Name/Manufacturer

Pregnancy

Ages

Category

Grown In

Afluria Package Insert

safety and effectiveness of AFLURIA
ages 5-64
(injectable) bioCSL Inc. have not been established in pregnant
women or nursing mothers.

embryonated
eggs

Fluarix Package Insert

(injectable)
GlaxoSmithKline

safety and effectiveness of FLUARIX

3 and up
have not been established in pregnant
women or nursing mothers.

embryonated
eggs

Fluarix Quadrivalent
Package Insert
(injectable)
GlaxoSmithKline

safety and effectiveness of FLUARIX

3 and up
QUADRIVALENT have not been
established pregnant women or nursing
mothers.

embryonated
eggs

Flublok Package Insert

(injectable) Protein
Sciences Corporation

no adequate and well-controlled studies 18-49

in pregnant women. Because animal
reproduction studies are not always
predictive of human response, this
vaccine should be used during
pregnancy only if clearly needed.
(Section 8.1)

insect cells

Flucelvax Package
Insert (injectable)

Canine Kidney

FluLaval Package Insert Safety and effectiveness of FLULAVAL 3 and up

(injectable)
have not been established in pregnant
GlaxoSmithKline
women or nursing mothers.

embryonated
eggs

FluLaval Quadrivalent
Package Insert
(injectable)
GlaxoSmithKline

Safety and effectiveness of FLULAVAL

QUADRIVALENT have not been
established in pregnant women or
nursing mothers.

embryonated
eggs

FluMist Quadrivalent
Package Insert
(intranasal)
MedImmune, Inc.

Safety and effectiveness of FluMist

ages 2-49
Quadrivalent have not been established
in pregnant women, nursing mothers,
geriatric adults, or children less than 2
years of age.

eggs

LIVE VIRUS

Safety and effectiveness of FLUCELVAX 18 and up

have not been established in pregnant
women or nursing mothers.

3 and up

Fluvirin Package Insert

(injectable) Novartis
Vaccines

Safety and effectiveness of FLUVIRIN 4 and up

have not been established in pregnant
women, nursing mothers or children
less than 4 years of age.

embryonated
eggs

Fluzone Package Insert Safety and effectiveness of Fluzone has 6 months

(injectable) Sanofi
not been established in pregnant
and up
Pasteur
women.

embryonated
eggs

Fluzone High-Dose
Package Insert
(injectable) Sanofi
Pasteur

embryonated
eggs

Safety and effectiveness of Fluzone

65 and older
High-Dose has not been established in
pregnant women.

Fluzone Intradermal
Package Insert Sanofi
Pasteur 2014-2015
Info

Safety and effectiveness of Fluzone

18-64
Intradermal have not been established
in pregnant women.

embryonated
eggs

Fluzone Quadrivalent
Package Insert
(injectable) Sanofi
Pasteur

Safety and effectiveness of Fluzone

6 months
Quadrivalent have not been established and up
in pregnant women or children less
than 6 months of age.

embryonated
eggs

B = Animal studies done

C = Animal studies NOT done

Strain Types Included

A/California/7/2009 (H1N1), NYMC X- 181,
A/South Australia/55/2014 (H3N2), IVR-175,
(an A/Switzerland/9715293/2013-like strain)
and B/Phuket/3073/2013.

A/Christchurch/16/2010 NIB-74XP (H1N1) (an

A/Califor nia/7/2009-like virus),
A/Switzerland/9715293/2013 NIB-88 (H3N2),
and B/Phuket/3073/2013.

A/Christchurch/16/2010 NIB-74XP (H1N1) (an

A/California/7/2009-like virus),
A/Switzerland/9715293/2013 NIB-88 (H3N2),
B/Phuket/3073/2013, and
B/Brisbane/60/2008.
A/California/7/2009 (H1N1),
A/Switzerland/9715293/2013(H3N2), and
B/Phuket/3073/2013.

A/Brisbane/10/2010 (wild type) (an

A/California/7/2009 (H1N1)pdm09-like virus);
A/South Australia/55/2014 (wild type) (an
A/Switzerland/9715293/2013 (H3N2)-like
virus); B/Utah/9/2014 (a B/Phuket/3073/2013like virus).
A/California/7/2009 NYMC X-179A (H1N1),
A/Switzerland/9715293/2013 NIB-88 (H3N2),
and B/Phuket/3073/2013.

60 micrograms (mcg) hemagglutinin (HA)

per 0.5-mL dose in the recommended ratio of
15 mcg HA of each of the following 4 viruses
(two A strains and two B strains):
A/California/7/2009 NYMC X-179A (H1N1),
A/Switzerland/9715293/2013 NIB-88 (H3N2),
B/Phuket/3073/2013, and
B/Brisbane/60/2008.

an A/H1N1 strain, an A/H3N2 strain and two B

strains. FluMist Quadrivalent contains B
strains from both the B/Yamagata/16/88 and
the B/Victoria/2/87 lineages.

45 mcg hemagglutinin (HA) per 0.5-mL dose

in the recommended ratio of 15 mcg HA of
each of the following 3 viruses:
A/Christchurch/16/2010, NIB-74 (H1N1) (an
A/California/7/2009 pdm09-like virus);
A/Switzerland/9715293/2013, NIB-88 (H3N2)
(an A/Switzerland/9715293/2013-like virus);
and B/Phuket/3073/2013 - wild type (a
B/Phuket/3073/2013-like virus).

A/California/07/2009 X-179A (H1N1),

A/Switzerland/9715293/2013 NIB-88 (H3N2),
and B/Phuket/3073/2013 (B Yamagata
lineage).

A/California/07/2009 X-179A (H1N1),

A/Switzerland/9715293/2013 NIB-88 (H3N2),
and B/Phuket/3073/2013 (B Yamagata
lineage).

A/California/07/2009 X-179A (H1N1),

A/Texas/50/2012 X-223A (H3N2), and
B/Massachusetts/02/2012 (B Yamagata
lineage).

A/California/07/2009 X-179A (H1N1),

A/Switzerland/9715293/2013 NIB-88 (H3N2),
B/Phuket/3073/2013 (B Yamagata lineage),
B/Brisbane/60/2008 (B Victoria lineage).

Ingredients

Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; th
products contain no preservative. The multi-dose presentation contains thimerosal, added as a preservative; eac
contains 24.5 mcg of mercury. A single 0.5 mL dose of AFLURIA contains sodium chloride (4.1 mg), monobasic so
(80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride
calcium chloride (1.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amo
taurodeoxycholate ( 10 ppm), ovalbumin (< 1 mcg), neomycin sulfate ( 3 nanograms [ng]), polymyxin B ( 0
propiolactone ( 2 ng).

FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal. Each 0.5-mL dose also conta
(TRITONX-100) 0.085 mg, -tocopheryl hydrogen succinate 0.1 mg, and polysorbate 80 (Tween 80) 0.415
may also contain residual a mounts of hydrocortisone 0.0016 mcg, gentamicin sulfate 0.15 mc g, ovalbumin
formaldehyde 5 mcg, and sodium deoxycholate 50 mcg from the manufacturing process.

FLUARIX QUADRIVALENT is formulated without preservatives. FLUARIX QUADRIVALENT does not contain thimero
dose also contains octoxynol-10 (TRITONX-100) 0.115 mg, -tocopheryl hydrogen succinate 0.135 mg, and
(Tween 80) 0.550 mg. Each dose may also contain residual amounts of hydrocortisone 0.0016 mcg, gentamic
mcg, ovalbumin 0.050 mcg, formaldehyde 5 mcg, and sodium deoxycholate 65 mcg from the manufacturin

A single 0.5 mL dose of Flublok contains sodium chloride (4.4 mg), monobasic sodium phosphate (0.195 mcg), di
phosphate (1.3 mg), and polysorbate 20 (Tween20) (27.5 mcg). Each 0.5 mL dose of Flublok may also contain r
of baculovirus and Spodoptera frugiperda cell proteins ( 28.5 mcg), baculovirus and cellular DNA ( 10 ng), an
100 mcg). Flublok contains no egg proteins, antibiotics, or preservatives.

Each dose of FLUCELVAX may contain residual amounts of MDCK cell protein (8.4 mcg), protein other than HA (
MDCK cell DNA ( 10 ng), polysorbate 80 ( 1125 mcg), cetyltrimethlyammonium bromide ( 13.5 mcg), and (<0.5 mcg), which are used in the manufacturing process. FLUCELVAX contains no preservative or antibiotics.The
pre-filled syringes may contain natural rubber latex.

Each 0.5-mL dose of either presentation may also contain residual amounts of ovalbumin (0.3 mcg), formaldeh
sodium deoxycholate (50 mcg), -tocopheryl hydrogen succinate (240 mcg), and polysorbate 80 (665 mcg
manufacturing process. Antibiotics are not used in the manufacture of this vaccine.

The prefilled syringe is formulated without preservatives and does not contain thimerosal. Each 0.5-mL dose fro
vial contains 50 mcg thimerosal (<25 mcg mercury); thimerosal, a mercury derivative, is added as a preservativ
dose of either presentation may also contain residual amounts of ovalbumin (0.3 mcg), formaldehyde (25 mc
deoxycholate (50 mcg), -tocopheryl hydrogen succinate (320 mcg) and polysorbate 80 (887 mcg) from th
process. Antibiotics are not used in the manufacture of this vaccine.

Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin
arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic pot
Each dose contains residual amounts of ovalbumin (< 0.24 mcg/dose), and may also contain residual amounts o
sulfate (< 0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 0.37 mcg/dose). FluMist Quadrivalen
preservatives.

The 0.5-mL prefilled syringe presentation is formulated without preservative. However, thimerosal, a mercury de
during manufacturing, is removed by subsequent purification steps to a trace amount ( 1 mcg mercury per 0.5mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL d
multidose vial contains 25 mcg mercury. Each dose from the multidose vial or from the prefilled syringe may also
amounts of egg proteins ( 1 mcg ovalbumin), polymyxin ( 3.75 mcg), neomycin ( 2.5 mcg), betapropiolacton
0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v). The tip caps of the FLUVIRIN prefilled syring
natural rubber latex. The multidose vial stopper and the syringe stopper/plunger do not contain latex.

Contraindications
History of severe allergic reactions (e.g.,
anaphylaxis) to any component of the
vaccine, including egg protein, or following
a previous dose of any influenza vaccine.

History of severe allergic reactions (e.g.,

anaphylaxis) to any component of the
vaccine, including egg protein, or following
a previous dose of any influenza vaccine.

History of severe allergic reactions (e.g.,

anaphylaxis) to any component of the
vaccine, including egg protein, or following
a previous dose of any influenza vaccine.

Severe allergic reaction (e.g., anaphylaxis)

to any component of the vaccine.

History of severe allergic reactions (e.g.,

anaphylaxis) to any component of the
vaccine.

History of severe allergic reactions (e.g.,

anaphylaxis) to any component of the
vaccine, including egg protein, or following
a previous dose of any influenza vaccine.

History of severe allergic reactions (e.g.,

anaphylaxis) to any component of the
vaccine, including egg protein, or following
a previous dose of any influenza vaccine.

Severe allergic reaction (e.g., anaphylaxis)

to any component of FluMist Quadrivalent,
including egg protein, or after a previous
dose of any influenza vaccine.
Concomitant aspirin therapy in children
and adolescents.

History of severe allergic reactions (e.g.,

anaphylaxis) to egg proteins, or any
component of FLUVIRIN, or lifethreatening reactions to previous influenza
vaccinations.

Severe allergic reaction to any component

of the vaccine, including egg protein, or
after previous dose of any influenza
vaccine.

Severe allergic reaction to any component

of the vaccine, including egg protein, or
after previous dose of any influenza
vaccine. (4)

Severe allergic reaction to any component

of the vaccine, including egg protein, or
after previous dose of any influenza
vaccine. (4)

Severe allergic reaction (e.g., anaphylaxis)

to any component of the vaccine, including
egg protein, or after previous dose of any
influenza vaccine.