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1、WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,A Presentation on management decisions and strategies for the introduction of new vaccine into national immunization programmes,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Management decisionstypes of vacci
2、ne,dosage&presentationPhasing invaccine administration including reconstitutionStorage temperature and shelf lifeIndications&ContraindicationsInterchangeabilitySafetyMultidose vial policy,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Management decisions-other issuesInjection
3、safetycold chain issueswastage reductionbirth dose for HepBForms/toolsTraining of health workersAdvocacy&social mobilisation,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Vaccine formulation&presentationavailable as monovalent and in combination with other vaccinescombinations
4、 include DTP-HepB or DTP-Hib(tetravalent),DTP-HepB+Hib(pentavalent),HepB-HibThe tetravalent,DTP-HepB,is a liquid formulation in 10 dose vials,where as the pentavalent is a 2 dose vial of lyophilised Hib vaccine to be reconstituted with liquid DTP-HepB,WHO/V&B/AVI,Managing introduction of new vaccine
5、(s)into national EPI,Vaccine formulation so cannot be put in refrigerators whose temperatures may reach zero or lower,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Vaccine formulation&presentation-HibHib vaccine is known as a conjugate vaccine as the bacterial capsular polysac
6、charide material is linked to tetanus toxoid,diphtheria toxoid,a diphtheria-like protein,or a mix of proteins from other bacteriaMany different formulations of Hib vaccine are produced every year,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Following are some of the formulati
7、onsLiquid Hib vaccine(monovalent)Liquid Hib&DTP vaccines in combinationLiquid Hib&HepB vaccines in combinationLyophilized(ie freeze-dried)Hib vaccine with saline diluent(monovalent)Lyophilized Hib vaccine that mixes with liquid DTP,DTP/HepB,DTP/IPV,DTaP,or DTaP/IPV in combinations,WHO/V&B/AVI,Managi
8、ng introduction of new vaccine(s)into national EPI,Vaccine formulation&presentation-HibThe pentavalent(DTP-HepB+Hib)uses liquid DTP-HepB as diluentThe pentavalent is a two dose preparationEvery vial of the pentavalent requires two ADs and one reconstitution syringeAnd because the diluent is DTP-HepB
9、,and HepB cannot be frozen,pentavalent vaccine should never be frozen,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Phasing in without catch-upThere are two options:(1)give the new vaccine only to those who come in for their first immunization visit(starting at a given point o
10、f time)or(2)give the new vaccine to every child presenting for immunization visits(in spite of likely incomplete vaccination of some children with HepB&HibMost countries awarded Vaccine Fund support opted for(2),WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Phasing in with cat
11、ch-upPhasing in with catch-up:in this case the child receives a full DTP series and a full HepB&Hib seriesAt the same time,particularly for HepB,catch-up for older children and those at high risk may be carried out,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Phasing in with
12、catch-upIt will require monovalent vaccine for HepB and Hib side by side with combinations containing DTP-greater potential for programme errorsIt will also require a more sophisticated information system to be able to identify the right child for the right vaccination,WHO/V&B/AVI,Managing introduct
13、ion of new vaccine(s)into national EPI,Phasing inCatch-up requires more technical skills in the programme to manage the complexities of having two groups of children receiving different vaccinesTherefore,the general recommendation is to proceed without catch-up,WHO/V&B/AVI,Managing introduction of n
14、ew vaccine(s)into national EPI,Vaccine administration including reconstitution-TetravalentThe tetravalent(DTP-HepB)is a liquid formulation and does not require reconstitution or any additional injection equipment than what DTP normally requiresThe tetravalent is injected,intramuscularly,in the anter
15、o-lateral aspect of the thigh of infantThe dose is 0.5 ml,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,vaccine administration including reconstitution-Tetravalentdo not inject in the buttock,fat reduces efficacy of the HepB vaccinedo not use the arm of the infant,the muscle m
16、ass is too smallDo not use tetravalent for HepB birth dose,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,vaccine administration including reconstitution-PentavalentThe pentavalent is lyophilised(freeze-dried)Hib that uses liquid DTP-HepB as diluentThe DTP-HepB must be drawn fr
17、om the vial using a reconstitution syringe and put in the vial containing the lyophilised Hib.Ensure that the entire content of the DTP-HepB is drawn and put in the Hib vialShake well before use-check for impurities,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,vaccine adminis
18、tration including reconstitution-PentavalentThe dose is 0.5 mlIt is injected,intramuscularly,in the anterolateral aspect of the thigh of the infantdo not inject in the buttock,fat reduces efficacy of the HepB vaccinedo not use the arm of the infant,the muscle mass is too small,WHO/V&B/AVI,Managing i
19、ntroduction of new vaccine(s)into national EPI,Storage temperature and shelf lifeHepatitis B vaccine and any of its combination should never be frozenWhile DTP freezes at around-50 C,HepB freezes at-0.50 CHepB vaccine and its combinations must be stored between+20 C to+80 CThe shelf life of tetraval
20、ent&pentavalent,if stored at the correct temperature,is at least 2 years,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Indications All infants under 1 year of should receive a full series of immunization with HepB and Hib vaccinesContraindicationsA child with known history of
21、severe allergic reaction to previous injection with DTP,HepB or HibHIV positive status is NOT a contraindication,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Safety-HepBHepatitis B vaccine is safe.Mild transient side effects may occur sometimes-soreness at injection site,fati
22、gue,headache,irritability,feverSerious allergic reactions are rare,eg,hives(1 in 600,000 vaccinated cases)There is no evidence of any association of HepB vaccine with multiple sclerosis&other chronic diseases,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Safety-HibHib vaccine
23、is very safeMild side effects such as redness,swelling,pain at injection site may occur in about 25%of children vaccinatedIrritability and fever occur even less commonly,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Multidose vial policyWHO multi-dose open vial policy applies
24、for vials of DTP,TT,HepB and OPV ifthe expiry date has not passedthe vaccines are stored under correct cold chain conditionsthe vaccine vial septum has not been submerged in wateraseptic technique has been used to withdraw all dosesthe VVM,if attached,has not reached discard point,WHO/V&B/AVI,Managi
25、ng introduction of new vaccine(s)into national EPI,Multidose vial policyWHO guidelines apply to Hib as follows:all liquid formulations of Hib contain preservative and can be used in subsequent immunization sessionsthe freeze-dried(lyophilised)pentavalent preparation contains no preservative,and afte
26、r reconstitution,must be discarded at the end of session or within six hours,whichever comes first(the same as for measles,BCG and yellow fever)Therefore,open vial policy cannot be applied to pentavalent vaccine,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Injection safetyAll
27、 Vaccine Fund eligible countries will receive auto-disable syringe for all immunization injectionsADs cannot be reusedNo recapping of needlesADs,after use,are to be put in safety boxes,the boxes when full are to be either burnt,incinerated or buried,WHO/V&B/AVI,Managing introduction of new vaccine(s
28、)into national EPI,cold chainBoth the tetravalent&pentavalent must be stored at+20 C to+80 CThese vaccine should never be frozenDo not keep vials in direct contact with ice packs,eg use brown paper to wrap vaccine vials before placing on ice packOr ensure that the ice packs have water around the ice
29、(shake to see if you can hear water sloshing around in the ice pack),WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Cold chaindo not store the pentavalent&tetravalent or other HepB vaccines in freezersIf you must,readjust the thermostat so that they do not freezeEven so,do not
30、place these vaccine in direct contact with the bottom or sides of the freezers(for top opening)or close to the freezer compartment(for front opening),WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,wastage reductionThe priority is to reach every child and to reduce missed opport
31、unities,but wastage can be reduced even within the framework of this policyCareful planning&ordering vaccine can reduce wastageProper storage and proper handling will reduce wasteCorrect reconstitution and correct administration can minimise wasteWastage must be monitored and reported,WHO/V&B/AVI,Ma
32、naging introduction of new vaccine(s)into national EPI,Birth dose for HepBIn all countries,priority is to achieve highest coverage with HepB vaccination series of all infantsIn countries with high perinatal transmission(eg south-east Asia)and where most births take place in health facilities,deliver
33、ing a birth dose may be appropriate,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Revision of formsMany forms will need revision to include details of new vaccinesAdditional forms may need to be introducedRevision must be planned well ahead of actual introductionHealth workers
34、 must be familiarised with the revised forms and new forms/registers,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Training of health workersIf you are introducing only the tetravalent,not much training of health workers will be required But with pentavalent vaccine,at least o
35、ne round of good training before the actual introduction of the new vaccine,followed by close supervision in the initial phase of introduction are important,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Training of health workersTraining of health workers must emphasise on ope
36、rational aspects and important dos and donts for the management of the new vaccinesA standardised training material is essential to maintain uniformity&quality of trainingSimple reference materials such as wall charts,posters etc.are usefulSupervision,supervision,supervision,WHO/V&B/AVI,Managing int
37、roduction of new vaccine(s)into national EPI,Advocacy&social mobilisationWhy advocacy is necessaryto inform policy makers so that government commitment is realisedto build coalitions for strong partnership among stakeholdersto inform health professionals so that they are aware of the issues and need
38、s and obtain their supportto inform the general public and combat effectively rumours&deliberate disinformation campaigns,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Advocacy&social mobilisationHow to launch an effective advocacy strategyIdentify issues for policy actionsIde
39、ntify knowledge gaps(among health professionals,development partners,lay public)Develop a strategic plan to meet those needsUse media(TV,newspapers,radios)to disseminate informationUse as advocates influential groups,community leaders,religious leaders,WHO/V&B/AVI,Managing introduction of new vaccin
40、e(s)into national EPI,Advocacy&social mobilisationTools and resources needed for an effective advocacy campaignA strong advocate,if you can get your countrys leader to express support,nothing like itPosters,pamphlets,information fact sheetsRegular public debates on national TV,radio stations etc.Regular printed materialsWorkshops,Consensus meetings,WHO/V&B/AVI,Managing introduction of new vaccine(s)into national EPI,Thank You,
