HomeMy WebLinkAboutCity of Tamarac Resolution R-2008-157Temp. Reso. #11505
October 8, 2008
Page 1
Rev. 1 — 10/16/08
CITY OF TAMARAC, FLORIDA
RESOLUTION NO. R-2008--1,5�
A RESOLUTION OF THE CITY COMMISSION OF THE CITY
OF TAMARAC, FLORIDA, AUTHORIZING THE APPROPRIATE
CITY OFFICIALS TO EXECUTE A HOLD HARMLESS
AGREEMENT BETWEEN THE CITY OF TAMARAC AND
UNIVERSITY HOSPITAL & MEDICAL CENTER RELATING TO
UNIVERSITY HOSPITAL & MEDICAL CENTER DONATING
AND ADMINISTERING FIVE HUNDRED (500) FREE FLU
SHOTS TO TAMARAC RESIDENTS AND CITY EMPLOYEES
AT THE TAMARAC COMMUNITY CENTER ON A DATE TO BE
DETERMINED; PROVIDING FOR CONFLICTS; PROVIDING
FOR SEVERABILITY; AND PROVIDING FOR AN EFFECTIVE
DATE.
WHEREAS, the Tamarac Parks and Recreation Department and University
Hospital & Medical Center Administrator's staff have coordinated a free flu shot program
for Tamarac residents and City employees; and
WHEREAS, University Hospital & Medical Center will donate and administer five
hundred (500) flu shots to Tamarac residents and City employees; and
WHEREAS, Tamarac residents & employees will be required to register and show
identification to receive the flu shots; and
WHEREAS, the City of Tamarac and University Hospital & Medical Center
Administrators agree that it is in the public interest to establish and execute a Hold
Harmless Agreement; attached hereto as Exhibit "A"; and
WHEREAS, the City of Tamarac does not intend to waive the City's sovereign
immunity under Florida Law; and
1
Temp. Reso. #11505
October 8, 2008
Page 2
Rev. 1 — 10/16/08
WHEREAS, everyone who receives a flu shot will receive a copy of the
manufacturer's information and physician's summary sheet regarding contraindications
connected to this inoculation herein and made a part hereof as Exhibit "B" and sign a
Consent Form & Waiver holding the City of Tamarac harmless from the potential effects
of the flu shot attached herein and made a part hereof as Exhibit "C"; and
WHEREAS, the Director of Parks and Recreation recommends approval; and
WHEREAS, the City Commission of the City of Tamarac, Florida deems it to be in
the best interest of the citizens and residents of the City of Tamarac to execute a Hold
Harmless Agreement with University Hospital & Medical Center for the 2008 Free Flu
Shot Program for the City of Tamarac residents and employees.
NOW, THEREFORE, BE IT RESOLVED BY THE CITY COMMISSION OF THE
CITY OF TAMARAC, FLORIDA:
SECTION 1: The foregoing "WHEREAS" clauses are hereby ratified and
confirmed as being true and correct and are hereby made a specific part of this
Resolution. All exhibits attached hereto are incorporated herein and made a specific
part hereof.
SECTION 2: That the appropriate City Officials are hereby authorized to execute
the Hold Harmless Agreement relating to University Hospital & Medical Center donating
and administering five hundred (500) free flu shots to Tamarac residents and employees
on a date to be determined.
SECTION 3: All resolutions or parts of resolutions in conflict herewith are hereby
repealed to the extent of such conflict.
1
Temp. Reso. #11505
October 8, 2008
Page 3
Rev. 1 — 10/16/08
SECTION 4: If any clause, section, other part or application of this Resolution is
held by any court of competent jurisdiction to be unconstitutional or invalid, in part or
application, it shall not affect the validity of the remaining portions or applications
of this Resolution.
SECTION 5: This Resolution shall become effective immediately upon its
passage and adoption.
PASSED ADOPTED AND APPROVED this day of �' °� 4" �` ' , 2008.
BETH FLANSBAUM-TALABISCO
MAYOR
ATTEST:
tCt'u'•�'
MARION SWENSON, CMC
CITY CLERK
I HEREBY CERTIFY that
I have approved this
RESOLUTION as to form.
yAftJ/) G /�rL��d
SAMUEL S. GO N
CITY ATTORNEY
RECORD OF COMMISSION VOTE
MAYOR FLANSBAUM-TALABISCO
DIST 1: COMM PORTNER
DIST 2: COMM ATKINS-GRAD--
DIST 3: V/M SULTANOF
DIST 4: COMM. DRESSLER
Temp. Reso. #11505
Exhibit "A"
Page 1
HOLD HARMLESS AGREEMENT
THIS AGREEMENT entered into on the J_L day of 20�'
is made by and between the City of Tamarac, a municipal corporation, hereinafter
referred to as the "CITY" and University Hospital & Medical Center, a private corporation,
hereinafter referred to as "HOSPITAL".
WITNESSETH
WHEREAS, the City Commission of the City of Tamarac has determined that the
execution of this Hold Harmless Agreement is in the public interest; and
WHEREAS, University Hospital & Medical Center is donating and administering five
hundred (500) free flu shots to Tamarac residents and City employees on a date to be
dermined at the Tamarac Community Center, 8601 W. Commercial Blvd, Tamarac, FL
33321; and
WHEREAS, the City is providing the premises and logistical support for
administration of the flu shot program.
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the
parties agree as follows:
SECTION 1: The CITY shall hold harmless the HOSPITAL from and against any
and all claims, damages, losses and expenses including attorney's fees arising out of or
resulting from the implementation of this flu shot program when due to any negligent act or
omission on the part of the CITY, its officers, employees and agents. Nothing contained
herein shall be deemed a waiver of the City's sovereign immunity under Florida Law,
SECTION 2: The HOSPITAL shall indemnify and hold harmless the CITY from and
against any and all claims, damages, losses and expenses including attorney's fees arising
out of or resulting from the implementation of this flu shot program when due to any
negligent act or omission on the part of the HOSPITAL, its officers, employees and agents.
SECTION 3: Nothing herein shall constitute a waiver of sovereign immunity by
either party.
SECTION 4: The above provisions shall survive the termination of this Agreement
and shall pertain to any occurrence during the term of this Agreement, even though the
claim may be made after the termination hereof.
Temp, Reso. #11505
Exhibit "A"
Page 2
IN WITNESS WHEREOF, the parties have hereunto set their hands and seals on
the day and year first above written.
UNIVERSITY HOSPITAL &
MEDIC
By: f
E EXECU,:IVE OFFICEF
Printed name
ATTEST:
CITY •9'.
A
By:.i.
BETH B.
u :► •
By:
JEF E .MILLER
CITY MANAGER
ATTEST:
fir}
MARION SWENSON, CMC
CITY CLERK
Approved as to Form:
�" i OILLI eF
SAMUEL OREN
CITY A ORNEY
Influenza Virus Vaccine 1
�) NOVARTI5
Fiuvirin"' VACCINOS
E 1 :2009 FORMULA
i
HIGHLIGHTS OF PRESCRIBING INFORMATION Each 0.5-mL dose contains a total of 45 micrograms (mcg) of influenza A f,
These highlights do not Include all the Information needed to use FLUVIAIN• hemagglutinin (HA) from each of the following 3 strains: A/Brisbanelfw
(Influenza Virus Vaccine) safely and effectively. See full prescribing information 2007(HII'll A/Uruguay/716/2007(H3N2).an A/Brisbane/10/2007-like strain; and
for FLUVIRIN'. 11/Florida/4/2006. (3, 11)
FLUVIRIN" (Influenza Virus Vaccine) CONTRAINDICATIONS
Suspension for Intramuscular Injection • History of systemic hypersensitivity reactions to egg proteins, or any other
2008-2009 Formula component of FLUVIRIN•, or life -threatening reactions to previous influenza i
Initial US Approval: 1988 vaccinations. (4.1, 11)
INDICATIONS AND USAGE
WARNINGS AND PRECAUTIONS
. FLUVIRIN• Is an Inactivated influenza virus vaccine Indicated for active
If Gulllain-Barre syndrome has occurred within 6 weeks of receipt of prior
immunization of persons 4 years of age and older against influenza disease
influenza vaccine, the decision to give FLUVIRIN' should be based on careful
caused by influenza virus subtypes A and type 8 contained in the vaccine (1).
consideration of the potential benefits and risks. (5.1)
• FLUVIRIN• is not indicated for children less than 4 years of age because there is
Immunaccmpromised persons may have a reduced Immune response to
evidence of diminished Immune response in this age group IRA).
FLUVIRIN•. (5.2)
DOSAGE AND ADMINISTRATION
ADVERSE REACTIONS
Children
The most frequently reported adverse reactions are mild hypersensitivity reactions
• 4 to 8 years of age: 0.5,,mL dose via Intramuscular injection, one or two doses,
(such as rash), local reactions at the injection site, and Influenza•like symptoms.
Previously unvaccinated Children 4 to 8 years of age should receive two 0.5-ml-
(6)
doses, one on day 1 followed by another 0.5-mi. injection at least 1 month later
(2.2).
To report SUSPECTED ADVERSE REACTIONS contact Novartis Vaccines at
Children 4 to 8 years of age who have been previously vaccinated with one or
1-900-244-7669, orVAERS at 1-B00-822.7%7 and WVYw.vars.hhs.aov. B�
two doses of any Influenza virus vaccine should receive only one 0.5-mL dose
(2,2),
DRUG INTERACTIONS
• 9 years and older; A single 0.5-mt intramuscular injection (2.2).
Do not mix with any other vaccine in the same syringe or vial. (7.1)
Adults
• Immunosuppressive therapies may reduce Immune response to FLUVIRIN'.
• A single 0.5-mL intramuscular Injection (2.2).
(7 2) iBB
DOSAGE FORMS AND STRENGTHS
FLUVIRIN•, a sterile suspension for intramuscular injection, Is supplied in two
npresentations:
• Prefilled syringe, 0.5-mL. Thimerosal, a mercury derivative used during
manufacture, is removed by subsequent purification steps to a trace amount
(a 1 mcg mercury per 0.5-nit. dose). (3, 11)
Multldose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury
per 0.5-mL dose). Thlmwosal Is added as a preservative. (3,11)
FULL PRESCRIBING INFORMATION: CONTENTS"
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Adtnlni9tration
2.2 Recommended Dose and Schedule
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDNCATIONS
4.1 Hypersensitivity
S WARNINGS AND PRECAUTIONS
5.1 Gulllain-Barre Syndrome
5.2 Altered Immunocompetence
5.3 Preventing and Managing Allergic Reactions
SA Limitations of Vaccine Effectiveness
S ADVERSE REACTIONS
6.1 Overall Adverse Reaction Profile
6.2 Clinical Trial Experience
6.3 Postmarketing Experience
6.4 Other Adverse Reactions Associated with Influenza
Vaccination
F DRUG INTERACTIONS
7.1 Concomitant Administration with Other Vaccines
7,2 Concurrent Use with Imrnunosuppresslve therapies
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
FLUVIRIN' is an Inactivated influenza virus vaccine inrlicated for immunization of
persons 4 years of age and older against Influenza virus disease caused by influenza
virus subtypes A and type R contained in the van 1ne. (see DOSAGE FORMS AND
STRENGTHS (3)I
FLUVIRIN• 1%not Indicated for children less than 4 years of aqe because there Is evidence
of diminished immune response in this age group.
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
Inspect FLUVIRIN' syringes and multidose vials visually for particulate matter and/or
discoloration prior to administration. If either of these conditions exists, the vaccine
should not Ire administered.
Shake the syringe vigorously before administering the vaccine ;md shake the
multidow vial preparation each time before withdrawing a dose of vac ire.
Between uses, return the rnultidow vial to the recommended durage conditions
between Z" and 8°C 136° and m f 1. Do not freeze. Discard if the vaccine has been
frwriw
A separate syringe and needle or a sterile Aisposahle unit should Iw us,,d for each
Injeunon to prevent oan%rne51on of itifel rims agents from one person to another.
Needles should br diaprned ul prnpelly and not recapped,
II is recommended that small syringe (0.5 mL or 1 ml-) should be used to minimize
Any Product loss-
2.2 Recommended Dose and Schedule
Children (4 to 17 years of age):
For children 4 to � yedO of age, who have riot pit s"'o,ly belen vaccinated mdh an
BBBBB� influenza vaccine. FLUVIRIN' should he given as ,9 0.5 nil. intrannuScFilar injection on
clay 1 followed by :mother 0.5 nil lntramus, ular injee bon at least I month later If a
chdd her -en the ages of 4 and 8 years does na[ re(•rve a second dose of varrine
wlfhu, the same ve-n, only one dose of vaccine should he,ldnllnistered the following
,coon. ISA)
(. Pddrrn, 4 to H years of aqe, who have Ix•en vauinated in prno edinq years) with one or
rwu doses 4,10y m11r1en7a virus vaccine should rr•eeivf^ only rme dose (15.3)
children over the aye• o(9 should reru•rve a single o 5 n1L irnlnnsuscular injection.
n.....,....n„ ,,,,,. ,,,,,,,, ..-, • v ,,. 11
USE IN SPECIFIC POPULATIONS
Safety and effectiveness of FLUVIRIN• have not been established In pregnant
women, nursing mothers or children less than 4 years of age. 1&1, 8.3, li
• Antibody responses were lower In the geriatric population than In younger
subjects. (8.5)
Sea 17 for PATIENT COUNSELING INFORMATION.
Revised: July 2000
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
DESCRIPTION
CLINCAL PHARMACOLOGY
72.1 Mechanism of Action
NONCLINICAL TOXICOLOGY
13.1 Carcintagenesis, Mutagenesis, Impairment of Fertility
CLINICAL STUDIES
14.1 Immuntagenicity in Adults (18 to 64 years of age)
74.2 Immunogenicity in Geriatric Subjects (65 years of age and
over)
14.3 Immunagenlrity In Pediatric Subjects
REFERENCES
HOW SUPPLIED/STORAGE AND HANDLING
161 How Supplied
16,2 Storage and Handling
PATIENT COUNSELING INFORMATION
Sections or subsections omitted from the lull prescribing information are not listed.
TABLE 1, Solicited Adverse Events in the First 72 % Hours After Administration
of FLUVINiM' in Adult (18,64 years of aqe) and Geriatric (z65 years of age)
Subjects.
18-64 ym
N=66
? 65 Ins
N=44
1999-2000'4
18-64 ins;
N-76
165 yes
N-34
2000-2001.4
IB 64 yes
N=15
? 65 yn
N =35
LocaAAverse Frenh
Pam
16(24%)
419%)
16121%1
1(12%1
M455
70I v,)
1(2%)
4(5%)
8(11%)
113%)
Inflammatcon
' I8%1
2 �5%)
6I8%)
,Y%)
11390
Fa.hymvNs
416%i
112%)
114%)
113%)
4(5%)
I demd
2(31,1
11216)
1(1%)
2(6%)
3(4%)
I(Pk)
Reaction
213'16)
211%)
4(5%I
Il3%)
Hemorrhage
1 it%I
Systemic Adreru Events
Headxhe
7111%I
121t2%I
S19%1
41S%I
imque
ii5'TI
ZIS%1
415%)
111%)
314%,)
Malaise
1(3%1
I(2%)
2()%)
113'Ihl
Illw,)
Myalgld
1121v)
2(34)
Few
1(2%)
1 (I%)
FLUVIRIN" should be administered as a single 0.5 mL intramuscular injection preferably
in the region of the deltoid muscle of the upper arm,
The vaccine should not be injected in the glutellTegion or areas where there may be a
major nerve trunk. A needle of > 1 inch is preferred because needles .c l inch might be
of insufficient length to penetrate muscle tissue in remain adults.
3 DOSAGE FORMS AND STRENGTHS
FLUVIRIN* is a sterile, suspension for intramuscular injection. Each 0.5•mL dose contains
a total of 45 mcg hemagglutinin from the 3 influenza virus types in the vaccine. [see
DESCRIPTION (I III
FLUVIRIN• is available in two presentati(ns:
1) Prefilled syringe, OS-mi Tliimerosal, a mercury derivative used during manufacture,
is removed by subsequent purification steps to a vane amount (� I mcg mercury per
0.5-mL dose).
2) htultidose vial. 5-mL. Contains thimerosal, a mercury denvatve, added as a
preservative. Each 0.5-mL dose from the multi -dose vial contains 25 mcg mercury.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
FLUVIRIN' should not be administered to anyone with known systemic hypersensitivity
reactions to egg proteins (eggs or egg products), or to any component of FLUVIRIN•, or
who has had a life -threatening reaction to previous influenza vaccinations,
S WARNINGS AND PRECAUTIONS
5,1 Guillain-Bard Syndrome
If Guillain-Barr2 syndrome has occurred within 6 weeks of Weipt of prior influenza
vaccine, the decision to give FLUVIRIN• should be based on careful consideration of the
Potential benefits and risks.
5.2 Altered Immunncnmpretence
If FLUVIRIN• is administered to immunacumpromised persons, including individuals
receiving immuncesuppressive therapy, the expected immune response may not be
obtained,
5.3 Preventing and Managing Allergic Reactions
Prior to administration of any dose of FLUVIRIN•, the healthcare provider should review
the patient's prior immunization history for possible adverse events, to determine the
existence of any contraindication to immunization with FLUVIRIN' and to allow an
assessment of benefits and risks. Appropriate medical treatment and supervision must
be available to manage possible anaphylactic reactions following administration of the
vaccine
5.4 Limitations of Vaccine EffectWeness
Vaccination with FLUVIRIN' may not protect all individuals.
6 ADVERSE REACTIONS
61 Overall Adverse Reaction Profile
Serious allergic reactions, including anaphylactic 'hock, have been observed in
individuals receiving FLUVIRIN• during postinarketinq surveillance.
6.2 Clinical Trial Experience
Adverse event information from clinical trials provides a basis for Identifying adverse events
that appear to be related to vaccine use and for approximating the fates of these events.
However, because clinical trials are conducted under widely varying conditions, the
adverse reaction rates observed In the clinical trials of a vaccine cannot be directly
compared to rates In the clinical trials of another vaccine, Arid may not reflect rates
observed In clinical practice.
Adult and Geriatric Subjects
Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age
and older) who have received FLUVIRIN" in 29 clinical studies since 1982,
In 9 clinical studies since 1997, among 1261 recipients of FLUVIRIN•, 745 (59%) were
women; 1211 (96%) were White, 2312%) Asian, 15 (1%) Black and 12 0%) other; 370
(29%) of subjects were elderly (z65 years of age), All studies have been conducted In
the UK, apart from a study run In the US in 2005-2o06 where FLUVIRIN• was used as a
comparator for an unlicensed vaccine.
After vaccination, the subjects were observed for 30 minutes for hypersensitivity or
other immediate reactions. Subjects were instructed to complete a diary card for three
days following immunization (i.e. Cay 1 to 4) to collect local and systemic reactions see
Tables 1 and 2), All local and systemic adverse events were considered to be at least
Possibly related to the vaccine. Local and systemic reactions mostly began between day
1 and day 2. The overall adverse events reported in dlnical trial, since 1998 in at least
5%of the subjects are summarized in Table 3.
Adults (18 to 64 years of age)
In adult subjects, solicited local adverse events occurred with similar frequency In All
vials, The most common solicited adverse events occurring in the first 96 hours after
administration (Tables 1 and 2) were associated with the injection site (such as pain,
erythema, mass, induration and swelling) but were generally mild/moderate and
transient. The most common solicited systemic adverse events were headache and
myalgia.
The most common overall events in adult subjects (18-64 yearsof age) were headache,
fatigue, injectlon site reactions (pain, mass, erythema, And induration) and malaise
( Table 3).
Geriatric Subjects (65 years and over)
In geriatric subjects, solicited local and systemic adverse events occurred less frequently
than in adult subjects. The most common solicited local and systemic adverse events
were injection site pain, and headache (Tables I and 2). All were considered mild/
moderate and were transient.
The most common overall events in elderly subjects (a6.5 years of age) were headache
and fatigue.
Only 11 serious adverse events in adult and geriatric subjects (I R years and older) have
been reported to date from all the trials performed. These serinu5 adverse events were
a minor stroke experienced by a to' year old sublect 14 days after vaccination a to%),
death of an 82 year old subject 15 days after vaccination (1990) In very early studies;
death of a 72 year old subject 19 days after vaccination (1998 1Wq!, A hospitalization
for hemorrhoidectomy of a 38 year old male subject (1999.1(1006 A severe respiratory
tract infection experienced by A 74 year old subject 12 days after vaccination 12002
20031, A planned nanwrethral resection of the prostate in a subject with prior history
of pfostatrsm (2004 2005), two cases of Influenza (2005 1006). a druq overdose (2005-
nail, cholelithlasil 12005 2006) and a nasal septal operation '20EI5 2,0061. None of
mese events were a onsidered causally related to vacs mafi6n.
Clinical trial Experience in Pediatric Subjects
Inn 981 a s Imo al study wA, earned out m .38'it risk', hddren aged between 4 and 12 years
I J females And 71 males) To fe•furd the Safety of 11 (.IVIRIN', parrlrlpa m5 rrt'ordf d their
symptoms on i diary , and dudnq the three days after vaccination and noted any further
symptoms they thought weir attnbutdble In the vacc lne The only reactions arc nrded
ware renderrress at the rile of vaccinaliorl In 21'N, of the pafhnpann on day 1, vh,(h
vas still present in if) b on dAy 2 and 51k, on day 3 In one child, the tenderness was also
aa.nmpanied by redness At ihf• slip of Injection for Two days. The reactions were not
age dependem and there was no hie•, towards fhe younger,.hildren.
Three clime All studies were tarried out between 1995 And 2004 in a total of 520 pedwrrlc
utb)rr1, ,{qe Tango 47months). Of these.285 IIr,,ahhy sirbjvc is plus 41'At fink suhjec is
mceiad FLl3VIRN" No.,n mus :idvetsc' events wen'reporwd.
FI UVIRIN4 should wily he used for the• inv1un12Anon or per;nns aged 4 years and river
2001-2002"a
2002-2003eA
1 2004-2005A
yn
yn
lWyn
,elli
lWynsl2di
111=75
L-35
N-107
N-88
4=74
11=61
e ts
Pain
12(16%)
1(3%)
1403%)
70)
15(20%)
9(15%)
Mass
4 (5%)
1(3%)
-
-
-
F(chyini
2 (3%)
-
313%)
3 (3%)
2 (3%)
1(2%)
Edema
2 (3%1
10%)
601
2 (1%)
1
-
Erythemd
517%)
17 00%)
5 (6%)
16 02%)
s (8%)
Swelling
-
-
il(I5%)
4(7%)
Reaction
-
-
2(2%)
-
-
.
Induration
14113%)
3 (3%)
17 (15%)
1(2%)
Rufflus
-
1(1%)
-
Systemk Adverse Evens
Headace
Bill%)
1(3%)
1201%)
9(10%)
74(19%)
3t5%)
Fatigue
10%)
10%)
-
5 0%)
2 0%)
Malaise
314%)
-
3 (336)
415%)
1(1%)
1(2%)
Myalgia
3(4%)
50%)
30%)
8(I1%1
1(2%)
Few
-
-
--
Arthrakila
-
2(2%)-
Swelatirg
3(4%)
I13%)
-
2(2%)
-
-
5hisertng
mrPonram nx•Irxaml.rlore Pmem; rev,x Sedan 36t
rim nq ,led
SMvrtw e4rn5e evrrro in thefirst 721twnaRerrinny5oi n1lruno '
4 Visited sdwnr ewn11 rrportrd 6y tOSTART pilfered lean
^ k4kiced admu evrm5 repaid by MEDDRA gr6ned seem
TABLE 2, Solicited Adverse Events In the First 72 Noun After Administration of
FLUVIRIN" In Adult Subjects (mirg years of age),
2005.2006 US Trial
FLUVIRIN•
N = 304
Local Adverse Events
Pain
168(55%)
Erythema
4806%)
Ecchimi
22 (1%)
Induration
III
Swelling
16 (5%)
systemic Adverse Ewes
Headache
91 (30%)
Myalgia
64121%)
Malaise
11L19%)
Fatigue
56 (18%)
Sore throat
23 (8%)
chills
22(7%)
Nausea
21(7%)
Arthralgia
20(7%)
Sweating
17 (6%)
Cough
18(6%)
Wheezing
4(1%)
Chesttlghtness
4(1%)
Other difficulties breathing
30%)
Facial edema
RT,Aja nPatedto the shalt wlwf perrzM
w repented
TABLE 3, Advww Evert Reported by at least 5% of Subjects In Clinical Trials
since 1998
1"11-19"1
1999-20004
20*20014
18-64 yrs
265 In
18-64 yrs
z 65 yrs
18-64 yn
z 65
N=66
N=44
N-76
N=34
N=15
N�r3
A erne Frerrts
Fatigue
802%)
2(5%)
801%)
I(696)
5(796)
-
Back pain
4 (6%)
3 (7%)
-
-
Cough increased
2 (3%)
2 (S%)
-
-
-
Ecchymosls
4(6%)
112%)
4(5%)
I(3%)
5(7%)
fever
30%)
Headache
12 011%)
5 (11 %)
22 (29%)
5 05%)
14119961
2 (696)
Infection
1(5%)
2 (5%)
-
Malaist
4 (6%)
4 (9%)
4 (5%)
1 (3%)
-
-
Migraine
4 (6%)
1(2%)
-
-
-
Myalgia
4(6%)
1(2%)
"
Sweating
5 (8%)
1(2%)
-
-
-
Rhimi
3 (5%)
1 (2%)
-
5 (7%)
2 (il
Pharingim
ii
) (1%)
10 (13%)
-
6 (8%)
Arthralgu
-
-
-
2 (6%)
-
-
Injection site Palo
16124%1
419%)
16(21%)
-
9(11%)
Injection site «chymosis
4 (6%)
1 0%)
-
4 (5%)
Injection site mass
7(Ilist)
1(2%)
4(5%)
8(11%)
1(.3%)
Injection Site edema
10%)
2(6%)
-
In)(ction site IntlammaBon
5 (8%)
2 (5%)
6 (89h)
7 (9%)
10%)
Injection site reaction
-
-
4(5%)
1 (3%)
ZOOI-2002A
2002.2003n
20042005A
It 64 yn
a65 yes
16.64yn
z65 Jr.
1844
a65 not
N=75
N-35
111
a88
Nr74
N=61
A
Fatigue
S(7%)
4(11%)
11(1")
8(9%)
4(5%)
Z(3%)
Hypertension
IOre)
4f5%)
-
Rinonhea
2 (29h)
5 (6%)
.
Heartache
20127%)
2(6%)
351334118(20%)
1206%)
11290
Mauve
618%)
113%)
1102161
819%)
Myalgia
4 u.5%1
1 (3%)
10 (gib)
4 (5%I
Swearing
314%)
3 (9%)
2 (2%)
516%1
Rhowns
4 (5%)
Phanngitis
-
6 (8%)
Arthr4lgu
51S-)
4(5%)
Sort Threat
415%)
10%)
SIS%)
4(1,%)
Injection Tire Pam
I:I (11%I
1 is%)
14 (13`0
718%)
ti'tl%I
2 (1%1
Injection site enhymosn
4!5%)
1131k)
4�4%)
4(5%)
In)H hen site orythenu
5i7%I
2.6%I
11(1p%1
5oQol
A15%1
! nfettlon"Te mats
416%
113%I
Infection the edema
bl6`x.1
1i2%)
415%) 1',2'M)
Ime ton 5rtPlndo ion
14(I{'f,l 313%)
,'i94n1
r!•SlrltS rrpurM lu lee teem'wNar sir„+"''.",,lrhnrd a, 'a
InI gattxlp Inv nq !Itt n1 Sv4
,.,outPo.drrnr r.erre npxre04 nu` IAR r p 1b 41nn)
„IIr„Irv) nlrrr,r.rwn5 regxr�a Ire Mf nl?fen Ir•; rri�rvf :rcn1
RFVRF001(0708A)
6.3 Postmarketing Experience
TheMollnwlnq acl lal adverse reactions have been feportod during Post approval use of FLUVIRIN".
Because Ihese reactions are reported volurn,wly from a population of uncertain size, It is not always
Possible to relinbly psoniate their frequency or establish a (.ausal relationship to vaccine exposure.
Adverse events described here are included because: a) they represent eac,lions which are known to
occur following immunizations generally or influenza immunizations specifically: b) they are potentially
"enacts; or cl the frequency of reporting.
Body us rl whoie. Loral injection Site reactions (indudiay pain, pain limiting limb movement, redness,
swelling, warmth, erchymosis, induration), hot Rashes flushes; chills; fever; malaise; shivering; fatigue;
a%rhenia; facial edema.
Immune system disorders: Hypersensitivity reaUlods bnrludlnq throat and/O( mouth edema). In rate
cases, hyperserlsillvity reactions have lead to anaphylactic shock and death.
• (.nrdlevasodor dllofde,.5: vascullm iin rare cases will) ra ,wnt n1niii Involvement), sync a1x+ shortly
after _ecinatinn.
• Digostiye disorders: Diairhea; nausea; vomilinq; abdominal pain.
Bioral and lymphatic disorden. Local Iymphadenopathy, transient thrombocyroperoa.
Meraboirc and outnlionnl disorders: t os5 of appeure.
MiAl ulp)kr•ierdiArdiralgia; myalgia: myaslhenla.
Nervous %yetem disorders Headache; dltzlness; neuralgia; pataesthPsia; confusion; febrile convulsions;
(iuillain Bartel Syndrome; myelitis (including enrephaloo ills and transverse myelitisL neuropathy
(including neonlis), paralysis Includlnq Belts Palsy),
Respiratory disorders; Dyspnea; chest pain: cough; pharyngitis; minitis.
Skin ;Ind appendages: Stevens Johnson Vrldroma; sweating; pruritus; urticaria, rash (including non-
spe(ificm6171,110p6puldr, and vesictdobulbous).
6.4 Other Adverse Reactions Associated with Influenza Vaccination
Anaphylaxis has been reported after administration of FLUVIRIN". Although FLUVIRIN' contains only
a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions anionq
pe,sons who have severe egg allergy. Alleigic reactions Inc ludo hives, angwedernd, allergic asthma, and
systemic anaphylaxis Isee CONTRAINDICATIONS (4)).
file 1976 swine influenza vaccine was associated with an increased frequency of Gudlaoi Barre syndrome
(GBS). Evidence for a causal relation of 685 with subsequent vaccines prepared from other influenza
viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more- than 1 additional
,aW/I million persons vaccinated.
Noorulog3ral disorders temporally associated with Influenza vaccination such as encephalopathy, optic
neuritis/neurvpathy, partial facial Paralysis, and brachial plexus neuropathy have been reported.
Mlcroscopu polyanglitis (vasculitis) has been reported ren',porally associated with Infi enre vaccination.
7 DRUG INTERACTIONS
7.1 Concomitant Administration with Other Vaccines
There are no data to assess the coni omitant administration of FLUVIRIN' with other vaccines, If
FI UVIRIN" is to be given in the same time 65 another injectable vat duets), the vaccines should always be
Administered At different injection sites.
H.UVIRIN' should not be mixed with any other vaccine in the same syringe or vial.
Z2 Concurrent Use with Immunosuppressive Therapies
Imnwnnsuppressive therapies, including irradiation, antimetabolites, alkylatiog agents, rymtoxic
drugs, and (orticosteroids fused in greater than physiologic doses), may reduce the immune response
to FLUVIRIN".
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C; Animal reproduction studies have not been conducted with FLUVIRIN". It n also
nut known whether FI IIVIRIN" can cause fetal harm when adnunivered to a pregnant woman or can
affect reproduction capacity. FI.IJVIRIN" should be given to a pregnant woman only if clearly needed.
8.3 Nursing Mother
It is not known whether FLUVIRIN° is excreted in human milk. Because many drugs are excreted in
human milk, caution should be Polio, sed when FLUVIRIN" is administered to a nursing wonlan.
8.4 Pediatric Use
The safety and inlmunogenirity of FLUVIRIN' have not been established in rhlldren under 4 years of
age.
The safety and immunogenic ity of FLUVIRIN" have been established in the age qroup 4 years to 16 years.
the use of FI UVIRIN' in these age groups Is supported by evidence from adequate and well controlled
studies of FLUVIRIN' in adults that demonstrate the immunogenicity of FLUVIRIN' Lsel+ ADVERSE
REAC71ONS (6) and CL INICAL STUDIES (14)1.
8.5 Geriatric Use
Since 1997, of the total number of geriantr "objects In -.397) in clinical studies of FLUVIRIN', 2,1%, were
65 years and over, while 2. V4, were 75 years and over.
Antibody Iesponses well, Inwer in the geriatru population than In younger subjects. Adve,se events
occurred h:+ss frequently in geriatric subjects (•65 years) than in younger adults Other reported clinical
experience h;ts not identified different e% in response% between the elderly and younger patients. ISpe
ADVFRSE REACTION (6) and Cl INICAL STUDIES (14)1,
11 DESCRIPTION
FLUVIRIN" Is i trivalent sub -unit (pwdiPol ewfdce antigun) influenza virus vaccine prepared hone vents
pinpagated in the allanroic cavity of enlhryonated hem; eggs inoculated with a specific Type of Infuenz6
virus suspension containing neomycin and polymyxin. Far of the influenza virus shams is harvested
,)nd clarified separately by centrifugatinn and filtration prior to indctivation with betapioplolaclone.
the inacllvaled vmu is concentrated and purified by rondl centrifugatinn. The surface anligens,
ht+n t, ggluonln and neurarnmidase, dre nbtalned from the influence virus p4rticlf` by further
"'o"f fation in the presence of nonylphenol Mhoxylate, a process which removes most lit thl� Internal
proteinsf he nunlphpnul ethoxylate Is removed from the surface a ingen preparation.
FLUVIRIN' Is 6 honlug01olvd, sterile, shghtiv (ip,deslent suspension h1 a phosphate buffered sapne.
F'LUVIHIN' has Bern standardrZed ffccordinq in USPHS requirements for Ihre 200R20091nFlurn7a season
and is fnnn14lated to t nntdln 4S mcc3 hr•magghmnin iHA! per O.Snil dust' �n the remmmenderl 16tio of
f S nu.g h1A of each of the fnllawiny 3 ;trains'. A,Rnsbnnei S9/20071H1N I I; NUroquay/716RIX]! iH3N21.
,3n A: Rrlsl7ane/10,'1007 uke slr6in;.+nil B•Floridaia/1006.
Tile 03 , rill. f fillet( .yonge pn %prit,itlon is toril,lilt d w ll trot �t,Setyarire. Hnwevw, th nli, a
File'ri's Hf•riy'! d d11r nq 1'lanifac 1 ,ring Is ,,:nova by bwquert puntw,moo ,ot)p to o t'3re
it 1' I i, 1 J y pi, 0 `, ml Heise
the 5 11,t mult1 If.rrmuI.Ils I,rroios thirrpmsal 1 "ury derivative. added 1' i l;resetvahve.
Lach0 'mLd sr.fit,othe ,ltulticlow vial contans 15 rncq ).,r:ury
F arh iow it 11 Ihf+Inolodoo, reel s f,orn th, pl,filllll ;Yl o9 rlay,vlin rnntalll req,jo,ij im„l I1tS I; f,"Ig
ornulms , I mcq uvalbumin i, polynlyx in', 3 7S not 11 neorl,,I 2., Incbetapnlplolac tune Inns
tTlOO' than 0 5 meg) and nonylphenoi eth,>xylate (not mote Than nl0j sect. N;vi.
he ,•oolodose vial stonpvr and the syringe stoppedPlungel tin ,•.1 snntal, lah,x,
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
infhwn7a Illness and its complitaoarls follow Infe(bon with Inflw+e�za ;n., ,lobal w -Wance of
Irlfll,r+nra id,mifie5'Pally nntlgenir variants I )r Pram Ple, Sln,e 1977 n �titl)+!ear v11IanTS It ir,fl,.Ienla
4 lit N nn<1 HIN21 !i, a ad ntluelua B r , ,se, hdve tii,en , gent, Il ill 111,clon p H I,dels of
t '. 11q:)iubnanro rid) hewn IHII antibody toe post eau nu c n w Ih n 3 t C 1 nfll,, tr a % dI In -
nlnot hr+ell, an<aated Mill P,nir(nun frcml Influenza IRI s+. in r, ,e h1a,,..trl '.h,dn•1. limb, -1, r
v1 t..111 hove been I.. urea w,lh prnler. nun horn n'Rnrn,6 JI, a, :nt to ',a^•. rt '•ublw e
HhfLPFN(I', I',.1, 15.211�
4n1,bl,dy atJamSt one ,nf)urn;a "'I'S'YPe `1 Innu• d vI .:� nnitfrtu)n .I'(,nn51 n'., Ither
Furth,ernl'Ir.,, ,,ldwdy to a,.. anngemr venom if mnir. m,lh1 dolt prntert
It rl4 I )f 0,err I11 lhtyl I 'r I 1 I.l' if a lIcerlic 1 'I Inuyh
t 3' �nfi lo,, r ;hnli Inns I'll ;:a,n ,tl -p lr" ,nil Ihr ,,, 1 to, the .r.ual hangr .A
fillo. I I i1oll,I ns n , wh'eari5 ,lour ra vac , I 1 4n" 1 ned ruff i�
VC the h,+maggll.t WHI at 'tr i 1 Tyl) till I— ,yp,, A a I
"I", r,,innlj Il i.e ,I'Ifl,t,�nra rII,,I S,,�S IIY.r It' t:� tlr�,. at I11"ttlt) in the InlhI'll, •, .II III,:,pcn„1!r'l
Annual r,w. tt;n,nlon ,•.ah the ...'o„I raa:nt• �, I,,,.,nu,•.rndrd b•,.11, „nlunity do II.,r, Ln,I,q •he
y if VliCr I 'n ;,lei th"o r r1 ,II Rl i nuns of fit !d 'm,l. 1 I I Vp hum y' I
II I I RI J( f S it, 3.I I.
TABLE 4. Summary of the Serocomenion and Proportion of Subiactii
Achievino an Nl titer a 1:40 far Adult W hierta
year/Strain
No, of subjech
5ermonversion'"
HI titer at:d0r
N
%
1 95%cl"
N
%
95960"
199 -1 99
A/H1N1
4A
73
162, A3)
SO
76
(65,86)
AiIHN2
66
43
Ill
11 77)
41
/1
(60,A2)
B
42
64
(52, 75)
62
94
(88, 100)'
19" 20M
A1NIN1
45
59
148, 70)
50
66
(55, 76)
AIHN2
76
51
67
(57, 78)
66
87
179. 94)
8
-
53
70
(59,80)
75
99
(96, 100)
201162001
...
AMINI
41
55
(44.67)
41
55
(44.67)
A/H3N2
74
45
61
IS0, 72)
52
84
(75, 92)
A
50
68
157,78)
73
49
(%,100)
2001-2002
A/HINT
44
59
148,70)
48
64
153, 75)
A/113112
/s
46
61
150,72)
68
91
(84,97)
8
42
56
(45, 67)
66
88
(81,95)
2002-2003'
A/H1N1
62
58
(49,68)
73
69
(60,78)
A/143112
106
72
68
(59, 77)
93
B8
(81,94)
B
78
74
I6S, A2)
101
95
(91, 99)
2004-200S
A/N1111
52
70
(59, 80)
66
89
(80,95)
A1143N2
14
60
81
(70,89)
73
99
(93,100)
B
57
/7
(66,86;
69
93
185,9A1
2005-2006
A/HINT
191
63
(57,68)
296
98
(95, 99)
A/1131,12
303
273
90
(86,93)
294
97
(94, 99)
B
213
70
165, 75)
263
87
(82, 901
Serixunvenlon proportion of subjects with either d post vaconadon HI liter
140 from a pre vacanallon titer 1:10 or at IPaq a four fold increase from pre-
vdumalionIII hter P 101n antibody titer.
' HI titer a1:40. proportion of subjects with a post vaccination titer 1:40.
• 95%CI'. 954, confidence interval
TABLE 5. Summary of the Geometric Mean Nemagglutination Inhibition
Antibody TRers, Pro- and Post Immunization, for Adult Subjects
Year/Stcaln
Nohubjens
Geometric Mean
ther(GMT)
uon
Pmt-16097 tlen
Fes2
e
1998 19"
A;H1N1
2ln.a1e6a
(14.1"2955"5,
34.46)
)
AIH3N2
fb
7741
97.02
10.57
091, 16.16)
B
231.07
110.2
(6.90, 17,59)
199-2000
A/H1N1
58.9s
793
15 73, 10.97)
AIH3112
76
15,29
12''3
8.03
(5.80, 11.13)
6
•...
25.70
...�_
211.76
991
11.17, 14 11)
20002001
A/HIH1
S.42
33.80
624
(4.49,8.69)
A,H3N2
24
1598
126.01
7.89
(5.61, 11 (to)
A
)624
10A.25
11.75
(7.73, 17.85)
A/H1N1
7.76
54.78
7.06
(5.24,9.52)
A/1431,12
75
23.67
153.81
6.50
(4.78, B.84)
8
1991
10/53
5.40
(3.95, 738)
2002 2003
A7H1N1
7 /8
60.39
177
IS.91, 1O.39)
AlH.3N2
)0fi
1132
292.03
12.57
f8,77, 17.871
8
r 20
314.11
1040
17.54. 14. 34)
20042005
A,HIN1
13
14)
12
IA.39, 17)
A/H3N2
74
37
658
IA
!I2,26)
B
1'I
156
11
17.87, 14)
2005 2006
4.HINt
2,t
232
B
;6.68, 9591
4,Ho112
303
14
221
15
114. 171
3
13
63
G.5
(5 73, 7 37)
13 NONCLINICALTOAICOLOGY
13-1 Carcinogenesls, M rtagenesis, impairment of Fertility
FL17VIRIN• has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility,
14 CLINICAL STUDIES
Between 1 g82 and 1991, twelve clinical studies were conducted in healthy adult and geriatric subjects
and one in children between 4 and 12 years of age who were considered to beat risk: Since 1991 an
annual clinical study has been conducted in the UK in healthy adults aged 18 years or older. FLUVIRIN'
was also used as a control in a US clinical trial in adults (1849 years of age). In all the trials, blood
samples were taken prior to vaccination and approximately three weeks after vaccination to assess the
immunogenic response to vaccination by measurement of anti -HA antlb iciies.
Three clinical studies were carried out between 1995 and 2004 In a total of 520 pediatric subjects
(age range 6-A8 months). Of these, 285 healthy subjects plus 41 'at risk' pediatric subjects, received
FLUVIRIN•.
FLUVIRIN• should only be used for the immunization of persons aged 4 years and over.
141 Immunogeri in Adults (18 to 64 years of age)
,able, 4 and 5 show the immunogenicity data for the aduk age group. The seven clinical studies
presented enrolled a total of 774 adult subjects In the adult group, for all anugerrs (A/HINI, A/H31,12
and 8) al least one of the following point estimate criteria was met: the proportion of subjects with
seroconversign (post -vaccination titer >1:40 Rom a pre-va(dnation titer 0.10) or significant increase
tat least a four -fold increase from pre -vaccination titer 11:10) in antibody titer was greater than 40%;
the geometric mean titer (GMT) increase was ?25; the proportion of subjects with a post -vaccination
hemagglutination inhibition (HI) antbody titer>1:40 was greater than 70%.
14.2 Immunogenicity in Geriatric Subjects (65 years and over)
Tables 6 and 7 show the immunogenicity of FLUVIRIN• In the geriatric age group. The six clinical
studies presented enrolled a total of 296 geriatric subjects. For each of the influenza antigens,
the percentage of subjects who achieved seroconversign and the percentage of subjects who
achieved HI titers of 21:40 are shown, as well as the fold increase in GMT
For all antigens (A/HI N I, A/H3N2 and 8) at least one of the following point estimate criteria was
met the proportion of subjects with seroconversign (post -vaccination titer 21;40 from a pre -
vaccination titer •::1:10) or significant increase (at least a four -fold increase from pie vaccination
titer >1:10) in antibody titer was greater than 3096; the geometric mean titer (GMT) increase
was :•2.0; the proportion of subjects with a past vaccination hemagglutination Inhibition (HI)
antibody titer 21:40 was greater than 60%. The pre -specified efficacy criteria were met in each
study, although a relatively lower immunogenicity of A/H1N1 strain was seen in the last four
studies (the same strain was in each of the formulations),
14.31mmunogenicity In Pediatric Subjects
A small-scale study, was conducted in 1987 to evaluate safety and immunogenicity of FLUVIRIN' in
38'at risk' children, with diabetes and/or asthma, or lymphoid leukemia. Thirty eight participants
aged between 4 and 17 years of age were assessed. Ten subjects had diabetes, 21 had asthma,
two had bath diabetes and asthma, and one had lymphoid leukemia, there were four healthy
control subjects. All participants received a single 0.5-mL dose of FLUVIRIN".
Immunogenicity results were obtained for 19 of the 38 subjects enrolled in the study, The point
estimate of the percentage of subjects achieving a titer of a 1:40 was 84% for the A/HI N1 strain
79'3n for the B strain, and 53% for the A/1-13142 strain. The GMT fold increases were 5.8 for the
A/H1 N1 strain, 40 for the B strain and 17.7 for the A/H3N2 strain.
Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects
(age range 6-47 months). Of these, 285 healthy subjects plus 41 'at risk' pediatric subjects,
received FLUVIRIN'.
In a 1995/1996 clinical study, 41 subjects (aged 6-36 months) at increased risk for influenza -
related complications received two 0.25 mL doses of FLUVIRIN•. At least 49%of subjects showed
a 24-fold increase In HI antibody titer to all three strains. HI antibody titers of 1 A0 or greater were
seen in at least 71% of the subjects for all three Influenza strains, with increases in geometric
mean titer of 6.0-fold or greater to all three strains.
Two clinical studies (1999-2000 and 2004) indicated a lower immunogenicity profile for FLUVIRIN°
compared with two commercial split; in a study in the age group 6-48 months the comparator
was a US licensed vaccine, Fluzone', and in another study In the age group 6-36 months the
comparator was a non -US licensed inactivated influenza vaccine. Despite the small sample
we (a total of 285 healthy Subjects received FLUVIRIN• in these two clinical studies) the Igwer
immunogenicity profile of FLUVIRIN• was greatest versus the comparator vaccines in children
36month5 but was also evident in those 36-48 months of age, though the differences were
less.
FLUVIRIN' should only be used for the immunization of persons aged years and over.
15 REFERENCES
15.1 Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza
vaccination. Virus Res 2004;103:133-138,
15.2 Hobson D, Curry RL, Beare A, et. al. The role of serum hemagglutinin-inhibiting antibody
in protection against challenge infection with influenza A2 and B viruses. 1 Hyg Comb 1972;
767-7'77
1S..3 Centers for Disease Control and Prevention. Prevention and Control of Influenza:
RPfqulmenddtions of the Advisory Committee on Immunization Practices (ACIP). MMWR
2006 55(RR- l0):1-d2.
16 NOW SUPPLIEDIS70RAGE AND HANDLING
16.1 How Supplied
FLUVIRIN• is supplied as a 0.5-mL prefilled syringe, package of 10 prefilled syringes per carton.
NDC 66521.111-01
FLUVIRIN" is supplied as a S cot multidose vial, individually packaged in a carton.
NDC 66521 111 10
16.2 Storage and Handling
Store FLUVIRIN• refrigerated between 2' and B' C (36' and 46'F).
Do not freeze. Discard if the vaccine has been frozen.
Store in the original package to protect from light.
Do nor use after the expiration date.
Between uses, return the multidose vial to the recommended storage conditions.
17 PATIENT COUNSELING INFORMATION
Vaccine recipients and guardians should be informed by their health care provider of the
POWntial benefits and risks of Immunization with FLUVIRIN•. When educating vaccine recipients
and quardians regaldmq the potential side effects, clinicians should emphasize that (1) FLUVIRIN'
contains non-infectious particles and cannot cause influenza and (2) FLUVIRIN• is intended to
provide protection against illness due to influenza viruses only, and cannot provide protection
against all respiratory illness.
Vat cme recipients and quardians should be instructed to rejwrt any severe or unusual adverse
reanium to their healthcare provider.
Vaccine recipients and guardians should be Instructed that annual vaccination is recommended.
FLUVIRIN• Is a registered tradenidri, of Novartis Varones and Diagnostics Limited.
Manufactured by Novartis Vaccines and Diagnostics l.imned, Speke, Liverpool, UK
An affiliate of: Novartis Vaccines and Diagnostics, In., 350 Massachusetts Avenue, Cambridge,
MA 02139 USA
1 H00 244 7668
TABLE),.SemmMoftheSeromnwrslenmwpropa mofSW*mu
Adikeving an Writer el>40 far Wriairk Suhlecu
Year/Strain
awertian'95%C'N
%
95%cl,
1998-19"
AM1N1
(66,91)
38
90
(82,99)
A/H3N2
(66,91)
36
86
(75,%)
8(17.45)
T3379
42
10O
(100,1o0)
1899.2000AMIN1(14,45)
23
68
152,al)
A/WA2
(36, 701
31
91
(82. 100)
(12,41)
32
94
(86,100)
7000.2001
AJHIN1
5
14
(3,26)
10
29
(14.44)
A4f3N2
35
22
63
(47.79)
31
89
(78.99)
B
13
37
(21,53)
33
94
(87. 100)
2001-2007
A/H1N1
5
14
(3,26)
14
40
(24,56)
A/91112
35
IS
43
(26,59)
33
94
(87,100)
B
6
17
(5,301
32
91
(82,100)
2OW-2003
A/H1N1
N
27
(18, 361
51
58
(48,69)
NH3B2
89
42
47
137, 58)
85
%
191, 100)
B
41
46
(36,56)
86
97
(93,100)
2004-MS
A/HiNI
17
28
(17, 41)
46
75
(63,86)
NH3142
61
29
0
(35,61)
60
98
(91.100)
8
38
62
(49,74)
51
84
(72,92)
Sert"arse "r: pmpptWn of 5iib(ern wnh HIM a c05tYKIina1100 HI titer 1413 6ma a
P11 •akclnrtim tW .1:10 nr at ken a min-Wtr inoeax 6m pre-w Nvu x 41 vor a 1:to in
wo.0 txr
N1 Ia,, , NO pr0ptauvi of s.bj a wOh a "T-vkdrnim rxer _ I:b
•9110, G 9 %..ixi rite it s,_x
TAW 7, Summary of the fieomabk Maxi IkmeggWdnatlen InM4idon
Antihsdy Then, Pw and Post-Immonftagon, fer 6arletdc Srahia ch
YearlSnaln
xa.re,atijKta
GeontehicMeanTNer(6MT)
Fe-r4WastMn
Post-rxAstllm
ioNaloeme
H3%OI•
1998-1999
A/H1N1
13.92
176.65
12.69
(3,24,19.56)
A/H3N2
42
10.69
124.92
11.69
(7.02, 19.46)
8
114.1
273.56
2.40
(1.82,3.17)
1999-7000
A/NINI
15.82
50.SA
3,20
(2.13,4,80)
A/H3N2
34
28.00
133,19
4.76
(2.92, 7.76)
B
17.16
127.86
224
(1.56,3.20)
2000-2001
AMIN7
6,66
18.85
2.83
(1,91,418)
A/113142
35
25.87
140.68
S.44
(3.72, 7.%)
8
61.24
191.23
3.17
(2.13, 4.59)
2001-2002
kNINi
12,69
26-65
2.10
(1.55, 2.84)
N1113112
35
47.33
114.26
2,41
11.73, 3d8)
B
45.49
91,89
2.02
0,47, 2J8)
2007 2001
NH1N1
13.29
31.92
2.40
(1.90,3.03)
A1113N2
89
65.86
272.79
4.14
(3.09, 5.55)
B
7487
288.57
3.85
(2,89,5.13)
2004-ZOOS
NH1N1
21
(AM3N2
61
)7
jMJ
4,43
(3.20
5.69 1
(4,39,7.38)
" 954e U: 95% confiderce Interval
Temp Reso# 11505
Exhibit "c"
INFLUENZA
C1
VACCINATION 2008 fi2009
DNSENT FORM
PLEASE COMPLETE THE FOLLOWING MEDICAL HISTORY:
1. Are you allergic to eggs?
2. Are you allergic to egg proteins?
3. Have you ever had a life -threatening reaction to
a previous influenza vaccinations?
4. Are you allergic to thimerisol?
5. Do you have an active respiratory disease or any other
infectious disease at this time?
6. Are you pregnant or think you may be pregnant?
7. Are you a nursing mother?
8. Have you ever had Guillain-Barre Syndrome?
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
FLUVIRIN is an influenza virus vaccine for persons 4 years of age an older. FLUVIRIN is not
for children less than 4-years of age.
[� IF YOU ANSWERED "YES"µTO„ANY OF THE ABOVE QUESTIONS, THE VACCINE MAY NOT BE GIVEN.
1. You may experience pain, redness and/or swelling at the injection site.
2. You may experience headache, fatigue and myalgia (muscle aches), low grade fever
and malaise lasting 1 — 2 days.
3. Immediate allergic reaction such as hives, angioedema, allergic asthma or systemic
anaphylaxis may occur among persons with an egg allergy.
4. Guillain-Barre Syndrome has been associated with the vaccine in the past, although
current vaccines have no clear association with the disease.
5. Additional side effects associated with the influenza vaccination that have also been
reported may include but are not limited to: hypersensitivity reactions, digestive disorders,
optic neuritis/neuropathy, partial facial paralysis and/or edema, and microscopic
polyangitis (vasculitis).
6. FLUVIRIN contains non-infectious particles and cannot cause influenza. FLUVIRIN is
intended to provide protection against illness due to influenza viruses only, and cannot
provide protection against all respiratory illness.
7. Report any severe or unusual adverse reactions from the FLUVIRIN influenza vaccine
to your healthcare provider.
Temp Reso# 11505
Exhibit " C ,
PLEASE READ THE ATTACHE - D INFLUENZA VIRUS VACCINE FLUVIRIN 2008 2009
FORMULA WARNINGS, PRECAUTIONS, AND CONTRAINDICATIONS.
I, , authorize the administration of a flu shot. I understand
that there are possible risks associated with the flu shot and there exists the possibility that I
will have an adverse reaction. I have had an opportunity to discuss the potential medical
consequences of a flu shot with my physician, and have read and understood this Consent
Form and the attached influenza virus vaccine FLUVIRIN 2008-2009 Formula warnings,
precautions, and contraindications. I understand that there are potential benefits and risks
associated with taking the influenza vaccine, and I request that it be given to me.
In consideration of my receipt of a free flu shot, I, my heirs and assigns, agree to hold the City
of Tamarac, its elected officials, officers, employees and agents harmless from any liability for
adverse reactions or injuries, up to and including death, which I shall or may suffer as a result
of receiving the flu shot, and for any claims, causes of action, damages, costs, expenses and
attorney's fees which I or my heirs and assigns may have as a result of my receipt of flu shot
Name
r_ri5am,
Telephone
Signature
Witness
Date of Birth
City State Zip Code
Date
Date