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1117600347345Federal Democratic Republic of EthiopiaMinistry of HealthHUMAN PAPILLOMA VIRUS (HPV) VACCINE INTRODUCTION HEALTH EXTENSION WORKERS (HEW)POCKET GUIDEJune 2018TABLE OF CONTENT TOC \o "1-3" \h \z \u LIST OF TABLES PAGEREF _Toc505075818 \h IIILIST OF FIGURES PAGEREF _Toc505075820 \h IIIFOREWORD PAGEREF _Toc505075821 \h IVLIST OF ABBREVIATIONS PAGEREF _Toc505075823 \h VHUMAN PAPILLOMAVIRUS & CERVICAL CANCER: INTRODUCTION PAGEREF _Toc505075827 \h 11.1.WHAT IS THE CERVIX? PAGEREF _Toc505075828 \h 11.2.WHAT IS CERVICAL CANCER? PAGEREF _Toc505075829 \h 11.3.SIGNS AND SYMPTOMS OF CERVICAL CANCER PAGEREF _Toc505075830 \h 21.4.WHAT IS HUMAN PAPILLOMAVIRUS (HPV)? PAGEREF _Toc505075831 \h 21.5.WHAT OTHER DISEASES DOES HPV CAUSE? PAGEREF _Toc505075832 \h 21.6.RISK FACTORS FOR CONTRACTING HPV PAGEREF _Toc505075833 \h 31.7.THE DEVELOPMENT OF CERVICAL CANCER PAGEREF _Toc505075834 \h 31.8.HIV AND CERVICAL CANCER PAGEREF _Toc505075835 \h 3CERVICAL CANCER PREVENTION AND THE HPV VACCINE PAGEREF _Toc505075838 \h 42.1.THE PREVENTION AND CONTROL OF CERVICAL CANCER PAGEREF _Toc505075840 \h 42.2.THE HPV VACCINE PAGEREF _Toc505075841 \h 52.3.GARDASIL PACKAGING AND STORAGE PAGEREF _Toc505075842 \h 62.4.TARGET GROUP FOR VACCINATION PAGEREF _Toc505075843 \h 62.5.DOSAGE AND IMMUNIZATION SCHEDULE PAGEREF _Toc505075844 \h 62.6.VACCINE SAFETY PAGEREF _Toc505075845 \h 82.7.CONTRAINDICATIONS AND SPECIAL PRECAUTIONS PAGEREF _Toc505075846 \h 82.8.VACCINE CO-ADMINISTRATION PAGEREF _Toc505075847 \h 8LESSONS FROM HPV DEMO & HPV PROGRAMMES IN OTHER COUNTRIES PAGEREF _Toc505075850 \h 93.1BASICS FOR SUCCESSFUL HPV VACCINE DELIVERY PROGRAM PAGEREF _Toc505075851 \h 93.2USING LESSON FOR NATIONAL ROLLOUT PAGEREF _Toc505075852 \h 10ADVOCACY, COMMUNICATION AND SOCIAL MOBILIZATION PAGEREF _Toc505075855 \h 114.1ADVOCACY PAGEREF _Toc505075860 \h 114.2SENSITIZATION AND MOBILIZATION PAGEREF _Toc505075869 \h 124.3SELECTING CHANNELS TO MOBILIZE THE COMMUNITY PAGEREF _Toc505075874 \h 154.4INTER PERSONAL COMMUNICATION (IPC) PAGEREF _Toc505075878 \h 154.5MANAGING RUMORS AND MISINFORMATION PAGEREF _Toc505075879 \h 16LOGISTICS AND MANAGEMENT OF THE HPV VACCINE PAGEREF _Toc505075898 \h 185.1HPV IMMUNIZATION LOGISTICS REQUIREMENTS PAGEREF _Toc505075900 \h 185.2HPV VACCINE HANDLING AND MANAGEMENT PAGEREF _Toc505075904 \h 19MICRO-PLANNING & COORDINATION OF HPV ACTIVITIES PAGEREF _Toc505075917 \h 246.1WOREDA LEVEL MICRO-PLANNING PAGEREF _Toc505075919 \h 246.2MICRO-PLANNING AT HEALTH FACILITIES PAGEREF _Toc505075920 \h 25HPV IMMUNIZATION SESSION ORGANIZATION & VACCINE DELIVERY PAGEREF _Toc505075923 \h 257.1PLANNING FOR THE IMMUNIZATION SESSION PAGEREF _Toc505075925 \h 257.2THE IMMUNIZATION SESSIONS PAGEREF _Toc505075926 \h 257.3THE IMMUNIZATION SESSIONS PAGEREF _Toc505075927 \h 267.4SUPPLIES REQUIRED FOR THE HPV VACCINATION SESSION PAGEREF _Toc505075928 \h 267.5ROLES & RESPONSIBILITIES OF STAFF AT SESSION POST PAGEREF _Toc505075929 \h 277.6STEP FOR ADMINISTERING THE GARDASIL HPV VACCINE PAGEREF _Toc505075934 \h 287.7IPC MESSAGES ABOUT HPV FOR GIRLS & PARENTS AT SERVICE DELIVERY PAGEREF _Toc505075935 \h 29ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) PAGEREF _Toc505075938 \h 308.1DEFINITION AND CATEGORIZATION OF AEFI PAGEREF _Toc505075940 \h 308.2AEFI PRESENTATIONS PAGEREF _Toc505075943 \h 318.3MANAGEMENT AND PREVENTION OF AEFI PAGEREF _Toc505075944 \h 318.4AEFI SURVEILLANCE PAGEREF _Toc505075950 \h 35MONITORING AND EVALUATION OF HPV INTRODUCTION PAGEREF _Toc505075955 \h 369.1MONITORING TOOLS PAGEREF _Toc505075957 \h 369.2EVALUATION TOOLS PAGEREF _Toc505075964 \h 39FREQUENTLY ASKED QUESTIONS AND ANNEX PAGEREF _Toc505075970 \h 3910.1FREQUENTLY ASKED QUESTIONS PAGEREF _Toc505075972 \h 3910.2ANNEX PAGEREF _Toc505075973 \h 42LIST OF TABLES TOC \h \z \c "Table" Table 1: Summary of the vaccine dose schedule PAGEREF _Toc518633369 \h 5Table 2: Roles and responsibilities of KEY stakeholders on HPV communication at Kebele levels PAGEREF _Toc518633370 \h 8Table 3: Estimating Vaccines, AD Syringes, and Safety Boxes Needed for Vaccination Session PAGEREF _Toc518633371 \h 14Table 5: Categorization of AEFI PAGEREF _Toc518633372 \h 26Table 5: showing minor reaction of vaccines and their management PAGEREF _Toc518633373 \h 28Table 6: Adrenalin dosage based on age for (IM) administration for unknown Wight PAGEREF _Toc518633374 \h 29LIST OF FIGURES TOC \h \z \c "Figure" Figure 1:Female reproductive tract PAGEREF _Toc518633381 \h 1Figure 2: Gardasil ? vaccine package PAGEREF _Toc518633382 \h 4Figure 3: HPV vaccine storage location in front or side opening refrigerators PAGEREF _Toc518633383 \h 15Figure 4: HPV storage location in top opening refrigerators PAGEREF _Toc518633384 \h 15Figure 5: Baskets must be used to store vaccine in the refrigerators PAGEREF _Toc518633385 \h 16Figure 6: How to condition ice packs PAGEREF _Toc518633386 \h 16Figure 7: Application of a foam pad at immunization session PAGEREF _Toc518633387 \h 17Figure 8: Shake test with frozen and normal vials PAGEREF _Toc518633388 \h 18Figure 9: Vaccine Vial Monitor stages PAGEREF _Toc518633389 \h 19Figure 10: Model for HPV immunization session at school or community out reach PAGEREF _Toc518633390 \h 22Figure 11: Illustration of a girl receiving Gardasil vaccine intramuscular injection (IM) PAGEREF _Toc518633391 \h 25Figure 12:Trendelenburg position the first step in the treatment of Anaphylactic Shock PAGEREF _Toc518633392 \h 29Figure 13: AFI reporting flow chart PAGEREF _Toc518633393 \h 31ACKNOWLEDGEMENTThe Federal Ministry of Health would like to extend its gratitude to the Government of Ethiopia for its commitment and leadership in prioritizing cervical cancer as major public health concern and devising a clear comprehensive prevention strategies including HPV Vaccine introduction. The FMoH would also like to convey its special thanks to partner organizations and stakeholders who provided their unreserved technical assistance in the development of this training manual. The support and feedback from EPI Colleagues, different directorates at the MoH, technical working groups and EPI partners were extremely useful and highly appreciated. .FOREWORDEthiopia is among the countries which have the highest incidence of cervical cancer in the world, and Cervical cancer is becoming one of the most common cancer in women living in Ethiopia, for these reasons, Cervical cancer is becoming major public health concern of the Ministry of Health. Series of discussions have been conducted and consensus reached on cervical cancer burden and epidemiology in Ethiopia. The country has conducted HPV demonstration from 2015 through 2017 in two selected woredas of the country, namely Gomma in Jimma Zone and Aheferom of Central Tigray. The lessons learnt and findings from the HPV demonstration has led the country to decide national rollout of HPV Vaccine. The National Technical Working Groups (TWG) and NITAG (National Immunization Technical Advisory Group) recommendation was endorsed by the Interagency Coordination Committee (ICC) for introduction of HPV vaccine (Gardasil) in to the national immunization program. The target age group recommended by the WHO for this vaccine is between girls of age 9 and 14 years preferably vaccine to be administered before exposure to the HPV virus or before their first sexual debut. However, due to global shortage of HPV vaccine (Gardasil) in 2017 and 2018, the country is obliged to opt for the upper age cohort of 14 years old girls in the introduction year of 2018 until global shortage of the vaccine resolves. Given the high rates of school enrolment in Ethiopia, the primary vaccine delivery strategy will be school based and other strategies of community outreach and facility based service delivery will be employed as appropriate.This pocket guide intended for use by vaccinators at the front line service delivery points as well as program managers. It can also be used by other stakeholders such as school teachers, who play a critical role in the organization of vaccination posts at school. The government plans to strengthen and expand all the three cervical cancer prevention strategies: primary (HPV vaccination), secondary prevention (screen and treat); cervical cancer and tertiary prevention (treatment and rehabilitation). This manual will serve to train immunization cadres and mobilizers in structured manner. Therefore, it is strongly recommended that all vaccinators, to familiarize themselves with this guide, so that they can be able to provide high quality services and information to the beneficiaries so as to protect girls in Ethiopia from cervical cancer.Kebede Worku (MD,MPH)State Minister, FMoHLIST OF ACRONYMS AND ABBREVIATIONSADAuto-disableAIDSAcquired Immuno deficiency SyndromeAEFIAdverse Event Following ImmunizationBCGBacille-Calmette-Guerin (vaccine)cMYPComprehensive Multi-Year PlanEPIExpanded Program on ImmunizationFEFOFirst-Expiry First-OutFMOHFederal Ministry of HealthHEWHealth Extension WorkersHIVHuman Immunodeficiency VirusHMISManagement Information System HPVHuman PapillomavirusIECInformation, Education, and CommunicationIPCInter Personal Communication IPVInactivated Polio VaccineMCHMother and Child HealthMDVPMulti-Dose vial policyMoHMinistry of HealthNGONon-Governmental OrganizationNVINew Vaccine IntroductionPCVPneumococcal Conjugate VaccinePentavalent vaccineDPT+HepB+HibPHCPrimary Health CareRED/CReach Every District/Community RIRoutine ImmunizationSTISexually Transmitted InfectionsTAGTechnical Advisory GroupTTTetanus ToxoidUNICEFUnited Nations Children FundVIAVisual Inspection with Acetic AcidVLPViral Like ParticleVVMVaccine Vial MonitorWHOWorld Health OrganizationCHAPTER1HUMAN PAPILLOMAVIRUS & CERVICAL CANCER INTRODUCTIONWHAT IS THE CERVIX?The female reproductive system refers to the parts of the body which allow a woman to get pregnant, give birth, and nourish babies. The female reproductive system has three main parts:The uterus The cervix The vagina Figure SEQ Figure \* ARABIC 1:Female reproductive tractThe cervix is the lower part of the uterus. The uterus has two parts, the upper part (body) where a baby grows, and the lower part (cervix), which connects the body of the uterus to the vagina (birth canal)WHAT IS CERVICAL CANCER?Cancer is a disease in which a group of cells in the body displays uncontrolled growth and cervical cancer is uncontrolled growth of cells and a serious disease and can cause death. However, if recognized and treated early, cervical cancer can be easily prevented. Almost all cases of cervical cancer are caused by a virus called human papillomavirus, or HPV.SIGNS AND SYMPTOMS OF CERVICAL CANCERThe development of cervical cancer is very slow, taking up to 20 years from infection with HPV to cancer.Most of the time, early cervical cancer has no symptoms. Symptoms of cervical cancer tend to appear only after the cancer has reached an advanced stage, and may include;Irregular, intermenstrual or abnormal vaginal bleeding after sexual intercourseBack, leg, and/or pelvic painFatigue, weight loss, loss of appetiteVaginal discomfort or odorous discharge which may be watery, pink, brown, or bloody.Single swollen leg.WHAT IS HUMAN PAPILLOMAVIRUS (HPV)?A virus called human papillomavirus (HPV) causes almost all cervical cancers (99%). HPV is a sexually transmitted infection (STI). HPV is a very common virus that can infect both men and women..RISK FACTORS FOR CONTRACTING HPVRisk factors for contracting HPV include:Early age at first sexual intercourseHaving multiple sexual partnersHaving a sexual partner with multiple sexual partnersPresence of other genital infectionsWeakened immune systems as in people with HIV/AIDSEXERCISESWhat is the cause of cervical cancer?What are the signs and symptoms of cervical cancer?How does cervical cancer develop?Who is most at risk of getting infected with HPV? Why?How does HPV spread?KEY MESSAGES The cervix is the lower part of the wombCervical cancer is a serious disease of the cervix that can be treated if detected earlyCervical cancer is the most common cancer in Ethiopia next to Brest cancer HPV causes cervical cancerCHAPTER2THE HPV VACCINETHE HPV VACCINEThree types HPV vaccines are currently available worldwide: A bivalent vaccine, Cervarix, A quadrivalent vaccine, Gardasil. and 9-VALENT (GARDASIL 9) The quadrivalent (Gardasil) 1 dose vail vaccine will be used for the national introduction. It prevents against cancers of the cervix, vagina, and vulva, and genital warts.GARDASIL PACKAGING AND STORAGEGardasil is provided as 0.5 ml white liquid formulation in single-dose vials. It is intramuscular injection preparation with each vial having a Vaccine Vial Monitor (VVM). Gardasil is VVM 30 and Vaccine vials are available in pack sizes of 1, 10, and 100. Figure SEQ Figure \* ARABIC 2: Gardasil ? vaccine packageGardasil HPV vaccine should be stored at +2°C to +8°C. It is sensitive to freezing, so it should never be frozen. It should be stored under the same conditions as TT and DPT-HepB+Hib vaccinesREMEMBER! If you suspect that the vaccine has been exposed to freezing, conduct the shake test described in chapter 5(section 5.2.3).TARGET GROUP FOR VACCINATIONThe WHO recommends administering the HPV vaccine to girls 9-14 years of age, because the vaccine is more effective in girls who have not been exposed to the HPV virus.DOSAGE AND IMMUNIZATION SCHEDULEThe immunization schedule consists of two doses. The recommended vaccination schedule is 0 (first dose or 1st contact), and the second dose 6 months after the first dose (defined as on day 180 after first dose).Table SEQ Table \* ARABIC 1: Summary of the vaccine dose scheduleVACCINEDATE OF 1ST DOSE RECOMMENDED DATE OF 2ND DOSE Gardasil- Merck - 0,6 scheduleDay 0(at first contact)After 6 months/Day 180 after dose 1/REMEMBER A girl must receive the two doses of the HPV vaccine to be fully protectedGirls who are absent on the day of vaccination at a school will be given a referral slip to go to the nearest health outreach or facility to receive the vaccine doses they missed. Girls who receive dose 1, but are absent at dose 2, should be given the missed dose at the earliest opportunity.Health workers, teachers, parents, guardians and others involved in the vaccinations must inform the vaccinated girls when and where they should receive their subsequent or missed doses.HEALTH EXTENSION WORKERS SHOULD COMMUNICATE:The benefits of HPV vaccinationThe HPV immunization scheduleImportance of completing the two doses of the scheduleThese messages should be communicated during routine immunization visits, antenatal care, school health programs and home visits by health workers and Health Extension Workers (HEW)VACCINE SAFETYThe HPV vaccine has a good safety profile. The most common normal reactions are pain, swelling, itching, redness, and soreness at the site of injection (the arm). These reactions are mild and they disappear within a few days after vaccination. The following injection site reactions were observed among recipients of Gardasil;PainSwellingErythemaBruisingPruritusCONTRAINDICATIONS AND SPECIAL PRECAUTIONSHypersensitivity to active substances or to any of the components of the vaccine.Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.Caution should be exercised when vaccinating any girl who has a bleeding disorder or who is taking anticoagulant therapy. Bleeding may occur after an intramuscular injection in these individuals.As with other vaccines, administration of the HPV vaccine should be postponed if a girl is suffering from acute severe febrile illness. However, a minor infection such as a cold is not a contraindication for vaccination.As with any injectable vaccine, the appropriate medical treatment for rare anaphylactic reaction should be readily available.HPV vaccine is a preventative vaccine. It is not intended to prevent progression of HPV-related lesions already present at the time of vaccination.Girls who are HIV-positive can still receive the Gardasil vaccine.VACCINE CO-ADMINISTRATION Results from clinical studies indicate that GARDASIL can be co-administered (at a separate injection site and in separate limbs) with:Tetanus Toxoid (TT) and reduced diphtheria toxoid(Td)Hepatitis B vaccine (recombinant)Meningococcal (Groups A, C, Y and W-135) polysaccharide vaccineDiphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine, (adsorbed, reduced antigen(s) content)CHAPTER4ADVOCACY, COMMUNICATION AND SOCIAL MOBILIZATIONADVOCACYInvolvement of political/civic/traditional/cultural/religious leaders, youth and women’s groups, school or teacher’s associations, and NGOs is critical in providing accurate information to the population and mobilizing girls for HPV vaccination. Any rumor or misconception should be clarified with facts.ADVOCACY TARGETS For HPV to the minimum the following key areas need to be considered for advocacy by HEWGovernment Departments, such as education sector, women & child affairs, Youth and Sport and, any other sector offices. Schools Leaders at community level (e.g. village heads, religious leaders, teachers);Communities and families, etc.ACTIVITIES Identify and list influential leaders and decision makers Develop advocacy issues and advocacy kits for HPVOrganize advocacy visitFacilitate advocacy meeting Document and follow up performanceAcknowledge contribution ADVOCACY TO COMMUNITY AND RELIGIOUS LEADERSCommunity and local religious leaders play a very influential role on the attitudes and behaviors of community members. For this reason, they must be engaged and informed about any change to the immunization programme, the reasons for the change and the benefits and risks. Rumors and resistance to vaccination can often be overcome if community and religious leaders endorse and support the immunization programme. Advocacy activities should include:Organizing meetings with community/religious leaders, especially with leaders of resistant religious groups;Engaging the community to develop appropriate messages, pre-test messagesSENSITIZATION AND MOBILIZATION Effective sensitization and mobilization are critical to a successful immunization programme. In preparation for the HPV vaccination, sensitization and social mobilization will be undertaken and the population will be informed of the importance and benefits of HPV vaccination. Advocacy is essential to enlist the support and participation of leaders at all levels. When people are equipped with correct information, they can prevent or dispel rumors and misinformation. ROLES AND RESPONSIBILITIES OF HEWTable SEQ Table \* ARABIC 2: Roles and responsibilities of KEY stakeholders on HPV communication at Kebele levels STAKEHOLDERSSTAKEHOLDERS ROLES & RESPONSIBILITIESReligious/ cultural/ civic leaders/ community leaders/Advocate and promote HPV vaccination in the community. Educate communities about the importance of preventing cervical cancer using HPV vaccine. Mobilize parents/ guardians to take their eligible daughters to receive HPV vaccination and complete the two doses. Emphasize importance of completing the 2 doses. Mobilize all eligible girls in the target population for HPV vaccination. Health Extension Workers (HEW), Health development army women development Army(WDA) Link the community to where vaccination services are being provided. Educate community on HPV vaccination as an effective preventive option for cervical cancer. Distribute relevant print materials to the community. Mobilize parents/ guardians to take their eligible girls to get vaccinated. Emphasize importance of completing the 2 doses. Inform and prepare all eligible girls both in school and out of school for HPV vaccination. School teaching staff Provide information on cervical cancer. Support HPV vaccination and school health program in the schools. Work with health workers to have all eligible girls vaccinated. Emphasize the importance of completing 2 doses. Mobilize all eligible girls for HPV vaccination. Parents and guardians Support the HPV vaccine program. Inform and prepare your eligible daughters for HPV vaccination. Take your eligible daughters for HPV vaccination and ensure that they complete the two doses. Mobilize fellow parents and guardians to take their eligible daughters for HPV vaccination Eligible girls Go for HPV vaccination and complete the two doses. Educate peers on cervical cancer prevention and the HPV vaccine. Remind guardians and parents to take their eligible daughters for HPV vaccination. Mobilize and encourage your eligible friends for HPV vaccination, too. STEPS TO DELIVER HPV VACCINE RELATED MESSAGESStep 1.Explain key points about cervical cancer and its consequences.Cancer of the cervix is a disease that kills many women in EthiopiaCervical cancer is the commonest cancer killer of women in Ethiopia. The cervix is in the opening of the womb. Cancer is the abnormal uncontrolled growth of some cells in body. Cancer is like the rot on a fruit. It starts in the body and spreads slowly. If left untreated, the cancer takes over the body and a woman will likely die.Step 2.Where does cancer of the cervix come from? Cancer of the cervix comes from a virus called the human papillomavirus (HPV). It is a common virus, and is sexually transmitted. Most sexually active people will be infected with HPV sometime in their lives. Most infected people will never experience any health problems. However, for a small number of young women who are infected with the HPV virus, a problem may occur when they grow older. When these young women grow older (between the ages of 25 and 50 years of age) sometimes this HPV infection will cause a sore or lesion to grow on the lower part/mouth of the womb (called the cervix). This lesion continues to grow on the cervix, spreads slowly, and may turn into cancer. For a while, women do not feel anything when it starts – no pain, no bleeding. It may continue to spread very deeply into the womb. When this happens, it is very difficult to treat. Signs that this has happened include bleeding after sex or between menstrual cycles, smelly discharge from the vagina, or bleeding after menopause. If left untreated, these changes may grow into cancer. And signs and symptoms will appear. Unfortunately many women go on to die of cervical cancer in Ethiopia.Step 3Explain that cancer of the cervix can be prevented in two ways:Cervical screening (health check-ups) for women aged 25 and older (where services are available). A cervical cancer vaccine for girls aged 9-14 years and onwards. A vaccine has been developed and licensed by the Government of Ethiopia. It is going to be available in your area soonStep 4Explain cervical cancer screening for women aged 25 and aboveA special test is available for women aged 25 and above called “cervical cancer screening”Women 25 and above need to go for a checkup at least once every 3 years (where screening services are available). This test may not be available at all health facilities. Step 5Explain why the cervical cancer vaccine is for young girls only and why it is importantThe majority of 9-14 years old girls are not sexually active. The vaccine works best if the girls do not have the HPV infection before. It is therefore important that a young girl is vaccinated BEFORE she runs the chance of having the HPV infection, that is, before she becomes sexually active. The vaccine works and can prevent a young girl from developing cervical cancer as a woman. Step 6.Explain how the vaccine is given.It is given by a trained health worker/vaccinator in the form of an injection in the muscle of the upper arm (point to location on arm). It is administered with a single-use clean (sterile) syringe and needle. The needle will NOT be used again. It is given in 2 doses. The second dose is given 6 month after the first dose.Step 7.Explain vaccine safetyThe vaccine is approved by the Government of Ethiopia. The vaccine is being delivered in many other countries (Great Britain, Europe, Australia, as examples) The vaccine is safe and effective. The vaccine only works against cervical cancer. The vaccine does NOT prevent against pregnancy, HIV, or other sexually transmitted infections. The HPV vaccine does NOT cause infertility.Step 8Explain where the vaccine will be given.The vaccine will be administered at: (give the location/time/dates) Step 9Remind your audience of good health practicePromote a girl’s health by getting regular health checkups and vaccinating all eligible girls against cancer of the cervix. Promote a woman’s health by getting regular health checkups and participating in a cervical screening program (if available). Tell audience they can be proud for taking steps to promote the HPV vaccine program and prevent cancer of the cervix in Ethiopia. Social mobilisers should be prepared to address questions such as: Can the vaccination help girls/women who are sexually active? SELECTING CHANNELS TO MOBILIZE THE COMMUNITYIt is important to select a channel which will be most effective when delivering your messages to the target audience. You should also ensure that the media you have chosen is accessible to the target audience. Some of the channels and methods of communication that can be used are below.SCHOOL MINI MEDIAThis involves the use of school mini media channels to deliver messages on immunization. Such channels include: Electronic media:, telephone messages and talk shows to disseminate messages to target audiences in form of programmers and school broadcast spots Print media: newspapers and IEC promotional materials in appropriate languages FOLK MEDIAUse of traditional media that includes music, dance, drama, stories and puppetCOMMUNITY FILM SHOWSThis involves use of cinema vans which have audio-visual equipment for showing outdoor films. During the day, the van is good for mobilizing people using mega phones/loud speakers informing them of any upcoming event. The same van is used at night to project relevant films that stimulate the audience and triggers discussion at the end of the show.INTER PERSONAL COMMUNICATION (IPC)This involves face-to-face interaction individually or in a small group between a health worker and a parent or parents at the immunization session. One way of communicating with parents/caretakers is to interact with them on individual basis, which could be done through counselling a parent who comes to the immunization post/center with their child. Steps to deliver IPCAsk parents/caretakers about their experiences of immunization, including dealing with any problems. Invite them to ask any questions.Use stories when teaching parents/caretakers and ask them to tell you what they think about the immunization program. Use short plays to deliver messages on immunizationKEY FOCUS AREA IPC MESSAGES TO INCREASE HPV VACCINE ACCEPTABILITYHPV vaccine for young girls protects them from cervical cancer later in life when they are grown women with families of their own.Cervical cancer affects the reproductive organs of women and is a leading cause of death among women of child bearing age.Girls should be vaccinated when they are young before exposure to HPV.You can protect your daughter and her future by getting her vaccinated.The vaccine is safe, causes no major side-effects, and will not harm a girl’s ability to have children in the future.HPV vaccine is available free-of-charge given at all health facilitiesMost girls should be vaccinated twice, with 6 months interval (or indicate chosen schedule) between doses.The government supports HPV vaccination and has included it to the national immunization programme.MANAGING RUMORS AND MISINFORMATIONRumors and misinformation about immunization are among the most serious threats to the success of the immunization program. Once rumors and misinformation start, they can be very hard to stop. MEANING OF RUMORSRumors refer to information that is spread in the community on a certain subject but is not necessarily true. In regard to immunization, rumors refer to negative information about vaccines and the entire immunization program whose intention is to tarnish the good name/image and benefits of immunization by stopping parents/caretakers from taking their children for immunization. MEANING OF MISCONCEPTIONS & MISINFORMATIONMisconceptions in immunization refer to wrong beliefs and thinking that are held by some members of the community about immunization. Misinformation refers to giving false information either accidentally or deliberately. Once people have misconceptions and believe rumors about immunization, they look at it negatively and start discrediting the benefits accrued by children, parents/caretakers and the entire nation COMMON SOURCES OF RUMORSWho starts rumors? Rumors are started by people who lack knowledge on the subject or who may have vested interests in the failure of the services being provided. These may include: Traditional healers: Religious sects/cultural groups: Anti-vaccine/lobby groups: Some misguided elements in the community: Sometimes health workersMay not be well equipped with information to dispel rumors or misconceptions circulating in their communities. CAUSES OF RUMORS ABOUT IMMUNIZATIONRumors often spread as a result of a number of factors that include the following:Lack of adequate and correct information about immunizationMistrust of health workers by the community Coincidental events Occurrence of some events that coincide with routine and supplemental immunization activities is another factor that fuels rumors. Common Examples of rumors and misconceptions about immunization There are three common themes of rumors about vaccination are: “Vaccines are contaminated with the HIV/AIDS virus” “Vaccines are contraceptives to control the population growth” “Children die after receiving vaccination” HOW TO RESPOND TO RUMORS AND MISCONCEPTIONS If there is any rumors that potentially harm the program and disseminate fast, the woreda Rapid Response Team (WRRT) should investigate the rumors and manage it accordingly. CHAPTER5LOGISTICS AND MANAGEMENT OF THE HPV VACCINEHPV IMMUNIZATION LOGISTICS REQUIREMENTS ESTIMATING SIZE OF THE TARGET POPULATIONThe number of girls in the target age groups (9-14Yrs) old both in and out-of-school girls will be determined by actual head count of out of school girls and through existing records at ministry of education (MOE) at each level. ESTIMATING VACCINE REQUIREMENT Estimated vaccine coverage for dose 1 assumes no drop-out between dose 1 and dose 2. ? Wastage factor must be adjusted for 1-dose or 2-dose vials.Target population size = for the first year of national introduction 14 yrs old female Estimated HPV1 coverage = Assumes no drop out between HPV 1 and HPV 2Number of doses = 2 (HPV1 and HPV 2)Wastage Factor = 1.05 After each round of HPV vaccination, the unused HPV vaccine should be transported to the woredas /health center vaccine store for proper storage.ESTIMATING OTHER LOGISTICS REQUIREMENTSTable SEQ Table \* ARABIC 3: Estimating Vaccines, AD Syringes, and Safety Boxes Needed for Vaccination SessionVACCINES/SUPPLIESFORMULAEXAMPLETotal Population in woreda “X”Census data1,000,000ATarget of girls age 9-14 years for HPV vaccine (8%)Data from CSA (MOE)10,000BNumber of vials per girl11WFWastage factor1.051.05CNumber of HPV dosesA x B x WF10500DNumber of doses per vial11ENumber of HPV vaccine vialsC/D10500FAD syringes (wastage factor =1.05)A x WF10500GNumber of safety boxes (1.05 wastage factor)(F x 1.05)/100(110.25)= 111HPV VACCINE HANDLING AND MANAGEMENTHPV vaccine is very sensitive to temperatures below +2°C, which can easily cause freezing. Once it freezes, it loses potency and cannot be used. The following are the recommended storage conditions of the vaccine. The recommended storage temperature is +2oC to +8oC at all levels.The thermostat should therefore be set to maintain temperatures between +2oC and +8oC.If the refrigerator doesn’t have, fridge tag, there should be twice-daily monitoring of the refrigerator temperatures – morning and afternoon, including weekends and public holidays using a thermometer inside the refrigerator.HPV VACCINE STORAGESide /front opening refrigerators HPV vaccine should be arranged in shelf 2 or 3 below the freezer compartment for the side opening refrigerators & the vaccine should be arranged away from the inner wall of the refrigerator.Figure SEQ Figure \* ARABIC 3: HPV vaccine storage location in front or side opening refrigeratorsTop-Opening RefrigeratorsAnd similarly on top opening (chest opening) refrigerators, HPV vaccine should be arranged away from the freezer space for the top opening fridges or chest refrigerators Figure SEQ Figure \* ARABIC 4: HPV storage location in top opening refrigeratorsHPV vaccine should be protected from freezing. Therefore, do not place vaccines on frozen ice packs; always use conditioned or chilled packs in the vaccine carrier. If you suspect that the vaccine has been frozen, carry out the shake test described below.The use of baskets Vaccine are safe when stored in the baskets provided. As rule, don’t store vaccines on the floor of the fridge.Figure SEQ Figure \* ARABIC 5: Baskets must be used to store vaccine in the refrigeratorsHPV VACCINE TRANSPORTATION HPV Vaccine is transported using fast cold chain equipment (cold boxes or vaccine carriers and ice packs). As HPV is freeze sensitive use conditioned ice packs or chilled water packs to transport HPV vaccine. NOTE: Close contact with frozen icepacks can cause the vaccine to get frozen & loose potency.Figure SEQ Figure \* ARABIC 6: How to condition ice packsSteps in conditioning ice packs:Lay out frozen ice packs, preferably in single rows but never in more than two rowsWait until there is a small amount of liquid water inside the ice packs. This will take up to one hour at +20?C and rather less at higher temperatures.Shake one of the ice packs every few minutes. The ice is conditioned as soon as it begins to move about slightly inside the ice pack.Before packing into the cold box or vaccine carrier, put the vials in a polythene (nylon) bag to keep the vials dry and prevent the label from peeling off. Place the bag in the top level of the cold box/vaccine carrier. HPV VACCINE HANDLING AT IMMUNIZATION SESSIONS At immunization sites, vaccine carriers or vaccine carriers large enough to hold at least 4 ice packs and a foam pad are used to keep vaccines at recommended temperatures during the sessions. Figure SEQ Figure \* ARABIC 7: Application of a foam pad at immunization session THE SHAKE TESTHPV vaccine should never be frozen; freezing damages the vaccine. The shake test is used to test a vial that has been suspected of freezing, to see if the vaccine has been damaged by freezing. The below steps describe how to perform the shake test.Step 1. Prepare a frozen control sample Take a vial of vaccine of the same type, batch number and manufacturer as the vaccine you want to test. Freeze the vial until the contents are solid, (at least 10 hours at -10°C) and then let it thaw. This vial is the control sample. Mark the vial clearly “CONTROL” so that it is easily identifiable and will not be used by mistake. Step 2. Choose a test sample Take a vial of vaccine from the batch that you suspect has been frozen. This is the test sample. Step 3. Shake the control and test samples Hold the control sample and the test sample together in one hand and shake gently for 10-15 seconds. Step 4. Allow to settle Leave both vials on a flat surface to settle. Step 5. Compare the vials View both vials against the light to compare the sedimentation rate (Figure 6). If the test sample shows a much slower sedimentation rate than the control sample (milky appearance), the test sample has most probably not been frozen and can be used. If the sedimentation rate is similar and the test sample contains flakes, the vial has probably been damaged by freezing and should not be used.Step 6. NoteIf the test procedure indicates that the test sample has been damaged by freezing, you should notify your supervisor immediately.Figure SEQ Figure \* ARABIC 8: Shake test with frozen and normal vialsIf the test procedure indicates that the test sample has been damaged by freezing, you should notify your supervisor immediately. (Don’t use!!!!)THE VACCINE VIAL MONITOR (VVM)The VVM is used to monitor the individual vaccine vial as well as the cold chain equipment (in addition to the thermometer readings, a changed VVM is an indication that the refrigerator may be faulty). Change in the VVM is indicative of cumulative exposure to high temperature.Figure SEQ Figure \* ARABIC 9: Vaccine Vial Monitor stages VACCINE WASTAGE & STRATEGIES TO REDUCEVaccine wastage is the loss of vaccine by use, decay, erosion, or leakage. The causes of vaccine wastage may be system or programme related. Causes of vaccine wastage include:Breakage of vialsFreezingVVM color change to discard pointLoss of labelsExpiryBreak down in the cold chain systemTo reduce vaccine wastage, make sure that:Accurate data are used to estimate vaccine and injection materials needed. Vaccine use and wastage are monitored..A checklist is used to carefully distribute vaccines & supplies to the health facilities.Cold chain maintenance is carried out to avoid fridge break down or freezing of vaccines.KEY MESSAGESRecord vaccines & injection materials received as soon as they are put in refrigerator/store.At the time of issuing for the static or outreach sessions, record the amount issued without waiting for the teams to come back.Balance the vaccine control book every time you receive or issue vaccines and injection materials and on returning from the outreach or static session.CHAPTER6MICRO-PLANNING & COORDINATION OF HPV ACTIVITIES HEALTH FACILITY LEVEL MICRO-PLANNINGAt the micro-planning meeting, each health facility in-charge should present the list of school and the number of girls age 9-14 or particular age group or depending on the situation specific grades in their catchment area. Additionally, expected number of Girls out of school should be registered and presented by catchment health center representatives. This data should be the summary of the one submitted by HEW and HDA. It is at this meeting that community leaders should be assigned with the responsibility of announcing the vaccination dates in all public gatherings including markets and places of worship.CHAPTER7HPV IMMUNIZATION SESSION ORGANIZATION & VACCINE DELIVERY PLANNING FOR THE IMMUNIZATION SESSIONDuring micro-planning and training for HPV vaccination, the health workers must: List all schools in their catchment area.Make a schedule of when they are visiting each school and who will visit each school.Establish contacts with the school to plan for the vaccination day. The school authority should schedule the day of vaccination in relation to school programs. The school authorities should identify a convenient location within the school where the vaccination can be carried out.THE IMMUNIZATION SESSIONSImmunization sessions (static or outreach) should be conducted in a clean environment, preferably in a building or in a shady spot.THE IMMUNIZATION SESSIONSThe immunization session post needs to be well-organized to create a conducive environment for efficient vaccination delivery. The following areas are essential:Waiting areaRegistration/screeningImmunization tableCheck point/recording area (tallying area)Design the immunization post for efficient flow. Avoid “bottle necks,” excess crowding, long waiting times, or confusion. Ways to avoid overcrowding and inefficient flow of clients include:Opening the post as early as possible Ensuring adequate space at the post site chosenEffective crowd control by the mobiliserImmunization on a “first come, first serve” basisDesignated entry and exit points and a one-way flow of girls through the post to prevent backtracking through the crowd following immunizationFigure SEQ Figure \* ARABIC 10: Model for HPV immunization session at school or community out reachSUPPLIES REQUIRED FOR THE HPV VACCINATION SESSIONHealth workers must prepare a checklist before packing the vaccines for the session. Below is standard checklist in preparation of administering EPI vaccines.Chairs and tablesPlastic sheeting (optional)Water and soap for washing handsCotton swabs and cool boiled water for cleaning the site of injectionA vaccine carrier with cool packs, HPV vaccines, thermometer, and a sponge.Shallow large tray (1), kidney dish (1), gallipots (2)0.5 ml AD syringes for administering HPV vaccineSafety boxesContainers for used/empty vaccine vials and swabsEmergency trayMonitoring tools HPV vaccination register, HPV immunization cards, & tally sheetsGuide for vaccinatorsCalendar for the return dateAEFI form and penPosters and leaflets about HPVYou may need more than one vaccine carrier depending on the day’s target population.ROLES & RESPONSIBILITIES OF STAFF AT SESSION POSTA health worker, teacher (or volunteer), and mobiliser (or volunteer) should be available at the immunization post to organize the post, vaccinate, and keep proper records. ROLES OF THE VACCINATOR Ensures adequate vaccine is packed in vaccine carrier with at least three cool packs Ensures adequate availability of auto-disable (AD) syringes and needles Ensures order in the vaccination post Ensures that the 15 minute observation of each girl is completed Assists the team in crowd control Assists the team with any other tasks assigned Prepares the AD syringes for vaccine administration Vaccinates the children Ensures that the vaccination area remains safe and clean Ensures correct storage of vaccine Ensures safety in immunization procedures Gives health advice to parents and girls about HPV vaccine and possible side effects Monitors any reactions and responds to parent’s/caretaker’s/children’s questions Manages and reports AEFI Makes sure the tally sheets are completed Ensures return of all equipment tally sheets, unused vaccines to storage center Ensures proper disposal of all used syringes & needles using recommended procedure ROLES OF THE TEACHER Thanks parent/caretaker/girl for coming Writes the age of the girl on the HPV immunization card Keeps the vaccination card for each girl until all three doses are given Tallies HPV vaccinations Informs the parent/caretaker/girl of the next vaccination date ROLES OF THE VOLUNTEER Ensures order/crowd control at the vaccination post Ensures that the 15 minute observations is completed Assists the team with any other tasked assigned ROLES & RESPONSIBILITIES OF HEALTH CENTRE STAFFDuring the month of HPV vaccinations, supervisors at all levels should be actively visiting schools. The supervisors should: Disseminate prime messages on HPV vaccination Enlist reactions of community on HPV immunization and EPI in general Build alliances with opinion leaders and community leaders Detect rumors from the community and address them immediately Promote and co-ordinates all HPV vaccination activities at the health center level Monitor and supervise all activities at immunization posts during HPV immunizations and advise operational staff accordingly Supervise the distribution and replenishment of vaccine, cool packs, & tally sheets at distribution center, both at the beginning & throughout the vaccination program During HPV vaccination implementation, carry extra vaccines and supplies for distribution to immunization posts with shortages Receive tally sheets, returned vaccines and other supplies from the posts Collect tally sheets for onward submission to the District Medical Officer within two days of completion of the vaccination Ensure proper collection and disposal of the waste generated at the vaccination post STEP FOR ADMINISTERING THE GARDASIL HPV VACCINEMake sure girl is in a seated position to minimize risk of syncope (i.e. fainting) Check expiry date on the vial Check the vaccine vial monitor (VVM) Hold the vial between the thumb and middle finger and check condition. Do not use if packaging is punctured, torn, or damaged, or if vial contains particles or if there is discoloration Mix the vaccine suspension by shaking the vial until the liquid is white and cloudy Open the AD syringe package and remove the syringe and needle from package Take off the needle cap without touching any part of the needle Insert the needle into the vaccine vial and bring the tip of the needle to the lowest part of the bottom of the vial Draw the entire contents of the vial into the 0.5 mL syringe until you notice a “click” Inject entire content of the syringe into the deltoid muscle of the upper arm using a perpendicular 90 degree angle Place a swab on the injection site & ask the girl to hold firmly. Do not massage the injection site Discard the syringe and needle in the safety box immediately after administration Determine due date for next vaccine dose and record on vaccination card Remind her that she must receive 3 doses and the date for her next scheduled vaccination Indicate date of next dose on vaccination card.Return updated vaccination card to the girl & ask her to bring it back on her next scheduled vaccination Observe the girl for 15 minutes after administration in case of syncope Should an adverse event occur, manage and document any adverse reaction Figure SEQ Figure \* ARABIC 11: Illustration of a girl receiving Gardasil vaccine intramuscular injection (IM)Remember An auto-disable syringe should be used for each injectionGardasil should be administered intramuscularly, into the deltoid muscle of the upper arm.IPC MESSAGES ABOUT HPV FOR GIRLS & PARENTS AT SERVICE DELIVERYTell the girl she is receiving the HPV vaccine that prevents cervical cancer. Give her information on the number of doses (3) for her to be protected. Insist on the importance of completing all three doses according to the vaccination calendar. Keep the arm relaxed to diminish the risk of swelling at the point of injection. Remind the girl that nothing needs to be applied to the site of injection after vaccination. Swelling and pain might be present at the point of injection, but it is temporary. Observe the girl for at least 15 minutes after vaccination. Give the dates of the next doses. Thank the girl for coming for the vaccination. When she finishes the third dose, congratulate her. CHAPTER8ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI)DEFINITION AND CATEGORIZATION OF AEFI DEFINITION AND CATEGORIZATION OF AEFIAdverse Events Following Immunization (AEFI) are events or reactions observed within four weeks following immunization. Some of these may be due to the vaccine or error in the administration of the vaccine. Others may have causes that are not vaccine-related.CLASSIFICATION OF ADVERSE EVENTS FOLLOWING IMMUNIZATIONAEFIs can be classified into five categories (Table 4). There are a variety of strategies health workers can employ to minimize events, prevent them completely, or manage the event should it occur.Table SEQ Table \* ARABIC 5: Categorization of AEFIS.NOCAUSE-SPECIFIC TYPE OF AEFIDESCRIPTION1.Vaccine product related reactionAn AEFI that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product.2.Vaccine quality defect related reaction An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccine product, including its administration device as provided by themanufacturer.3.Immunization error related reactionAn AEFI that is caused by inappropriate vaccine handling, prescribing or administration and thus by its nature is preventable.4.Immunization Anxiety related reactionAn AEFI arising from anxiety about the immunization.5.Coincidental eventAn AEFI that is caused by something other than the vaccine product, immunization error or immunization anxiety, but a temporal association with immunization exists.AEFI PRESENTATIONSVaccine reactions may be classified into: a) Common minor reactions or b) Rare more serious reactions. Most vaccine reactions are mild and settle on their own. The serious ones are rare and in general do not result in long-term problem.. Common minor reactions that results from normal body reaction to Vaccination process include;Local reactionsRedness at injection sitesPainSwellingFever <380 C IrritabilityMalaiseGeneral apathyThe rare, more serious vaccine related reactions include:ConvulsionAnaphylactic shockSevere allergic reactions e.g. generalized urticaria and angioedemaAdenopathyEncephalopathyAdvice on managing the common reactions should be given to parents, as well as instructions to return if there are more serious symptoms. This will help to reassure parents about immunization and prepare them for these common reactions.For more serious problems, the parent and the child should be advised to return to the health facility or seek medical attention to allow detection of an AEFI. They should be advised not to delay treatment of a coincidental illness falsely attributed as a vaccine reaction.MANAGEMENT AND PREVENTION OF AEFIVaccines are administered as a preventive measure to large numbers of healthy individuals particularly children – and are among the safest of pharmaceuticals. Although there is only a slight risk of adverse reactions, vaccines are complex biological preparations that can cause unexpected effects of very variable appearance and intensity among some individuals under certain circumstances. Although such effects are exceptional, we must be prepared, take precautionary measures and act with therapeutic urgency when necessary.MINOR VACCINE REACTIONSTable SEQ Table \* ARABIC 5: showing minor reaction of vaccines and their managementREACTIONTREATMENTSoreness, reddening, edema & indurationRarely require treatment, but if necessary give Paracetamol 10mg/kg every 6 hours for children to relieve pain.FeverRarely lasts for 48 hours. If so, first rule out any infection, for example malaria, by doing a blood slide and treat accordingly. Meanwhile, you may give Paracetamol 10mg/kg every 6 hours for children.HeadacheGive Paracetamol 10mg/kg every 6 hours for childrenMyalgiaGive Paracetamol 10mg/kg every 6 hours for children.Nausea, vomiting, diarrhea & abdominal painReassure the client, investigate for any infection and give ORS.Itching/pruritus, rash, urticarialGive chlorphenamine 2mg every 8 hours for children.ArthralgiaGive Paracetamol 1g 10mg/kg every 6 hours for childrenIMMUNIZATION ERROR RELATED REACTIONSThe following measures should be put in place to prevent occurrence of AEFIs due to immunization error related reactions:Comprehensive training of health workers with emphasis on proper administration techniques and communication.Identification of at least one qualified health worker per immunization session (static or outreach).Proper distribution of HPV vaccine ensuring bundling with injection materials.Use of vaccine control book to ensure that quality vaccines are used.Exclusive use of auto-disable syringes and needles.Proper waste disposal of injection materials.Proper cold chain maintenance.Proper storage and handling to avoid freezing. This vaccine should never be frozen.Strengthened Pharmacovigilance Team to manage and investigate AEFI effectively.An abscess at the site of injection is a programme error that, while minor, can still require clinical intervention. If an abscess develops at the injection site, treatment should be as follows: depending on the extent and size of abscess incision and drainage can be indicated, give a pain killer, and dress the wound daily and follow up. RARE & MOST SERIOUS REACTIONSRarely, a serious adverse reaction, such as an anaphylactic reaction, may occur after an immunization.However, to be prepared if an unexpected or serious event occurs, it is recommended that each vaccination session has an emergency tray with the following drugs. The District Medical Office should ensure these emergency trays are available at the health posts.Table SEQ Table \* ARABIC 6: Adrenalin dosage based on age for intramuscular (IM) administration for unknown WightAGEDOSE OF ADRENALIN0-6 months0.05 ml7-23 months0.1 ml2 years0.2 ml3 years0.3 ml4 years0.4 ml>5 years0.5 mlIn the unlikely event that a serious reaction should occur, below are notes on the signs and symptoms and treatment of persons who may experience an anaphylactic reaction following immunization Treatment should be administered immediately by any trained professional on the slightest suspicion of above. It is strongly recommended that written protocols be placed somewhere visible and known by all the professionals involved.Figure 12:Trendelenburg position the first step in the treatment of Anaphylactic ShockLOCAL & SYSTEMIC REACTIONS THAT ARE REQUIRED TO BE REPORTED IN AEFI PROCESSLocal reactions are mild, non-serious reactions during or after HPV vaccination. Severe local reactions including swelling more than 5cm in size, pain, redness, and swelling that lasts more than 3 days after the date of vaccination. All injection site abscesses should be reported. Systemic reactions are serious reactions during or after HPV vaccination. The following systemic reactions should be reported:All cases of anaphylaxis suspected to be related to immunization with HPV vaccineCollapse or shock-like state within 48 hours of immunization with HPV vaccineSeizures within 3 days of immunization with HPV vaccineAll deaths thought to be related to immunization with HPV vaccineAny severe or unusual events due to immunization with HPV vaccine or thought by staff or parents to be due to HPV vaccine (including clusters.AEFI SURVEILLANCE The major goal of immunization safety surveillance is early detection and appropriate and quick response to adverse events in order to lessen the negative impact on the health of the individuals and on the immunization program. It is a key indicator of program quality and enhances program credibility by providing actual country data on vaccine risk. NOTIFICATION OF AEFIReporting common minor reactions such as local reactions, fever, and self-limiting systemic symptoms which are expected to occur will overwhelm the system while contributing information of limited value. The following AEFIs should be reported;All injection site abscessesAll cases of BCG lymphadenitisAll deaths that occur within one month of an immunization excluding obvious causes of death eg. Car accident All cases requiring hospitalization that occur within one month of an immunizationAll medical events believed to be caused by immunization and about which people are concerned.AEFIs should be reported, and if there are no cases, there must be zero reporting, using a monthly AEFI Surveillance form. COMMUNICATING ABOUT AEFIWhen suspected AEFI has been reported, the health worker should actively and openly communicate to the communities. Do not speculate if you are not sure of the cause of the AEFI rather inform the community that investigations are going on. Once investigations are completed, the facts should be communicated to all concerned parties.Since AEFIs generate a lot of media and political interest, it is advisable to refer all queries to the higher technical and political authorities within the woreda and region, who will take responsibility on behalf of the Ministry of Health. Figure SEQ Figure \* ARABIC 13: AFI reporting flow chartCHAPTER9MONITORING AND EVALUATION OF HPV VACCINE INTRODUCTIONMONITORING TOOLSThe main recording and reporting tools that are used for immunization should be adapted to include HPV vaccine. These are:Immunization registerTally sheetImmunization card (Home-based Record)Defaulter tracking systemStock recordIntegrated monthly report IMMUNIZATION REGISTERSImmunization registers record doses given to an individual and helps health workers keep track of each dose that has been administered and the completion of the vaccination series. The immunization register is the basis for tracking individual immunization status (should for example, the vaccination card be lost) and for tracking defaulters.Depending on the HPV vaccination delivery strategy that is being used it may not always be possible to take the immunization register away from the health facility. In these circumstances it may be. TALLY SHEETSTally sheets are the forms that health workers use to document an immunization session by making a record for every dose of vaccine given. Tally sheets should be used at all vaccination sessions whether at the health center, fixed outreach, school, or conducted by mobile teams. IMMUNIZATION CARDSImmunization or vaccination cards are an essential tool to track immunization history, An HPV vaccination card will be produced for each vaccinated girl, and each vaccination will be recorded on this card and in a vaccine register. The register will be kept at the health facility and used at all immunization sessions, including outreach. The vaccination cards shall be retained at school until the immunization schedule is completed. The teachers will use the cards to remind the girls of the next dose and to track defaulters. Once a girl has received the two doses, the vaccination card will be given to her.For girls who will receive their HPV doses at a health facility or outreach, their cards will be kept by their parents/guardian, who will ensure that they complete the vaccination schedule.CHAPTER10FREQUENTLY ASKED QUESTIONS AND ANNEX FREQUENTLY ASKED QUESTIONS Why are HPV vaccines needed?Certain human papillomavirus (HPV) types cause cancer, including: cervical, vulvar, vaginal, penile, anal, and oropharyngeal (base of the tongue, tonsils and back of throat) cancers. Certain HPV types also cause most cases of genital warts.HPV is a common virus that is easily spread by skin-to-skin contact during sexual activity with another person. It is possible to have HPV without knowing it, so it is possible to unknowingly spread HPV to another person.HPV vaccine is a strong tool in prevention. These safe, effective vaccines are available to protect against HPV types 16 and 18 that cause approximately 70% of cervical cancers worldwide.ow common are the health problems caused by HPV?HPV is the main cause of cervical cancer, the 2nd most common cancer in women in the developing world. Of the 275,000 women who die every year from cervical cancer, over 85% live in developing countries.What are the currently available HPV vaccines?Three HPV vaccines are currently available worldwide. These vaccines are Cervarix (made by GlaxoSmithKline) and Gardasil quadrivalent and Gardasil a 9-Valent (made by Merck). How are the three HPV vaccines similar? All the three vaccines are very effective against diseases caused by HPV types 16 and 18; HPV 16 and 18 cause most cervical cancers, as well as other HPV associated cancers. All vaccines have been shown to prevent cervical precancers in women. All vaccines are very safe. All vaccines are non-infectious and cannot cause disease. All vaccines are given as shots and require two doses. How are the three HPV vaccines different? The vaccines have different adjuvants a substance that is added to the vaccine to increase the body's immune response Cervarix vaccine protects from HPV types 16 and 18 which are responsible for most of the cervical cancer.Gardasil quadrivalent gives additional protection against HPV types 6 and 11, the types that cause most genital warts in females and males. Gardasil 9-valent gives another additionalWho should get HPV vaccine? The target population for HPV vaccination is girls who are 9-13 years old. The vaccines are not recommended in girls younger than 9 years of age. Why HPV vaccine is recommended at ages 9-14years old? For the HPV vaccine to work best, it is very important for preteens to get all three doses (shots) long before any sexual activity with another person begins. It is possible to be infected with HPV the very first time that a person has sexual contact with another person. Also, the vaccine produces higher antibody levels when given at this age compared to older ages. What is the recommended schedule (or timing) of the three HPV doses (shots)? Three doses (shots) are recommended over six months. Are the HPV vaccines safe and effective? Most national regulatory agencies, including the Food and Drug Administration in the U.S.A. and the European Medicines Agency, have licensed the vaccines and note them to be safe and effective. Both vaccines have been administered to millions of girls and women around the world without serious side effects. Common, mild side effects included pain where the shot was given, fever, headache, and nausea. As with all vaccines, the safety of these vaccines is monitored very carefully. Ongoing vaccine safety studies continue to show that HPV vaccines are safe. Can HPV vaccines treat HPV infections or cervical cancer? HPV vaccines will not treat or get rid of existing HPV infections. In addition, HPV vaccines do not treat or cure health problems (like cancer or warts) caused by an HPV infection that occurred before vaccination. It is important for adult women to still get cervical cancer screening even if they have completed the HPV vaccine series. How important is it to get HPV vaccine? The HPV vaccines are important tools to prevent cervical cancer caused by HPV types targeted by the vaccine. Should pregnant women be vaccinated? HPV vaccines are not recommended for use in pregnant women. However, studies have shown neither vaccine caused problems for babies born to women who got the HPV vaccine while they were pregnant. Getting the HPV vaccine when pregnant is not a reason to consider ending a pregnancy. But, to be on the safe side until more is known, a pregnant woman should not get any doses of either HPV vaccine until her pregnancy is completed. What should a woman do if she realizes she received HPV vaccination while pregnant? If a woman realizes that she got any shots of an HPV vaccine while pregnant, she should wait until after her pregnancy to finish the remaining HPV vaccine doses. Can women with HIV infection be vaccinated? Studies show that HPV vaccination is safe and immunogenic and does not cause problems for HIV-infected women who got the vaccine. HPV vaccine is not contraindicated in HIV-infected women. Can boys get vaccinated? HPV vaccines are currently not recommended by WHO for administration to boys for prevention of cervical cancer because high vaccine coverage (>70%) in the primary target population of 9-13 year old girls is more cost-effective in reducing cervical cancer than including boys. Do people faint after getting HPV vaccines? People faint for many reasons. Some preteens and teen may faint after any medical procedure, including receiving vaccines. It is possible for falls and injuries to occur after fainting. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and related injuries.ANNEX: HMIS TOOLS3617595-266700: HPV immunization CardFederal Democratic Republic of EthiopiaMinistry of Health HPV (CERVICAL CANCER) VACCINATION CARD Keep this card safely and produce it when you come for the subsequent doses Serial No. _____________________________ Name _____________________________ Date of Birth _____________________________ Name of House hold head _____________________________ Name of school _____________________________ Class in school _____________________________ Village/Gote _____________________________ Kebele_____________________________ Woreda_____________________________ Region _____________________________DoseDate vaccinated Next vaccination date FACTS ABOUTHPV and CERVICAL CANCER) HPV vaccine prevents human Papillomavirus (HPV) infection.The HPV virus causes cervical cancer.Cervical cancer is the biggest cancer killer of women in Ethiopia HPV vaccine prevents most Cervical cancer.HPV1 is currently given for all girls aged 14 yrs.HPV2 is given 6 month after HPV1HPV1 HPV2 Other Dose You must receive at least two dose to be protected fully : HPV immunization register Region______________________Woreda________________________Name of facility________________________Name of school________________________Name Out reach_____________________________Kebele _______________________S.NFull NameDate of BirthAgeMother/GardianNameVillage/GoteHouseNoGradeDate (DD/MM/YY) forHPV1HPV2Other: Immunization tally sheetFORM 1b: TALLY SHEET FOR HPV VACCINATION 1st DOSEUse a separate tally sheet each day of vaccinationREGION --------------------------ZONE ------------------------------WOREDA --------------------------------NAME OF THE POST/SCHOOL __________________________________________________VILLAGE/GOTE ------------------ DATE OF VACCINATION ______/____/_____ (dd / mm / yy )Tally sheet to record the number (No.) of HPV doses given on a single vaccination and ages of the girls.DOSE GIRLS VACCINATEDTOTAL HPV 1 00000 00000 00000 00000 00000 0000000000 00000 00000 00000 00000 00000 00000 0000000000 00000 00000 00000 00000 00000 00000 0000000000 00000 00000 00000 00000 00000 00000 0000000000 00000 00000 00000 00000 00000 00000 0000000000 00000 Total FORM 1b: TALLY SHEET FOR HPV VACCINATION 2ND DOSEUse a separate tally sheet each day of vaccination.REGION ____________________ZONE _____________________WOREDA___________________NAME OF POST/SCHOOL _____________________________________________________-VILLAGE ________________________________________DATE of VACCINATION ______/ _____/ _____Tally sheet to record the number (No.) of HPV doses given on a single vaccination and ages of the girls. Girls Vaccinated Total HPV 1 00000 00000 00000 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000TOTAL HPV 1 HPV 2 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 TOTAL HPV 2 FORM 2a. HEALTH POST MONTHLY HPV SUMMARY REPORT FORMAT REGION ____________________________ZONE ________________WOREDA____________________________HEALTH FACILITY ________________________________________________________NAME OF HEALTH WORKER____________________________ DATE OF REPORT COMPILATION (dd/mm/yy) _________________________ Immunization Date Name of Immunization Post (static or outreach, or school) No. girls immunized HPV 1 No. girls immunized HPV 2VACCINE USAGE No.Vials issued (received) No.Vials returned (unopened) Wastage Contamination Breakage Other (Specify) 1 2 3 4 5 6 7 8 9 10 Total ................
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