Here we go folks. Just say no to tamaflu. It is a Killer

[Rev Sister Lilli]

UK races to halt killer bird flu
POSTED: 6:16 p.m. EST, February 3, 2007
Story Highlights• European Commission confirms UK bird flu outbreak is deadly H5N1 strain
• More than 2,000 turkeys killed by avian influenza at poultry farm in England
• H5N1 strain can be deadly to humans

Adjust font size:
HOLTON, England (Reuters) -- Britain scrambled to contain its first outbreak of the highly pathogenic H5N1 strain of bird flu in domestic poultry on Saturday after the virus was found at a farm run by Europe's biggest turkey producer.

Some 2,500 turkeys have died since Thursday at the Bernard Matthews farm near Lowestoft in eastern England. The Department for the Environment, Food and Rural Affairs (Defra) said all 159,000 turkeys on the farm would be culled.

"We're in new territory," National Farmers' Union Poultry Board chairman Charles Bourns told Reuters. "We've every confidence in Defra but, until we know how this disease arrived, this is a very apprehensive time for all poultry farmers." (Watch how bird flu plays out at the grocery store )

The outbreak mirrored a similar case in which hundreds of turkeys died at a farm in eastern France almost a year ago.

That outbreak was contained and there followed a lull in cases of H5N1 in European poultry until last month, when it was found to have killed thousands of geese on a farm in Hungary.

The strain tends to be transmitted to poultry by infected migrating wildfowl.

It has killed at least 164 people worldwide since 2003, most of them in Asia, and more than 200 million birds have died from it, or been killed to prevent its spread.

But it has not yet fulfilled scientists' worst fears by mutating into a form that could be easily transmitted between humans and possibly cause a global pandemic.

Avian flu expert Colin Butter of the Institute of Animal Health said the British outbreak was surprising as it had happened outside the main bird migration period.

"The next thing we need to know is if this is a primary or secondary case. If this is a secondary case, it is much more serious. If this is the first case, or 'reference case', and we can stamp it out, the outbreak will be controlled," he said.

A protection zone was established with a radius of 3 km (2 miles) and a surveillance zone of 10 km around the infected farm. Bird gatherings such as bird shows and pigeon racing were suspended nationwide.

Further tests were being taken to determine whether it was the Asian strain of the virus. Across the North Sea, Norway, which has had no cases of the deadly birdflu strain, responded to the news by ordering farmers to keep poultry indoors in the area south of Nordland county and banned bird gatherings, such as bird shows and competitions.

Britain's poultry industry is worth 3.4 billion pounds ($6.7 billion), with 800 million birds produced each year.

The Health Protection Agency said the current level of risk to humans from H5N1 was extremely low.

In May, 50,000 chickens at three farms in Norfolk, also in eastern England and home to some of Europe's biggest poultry farms, were culled after another strain, H7N3, was detected.

A wild swan found dead in Scotland in March had the H5N1 version of the virus. It was thought to have caught the disease elsewhere, died at sea and been washed ashore in Scotland.

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Winds near 165 mph created 'moonscape' in Florida
Stunned residents, working in the rain Saturday, poked through debris for pieces of their lives deposited the day before by central Florida storms and a tor ...

[nannymouse]

One hundred and sixty some cases of it worldwide.

There are thousands of strains of the flu that have many many more deaths, and here we are STILL obsessing over one strain. Some entitiy is going to great lengths to keep this fear alive in the minds of the world.

[Rev Sister Lilli]

And if more states mandate that inoculation for the girls prepubecent age Rumsfeld owns Merk and he would gain 360 billion dollars if it was mandated in all states. I read somewhere.

[Rev Sister Lilli]

Swine flu bump up. DO NOT TAKE TAMIFLU!!

The Holy oil works better then a flu shot. I am living proof! Call Roger
Make your donation and stay healthy!

God thats great and thank you for showing us the blessing in this!

[Rev.Johnson]

i was listening to a video and it was said that Tamiflu accelerates as it enables these viruses to mutate and become stronger. I have been having problems with Internet explorer that end up closing the windows i have open so I lost it or i would post it here. if I run across it I will do that.

this is not it but still important.

You Tube

i went to the Tamiflu site and found this...

Side Effects and Safety of TAMIFLU

Rare but serious skin reactions and allergic reactions have been reported. Stop taking TAMIFLU and call your doctor if you experience any of these reactions, as they could be very serious.

People with the flu, particularly children and adolescents, may be at an increased risk of self injury and confusion shortly after taking TAMIFLU and should be closely monitored for signs of unusual behavior. A health care professional should be contacted immediately if the patient taking TAMIFLU shows any signs of unusual behavior.

The most common side effects of TAMIFLU are mild to moderate nausea and vomiting. TAMIFLU is generally well tolerated.

In addition, take the following precautions when using TAMIFLU:

You should not take TAMIFLU if you are allergic to oseltamivir phosphate or any other ingredients of TAMIFLU.
TAMIFLU is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. If you are pregnant, planning to become pregnant or breastfeeding while taking TAMIFLU, talk to your doctor before taking TAMIFLU.
If you have any type of kidney disease, talk to your doctor before starting TAMIFLU therapy.
The use of TAMIFLU along with an intranasal flu vaccine like FluMist has not been evaluated. However, due to the possibility for interference between these products, an intranasal flu vaccine should not be given within 2 weeks before or 48 hours after taking TAMIFLU, unless it is deemed appropriate by your doctor. The type of flu vaccine administered as a shot through the skin can be given at any time relative to use of TAMIFLU.
As with any medication, be sure to discuss with your doctor any over–the–counter or prescription medicines you are currently taking before beginning TAMIFLU therapy.

side effects of FluMist (Vaccination with a Live Virus Vaccine)

FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
FluMist is a vaccine indicated for the active immunization of individuals 2-49 years of age against
influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
2 DOSAGE AND ADMINISTRATION
FOR INTRANASAL ADMINISTRATION BY A HEALTH CARE PROVIDER.
2.1 Dosing Information
FluMist should be administered according to the following schedule:
Age Group Vaccination Status Dosage Schedule
Children age 2 years through Not previously vaccinated 2 doses (0.2 mL* each,
8 years with influenza vaccine at least 1 month apart)
Children age 2 years through Previously vaccinated with 1 dose (0.2 mL*)
8 years influenza vaccine
Children, adolescents and Not applicable 1 dose (0.2 mL*)
adults age 9 through 49 years
* Administer as 0.1 mL per nostril.
For children age 2 years through 8 years who have not previously received influenza vaccine, the
recommended dosage schedule for nasal administration is one 0.2 mL dose (0.1 mL per nostril)
followed by a second 0.2 mL dose (0.1 mL per nostril) given at least 1 month later.
For all other individuals, including children age 2-8 years who have previously received influenza
vaccine, the recommended schedule is one 0.2 mL dose (0.1 mL per nostril).
FluMist should be administered prior to exposure to influenza. Annual revaccination with influenza
vaccine is recommended.
2.2 Administration Instructions
Each sprayer contains a single dose of FluMist; approximately one-half of the contents should be
administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered
into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just
inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dosedivider
clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the
other nostril. Once FluMist has been administered, the sprayer should be disposed of according to the
standard procedures for medical waste (e.g., sharps container or biohazard container).
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FluMist safely and effectively.
See full prescribing information for FluMist.
FluMist® Influenza Virus Vaccine Live, Intranasal
Intranasal Spray
2008-2009 Formula
Initial U.S. Approval: 2003
- - - - - - - - - - - - - - - - - - - - - - - - RECENT MAJOR CHANGES - - - - - - - - - - - - - - - - - - - - - - - -
Indications and Usage (1) 9/2007
Dosage and Administration, Dosing Information (2.1) 9/2007
Warnings and Precautions (5) 9/2007
- - - - - - - - - - - - - - - - - - - - - - - - INDICATIONS AND USAGE - - - - - - - - - - - - - - - - - - - - - - - -
FluMist is a vaccine indicated for the active immunization of individuals 2-49 years of age against
influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. (1)
- - - - - - - - - - - - - - - - - - - - - - DOSAGE AND ADMINISTRATION - - - - - - - - - - - - - - - - - - - - - -
For intranasal administration by a health care provider.
Age Group Vaccination Status Dosage Schedule
Children (2-8 years) Not previously vaccinated 2 doses (0.2 mL* each,
with influenza vaccine at least 1 month apart) (2.1)
Children (2-8 years) Previously vaccinated with 1 dose (0.2 mL*) (2.1)
influenza vaccine
Children, adolescents Not applicable 1 dose (0.2 mL*) (2.1)
and adults (9-49 years)
* Administer as 0.1 mL per nostril.
- - - - - - - - - - - - - - - - - - - - - DOSAGE FORMS AND STRENGTHS - - - - - - - - - - - - - - - - - - - -
0.2 mL pre-filled, single-use intranasal spray (3)
Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza
virus reassortants of each of the three strains for the 2008-2009 season: A/South Dakota/6/2007
(H1N1) (A/Brisbane/59/2007-like), A/Uruguay/716/2007 (H3N2) (A/Brisbane/10/2007-like), and
B/Florida/4/2006. (3)
- - - - - - - - - - - - - - - - - - - - - - - - - CONTRAINDICATIONS - - - - - - - - - - - - - - - - - - - - - - - - -
• Hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or life threatening reactions
to previous influenza vaccination. (4.1)
• Concomitant aspirin therapy in children and adolescents. (4.2)
- - - - - - - - - - - - - - - - - - - - - - WARNINGS AND PRECAUTIONS - - - - - - - - - - - - - - - - - - - - - -
• Do not administer FluMist to children <24 months of age because of increased risk of hospitalization
and wheezing observed in clinical trials. (5.1)
• FluMist should not be administered to any individuals with asthma or children < 5 years of age with
recurrent wheezing because of the potential for increased risk of wheezing post vaccination. (5.2)
• If Guillain-Barré syndrome has occurred with any prior influenza vaccination, the decision to give
FluMist should be based on careful consideration of the potential benefits and risks. (5.3)
• Administration of FluMist, a live virus vaccine, to immunocompromised persons should be based
on careful consideration of potential benefits and risks. (5.4)
• Safety has not been established in individuals with underlying medical conditions predisposing
them to wild-type influenza infection complications. (5.5)
- - - - - - - - - - - - - - - - - - - - - - - - - ADVERSE REACTIONS - - - - - - - - - - - - - - - - - - - - - - - - -
Most common adverse reactions (≥ 10% in FluMist and at least 5% greater than in control) are runny nose
or nasal congestion in all ages, fever >100°F in children 2-6 years of age, and sore throat in adults. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact MedImmune at 1-877-633-4411 or VAERS at
1-800-822-7967 or http://vaers.hhs.gov.
- - - - - - - - - - - - - - - - - - - - - - - - - DRUG INTERACTIONS - - - - - - - - - - - - - - - - - - - - - - - - -
• Antiviral agents active against influenza A and/or B: Do not administer FluMist until 48 hours after
antiviral cessation. Antiviral agents should not be administered until 2 weeks after FluMist administration
unless medically necessary. (7.2)
- - - - - - - - - - - - - - - - - - - - - - USE IN SPECIFIC POPULATIONS - - - - - - - - - - - - - - - - - - - - - -
• Safety and effectiveness of FluMist have not been studied in pregnant women or nursing mothers.
(8.1, 8.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 06/2008
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Concomitant Pediatric and Adolescent Aspirin Therapy and Reye’s Syndrome
5 WARNINGS AND PRECAUTIONS
5.1 Risks in Children <24 Months of Age
5.2 Asthma/Recurrent Wheezing
5.3 Guillain-Barré Syndrome
5.4 Altered Immunocompetence
5.5 Medical Conditions Predisposing to Influenza Complications
5.6 Preventing and Managing Allergic Vaccine Reactions
5.7 Limitations of Vaccine Effectiveness
6 ADVERSE REACTIONS
6.1 Adverse Reactions in Clinical Trials
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Aspirin Therapy
7.2 Antiviral Agents Against Influenza A and/or B
7.3 Concomitant Inactivated Vaccines
7.4 Concomitant Live Vaccines
7.5 Intranasal Products
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Use in Individuals 50-64 Years of Age
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Biodistribution
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Studies in Children and Adolescents
14.2 Study in Adults
14.3 Study in Adults with HIV Infection
14.4 Refrigerated Formulation Study
14.5 Transmission Study
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Asthma and Recurrent Wheezing
17.2 Vaccination with Live Viral Vaccines
17.3 Adverse Event Reporting
*Sections or subsections omitted from the full prescribing information are not listed.
Note:
Active inhalation (i.e., sniffing) is
not required by the patient during
FluMist administration.
3 DOSAGE FORMS AND STRENGTHS
0.2 mL pre-filled, single-use intranasal spray.
Each 0.2 mL dose of FluMist is formulated to contain 106.5-7.5 FFU (fluorescent focus units) of each of
three live attenuated influenza virus reassortants: A/South Dakota/6/2007 (H1N1) (A/Brisbane/59/2007-
like), A/Uruguay/716/2007 (H3N2) (A/Brisbane/10/2007-like), and B/Florida/4/2006 [1].
4 CONTRAINDICATIONS
4.1 Hypersensitivity
FluMist is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic
reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to
previous influenza vaccinations.
4.2 Concomitant Pediatric and Adolescent Aspirin Therapy and Reye’s Syndrome
FluMist is contraindicated in children and adolescents (2-17 years of age) receiving aspirin therapy or
aspirin-containing therapy, because of the association of Reye’s syndrome with aspirin and wild-type
influenza infection.
5 WARNINGS AND PRECAUTIONS
5.1 Risks in Children <24 Months of Age
Do not administer FluMist to children <24 months of age. In clinical trials, an increased risk of
wheezing post-vaccination was observed in FluMist recipients <24 months of age. An increase
in hospitalizations was observed in children <24 months of age after vaccination with FluMist.
[See Adverse Reactions (6.1).]
5.2 Asthma/Recurrent Wheezing
FluMist should not be administered to any individuals with asthma or children <5 years of age with
recurrent wheezing because of the potential for increased risk of wheezing post vaccination unless the
potential benefit outweighs the potential risk.
Do not administer FluMist to individuals with severe asthma or active wheezing because these individuals
have not been studied in clinical trials.
5.3 Guillain-Barré Syndrome
If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision
to give FluMist should be based on careful consideration of the potential benefits and potential risks
[see also Adverse Reactions (6.2)].
5.4 Altered Immunocompetence
Administration of FluMist, a live virus vaccine, to immunocompromised persons should be based on
careful consideration of potential benefits and risks. Although FluMist was studied in 57 asymptomatic
or mildly symptomatic adults with HIV infection [see Clinical Studies (14.3)], data supporting the
safety and effectiveness of FluMist administration in immunocompromised individuals are limited.
5.5 Medical Conditions Predisposing to Influenza Complications
The safety of FluMist in individuals with underlying medical conditions that may predispose them to
complications following wild-type influenza infection has not been established. FluMist should not be
administered unless the potential benefit outweighs the potential risk.
5.6 Management of Acute Allergic Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic
reactions following administration of the vaccine [see Contraindications (4.1)].
5.7 Limitations of Vaccine Effectiveness
FluMist may not protect all individuals receiving the vaccine.
6 ADVERSE REACTIONS
FluMist is not indicated in children <24 months of age. In a clinical trial, among children 6-23 months
of age, wheezing requiring bronchodilator therapy or with significant respiratory symptoms occurred
in 5.9% of FluMist recipients compared to 3.8% of active control (injectable influenza vaccine made by
Sanofi Pasteur Inc.) recipients (Relative Risk 1.5, 95% CI: 1.2, 2.1). Wheezing was not increased in
children ≥24 months of age.
Hypersensitivity, including anaphylactic reaction, has been reported post-marketing.
[See Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2).]
6.1 Adverse Reactions in Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed
in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug
and may not reflect the rates observed in practice.
A total of 9537 children and adolescents 1-17 years of age and 3041 adults 18-64 years of age received
FluMist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019 and AV009
described below. In addition, 4179 children 6-59 months of age received FluMist in Study MI-CP111,
a randomized, active-controlled trial. Among pediatric FluMist recipients 6 months-17 years of age,
50% were female; in the study of adults, 55% were female. In MI-CP111, AV006, D153-P526, AV019
and AV009, subjects were White (71%), Hispanic (11%), Asian (7%), Black (6%), and Other (5%),
while in D153-P501, 99% of subjects were Asian.
Adverse Reactions in Children and Adolescents
In a placebo-controlled safety study (AV019) conducted in a large Health Maintenance Organization
(HMO) in children 1-17 years of age (n = 9689), an increase in asthma events, captured by review of
diagnostic codes, was observed in children <5 years of age (Relative Risk 3.53, 90% CI: 1.1, 15.7).
This observation was prospectively evaluated in Study MI-CP111.
In MI-CP111, an active-controlled study, increases in wheezing and hospitalization (for any cause) were
observed in children <24 months of age, as shown in Table 1.
Table 1
Percentages of Children with Hospitalizations and Wheezing from MI-CP111
Adverse Reaction Age Group FluMist Active Controla
Hospitalizationsb 6-23 months (n = 3967) 4.2 % 3.2 %
24-59 months (n= 4385) 2.1 % 2.5 %
Wheezingc 6-23 months (n = 3967) 5.9 % 3.8 %
24-59 months (n = 4385) 2.1 % 2.5 %
a Injectable influenza vaccine made by Sanofi Pasteur Inc.
b From randomization through 180 days post last vaccination.
c Wheezing requiring bronchodilator therapy or with significant respiratory symptoms evaluated
from randomization through 42 days post last vaccination.
Most hospitalizations observed were gastrointestinal and respiratory tract infections and occurred
more than 6 weeks post vaccination. In post hoc analysis, rates of hospitalization in children 6-11
months of age (n = 1376) were 6.1% in FluMist recipients and 2.6% in active control recipients.
Table 2 shows an analysis of pooled solicited events, occurring in at least 1% of FluMist recipients and
at a higher rate compared to placebo, post Dose 1 for Study D153-P501 and AV006 and solicited
events post Dose 1 for Study MI-CP111. Solicited events were those about which parents/guardians
were specifically queried after vaccination with FluMist. In these studies, solicited events were documented
for 10 days post vaccination. Solicited events post Dose 2 for FluMist were similar to those
post Dose 1 and were generally observed at a lower frequency.
Table 2
Summary of Solicited Events Observed within 10 Days after Dose 1 for
Vaccinea and either Placebo or Active Control Recipients; Children 2-6 Years of Age
D153-P501 & AV006 MI-CP111
FluMist Placebo FluMist Active Controlb
N=876-1759c N=424-1034c N=2170c N=2165c
Event % % % %
Runny Nose/
Nasal Congestion 58 50 51 42
Decreased Appetite 21 17 13 12
Irritability 21 19 12 11
Decreased Activity
(Lethargy) 14 11 7 6
Sore Throat 11 9 5 6
Headache 9 7 3 3
Muscle Aches 6 3 2 2
Chills 4 3 2 2
Fever
100-101°F Oral 9 6 6 4
101-102°F Oral 4 3 4 3
a Frozen formulation used in AV006; Refrigerated formulation used in D153-P501 and MI-CP111.
b Injectable influenza vaccine made by Sanofi Pasteur Inc.
c Number of evaluable subjects (those who returned diary cards) for each event. Range reflects
differences in data collection between the 2 pooled studies.
In clinical studies D153-P501 and AV006, other adverse reactions in children occurring in at least 1%
of FluMist recipients and at a higher rate compared to placebo were: abdominal pain (2% FluMist vs.
0% placebo) and otitis media (3% FluMist vs. 1% placebo).
An additional adverse reaction identified in the active-controlled trial, MI-CP111, occurring in at least
1% of FluMist recipients and at a higher rate compared to active control was sneezing (2% FluMist vs.
1% active control).
In a separate trial (MI-CP112) that compared the refrigerated and frozen formulations of FluMist in
children and adults 5-49 years of age, the solicited events and other adverse events were consistent
with observations from previous trials. Fever of >103°F was observed in 1 to 2% of children 5-8 years
of age.
In a separate placebo-controlled trial (D153-P526) using the refrigerated formulation in a subset of
older children and adolescents 9-17 years of age who received one dose of FluMist, the solicited events
and other adverse events were generally consistent with observations from previous trials. Abdominal
pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients and decreased
activity was reported in 6% of FluMist recipients compared to 0% of placebo recipients.
Adverse Reactions in Adults
In adults 18-49 years of age in Study AV009, summary of solicited adverse events occurring in at least
1% of FluMist recipients and at a higher rate compared to placebo include runny nose (44% FluMist
vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17%
placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15%
placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo).
In addition to the solicited events, other adverse reactions from Study AV009 occurring in at least 1%
of FluMist recipients and at a higher rate compared to placebo were: nasal congestion (9% FluMist vs.
2% placebo) and sinusitis (4% FluMist vs. 2% placebo).
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of FluMist. Because these
reactions are reported voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Congenital, familial and genetic disorder: Exacerbation of symptoms of mitochondrial encephalomyopathy
(Leigh syndrome).
Gastrointestinal disorders: Nausea, vomiting, diarrhea
Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema
and urticaria)
Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy
Respiratory, thoracic and mediastinal disorders: Epistaxis
Skin and subcutaneous tissue disorders: Rash
7 DRUG INTERACTIONS
7.1 Aspirin Therapy
Do not administer FluMist to children or adolescents who are receiving aspirin therapy or aspirincontaining
therapy [see Contraindications (4.2)].
7.2 Antiviral Agents Against Influenza A and/or B
The concurrent use of FluMist with antiviral agents that are active against influenza A and/or B viruses
has not been evaluated. However, based upon the potential for antiviral agents to reduce the effectiveness
of FluMist, do not administer FluMist until 48 hours after the cessation of antiviral therapy and
antiviral agents should not be administered until two weeks after administration of FluMist unless
medically indicated. If antiviral agents and FluMist are administered concomitantly, revaccination
should be considered when appropriate.
7.3 Concomitant Inactivated Vaccines
The safety and immunogenicity of FluMist when administered concurrently with inactivated vaccines
have not been determined. Studies of FluMist excluded subjects who received any inactivated or
subunit vaccine within two weeks of enrollment. Therefore, healthcare providers should consider the
risks and benefits of concurrent administration of FluMist with inactivated vaccines.
7.4 Concomitant Live Vaccines
Concurrent administration of FluMist with the measles, mumps and rubella vaccine and the varicella
vaccine was studied in 1245 children 12-15 months of age. Adverse events were similar to those seen
in other clinical trials with FluMist [see Adverse Reactions (6.1)]. No evidence of interference with
immune responses to measles, mumps, rubella, varicella and FluMist vaccines was observed. The
safety and immunogenicity in children >15 months of age have not been studied.
7.5 Intranasal Products
There are no data regarding co-administration of FluMist with other intranasal preparations.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with FluMist. It is not known whether FluMist
can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
FluMist should be given to a pregnant woman only if clearly needed.
The effect of the vaccine on embryo-fetal and pre-weaning development was evaluated in a developmental
toxicity study using pregnant rats receiving the frozen formulation. Groups of animals were
administered the vaccine either once (during the period of organogenesis on gestation day 6) or twice
(prior to gestation and during the period of organogenesis on gestation day 6), 250 microliter/rat/
occasion (approximately 110-140 human dose equivalents), by intranasal instillation. No adverse effects
on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There
were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study.
8.3 Nursing Mothers
It is not known whether FluMist is excreted in human milk. Therefore, as some viruses are excreted
in human milk and additionally, because of the possibility of shedding of vaccine virus and the close
proximity of a nursing infant and mother, caution should be exercised if FluMist is administered to
nursing mothers.
8.4 Pediatric Use
Safety and effectiveness of the vaccine has been demonstrated for children 2 years of age and older
with reduction in culture-confirmed influenza rates compared to active control (injectable influenza
vaccine made by Sanofi Pasteur Inc.) and placebo [see Clinical Studies (14.1)]. FluMist is not
indicated for use in children <24 months of age. FluMist use in children <24 months has been
associated with increased risk of hospitalization and wheezing in clinical trials [see Warnings and
Precautions (5.1) and Adverse Reactions (6.1)].
8.5 Geriatric Use
FluMist is not indicated for use in individuals ≥65 years of age. Subjects with underlying high-risk
medical conditions (n=200) were studied for safety. Compared to controls, FluMist recipients had a
higher rate of sore throat.
8.6 Use in Individuals 50-64 Years of Age
FluMist is not indicated for use in individuals 50-64 years of age. In Study AV009, effectiveness was
not demonstrated in individuals 50-64 years of age (n=641). Solicited adverse events were similar in
type and frequency to those reported in younger adults.
11 DESCRIPTION
FluMist (Influenza Virus Vaccine Live, Intranasal) is a live trivalent vaccine for administration by
intranasal spray. The influenza virus strains in FluMist are (a) cold-adapted (ca) (i.e., they replicate
efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses);
(b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strains) or 39°C
(Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c)
attenuated (att) (they do not produce classic influenza-like illness in the ferret model of human influenza
infection). The cumulative effect of the antigenic properties and the ca, ts, and att phenotypes is that
the attenuated vaccine viruses replicate in the nasopharynx to induce protective immunity.
No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135
of possible 250 recovered isolates) [see Clinical Studies (14.5)]. For each of the three reassortant
strains in FluMist, the six internal gene segments responsible for ca, ts, and att phenotypes are derived
from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins,
hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant
wild-type influenza viruses that have been recommended by the USPHS for inclusion in the annual
vaccine formulation. Thus, the three viruses contained in FluMist maintain the replication characteristics
and phenotypic properties of the MDV and express the HA and NA of wild-type viruses that are
related to strains expected to circulate during the 2008-2009 influenza season. For the Type A MDV, at
least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes.
For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to
both the ts and att properties; five genetic loci in three gene segments control the ca property.
Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to
allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled and then clarified
by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain
the final sucrose and potassium phosphate concentrations. Ethylene diamine tetracetic acid (EDTA) is
added to the dilution buffer for H3N2 strains. The viral harvests are then sterile filtered to produce the
monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by
in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the three strains are
subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to
produce the trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for
nasal administration.
Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains
106.5-7.5 FFU of live attenuated influenza virus reassortants of each of the three strains: A/South
Dakota/6/2007 (H1N1) (A/Brisbane/59/2007-like), A/Uruguay/716/2007 (H3N2) (A/Brisbane/10/2007-
like), and B/Florida/4/2006 [1]. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate,
2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose,
2.26 mg/dose dibasic potassium phosphate, 0.96 mg/dose monosodium phosphate, and
<0.015 mcg/mL gentamicin sulfate. FluMist contains no preservatives.
The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily
deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow liquid and is clear to
slightly cloudy.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are
not fully understood. Likewise, naturally acquired immunity to wild-type influenza has not been
completely elucidated. Serum antibodies, mucosal antibodies and influenza-specific T cells may play a
role in prevention and recovery from infection.
Influenza illness and its complications follow infection with influenza viruses. Global surveillance of
influenza identifies yearly antigenic variants. For example, since 1977, antigenic variants of influenza A
(H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Antibody against one
influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody
to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same
type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic
basis for seasonal epidemics and the reason for the usual change of one or more new strains in each
year’s influenza vaccine. Therefore, influenza vaccines are standardized to contain the strains (i.e.,
typically two type A and one type B), representing the influenza viruses likely to be circulating in the
United States in the upcoming winter.
Annual revaccination with the current vaccine is recommended because immunity declines during the
year after vaccination, and because circulating strains of influenza virus change from year to year.
12.2 Biodistribution
A biodistribution study of intranasally administered radiolabeled placebo was conducted in 7 healthy
adult volunteers. The mean percentage of the delivered doses detected were as follows: nasal
cavity 89.7%, stomach 2.6%, brain 2.4%, and lung 0.4%. The clinical significance of these findings
is unknown.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
FluMist has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair
fertility.
14 CLINICAL STUDIES
FluMist, in refrigerated and frozen formulations, was administered to approximately 35,000 subjects in
controlled clinical studies. FluMist has been studied in placebo-controlled trials over multiple years,
using different vaccine strains. Comparative efficacy has been studied where FluMist was compared to
an inactivated influenza vaccine made by Sanofi Pasteur Inc.
14.1 Studies in Children and Adolescents
Study MI-CP111: Pediatric Comparative Study
A multinational, randomized, double-blind, active-controlled trial (MI-CP111) was performed to assess
the efficacy and safety of FluMist compared to an injectable influenza vaccine made by Sanofi Pasteur
Inc. (active control) in children <5 years of age, using the refrigerated formulation. During the 2004-
2005 influenza season, a total number of 3916 children <5 years of age and without severe asthma,
without use of bronchodilator or steroids and without wheezing within the prior 6 weeks were randomized
to FluMist and 3936 were randomized to active control. Participants were then followed through
the influenza season to identify illness caused by influenza virus. As the primary endpoint, cultureconfirmed
modified CDC-ILI (CDC-defined influenza-like illness) was defined as a positive culture for
a wild-type influenza virus associated within ±7 days of modified CDC-ILI. Modified CDC-ILI was
defined as fever (temperature ≥100°F oral or equivalent) plus cough, sore throat, or runny nose/nasal
congestion on the same or consecutive days.
In the primary efficacy analysis, FluMist demonstrated a 44.5% (95% CI: 22.4, 60.6) reduction in
influenza rate compared to active control as measured by culture-confirmed modified CDC-ILI caused
by wild-type strains antigenically similar to those contained in the vaccine. See Table 3 for a description
of the results by strain and antigenic similarity.
Table 3
Comparative Efficacy against Culture-Confirmed Modified CDC-ILIa Caused by
Wild-Type Strains in Children <5 Years of Age
FluMist Active Controlb %
Reduction 95% CI
# of Rate # of Rate in Rate for
N Cases (cases/N) N Cases (cases/N) FluMistc
Matched Strains
All strains 3916 53 1.4% 3936 93 2.4% 44.5% 22.4, 60.6
A/H1N1 3916 3 0.1% 3936 27 0.7% 89.2% 67.7, 97.4
A/H3N2 3916 0 0.0% 3936 0 0.0% — —
B 3916 50 1.3% 3936 67 1.7% 27.3% -4.8, 49.9
Mismatched Strains
All strains 3916 102 2.6% 3936 245 6.2% 58.2% 47.4, 67.0
A/H1N1 3916 0 0.0% 3936 0 0.0% — —
A/H3N2 3916 37 0.9% 3936 178 4.5% 79.2% 70.6, 85.7
B 3916 66 1.7% 3936 71 1.8% 6.3% -31.6, 33.3
Regardless of Match
All strains 3916 153 3.9% 3936 338 8.6% 54.9% 45.4, 62.9
A/H1N1 3916 3 0.1% 3936 27 0.7% 89.2% 67.7, 97.4
A/H3N2 3916 37 0.9% 3936 178 4.5% 79.2% 70.6, 85.7
B 3916 115 2.9% 3936 136 3.5% 16.1% -7.7, 34.7
ATP Population.
a Modified CDC-ILI was defined as fever (temperature ≥100°F oral or equivalent) plus cough, sore
throat, or runny nose/nasal congestion on the same or consecutive days.
b Injectable influenza vaccine made by Sanofi Pasteur Inc.
c Reduction in rate was adjusted for country, age, prior influenza vaccination status, and wheezing
history status.
Study D153-P501: Pediatric Study
A randomized, double-blind, placebo-controlled trial (D153-P501) was performed to evaluate the
efficacy of FluMist in children 12 to 35 months of age without high-risk medical conditions against
culture-confirmed influenza illness, using the refrigerated formulation. A total of 3174 children were
randomized 3:2 (vaccinelacebo) to receive 2 doses of study vaccine or placebo at least 28 days apart
in Year 1. See Table 4 for a description of the results.
Study AV006: Pediatric Study
AV006 was a multi-center, randomized, double-blind, placebo-controlled trial performed in U.S. children
without high-risk medical conditions to evaluate the efficacy of FluMist against culture-confirmed
influenza over two successive seasons using the frozen formulation. The primary endpoint of the trial
was the prevention of culture-confirmed influenza illness due to antigenically matched wild-type
influenza in children, who received two doses of vaccine in the first year and a single revaccination dose
in the second year. During the first year of the study 1602 children 15-71 months of age were randomized
2:1 (vaccinelacebo). Approximately 85% of the participants in the first year returned for the
second year of the study. In Year 2, children remained in the same treatment group as in year one
and received a single dose of FluMist or placebo. See Table 4 for a description of the results.
Table 4
D153-P501 & AV006, Years 1a: Efficacy of FluMist vs. Placebo against
Culture-Confirmed Influenza Illness due to Wild-Type Strains
D153-P501 AV006
FluMist Placebo % Efficacy FluMist Placebo % Efficacy
nb (%) nb (%) (95% CI) nb (%) nb (%) (95% CI)
Nc=1653 Nc=1111 Nc=849 Nc=410
Any strain 56 (3.4%) 139 (12.5%) 72.9%d 10 (1%) 73 (18%) 93.4%
(62.8, 80.5) (87.5, 96.5)
A/H1N1 23 (1.4%) 81 (7.3%) 80.9% 0 0 —
(69.4, 88.5)e
A/H3N2 4 (0.2%) 27 (2.4%) 90.0% 4 (0.5%) 48 (12%) 96.0%
(71.4, 97.5) (89.4, 98.5)
B 29 (1.8%) 35 (3.2%) 44.3% 6 (0.7%) 31 (7%) 90.5%
(6.2, 67.2) (78.0, 95.9)
a D153-P501 and AV006 data are for subjects who received two doses of study vaccine.
b Number and percent of subjects in per-protocol efficacy analysis population with culture-confirmed
influenza illness.
c Number of subjects in per-protocol efficacy analysis population of each treatment group of each
study for the “any strain” analysis.
d For D153-P501, influenza circulated through 12 months following vaccination.
e Estimate includes A/H1N1 and A/H1N2 strains. Both were considered antigenically similar to the
vaccine.
During the second year of Study AV006, the primary circulating strain was the A/Sydney/05/97 H3N2
strain, which was antigenically dissimilar from the H3N2 strain represented in the vaccine,
A/Wuhan/359/95; FluMist demonstrated 87.0% (95% CI: 77.0, 92.6) efficacy against cultureconfirmed
influenza illness.
14.2 Study in Adults
AV009 was a multi-center, randomized, double-blind, placebo-controlled trial to evaluate effectiveness
in adults 18-64 years of age without high-risk medical conditions. Participants were randomized 2:1,
vaccinelacebo. Cultures for influenza virus were not obtained from subjects in the trial, so that the
efficacy against culture-confirmed influenza was not assessed. The A/Wuhan/359/95 (H3N2) strain,
which was contained in FluMist, was antigenically distinct from the predominant circulating strain of
influenza virus during the trial period, A/Sydney/05/97 (H3N2). Type A/Wuhan (H3N2) and Type B
strains also circulated in the U.S. during the study period. The primary endpoint of the trial was the
reduction in the proportion of participants with one or more episodes of any febrile illness and prospective
secondary endpoints were severe febrile illness, and febrile upper respiratory illness. Effectiveness
for any of the three endpoints was not demonstrated in a subgroup of adults 50-64 years of age.
Primary and secondary effectiveness endpoints from the age group 18-49 years of age are presented
in Table 5. Effectiveness was not demonstrated for the primary endpoint in adults 18-49 years of age.
Table 5
Effectiveness of FluMista in Adults 18–49 Years of Age
During the 7-week Site-Specific Outbreak Period
FluMist Placebo
Endpoint N=2411b N=1226b Percent (95% CI)
n (%) n (%) Reduction
Participants with one or
more events of:c
Primary Endpoint:
Any febrile illness 331 (13.73) 189 (15.42) 10.9 (-5.1, 24.4)
Secondary Endpoints:
Severe febrile illness 250 (10.37) 158 (12.89) 19.5 (3.0, 33.2)
Febrile upper respiratory
illness 213 (8.83) 142 (11.5 23.7 (6.7, 37.5)
a Frozen formulation used.
b Number of evaluable subjects (92.7% and 93.0% of FluMist and placebo recipients, respectively).
c The predominantly circulating virus during the trial period was A/Sydney/05/97 (H3N2), an antigenic
variant not included in the vaccine.
Effectiveness was shown in a post-hoc analysis using CDC-ILI in the age group 18-49 years.
14.3 Study in Adults with Human Immunodeficiency Virus (HIV) Infection
Safety and shedding of vaccine virus following FluMist administration were evaluated in 57 HIV-infected
[median CD4 cell count of 541 cells/mm3] and 54 HIV-negative adults 18-58 years of age in a randomized,
double-blind, placebo controlled trial using the frozen formulation. No serious adverse events were
reported during the one-month follow-up period. Vaccine strain (type B) virus was detected in 1 of
28 HIV-infected subjects on Day 5 only and none of the HIV-negative FluMist recipients. No adverse
effects on HIV viral load or CD4 counts were identified following FluMist. The effectiveness of FluMist in
preventing influenza illness in HIV-infected individuals has not been evaluated.
14.4 Refrigerated Formulation Study
A double-blind, randomized multi-center trial was conducted to evaluate the comparative immunogenicity
and safety of refrigerated and frozen formulations of FluMist in individuals 5 to 49 years of age
without high risk medical conditions. Nine hundred and eighty-one subjects were randomized at a 1:1
ratio to receive either vaccine formulation. Subjects 5-8 years of age received two doses of study
vaccine 46-60 days apart; subjects 9-49 years of age received one dose of study vaccine. The study
met its primary endpoint. The GMT ratios of refrigerated and frozen formulations (adjusted for baseline
serostatus) for H1N1, H3N2 and B strains, respectively, were 1.24, 1.02 and 1.00 in the two dose
group and 1.14, 1.12 and 0.96 in the one dose group.
14.5 Transmission Study
FluMist contains live attenuated influenza viruses that must infect and replicate in cells lining the
nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication
can be cultured from nasal secretions obtained from vaccine recipients. The relationship of viral
replication in a vaccine recipient and transmission of vaccine viruses to other individuals has not
been established.
Using the frozen formulation, a prospective, randomized, double-blind, placebo-controlled trial
was performed in a daycare setting in children <3 years of age to assess the transmission of vaccine
viruses from a vaccinated individual to a non-vaccinated individual. A total of 197 children 8-36 months
of age were randomized to receive one dose of FluMist (n=9 or placebo (n=99). Virus shedding was
evaluated for 21 days by culture of nasal swab specimens. Wild-type A (H3N2) influenza virus was
documented to have circulated in the community and in the study population during the trial, whereas
Type A (H1N1) and Type B strains did not.
At least one vaccine strain was isolated from 80% of FluMist recipients; strains were recovered
from 1-21 days post vaccination (mean duration of 7.6 days ± 3.4 days). The cold-adapted (ca) and
temperature-sensitive (ts) phenotypes were preserved in 135 tested of 250 strains isolated at the local
laboratory. Ten influenza isolates (9 influenza A, 1 influenza B) were cultured from a total of seven
placebo subjects. One placebo subject had mild symptomatic Type B virus infection confirmed as a
transmitted vaccine virus by a FluMist recipient in the same playgroup. This Type B isolate retained the
ca, ts, and att phenotypes of the vaccine strain, and had the same genetic sequence when compared
to a Type B virus cultured from a vaccine recipient within the same playgroup. Four of the influenza
Type A isolates were confirmed as wild-type A/Panama (H3N2). The remaining isolates could not be
further characterized.
Assuming a single transmission event (isolation of the Type B vaccine strain), the probability of a young
child acquiring vaccine virus following close contact with a single FluMist vaccinee in this daycare
setting was 0.58% (95% CI: 0, 1.7) based on the Reed-Frost model. With documented transmission
of one Type B in one placebo subject and possible transmission of Type A viruses in four placebo
subjects, the probability of acquiring a transmitted vaccine virus was estimated to be 2.4% (95%
CI: 0.13, 4.6), using the Reed-Frost model.
The duration of FluMist vaccine virus replication and shedding have not been established.
15 REFERENCES
1. Centers for Disease Control and Prevention. Prevention and Control of Influenza:
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR
2007;56(RR-6):1-54.
16 HOW SUPPLIED/STORAGE AND HANDLING
FluMist is supplied for intranasal delivery in a package of 10 pre-filled, single-use sprayers.
NDC 66019-106-01
Storage and Handling
Once FluMist has been administered, the sprayer should be disposed of according to the standard
procedures for medical waste (e.g., sharps container or biohazard container).
FLUMIST SHOULD BE STORED IN A REFRIGERATOR BETWEEN 2-8°C (35-46°F) UPON RECEIPT AND
UNTIL USE. THE PRODUCT MUST BE USED BEFORE THE EXPIRATION DATE ON THE SPRAYER
LABEL.
DO NOT FREEZE.
The cold chain (2 to 8°C) must be maintained when transporting FluMist.
17 PATIENT COUNSELING INFORMATION
Vaccine recipients or their parents/guardians should be informed by the health care provider of
the potential benefits and risks of FluMist, and the need for two doses at least 1 month apart in
children 2-8 years old who have not previously received influenza vaccine.
17.1 Asthma and Recurrent Wheezing
Ask the vaccinee or their parent/guardian if the vaccinee has asthma. For children <5 years of age, also
ask if the vaccinee has recurrent wheezing since this may be an asthma equivalent in this age group.
17.2 Vaccination with a Live Virus Vaccine
Vaccine recipients or their parents/guardians should be informed by the health care provider
that FluMist is an attenuated live virus vaccine and has the potential for transmission to immunocompromised
household contacts.
17.3 Adverse Event Reporting
The vaccine recipient or the parent/guardian accompanying the vaccine recipient should be told to
report any suspected adverse events to the physician or clinic where the vaccine was administered.
FluMist® is a registered trademark of MedImmune, LLC.
Manufactured by:
MedImmune Vaccines, Inc.
Gaithersburg, MD 20878
1-877-633-4411
Issue Date: June 2008 RAL-FLUV8
U.S. Government License No. 1652 Component No: FLU08-172CR1

[Rev Sister Lilli]

The news said they have closed the soccer stadiums, and are warning people against non essential use of public transportation.

Friends you are our Ohana, take precautions to stay safe. You are loved we are safe. I pray Psalms 91 on all of us.

[Rev.Johnson]

Thank you Lilli, I have seen the word Ohana a few times and had to look it up. let us be a large family with love for one another in grateful peace.

Part of Hawaiian culture, ʻOhana means family in an extended sense of the term including blood-related, adoptive or intentional. It emphasizes that family are bound together and members must cooperate and remember one another.

http://en.wikipedia.org/wiki/Ohana

[Rev Sister Lilli]

Indeed and we love each and everyone of you.

[Rev Sister Lilli]

300 schools closed nationwide. Brothers and Sisters guests and countrymen. Here is a heads up for you. With the ailments I been dealing with they always gave me my flu shots with the elderly first, the chronicaly ill and the elderly were priority.

Since Reverend Roger Christie first blessed me with some oil back in 03 I have not had to have a flu shot. And I have not had the flu.

The Holy Anointing oil is a natural anti virus. Please join The Hawaii Cannabis Ministry..donate for some oil, he can not do it without donations.

This Holy Oil could be what saves mankind from this manmade pandemic.

It could save some one in your family. The Hawaii Cannabis Ministry was founded for such a time as this.

God this is GreaT!! Thank you so much for showing us the blessing in this!
God watch over Roger and give him strength and help for the task at hand.
In Christ Jesus the anointeds name amen!

And if you havnt seen this thread please read it!
http://www.thc-ministry.org/forum/showthread.php?t=8612

[Rev Sister Lilli]

^^