2014/2015 Seasonal Trivalent Inactivated Influenza Vaccine (TIIV) and Live Attenuated Influenza Vaccine (LAIV)

Transcription

1 Page /2015 Seasonal Trivalent Inactivated Influenza Vaccine (TIIV) and Live Attenuated Influenza Vaccine (LAIV) Contains: A/California/7/2009 (H1N1)pdm09-like virus A/Texas/50/2012 (H3N2)-like virus B/Massachusetts/2/2012-like virus (B/Brisbane/60/2008-like virus in quadrivalent vaccines only) The strains in the trivalent vaccines are unchanged from the 2013/14 season. Recommended and provided free to the following groups: 1. People at high risk: People aged 65 years and older People of any age who are residents of long-term care facilities Adults (including pregnant women) and children with the following chronic health conditions: Cardiac or pulmonary disorders (e.g., bronchopulmonary dysplasia, cystic fibrosis, asthma) Diabetes and other metabolic diseases Cancer; immunodeficiency (including human immunodeficiency virus [HIV] infection); immunosuppression due to underlying disease or therapy (e.g., severe rheumatoid arthritis requiring immunosuppressive therapies) Chronic kidney disease Chronic liver disease, including hepatitis C Anemia and hemoglobinopathy Conditions that compromise the management of respiratory secretions and are associated with an increased risk of aspiration (e.g., cognitive dysfunction, spinal cord injury, seizure disorder, and neuromuscular disorders) Children and adolescents (age 6 months to 18 years) with conditions treated for long periods with acetylsalicylic acid Children and adults who are morbidly obese (adult BMI 40; child BMI assessed as 95 th percentile adjusted for age and sex) Aboriginal peoples (on and off reserve) Healthy children 6 to 59 months of age Pregnant women at any stage of pregnancy during the influenza season (typically spanning November to April) Inmates of provincial correctional institutions People working with live poultry (immunization may reduce the potential for human-avian re-assortment of genes should such workers become co-infected with human and avian influenza.) 2. People capable of transmitting influenza to those at high risk: All health care workers (including all health authority staff, accredited physicians and residents, volunteers, students, contractors, and vendors) who come into contact with patients at health care facilities including long-term care facilities. This includes independent health care practitioners and their staff in community settings. Visitors to health care facilities and other patient care locations. Household contacts (including children) of people at high risk whether or not those high-risk people have been immunized Those who provide care and/or service in potential outbreak settings housing high risk persons (e.g., crew on ships) Household contacts of healthy children 0 to 59 months of age Those providing regular child care to healthy children 0 to 59 months of age, whether in or out of the home 3. People who provide essential community services: First responders: police, fire fighters, ambulance Corrections office

2 July 2014 Page 31a Safety Issues Applicable to Influenza Vaccines 1. Egg Allergic Individuals Since the 2013/2014 influenza season, British Columbia guidelines have allowed for the immunization of egg allergic individuals (including those who have experienced anaphylaxis following egg ingestion) with inactivated influenza vaccine, in any setting, following standard vaccine administration practices. These changes were based on recommendations issued by the US Joint Task Force on Practice Parameters (2013) and were reflected in the SPECIAL CONSIDERATIONS section of each of the inactivated influenza vaccine product pages for the 2013/2014 season. A The 2014/2015 NACI statement on influenza also indicates that egg allergic individuals, including those who have experienced anaphylaxis following egg ingestion, can be immunized with a full dose of inactivated influenza vaccine (trivalent and quadrivalent) according to standard practices. This recommendation is supported by accumulating data on the safe immunization of these individuals using inactivated influenza vaccines. B C The live intranasal influenza vaccine (FluMist ) is contraindicated for egg allergic persons because of lack of supporting data for such use. 2. Oculo-Respiratory Syndrome (ORS) ORS, defined as the onset of bilateral red eyes and/or respiratory symptoms (cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, or sore throat) and/or facial swelling occurring within 24 hours of influenza immunization, was reported following receipt of trivalent inactivated influenza vaccine (TIIV) during the influenza season. Since this time, fewer cases have been reported. Although the pathophysiologic mechanism underlying ORS remains unknown, it is considered distinct from an IgE-mediated allergic response. Those who have experienced ORS including severe manifestations (such as bilateral red eyes, cough, sore throat, hoarseness and facial swelling) but without lower respiratory tract symptoms, may be safely immunized with influenza vaccine. Those who experienced lower respiratory symptoms or those unsure if the prior episode was ORS or an IgE-mediated hypersensitivity reaction should be referred for an expert consultation prior to immunization with influenza vaccine. Persons who have a recurrence of ORS upon revaccination do not necessarily experience further episodes with future vaccinations. Data on clinically significant adverse events do not support the preference of one vaccine product over another when revaccinating those who have previously experienced ORS. For further details on ORS, consult the Canadian Immunization Guide and CCDR Volume 31 at A Kelso JM, Greenhawt MJ, Li JT. Joint Task Force on Practice Parameters. Update on influenza vaccination of egg allergic patients. Ann Allergy Asthma Immunol Oct;111(4): This updates the earlier published guideline: Kelso JM, Greenhawt MJ, et al. Adverse reactions to vaccine practice parameter 2012 update. J Allergy Clin Immunol. 2012;130: B Des Roches A, Paradis L, Gagnon R, et al. Egg-allergic patients can be safely vaccinated against influenza. J Allergy Clin Immunol. 2012;130(5): C Greenhawt MJ, Spergel JM, Rank MA, et al. Safe administration of the seasonal trivalent influenza vaccine to children with severe egg allergy. Annals of Allergy, Asthma and Immunology. 2012;109(6):

3 Page 31b The following pages provide guidance on the use of influenza vaccines that are publicly-funded in BC in the 2014/15 season: FLUVIRAL, FLUAD AGRIFLU, FLUMIST QUADRIVALENT, and FLUMIST. For information on other influenza vaccines please refer to the product monograph and the NACI statement for the 2014/15 influenza season available at National Advisory Committee on Immunization (NACI) Recent Statements.

4 Trivalent Inactivated Influenza Vaccine (Inactivated Split Virion) (TIIV) FLUVIRAL Supplier: GlaxoSmithKline Inc. INDICATIONS: See Seasonal Trivalent Influenza Vaccine This vaccine is not approved for use in those younger than 6 months of age. DOSES AND SCHEDULE: Children 6 months- 8 years of age: 1 or 2 doses given as 0.5 ml IM Communicable Disease Control July 2014 Page 32a Children under 9 years of age who have not previously received seasonal influenza vaccine require 2 doses given 4 weeks apart. If the child has received 1 or more doses in any previous season, only a single dose is required. For children requiring 2 doses within the season, TIIV may be given interchangeably with LAIV with either product used for the 1 st or 2 nd dose if LAIV is not available. Individuals aged 9 years and older: 1 dose given as 0.5 ml IM ADMINISTRATION: Discard multi-dose vials 28 days after first entry. BOOSTER DOSES AND RE-IMMUNIZATION: Annually. SEROLOGICAL TESTING: Serological testing is not recommended before or after immunization. CONTRAINDICATIONS: 1. History of anaphylactic reaction to a previous dose of any type of influenza vaccine. 2. History of anaphylactic reaction to any component of FLUVIRAL. 3. History of Guillain-Barré syndrome (GBS) within 8 weeks of receipt of a previous dose of influenza vaccine without another cause being identified. PRODUCT COMPONENTS: Potential allergens: egg protein (ovalbumin), polysorbate 80, thimerosal (50 μg per 0.5 ml, = 0.01% w/v) (See SPECIAL CONSIDERATIONS). Other components: potassium chloride, disodium hydrogen phosphate heptahydrate, potassium dihydrogen phosphate, α-tocopheryl hydrogen succinate, sodium deoxycholate, ethanol, formaldehyde, sucrose. PRECAUTIONS: Severe oculo-respiratory syndrome (ORS) after a previous dose of influenza vaccine. A SPECIAL CONSIDERATIONS: Egg allergic individuals (including those who have experienced anaphylaxis following egg ingestion) can be immunized with inactivated influenza vaccine in any setting attended by immunization service providers who are following standard vaccine administration practice. B ADVERSE EVENTS: Local: pain, swelling, redness. Systemic: fatigue, headache, myalgia, red eyes, sore throat, cough, arthralgia, fever, chills, malaise, chest tightness. Fewer than 1 in 20 people may develop oculo-respiratory syndrome (ORS). Symptoms include red eyes, a cough, and/or sore throat and/or hoarseness. A See Safety Issues Applicable to Influenza Vaccines, Section 2. Oculo-Respiratory Syndrome (ORS). B See Safety Issues Applicable to Influenza Vaccines, Section 1. Egg Allergic Individuals.

5 July 2014 Page 32b Trivalent Inactivated Influenza Vaccine (Inactivated Subunit, Adjuvanted with MF59C.1) (TIIV) FLUAD Supplier: Novartis Pharmaceuticals Canada Inc. INDICATIONS: Individuals aged 65 years and older This vaccine is not approved for use in those younger than 65 years of age. DOSES AND SCHEDULE: 1 dose given as 0.5 ml IM ADMINISTRATION: No additional requirements. BOOSTER DOSES AND RE-IMMUNIZATION: Annually. SEROLOGICAL TESTING: Serological testing is not recommended before or after immunization. CONTRAINDICATIONS: 1. History of anaphylactic reaction to a previous dose of any type of influenza vaccine. 2. History of anaphylactic reaction to any component of FLUAD. 3. History of Guillain-Barré syndrome (GBS) within 8 weeks of receipt of a previous dose of influenza vaccine without another cause being identified. PRODUCT COMPONENTS: Potential allergens: polysorbate 80, ovalbumin, neomycin, kanamycin (See SPECIAL CONSIDERATIONS). Other components: potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate. formaldehyde, cetyltrimethylammonium bromide (CTAB), barium, squalene, sorbitan trioleate, sodium citrate, citric acid. PRECAUTIONS: Severe oculo-respiratory syndrome (ORS) after a previous dose of influenza vaccine. A SPECIAL CONSIDERATIONS: Egg allergic individuals (including those who have experienced anaphylaxis following egg ingestion) can be immunized with inactivated influenza vaccine in any setting attended by immunization service providers who are following standard vaccine administration practices. B ADVERSE EVENTS: Local: pain, warmth, redness occur more often than after non-adjuvanted vaccines. Systemic: headache, fatigue, malaise, myalgia. Fewer than 1 in 20 people may develop oculo-respiratory syndrome (ORS). Symptoms include red eyes, a cough, and/or sore throat and/or hoarseness. A See Safety Issues Applicable to Influenza Vaccines, Section 2. Oculo-Respiratory Syndrome (ORS). B See Safety Issues Applicable to Influenza Vaccines, Section 1. Egg Allergic Individuals

6 July 2014 Page 32c Trivalent Inactivated Influenza Vaccine (Inactivated Subunit) (TIIV) AGRIFLU Supplier: Novartis Pharmaceuticals Canada Inc. INDICATIONS: See Seasonal Trivalent Influenza Vaccine Use for individuals with a known hypersensitivity to thimerosal. May be used for pregnant women who request a thimerosal-free vaccine. This vaccine is not approved for use in those younger than 6 months of age. DOSES AND SCHEDULE: Children 6 months-8 years of age: 1 or 2 doses given as 0.5 ml IM Children under 9 years of age who have not previously received seasonal influenza vaccine require 2 doses given 4 weeks apart. If the child has received 1 or more doses in any previous season, only a single dose is required. For children requiring 2 doses within the season, TIIV may be given interchangeably with LAIV with either product used for the 1 st or 2 nd dose if LAIV is not available. Individuals aged 9 years and older: 1 dose given as 0.5 ml IM ADMINISTRATION: No additional requirements. BOOSTER DOSES AND RE-IMMUNIZATION: Annually. SEROLOGICAL TESTING: Serological testing is not recommended before or after immunization. CONTRAINDICATIONS: 1. History of anaphylactic reaction to a previous dose of any type of influenza vaccine. 2. History of anaphylactic reaction to any component of AGRIFLU. 3. History of Guillain-Barré syndrome (GBS) within 8 weeks of receipt of a previous dose of influenza vaccine without another cause being identified. PRODUCT COMPONENTS: Potential allergens: egg proteins, ovalbumin, polysorbate 80, neomycin, kanamycin (See SPECIAL CONSIDERATIONS). Other components: potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, formaldehyde, cetyltrimethylammonium bromide (CTAB), barium, citrates. PRECAUTIONS: Severe oculo-respiratory syndrome (ORS) after a previous dose of influenza vaccine. A SPECIAL CONSIDERATIONS: Egg allergic individuals (including those who have experienced anaphylaxis following egg ingestion) can be immunized with inactivated influenza vaccine in any setting attended by immunization service providers who are following standard vaccine administration practices. B ADVERSE EVENTS: Local: pain, induration, redness, swelling. Systemic: headache, myalgia, malaise, fatigue. Fewer than 1 in 20 people may develop oculo-respiratory syndrome (ORS). Symptoms include red eyes, a cough, and/or sore throat and/or hoarseness. A See Safety Issues Applicable to Influenza Vaccines, Section 2. Oculo-Respiratory Syndrome (ORS). B See Safety Issues Applicable to Influenza Vaccines, Section 1. Egg Allergic Individuals

7 Page 33a Influenza Vaccine (Live attenuated influenza vaccine (LAIV)) FLUMIST QUADRIVALENT (LAIV-Q) Supplier: AstraZeneca Canada FLUMIST (LAIV-T) INDICATIONS: See Seasonal Trivalent Influenza Vaccine LAIV is publicly funded for children 2 to 17 years old, inclusive. These vaccines are not approved for use in those younger than 2 years or older than 59 years. DOSES AND SCHEDULE: Children 2-8 years of age: 1 or 2 doses given as 0.2 ml (0.1 ml in each nostril) intranasal spray; these products should be preferentially offered to children in this age group. Children under 9 years of age who have not previously received seasonal influenza vaccine require 2 doses given 4 weeks apart. If the child has received 1 or more doses in any previous season, only a single dose is required. If a child presents for the 2 nd dose within the season and LAIV-Q is unavailable, administer either LAIV-T or trivalent inactivated influenza vaccine (TIIV). Children and Adolescents 9-17 years of age: 1 dose given as 0.2 ml (0.1 ml in each nostril) intranasal spray; this product is recommended for use in this age group and offers the advantage of needle-free administration. Adults years of age: 1 dose: 0.2 ml (0.1 ml in each nostril) intranasal spray; this product is approved for use in this age group but TIIV provides better protection against influenza. LAIV is not provided free in BC for this age group. ADMINISTRATION: The shelf-life of LAIV (approximately 4 months) is considerably shorter than that of inactivated influenza vaccines. Be sure to check the expiry date before administering the vaccine. LAIV IS AN INTRANASAL SPRAY AND IS NOT FOR INJECTION. DO NOT INJECT. The product is provided in a sprayer in a firm device that looks like a syringe with a tip protector at one end and a plunger with a dose divider clip at the other end. Details and a diagram on how to administer LAIV-Q and LAIV-T are contained in the product monographs and the accompanying text is reproduced below: 1. Remove the rubber tip protector. Do not remove the dose-divider clip at the other end of the sprayer. 2. With the recipient sitting upright, place tip of the sprayer just inside a nostril to ensure vaccine is delivered into the nose. 3. In one motion depress the plunger as rapidly as possible until the dose-divider clip prevents you from going further. 4. Pinch and remove the dose divider clip from the plunger. 5. Place the tip of the sprayer just inside the other nostril and with a single motion depress the plunger as rapidly as possible to deliver the rest of the vaccine. BOOSTER DOSES AND RE-IMMUNIZATION: Annually. SEROLOGICAL TESTING: Serological testing is not recommended before or after immunization.

8 Page 33b Influenza Vaccine (Live, attenuated) FLUMIST QUADRIVALENT (LAIV-Q) FLUMIST (LAIV-T) Supplier: AstraZeneca Canada CONTRAINDICATIONS: 1. History of anaphylactic reaction to a previous dose of any type of influenza vaccine or to any component of LAIV. 2. Egg allergy. Such individuals should receive inactivated influenza vaccine. A 3. Severe asthma or active wheezing (on high dose inhaled or oral steroids or medically attended wheezing in the 7 days prior to vaccination). 4. Adults and children with immune compromising conditions. 5. HCWs working with immunocompromised individuals (See PRECAUTIONS 2 nd bullet). 6. Pregnancy. 7. Individuals 2-17 years of age receiving aspirin-containing therapy because of the association of Reye syndrome with aspirin and wild-type influenza infection. It is recommended that aspirin-containing products in children under 18 years of age be delayed for four weeks after receipt of LAIV. 8. History of Guillain-Barré syndrome (GBS) within 8 weeks of receipt of a previous dose of influenza vaccine without another cause being identified. PRODUCT COMPONENTS: Potential allergens: ovalbumin, gelatin hydrolysate (porcine Type A), gentamicin, arginine hydrochloride. Other components: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, monosodium glutamate. PRECAUTIONS: Severe oculo-respiratory syndrome (ORS) after a previous dose of influenza vaccine. B Vaccine recipients should be informed that LAIV is a vaccine that contains a weakened strain of influenza virus and could potentially be transmitted to another person through contact with respiratory secretions. An infection with this weakened virus could cause a serious infection in a small category of patients who are severely immunocompromised and receiving care in hospital in a protected environment (e.g., post bone marrow transplant). Both health care workers and close contacts of such patients should avoid contact with these patients for two weeks after receiving LAIV. If such contact cannot be avoided offer an inactivated influenza vaccine instead of LAIV. A See Safety Issues Applicable to Influenza Vaccines, Section 1. Egg Allergic Individuals B See Safety Issues Applicable to Influenza Vaccines, Section 2. Oculo-Respiratory Syndrome (ORS).

9 Page 33c Influenza Vaccine (Live, attenuated) FLUMIST QUADRIVALENT (LAIV-Q) FLUMIST (LAIV-T) Supplier: AstraZeneca Canada SPECIAL CONSIDERATIONS: As for other live vaccines, LAIV can be given concurrently with MMR and varicella vaccines to young children without reducing the immunogenicity or safety of any of the vaccines. If not given at the same visit, administration of live vaccines should be separated by at least four weeks to reduce or eliminate interference from the vaccine given first on the vaccine given second. Antiviral agents active against influenza (oseltamivir and zanamivir) interfere with the immune response to LAIV. LAIV should not be administered to individuals while taking these antiviral agents. Such individuals should receive inactivated influenza vaccine. If antiviral agents are administered from 48 hours before to 2 weeks after receipt of LAIV, revaccinate when antiviral agents have been discontinued for at least 48 hours. No information on the effect of LAIV on a TB skin test is available. It is prudent to do TB skin testing on the same day as LAIV immunization, or delay TB skin testing 4 weeks, to avoid having a false negative TB skin test result. A This advice is extrapolated from the experience with measles vaccine. ADVERSE EVENTS: Local: runny nose or nasal congestion. Systemic: decreased appetite, weakness, headache, fever, sore throat, cough. A Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Wolfe S, Hamborsky J, eds. 12th ed., second printing. Washington DC: Public Health Foundation, p.26. Available from