Delaware Health & Social Services Division of Public Health

IMMUNIZATION STANDING ORDERS 2016-2017

SEASONAL INFLUENZA VACCINATION

Delaware Division of Public Health 2016–2017 Influenza Standing Orders

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Delaware Division of Public Health 2016-2017 Seasonal Influenza Standing Orders 2016-2017 Seasonal Influenza Vaccine Formula: Quadrivalent Vaccines will contain hemagglutinin derived from:  A/California/7/2009 (H1N1)-like virus  A/Hong Kong/4801/2014 (H3N2)-like virus  B/Brisbane/60/2008-like virus (B/Victoria lineage)  B/Phuket/3073/2013-like virus (B/Yamagata lineage) (only in quadrivalent vaccine) Vaccine prepared for a previous influenza season should NOT be administered to provide protection for the current season. All persons aged > 6 months and who have no contraindications should be vaccinated annually. Influenza vaccination should not be delayed to procure a specific vaccine preparation if an appropriate one is already available. An age-appropriate formulation of vaccine should be used. When vaccine supply is limited vaccination efforts should focus on delivering vaccination to persons who:  are aged 6 months to less than 5 years (<60 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  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 2016–2017 Influenza Standing Orders

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Intramuscular Inactivated Influenza Vaccines (IIV IM) for Different Age Groups VACCINE

Fluzone®Quad Fluarix®Quad Fluzone®Quad Fluzone®Quad

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 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

Yes

IM*

No

1

Yes

Yes

No

1

No

1

1

No

No

1

*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". .

Delaware Division of Public Health 2016–2017 Influenza Standing Orders

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Inactivated Influenza Vaccine (IIV) IIV DOSE Influenza vaccine dosage by age group - United States 2016-17 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, 2016–17 influenza season

CDC MMWR Weekly Report. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2016–17 Influenza Season 65(5); 1-52. http://www.cdc.gov/mmwr/volumes/65/rr/rr6505a1.htm.

Delaware Division of Public Health 2016–2017 Influenza Standing Orders

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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 (pp 7).

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. Refer client to primary care provider.

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 is estimated at less than 1 in a million doses.)

Delaware Division of Public Health 2016–2017 Influenza Standing Orders

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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 who has received: No (zero) or one dose trivalent or quadrivalent influenza vaccine before July 1, 2016 Give 2 doses this season OR Infant/Child 6 months through 8 years of age for whom vaccine history before July 1, 2016 cannot be determined

Infant/Child 6 months through 8 years of age who has received: Two or more doses of trivalent or quadrivalent influenza vaccine prior to July 1, 2016

Well individual, eligible for vaccine, who received a 2015-2016 seasonal vaccine

Give 1 dose this season

Immunize

Delaware Division of Public Health 2016–2017 Influenza Standing Orders

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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

Contains octoxynol-10 (Triton X-100), α-tocopheryl hydrogen succinate, polysorbate 80 (Tween 80), hydrocortisone, gentamicin sulfate, ovalbumin (egg protein), sodium deoxycholate, and formaldehyde ovalbumin(egg protein), sodium phosphatebuffered isotonic sodium chloride solution, formaldehyde, octylphenol ethoxylate and thimerosal/mercury (multi-dose vial only)

Influenza (Fluarix Quadrivalent) Influenza (Fluzone: Quadrivalent)

Source: Manufacturer’s P.I. Dated

Revised: 5/2016

Revised: June 2016

®

GlaxoSmithKline Fluarix Quadrivalent Influenza Virus Vaccine Suspension for Intramuscular Injection. Highlights of and Full Prescribing Information, 2016-2017 Formula, Revised: 5/2016, Accessed: 8/19/16. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Fluarix_Quad rivalent/pdf/FLUARIX-QUADRIVALENT.PDF ®

Sanofi Pasteur 450/477 Fluzone Quadrivalent, Highlights of and Full Prescribing Information, 2016-2017 Formula, May 1, 2016, Accessed: 8/19/16. https://www.vaccineshoppe.com/image.cfm?pi=fluQIV&image_type=product_pdf

Delaware Division of Public Health 2016–2017 Influenza Standing Orders

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References and Resources: Center for Disease Control and Prevention. MMWR Weekly. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2016–17 Influenza Season 65(5); 1-52.. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6430a3.htm http://www.cdc.gov/mmwr/pdf/wk/mm6430.pdf Centers for Disease Control and Prevention. Vaccine Information Statement, Flu Vaccine, Inactivated (8/7/15) 42 U.S.C. §300aa-26. http://www.cdc.gov/vaccines/hcp/vis/vis-statements/flu.pdf GlaxoSmithKline Fluarix® Quadrivalent Influenza Virus Vaccine Suspension for Intramuscular Injection. Highlights of and Full Prescribing Information, 2016-2017 Formula, Revised: 5/2016, Accessed: 8/19/16. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Flu arix_Quadrivalent/pdf/FLUARIX-QUADRIVALENT.PDF Sanofi Pasteur 450/477 Fluzone® Quadrivalent, Highlights of and Full Prescribing Information, 20162017 Formula, Revised: May 1 2016, Accessed: 8/19/16. https://www.vaccineshoppe.com/image.cfm?pi=fluQIV&image_type=product_pdf

Delaware Division of Public Health 2016–2017 Influenza Standing Orders

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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:

September 6, 2016 – June 30, 2017

____________________________________________

Influenza Vaccination SO Final 2016-2017 MMDDYY

Delaware Division of Public Health 2016–2017 Influenza Standing Orders

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