1.7
36.2
14.2
30.2
30.0
The national flu immunisation programme 2016/17
Clinical risk groups and pregnant women
25 The national flu immunisation programme 2016/17
Flu vaccine uptake rates 2012/13 – 2015/16
2015/16
2014/15
2013/14
2012/2013
Uptake
ambition
2016/17
Patients aged 65 years or older
71.0%
72.7%
73.2%
73.4%
75%
Patients aged six months to
under 65 years in risk groups
(excluding pregnant women
without other risk factors)
45.1%
50.3%
52.3%
51.3%
55%
Pregnant women
42.3%
44.1%
39.8%
40.3%
55%
Health care workers
50.6%
54.9%
54.8%
45.6%
75%
Carers
37.4%
45.1%
44.8%
46.3%
-
35.4%
38.5%
42.6%
N/A
40-65%
Children aged two years old
(including those in risk groups)
Children aged three years old
(including those in risk groups)
Children aged four years old
(including those in risk groups)
26
37.7%
41.3%
39.5%
N/A
30.0%
32.9%
N/A
N/A
The national flu immunisation programme 2016/17
(eligible
children
aged 2y to
school year
3 age)
Pregnant women
All pregnant women are recommended to receive the inactivated flu vaccine
irrespective of their stage of pregnancy
27
•
pregnant women at increased risk from complications if they contract flu
•
having flu during pregnancy may be associated with premature birth and smaller
birth size and weight
•
flu vaccination during pregnancy provides passive immunity against flu to infants in
the first few months of life
•
studies on safety of flu vaccine in pregnancy show that inactivated flu vaccine can
be safely and effectively administered during any trimester of pregnancy
•
no study to date has demonstrated an increased risk of either maternal
complications or adverse fetal outcomes associated with inactivated flu vaccine
•
women should be offered the vaccine every time they are pregnant
The national flu immunisation programme 2016/17
London’s ‘flu vaccine cohort:
pregnant women; UK data
36
27
5
1
3
women died from
‘flu (2009 – 2012)
confirmed
H1N1
probable
H1N1
Source: MBRRACE-UK
(Tim Hillard)
influenza A
influenza B
Why vaccinate children against flu?
Extension of the seasonal flu vaccination programme to all children aims to
appreciably lower the public health impact of flu by:
•providing direct protection thus preventing a large number of cases of flu
infection in children
•providing indirect protection by lowering flu transmission from children:
• to other children
• to adults
• to those in the clinical risk groups of any age
Reducing flu transmission in the community will avert many cases of severe flu and
flu-related deaths in older adults and people with clinical risk factors.
Annual administration of flu vaccine to children is expected to substantially reduce
flu-related illness, GP consultations, hospital admissions and deaths.
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The national flu immunisation programme 2016/17
Health and social care workers
30
•
frontline health and social care workers have a duty of care to protect their patients and
service users from infection
•
vaccination of health and social care workers protects them and reduces risk of spreading
flu to their patients, service users, colleagues and family members
•
evidence vaccination significantly lowers rates of flu-like illness, hospitalisation and
mortality in vulnerable patients in long-term healthcare settings
•
reduces transmission of flu to vulnerable patients, some of whom may have impaired
immunity that may not respond well to immunisation
•
vaccination of frontline workers also helps reduce sickness absences and contributes to
keeping the NHS and care services running through winter pressures
The national flu immunisation programme 2016/17
Health and social care workers (cont)
•
NHS and social care bodies have a responsibility to ensure, as far
as is reasonably practicable, that health and social care workers
are free of, and are protected from exposure to infections that can
be caught at work
(Health and Social Care Act 2008, Code of Practice on the prevention and
control of infections)
31
•
responsibility for funding and administering seasonal flu vaccine to
staff lies with employers
•
trusts/employers must ensure that health and social care staff
directly involved in delivering care are encouraged to be immunised
and that processes are in place to facilitate this
•
overall level of flu vaccine uptake in health care workers is still
below the 75% aspiration
•
see NHS Employers flu fighter campaign
www.nhsemployers.org/flu
The national flu immunisation programme 2016/17
Key messages to health and social care workers
• duty of care as professionals to patients or residents to do everything in your power to
protect them against infection, including being immunised against flu
• getting vaccinated against flu can help protect you, your patients and family
• everyone is susceptible to flu, even if you are in good health and eat well
• you can be infected with the virus and have no symptoms but can still pass flu virus to
others including patients or residents
• good infection control measures reduce spread of flu and other acute respiratory
infections in healthcare settings but are not sufficient alone to prevent them
• impact of flu on frail and vulnerable patients can be fatal and outbreaks can cause
severe disruption in communities, care homes and hospitals
• flu vaccine has a good safety record and will help protect you. It cannot give you flu.
Having the vaccination can encourage your colleagues to do likewise
• throughout the last ten years there has generally been a good to moderate match
between the strains of flu virus in the vaccine and those that subsequently circulated
• staff act as positive role models for patients aged 65 and over, those with long-term
health conditions and pregnant women to take up the offer too
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The national flu immunisation programme 2016/17
When to vaccinate
33
•
those eligible should be given flu vaccination as soon as vaccine is available so
that people are protected when flu begins to circulate in the community
•
ideally most vaccination should be completed before the end of December
before flu circulation usually peaks
•
flu can circulate considerably later than this however so clinical judgement
should be applied to assess needs of individual patients and whether it is
appropriate to continue to offer vaccination from January to March
•
this decision should take into account level of flu-like illness in community and
fact that the immune response following flu vaccination takes about two
weeks to develop fully
•
protection afforded by the vaccine thought to last at least one influenza season
•
however, as antibody levels likely to reduce in subsequent seasons and may be
changes to circulating strains from one season to next, annual revaccination
is important
The national flu immunisation programme 2016/17
Which flu vaccine should be used?
34
The national flu immunisation programme 2016/17
Flu vaccine composition 2016/17
Trivalent vaccines will contain the following three viruses:
• an A/California/7/2009 (H1N1)pdm09-like virus
• an A/Hong Kong/4801/2014 (H3N2)-like virus
• a B/Brisbane/60/2008-like virus
In addition to the above, the quadrivalent vaccine will also contain:
B/Phuket/3073/2013-like virus
None of the influenza vaccines for the 2016/17 season contain thiomersal as an
added preservative.
More detailed information on the characteristics of the available vaccines, including
age indications can be found in the Influenza chapter of the Green Book
(Immunisation against infectious disease) and the product SPCs.
35
The national flu immunisation programme 2015/16
Types of flu vaccines
Two main types of vaccine available:
• inactivated – by injection
• live attenuated – by nasal application
None of the flu vaccines can cause clinical influenza in those that can be vaccinated
 Trivalent: flu vaccines contain two subtypes of Influenza A and one type B virus
 Quadrivalent vaccines contain two subtypes of Influenza A and both B virus types*
As quadrivalent vaccines contain both lineages of B viruses and therefore may provide
better protection against the circulating B strain(s) than trivalent flu vaccines, the live
intranasal vaccine offered to children aged 2 years and over is a quadrivalent
vaccine, as is the inactivated vaccine recommended for children aged 3 years and
above who cannot receive live attenuated vaccine.
*Quadrivalent inactivated flu vaccine only authorised for children aged 3 years and older.
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The national flu immunisation programme 2016/17
Inactivated flu vaccines
37
•
a number of different manufacturers produce flu
vaccines. Those available for 2016/17 season are
listed in ‘The national flu immunisation programme
2016/17’ letter available on PHE website
•
most of the inactivated vaccines are administered
by intramuscular injection, although one vaccine
(Intanza®) is administered by the intradermal
route
•
all currently available flu vaccines are prepared
from viruses grown in embryonated hens’ eggs –
details of ovalbumin content available in the
product SPC
•
some flu vaccines are restricted for use in
particular age groups. The SPC for individual
products should always be referred to when
ordering vaccines for particular patients
The national flu immunisation programme 2016/17
Live attenuated influenza vaccine (LAIV)
38
•
a live attenuated intranasal spray is the recommended vaccine for the childhood flu
programme
•
the live attenuated influenza vaccine (LAIV) has been shown to be more effective in
children compared with inactivated influenza vaccines
•
it may offer some protection against strains not contained in the vaccine as well as to
those that are and has the potential to offer better protection against virus strains
that have undergone antigenic drift
•
since this vaccine is comprised of weakened whole live virus, it replicates natural
infection which induces better immune memory (thereby offering better long-term
protection to children than from the inactivated vaccines)
•
in addition to being attenuated (weakened), the live viruses in LAIV have been
adapted to cold so that they cannot replicate efficiently at body temperature
•
LAIV has a good safety profile in children aged two years and older
The national flu immunisation programme 2016/17
Is LAIV effective?
• results from the 2013/14 child flu vaccine pilot programme suggest a positive
impact on levels of flu in that flu season
In pilot areas compared to non-pilot areas, there were fewer GP consultations
and A&E attendances for ‘influenza like’ and respiratory illness and fewer
people tested positive for flu in primary care
• in the 2014/15 flu season, vaccination of healthy primary school age children
resulted in a population-level impact despite the circulation of drifted A and B
influenza strains
GP influenza-like consultations, A&E respiratory attendance, respiratory swab
positivity, hospitalisation and excess respiratory mortality were consistently
lower in both vaccinated and non-vaccinated individuals in the primary school
age pilot areas
• for the 2015/16 flu season, the provisional end of season vaccine effectiveness
for LAIV in children aged 2-17years was 57.6%
39
The national childhood flu immunisation programme 2016/17
Vaccines supplied by PHE for childhood flu
programme 2016/17
41 The national childhood flu immunisation programme 2016/17
Administration of flu vaccines
42
The national flu immunisation programme 2016/17
Flu vaccine presentation and dosage
43
•
inactivated flu vaccines for intramuscular (IM) administration supplied as
suspensions in pre-filled syringes containing a 0.5ml dose
•
if SPC for IM inactivated flu vaccine states young children can be given
either a 0.25ml or a 0.5ml dose, give 0.5ml dose
•
Intanza®, the intradermal vaccine, is supplied in a micro-needle injection
system
•
the live intranasal flu vaccine is supplied as a nasal spray suspension in a
special single use, pre-filled, nasal applicator. No reconstitution or dilution
required. Each applicator contains 0.2ml (administered as 0.1 ml per
nostril)
The national flu immunisation programme 2016/17
Vaccine administration (inactivated vaccines)
Intramuscular flu vaccines should be given into the upper arm (or anterolateral thigh in
infants under one year of age).
Individuals with a bleeding disorder should be given vaccine by deep subcutaneous injection
to reduce the risk of bleeding
Intradermal: Intanza® is supplied in a micro-needle injection system that should be held at
right-angles to the skin. The device allows intradermal vaccination to be performed without
the need for additional training
44
•
both inactivated and live flu vaccines can be given at the same time as, or at any
interval before or after, other live and inactivated vaccines
•
different vaccines should be given at separate sites, preferably in a different limb. If
given in the same limb, they should be given at least 2.5cm apart
The national flu immunisation programme 2016/17
Administration of LAIV
• LAIV is different from other flu vaccines – it is a live attenuated nasal
vaccine and must not be injected
• LAIV can be administered at the same time as, or at any interval from
other vaccines including live vaccines
• patient should breathe normally – no need to actively inhale or sniff
• the vaccine is rapidly absorbed so no need to repeat either half of dose if
patient sneezes, blows their nose or their nose drips following
administration
45
The national flu immunisation programme 2016/17
Flu vaccines for patients in clinical risk groups
Age
Which vaccine?
How many doses?
Children aged six
months to less than
two years of age in
clinical risk groups
These children should be offered inactivated trivalent
influenza vaccine
Those who have not received flu
vaccine before should receive a
second dose of vaccine at least four
weeks later.
Children aged two to
less than 18 years of
age in clinical risk
groups
These children should be offered the live intranasal vaccine
unless it is medically contraindicated
Those aged two to less than nine
years who have not received flu
vaccine before should receive a
second dose of vaccine at least four
weeks later
For those children for whom the live vaccine is medically
contraindicated, a suitable inactivated flu vaccine should be
offered.
The quadrivalent inactivated influenza vaccine (Fluarix™
Tetra) is authorised for children from the age of three years
and is preferred because of the additional protection
offered. The quadrivalent vaccine has both lineages of
influenza B and may therefore provide better protection
against the circulating B strain(s) than trivalent inactivated
influenza vaccines.
Over 18 years
46
Children aged two years should be given an inactivated
trivalent vaccine.
Any of the inactivated vaccines (except Intanza®15μg
which is for those age 60 years and over)
The national flu immunisation programme 2016/17
A single dose
Which vaccine and how many doses?
Vaccine type
Authorised age indication Dose
Live attenuated intranasal
vaccine
Children aged two to under 18
years (if no contraindications)
Single application in each nostril of 0.1ml
Children NOT in clinical risk groups only
require one dose of this vaccine.
Children in clinical risk groups aged two to
under nine years who have not received
influenza vaccine before should receive a
second dose of vaccine at least four weeks
later.
47
N.B Follow Green Book not SPC
Single injection of 0.5ml
Inactivated intramuscular
vaccine (number of different
brands)
Children aged six months and
older and adults
(N.B some of the vaccines are
not authorised for young
children)
Children aged six months to under nine
years who have not received influenza
vaccine before should receive a second
dose of vaccine at least four weeks later.
Inactivated intradermal
vaccine - Intanza® 15µg
Adults aged 60 years and older
Single injection of 0.1ml
The national flu immunisation programme 2016/17
Which type of vaccine to offer children under 18 years old
Children in clinical risk groups aged two years to less than nine years who have not
received flu vaccine before should be offered two doses of flu vaccine at least four
weeks apart (LAIV or a suitable inactivated vaccine if LAIV is medically contraindicated).
48 The national childhood flu immunisation programme 2016/17
Porcine gelatine
•
the LAIV contains a highly purified form of gelatine derived from pigs
•
gelatine is used to stabilise live viral vaccines and is commonly used in a range of
pharmaceutical products, including many capsules and some vaccines
•
some faith groups do not accept the use of porcine gelatine in medicinal products
•
there is no other live attenuated vaccine available that does not contain porcine gelatine.
The manufacturer of LAIV (Fluenz Tetra®) tested 40 potential stabilisers – gelatine was
chosen because without it, stability was significantly reduced
•
PHE and Department of Health’s view is that, for universal vaccination of healthy
individuals, there is no suitable alternative to Fluenz Tetra®. The purpose of the childhood
programme is to interrupt transmission and therefore indirectly protect whole population.
This is best achieved by offering LAIV (Fluenz Tetra®)
•
see www.gov.uk/government/news/vaccines-and-gelatine-phe-response for Q&As and
more information on vaccines and gelatine
49 The national childhood flu immunisation programme 2016/17
Storage and ordering
50
The national flu immunisation programme 2016/17
Storage of flu vaccine
Efficacy, safety and quality may be adversely affected if vaccines are not
stored at the temperatures specified in the licence
Flu vaccines must be stored in accordance with manufacturer’s instructions:
• store between +2⁰C and +8⁰C
• do not freeze
• store in original packaging
• protect from light
Check expiry dates regularly:
• the LAIV has an expiry date 18 weeks after manufacture – this is much shorter
than inactivated flu vaccines
• it is important that the expiry date on the nasal spray applicator is checked
before use
In the event of cold chain failure involving LAIV, refer to the document
‘Responding to cold chain failures involving the live attenuated intra-nasal
influenza vaccine (LAIV)’ available on PHE Immunisation gov.uk website
51
The national flu immunisation programme 2016/17
Vaccine ordering
•
all flu vaccines for children (both live and inactivated) are purchased centrally by PHE. In
2016/17 this will be for:
• all children aged 2, 3 and 4yrs, and of school years 1, 2 and 3 age and
• all children in clinical risk groups aged 6 months to 18 years
ie PHE will supply LAIV for those who can receive it and inactivated flu vaccine for those
children for whom LAIV is contraindicated.
• the quadrivalent inactivated flu vaccine (Fluarix™ Tetra®) is authorised for children
aged from three years and is preferred because of the additional protection offered.
• children aged from six months to less than three years should be given Inactivated
Influenza Vaccine (Split Virion) BP®
52
•
flu vaccines for children can be ordered through the ImmForm website as for other
centrally purchased vaccines (www.immform.dh.gov.uk)
•
it is important not order or hold more than two weeks’ worth of LAIV – stockpiling increases
the risk of significant loss if there are cold chain failures
The national childhood flu immunisation programme 2016/17
Supply and administration of flu vaccines
A range of mechanisms can be used for the supply and administration of vaccines,
including:
• patient specific prescription written manually or electronically by a registered
medical practitioner or other authorised prescriber
• Patient Specific Direction (PSD)
• Patient Group Direction (PGD)
PGD templates for the administration of the live and inactivated flu vaccines are
available on the PHE website:
https://www.gov.uk/government/collections/immunisation-patient-group-direction-pgd
NB Local authorisation is required before PHE PGD templates can be used
53
The national flu immunisation programme 2016/17
Contraindications and precautions
54
The national flu immunisation programme 2016/17
Contraindications
There are very few individuals who cannot receive any flu vaccine
Where there is doubt, expert advice should be sought promptly so that the period the
individual is left unvaccinated is minimised
For children aged 2 up to their 18th birthday, where live flu vaccine cannot be
given, it is likely that inactivated vaccine could be given instead
55
The national flu immunisation programme 2016/17
Contraindications to flu vaccines
None of the influenza vaccines should be given to those who have had:
•
confirmed anaphylactic reaction to a previous dose of the vaccine
•
confirmed anaphylactic reaction to any component of the vaccine
The live attenuated flu vaccine should not be given to children who are:
• clinically severely immunodeficient due to conditions or immunosuppressive therapy:
 acute and chronic leukaemias
 lymphoma
 HIV infection not on highly active antiretroviral therapy
 cellular immune deficiencies
 high dose corticosteroids
• receiving salicylate therapy
• known to be pregnant
56
The
The
national
national
fluflu
immunisation
immunisation
programme
programme
2014/15
2016/17
Inactivated influenza vaccine for children
contraindicated to receive LAIV
•
children for whom LAIV is contraindicated should be offered a suitable alternative
inactivated flu vaccine
•
some inactivated flu vaccines have been associated with high rates of febrile convulsions
in children
•
some inactivated flu vaccines contain too much ovalbumin for egg allergic children
•
check SPC for vaccine suitability before administration
Guidance on which vaccines to use for those children who cannot receive LAIV can be
found in the Green Book Influenza chapter
• Fluarix Tetra® is the preferred vaccine for children aged ≥ 3years who cannot receive
Fluenz Tetra®
• children 6m to <3years should be given inactivated influenza vaccine (Split Virion) BP®
57
The national flu immunisation programme 2016/17
Beware of product confusion!
Fluarix® Tetra is an inactivated vaccine licensed from three years of age that
can be given to children who cannot receive the live intranasal flu vaccine, the
65 and overs, the under 65s at risk, pregnant women and healthcare workers
Care must be taken not to confuse the two ‘Tetra’ brands.
One way of remembering which vaccine is which is:
58
•
Fluenz is the nazal flu vaccine
•
Fluarix is the arm injected vaccine
The national flu immunisation programme 2016/17
Precautions to flu vaccines
Acutely unwell:
•
defer until recovered
Heavy nasal congestion:
•
defer live intranasal vaccine until resolved or, if the child is in a risk group,
consider inactivated flu vaccine to provide protection without delay
Use with antiviral agents against flu:
59
•
LAIV should not be administered at the same time or within 48 hours of cessation
of treatment with flu antiviral agents
•
administration of flu antiviral agents within two weeks of administration of LAIV
may adversely affect the effectiveness of the vaccine
The national flu immunisation programme 2016/17
Severe asthma or active wheezing
•
live flu vaccine is not recommended for children and adolescents with
severe asthma or active wheezing eg those who are currently taking or
have been prescribed oral steroids for respiratory disease in the last 14
days
•
children currently taking a high dose inhaled steroid - Budesonide
>800mcg/day or equivalent (eg Fluticasone > 500mcg/day) should only be
given live flu vaccine on the advice of their specialist
As these children are a defined flu risk group, those who cannot receive
LAIV should receive an inactivated flu vaccine
•
60
vaccination with LAIV should be deferred in children with a history of active
wheezing in the past 72 hours or those who have increased use of
bronchodilators in the previous 72 hours. If condition not improved after a
further 72 hours then inactivated flu vaccine should be offered to avoid
delaying protection in this high-risk group
Presentation title - edit in Header and Footer
Egg allergy – adults
61
•
most flu vaccines are prepared from flu viruses grown in embryonated
hens’ eggs – the final vaccine products contains varying amounts of egg
(as ovalbumin)
•
adults with egg allergy can be immunised in any setting using an
inactivated flu vaccine with an ovalbumin content less than 0.12
µg/ml (equivalent to <0.06µg for 0.5ml dose)
•
adults with severe anaphylaxis to egg that has previously required
intensive care should be referred to specialists for immunisation in
hospital
•
there is no ovalbumin-free vaccine available for the 2016/17 flu season
The national flu immunisation programme 2016/17
Egg allergy – children
•
children with an egg allergy can be safely vaccinated with the LAIV in any
setting (including primary care and schools)
•
those with both egg allergy and clinical risk factors* that contraindicate
LAIV (eg immunosuppression) should be offered an inactivated flu vaccine
with a very low ovalbumin content (less than 0.12μg/ml)
•
children with a history of severe anaphylaxis to egg that has previously
required intensive care, should be referred to specialists for immunisation
in hospital
•
LAIV is not otherwise contraindicated in children with egg allergy. Eggallergic children with asthma can receive LAIV if their asthma is wellcontrolled (see previous slide on severe asthma)
*Children in a clinical risk group and aged under nine years who have not been previously
vaccinated against influenza will require a second dose whether given LAIV or inactivated
vaccine
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The national flu immunisation programme 2016/17
Flu vaccines with low or no ovalbumin content
The following vaccines, available for the 2016/17 flu season, are egg-free or have a very low
ovalbumin content (<0.12μg/ml – equivalent to <0.06μg for a 0.5ml dose)
They may be used safely in individuals with egg allergy
Supplier
Name of product
Vaccine type
Age
indication
Ovalbumin content
per dose ( μg/dose)
GSK
Fluarix Tetra
Split virion inactivated virus
From three
years
≤0.1 (≤0.05/0.5ml dose)
MASTA
Inactivated Influenza
Vaccine (Split Virion) BP
Split virion inactivated virus
From six
months
≤0.1 (≤0.05/0.5ml dose)
Sanofi
Pasteur
MSD
Inactivated influenza
vaccine (split virion) BP
Split virion inactivated virus
From six
months
≤0.1 (≤0.05/0.5ml dose)
Sanofi
Pasteur
MSD
Intanza
Split virion inactivated virus
60 years of
age and over
≤0.24(≤0.024/0.1ml dose)
15 micrograms
LAIV (Fluenz Tetra®), which has an upper ovalbumin limit of 1.2μg/ml, has also been shown to be safe for
use in most egg allergic children
A list of all flu vaccines for the 2016/17 season and their ovalbumin content is available in Vaccine Update
June 2016
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Risk of transmission of live vaccine virus
64
•
theoretical potential for transmission of live attenuated virus to
immunocompromised contacts
•
risk is for one to two weeks following vaccination
•
extensive use of the live attenuated influenza vaccine in US – no reported
instances of illness or infections from the vaccine virus among
immunocompromised patients inadvertently exposed to vaccinated children
•
however, where close contact with very severely immunocompromised
patients (eg bone marrow transplant patients requiring isolation) is likely or
unavoidable (eg household members) consider an appropriate inactivated
flu vaccine instead
The national flu immunisation programme 2016/17
Exposure of healthcare workers to live attenuated
influenza vaccine viruses
65
•
theoretically there may be some low level exposure to the vaccine viruses for those
administering LAIV and/or from recently vaccinated patients
•
in the US, where there has been extensive use of LAIV, no reported instances of illness
or infections from the vaccine virus among healthcare workers inadvertently exposed
•
risk of acquiring vaccine viruses from the environment is unknown but probably low
•
the vaccine viruses are cold-adapted and attenuated and therefore unlikely to cause
symptomatic influenza
•
as a precaution, very severely immunosuppressed individuals should not
administer LAIV
•
other healthcare workers who have less severe immunosuppression or are pregnant,
should follow normal clinical practice to avoid inhaling the vaccine and ensure that they
themselves are appropriately vaccinated
The national flu immunisation programme 2016/17
Inadvertent administration of LAIV
66
•
if an immunocompromised individual receives LAIV, the degree of
immunosuppression should be assessed
•
if patient is severely immunocompromised, antiviral prophylaxis should be considered
•
otherwise they should be advised to seek medical advice if they develop flu-like
symptoms in the four days following administration of the vaccine
•
if antivirals are used for prophylaxis or treatment, patient should also be offered
inactivated flu vaccine in order to maximise their protection in the forthcoming flu
season (this can be given straight away)
The national flu immunisation programme 2016/17
Commonly reported adverse reactions
Following inactivated flu vaccine:
•
pain, swelling or redness at the injection site, low grade fever, malaise, shivering,
fatigue, headache, myalgia and arthralgia
•
a small painless nodule (induration) may also form at the injection site
•
these symptoms usually disappear within one to two days without treatment
Following live attenuated flu vaccine:
•
nasal congestion/rhinorrhoea, reduced appetite, weakness and headache
Rarely, after live or inactivated vaccine, immediate reactions such as urticaria, angiooedema, bronchospasm and anaphylaxis can occur
67
The national flu immunisation programme 2016/17
Reporting suspected adverse reactions
All serious suspected reactions following flu
vaccination should be reported to the Medicines
and Healthcare products Regulatory Agency
using the Yellow Card scheme at
http://yellowcard.mhra.gov.uk/
Fluenz Tetra® and Fluarix™ Tetra carry a black
triangle symbol (▼) (as do all vaccines during
the earlier stages of their introduction).
This is to encourage reporting of all suspected
adverse reactions
68
The national flu immunisation programme 2016/17
Record keeping
69
The national flu immunisation programme 2016/17
Recording of flu vaccine given
As a wide variety of influenza vaccines are on the UK market each year, it is especially
important that the following information be recorded:
•
vaccine name, product name, batch number and expiry date
•
dose administered
•
date immunisation given
•
route/site used
•
name and signature of vaccinator
This information should be recorded in:
70
•
patient's GP record (or other patient record, depending on location)
•
personal Child Health Record (the ‘Red Book’) if a child
•
practice computer system
•
Child Health Information System
The national flu immunisation programme 2016/17
Data collection
71
•
flu vaccine uptake data is collected via the web-based ImmForm system
(www.immform.dh.gov.uk) where it is managed and published by PHE
•
over 90% GP practices are able to make automated data returns where the
number of their patients vaccinated is directly extracted from their IT system
and put into ImmForm
•
for data to be accurate and complete, it is critical that vaccines given outside
the surgery, eg in antenatal clinics or pharmacies, are reported to the
patient’s GP
•
uptake data for school years 1, 2 and 3 and pilot areas will be manually
submitted by providers onto ImmForm
•
uptake data for HCWs is manually submitted by trusts and area teams via
ImmForm
•
data is collected and published monthly on all the groups for whom flu
vaccine is indicated at national level and local NHS England team level to
enable performance to be reviewed and time to take action if needed
The national flu immunisation programme 2016/17
Achieving high uptake
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The national flu immunisation programme 2016/17
Achieving high uptake (GP Practice checklist)
In order to obtain high vaccine uptake, it is recommended that GP practices:
1. Identify a named lead individual within the practice who is responsible for the
flu vaccination programme and liaises regularly with all staff involved in the
programme
2. Hold a register that can identify all pregnant women and patients in the under
65 years at risk groups, those aged 65 years and over, and those aged two to
four years
3. Update the patient register throughout the flu season, paying particular
attention to the inclusion of women who become pregnant and patients who
enter at-risk groups during the flu season
4. Submit accurate data on the number of its patients eligible to receive flu
vaccine and the flu vaccinations given to its patients on ImmForm
(www.immform.dh.gov.uk), ideally using the automated function, and submit
data on uptake among healthcare workers in primary care using the ImmForm
data collection tool
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The national flu immunisation programme 2016/17
Achieving high uptake (GP Practice checklist cont’d)
5. Order sufficient flu vaccine taking into account past and planned improved
performance, expected demographic increase, and to ensure that everyone at
risk is offered the flu vaccine. It is recommended that vaccine is ordered from
more than one supplier and from PHE central supplies through the ImmForm
website in respect of children
6. It is a requirement of the enhanced service specification that patients
recommended to receive the flu vaccine are invited to a flu vaccination clinic or
to make an appointment (eg by letter, email, phone call, text)
7. Follow-up patients, especially those in at risk groups, who do not respond or
fail to attend scheduled clinics or appointments
8. Start flu vaccination as soon as practicable after receipt of the vaccine. This will
help ensure the maximum number of patients are vaccinated as early as
possible and protected before flu starts to circulate. Aim to complete
immunisation of all eligible patients before flu starts to circulate and ideally by
end of December
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The national flu immunisation programme 2016/17
Achieving high uptake (GP Practice checklist cont’d )
9. Collaborate with maternity services to offer and provide flu vaccination to pregnant
women and to identify, offer and provide to newly pregnant women as the flu
season progresses
10. The GP practice should offer flu vaccination in clinics and opportunistically
11. The GP practice and/ or CCG should collaborate with other providers such as
community pharmacies and community or health and social care trusts to identify
and offer flu vaccination to residents in care homes, nursing homes and housebound patients and to ensure that mechanisms are in place to update the patient
record when flu vaccinations are given by other providers
The GP practice checklist highlights good practice.
75
•
it is based upon the findings from a study examining the factors associated with
higher vaccine uptake in general practice
•
GP practices are encouraged to review their systems in the light of the checklist
•
most recommendations will apply to other settings where flu vaccine is given
The national flu immunisation programme 2016/17
76
Presentation title - edit in Header and Footer
Key messages
77
•
flu immunisation is one of the most effective interventions we can provide to
reduce harm from flu and pressures on health and social care services during
the winter
•
it is important to increase flu vaccine uptake in clinical risk groups because of
increased risk of death and serious illness if people in these groups catch flu
•
for a number of years, only around half of patients aged six months to under 65
years in clinical risk groups have been vaccinated
•
influenza during pregnancy may be associated with perinatal mortality,
prematurity, smaller neonatal size, lower birth weight and increased risk of
complications for mother
•
vaccination of health and social care workers protects them and reduces risk of
spreading flu to their patients, service users, colleagues and family members
•
by preventing flu infection through vaccination, secondary bacterial infections
such as pneumonia are prevented. This reduces the need for antibiotics and
helps prevent antibiotic resistance
The national flu immunisation programme 2016/17
Resources
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The national flu immunisation programme 2016/17
Administration video
A video for health professionals on
how to administer the LAIV vaccine
has been produced by NHS
Education for Scotland.
It is available to view on the NES
website at:
http://www.nes.scot.nhs.uk/educationand-training/by-theme-initiative/publichealth/healthprotection/immunisation/seasonalflu.aspx
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The national childhood flu immunisation programme 2016/17
Resources
80
•
Flu Plan and Supporting Letter detailing 2016/17 flu programme
Department of Health, Public Health England, NHS England. Published 26 May 2016. Available at:
https://www.gov.uk/government/publications/flu-plan-winter-2016-to-2017
•
Green Book Influenza chapter Available at:
https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
•
Leaflets, posters, Q&As and other resources to support the annual flu programme Available
at: https://www.gov.uk/government/collections/annual-flu-programme
•
Summary of Product Characteristics (SPC) for flu vaccines are available at
http://www.medicines.org.uk/emc/
•
PGD templates for flu vaccines https://www.gov.uk/government/collections/immunisation-patientgroup-direction-pgd
•
Find out more about antibiotic resistance, other ways to reduce its rise and how you can help
through www.antibioticguardian.com
•
Flu immunisation interactive e-learning http://www.e-lfh.org.uk/programmes/flu-immunisation/
The national flu immunisation programme 2016/17
Resources children
81
•
Flu immunisation: toolkit for programme extension to children Available at:
https://www.gov.uk/government/publications/flu-immunisation-toolkit-forprogramme-extension-to-children
•
Increasing flu immunisation uptake among children. Best Practice
Guidance for General Practice. Available at
https://www.gov.uk/government/organisations/public-healthengland/series/annual-flu-programme
•
Leaflets and posters prepared specifically for the childhood flu programme.
Available at: https://www.gov.uk/government/organisations/public-healthengland/series/annual-flu-programme
•
A video for health professionals on how to administer the live vaccine
produced by NHS Education for Scotland is available at
www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/publichealth/health-protection/immunisation/seasonal-flu.aspx
•
Responding to cold chain failures involving the live attenuated intra-nasal
influenza vaccine (LAIV). Public Health England. Available at
https://www.gov.uk/government/publications/live-attenuated-influenza-vaccineresponding-to-cold-chain-failures
The national childhood flu immunisation programme 2016/17
About Public Health England
Public Health England exists to protect and improve the nation's health and wellbeing, and reduce health inequalities. It
does this through world-class science, knowledge and intelligence, advocacy, partnerships and the delivery of specialist
public health services. PHE is an operationally autonomous executive agency of the Department of Health.
Local Health Protection Teams
Public Health England
Wellington House
133-155 Waterloo Road
London SE1 8UG
Tel: 020 7654 8000
www.gov.uk/phe
Twitter: @PHE_uk
Facebook: www.facebook.com/PublicHealthEngland
North East & North Central London
020 3837 7084
North West London
020 3326 1658
South London
0344 326 2052
For enquiries relating to this document, please contact: [email protected]
© Crown copyright 2016
You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open
Government Licence v3.0. To view this licence, visit OGL or email [email protected]. Where we have
identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
Published July 2016
PHE publications gateway number: 2016174
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The national flu immunisation programme 2016/17