Seasonal influenza vaccines

By Dr. Ashraf El-Adawy
Consultant Chest Physcian
TB TEAM Expert – WHO
Mansoura - Egypt

Facts, Myths and Misconceptions!

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

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

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 .

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

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

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

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!”

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?

Pandemic influenza in the 20th Century
1920 1940 1960 1980 2000
H1N1
H2N2
H3N2
1918 “Spanish Flu”
1957 “Asian Flu”
1968 “Hong Kong Flu”
20-40 million deaths
1 million deaths
1 million deaths

Seasonal influenza refers to the viruses that circulate in
the human population and cause widespread illness each
influenza season
Influenza (flu) is a contagious respiratory disease that can
lead to serious complications, hospitalization, or even
death.
Anyone can get the flu, and vaccination is the single best
way to protect against influenza.

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

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.

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

Although there are medications to treat the flu, they are
expensive, not as effective as vaccination, 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

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

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 viruses and disease activity. These laboratories then send influenza viruses for additional analyses to the five WHO Collaborating Centers for Reference and Research on Influenza
How are the vaccines made?

The five WHO Collaborating Centers for Reference and Research on Influenza located in :
● Atlanta, Georgia, USA (Centers for Disease Control and Prevention,CDC)
● London, United Kingdom (National Institute for Medical Research)
● Melbourne, Australia (Victoria Infectious Diseases Reference Laboratory) ●Tokyo, Japan (National Institute for Infectious Diseases)
● Beijing, China (National Institute for Viral Disease Control and Prevention).
How are the vaccines made?

Reasons for getting a yearly flu vaccine ?
The first reason is that because flu viruses are constantly changing, flu vaccines may be updated from one season to the next to protect against the most recent and most commonly circulating viruses.
The second reason that annual vaccination is recommended is that a person’s immune protection from vaccination declines over time and annual vaccination is needed for optimal protection.

Reasons for getting a yearly flu vaccine ?
The decline in protection against the flu that occurs after vaccination or after flu infection may be influenced by several factors, including a person’s age, the antigen used in the vaccine, and the person’s health situation (chronic health conditions that weaken the immune system may have an impact). This decline in protection has the potential to leave some people more vulnerable to infection, illness and possibly serious complications even from the same influenza viruses a year after being vaccinated

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

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
and the emergence and spread of new strains.

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

• A/New Caledonia/20/1999-like (H1N1)
• A/Wisconsin/67/2005-like (H3N2)
• B/Malaysia/2506/2004-like

• A/Solomon Islands/3/2006-like (H1N1)
• A/Wisconsin/67/2005-like (H3N2)
• B/Malaysia/2506/2004-like

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

• B/Brisbane/60/2008 strains.

WHO declares pandemic of novel H1N1 virus
Jun 11, 2009 The A (H1N1) influenza outbreak has officially reached global pandemic levels Phase 6

— an A/California/7/2009 (H1N1)-like virus (pandemic strain) — an A/Perth/16/2009 (H3N2)-like virus; — a B/Brisbane/60/2008-like virus
Trivalent vaccines that contain all three of the WHO recommended viruses are expected to protect influenza seasonaland pandemicagainst both
WHO recommendations on the composition of the next season's influenza vaccines during 2010-2011 in northern hemisphere

• A/California/7/2009(H1N1)
• A/Perth/16/2009 (H3N2)

10 August 2010 - WHO Declares End to 2009 H1N1 Influenza Pandemic

This declaration was based on strong indications that influenza, worldwide, is transitioning toward seasonal patterns of transmission
The intensity of 2009 H1N1 influenza virus transmission is lower than that reported during 2009 and early 2010.
The 2009 H1N1 viruses will likely continue to circulate for some years to come, taking on the behavior of a seasonal influenza virus

• A/Perth/16/2009 (H3N2)

• 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 ?

for optimal protection against influenza,
annual vaccination is recommended
regardless of whether the viruses
in the vaccine have changed or
not since the previous season

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

• A/Victoria/361/2011 (H3N2)
• B/Wisconsin/1/2010-like virus
.

• A/Victoria/361/2011 (H3N2)
• B/Massachusetts/2/2012-like
virus.

• A/Texas/50/2012 (H3N2)
• B/Massachusetts/2/2012-like
virus.

Some of the 2014-2015 flu vaccine also protects against an additional B virus (B/Brisbane/60/2008-like virus).
Vaccines that give protection against three viruses are called trivalent vaccines. Vaccines that give protection against four viruses are called quadrivalent vaccines
It is recommended that quadrivalent vaccines containing two influenza B viruses contain the above three viruses and a B/Brisbane/60/2008 like virus.

It is recommended that everyone 6 months
of age and older get vaccinated this season,
regardless of whether they were vaccinated
last season

Vaccines have been our main defense against influenza for more than 50 years
The first seasonal influenza vaccine in the United States became available in 1945
Many millions of doses of seasonal vaccine influenza have been distributed every year for many years, and have a well-established safety profile

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

therapeutic •
Timing of Vaccination

, WHO experts assess the flu strains Each Februarycirculating throughout the globe before recommending the strains for the Northern Hemisphere's next seasonal flu vaccine. for vaccine manufacturers to grow months 6 It takes about the viruses in chicken eggs and formulate them into trivalent vaccines
Flu vaccine shipments began in August and will continue throughout September and October until all vaccine is distributed

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.

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.

What is the duration of protection?
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
Public Health Agency of Canada October 30, 2009

How much protection does the seasonal influenza vaccine provide?

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.

The effectiveness of influenza vaccine depends
primarily on :
1 . the age and health status of the person getting
the vaccine
2 . the similarity or "match" between the viruses or
virus in the vaccine and those in circulation
Vaccine effectiveness is not 100%, and some people
can still get the flu after being vaccinated.

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.
.

Inactivated Influenza Vaccine Efficacy
years 65
Adults <
• 70-90% protection against influenza
years65
Adults >
• 30 - 40% effective among frail elderly persons
• 50-60% effective in preventing hospitalization
• 80% effective in preventing death

influenza season 2011 -2010Preliminary data for the was about indicate that influenza vaccine effectiveness , and that almost all % for all age groups combined60influenza viruses isolated from study participants were well-matched to the vaccine strains . ) looking at the et al Montoby A randomized study ( influenza season found trivalent inactivated 2008 -2007people from 10 out of 7 protected vaccine (flu shot) influenza illness. Studies show that LAIV works about as well as the flu shot
.
What do recent vaccine effectiveness studies show?

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
For these reasons, even during seasons when there is a
mismatch, CDC continues to recommend seasonal
influenza vaccination.
.

•Antibodies created through vaccination with one strain
of influenza viruses will often offer protection against
related strains of influenza viruses.
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.
.

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.
This is particularly important in people at high risk for
serious flu-related complications and for close contacts
of high risk people.

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

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

Both seasonal LAIV and TIV contain three strains of influenza viruses that are antigenically equivalent to the : annually recommended strains• one influenza A (H1N1) virus • one influenza A (H3N2) virus • one influenza B virus.
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 and the emergence and spread of new strains.

Trivalent Inactivated Influenza Vaccine (TIV)
The "flu shot“
OR
• Most commonly used – Given IM (shot)
• Containing killed virus
• Injected into the muscle of the upper arm or thigh. , months of age or older6 It can be used for people •
chronicpeople, those with healthyincluding pregnant women, and medical conditions
CDC

FluMist
Live Attenuated Influenza Vaccine (LAIV) or
• Made with live, weakened flu viruses • Given as a nasal spray. of age years49 -2people healthys an option for I
• .Not pregnantwho are
In June 2003, a live virus influenza vaccine was first licensed
CDC

Several studies have shown excellent efficacy with respect to prevention of flu in children with the nasal vaccine, even better than the injectable vaccine. Among adults, efficacy of the injectable vaccine varies from year to year, but one recent study demonstrated that injectable vaccine was substantially more efficacious than nasal vaccine at preventing flu.

Viruses for both vaccines are grown in eggs

Technology developed in the 1940s
Virus is inoculated into embryonated chicken eggs
Each egg produces enough virus for 1 to 3 doses of vaccine
At least 6 months are required to produce adequate amounts of seasonal influenza vaccine each year

Right Route for Right Vaccine
Live Attenuated Influenza Vaccine
Intranasal only

Right Route for Right Vaccine
Inactivated Influenza Vaccine
Intramuscular only

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° Angle
Acromial Process
Axillary Fold

x x
Anterolateral thigh
IM Injections
Deltoid

IM Injections – Infant (6-12 months) Anterolateral thigh Needle gauge - 22 - 25 gauge Needle length - 1 inch

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

Standard Technique for Injection

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.

• 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

TIV Schedule
Age
Group
6-35 mos
3-8 yrs
9 yrs and older
Dose
0.25 mL
0.50 mL
0.50 mL
doses of 2 one dose is needed if the child received Only
* influenza vaccine during the previous influenza season
.
No
Doses
1 or 2
(4 week interval )
1 or 2 (4 week interval)
1

Influenza vaccine dosage for specific ages
months of age35 months up to & including
6
0.25 ml (1 or 2 doses)
2 doses if never been previously immunized with a seasonal influenza vaccine (spaced 4 weeks apart – minimum interval)
1 dose only if previously immunized with seasonal influenza vaccine
years8 years up to & including
3
0.5 ml (1 or 2 doses)
2 doses if never been previously immunized with a seasonal influenza vaccine (spaced 4 weeks apart – minimum interval)
1 dose only if previously immunized with seasonal influenza vaccine
years of age and older
9
0.5 ml (one dose)

Second Vaccination Season
season st1
Doses in
1
2
Doses this Season
2
1
ACIP does not recommend a second dose of influenza vaccine , in the same season except for children 6 months through 8 years of age being vaccinated for the first time
Source: MMWR 2009

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

Any vaccination using less than the standard dose(0.25mL for children 6-35 months; 0.5mL for persons 36 months , and the should not be counted as valid )and olderaccording to age. vaccinated-reperson should be The second dose should be administered at least 4 weeks after the first dose.

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

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

People may become ill from other (non-flu) viruses that circulate during the flu season, which can also cause flu-like symptoms (such as rhinovirus).
A person may be exposed to an influenza virus that is not included in the seasonal flu vaccine. 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

Does seasonal influenza vaccine cause influenza?
The viruses in the inactivated influenza vacine are killed virues while the virues in live attenuated influenza vaccine are weakened, therefore both vaccines cannot cause influenza.

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

Vaccine Storage
Store vaccine between 2º and 8º C at all times.
Vaccine should be placed on the middle shelves of
the refrigerator (not in refrigerator doors).
Influenza vaccine should never be exposed to
freezing temperature!
The vaccine effectiveness can be decreased by
exposure to light

must not be frozen. Vaccine Influenza:
Note 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!

therapeutic •
Who should get a seasonal
flu shot?

Who Should Get Vaccinated
FDA
The Centers for Disease Control 2010 , 24On February Advisory Committee on and Prevention’s (CDC) that ) recommendsImmunization Practices (ACIPeveryone 6 months of age and older receive the influenza vaccine every year
Routine influenza vaccination is recommended
months and older6 for all persons aged

While everyone should get a flu vaccine every year , it’s especially important that certain people get vaccinated either because they are at high risk of having serious flu–related complications or because they live with or care for people at high risk for developing flu–related complications.

FDA
• Pregnant women are or will be pregnant during the influenza season
• Children younger than 5, but especially children younger than 2 years old
• People 50 years of age and older
• People of any age with certain chronic medical conditions

FDA
Persons with the following chronic illnesses should be :considered for inactivated influenza vaccine
Pulmonary (e.g., asthma, COPD)
Cardiovascular (e.g., CHF)
Metabolic (e.g., diabetes)
Renal dysfunction
Hepatic dysfunction
Hemoglobinopathy
Immunosuppression, including HIV infection

FDA
People who live in nursing homes and other long-term care facilities
People who live with or care for those at high risk for : complications from flu, including
• Health care workers
• Household contacts of persons at high risk for complications from the flu
• Household contacts and out of home caregivers of children less than 6 months of age (these children are too young to be vaccinated)

Only 45.3 percent of U.S. health-care personnel were vaccinated in 2007
Persons working in health care settings should be vaccinated annually against influenza.

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.

therapeutic •
Monitoring vaccine safety?

•Local reactions 15% - 20%
•Fever, malaise uncommon
•Allergic reactions rare
•Neurological very rare (Guillain-Barre Syndrome 1 in 1 million)
Adverse Reactions

FDA
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. Life-threatening allergic reactions from vaccines are very rare.
Adverse Reactions

Can influenza vaccination cause Guillain Barré Syndrome ?

Each year about 3,000 to 6,000 people in the United States develop GBS whether or not they received a vaccination. thus, the background rate is 1 to 2 people out of every 100,000.
GBS occurs at a rate of 10---20 cases per 1 million adults, per year, regardless of vaccination
January 14, 2010 CDC
Guillain-Barré Syndrome

Guillain-Barré Syndrome
February 1976: Fort Dix NJ: Swine flu outbreak
45M vaccinated: 500 GBS – 25 died
– GBS rate 1/100,000 (within 6 weeks of vaccine)
000,100additional case of GBS per 1
Approximately swine flu 1976occurred with the vaccinatedpersons led whichincidence,in excess of background vaccineto the withdrawal of the vaccine

Most studies done on seasonal flu vaccines after the 1976 vaccine showed No increased risk of GBS. However, two studies did demonstrate a small risk of approximately 1 additional case of GBS per 1 million persons vaccinated with the seasonal influenza vaccine
The benefit of the vaccine outweighs this theoretical risk
January 14, 2010 CDC
After 1976…

In addition, studies suggest that the risk of developing GBS after having influenza is higher than the potential risk of developing GBS after vaccination

Does the the influenza vaccine contain mercury ?

FDA
All multiple-dose vials of influenza inactivated vaccine contain thimerosal as a mercury- containing preservative. TIV single-dose vials and syringes are either Thimerosal free (Preservative Free) OR Contain only a trace amount of thimerosal. LAIV (nasal sprayers) do not contain thimerosal

FDA
that has been preservativeis a very effective
Thimerosalused to prevent bacterial contamination and fungal growth ( in multi-dose vials of vaccines ) for more than 50 years. ethylmercurymercury known as It is comprised of a type of ,It is different from methylmercury
There is no evidence to suggest that the amount of Thiomersal has been used in vaccines poses a health risk
There is No association between thimerosal-containing vaccines and autism in children.

Who Should Not Be Vaccinated ?

● Influenza vaccine is not approved for use in children
younger than 6 months so they should not be vaccinated,
but their caregivers should be vaccinated instead.
● People who have a severe allergy to chicken eggs
● People who have had a severe reaction to
an influenza vaccination in the past.

● People who have a moderate-to-severe illness with a
fever (they should wait until they recover to get
vaccinated.)
● People who developed Guillian-Barré syndrome (GBS)
within 6 weeks of getting an influenza vaccine (TIV or
LAIV) previously and who are not at risk for severe
illness from influenza should generally not
receive vaccine.

Spacing of Influenza Vaccines and Other Vaccines
Vaccine combination
Spacing
Inactivated influenza and other inactivated vaccine (e.g., PPSV)
Any time
Inactivated influenza and live vaccine (e.g., MMR)
Any time
Live attenuated influenza and inactivated vaccine
Any time
Live attenuated influenza and other live vaccine
Same day or separated by 4 weeks

Seasonal Influenza Vaccination & pregnancy

Pregnant Women at Increased Risk for Severe Influenza illness

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

1.7
2.1
5.1
0
2
4
6
8
1st trimester 2nd trimester 3rd trimester
Rate Ratios
Risk 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

ACIP Recommendations for Seasonal Flu Vaccination
Because pregnant women are at increased risk for influenza complications, seasonal influenza vaccine is recommended for women who will be pregnant during influenza season
This includes all pregnant women in any trimester, regardless of gestational age .

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

The CDC and its ACIP recommend that all pregnant women receive the inactivated seasonal influenza vaccine during any stage of pregnancy.
The live intranasal vaccine is not licensed for use in pregnant women
FDA

Safety of influenza vaccination during pregnancy
11 studies published between 1964 and 2008 about safety of seasonal influenza vaccination during pregnancy
None identified maternal or fetal problems with influenza vaccination
Tamma et al., Am J Obstet Gynecol 2009 Oct 20. [Epub ahead of print]

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 if there is a determination that the vaccine is clearly needed, as recommended by the ACIP
FDA

Postpartum women, should be considered to be at increased risk of influenza-related complications up to 2 weeks postpartum (including following pregnancy loss )
postpartum women can receive LAIV or TIV.

In recommendations regarding seasonal influenza vaccine, ACIP states that either intranasal live influenza vaccine or parenteral inactivated influenza vaccine can be used in nursing women, unless contraindicated

• Seasonal influenza vaccines can be given to pregnant women in any trimester.
• Pregnant women should receive inactivated vaccine (flu shot) but should NOT receive the live attenuated vaccine (nasal spray).
• Postpartum women, even if they are breastfeeding, can receive either inactivated vaccine or live attenuated vaccine (nasal spray).
(AAFP) , (ACOG) , (AMA) (CDC)

Pregnancy and flu are a bad combination, the benefit of vaccination far outweighs any possible risk from the vaccine itself.. The risk is actually in not getting a flu shot
We do have 50 years of experience giving the flu vaccine to women who are or who become pregnant..
Some research that suggests babies born to vaccinated women are less likely to get the flu in their first 6 months of life.

Laboratory-Proven Influenza in Infants Whose
Mothers Received Influenza Vaccine vs Controls
Zaman et al., N Engl J Med 359:1555-64, 2008

Health is a state of complete physical, mental and social well-being & not merely the absence of disease or infirmity .
WHO definition of Health

Doing the right thing sometimes is the hardest thing to do.

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

Seasonal influenza vaccines

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