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