..

2. Trivalent Inacivated Seasonal
Influenza Vaccine(TIV)
2015-2016

3. By
Dr. Ashraf El-Adawy
Consultant Chest Physcian
TB TEAM Expert - WHO

6. Facts, Myths and Misconceptions!

7. Influenza
Highly infectious viral illness
Epidemics reported since 16th century
Virus first isolated in 1933
Single-stranded RNA virus
3 types: A, B, C

8. Influenza Types – A and B
Type A
(Seasonal, avian, swine
influenza,….)
Type B
(Seasonal influenza)
Can cause significant disease
Generally causes milder
disease but may also cause
severe disease
Infects humans and other
species (e.g., birds; H5N1)
Limited to humans
Can cause epidemics and
pandemics (worldwide epidemics)
Generally causes milder
epidemics

9. Influenza types A and B are responsible for epidemics of
respiratory illness that occur almost every winter.
Influenza type C usually causes either a very mild
respiratory illness or no symptoms at all , it does
not cause epidemics and does not have the
severe public-health impact of influenza
types A and B .

10. Wild birds are “natural” reservoir for all
influenza A subtypes

11. Neuraminidase (NA)–9 subtypes
)
Hemagglutinin (HA)–16 subtypes
Influenza A Virus is subtyped by
surface proteins

12. H1 N1
H2 N2
H3 N3
H4 N4
H5 N5
H6 N6
H7 N7
H8 N8
H9 N9
H10
H11
H12
H13
H14
H15
H16
Haemagglutinin subtype Neuraminidase subtype

13. Avian Influenza
A viruses
H1 - H16
N1 - N9
H1 - H3
N1 –N2
Human Influenza
A Viruses
Natural Reservoir for New Human Influenza A Virus
Subtypes: Waterfowl (Aquatic Ducks, Geese)

14. All subtypes of influenza A are maintained in
aquatic birds
In human
H1 to H16 N1 to N9
H1, H2, H3 N1, N2
The current subtypes of influenza A viruses found in
people are
A (H1N1) and A (H3N2).

16. Influenza Virus
A/Fujian/411/2002 (H3N2)
Neuraminidase
Hemagglutinin
Type of nuclear
material
Virus
type
Geographic
origin
Strain
number
Year of
isolation
Virus
subtype

17. How does influenza virus change ?
●Type A viruses undergo changes in their
surface antigens or proteins
● Minor changes Antigenic drift
● Major changes Antigenic shift

19. How do yearly epidemics occur?
• Answer: A process called antigenic DRIFT.
• Imperfect “manufacturing” of virus
– Small changes in H and N
– Partial immunity in population
• Incomplete protection; still get sick
• Need new flu vaccine every year
H3N2 H3N2
Immune
System: “Do I
know you? You
look vaguely
familiar!”

20. Antigenic ShiftAntigenic Shift

21. What drives the occurrence of a pandemic ?
Answer:
Instead of antigenic DRIFT occurring,
an antigenic…
…happens.
Immune
System: “Oh
my gosh…I
don’t know you
at all!”
H?N?

23. The burden of influenza

24. In developed countries, annual influenza epidemics infect
about 10–20% of the population each season, and cause
febrile illnesses that range in severity from mild to
debilitating and can lead in some instances to
hospitalization and even cause death .

25. Death mostly occur as a consequence of primitive fulminant
influenza virus pneumonia or of secondary respiratory
bacterial infections and are facilitated by underlying
pulmonary or cardiopulmonary pathologies.
The risk of developing serious complications is aggravated
in the very young and in the
elderly.

26. In the average global burden of inter-pandemic influenza
may be on the order of
~1 billion cases of flu
~3–5 million cases of severe illness
~300 000–500 000 deaths annually

27. Anyone can get the flu, Although there are medications
to treat the flu, they are expensive, and need to be
started within 24-48 hours of the start of symptoms.
The single best way to protect against the flu
is to get vaccinated each year

28. Each year, the influenza virus can mutate, or change its
structure, rapidly, leading to new subtypes of the virus,
making the vaccine used in previous years ineffective.
Each year, a new vaccine must be prepared that will be
effective against the expected type of influenza virus.
The trick is to be able to predict which influenza viruses
are going to cause infection and to prepare a vaccine
against those viruses

29. Each year, based on global surveillance data, the World
Health Organization recommends the strains that they
believe will be circulating in the upcoming influenza
season
Currently, 136 national influenza centers in 106 countries
conduct year-round surveillance for influenza viruse and
disease
activity.
How are the vaccines made?

30. Each year, before influenza season starts, one or more
virus strains in the vaccine might be changed on the
basis of global surveillance for influenza viruses&
the emergence and spread of new strains.

31. 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.

32. In February, the WHO 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.

33. Reasons for getting a yearly flu
vaccine?
The first reason is that because flu viruses are constantly
changing (Antigenic drift) , which may occur in one or
more influenza virus strains, flu vaccines may be updated
from one season to the next to protect against the most
recent and most commonly circulating viruses.

34. Reasons for getting a yearly flu vaccine
?
The second reason that annual vaccination is recommended
is 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.

35. Each seasonal influenza vaccine contains three
influenza viruses ( Trivalent vaccine ) :
● Influenza A (H1N1) virus
● Influenza A (H3N2) virus
● Influenza B virus.
Influenza Virus Vaccine
Strain Selection

36. 2005-2006 Influenza Vaccine
• A/New Caledonia/20/1999-like (H1N1)
• A/California/7/2004-like (H3N2)
• B/Jiangsu/10/2003-like

37. 2006-2007 Influenza Vaccine
• A/New Caledonia/20/1999-like (H1N1)
• A/Wisconsin/67/2005-like (H3N2)
• B/Malaysia/2506/2004-like

38. 2007-2008 Influenza Vaccine
• A/Solomon Islands/3/2006-like (H1N1)
• A/Wisconsin/67/2005-like (H3N2)
• B/Malaysia/2506/2004-like

39. 2008- 2009 Seasonal Influenza Vaccine
• A/Brisbane/59/2007 (H1N1)
• A/Brisbane/10/2007 (H3N2)
• B/ Florida /4/2006 strains.

40. 2009- 2010 Seasonal Influenza Vaccine
• A/Brisbane/59/2007 (H1N1)
• A/Brisbane/10/2007 (H3N2)
• B/Brisbane/60/2008 strains.

41. 2010- 2011 Seasonal Influenza Vaccine
• A/California/7/2009(H1N1)
• A/Perth/16/2009 (H3N2)
• B/Brisbane/60/2008 strains.

42. 2011- 2012 Seasonal Influenza Vaccine
• A/California/7/2009(H1N1)
• A/Perth/16/2009 (H3N2)
• B/Brisbane/60/2008 strains.

43. • The viruses selected for the vaccine remained the same
because they continued to be the main viruses causing
human illness
• It’s uncommon that the same three vaccine virus
strains are the same from one season to the next, but
this has happened before.
• Since 1969, the viruses selected for inclusion in the
influenza vaccine have remained the same eight times
• Each time, CDC has stressed the importance of getting
vaccinated each season worldwide.
Why did the vaccine composition remain
the same in 2011-2012 flu season ?

44. People should get vaccinated every year because even
if the viruses in the vaccine are the same as the year
before, immunity to influenza viruses declines over
time and may be too low to provide protection after
a year

48. 2015- 2016 Seasonal Influenza Vaccine
• A/California/7/2009(H1N1)
• A/Switzerland/9715293/2013
(H3N2)-like virus
• B/Phuket/3073/2013-like
virus..

49. Everyone 6 months of age and
older get vaccinated
CDC

51. How do seasonal influenza
vaccines work?
The seasonal influenza vaccine induces development of
antibodies against influenza virus infection in the body
It takes about two weeks after vaccination for antibodies
to develop in the body and provide protection against
influenza virus infection.
The vaccine is only effective against the strains
of the virus that match the vaccine

52. •therapeutic
Timing of Vaccination

53. Flu season can begin in October and last as late as May.
In recent seasons, most infections have occurred in
January and February.
October and November are considered the best times to
receive the vaccination, but it is still effective when
administered later.
Getting vaccinated in December, or even later, will still be
beneficial in most years.

54. CDC recommends that people get vaccinated against
influenza as soon as vaccine becomes available in
their community, but vaccination can take place at
any time throughout the influenza season.
Vaccination before December is best since this timing
ensures that protective antibodies are in place before
flu activity is typically at its highest.

55. What is the duration of protection?
Public Health Agency of Canada October 30, 2009
Seasonal influenza vaccine usually provides
protection from the specific strains included
in it for about six months or longer.
In general, the immunity following seasonal
influenza vaccination rarely lasts longer
than a
year

56. How much protection does the seasonal
influenza vaccine provide?

57. The Seasonal influenza vaccine is about
70 to 90% effective in preventing illness
from seasonal influenza in healthy
adults when the vaccine and
circulating viruses are well-
matched.

58. In years when the vaccine strains are not well matched to
circulating strains, vaccine effectiveness is generally
lower.
The vaccine may also 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 seasonal influenza
disease among the elderly, it is effective in
preventing complications and death.
.

59. Inactivated Influenza Vaccine Efficacy
Adults < 65 years
• 70-90% protection against influenza
Adults > 65 years
• 30 - 40% effective among frail elderly
persons
• 50-60% effective in preventing
hospitalization
• 80% effective in preventing death

60. 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 60% among the
overall population, for all age groups combined.
.

61. 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
.

62. •So even though circulating influenza viruses may “drift”
or change from the time the vaccine composition is
recommended, the vaccine may cross-protect
against circulating viruses.
•The mismatch may result in reduced effectiveness
against the variant viruses, but it still can provide
some protection. .

63. In addition, it's important to remember that the influenza
vaccine contains three virus strains; so the vaccine
would still protect against the other two viruses.
For these reasons, even during seasons when there is a
mismatch, CDC continues to recommend seasonal
influenza vaccination..

64. Seasonal influenza vaccine provides the best protection
available from seasonal flu –even when the vaccine does
not closely match circulating flu strains, and even when
the person getting the vaccine has a weakened immune
system.
Vaccination can lessen illness severity and is particularly
important for people at high risk for serious flu-related
complications and for close contacts of high-risk people

65. Seasonal Influenza Vaccines
Inactivated subunit (TIV)
Intramuscular
Trivalent
Annual
Live attenuated vaccine (LAIV)
Intranasal
Trivalent
Annual

66. Trivalent Inactivated Influenza Vaccine (TIV)
OR The "flu shot“
• Most commonly used – Given IM (shot)
• Containing killed virus
• Injected into the muscle of the upper arm or thigh.
• It can be used for people 6 months of age or older,
including healthy people, those with chronic
medical conditions, and pregnant women
CDC

67. Live Attenuated Influenza Vaccine (LAIV)
OR Flu Mist
• Made with live, weakened flu viruses
• Given as a nasal spray.
• Is an option for healthy people 2-49 years of age who
are not pregnant.
• In June 2003, a live virus influenza vaccine was first
licensed
CDC

69. Viruses for both vaccines are
grown in eggs

70. Vaccine Administeration

71. Right Route for Right Vaccine
Live Attenuated Influenza Vaccine
Intranasal only

73. Right Route for Right Vaccine
Inactivated Influenza Vaccine
Intramuscular only

74. Inactivated Influenza Vaccine is Administered by
the Intramuscular Route
Needle length & Site depend on:
Muscle size, Fatty tissue thickness,
Vaccine volume, Injection technique
Aspiration is NOT required
Fatty tissue (SubQ)
Dermis
Fatty tissue
(subQ)
Muscle tissue
90° AngleAcromial
Process
Axillary Fold

75. x
x
Anterolateral thigh
Inactivated Influenza Vaccine
IM Injections
Deltoid

76. Inactivated Influenza Vaccine
IM Injections – Infant (6-12 months)
Anterolateral thigh
Needle gauge
- 22 - 25 gauge
Needle length
- 1 inch

77. Needle size
- 22 - 25 gauge
Needle length
- anterolateral thigh – 1 inch
- deltoid – 1 inch
Inactivated Influenza Vaccine
IM Injections – Toddlers (1-2 years)

78. For adults and older children, the
recommended site of vaccination
is the deltoid muscle.
The preferred site for infants (< 12
months old ) and young children
(older than 12 months of age with
inadequate deltoid muscle mass)
is the anterolateral aspect of
the thigh.

79. Standard Technique for Injection

80. Correct!
NO!!!
Incorrect!

81. Precautions
• Shake vaccine vial before withdrawing a dose
• Discard vaccine if it contains particulates, appears
discolored
• Do not administer into buttock muscle because of
potential for injection-associated injury to sciatic nerve
• ACIP states that aspiration (i.e., pulling back on the
syringe plunger after needle insertion and before
injection) is not required because large blood vessels
are not present at recommended IM injection sites
• Do not mix with any other vaccine or
solution

82. Vaccine Storage
Store vaccine between 2º and 8º C at all times.
Vaccine should be placed on the middle shelves of
the refrigerator .
Influenza vaccine should never be exposed to
freezing temperature!
The vaccine effectiveness can be decreased by
exposure to light

83. Note: Influenza Vaccine must not be frozen.
It should never come into direct contact with ice.
Transporting Vaccine
Use insulated containers with a temperature
monitoring device and appropriate cooling agents.
Keep vaccine in insulated bags – do not carry it in your
pocket!

84. TIV Dosage and frequency of
administration
• For trivalent inactivated influenza vaccine (TIV), the
dose is 0.5 mL for all age groups, This information is
now included in all the TIV product monographs.
• Adults & Children who have been previously immunized
with seasonal influenza vaccine are to receive one dose
of influenza vaccine each year.
•

85. TIV Dosage and 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.
•

86. • Should I repeat a dose of inactivated influenza vaccine
administered by an incorrect route (such as intradermal
or subcutaneous)?
• If the DOSE (amount) of vaccine was age-appropriate, it
can be counted as valid regardless of the route by which
it was given.

87. • Any vaccination using less than the standard dose
should not be counted as valid, and the person should be
re-vaccinated according to
age.
• The second dose should be administered at least 4 weeks
after the first dose.

88. Can TIV be administered simultaneously
with other vaccines?
• TIV 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 and separate needles and syringes should be used
•

90. •therapeutic
Who should get a seasonal
flu shot?

91. According to CDC Routine influenza vaccination is
recommended for all persons aged 6 months & older
Vaccination is especially important for people at higher risk
of serious influenza complications, and for people who
live with or care for high risk individuals.
•

92. WHO recommends annual seasonal influenza vaccine for:
(A) Highest priority group.:
Pregnant women (at any stage of pregnancy)
(B) 4 other priority groups (in no order of priority) are:
Health-care workers
Children aged 6 months to 5 years
Elderly(≥65 years of age)
Individuals with specific chronic medical condition
•

93. Persons with the following chronic illnesses should be
considered for inactivated influenza vaccine
Pulmonary (e.g., asthma , COPD, Bronchiectasis)
Cardiovascular (e.g., CAD,CHF)
Metabolic (e.g., diabetes)
Renal dysfunction
Hepatic dysfunction
Hemoglobinopathy
Immunosuppression, including HIV infection
Chronic neurological and neurodevelopmental conditions
Morbid obesity

94. Health care workers should use every opportunity to give
Inactivated seasonal influenza vaccine to individuals at
risk of serious influenza complications, who have not
been immunized during the current season, even after
influenza activity has been documented in the
community

95. Seasonal Influenza
Vaccination & pregnancy

96. Pregnant Women at Increased Risk
for Severe Influenza illness

97. Pregnancy and Influenza
Bad combination
Pregnant women are at higher risk to have severe
complications and death from influenza
Preterm labor
Maternal death
Severe pneumonia
Fetal distress
December 29, 2009 CDC

98. Pregnancy and Influenza
Bad combination
Pregnant women, both healthy pregnant women and those
with chronic health conditions, are at increased risk of
influenza related complications& hospitalization.
The risk increases with length of gestation i.e. it is higher
in the third than in the second trimester)

99. 1.7
2.1
5.1
0
2
4
6
8
1st trimester 2nd trimester 3rd trimester
RateRatiosRisk of Hospital Admission for Respiratory Illness during Influenza
Season by Pregnancy Status among Women with No Comorbidity,
Nova Scotia, 1990-2002
Dodds et al., CMAJ 176:463-8, 2007
*Compared to year before pregnancy

100. Statement endorsed by:
March of Dimes
American College of Obstetricians and Gynecologists
American Academy of Pediatrics
American Academy of Family Physicians
American College of Nurse-Midwives
Association of Women’s Health, Obstetric, and Neonatal Nurses
Infectious Disease Society for Obstetrics and Gynecology
Society of Maternal-Fetal Medicine

101. Trivalent inactivated Influenza vaccine is considered safe
for use in pregnant women at all stages of pregnancy, in
any trimester , regardless of gestational age
WHO considers pregnant women as a high priority group
and recommends immunization
Pregnant women should receive inactivated vaccine (flu
shot) but should NOT receive the live attenuated vaccine
(nasal spray).

102. FDA
The pregnancy section of the prescribing information for
the licensed influenza vaccines carry either a Category
B or C , this allows influenza vaccines to be given to
pregnant women,as recommended by the ACIP

103. 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.
The benefit of vaccination far outweighs any possible risk
from the vaccine itself.. The risk is actually in not getting
a flu shot
•

104. 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)..

105. The trivalent inactivated vaccine (TIV) is also safe for breast
feeding mothers and their babies (via breast milk)
Women who are breast feeding may receive either either
inactivated vaccine or live attenuated vaccine (nasal spray)

107. Reasons for Rejecting Vaccination
Among Health-care Personnel
Reason Physician
%
Nurse
%
Technician
or Aide %
Admin.
Worker
%
Medical
Student %
Other
%
Vaccine
shortage
57 40 58 53 34 48
Concern about
side effects
17 34 36 25 23 28
Never get
influenza
14 25 27 18 23 22
Inconvenience* 26 9 4 7 34 13
Forgot 18 8 5 2 11 8
Christini AB, et al. Infect Control Hosp Epidemiol 2007;28:171-7
*Vaccine needs to be made available during all employment shifts.

108. Health-care workers 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 groups.
Vaccination of HCWs should be considered part of a
broader infection control policy for health-care facilities.

109. 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
their patients.”

111. Can people still get influenza if they have
had the influenza vaccine?

112. 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
Public Health Agency of Canada October 30, 2009

113. Public Health Agency of Canada October 30, 2009
Respiratory pathogens that are not related to influenza
viruses can cause “flu-like” symptoms (e.g rhinovirus).
The influenza vaccine does not protect you against these
pathogens.
A person may be exposed to an influenza virus that is not
included in the seasonal flu vaccine.

114. Public Health Agency of Canada October 30, 2009
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, it can still
help to prevent influenza complications

115. Does seasonal influenza vaccine
cause influenza?
No! Neither the injectable (inactivated) vaccine nor the live
attenuated (nasal spray) vaccine can cause influenza..
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

116. Side effects of the flu shot?

118. Inactivated seasonal influenza vaccine is very safe and
usually well tolerated apart from occasional soreness,
redness or swelling at the injection site.
Some recipients may experience fever, muscle and joint
pains, and tiredness beginning 6 to 12 hours after
vaccination and lasting up to two days.
Experiencing these non-specific side effects does not
mean that you are getting influenza.
Inactivated Influenza Vaccine
Adverse Reactions

119. Life-threatening allergic reactions from TIV are very rare .
It is important to stay in the clinic for 15 minutes after
getting any vaccine because there is an extremely rare
possibility of a life‐threatening allergic reaction called
anaphylaxis, this may include hives, difficulty breathing,
or swelling of the throat, tongue or lips.
This reaction can be treated, and occurs in less than 1 in
a million people who get the vaccine.
Inactivated Influenza Vaccine
Adverse Reactions

120. Can influenza vaccination cause
Guillain Barré Syndrome ?

121. In very rare instances (a risk of approximately 1 additional
case of Guillain-Barré Syndrome (GBS).. per 1 million
persons vaccinated with the seasonal influenza
vaccine
Studies suggest that the risk of developing GBS after
having influenza is higher than the potential risk of
developing GBS after vaccination
The benefit of the vaccine outweighs this theoretical risk

122. Who Should Not Be Vaccinated ?

123. ● Influenza vaccine is not approved for use in children
younger than 6 months.
● Persons who had an anaphylactic reaction to a previous
dose of influenza vaccine OR to any vaccine components,
with the exception of egg ( due to changes in vaccine
manufacturing, the amount of egg protein in the majority
of influenza vaccines has been reduced)..

124. ● People with egg allergy, including egg-induced
anaphylaxis, can be vaccinated with influenza vaccines
that have less than 1 μg of residual egg ovalbumin per
dose.
● Persons who had Guillain-Barré syndrome (GBS) within
six weeks of of a previous influenza vaccine.
● 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).

125. ● 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.
● Annual influenza vaccination is the most effective method
for preventing influenza virus infection and its
complications.

136. “Things should be described as
simply as possible – But not
simpler!”
--Albert Einstein