Kuwait flu vaccine booklet for workshop

Flu Season 2017 / 2018
Ministry of Health
State of Kuwait
By
Dr. Ashraf El-Adawy
Consultant Chest Physician
Chest Diseases Expert – WHO
With the Guidance & Supervision of
Dr. Majda Alqattan the Assistant
Undersecretary of Public Health
Kuwait Booklet for
Inactivated Influenza Vaccine
for the 3rd Annual Kuwait National Workshop
of Clinical Management of Influenza Cases

2017 / 2018 Kuwait Booklet for Influenza Inactivated Vaccine
2 Ministry of Health - State of Kuwait
For
The 3rd Annual Kuwait National Workshop
for Clinical Management of Influenza Cases (2017)
Kuwait Booklet for
Inactivated Influenza Vaccine
With the Guidance & Supervision of Dr. Majda Alqattan
the Assistant Undersecretary of Public Health
By: Dr. Ashraf El-Adawy
Consultant Chest Physician
Chest Diseases Expert for WHO
Reviewed & revised by special team from Public Health Department
Copyright Protected © 2017
This booklet is written by WHO experts and was reviewed
and edited by the Public Health Department at Kuwait
Ministry of Health, all rights are reserved. This booklet or
any portion thereof may not be reproduced or used in any
manner whatsoever without the clear expressed written
permission of the publisher except for the use of brief
quotations in review.
Publisher: MOH-Kuwait
Second Edition, October 2017
ISBN: in process

Content
Introduction........................................................................................................5
Antigenic change of influenza viruses.................................................................6
"Antigenic drift" - Continual, Small Changes ....................................................... 7
" Antigenic shift".................................................................................................8
1. What is flu? ..............................................................................................8
2. Is Flu Serious............................................................................................9
3. Who can get influenza?.......................................................................... 10
4. When is influenza activity highest? ........................................................ 10
5. What is the best way to prevent influenza? ............................................ 10
6. Why do I need a flu vaccine every year?.................................................. 11
7. What is the recommended composition of seasonal influenza vaccines? 11
8. How are the vaccines made? .................................................................. 12
9. When should I get Seasonal Influenza Vaccine? ......................... 13
10. How do seasonal influenza vaccines work?............................................. 14
11. What does vaccine “match” and “mismatch” mean? .............................. 14
12. Can the vaccine provide protection even if the vaccine is not a "good"
match?................................................................................................... 15
13. How much protection does the seasonal influenza vaccine provide? ...... 15
14. Can people still get influenza if they have had the influenza vaccine?..... 16
15. WHO should get vaccinated? ..................................................................17
16. Should pregnant women receive the trivalent inactivated influenza
vaccine?................................................................................................. 19

17. Is trivalent inactivated influenza vaccine safe for breastfeeding mothers?
20
18. How does trivalent inactivated influenza vaccine given & What is the
dosage and frequency of administration?...............................................20
19. How should influenza vaccines be stored?..............................................24
20. Can inactivated seasonal influenza vaccine be administered
simultaneously with other vaccines? ......................................................24
21. Can the inactivated vaccine cause influenza? ......................................... 25
22. What are the side effects of the flu shot? ............................................... 25
23. Who should NOT be given the trivalent inactivated influenza vaccine? .. 27
24. What can you tell me about the preservative thimerosal that is in some
injectable influenza vaccines and the claim that it might be associated
with the development of autism?...........................................................29
25. Influenza vaccine Products that are licensed for use in Kuwait ..........Error!
Bookmark not defined.
Multiple choice questions ................................................................................. 31
References.........................................................................................................37
Be Wise and Immunize...................................................................................... 39
Acknowledgement............................................................................................40

Introduction
▪ The influenza virus is an enveloped RNA orthomyxovirus, that is
classified antigenically as type A, B and C ,on the basis of antigenic
differences between their matrix and nucleoproteins (M and NP) .
▪ The A and B viruses contain two major envelope
glycoproteins,haemagglutinin (HA) and neuraminidase (NA) .
▪ Haemagglutinin (HA) is responsible for infectious entry of the virus into
cells, it is also the virus most important surface antigen, against which
virus- neutralizing antibodies are directed.
▪ Neuraminidase (NA) cleaves the sialic acid receptor, thus releasing
progeny virus from the infected cell surface, it is the target for the
antiviral drugs Zanamivir and Oseltamivir (Neuraminidase inhibitors),
which are sialic acid analogues and inhibit release of progeny virus from
infected cells.
▪ Type A influenza viruses are further classified into subtypes according to
the combinations of two kinds of virus surface antigens mainly: 16
different Haemagglutinin (HA) subtypes and 9 different Neuraminidase
(NA) subtypes.
▪ Many different combinations of HA and NA proteins are possible, all of
which have been found in wild birds, which is the natural reservoir of
influenza A viruses.
▪ Only some influenza A subtypes (i.e., H1N1 and H3N2) are currently
circulating among humans as seasonal Influenza strains.
▪ Type B influenza virus is not categorized into subtypes, but lineages.
Currently circulating influenza B viruses belong to one of two lineages:
B/Yamagata and B/Victoria, and these can be further broken down into
different strains.

▪ Influenza A virus infects humans and other animals e.g Avian species
and pigs, in humans itcauses moderate to severe illness and affects all
age groups.
▪ In humans, Influenza A viruses are responsible for all pandemics and
most epidemic outbreaks.
▪ Influenza B viruses affects only humans, generally causes milder disease
than type A and primarily affects children.
▪ Influenza A and influenza B are responsible for most clinical illness, can
cause seasonal influenza epidemics in humans.
▪ Influenza C is rarely reported as a cause of human illness, is of little
clinical importance, probably because most cases are subclinical.
▪ Influenza caused by type C virus is not thought to cause seasonal
epidemics, that is why only influenza A and B viruses are included in
seasonal influenza vaccines.
▪ There are many different strains of influenza B viruses and of influenza
A subtypes and by time new strains of influenza viruses appear and
replace older strains, this process occurs through a type of change is
called “Antigenic Drift”.
Antigenic change of influenza viruses
▪ Influenza viruses can change in two different ways, both antigenic drift
and antigenic shift are terms used to describe ways in which the flu
viruses change over time, A drift is a minor change while a shift is a
major one.

▪ Influenza viruses are constantly changing, the antigenic evolution of
influenza viruses forms the primary basis for the occurrence of seasonal
influenza epidemics and occasional pandemics.
"Antigenic drift" - Continual, Small Changes
o Occurs through relatively minor genetic changes to the HA and NA
genes of both influenza A and B (point mutation) that happen
continually over time, and as they lack a poof-reading mechanism, the
small errors that occur when the virus copies itself are left uncorrected.
o When a flu virus mutates or changes slightly, new strains of influenza
viruses appear and replace older strains.
o As it looks different to our immune system, when a new strain of human
influenza virus emerges, antibody protection that may have developed
after infection or vaccination with an older strain may not provide
protection against the new strain. Thus, the influenza vaccine is updated
on a yearly basis to keep up with the changes in influenza viruses.
o Seasonal influenza viruses evolve continuously (antigenic drift), which
means that people can get infected multiple times throughout their
lives. Therefore the components of seasonal influenza vaccines are
reviewed frequently (currently biannually) and updated periodically to
ensure continued effectiveness of the vaccines.
o In most years, one or two of the three virus strains in the influenza
vaccine are updated to keep up with the changes in the circulating flu
viruses, this usually requires seasonal influenza vaccines to be
reformulated annually.
o Antigenic drift may result in an epidemic, since the protection that
remains from past exposures to similar viruses is incomplete.
o Scientists try to predict which changes are likely to occur to currently
circulating flu viruses, they create a vaccine designed to fight the
predicted virus.
o Sometimes the prediction is accurate, and the flu vaccine is effective,

Other times the prediction misses the mark, and the vaccine won’t
prevent disease.
" Antigenic shift"
o An abrupt, major change in the influenza A viruses, resulting in a new
influenza virus subtype that can infect humans and has a
hemagglutinin protein or hemagglutinin and neuraminidase protein
combination that has not been seen in humans before & to which
general populations are immunologically naïve.
o New subtypes of influenza A virus can emerge among humans through
direct transmission of an animal influenza virus to humans “Adaptive
mutation” or through “Re-assortment ” or genetic exchange of genes
derived from an animal influenza virus (e.g. avian viruses) and a human
influenza virus during co-infection of a human or pig (serving as a mixing
vessel).
o Antigenic shift results in a new influenza A subtype, if it is introduced
into the human population, if most people have little or no protection
against the new virus, and if the virus can spread easily from person to
person, a pandemic (worldwide spread) may occur.
o Influenza viruses are changing by antigenic drift all the time, but
antigenic shift happens only occasionally.
o Influenza type A viruses undergo both kinds of changes, influenza type
B viruses change only by the more gradual process of antigenic drift.
o influenza B viruses do not cause pandemics, this property may be a
consequence of the limited host range of the virus – humans only –
which limits the generation of new strains by re-assortment.
1. What is flu?
▪ Seasonal influenza, or ‘the flu’ as it is often called, is an acute viral
infection caused by an influenza virus, mainly affects the respiratory
system.

▪ The disease is characterized by the sudden onset of fever, cough
(usually dry), headache, myalgia and extreme fatigue, other common
symptoms include a sore throat and stuffy nose.
▪ For otherwise healthy individuals, influenza is an unpleasant but usually
self-limiting disease with recovery usually within two to seven days
without requiring medical attention.
▪ The illness may be complicated by (and may present as) bronchitis,
secondary bacterial pneumonia or, in children, otitis media.
▪ Influenza can be complicated more unusually by meningitis, encephalitis
or meningoencephalitis.
2. Is Flu Serious
▪ Seasonal influenza is a serious public health problem, it has been
estimated that in developed countries, annual influenza epidemics
infect about 10–20% of the population each season.
▪ Worldwide, annual influenza epidemics are estimated to result in ~1
billion cases of flu, about 3–5 million cases of severe illness and
300,000–500,000 deaths annually.
▪ Seasonal influenza epidemics can cause febrile illnesses that range in
severity from mild to debilitating and can lead in some instances to
hospitalization and even cause death, mainly among high-risk groups.
Influenza Complications
▪ Pneumonia
▪ Secondary bacterial
▪ Primary influenza viral
▪ Reye syndrome
▪ Myocarditis
▪ Death is reported in less than 1 per 1,000 cases

▪ The most frequent complication of influenza is pneumonia, most
commonly secondary bacterial pneumonia (e.g. Streptococcus
pneumoniae, Haemophilus influenzae, or Staphylococcus aureus).
▪ Primary influenza viral pneumonia is an uncommon complication with a
high fatality rate.
3. Who can get influenza?
▪ Seasonal influenza viruses circulate worldwide and can affect anybody in any
age group
▪ The highest risk of complications from influenza occurs especially, in the
very young children, the elderly, those with pre-existing medical conditions
and pregnant women but even healthy people can get severe influenza.
▪ Anyone, including healthy people, can get the flu, and people of any age can
develop serious problems related to flu.
4. When is influenza activity highest?
▪ Although influenza epidemics occur yearly, the timing, severity, and length
of the season vary from year to year.
▪ In the Northern Hemisphere, the season is generally from October to May,
with peak activity in January or February, whereas in the Southern
Hemisphere, it is generally from May to October, with peak activity in July or
August.
5. What is the best way to prevent influenza?
▪ Influenza vaccination is the most effective way to prevent influenza
infection and/or severe outcomes from the illness, rather than antiviral
chemoprophylaxis.

▪ The protection of influenza
vaccine depends on inducing
humoral immunity, namely
neutralizing antibodies against
viral capsular antigens, which
boost the immune system
against the serotypes included
in the vaccine.
▪ Safe and effective vaccines are
available and have been used
for more than 60 years.
6. Why do I need a flu vaccine
every year?
Every flu season is different; A flu vaccine is needed every season for two
reasons:
1) First, the body’s immune response from vaccination declines over time,
so an annual vaccine is needed for optimal protection , Even if the
strains have not changed, getting influenza vaccine every year is
necessary to maximize protection.
2) Second, because flu viruses are constantly changing (Antigenic drift),
which may occur in one or more influenza virus strains. The seasonal
influenza vaccine must be re-made (updated) each year to protect
against the most recent and most commonly circulating viruses.
7. What is the recommended composition of seasonal influenza
vaccines?
▪ Influenza vaccines are manufactured in two forms: Inactivated influenza
vaccines (IIVs) and live-attenuated virus vaccines (LAIVs).
WHO Statement: Influenza (flu) is
a contagious respiratory disease
that can lead to serious
complications, hospitalization, or
even death. Anyone can get the
flu, including people who are
otherwise healthy and vaccination
is the single best way to prevent
influenza and its complications.

▪ As the LAIV is not yet
available in the
Middle east,
influenza vaccination
guidelines will focus
on TIIV (mainly TIV).
▪ Traditional seasonal
flu vaccines (called
"trivalent" vaccines)
protects against the
influenza viruses that
research indicates
will be most common
during the upcoming
season & are made to
protect against three strains, an influenza A (H1N1) , an influenza A
(H3N2) , and an influenza B virus.
▪ Because the trivalent vaccine contains an influenza B strain from a
single lineage, mismatches between the vaccine and the circulating B
strain occur more frequently.
▪ The use of quadrivalent influenza vaccines containing a B strain from
each lineage is expected to improve the matching of the vaccine in the
future.
▪ Recently, from 2015 in USA & Australia, a newer quadrivalent influenza
vaccines (QIV) contain the same strains as trivalent vaccine (TIV) plus an
additional second B strain has been introduced.
8. How are the vaccines made?
▪ Each year, before influenza season starts, one or more virus strains in
the vaccine might be changed and based on the global surveillance data
WHO Recommended composition of
influenza vaccines for use in 2017-2018
Northern hemisphere. Trivalent
inactivated seasonal influenza vaccines
(TIV) include 2 influenza (A) strains and 1
influenza (B) strain most likely to
circulate incoming season.
 an A/Michigan/45/2015 (H1N1) pdm09;
 an A/Hong Kong/4801/2014 (H3N2;
 and B/Brisbane/60/2008-like virus.

for influenza viruses, The World Health Organization recommends the
strains that they believe will, be circulating in the upcoming influenza
season.
▪ To ensure optimal vaccine efficacy against prevailing strains in both the
northern and southern hemispheres, the antigenic composition of the
vaccines is revised twice annually and adjusted to the antigenic
characteristics of circulating influenza viruses.
▪ The recommendations are based on information collected from more
than 100 national influenza centers in over 100 countries that conduct
year-round influenza surveillance.
▪ In February, The World Health Organization makes recommendations
concerning the virus strains to be included in vaccine production for the
forthcoming winter in the Northern Hemisphere.
▪ It takes about 6 months for vaccine manufacturers to grow the viruses in
chicken eggs.
▪ Flu vaccine is produced by private manufacturers, and the timing of
availability depends on when production is completed, shipments began
in August and will continue throughout September and October until all
vaccine is distributed.
▪ A second recommendation is made in September which relates to
vaccines to be used for the winter in the Southern Hemisphere
9. When should I get Seasonal Influenza Vaccine?
▪ People get vaccinated against influenza as soon as vaccine becomes
available in their community, if possible by October.

▪ In general vaccination before December is best since this timing ensures that
protective antibodies are in place before flu activity is typically at its highest.
However, flu season can last as late as May so getting vaccinated later
throughout the flu season, even in January or later, could still provide
protective benefit.
10. How do seasonal influenza vaccines work?
▪ The standard flu vaccine (or, the "flu shot") is made from flu viruses that
have been grown on fertilized chicken eggs.
▪ The viruses are killed during manufacturing, a process known as
“inactivation” These inactivated viruses are a source of proteins or antigens
that trigger a protective antibody response.
▪ The vaccine is generally effective against the influenza virus within two
weeks of administration, Antibodies against flu viruses may last for six
months or longer, and sometimes even up to one year.
▪ The vaccine is only effective against the strains of the virus that match the
vaccine
11. What does vaccine “match” and “mismatch” mean?
▪ Influenza viruses are constantly changing, including during the time
between vaccine virus selection and the influenza season or they can even
change within the course of one flu season.
▪ If these changes lead to antigenic differences between the circulating
seasonal influenza viruses and those viruses that are included in the seasonal
influenza vaccine, then the vaccine and circulating viruses may not be closely
related “vaccine mismatch”.

▪ The degree of similarity or difference between the circulating viruses and the
viruses in the vaccines is often referred to as “vaccine match” or “vaccine
mismatch”.
12. Can the vaccine provide protection even if the vaccine is not a
"good" match?
▪ It's not possible to predict with certainty which flu viruses will predominate
during a given season, there is always the possibility of a less than optimal
match between circulating viruses and the viruses in the vaccine.
▪ It’s important to remember that even when the viruses are not closely
matched, the vaccine can still protect many people and prevent flu-related
complications. Such protection is possible because antibodies made in
response to the vaccine can provide some protection (called cross-
protection) against different, but related strains of influenza viruses.
▪ In addition, even when there is a less than optimal match or lower
effectiveness against one virus, it's important to remember that the flu
vaccine is designed to protect against three flu viruses.
▪ For these reasons, even during seasons when there is a less than optimal
match, it is recommended to give annual flu vaccination (or re-vaccination, if
the vaccine strains are identical) , This is particularly important for people at
high risk for serious flu complications, and their close contacts.
13. How much protection does the seasonal influenza vaccine
provide?
▪ The ability of flu vaccine to protect a person (vaccine effectiveness)
depends on various factors, including the age and health status of the
person being vaccinated, and also the similarity or “match” between the

viruses used to make the vaccine and those circulating in the
community.
▪ During seasons when most circulating influenza viruses are similar to
the viruses in the influenza vaccine, the vaccine can reduce the risk of
illness caused by influenza virus infection by about 50-60% among the
overall population.
▪ The vaccine effectiveness may be lower among persons with chronic
medical conditions and among the elderly, as compared to healthy
young adults and children.
▪ It is important to understand that although the vaccine is not as
effective in preventing influenza disease among the elderly, it is
effective in preventing complications and death.
14. Can people still get influenza if they have had the influenza
vaccine?
▪ Protection is never 100%, and some people can still get the flu after
being vaccinated. It is possible to get influenza-like illness even if you
have been vaccinated because of the following reasons:
1) Since it takes about two weeks to build protective antibodies after
receiving the vaccine, it is possible for someone to become infected
in that time period or shortly before getting vaccinated. This can
result in someone erroneously believing they developed the disease
from the vaccination.
2) You may be exposed to a virus not included in the vaccine and
develop illness.
3) Respiratory pathogens that are not related to influenza viruses can
cause “flu-like” symptoms (such as rhinovirus). The influenza
vaccine does not protect you against these pathogens.

4) Unfortunately, some people can remain unprotected from flu
despite getting the vaccine, this is more likely to occur among
people that have weakened immune systems, However, even
among people with weakened immune systems, the flu vaccine can
still help prevent influenza complications.
15. WHO should get vaccinated?
WHO recommends annual vaccination against seasonal influenza for:
a) Highest priority group.:
Pregnant women at any stage of pregnancy(first, second or
third trimesters).
b) Four other priority groups (in no order of priority) are:
1. Health-care workers
2. Children aged 6 months to 5 years
3. Elderly (≥65 years of age)
4. Individuals with specific chronic medical condition as
follows:
Medical conditions with an increased risk of influenza
disease complications and eligible for vaccination
Cardiac diseases
▪ Coronary artery disease
▪ Congestive heart failure
▪ Cyanotic congenital heart disease
Chronic pulmonary
disorders
▪ Bronchial 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
▪ Cystic fibrosis
▪ Bronchiectasis
▪ Interstitial lung fibrosis
▪ Pneumoconiosis
▪ Bronchopulmonary dysplasia (BPD)

Medical conditions with an increased risk of influenza
disease complications and eligible for vaccination
Chronic neurological
conditions
▪ Hereditary and degenerative CNS diseases (including
multiple sclerosis)
▪ Stroke, transient ischemic attack (TIA).
▪ Conditions in which respiratory function may be
compromised due to neurological disease (e.g. polio
syndrome sufferers).
▪ Cerebral palsy
▪ learning disabilities
▪ Seizure disorders
▪ Spinal cord injuries
▪ Neuromuscular disorders
Immunocompromising
conditions
▪ Immunocompromised due to disease or treatment (e.g.
malignancy, transplantation and /or chronic steroid use,
immunosuppressive drugs)
▪ Asplenia or splenic dysfunction
▪ HIV infection at all stages
▪ Multiple myeloma
Diabetes & metabolic
disorders
▪ Type 1 diabetes, type 2 diabetes requiring insulin or oral
hypoglycemic drugs, diet controlled diabetes.
Hematological
disorders
▪ Haemoglobinopathies
Chronic Renal disease
▪ Chronic kidney disease at stage 3, 4 or 5, chronic kidney
failure
▪ Nephrotic syndrome
▪ kidney transplantation.
Chronic liver disease
▪ Defined as histological evidence of fibrosis or cirrhosis,
or clinical evidence of chronic liver cell failure.
▪ Chronic hepatitis
▪ Biliary atresia
Morbid Obesity ▪ Defined as body mass index (BMI) ≥40 kg/m2

16. Should pregnant women receive the trivalent inactivated
influenza vaccine?
▪ When compared with non-pregnant women, pregnant women infected with
influenza viruses are prone to severe illnesses with higher morbidity and
mortality. They also have a greater risk for serious problems for their infants
and during delivery.
▪ Pregnant women, both healthy pregnant women and those with chronic
health conditions, are at increased risk of influenza related complications
and hospitalization. (The risk increases with length of gestation i.e. it is
higher in the third than in the second trimester)
CDCWHO state that:
 Health-care workers (HCWs) are an
important priority group for influenza
vaccination, not only to protect the
individual and maintain health-care
services during influenza epidemics,
but also to reduce spread of influenza
to vulnerable patient group.
 Vaccination of HCWs should be
considered part of a broader infection
control policy for health-care facilities.
CDCWHO: Health care workers
(HCWs) should use every opportunity
to give Inactivated seasonal influenza
vaccine to individuals at risk who have
not been immunized during the
current season, even after influenza
activity has been documented in the
community
CDCWHO: In the absence of
contraindications, refusal of HCWs
who have direct patient contact to be
immunized annually against influenza
implies failure in their duty of care to
patients.

▪ Infants born during influenza season to vaccinated women are less likely to
be premature, small for gestational age, and low birth weight, there is no
evidence that influenza vaccine causes any harm to mother or baby when
administered to a pregnant woman.
▪ Trivalent inactivated Influenza vaccine is considered safe for use in pregnant
women at any stage of pregnancy, WHO considers pregnant women as a
high priority group and recommends immunization.
▪ Furthermore, Children aged <6 months are not eligible to receive currently
licensed influenza vaccines and should be protected against influenza
through vaccination of their mothers during pregnancy (via passive transfer
of antibodies across the placenta and through breast milk).
▪ Pregnant women should receive inactivated vaccine (flu shot) but should
NOT receive the live attenuated vaccine (nasal spray).
17. Is trivalent inactivated influenza vaccine safe for breastfeeding
mothers?
▪ Yes. The trivalent inactivated
vaccine (TIV) is safe for
breastfeeding mothers and
their babies (via breast milk),
Women who are
breastfeeding may receive
either inactivated vaccine or
live attenuated vaccine (nasal
spray).
18. How does trivalent inactivated influenza vaccine given & What is
the dosage and frequency of administration?
According to CDCWHO
Pregnancy and breast-feeding
are NOT CONSIDERED
contraindications to Inactivated
seasonal influenza vaccination.

Dose:
▪ All trivalent inactivated seasonal influenza vaccine TIV preparations
contain 15 µg of HA per vaccine virus strain (45 µg total for all 3 strains).
Children aged 36 months through 18 years, and adults receiving IM
preparations of TIV, should receive a 0.5 mL dose (containing 15 µg of
HA per vaccine virus strain).
▪ Therefore, a full dose (0.5 mL) of TIV should be used for all age groups,
including children 6 to 35 months of age who are receiving influenza
immunization.
▪ Contrary to dosing information in product monographs, the Canadian
National Advisory Committee on Immunization (NACI) is no longer
recommending 0.25 mL doses for children 6 to 35 months of age.
▪ This recommendation is based on evidence showing improved antibody
response without increase in reactogenicity in children receiving the 0.5
ml dose, so children receiving 0.25 mL doses will be considered
inadequately immunized.
How to decide on the number of doses for children
Has the child received 2 total doses of
trivalent influenza vaccine before July 2017?
(Doses need not have been received during
the same season or consecutive seasons)
2 doses of influenza
vaccine (4 weeks apart)
1 dose of influenza
vaccine
No or don’t KnowYes

Site of administration and needle size:
▪ TIV should be administered intramuscularly (IM).
▪ The needle gauge for intramuscular injection is 22-25 gauge. A decision
on needle length and site of injection must be made for each person on
the basis of the size of the muscle, the thickness of adipose tissue at the
injection site, the volume of the material to be administered, injection
technique, and the depth below the muscle surface into which the
material is to be injected (Figure below).
▪ Aspiration before injection of vaccines (i.e., pulling back on the syringe
plunger after needle insertion but before injection) is not necessary
because no large blood vessels are present at the recommended
injection sites, and a process that includes aspiration might be more
painful for infants.
▪ The anterolateral thigh is the recommended site in infants 6 -12 months
of age (see table below for needle size).
▪ The deltoid muscle is the recommended site in adults and children over
12 months of age (nursing assessment is required to determine if the
deltoid muscle mass is of sufficient size).

Table of Needle length & injection Site by age and weight
Age group Needle length Injection site
Children (birth-18 years)
Neonates(a)
5/8 inch(b)
Anterolateral thigh
Infants, 1-12 months 1 inch Anterolateral thigh
Toddlers, 1-2 years
1-1.25 inch Anterolateral thigh(c)
5/8(b)
-1 inch Deltoid muscle of arm
Children, 3-10 years
5/8(b)
-1 inch Deltoid muscle of arm(c)
1-1.25 inches Anterolateral thigh
Children, 11-18 years
5/8(b)
-1 inch Deltoid muscle of arm(c)
1-1.5 inches Anterolateral thigh
Adults (≥19 years)
Men and women, <60 kg 1 inch (d)
Deltoid muscle of arm
Men and women, 60-70 kg 1 inch Deltoid muscle of arm
Men, 70-118 kg
1-1.5 inches Deltoid muscle of arm
Women, 70-90 kg
Men, >118 kg
1.5 inches Deltoid muscle of arm
Women, >90 kg
(a) First 28 days of life.
(b) If skin is stretched tightly and subcutaneous tissues are not bunched.
(c) Preferred site.
(d) Some experts recommend a 5/8-inch needle for men and women who weigh <60 kg.
Frequency of administration:
▪ Children 6 months to <9 years of age receiving seasonal influenza
vaccine for the first time should be given two doses, with a minimum
interval of four weeks between doses, they are then recommended to
receive one dose per year thereafter.
▪ Adults and Children who have been previously immunized with seasonal
influenza vaccine are to receive one dose of influenza vaccine each year.

Age group Dosage
Number of
doses
Route
6-35 months 0.5 ml 1* or 2* Anterolateral thigh
3-8 years 0.5 ml 1* or 2* Deltoid
< 9 years 0.5 ml 1 Deltoid
*Children less than 9 years of age require 2 doses given at a minimum of 4 weeks
apart if they have never received seasonal influenza vaccine in a previous year.
19. How should influenza vaccines be stored?
▪ Inactivated influenza vaccines for intramuscular administration are
supplied as suspensions in pre-filled syringes. They should be shaken
well before they are administered.
▪ All influenza vaccines must be maintained at refrigerator temperature
(2°C to 8°C) at all times during handling, storage and transport.
▪ Vaccine should not be stored in the refrigerator door or crisper
compartment and frequent opening of the refrigerator door should be
avoided.
▪ The vaccine should not be frozen.
▪ Vaccine should be transported in an insulated container with ice packs.
▪ Vaccine should be stored in original packaging in order to be protected
from light.
20. Can inactivated seasonal influenza vaccine be administered
simultaneously with other vaccines?
▪ Injectable inactivated seasonal influenza vaccine does not interfere with
the effectiveness of other vaccines, it can be given at the same time or
at any time before or after administration of other inactivated vaccines
(e.g. Hepatitis B vaccine) or live attenuated vaccines (e.g. Measles,
mumps and rubella vaccine).
▪ For concomitant parenteral injections, different injection sites,
preferably in different limbs and separate needles and syringes should
be used.

21. Can the inactivated vaccine cause influenza?
▪ No. Neither the injectable (inactivated) vaccine nor the live attenuated
(nasal spray) vaccine can cause influenza, the injectable influenza
vaccine contains only killed viruses and cannot cause influenza disease.
▪ Fewer than 1% of people who are vaccinated develop influenza-like
symptoms, such as mild fever and muscle aches, after vaccination, these
side effects are not the same as having the actual disease.
22. What are the side effects of the flu shot?
In general, Flu shots are safe and well-tolerated
1. local side effects (Injection site reactions) :
o Swelling, redness and pain at the injection site, are common after
receiving inactivated influenza vaccine and occur in more than 10%
of people.
o Injection site reactions are common but are generally classified as
mild and transient, these side effects may commence within a few
hours of vaccination and can last for 1–2 days.
2. low grade fever, malaise, shivering, fatigue, headache, myalgia and
arthralgia are among the commonly reported symptoms after
intramuscular Injection (1–10%) ,can last for 1 to 2 days following the
vaccination .
Post-vaccination symptoms may mimic influenza, experiencing these
non-specific side effects does not mean that you are getting influenza.
3. As with any vaccine, there is an extremely rare possibility of a life-
threatening allergic reaction called anaphylaxis:

o This can include hives, difficulty breathing, or swelling of the throat,
tongue or lips. For this reason, it is important to stay in the clinic for
15 minutes after getting any vaccine.
o This reaction can be treated, and occurs in less than 1 in a million
people who get the vaccine.
4. Guillain-Barre syndrome:
o In very rare instances, the flu shot has been associated with
Guillain-Barre Syndrome (GBS) , about 1 case per million doses
/year from influenza vaccine.
o The potential risk of GBS associated with influenza vaccination
must be balanced against the risk of GBS associated with influenza
infection itself.
o Actually the risk of GBS associated with influenza infection is larger
than that associated with influenza vaccination.
5. Oculo-respiratory syndrome (ORS):
o During the 2000/2001 influenza season, Health Canada had
received an increased number of reports of vaccine-associated
symptoms and signs that were subsequently described as oculo-
respiratory syndrome (ORS)
o ORS is defined as the presence of bilateral red eyes plus one or
more respiratory symptoms (cough, wheeze, chest tightness,
difficulty breathing, difficulty swallowing, hoarseness or sore
throat) with or without facial edema ,that starts within 24 hours of
vaccination, , and generally resolving within 48 hours of symptom
onset.
o Symptoms are typically mild and resolve quickly without specific
treatment.

o Oculo-respiratory Syndrome (ORS) was found during the 2000-
2001 influenza season, few cases have been reported since then.
o Recommendations for subsequent immunization following a report
of ORS are based on a risk/benefit assessment and the severity of
symptoms as perceived by the individual who experienced the
symptoms.
23. Who should NOT be given the trivalent inactivated influenza
vaccine?
Anyone who has:
1. Had a life-threatening anaphylactic reaction to a previous dose of
influenza vaccine, or to any of the vaccine components with the
exception of egg.
( NOTE - Egg allergy is no longer considered a reason not to get the flu
vaccine).
o Confirmed anaphylaxis is rare. Other allergic conditions such as rashes may
occur more commonly and are not contraindications for further
immunization.
2. Had developed Guillain-Barre Syndrome (GBS) within six weeks of a
previous dose influenza vaccination
3. Had experienced severe Oculo-respiratory Syndrome (ORS ) that
included lower respiratory symptoms within 24 hours of receiving
influenza vaccine.
4. Inactivated influenza vaccines are not licensed for use in infants less
than 6 months of age.
Precautions:

▪ Postpone vaccination in persons with serious acute illness until their
symptoms have resolved (there is no need to delay vaccination because
of minor illness, such as a cold, with or without fever) .
Administration of influenza vaccine to egg allergic persons:
▪ Influenza vaccines are grown in eggs and there has been concern that
residual egg protein (ovalbumin) could cause allergic reactions in egg-
allergic recipients. However, all studies to date have suggested that this
risk is very low.
▪ Due to changes in vaccine
manufacturing, the amount of
egg protein in most of influenza
vaccines has been reduced
including those used in Kuwait.
▪ The Product Information of the
vaccine to be given should be
checked for the vaccine’s
ovalbumin content prior to
vaccine administration.
▪ The risk of an allergic reaction to influenza vaccine in patients with egg
allergy is very low, likely due to the very low amount of ovalbumin in the
vaccines. Any such theoretical risk is far outweighed by the very real risk
of such patients remaining unvaccinated. Thus all patients with egg
allergy of any severity, including anaphylaxis, should receive influenza
vaccine.
▪ Skin testing with the vaccine and dividing the dose are not necessary.
▪ Even though the risk of anaphylaxis associated with influenza
vaccination of a person with egg allergy is very low, it is essential that
such patients are vaccinated in facilities with staff that are able to
recognize and treat anaphylaxis.
CDC/WHO: People with egg
allergy, including egg-induced
anaphylaxis, can usually be
safely vaccinated with
inactivated influenza vaccines
that have less than 1 μg of
residual egg ovalbumin per
dose.

▪ Egg-allergic individuals should receive inactivated influenza vaccine in a
setting where anaphylaxis can be recognized and treated and should be
observed for 30 minutes after vaccination.. Egg allergic individuals
should not receive their influenza vaccine from a pharmacy or other
non-medical office setting
▪ To deal with anaphylactic or hypersensitivity reactions, immediate
treatment, including epinephrine 1:1000, should be easily accessible
during the administration of the vaccine.
24. What can you tell me about the preservative thimerosal that is in
some injectable influenza vaccines and the claim that it might be
associated with the development of autism?
o Thimerosal is a very effective preservative that has been used to prevent
bacterial contamination in vaccines for more than 50 years.
o It is comprised of a type of mercury known as ethyl-mercury. It is
different from methylmercury, which is the form that is in fish and
seafood.
o Very high levels, methy-lmercury can be toxic to people, especially to
the neurological development of infants.
CDC/WHO: Flu Vaccines are very
safe, effective and have been used
for more than 60 years, it is much
safer to get the vaccine than to get
Influenza illness.
CDC/WHO: Egg allergy is no longer
considered a contraindication for TIV.
Those with confirmed egg anaphylaxis
and non-anaphylactic egg allergy can be
given an influenza vaccine with an
ovalbumin content <0.1μg per dose.

o In recent years, several large scientific studies have determined that
thimerosal in vaccines does not lead to serious neurologic problems,
including autism.
o However, because we generally try to reduce people’s exposure to
mercury if at all possible, the vaccine manufacturers have voluntarily
changed their production methods to produce vaccines that are now
free of thimerosal or have only trace amounts.
o They have done this because it is possible to do, not because there was
any evidence that the thimerosal was harmful.
25. Influenza vaccine Products that are licensed for use in Kuwait.
List of Licensed Influenza Vaccine in Kuwait 2017-2019
Trade name Manufacturer
Approved
by
Presentation
Age
indication
Route
Quadrivalent Inactivated influenza vaccines, in Kuwait for season 2018-2019 and beyond
Fluarix®
Quadrivalent
GlaxoSmithKline
UK
FDA,
EMA,
WHO
0.5 mL
prefilled
syringe
≥3 years IM
Fluzone®
Quadrivalent
Sanofi Pasteur
France
FDA,
EMA,
WHO
0.5 mL
prefilled
syringe
≥3 years IM
TrivalentInactivated Influenza Vaccines, in Kuwait for season 2017-2018
Vaxigrip® Sanofi Pasteur
France
WHO,
EMA
0.5 mL
prefilled
syringe
≥6 Months IM
Fluarix® GlaxoSmithKline
UK
FDA,
EMA,
WHO
0.5 mL
prefilled
syringe
≥3 years IM
Agrippal® Seqirus Vaccines
UK
WHO,
EMA
0.5 mL
prefilled
syringe
≥6 Months IM
Influvac® Abbott
Biologicals
WHO,
EMA
0.5 mL
prefilled
syringe
≥6 Months IM

Multiple choice questions
1. Which of the following statements is CORRECT? Influenza is an acute
febrile respiratory illness:
a) It is caused by influenza type A or type B viruses that occur in outbreaks and
epidemics every year.
b) Influenza B strains are predominant over Influenza A strains
c) WHO is unable to predict the appropriate influenza viruses to be included in
vaccines yearly
d) Anyone, including healthy people, can get the flu, and people of any age can
develop serious problems related to flu.
2. Which of the following is/are true:
a) Influenza is caused by type A, B or C viruses
b) Influenza A is the usual cause of epidemics
c) Minor changes in the surface antigens of influenza A occur every year
d) ‘Antigenic shift’ means a major change in the influenza A virus has occurred
e) The burden of influenza B disease is mostly in adults
3. Antigenic shift is seen in:
a) Influenza A
b) Influenza B
c) Influenza C
d) All of the above
4. What chance does a healthy person have of getting the flu during an
average year?
a) About 75%
b) About 50%
c) Between 10 and 20 per cent
d) Less than 2 per cent.
5.What are hemagglutinin and neuraminidase?

a) Exotoxins produced by the influenza virus
b) Glycoprotein receptors on influenza's target cells
c) Glycoproteins on influenza virus that contribute to virulence
d) Proteins found in the nucleus of influenza virus
e) Proteins that surround each segment of the nucleic acid in influenza
6. A number of complications are associated with influenza, which of the
following is NOT one of these complications?
a) Nephritis.
b) Pneumonitis.
c) Myocarditis.
d) Encephalitis.
e) Death.
7. Patients at high risk for developing complications from seasonal influenza
include all of the following except:
a) > 65 years old
b) A 35 year old busy mother who does not want the flu
c) Diabetics
d) Asthmatics
8. The most common complication of seasonal influenza is:
a) Bacterial pneumonia
b) Death
c) Meningitis
d) Reye syndrome
9. Which of the following is/are true about seasonal Influenza vaccines:
a) They must be given annually
b) Most current vaccines have two influenza B subtypes and one A subtype in them
c) A quadrivalent vaccine with an additional influenza A virus has been developed
d) Most of the vaccines are prepared from viruses grown in embryonated hens’
eggs
e) There is only live attenuated influenza vaccine registered for use in the gulf.

10. Influenza vaccine is specifically indicated in individuals with:
a) COPD
b) Cochlear implants
c) Congenital cyanotic heart disease
d) Cerebral palsy
e) Chronic kidney conditions (including hemodialysis)
11. The inactivated seasonal influenza vaccine contains:
A. Thimerosal
B. Two influenza A viruses, and one influenza B virus
C. Two influenza B viruses, and one influenza A virus
D. Both A and B
12. _________ week(s) is the minimum interval between administration of
two live vaccines, if not administered simultaneously.
A. 1
B. 4
C. 6
D. 8
13. The most suitable site(s) for intramuscular vaccination is/are:
a) Anterolateral aspect of the thigh
b) Deltoid area of the upper arm
c) Fatty area of buttock
d) Anywhere in buttock
e) All of the above
14. Patients with the following conditions should have seasonal influenza
vaccine:
a) Type 1 diabetes
b) Stage 2 chronic renal disease
c) Diabetes controlled by diet

d) Cystic Fibrosis
e) Severe learning disability
15. What is the best time of year for a person to be vaccinated against
influenza?
a) In Autumn, just before the peak flu season
b) In summer, well before the next peak flu season.
c) As soon as flu symptoms develop.
d) Anytime; it makes no difference.
16. Which of the following is/are true about inactivated influenza vaccine
administration:
a) It is better to inject vaccine into fat than muscle
b) The deltoid area of the upper arm is generally preferred for infants under 1-
year-old
c) The anterolateral region of the thigh is generally preferred for older children
and adults
d) Influenza vaccine should not be given at the same time as pertussis vaccine as
it might affect response to that vaccine
e) Non of the above
17. Among the overall population, the chance of avoiding catching seasonal
flu after being vaccinated is:
a) 100 per cent.
b) 50-60 per cent.
c) 40 per cent.
d) 10 per cent
18. Annual influenza vaccination should be recommended for which of the
following groups?
a) Children aged 6 months to 5 years.
b) Patients with chronic liver cell failure.
c) Health care workers.

d) Pregnant women at any trimester
e) All of the above.
19. Choose the correct statements you, can still get flu after you get a flu
shot?
Maybe if:
a) You are exposed to flu before or right after you get a flu shot,
b) The flu shot vaccine does not match all the flu viruses that are spreading
c) Flu viruses change after the flu shot is made
d) You have an illness or weak immune system that causes your body to take
longer to make antibodies
e) All of the above
20. Which of the following statements regarding seasonal influenza vaccine is
CORRECT?
a) Fever is a rare side effect of influenza vaccination.
b) Booster doses are required for children less than 9 years.
c) Should not be given to children below 1 year of age.
d) Should not be given to children with peanut allergy.
21. The most common reactions to inactivated vaccines include:
a) Pain at the injection site
b) Erythema
c) Swelling
d) All of the above e) None of the above
22. Contraindications to Influenza vaccination include:
a) Confirmed anaphylactic reaction to a previous dose of influenza vaccine
b) Confirmed anaphylactic reaction to egg products
c) A rash following a previous vaccination
d) Pregnancy
e) Aged less than two years
23. The following is/are true about flu vaccine in pregnancy:
a) Influenza vaccine is contraindicated in the first trimester of pregnancy

b) Influenza vaccine should be offered from the third trimester of pregnancy
c) Pregnant women who have received influenza vaccine are at slightly
increased risk of miscarriage
d) Influenza vaccine given to the mother may provide passive immunity to the
infant in the first few months of life
e) Inactivated influenza vaccines are preferred to live attenuated vaccine in
pregnancy
24. Adverse reactions to inactivated flu vaccine may include:
a) Pain and swelling at the injection site
b) High grade fever
c) Myalgia
d) Shivering
e) Clinical influenza
25. An example of a permanent contraindication to vaccination is:
a) Moderate or severe illness
b) HIV
c) Anaphylactic reaction to a previous dose
d) Concurrent antibiotic therapy

References
1. Recommended composition of influenza virus vaccines for use in the
2016-2017 northern hemisphere influenza season -WHO February 2016.
2. Key Facts About Seasonal Flu Vaccine CDC-May 2017
3. Vaccine effectiveness estimates for seasonal influenza vaccines -WHO
February 2015
4. Global Advisory Committee on Vaccine Safety (GACVS) ,information
sheet ,observed rate of influenza vaccine reactions -WHO July 2012
5. Vaccines against influenza , WHO position paper – November 2012
6. Seasonal Influenza - Fact sheet –WHO-March 2017
7. National Advisory Committee on Immunization (NACI) -Statement on
Seasonal Influenza Vaccine for 2013-2014- Public Health Agency of
Canada
8. Influenza Surveillance Protocol For Ontario Hospitals-July 2014
9. Influenza (Flu) Vaccines Fact sheet- Toronto Public Health - September
2014
10. Immunization Action Coalition Saint Paul, Minnesota-2015
11. Alberta Health Services Immunization Program Revised December
2014
12. Canadian Immunization Guide - National Advisory Committee on
Immunization (NACI)† Statement on Seasonal Influenza Vaccine for
2016-2017
13. Update on Egg Allergy and Influenza Vaccine (Nov 2011) - Centers for
Disease Control and Prevention(CDC) Advisory Committee on
Immunization Practices (ACIP) 2011 and the American Academy of
Pediatrics’ (AAP) Committee on Infectious Diseases 2011

14. Centers for Disease Control and Prevention(CDC) - ACIP 2015-2016
influenza vaccine guidelines
15. Influenza vaccines for Australians | NCIRS Fact sheet: July 2015
16. Community case management during an influenza outbreak- WHO 2011
17. immunization against infectious disease -The Green Book - Updated
version October 2015
18. The Kroger Pharmacy Vaccine Administration Training Program
19. Respiratory MCQ’s Multiple choice questions on immunization against
infectious disease- updated version October 2015
20. Questions and answers on seasonal influenza - Regional Office for the
Americas of the World Health Organization 2015
21. The scientific basis for offering seasonal influenza immunization to risk
groups in Europe. Euro Surveill-2008
22. The Joint Committee for Vaccination and Immunization statement on
the annual influenza vaccination programme – UK July 2017.

CDCWHO : Health care
workers (HCWs) should use every
opportunity to give Inactivated
seasonal influenza vaccine to
individuals at risk who have not
been immunized during the current
season, even after influenza activity
has been documented in the
community.
MOH Minister Dr. Hilal Al-Sayer in 2009 CDC Director Tom Frieden in 2016

Acknowledgement
This work would not have been possible without the supervision and
support of Dr. Majda Alqattan the Assistant Undersecretary of Public Health at
Kuwait Ministry of Health. We especially indebted to Dr. Ashraf El-Adawy how
was the main writer of this booklet, and who worked actively to provide us with
most of the information provided in this work.
The public Health sector is grateful to all of those who worked with us to
make this work reach its final scientific goals. Our utmost appreciation also
extends to those who helped in the review and revise of this booklet and
contributed in its final production. Therefore, we accentuate our gratitude and
acknowledgement to:
Dr. Sondos Alqabandi
Dr. Najla Alayhaady
Dr. Radiah Almathkori
Dr. Abdulrahaman Lotfy
Dr. Muhammad Barakat
H.I. Wadha N. Al-Hajri
Dr. Mona Alhajj Hussian
Dr. Lamia M. Basioni
‫ورعايته‬ ‫اهلل‬ ‫حبمد‬ ‫مت‬

Kuwait flu vaccine booklet for workshop

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