Immunization Protocol

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Delaware Health & Social Services
Division of Public Health
IMMUNIZATION
STANDING
ORDERS
2014-2015
SEASONAL INFLUENZA
VACCINATION
Delaware Division of Public Health
2014-2015 Seasonal Influenza Standing Orders
2014- 2015 Seasonal Influenza Vaccine Formulas:
Trivalent Vaccines will contain:
 A/California/7/2009 (H1N1) – like antigen
 A/Texas/50/2012 (H3N2)-like antigen
 B/Massachusetts/2/2012-like antigen (B/Yamagata lineage)
Quadrivalent Vaccines will include additional vaccine virus:
 B/Brisbane/60/2008 – like antigen (B/Victoria/2/87 lineage.)
Vaccine prepared for a previous influenza season should NOT be administered to provide
protection for the current season.
All persons aged > 6 months should be vaccinated annually.
When vaccine supply is limited vaccination efforts should focus on delivering vaccination to
persons who:
 are aged 6 months through 4 years (59 months);
 are ≥ 50 years;
 have chronic pulmonary (including asthma), cardiovascular (except isolated
hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including
diabetes mellitus);
 are immunosuppressed (including immunosuppression caused by medications or by
human immunodeficiency virus);
 are or will be pregnant during the influenza season;
 are aged 6 months through 18 years and receiving long-term aspirin therapy and who
therefore might be at risk for experiencing Reye syndrome after influenza virus
infections (these individuals should get intramuscular or intradermal IIV preparations
only, NOT LAIV);
 are residents of nursing homes and others chronic-care facilities;
 are American Indians/Alaska Natives;
 are morbidly obese (body-mass index > 40);
 are health care personnel*;
 are household contacts and caregivers of children aged <5 years and adults aged > 50
years, with particular emphasis on vaccinating contacts of children aged <6 months; and
 are household contacts (including children) and caregivers of persons with medical
conditions that put them at higher risk for severe complications from influenza.
*Including public health workers, as well as persons who are members of volunteer ambulance
companies or volunteer fire companies acting as "first responders" in the State of Delaware;
employees of the Delaware Emergency Management Agency; and any other person(s) at the
discretion of the Director, Division of Public Health.
To permit time for production of protective antibody levels, vaccination optimally should occur before
onset of influenza activity in the community. Therefore, vaccination providers should offer
vaccination as soon as vaccine is available, and if possible, by October. Vaccination should be
offered through the influenza season (i.e., as long as influenza viruses are circulating in the
community).
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 2
Intramuscular Inactivated Influenza Vaccines (IIV IM) for Different Age Groups
VACCINE
Fluzone®Quad
Fluarix®Quad
Fluzone®Quad
Fluzone®Tri
Fluzone®Quad
Fluzone®Tri
PRESENTATION THIMEROSAL ROUTE
0.25 mL syringe
Single dose
0.5 mL syringe
Single dose
0.5 mL vial or
0.5 mL syringe
Single dose
0.5 mL syringe
Single dose
5.0 mL vial
Multi-dose
5.0 mL vial
Multi-dose
6-35
mos
3 yrs
4 yrs
5–7
yrs
8-17
yrs
≥ 18
yrs
PREGNANT
No
IM*
Yes
No
No
No
No
No
No
No
IM*
No
Yes
Yes
Yes
Yes
Yes
Yes
No
IM*
.25mL
Yes
Yes
Yes
Yes
Yes
Yes
No
IM*
.25mL
Yes
Yes
Yes
Yes
Yes
Yes
Yes
IM*
No1
No1
No1
No1
Yes
Yes
No1
Yes
IM*
No1
No1
No1
No1
Yes
Yes
No1
*IM - Intramuscular
1
Presentations of influenza vaccine that contains thimerosal are approved by the FDA for vaccination of persons in these categories;
however, Delaware Law, Title 16 Delaware Code Chapter 5 §510 prohibits the administration of these mercury (thimerosal) containing
vaccines for children under 8 years of age and pregnant women unless an exemption to the law has been granted by the Director of the
Division of Public Health (or designee).
When an exemption is in effect, prior to administration of a thimerosal containing vaccine:
1. the provider shall inform client or parent/legal guardian of client that the vaccine contains thimerosal and is believed to be
medically necessary, and the Public Health Director (or designee) has formally determined the vaccine may be given;
2. the client or parent/guardian of client shall acknowledge receiving required information from the provider and ask that the
vaccine be given by placing signature on "Exemption Declaration Due To Shortage Client Consent Form".
Intranasal Live, Attenuated Influenza Vaccine (LAIV IN) for Different Age Groups
VACCINE
FluMist®Quad
PRESENTATION THIMEROSAL ROUTE
0.2 mL spray
Single dose
No
IN*
6-23 mos
24 mos4 yrs
5–49 yrs
≥ 50 yrs
PREGNANT
No
Yes2
Yes2
No
No
Reference: Adapted from CDC as noted above.
*IN - Intranasal
2. Healthy individuals 2-49 years of age.
See LAIV Contraindications (CDC Summary Recommendations 2014-2015, p694) including: individuals aged <2 years or > 49 years,
pregnancy, hypersensitivity, including anaphylaxis to any components of LAIV or to eggs;, immunosuppressed persons, children
or adolescents receiving aspirin or other salicylates, children 2-4 year whose parents or health care provider report (or health
record indicates) wheezing or asthma with 12 months; close contacts of immunosuppressed persons.
See LAIV Precautions (CDC Summary Recommendations 2014-2015, p694) including persons with asthma (greater or equal to 5
years) who might be at increased risk for wheezing after administration of LAIV; and those person with underlying medical conditions that
might predispose them to complications after wild-type influenza infection: e.g. chronic pulmonary, cardiovascular, renal, hepatic,
neurologic/neuromuscular, hematologic or metabolic disorders in which safety of LAIV has not been established. Persons who
care for severely immunosuppressed person who require a protective environment should not receive LAIV or should avoid
contact with such person for 7 days after receipt, given theoretical risk for transmission of live attenuate vaccine virus.
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 3
Inactivated Influenza Vaccine (IIV)
IIV DOSE
Influenza vaccine dosage by age group - United States 2014-15 Season
AGE GROUP
DOSE
NUMBER of DOSES ROUTE
6 – 35 months
0.25 mL
1 or 2 *
IM
3 – 8 years
0.5 mL
1 or 2 *
IM
 9 years
0.5 mL
1
IM
*NUMBER OF DOSES AND INTERVALS FOR CHILDREN
For simplicity use chart below
FIGURE 1. Influenza vaccine dosing algorithm for children aged 6 months through 8 years — Advisory
Committee on Immunization Practices, United States, 2014–15 influenza season*
†
* For simplicity, this algorithm takes into consideration only doses of seasonal influenza vaccine received since July 1, 2010, to determine
the number of doses needed for the 2014–15 season.
† Doses should be administered at least 4 weeks apart.
The figure above is a flow chart detailing the influenza vaccine dosing algorithm for children aged 6 months through 8 years in the United
States for the 2014-15 influenza season. Two approaches are recommended for determination of the necessary doses for the 2014-15
season; both are acceptable. The first approach considers only doses of seasonal influenza vaccine received since July 1, 2010. Where
adequate vaccination history from before the 2010-11 season is available, the second approach may be used. (See Circumstance/action
table below.)
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 4
IIV PREFERRED SITE
 The recommended site of vaccination is the deltoid muscle for adults and older children.
 The preferred site for infants and young children is the antero-lateral aspect of the thigh.
INDICATIONS
All persons aged ≥6 months should be vaccinated annually to protect from influenza infection and the
complications that may follow.
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg protein, or after previous
dose of any influenza vaccine. Such individuals should be referred to their primary care physician for
further evaluation. See vaccine components in each vaccine preparation in Vaccine Excipient
and Media Summary table (pp10).
PRECAUTIONS
 Moderate or severe acute illness with or without fever. However, minor illnesses with or without
fever do not contraindicate use of influenza vaccine.
 Guillain-Barre Syndrome (GBS) within 6 weeks following a previous dose of IIV is considered to
be a precaution for use of IIV.
POSSIBLE REACTIONS
 Soreness (in >50% of recipients), redness and/or swelling at the vaccination site are the most
frequent side effects of vaccination. Other mild problems include headache, lethargy, sore
throat, red itchy eyes, cough, fever and muscle aches. If these problems occur they usually
begin soon after the injection and last 1-2 days.
 Other possible infrequent, but severe problems include immediate responses such as hives,
angioedema, allergic asthma, or systemic anaphylaxis (severe allergic reaction estimated at less
than 1 in a million doses.)
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 5
GUIDELINES FOR INACTIVATED INFLUENZA VACCINE (IIV) VACCINATION OF
CHILDREN AND ADULTS
CIRCUMSTANCE
ACTION
Well individual, eligible for vaccine
as indicated above.
Immunize
Moderate or severe acute illness.
Defer immunization until symptoms have abated.
History of anaphylactic reaction or
hypersensitivity to eggs
Do NOT immunize. Refer to primary care provider.
HIV infected persons.
Immunize with IIV preparation
Pregnant and Lactating Women
Immunize at any gestation with IIV.
Simultaneous administration.
Can receive influenza vaccine at the same time they
receive other vaccinations.
Infant/Child 6 months through 8
years of age for whom vaccine
history before July 2010 cannot be
determined.
Give 2 doses this season.
Infant/Child 6 months through 8
years of age who has received:
1) At least 1 dose of 2013-2014
seasonal influenza vaccine
OR
2) Two or more doses of seasonal
influenza vaccine since July 1,
2010,
OR
Give 1 dose this season.
3) Two or more doses of seasonal
influenza vaccine before July 1,
2010, and 1 or more doses of
monovalent
2009
(H1N1)
vaccine;
OR
4) One or more doses of seasonal
influenza vaccine before July 1,
2010, and 1 or more doses of
seasonal influenza vaccine since
July 1, 2010.
Well individual, eligible for vaccine,
who received a 2013-2014 seasonal
vaccine.
Immunize
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 6
Live, Attenuated Influenza Vaccine (LAIV): FluMist®
CDC ACIP Recommendations re: Live Attenuate Influenza Vaccine (LAIV) for Children (2-8 yrs.)
“When immediately available, LAIV should be used for healthy children aged 2 through 8 years who have no
contraindications or precautions. If LAIV is not immediately available, IIV should be used. Vaccination should
not be delayed to procure LAIV…This recommendation should be implemented for the 2014-2015 season as
feasible, but not later than 2015-2016 season.”
LAIV is an option for vaccination of healthy persons aged 2 - 49 years, including healthcare workers
and other persons in close contact with groups at high risk for influenza. During periods when
inactivated vaccine is in short supply, use of LAIV is encouraged for eligible persons because use of
LAIV by these persons might increase availability of inactivated vaccine for persons with
contraindications that preclude them from receiving LAIV.
DOSE
AGE GROUP
PRODUCT
DOSE
NUMBER of DOSES
ROUTE
2 - 49 years
LAIV
0.2 mL divided equally
in each nostril.
1 or 2 *
Intranasal
*NUMBER OF DOSES AND INTERVALS
For simplicity see Influenza vaccine dosing algorithm for children aged 6 months
through 8 years --- Advisory Committee on Immunization Practices (ACIP), 2014-2015
influenza season on p.4 above.
 Children 2 through 8 years of age who received a seasonal influenza vaccine for the first time should
receive 2 doses, spaced ≥ 4 weeks apart.
 Children 2 through 8 years of age for whom vaccine history prior to July 2010 cannot be determined
should receive 2 doses; spaced ≥ 4 weeks apart.
 Children 2 through 8 years of age who received at least one dose of 2013-2014 seasonal influenza
vaccine should receive 1 dose.
 Children 2 through 8 years of age who received 2 or more doses of seasonal influenza vaccine since
July 1, 2010; should receive 1 dose .
 Children 2 through 8 years of age who received 2 or more doses of seasonal influenza before July 1,
2010, and 1 or more doses of monovalent 2009 (H1N1) vaccine should receive 1 dose.
 Children 2 through 8 years of age who received 1 or more doses of seasonal influenza vaccine before
July 1, 2010, and 1 or more doses of seasonal influenza vaccine since July 1, 2010 should receive
1 dose.
PREFERRED SITE
 For nasal use only.
 Approximately half of the total sprayer contents are sprayed into the first nostril while the
recipient is in the upright position. An attached dose-divider clip is removed from the sprayer to
administer the second half of the dose into the other nostril. If the vaccine recipient sneezes
after administration, the dose should not be repeated.
INDICATIONS
Healthy individuals 2 through 49 years of age to protect from influenza infection and the
compromising sequelae that may follow.
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 7
CONTRAINDICATIONS
 Individuals aged <2 years or >50 years.
 Pregnant Women
 Individuals with a history of hypersensitivity, including anaphylaxis, to any of the
components of LAIV including egg protein, gentamicin, gelatin, and arginine, or after a
previous dose of any influenza vaccine. See vaccine components in each
preparation in Vaccine Excipient and Media Summary table (pp10).
 Children and adults who have immunosuppression (including immunosuppression
caused by medications or by human immunodeficiency virus);
 Children or adolescents (6 months–18 years) receiving aspirin or other salicylates
(because of the risk, in these individuals, of developing Reye’s syndrome after receiving
LAIV).
 Children aged 2 - 4 years whose parents or caregivers report that a healthcare provider
has told them during the preceding 12 months that their child had wheezing or asthma,
or whose medical record indicates a wheezing episode has occurred during the
preceding 12 months.
 Close contacts of immunosuppressed persons requiring a protected environment (e.g.
hematopoietic stem cell transplant recipient).
PRECAUTIONS
 Persons of >5 years with asthma might be at increased risk for wheezing after
administration of LAIV. (Give IIV instead or refer to PCP if desires LAIV.)
 Individuals with chronic pulmonary, cardiovascular (except isolated hypertension), renal,
hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus).
(Give IIV instead or refer to PCP if desires LAIV.)
 LAIV should not be administered until 48 hours after cessation of influenza antiviral
therapy. Influenza antiviral medications should not be administered for 2 weeks after
receipt of LAIV.
 Guillain-Barre Syndrome (GBS) within 6 weeks following a previous dose of influenza
vaccine is considered to be a precaution for use of influenza vaccines. Refer client to
primary care provider.
 Moderate or severe acute illness with or without fever.
POSSIBLE REACTIONS
Mild problems that have been reported following LAIV:
Children and adolescents (2-17 years of age):
 Runny nose, nasal congestion or cough
 Fever
 Headache and muscle aches
 Wheezing
 Abdominal pain or occasional vomiting or diarrhea
Adults (18-49 years of age):
 Runny nose or nasal congestion
 Sore throat
 Cough, chills, tiredness/weakness
 Headache
A severe allergic reaction could occur after any vaccine (estimated less than 1 in a million
doses).
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 8
GUIDELINES FOR LIVE, ATTENUATED INFLUENZA VACCINE (LAIV) IMMUNIZATION
OF CHILDREN AND ADULTS:
CIRCUMSTANCE
ACTION
Well individuals 2 through 49 years
eligible for vaccine.
Immunize as indicated above.
Minor acute illness with or without fever.
Immunize
Persons with nasal congestion serious
enough to make breathing difficult, such
as a very stuffy nose.
Do NOT immunize with LAIV. Immunize with
inactivated flu vaccine.
Hypersensitivity to eggs.
Do NOT immunize. Refer to primary care
provider.
Pregnant Women
Do NOT immunize with LAIV. Immunize with
inactivated flu vaccine.
Individuals who are <2 or ≥ 50 years of
age.
Do NOT immunize with LAIV. Immunize with
inactivated flu vaccine.
Simultaneous administration with other
vaccines.
An inactivated vaccine can be administered
either simultaneously or at any time before or
after LAIV.
A live vaccine should either be administered on
the same day as LAIV or administered ≥4 weeks
before or after LAIV.
Well individual, eligible for vaccine, who
received 2013-2014 seasonal influenza
vaccine
Immunize with LAIV
Individuals with asthma, chronic
pulmonary, cardiovascular (except
isolated hypertension), renal, hepatic,
neurologic, hematologic, or metabolic
disorders (including diabetes mellitus).
Do not immunize with LAIV. Immunize with IIV.
Refer to primary care provider if desires LAIV.
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 9
Vaccine Excipient & Media Summary
Excipients Included in Influenza Vaccines Purchased by DPH, by Vaccine
This table includes not only vaccine ingredients (e.g., adjuvants and preservatives), but also
substances used during the manufacturing process, including vaccine-production media, that
are removed from the final product and present only in trace quantities. In addition to the
substances listed, most vaccines contain Sodium Chloride (table salt).
All reasonable efforts have been made to ensure the accuracy of this information. If in doubt,
check the manufacturer’s package insert. See links below.
Vaccine*
Influenza (Fluarix
(Quadrivalent)
Influenza (FluMist
Quadrivalent)
Influenza (Fluzone:
Quadrivalent)
Influenza (Fluzone)
Contains
octoxynol-10 (Triton X-100), α-tocopheryl hydrogen succinate,
polysorbate 80 (Tween 80), hydrocortisone, gentamicin sulfate,
ovalbumin (egg protein), sodium deoxycholate, and
formaldehyde
monosodium glutamate, hydrolyzed porcine gelatin, arginine,
sucrose, dibasic potassium phosphate, monobasic potassium
phosphate, ovalbumin (egg protein), gentamicin sulfate, and
ethylenediamine tetraacetic acid (EDTA)
ovalbumin(egg protein), sodium phosphate-buffered isotonic
sodium chloride solution, formaldehyde, octylphenol ethoxylate
and thimerosal/mercury (multi-dose vial only)
ovalbumin(egg protein), sodium phosphate-buffered isotonic
sodium chloride solution, formaldehyde, octylphenol ethoxylate,
gelatin and
thimerosal/mercury (multi-dose vial only)
Source:
Manufacturer’s
P.I. Dated
XX/2014
7/2014
20 Feb 2014
20 Feb 2014
GlaxoSmithKline Fluarix® Quadrivalent Influenza Virus Vaccine Suspension for Intramuscular Injection. Highlights of and
Full Prescribing Information 2014-2015 Formula.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM335392.pdf
MedImmune Flumist® Quadrivalent (Influenza Vaccine Live, Intranasal). Highlights of Prescribing Information, July 2014
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM294307.pdf
Sanofi pasteur 271/371 Fluzone®, Highlights of and Full Prescribing Information, 2014-2015 Formula, 20 Feb 2014 v0.4.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM305089.pdf
Sanofi pasteur 450/477 Fluzone® Quadrivalent, Highlights of and Full Prescribing Information, 2014-2015 Formula, 20 Feb 2014 v0.4.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM356094.pdf
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 10
References and Resources:
Centers for Disease Control and Prevention. Prevention and Control of Seasonal Influenza with
Vaccines: Recommendations of the Advisory Committee on Immunization Practices – (ACIP) – United
States, 2014-2015 Influenza Season http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6332a3.htm
http://www.cdc.gov/mmwr/pdf/wk/mm6332.pdf
Centers for Disease Control and Prevention. Prevention and Control of Influenza with Vaccines:
Recommendations of the Advisory Committee on Immunization Practices – (ACIP) – United States,
2013-2014
http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm
Centers for Disease Control and Prevention. Vaccine Information Statement, Flu Vaccine, Inactivated
(8/19/14) 42 U.S.C. §300aa-26. http://www.cdc.gov/vaccines/hcp/vis/vis-statements/flu.pdf
Centers for Disease Control and Prevention. Vaccine Information Statement Flu Vaccine, Live,
Intranasal (8/19/14) U.S.C. §300aa26 http://www.cdc.gov/vaccines/hcp/vis/vis-statements/flulive.pdf
GlaxoSmithKline Fluarix® Quadrivalent Influenza Virus Vaccine Suspension for Intramuscular
Injection. Highlights of and Full Prescribing Information 2014-2015 Formula.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM335392.pdf
MedImmune Flumist® Quadrivalent (Influenza Vaccine Live, Intranasal). Highlights of Prescribing
Information, July 2014
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM294307.pdf
Sanofi pasteur 271/371 Fluzone®, Highlights of and Full Prescribing Information, 2014-2015
Formuala, 20 Feb 2014 v0.4.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM305089.pdf
Sanofi pasteur 450/477 Fluzone® Quadrivalent, Highlights of and Full Prescribing Information, 20142015 Formula, 20 Feb 2014 v0.4.
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM356094.pdf
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 11
THE PRECEDING PROCEDURES, GUIDELINES AND INFLUENZA
STANDING ORDERS ARE APPROVED FOR USE BY DIVISION OF
PUBLIC HEALTH REGISTERED NURSES AND REGISTERED
NURSES WORKING UNDER THE DIRECTION OF THE DIVISION OF
PUBLIC HEALTH.
____________________________________________
EFFECTIVE DATES:
August 26, 2014 – June 30, 2015
____________________________________________
Delaware Division of Public Health 2014 – 2015 Influenza Standing Orders
Page 12
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