Hepatitis B Vaccine Bilgical Page Sectin 7: Bilgical Prduct Infrmatin Standard #: 07.234 Created by: Apprved by: Prvince-wide Immunizatin Prgram Standards and Quality Prvince-wide Immunizatin Prgram, Standards and Quality Apprval Date: March 1, 2013 Revised: February 15, 2018 Recmbivax HB Engerix -B Manufacturer Merck Canada Inc. GlaxSmithKline Inc. Bilgical Classificatin Inactivated: Recmbinant Indicatins fr Prvincially Funded Vaccine Nte: Fr questins related t Travel and r Fr Sale vaccine refer t AHS Travel Health and Cntracted Immunizatin Services resurces. Pre-expsure: Students in Grade 5 as part f the prvincial schl based immunizatin prgram. Students in Grades 6 thrugh 12 wh have nt received a series f hepatitis B vaccine. Fr students in ungraded classes, vaccine can be prvided n a case by case basis, generally at 9 years up t and including 18 years f age. The guiding principle shuld be t ffer prtectin t students prir t them leaving the schl system. Individuals brn in 1981 r later wh wuld have been eligible fr the schl universal hepatitis B vaccine prgram and wh have nt received a series f hepatitis B vaccine. Children frm birth up t and including 6 years f age, whse families have immigrated t Canada frm areas where there is a high prevalence (8% r higher) f hepatitis B.See Hepatitis B Virus Infectin High Endemic Gegraphic Areas. Nn-immune adults wh have immigrated t Canada frm areas where there is a high prevalence (8% r higher) f hepatitis B. See Hepatitis B Virus Infectin High Endemic Gegraphic Areas. Individuals wh are wrkers, vlunteers r students (accepted int pst-secndary educatinal prgrams) and wh have a reasnable anticipated risk f expsure t bld/bldy bdy fluids and/r sharps injuries during the curse f their wrk. Refer t Hepatitis B Risk Assessment. Residents and staff f institutins r grup hmes fr the develpmentally challenged. Nn-immune individuals with lifestyle risks f infectin including: Men having sex with men. Thse with multiple sexual partners (e.g., have had mre than ne sexual partner in the previus six mnths). Thse with a histry f sexually transmitted infectins (STI) r thse seeking evaluatin r treatment fr an STI. Thse wh engage in high risk sexual practices. Thse wh have unprtected sex with new partners. Thse wh use illicit drugs and assciated drug-using paraphernalia (e.g., needles, tubes used fr snrting), resulting in bld expsure. Hemphiliacs and thers receiving repeated infusins f bld r bld prducts (hepatitis B vaccine is nt prvided fr parents prviding hme infusin fr their children). Individuals with Inflammatry Bwel disease (IBD) wh will be n lng term immunsuppressive medicatins including but nt limited t Imuran r TNF antagnists like Remicade r Humira. Individuals with chrnic liver disease frm any cause, including hepatitis C infectin. Immunizatin Prgram Standards Manual Page 1 f 11 Ppulatin, Public and Indigenus Health
Recmbivax HB Engerix -B Nte: Individuals with chrnic liver disease with lab cnfirmatin f psitive anti-hbs but withut dcumentatin f any dses f hepatitis B vaccine shuld be ffered a series f hepatitis B vaccine t ensure lng term immunity. Individuals with chrnic liver disease with lab cnfirmatin f psitive anti-hbs with any incmplete series shuld have their series cmpleted. Nn-immune individuals with chrnic health cnditins that may be HYPORESPONSIVE t hepatitis B vaccine shuld receive a higher dse f hepatitis B (see dse sectin). These include: Individuals with chrnic renal disease r wh are underging chrnic hemdialysis/peritneal dialysis, including thse wh are pre-dialysis (prgressive renal insufficiency). Individuals with cngenital immundeficiencies. Individuals infected with HIV. Candidates and recipients f Slid Organ Transplant (SOT) See Standard fr Immunizing Transplant Candidates and Recipients. Recipients f Hematpietic Stem Cell Transplant (HSCT) See Standard fr Immunizing Transplant Candidates and Recipients. Nte: Individuals with lab cnfirmatin f psitive anti-hbs but withut dcumentatin f any dses f hepatitis B vaccine shuld be ffered a series f hepatitis B vaccine t ensure lng term immunity. Individuals with lab cnfirmatin f psitive anti-hbs with any incmplete series shuld have their series cmpleted. Peridic serlgical testing may be dne by the attending physician fr hyprespnsive individuals. See serlgy sectin fr mre infrmatin. Inmates in prvincial crrectinal facilities wh will be incarcerated fr a sufficient length f time t cmplete a hepatitis B vaccine series. Nte: Immunizatin f inmates in lng-term crrectinal facilities is the respnsibility f the Federal Crrectinal Service. Hwever, vaccine will be prvided prvincially fr cmpletin f immunizatin f discharged inmates wh began their hepatitis B series in federal prisns. Staff and children in child care settings in which there is a hepatitis B infected staff r child. If exceptinal circumstances such as biting behavir r special medical cnditins exist and Hepatitis B status is unknwn, cnsult with MOH/designate. Ppulatins r cmmunities in which hepatitis B is highly endemic, fllwing cnsultatin with MOH/designate. Nte: Cmbined hepatitis A and B vaccine may be indicated fr individuals 1 year f age and lder wh qualify fr bth hepatitis A and B vaccines fr pre-expsure if they d nt require the duble strength hepatitis B vaccine (see Twinrix Vaccine Bilgical Page). Pst-expsure: Infants: Newbrns brn t hepatitis B surface antigen psitive (HBsAg) mthers (acute cases r carriers) shuld receive hepatitis B immune glbulin (HBIg) and the first dse f hepatitis B vaccine as sn as pssible after birth (within 12 hurs) but within 7 days after birth if HBIg/hepatitis B vaccine is delayed fr any reasn. Nte: If prenatal screening has nt been dne prir t delivery, it shuld be dne as sn as pssible after admissin fr delivery. In additin, repeat testing shuld be cnsidered in uninfected, susceptible wmen with cntinuing high risk factrs. Immunizatin Prgram Standards Manual Page 2 f 11 Ppulatin, Public and Indigenus Health
Recmbivax HB Engerix -B If results can be btained within 12 hurs, the first dse f Hepatitis B vaccine shuld be administered with the decisin t administer HBIg awaiting results. If screening results are nt available within 12 hurs, administer hepatitis B vaccine and cnsider administratin f HBIg, taking int accunt maternal risk factrs and erring n the side f prviding HBIg if there is any questin f pssible maternal hepatitis B infectin. Infants (ther than newbrns) yunger than 12 mnths f age shuld receive: Hepatitis B vaccine and HBIg if the mther r primary caregiver is an acute case. Hepatitis B vaccine nly if the caregiver r significant husehld cntact is a chrnic carrier. Susceptible husehld cntacts, sexual partners and needle sharing partners f individuals with acute r chrnic hepatitis B infectin. Hepatitis HBIg may be recmmended fr sme individuals depending n the time frm expsure and the specifics f the expsure. Refer t: Public Health Ntifiable Disease Management Guidelines Hepatitis B Nte: Susceptible husehld cntacts, sexual partners and needle-sharing partners with lab cnfirmatin f psitive anti-hbs but withut dcumentatin f any dses f hepatitis B vaccine shuld be ffered a series f hepatitis B vaccine t ensure lng term immunity. Susceptible husehld cntacts, sexual partners and needle-sharing partners with lab cnfirmatin f psitive anti-hbs with any incmplete series shuld have their series cmpleted. Percutaneus (needle stick) r mucsal expsure. Pst-expsure fllw-up and prphylaxis shuld be based n the immunizatin histry and antibdy status f the expsed persn and, if knwn, the infectius nature f the surce. Nte: Individuals sustaining percutaneus (needle stick) r mucsal expsure with lab cnfirmatin f psitive anti-hbs but withut dcumentatin f any dses f hepatitis B vaccine shuld be ffered a series f hepatitis B vaccine t ensure lng term immunity. Individuals sustaining percutaneus (needle stick) r mucsal expsure with lab cnfirmatin f psitive anti-hbs with any incmplete series shuld have their series cmpleted. When a susceptible individual sustains a cmmunity needle stick injury (needle stick in a nn health care setting), the risk f expsure t hepatitis B is increased. If the individual has n histry f a hepatitis B vaccine series and the surce is HBsAg psitive, high risk, unknwn r nt available fr testing, HBIG shuld be administered (as sn as pssible but within seven days f expsure) with the first dse f the hepatitis B vaccine series. Susceptible individuals f sexual assault. HBIg and hepatitis B vaccine shuld be ffered. Fr further guidelines related t pst-expsure fllw-up refer t the fllwing (http://www.health.alberta.ca/prfessinals/ntifiable-diseases-guide.html): Public Health Ntifiable Disease Management Guidelines Hepatitis B Alberta Guidelines fr Nn-Occupatinal, Occupatinal and Mandatry Testing Disclsure Act Pst-Expsure Management and Prphylaxis: HIV, Hepatitis B, Hepatitis C and Sexually Transmitted Infectins https://pen.alberta.ca/dataset/58f4a061-4647-45a1-bd66-6c13c18c534e/resurce/2700d179-daee-4ae8-bbef- c6f61087ee9c/dwnlad/6861344-2015-alberta-pst-expsure-management- Prphylaxis-Guidelines-2015-02.pdf Immunizatin Prgram Standards Manual Page 3 f 11 Ppulatin, Public and Indigenus Health
Recmbivax HB Engerix -B Serlgy Alberta Prenatal Screening Prgram fr Selected Cmmunicable Diseases Public Health Guidelines https://pen.alberta.ca/dataset/5ed36147-a9b0-4643-a297- b54cbd8c66dd/resurce/fef4f6f2-99f0-4489-b62a-0daa07d3d475/dwnlad/prenatal- Screening-Prgram-July-2007.pdf Pre-immunizatin serlgy is recmmended fr the fllwing individuals if they are eligible as per the Indicatins Sectin: Antigen (HBsAg) and antibdy (Anti-HBs) testing is recmmended fr: Spuse r sexual partners and needle sharing partners f a hepatitis B case r chrnic carrier. Refer t AH Public Health Ntifiable Disease Management Guidelines http://www.health.alberta.ca/dcuments/guidelines-hepatitis-b- Chrnic-Carrier-2011.pdf Husehld cntacts (12 mnths f age and lder) f a hepatitis B case r chrnic carrier including thse previusly immunized thrugh a universal r endemic hepatitis B immunizatin prgram. Refer t AH Public Health Ntifiable Disease Management Guidelines http://www.health.alberta.ca/dcuments/guidelines- Hepatitis-B-Chrnic-Carrier-2011.pdf Thse with high prbability f past infectin: Thse wh have received repeated bld transfusins Thse with a histry f dialysis Thse with lifestyle risks f infectin Thse wh have immigrated t Canada frm a cuntry where hepatitis B is endemic see Hepatitis B Endemic Cuntries List Health care wrkers (HCWs) and Pst-secndary HCW students wh meet any f the abve recmmendatins fr pre-immunizatin serlgy. Health care wrkers and pst-secndary health care students wh have dcumented histry f a cmplete HBV immunizatin series r reprt HBV immunizatin but have n r incmplete dcumentatin shuld have serlgic testing dne as utlined in the Standard fr Immunizatin f Health Care Wrkers and Standard fr Immunizatin f Pst Secndary Students. Fr HCWs/health care students with high prbability f past infectin an Anti-HBc shuld als be dne. Pre-immunizatin serlgy is NOT recmmended fr: Rutine ppulatin-based hepatitis B immunizatin prgrams. Newbrns brn t hepatitis B psitive mthers and infants yunger than 12 mnths f age Children frm birth up t and including 6 years f age wh are eligible fr hepatitis B vaccine under the endemic prgram Pst-immunizatin serlgy (anti-hbs): Pst-immunizatin serlgy is NOT recmmended fllwing rutine immunizatin prgrams. If testing has been dne, and antibdy results are nn-prtective, there shuld be cnsultatin with the MOH/MOH designate regarding need fr further dses f vaccine. Pst-immunizatin testing (anti-hbs) and fllw-up is recmmended fr the fllwing grups nly as utlined belw: Grups Serlgy Fllw-up Infants brn t infected mthers Serlgy is recmmended 1 6 mnths fllwing the primary series f hepatitis Bth anti-hbs and HBsAg shuld be dne. If the individual is negative fr antibdy after the first series, a secnd hepatitis B vaccine series shuld be administered, with repeat serlgy testing ne mnth later. Immunizatin Prgram Standards Manual Page 4 f 11 Ppulatin, Public and Indigenus Health
Recmbivax HB Engerix -B Repeated Expsures: Individuals with repeated ptential and knwn expsure t hepatitis B (sexual partners, needle sharing partners and husehld cntacts f cases r chrnic carriers) Immuncmprmised: Individuals wh are hyprespnsive due t immuncmprmising cnditins (includes thse with cngenital immundeficiencies, HSCT, SOT, HIV infected) ften respnd subptimally t hepatitis B vaccine and may need additinal antigen t munt a respnse. If prtectin is achieved and then wanes, subsequent expsure may result in acute disease r carrier state. Renal disease: Individuals wh are hyprespnsive due t renal disease (hemdialysis, peritneal dialysis and pre-dialysis) ften respnd subptimally t hepatitis B vaccine and may need additinal antigen t munt a respnse. If prtectin is achieved and then wanes, subsequent expsure may result in acute disease r carrier state. Liver disease: Individuals with chrnic liver disease including disease caused by hepatitis C cnversin. Serlgy shuld be dne 1 6 mnths fllwing the primary series f hepatitis Serlgy shuld be dne 1 6 mnths fllwing the primary series f hepatitis Serlgy shuld be dne 1 6 mnths fllwing the primary series f hepatitis Serlgy shuld be dne 1 6 mnths fllwing the primary series f hepatitis If the individual is negative fr antibdy after the first series, a secnd hepatitis B vaccine series shuld be administered, with repeat serlgy testing ne mnth later. Individuals wh are immuncmprmised and are negative fr antibdy after the first series, shuld receive a secnd series, fllwed by serlgy ne mnth later. Peridic mnitring (by attending physician) fr the presence f anti-hbs shuld be cnsidered fr immuncmprmised individuals, taking int accunt the severity f the cmprmised state and whether r nt the risk fr hepatitis B infectin is still present. Shuld antibdy testing shw subptimal prtectin, a bster dse f vaccine and retesting shuld be undertaken. Individuals wh have renal disease (hemdialysis, peritneal dialysis and predialysis) and are negative fr antibdy after the first series, shuld receive a secnd series, fllwed by serlgy ne mnth later. Persns with chrnic renal disease r n dialysis shuld be evaluated yearly fr anti-hbs. Shuld antibdy testing shw subptimal prtectin, a bster dse f vaccine and retesting shuld be undertaken. If they have nt respnded t the first hepatitis B vaccine series, ffer a secnd series using higher dse vaccine schedule fr hyprespnsive individuals. Immunizatin Prgram Standards Manual Page 5 f 11 Ppulatin, Public and Indigenus Health
Schedule Recmbivax HB Engerix -B Occupatinal: All health care wrkers/students in health-related disciplines wh qualify fr hepatitis B immunizatin. Occupatinal (cnt d) Serlgy dne 1 6 mnths fllwing the primary series f hepatitis If immunizatin was cmpleted mre than six mnths previusly and pst-immunizatin screening was nt dne, testing shuld be dne as part f a rutine assessment. If the individual is negative fr antibdy after the first series, a secnd hepatitis B vaccine series shuld be administered, with repeat serlgy testing ne mnth later. If the individual is negative the wrker/individual shuld be given 1 bster dse f hepatitis B vaccine fllwed by serlgy ne mnth later. If the individual is still negative after the 4th dse, the secnd series f hepatitis B vaccine shuld be cmpleted fllwed by serlgy 1 mnth later. Once a psitive result is recrded fllwing a cmplete, dcumented series; n further serlgy is recmmended. HCWs upn hire r during their WHS cmmunicable disease assessment wh have lab cnfirmatin f psitive anti-hbs but withut dcumentatin f any dses f hepatitis B vaccine shuld be ffered a series f hepatitis B vaccine t ensure lng term immunity. HCWs wh have been previusly assessed d nt require reassessment r updating at this time. Pst-secndary HCW students wh have lab cnfirmatin f psitive anti-hbs but withut dcumentatin f any dses f hepatitis B vaccine shuld be ffered a series f hepatitis B vaccine t ensure lng term immunity. HCWs and Pst-secndary HCW students wh have lab cnfirmatin f psitive anti-hbs with any incmplete series shuld have their series cmpleted. Any individual wh fails t respnd t the secnd series f vaccine is unlikely t benefit frm further dses. Therefre, if prtective levels are nt achieved, the individual shuld be cnsidered a nn- respnder and susceptible. Healthy individuals (see belw fr hyprespnsive individuals): Infants brn t hepatitis B surface antigen psitive (HBsAg) mther: Dse 1 at birth, given with HBIg Dse 2 2 mnths f age Dse 3 6 mnths f age Nte: Third dse shuld nt be given t infants befre 6 mnths (24 weeks r 168 days) f age Pre-term Infants with birth weight less than 2000 grams brn t hepatitis B surface antigen psitive (HBsAg) mther: Dse 1 at birth, given with HBIg Dse 2 1 mnths f age Dse 3 2 mnths f age Dse 4 6 mnths f age Immunizatin Prgram Standards Manual Page 6 f 11 Ppulatin, Public and Indigenus Health
Recmbivax HB Engerix -B Pre-term infants with birth weight less than 2000 grams wh receive hepatitis B vaccine at birth (e.g., father r ther primary caregiver is HBsAg psitive): Dse 1 at birth Dse 2 1 mnths f age Dse 3 2 mnths f age Dse 4 6 mnths f age Ntes: The respnse t hepatitis B vaccine may be diminished in pre-term infants with a birth weight belw 2,000 grams. Nenates weighing less than 2,000 grams wh receive hepatitis B vaccine at birth require fur dses f vaccine; administered at birth, 1, 2 and 6 mnths f age, fllwed by serlgic testing ne mnth after cmpletin f series. Furth dse shuld nt be given t infants befre 6 mnths (24 weeks r 168 days) f age Other Infants frm birth up t and including 11 mnths f age: Dse 1 2 mnths f age Dse 2 4 mnths f age Dse 3 12 mnths f age Ntes: May cnsider use f Infanrix hexa in certain situatins. See Infanrix hexa Vaccine Bilgical Page (#07.214) fr indicatins. The schedule and spacing cnsideratins fr Infanrix-hexa vaccine varies slightly frm thse f the individual HBV and DTaP-IPV-Hib vaccines. Ensure the apprpriate schedule is fllwed fr the vaccine(s) that are being used. Infanrix-hexa shuld nt be used fr high risk infants weighing less than 2000g wh received Hepatitis B vaccine and/r HBIG at birth. These infants shuld cntinue t receive the separate Hepatitis B vaccine accrding t the schedule utlined abve. Third dse shuld nt be given t infants befre 6 mnths (24 weeks r 168 days) f age Fr children wh begin immunizatin ff schedule minimum intervals can be used. Refer t Spacing Cnsideratins. Students being immunized in the schl setting: Dse 1: day 0 Dse 2: 1 mnth after dse 1 Dse 3: 4 t 6 mnths after dse 1 Nte: The minimum acceptable schedule/cndensed schedule fr schl prgrams is 0, 1 and 4 mnths, with ne mnth (28 days) between the first and secnd dse, at least tw mnths (56 days) between the secnd and third dse and at least 4 mnths (112 days) between the first and third dse. Individuals 12 mnths f age and lder, and adults (excluding students receiving vaccine in a schl setting): Dse 1 day 0 Dse 2 1 mnth after dse 1 Dse 3 6 mnths after dse 1 Nte: May cnsider use f Infanrix hexa in certain situatins fr children up t and including 23 mnths. See Infanrix hexa Vaccine Bilgical Page (#07.214) fr indicatins. The schedule and spacing cnsideratins fr Infanrix-hexa vaccine varies slightly frm thse f the individual HBV and DTaP-IPV-Hib vaccines. Ensure the apprpriate schedule is fllwed fr the vaccine(s) that are being used. Immunizatin Prgram Standards Manual Page 7 f 11 Ppulatin, Public and Indigenus Health
Recmbivax HB Engerix -B Hyprespnsive individuals being immunized with Recmbivax HB and Recmbivax HB Dialysis Strength (40 mcg/1.0ml) Vaccine: Dse 1 day 0 Dse 2 1 mnth after dse 1 Dse 3 6 t 12 mnths after dse 1 (see abve schedules based n age) Hyprespnsive individuals being immunized with Engerix -B Vaccine: Hyprespnsive individuals frm birth up t and including 15 years f age shuld receive fur dses accrding t the fllwing schedule: Dse 1 day 0 Dse 2 1 mnth after dse 1 Dse 3 2 mnths after dse 1 Dse 4 12 mnths after dse 1 Hyprespnsive individuals 16 years f age and lder shuld receive fur dses accrding t the fllwing schedule: Dse 1 day 0 Dse 2 1 mnth after dse 1 Dse 3 2 mnths after dse 1 Dse 4 6 mnths after dse 1 Spacing Cnsideratins: Interruptin f the immunizatin schedule des nt require any dse(s) be repeated if the minimum intervals between dses are respected. Minimum acceptable schedule/cndensed schedule is 0, 1, and 4 mnths, with 1 mnth (28 days) between the first and secnd dse, at least 2 mnths (56 days) between the secnd and third dse and at least 4 mnths (112 days) between the first and third dse. Fr thse wh may have an alternate immunizatin histry refer t #03.110 Standard fr Recmmended Immunizatin Schedules If a secnd hepatitis B immunizatin series is required this can be started nce the need is identified. Immunizatin started in anther prvince r territry prir t grade 5 can be cmpleted as they present t public health using the current schedule and dse recmmended in Alberta. Preferred Use There is n preference indicated fr the use f Recmbivax HB r Engerix -B fr thse eligible fr regular strength vaccine. Dse Bth vaccines are safe and immungenic fr all ages Persns with medical cntraindicatins t ne prduct shuld be ffered the alternate prduct if supply is available Fr hyprespnsive individuals wh require higher cncentratin hepatitis B vaccine, Recmbivax HB allws fr a 3 dse series. If unavailable Engerix -B may be used fllwing the schedule utlined in the schedule sectin. If any dse f Engerix -B vaccine is used a 4 dse series is required. Whenever pssible the same vaccine prduct shuld be used fr ease f scheduling. Recmbivax HB (10mcg/1.0mL) Healthy individuals: birth up t and including 19 years f age 0.5mL (5.0mcg) 20 years f age and lder 1.0mL (10mcg) Hyprespnsive persns: birth up t and including 10 years f age: 0.5 ml Recmbivax HB (5.0mcg) 11 years f age up t and including 19 Engerix -B (20 mcg/1.0 ml) Healthy individuals: birth up t and including19 years f age 0.5mL (10mcg) 20 years f age and lder 1.0mL (20mcg) Hyprespnsive persns: birth up t and including 15 years f age: 1.0 ml Engerix -B (20 mcg) 16 years f age and lder: Immunizatin Prgram Standards Manual Page 8 f 11 Ppulatin, Public and Indigenus Health
Rute Cntraindicatins/ Precautins Pssible Reactins Recmbivax HB Engerix -B years f age: 2.0 ml Engerix -B (40 mcg) 1.0 ml Recmbivax HB (10mcg) Nte: 20 years f age and lder Thse initiating a fur-dse schedule with 1.0 ml Recmbivax HB Dialysis Strength Vaccine ENGERIX -B shuld cmplete the series using the same vaccine whenever pssible. (40mcg) Nte: Hyprespnsive persns 20 years f age and lder shuld receive Recmbivax HB Dialysis Strength Vaccine. If Recmbivax HB Dialysis Strength Vaccine is unavailable; Engerix -B may be used fllwing the schedule utlined in the schedule sectin. IM Nte: Vaccine shuld nt be administered in the gluteal area as this may result in lwer immune respnse. If vaccine is inadvertently given in the gluteal area the individual shuld be tested fr immunity and re-immunized if antibdy cncentratins are inadequate. 3 Cntraindicatins: Knwn severe hypersensitivity t any cmpnent f a hepatitis B cntaining vaccine Anaphylactic reactins r ther allergic reactin t a previus dse f vaccine cntaining similar cmpnents. Precautins: Nne identified Cmmn: Injectin site pain, sreness, tenderness, pruritus, erythema, swelling, warmth and ndule frmatin. Irritability, headache, fatigue, drwsiness, malaise, dizziness, myalgia, pharyngitis and fever Lss f appetite, nausea and diarrhea Rare: Anaphylaxis, allergic reactins As with any immunizatin, unexpected r unusual side effects can ccur. Refer t the prduct mngraph fr mre detailed infrmatin Pregnancy Hepatitis B vaccine shuld be administered t pregnant wmen when indicated. Data is nt available n the effect f hepatitis B vaccine n fetal develpment;hwever, the risk is expected t be negligible as the vaccine cnsists f nn-infectius subunits. Eligible pregnant wman shuld receive prvincially funded vaccine. Pregnant wmen at high risk f hepatitis B infectin shuld be tested fr antibdy respnse fllwing receipt f hepatitis B vaccine series. See serlgy sectin fr mre infrmatin. Lactatin Can be administered t eligible breastfeeding wmen. Cmpsitin Each 0.5 ml dse cntains: 5 mcg hepatitis B surface antigen 0.25 mg amrphus aluminum hydrxyphsphate 4.5 mg sdium chlride 35.0 mcg sdium brate Water fr injectin Each 1.0 ml dse cntains: 10 mcg hepatitis B surface antigen 0.5 mg amrphus aluminum hydrxyphsphate 9.0 mg sdium chlride Each 0.5 ml dse cntains: 10 mcg hepatitis B surface antigen 0.25 mg aluminum hydrxide Each 1.0 ml dse cntains: 20 mcg hepatitis B surface antigen 0.5 mg aluminum hydrxide Single dse presentatins are preservative free Immunizatin Prgram Standards Manual Page 9 f 11 Ppulatin, Public and Indigenus Health
Recmbivax HB Engerix -B 70.0 mcg sdium brate Water fr injectin Each 1.0 ml dse f Recmbivax HB Dialysis Strength cntains: 40 mcg hepatitis B surface antigen 0.5 mg amrphus aluminum hydrxyphsphate 9.0 mg sdium chlride 70.0 mcg sdium brate Water fr injectin The fllwing manufacturing residuals may be fund in the abve preparatins f Recmbivax HB vaccine: Less than 1% yeast prtein Less than 15 mcg/ml frmaldehyde These presentatins are preservative free Fr a detailed list f ingredients see the link belw t the Canadian Immunizatin Guide: http://www.phac-aspc.gc.ca/publicat/cig-gci/p01-14-eng.php Bld/Bld Cntains n human bld/bld prducts. Prducts Bvine/Prcine Cntains n bvine r prcine prducts Prducts Latex Latex in vial stpper Des nt cntain latex. Interchangeability Hepatitis B vaccines prduced by different manufacturers can be used interchangeably despite different dses and schedules. The dse administered shuld be that recmmended by the manufacturer fr the specific prduct being used. When pssible, series shuld be cmpleted with the same vaccine, especially with hyprespnsive individuals. If this is nt pssible, hyprespnsive individuals wh have received any dses f Engerix -B vaccine shuld be cmpleted using the 4 dse schedule. Refer t schedule sectin fr mre details. Administratin with Other Prducts Appearance May be given at the same time as ther inactivated and live vaccines using a separate needle and syringe fr each vaccine. The same limb may be used if necessary, but different sites must be chsen. Slightly paque, white suspensin Strage Stre at +2 t +8 C D nt freeze D nt use past the expiry date Stre in riginal packaging when pssible t prtect frm light. Vaccine Cde HBV regular strength prduct HBV HBVD dialysis strength vaccine Antigen Cde HBV Licensed fr Recmbivax HB regular strength: licensed fr persns f all ages A 0.5 ml dse has been apprved by Alberta Health fr ff license use f Individuals f all ages. Recmbivax HB fr eligible healthy children frm birth up t and including 10 years f age wh are nt cntacts f HBsAg psitive mthers. Immunizatin Prgram Standards Manual Page 10 f 11 Ppulatin, Public and Indigenus Health
Recmbivax HB Engerix -B Recmbivax HB Dialysis Strength: Licensed fr individuals 20 years f age and lder. Ntes: Hepatitis B vaccine became available in Alberta fr the nenatal prgram in January 1, 1983. Infanrix hexa became available in July 1, 2016 The rutine schl immunizatin prgram fr grade 5 students started in September 1995. The catch-up schl immunizatin prgram fr grade 12 students was available frm September 1999 t June 2002. Individuals brn in 1981 r later wh wuld have been eligible fr the schl universal hepatitis B vaccine prgram and wh have nt received a series f hepatitis B vaccine became eligible February 2018. Individuals with Inflammatry Bwel disease (IBD) wh will be n lng term immunsuppressive medicatins became eligible February 2018. Related Resurces: Hepatitis B Vaccine Infrmatin Sheet (104505). (January 1, 2015) References: 1. Alberta Health, Public Health and Cmpliance Divisin, Alberta Immunizatin Plicy Bilgical Prducts (2017, Octber 27). Hepatitis B Vaccine. 2. Alberta Health, Public Health and Cmpliance Divisin, Alberta Immunizatin Plicy (2017, August). Hepatitis B Virus Infectin High Endemic Gegraphic Areas. 3. Alberta Health. (2014). Adverse Events Fllwing Immunizatin (AEFI), Plicy fr Alberta Health Services Public Health. 4. Alberta Health (January 2011). Public Health Ntifiable Disease Management Guidelines - Hepatitis B http://www.health.alberta.ca/prfessinals/ntifiable-diseases-guide.html 5. Alberta Health (2015). Alberta Guidelines fr Nn-Occupatinal, Occupatinal and Mandatry Testing and Disclsure Act Pst-Expsure Management and Prphylaxis: HIV, Hepatitis B, Hepatitis C and Sexually Transmitted Infectins. http://www.health.alberta.ca/prfessinals/ntifiable-diseases-guide.html 6. Alberta Health Services. (2016 August 23). Jint Mem frm Dr. Gerry Predy, Senir Medical Officer f Heatlh; Dr. Stephen Tskereks, Medical Directr Wrkplace Health and Safety: HCW hepatitis B Immunizatin fllwing a BBFE incident. 7. American Academy f Pediatrics. Summaries f Infectius Diseases. In: Pickering LK, Baker CJ, Kimberlin DW, Lng SS, eds. Red Bk: 2012 Reprt f the Cmmittee n Infectius Diseases. 29th ed. Elk Grve Village, IL: American Academy f Pediatrics: pp. 21,369-390 8. Centers fr Disease Cntrl and Preventin. (2011, January). General Recmmendatins n Immunizatin: Recmmendatins f the Advisry Cmmittee n Immunizatin Practices (ACIP). Mrbidity and Mrtality Weekly Reprt, 60(2). 9. Centers fr Disease Cntrl and Preventin. (2011, April). Epidemilgy and Preventin f Vaccine- Preventable Diseases 12 th Editin (Pink Bk). 10. GlaxSmithKline Inc. (2015, Octber 19). ENERGIX-B : Hepatitis B vaccine (recmbinant). Prduct mngraph. 11. Merck Canada Inc. (2012, May 22). RECOMBIVAX HB : Hepatitis B vaccine (recmbinant). Prduct mngraph. 12. Natinal Advisry Cmmittee n Immunizatin, (1999, June 1). Statement n Cmbinatin Vaccines against Hepatitis A and Hepatitis B. Canada Cmmunicable Disease Reprt, 25 13. Natinal Advisry Cmmittee n Immunizatin. (2012). Canadian immunizatin guide (Evergreen Editin). Ottawa, ON: Public Health Agency f Canada. http://www.phac-aspc.gc.ca/publicat/cig-gci/ Immunizatin Prgram Standards Manual Page 11 f 11 Ppulatin, Public and Indigenus Health