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These are direct quotes These are direct quotes These are direct quotes These are direct

These are direct quotes


from the FDA memo from the FDA memo from the FDA memo from the FDA memo
Influenza A (H1N1) 2009 Influenza A (H1N1) 2009 Influenza A (H1N1) 2009 Influenza A (H1N1) 2009
Monovalent Vaccine (BLA Monovalent Vaccine (BLA Monovalent Vaccine (BLA Monovalent Vaccine (BLA
1750). A shorter link is 1750). A shorter link is 1750). A shorter link is 1750). A shorter link is
http://bit.ly/FDAmemo. http://bit.ly/FDAmemo. http://bit.ly/FDAmemo. http://bit.ly/FDAmemo.

8.1 "It is also not known 8.1 "It is also not known 8.1 "It is also not known 8.1 "It is also not known
whether Influenza A whether Influenza A whether Influenza A whether Influenza A
(H1N1) 2009 Monovalent (H1N1) 2009 Monovalent (H1N1) 2009 Monovalent (H1N1) 2009 Monovalent
Vaccine or FLUVIRIN Vaccine or FLUVIRIN Vaccine or FLUVIRIN Vaccine or FLUVIRIN
can cause fetal harm can cause fetal harm can cause fetal harm can cause fetal harm
when administered to a when administered to a when administered to a when administered to a
pregnant woman or can pregnant woman or can pregnant woman or can pregnant woman or can
affect reproduction affect reproduction affect reproduction affect reproduction
capacity." capacity." capacity." capacity."

8.4 "Safety and effective- 8.4 "Safety and effective- 8.4 "Safety and effective- 8.4 "Safety and effective-
ness in pediatric subjects ness in pediatric subjects ness in pediatric subjects ness in pediatric subjects
below the age of 4 years below the age of 4 years below the age of 4 years below the age of 4 years
have not been estab- have not been estab- have not been estab- have not been estab-
lished." lished." lished." lished."

6.4 "Neurological disor- 6.4 "Neurological disor- 6.4 "Neurological disor- 6.4 "Neurological disor-
ders temporally associ- ders temporally associ- ders temporally associ- ders temporally associ-
ated with influenza ated with influenza ated with influenza ated with influenza
vaccination such as vaccination such as vaccination such as vaccination such as
encephalopathy, optic encephalopathy, optic encephalopathy, optic encephalopathy, optic
neuritis/neuropathy, neuritis/neuropathy, neuritis/neuropathy, neuritis/neuropathy,
partial facial paralysis, partial facial paralysis, partial facial paralysis, partial facial paralysis,
and brachial plexus and brachial plexus and brachial plexus and brachial plexus
neuropathy have been neuropathy have been neuropathy have been neuropathy have been
reported." reported." reported." reported."

13.1 "Neither FLUVIRIN 13.1 "Neither FLUVIRIN 13.1 "Neither FLUVIRIN 13.1 "Neither FLUVIRIN
nor the Influenza A nor the Influenza A nor the Influenza A nor the Influenza A
(H1N1) 2009 Monovalent (H1N1) 2009 Monovalent (H1N1) 2009 Monovalent (H1N1) 2009 Monovalent
Vaccine have been evalu- Vaccine have been evalu- Vaccine have been evalu- Vaccine have been evalu-
ated for carcinogenic or ated for carcinogenic or ated for carcinogenic or ated for carcinogenic or
mutagenic potential, or mutagenic potential, or mutagenic potential, or mutagenic potential, or
for impairment of fertil- for impairment of fertil- for impairment of fertil- for impairment of fertil-
ity." ity." ity." ity."

Summary: "No controlled Summary: "No controlled Summary: "No controlled Summary: "No controlled
trials documenting a trials documenting a trials documenting a trials documenting a
decrease in influenza decrease in influenza decrease in influenza decrease in influenza
disease after vaccination disease after vaccination disease after vaccination disease after vaccination
with FLUARIX have with FLUARIX have with FLUARIX have with FLUARIX have
been performed." been performed." been performed." been performed."
Tarrant County Liberty Campaign Tarrant County Liberty Campaign Tarrant County Liberty Campaign Tarrant County Liberty Campaign
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