Extension of the seasonal flu vaccination
programme to children (2 to 17 years)
Phase 1 - 2013/14
An update for registered healthcare
practitioners in NHSGGC
August/September 2013
Contents
 Why extend the seasonal flu immunisation programme
to all children (2 to17 years of age)?
 Phased roll out details
 Vaccines to be used in children and administration
 Safety and efficacy of the vaccines
 Other operational issues
Influenza (flu) viruses
There are 3 types of influenza (flu) viruses:
A
 Causes epidemics and pandemics; animal reservoir –
wildfowl, also carried by other mammals
B
 May cause epidemics;
 Predominantly found in humans
C

Minor respiratory illness only.
Flu A virus
Genetic material (RNA) in the centre
Two surface antigens:
Haemagglutinin (H)
Neuraminidase (N)
Different types of each: The blue protuberances represent
haemagglutinin and the red spikes
neuraminidase.
Flu virus
Genetic change – what this means
Antigenic drift:
 Small constant mutations of H and N
 Occurs in all types of influenza (flu) viruses.
Flu virus- Antigenic shift
 Only occurs in Influenza A strains
 A major change in one or both surface antigens, characteristic
of Influenza type A viruses
 It is due to genetic recombination when virus particles of more
than one strain infect a cell simultaneously
 It can result in a worldwide pandemic.
Features of flu

Transmitted by large droplets, small-particle aerosols and by hand to
mouth/eye contamination from an infected surface

Incubation period 1-5 days (average 2-3 days) though may be longer
especially in hosts with immune deficiency

Acute viral infection of respiratory tract.
Common symptoms include:

Sudden onset of fever, chills, headache, myalgia & severe fatigue

Dry cough, sore throat and stuffy nose

In young children gastrointestinal symptoms such as vomiting and
diarrhoea may be seen.
Possible Complications of flu
Common:

Bronchitis

Otitis media (children), sinusitis

Secondary bacterial pneumonia.
Less common:
 Meningitis, encephalitis
 Primary influenza pneumonia
 Most serious illness in neonates, pregnant women, older people
and those with underlying disease.
Current Flu Vaccination Strategy in Scotland
 Vaccinate those at risk of complications (over 65s and those with
chronic medical conditions)
 Vaccinate Health Care workers and some carers to protect
themselves and their patients/clients
 Current strategy not adequate due to poor uptake and variable
immune response
 Flu still causes significant ill health and deaths every winter
Proposed extension to flu vaccination programme in
Scotland
 JCVI has recommended that this programme be extended to include
annual vaccination of all children aged 2 to17 years of age;
 A live intra-nasal flu vaccine rather than the current injectable
inactivated flu vaccine should be used;
 This programme should be introduced in a phased way so that it does
not have any negative impacts on the existing immunisation
programmes
 Partial implementation and pilots in some primary schools will take
place in 2013/14 and it is anticipated that in 2014/5 the programme
will roll out to all pre-school (age 2-5 years) and all primary school
children; from 2015/16, the programme will cover all pre-school, all
primary and secondary school pupils;
Why preventing flu is important?
Numbers, rates and relative risks with 95% lower and upper confidence intervals for seasonal
influenza clinical risk factors amongst confirmed influenza related fatalities aged 6 months to 64
years, Scotland, 2010/2011. Provisional and preliminary data from HPS up to 23rd June 2011.
Number of
fatal cases
With
Laboratory
Confirmed
influenza
Any risk factor (6m-64y)
Mortality rate
per 100,000
population
Age
Adjusted
Relative
risk (RR)*
Lower 95%
Confidence
Interval
Upper 95%
Confidenc
e
Interval
31
4.7
17.8
8.5
37.4
No risk factor (6m-64y)
9
0.3
Baseline
Chronic renal disease
2
6.3
23.9
5.2
110.8
Chronic heart disease
9
7.2
27.3
10.8
68.7
Chronic respiratory disease
14
4.6
17.5
7.6
40.5
Chronic liver disease
7
21.9
83.5
31.1
224.1
Diabetes
1
0.7
2.8
0.4
21.8
Immunosuppression
7
14.1
53.6
20
143.9
Chronic neurological
disease incl stroke
6
7.7
29.4
10.5
82.5
Total
40
1.0
Extension of seasonal flu vaccination programme
to children (2 to17 years of age)
Cost effectiveness
Studies commissioned by the JCVI 3 suggest that despite the high cost of
extending the flu vaccination programme to low risk children is:
 Highly likely to be cost-effective;
 Is well below the established cost-effectiveness threshold when
indirect protection to the whole population is taken into account,
particularly over the longer-term;
 Remains cost effective in circumstances where vaccine uptake
by clinical risk groups was substantially increased.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- Recent review of burden of influenza in children




Average influenza season: estimated 0.3% to 9.8% of 0-14 year old
children present to a GP with influenza; 7
Incidence rates can be markedly higher in the younger age groups;
Influenza associated hospitalisation rates; 8, 9, 10,11,12
- 83-1,038/ 100,000 children 0-59 months old (highest in <6 months)
- 16-210/100,000 children 5-17 years
Children with influenza contribute to the burden of influenza in all age
groups because they are more likely to pass on the infection than
adults. 15, 14
(Ruf & Knuf, 2013)6
Extension of the seasonable flu programme:
What is the additional evidence to support the use of
LAIV vaccine?
 Trivalent inactivated vaccine (TIV) shown to be effective in averting
influenza like illness but response variable
 Live attenuated influenza vaccine (LAIV) ~ 50% more effective than
TIV in averting laboratory confirmed influenza
 Meta-analysis of six LAIV studies showed median VE of 78%
(range: 57-93) in children 6 months to 7 years
 One dose of LAIV provides clinically significant protection against
influenza in young children, with a second dose providing additional
protection.
Expected Public health benefits
in Scotland
 (based on 30% uptake)
No flu
vaccination
programme
Current
programme
Extended
programme
Prevented
GP consultation
for flu related
illness
100,000
75,000
42,000
33,000
Hospitalisation
due to flu related
illness
5,000
2,800
1,700
1,100
Deaths due to flu
related illnesses
900
500
300
200
Extension of seasonal flu vaccination
programme to children (2 to 17 years of age)
– types of vaccines
Two main types of vaccine:
 Inactivated - by intramuscular injection;
 Live - by nasal application.
Antibody levels may take 10-14 days to reach protective
levels.
Protection lasts for at least one season.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
• Preferred vaccine to be used: live attenuated cold
adapted vaccine
 Brand name: Fluenz®
 Marketed by AstraZeneca
 Licensed from 24 months to less than 18 years of
age
 Nasal Spray (suspension) in a pre-filled nasal
applicator
 Supplied as pack containing 10 doses
Extension of seasonal flu vaccination programme
to children (2 to under 17 years of age)
Fluenz® composition:
Active ingredient:
A/California/7/2009 (H1N1)pdm09-like virus 107.0±0.5 FFU
A/Texas/50/2012 107.0±0.5 FFU
B/Massachusetts/2/2012-like virus 107.0±0.5 FFU.
Excipients:
Sucrose
Dibasic potassium phosphate
Monobasic potassium phosphate
Gelatin (porcine type A)
Arginine hydrochloride
Monosodium glutamate monohydrate
Water for injection.
Residues:
Egg proteins (e.g. ovalbumin)
Gentamicin.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
Fluenz® presentation:
 Pre-filled nasal applicator
 Nasal spray (suspension)
 Each applicator contains 0.2ml.
 Has an expiry date 18 weeks
 Store between 2 – 8 degree centigrade
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
Fluenz® dosage and schedule
 A single dose is 0.2ml (administered as 0.1ml per nostril)
 A single dose for all children not in clinical at risk group
• Children aged less than nine years who are in clinical at risk
groups who have not received influenza vaccine before should
receive two doses of Fluenz® with the second dose at least four
weeks after the first.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
 Fluenz® is different from other influenza vaccine, it is a live
nasal vaccine and must not be injected

Fluenz® can be administered at the same time as other vaccines
including live vaccines

Patient should breathe normally - no need to actively inhale or sniff

No need to repeat either half of dose if patient sneezes, blows their
nose or their nose drips following administration.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
Fluenz® Applicator
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- Administration of Fluenz®
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- Administration of Fluenz®
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- Administration of Fluenz®
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- the use of Fluenz®
Infection control issues:
 There are no specific infection control precautions
required when administering Fluenz®
 Routine hand hygiene procedures should be
performed before and after each child contact.
Disposal of clinical waste:
 Empty Fluenz® vaccines should be disposed of as
clinical waste.
Extension of seasonal flu vaccination programme to
children ( 2 to 17 years of age)
- use of Fluenz®
Contraindications
 Age under 2 years
 Age 18 years or above
 Confirmed anaphylactic reaction to a previous dose of influenza
vaccine
 Confirmed anaphylactic reaction to any component of the vaccine
 Confirmed allergy egg proteins.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- use of Fluenz®
Contraindications (cont’d)





Severe immunosuppression due to conditions or immunosuppressive
therapy:
 Acute and chronic leukaemias
 Lymphoma
 HIV positive patient not on highly active antiretroviral therapy
 Cellular immune deficiencies
 High dose steroids.
Individuals receiving salicylate therapy
Individuals with severe asthma (BTS/SIGN step 4 or above)
Active wheezing at the time of vaccination
Known to be pregnant.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- Administration of Fluenz®
Precautions

Acute severe febrile illness:
o
defer until recovered.

Heavy nasal congestion;
o
defer until resolved or consider inactivated influenza vaccine.
Please note: Minor illnesses without fever or systemic upset are
not valid reasons to postpone vaccination.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- Administration of Fluenz®
Precautions Cont’d:
 Fluenz® should not be administered at the same time
if also taking antiviral agent
 Fluenz® should not be administered within 48 hours
of cessation of treatment with flu antiviral agents
 Administration of flu antiviral agents within two weeks
of administration of Fluenz® may adversely affect the
effectiveness of the vaccine.
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- Administration of Fluenz®
Risk of transmission
 Potential for transmission of live attenuated virus to severely
immunocompromised contacts (e.g. bone marrow transplant
patients requiring isolation)
 Risk is for one to two weeks following vaccination
 Where close contact is likely or unavoidable (e.g. household
members) consider inactivated flu vaccine.
Extension of seasonal flu vaccination programme to children
(2 to 17 years of age): Inactivated vaccine
Use of Inactivated (injectable) Flu Vaccine : In those
where Fluenz® is contraindicated
• Severe asthma (BTS/SIGN step 4 or above and under
specialist care)
• severely Immunocompromised
• Severe egg allergy with anaphylactic reaction: use
egg free vaccine (optaflu but not licensed for those age
under 18 years) or refer to hospital specialist clinic
• Non severe confirmed egg allergy- use low ovalbumin
content flu vaccine
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- use of inactivated flu vaccine
Doses:
 Age 9 years and over- one dose
 Age less than 9 years require 2 doses 4 weeks apart
if no previous flu vaccine received
Age restrictions:
 Some flu vaccines (inactivated) are restricted to use
in particular age groups, so please check SPC and
use brand appropriate for age.
Call/Recall and eligibility
• Primary care to call all those aged 2 and 3 years
on 1st September 2013 in year 1
• Dates of birth between 02.09.2009 and
01.09.2011
• Like other flu vaccination, call/recall will be
practice responsibility;
• In year 1, all 2 and 3 year olds to get a central
letter during 3rd and 4th weeks of September
advising them to contact own practice and find
out arrangements for flu vaccination
Immunisation of school aged children
• All children in selected primary schools will
be offered the vaccine at school
• If currently attends GP practice because in
the at risk groups, can continue as before
but can also have it at school
• School will only offer one dose and a very
small number of at risk children may
approach practices for a second dose
Vaccine Supply arrangements
• Limited stock in year 1 starting in Oct 2013
• Practices will receive a maximum of 75%
of targeted cohorts
• Supply will be staggered during the winter
months
• Liaise closely with the PDC before
arranging clinics
• Vaccine can be supplied on a weekly
basis
Extension of seasonal flu vaccination programme
to children (2 to 17 years of age)
- 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://mhra.gov.uk/yellowcard;

See chapter 8 of Green Book for details.
Key message - Extension of the seasonal flu
programme to children (2 to 17 years of age)
 In 2012 the Joint Committee on Vaccination and Immunisation
(JCVI) recommended that the seasonal influenza programme
should be extended to all children aged 2 to under 17 years of
age, the phased introduction of this will begin in 2013
 From 1st October 2013 the seasonal flu vaccination programme
will be extended to all two and three year old children, with a
pilot to include some primary school aged children this season
 From 1st October 2015, all children aged 2 to under 17 years will
be targeted
 It is expected that this extension to the flu vaccination
programme will reduce the impact of seasonal flu on children
and reduce transmission of flu within the community
Extension of the seasonal flu programme to
children (2 to 17 years of age)
Resources




Green Book available at: http://www.dh.gov.uk/greenbook
Patient Group Directions
Policy for the Storage and Handling of Vaccines:
NES website: for full slide sets and references
Acknowledgement



Some slides adapted from slide set from NES/HPS
Colleagues at PHPU
All those taking part in the campaign