Immunization Handbook for Health Workers (2018) PDF

Contents x | Acronyms 1 | Unit 1 : Introduction and role of health workers in immunization 9 | Unit 2 : Diseases prevented by vaccination 17 | Unit 3 : National immunization schedule and frequently asked questions 27 | Unit 4 : Micro-planning for immunizatio...

Contents x | Acronyms 1 | Unit 1 : Introduction and role of health workers in immunization 9 | Unit 2 : Diseases prevented by vaccination 17 | Unit 3 : National immunization schedule and frequently asked questions 27 | Unit 4 : Micro-planning for immunization services 67 | Unit 5 : Managing the cold chain and the vaccine carrier 79 | Unit 6 : Safe injections and waste disposal 87 | Unit 7 : Managing an immunization session 107 | Unit 8 : Adverse Events Following Immunization (AEFI) 127 | Unit 9 : Records, reports and using data for action 135 | Unit 10 : Mother and Child Tracking System (MCTS)/ Reproductive and Child Health (RCH) Portal and ANMOL Application 143 | Unit 11 : Partnering with communities to increase coverage 151 | Unit 12 : Surveillance of vaccine preventable diseases ix  Immunization Handbook for Health Workers (2018) Acronyms ADS Auto Disable Syringe AEFI Adverse Events Following Immunization AES Acute Encephalitis Syndrome AFP Acute Flaccid Paralysis AIDS Acquired Immuno Deficiency Syndrome ANC Ante-Natal Care ANM Auxiliary Nurse Midwife ASHA Accredited Social Health Activist AVD Alternate Vaccine Delivery AWC Anganwadi Centre AWW Anganwadi Worker BCG Bacillus Calmette-Guerin CBO Community Based Organization CBWTF Common Biomedical Waste Treatment Facility CHC Community Health Centre CRS Congenital Rubella Syndrome CPCB Central Pollution Control Board DF Deep Freezer DIO District Immunization Officer DPT Diphtheria , Pertussis , Tetanus DTF-I District Task Force – Immunization EDD Expected Date of Delivery EEFO Early Expiry First Out FAQs Frequently Asked Questions FLW Front Line Worker GMP Good Manufacturing Practices HHE Hypotonic, Hypo responsive Episode Hib Haemophilus influenzae type b HIV Human Immunodeficiency Virus HMIS Health Management Information System HRA High Risk Area H-t-H House to House HW Health Worker ICDS Integrated Child Development Services x IEC Information, Education, Communication ILR Ice Lined Refrigerator IM Intra Muscular IPC Inter Personal Communication IPV Inactivated Poliovirus Vaccine JE Japanese Encephalitis LHV Lady Health Volunteer LMP Last Menstrual Period LS Lady Supervisor LW Link Worker MCH Maternal and Child Health MCP Mother and Child Protection MCTS Mother and Child Tracking System MO Medical Officer MOIC Medical Officer In-Charge MR Measles Rubella NGO Non-Government Organization NIS National Immunization Schedule OPV Oral Polio Vaccine OVP Open Vial Policy Penta Pentavalent PHC Primary Health Centre PIP Project Implementation Plan PRI Panchayat Raj Institution PW Pregnant Women RCH Reproductive and Child Health RI Routine Immunization RVV Rotavirus Vaccine SC Sub Centre SHG Self Help Group SOP Standard Operating Procedure TT Tetanus Toxoid UHC Urban Health Centre UIP Universal Immunization Program VHSC Village Health and Sanitation Committee VHND Village Health and Nutrition Day VPD Vaccine Preventable Disease VVM Vaccine Vial Monitor WMF Wastage Multiplication Factor WPV Wild Polio Virus xi  Immunization Handbook for Health Workers (2018) Unit 1: Introduction and role of health workers in immunization Learning Objectives At the end of the unit, you should be able to: zz Describe the importance of immunization and reasons for low immunization coverage. zz List the responsibilities of Health Workers in Routine Immunization. Contents ¾¾Importance of immunization and reasons for low immunization coverage. ¾¾Responsibilities of Health Workers in Routine Immunization. 1.1 Immunization and its importance Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against later infection or disease. Immunization is a proven tool for controlling and eliminating life-threatening infectious diseases and is estimated to prevent between 2 and 3 million deaths each year. It is one of the most cost- effective health investments, with proven strategies that make it accessible to even the most hard-to- reach and vulnerable populations. It has clearly defined target groups; it can be delivered effectively through outreach activities; and vaccination does not require any major lifestyle change. Over the years various strategies to make vaccines available to all beneficiaries across the community/ area, including to the most hard-to-reach and vulnerable populations have saved countless lives. The benefits to the individual include not only the prevention of disease and disabilities but also the opportunity for a healthier and a more productive life. Each vaccine provides immunity against a particular disease; therefore, a number of vaccines are administered to children and women to protect them from many vaccine-preventable diseases. India’s Universal Immunization Programme (UIP) is one of the largest immunization programs in the world. The UIP targets to vaccinate nearly 2.7 crore new-borns each year with all primary doses and an additional ~10 crore children of 1- 5 year age with booster doses. In addition, nearly 3 crore pregnant mothers are targeted for TT vaccination each year. Every year ~90 lakh immunization sessions are conducted to vaccinate the beneficiaries, majority of which are at village level. Who is a beneficiary? All children and pregnant women in your area should receive the benefits of immunization. This includes all imgrants populations temporarily staying in your sub-centre area even if they are not in your list or records. 2  Unit 1 1.2 Key achievements of the Immunization Programme in India The immunization programme in India has grown over the years, various new vaccines have been introduced and many mile stones achieved. The health workers in the field, the ANMs and the ASHA and AWW continuously contribute to making these milestones and sustaining them. See Table 1.1 below to know how the system evolved and some important activities and events in immunization. Table 1.1 Key achievements under UIP 1978 Expanded programme of immunization BCG, DPT, OPV, typhoid (urban areas) 1983 TT vaccine for pregnant women 1985 Universal Immunization Programme - measles added, typhoid removed, focus on children less than 1yr of age 1990 Vitamin-A supplementation 1995 Polio National Immunization Days 1997 VVM introduced on vaccines in UIP 2002 zz National Rural Health Mission Launched zz Auto Disable (AD) Syringes introduced into UIP 2006 JE vaccine introduced after campaigns in endemic districts 2007-08 Hep B expanded to all districts in 10 states & schedule revised to 4 doses from 3 doses 2010 Measles 2nd dose introduced in RI and MCUP (14 states) 2011 zz Hepatitis B universalized and Haemophilus influenza types b introduced as pentavalent in 2 states zz Open Vial Policy for vaccines in UIP 2013 zz Pentavalent expanded to 9 states zz Second dose of JE vaccine 2014 India and South east Asia Region certified POLIO-FREE 2015 zz India validated for Maternal and Neonatal Tetanus elimination zz Pentavalent expanded to all states zz IPV introduced 2016 zz Rotavirus vaccine introduced in 4 states in Phase 1 zz tOPV to bOPV Switch zz Switch to fractional IPV (Phased) zz Rotavirus vaccine introduced (Phased launch) 2017 zz MR vaccine introduced (Phased launch) zz PCV (Phased launch) zz Use of adrenaline single dose IM by ANM for anaphylaxis 3  Immunization Handbook for Health Workers (2018) 1.3 Responsibilities of Health Workers in Routine Immunization As Health workers, you play a very important role in providing Immunization services to mothers & children. You are expected to vaccinate all children and pregnant women according to the National Immunization Schedule. Your responsibilities can be highlighted under the following headings a) Planning for Immunization b) Managing the Cold chain c) On receiving the vaccine carrier and logistics or at the immunization session site, you must d) Preparing and conducting the immunization session e) Communicating with caregivers f) Recording, Reporting and tracking of dropouts g) Capacity building of ASHAs and AWWs to perform their roles in UIP h) Coordination with ICDS supervisor The lists under each heading will guide and help you to understand the processes and activities needed to enable all beneficiaries to be vaccinated correctly and in time. Some of the points such as managing cold chain are listed to remind you of the importance of ensuring safety and quality while you are administering vaccines. a) Planning for Immunization Once a year: Actively participate in preparing and generating new RI microplans including house to house survey and head counting: ™™ Ensure that all areas are included into the list, confirm the master list of villages and HRAs; Form 1; ™™ Prepare map of areas under SC with names of villages, urban areas including all hamlets (tola), subvillages, sub-wards, sector, mohalla, hard to reach areas, etc. showing exact boundaries and areas for ASHAs and AWWs; Form 2; ™™ Ensure that migratory populations, temporary settlements are also listed and included in the map; ™™ Provide actual population and beneficiary counts through house to house survey and head counting; Form 3, 4 & 5; ™™ Generate needed information for planning sessions, vaccine and logistic calculations. Forms 6 & 7. Every six months: Conduct only the house-to-house survey and head counting. This activity in coordination with ICDS and partners will help to: ™™ Identify any new sites for inclusion / mobilization (add into Form 1) and; ™™ Update the beneficiary due lists for effective mobilization (add into Form 3, 4 & 5). Every three months: Participate in RI microplan review to help: ™™ Update the plans to incorporate information on sub centres where staff are on leave or if vacant and; ™™ Respond to changes in vaccine delivery and inclusion of new areas - nomads / HRAs and other issues based on monitoring results. 4  Unit 1 Every month: At Sub centre: with ASHA/AWW ™™ Review due lists of all the sessions held in the previous month; ™™ Make use of the tracking bag and place counterfoils as needed (see page 126) ™™ Update coverage monitoring chart to quantify leftouts and dropouts; ™™ At PHC share important issues with the sector medical officer, so that MO can make plans to visit your sub-centre and support you. After every RI session take help of ASHA/AWW to: ™™ Review the session due list and; ™™ Identify dropout / left-out beneficiaries and enter their names into the next session’s due list for follow-up and mobilization; ™™ Ensure follow-up visits to beneficiaries to identify minor vaccine reactions or AEFIs; ™™ Guide ASHA/mobilizer to identify, newborns/pregnant women for inclusion in next due list; ™™ Guide ASHA/mobilizer to visit these houses during other field visits and remind beneficiaries of immunization. b) Managing the Cold chain (if applicable) As vaccine and cold chain handler at the cold chain point, you are responsible for: ™™ Daily maintenance and cleanliness of cold chain equipment; ™™ Twice daily temperature recording; ™™ Monthly vaccine and logistics indenting, receipt and storage; ™™ Timely issue of vaccine to the lower store/sessions as per microplan; ™™ Timely update of stock and issue registers for vaccines and logistics; ™™ Breakdown reporting immediately; ™™ Monthly vaccine utilization including wastage reporting; ™™ Refer and follow eVIN guidelines (if launched in your state). c) On receiving the vaccine carrier and logistics or at the immunization session site, you must: ™™ Ensure that vaccines are brought in a vaccine carrier with 4 well-sealed conditioned ice packs; ™™ Ensure vaccine carriers are kept in shade and are not opened frequently; ™™ Check the labels for expiry date and VVM of the vaccine vials before use; ™™ Ensure Open Vial Policy applicable vaccine vials have readable labels with date and time of opening / reconstitution; ™™ Check that T-Series and HepB vaccines are not frozen; ™™ Follow the guidelines for use of open vaccine vials; ™™ Check that required diluents are placed in separate bag and in cold chain; ™™ Required number of syringes are available; ™™ AEFI / Anaphylaxis kit contains all needed items as per checklist. 5  Immunization Handbook for Health Workers (2018) d) Preparing and conducting the immunization session ™™ Prepare for the session by selecting appropriate site; arranging for required equipment and supplies; review due list of beneficiaries and sharing with AWW and ASHA to mobilize beneficiaries to bring them for the session and also to help you in arranging the vaccination session site; ™™ Involve community influences and leaders to support you; ™™ Assess infants for vaccination and possible contraindications before vaccinations; ™™ Use aseptic technique to prepare and reconstitute vaccines; ™™ After reconstitution, write the date and time of reconstitution on the label of vaccine vial; ™™ Use Auto Disable Syringe (ADS) for each injection; ™™ Explain to the caregiver the correct positioning to keep the child still and the caregiver and vaccinator comfortable; ™™ Administer the vaccines by using correct technique; ™™ After the session, store opened vials based on open vial policy guidelines; ™™ Ensure separate packing of used vials with Session site name and date; ™™ Pack the vaccine carrier and return vaccines to the ILR; ™™ Follow immunization waste disposal as per guidelines. e) Communicating with caregivers At the start ™™ Greet the caregiver in a friendly manner. Thank them for coming for vaccination and for their patience if they had to wait; ™™ Ask the caregiver if they have any questions or concerns and answer them politely. During assessment - Key messages ™™ Explain what vaccine(s) will be given and the disease it prevents; ™™ Mention possible adverse events (minor AEFIs) and explain how to handle them; ™™ Explain the need for the child to return for each contact in the immunization schedule to be fully protected. Write the date for the next vaccination on the immunization card and tell the caregiver; ™™ Remind the caregiver to bring the immunization card when they bring the child back for the next vaccination; ™™ Explain the importance of waiting for 30 minutes after vaccination; ™™ Check vaccine name and sure the correct vaccine is being given. After vaccination ™™ Ask the beneficiaries to wait for half an hour after vaccination to observe for any AEFI; ™™ Explain how to manage mild fever and local reactions and to contact ASHA/AWW if needed; ™™ Remind the caregiver when to return with the infant; ™™ In the event of any out-of-stocks of vaccine at the time of the session, inform the caregiver where and when to return for the next doses; ™™ Ask the caregiver if they have any questions or concerns and answer them politely. f) Recording, Reporting and tracking of dropouts ™™ Record all vaccinations in a due list cum tally sheet, immunization card and immunization register; 6  Unit 1 ™™ Mark the date of vaccination and the next due date on the card if another dose is needed, and ensure that the caregiver understands when and where to return for the next dose(s) of vaccine(s); ™™ Keep the updated counter foil of the immunization card in tracking bag; ™™ Share the list of dropouts with AWW and ASHA and ensure they track them; ™™ Maintain immunization coverage monitoring chart at the sub center; ™™ Report all suspected cases of TB, Diphtheria, Pertussis, Neonatal Tetanus, Measles, AES and AFP to the medical officer; ™™ Report all AEFIs. Ensure recording of all AEFIs in the Block AEFI register. g) Capacity building of ASHAs and AWWs to perform their roles in UIP For Immunization planning - train them to: ™™ Describe the national immunization schedule and address FAQs; ™™ Conduct the house-to-house survey to undertake head count and generate beneficiary list; ™™ Contribute to finalizing master list of villages/areas, including HRAs and underserved population; ™™ Confirm area demarcation between ASHA, AWW /LW/ surveyor; ™™ Help to create working maps for each area; ™™ Help in preparing the beneficiary due list; ™™ Help in planning and selection of the site, day and time of the session in the village; ™™ Share the list of newborns in the area with the ANM every month; ™™ Suggest community mobilization activities for each session site and sub centre area; ™™ Visit households to inform the due beneficiaries for vaccination day and site; ™™ Report all suspected VPDs. For managing immunization session - train them to: ™™ Assist in setting up RI session site; ™™ Ensure that all beneficiaries are brought to the session site as per due beneficiary list; ™™ Assist in conducting the immunization session. (Control the crowd, assist in recording etc.); ™™ Remind caregivers of the 4 key messages about immunization; ™™ Ensure beneficiaries wait for 30 minutes at the session site after immunization; ™™ Help with preparing the due list for next session. For post immunization follow-up - train them to: ™™ Report any AEFI i.e. a case of High fever, any allergic reaction or convulsions after immunization to the ANM and ensure the treatment; ™™ Visit the houses of dropouts and leftouts to counsel the mothers to immunize their children; ™™ To contact you for any advise or questions. h) Coordination with ICDS supervisor Use the following sources of information in planning immunization: ™™ List and map of villages including hamlets /urban areas /wards; ™™ 0-6 years registers, eligible couple register, etc for total and beneficiary population; ™™ VHND microplans; ™™ AWW/Helper list; ™™ Panchayath records or lists. 7  Immunization Handbook for Health Workers (2018) Involve the ICDS supervisors to: ™™ Visit field to monitor the house-to-house survey conducted by AWWs; ™™ Supervise the filling of forms 3, 4 and 5; ™™ Support in review of all survey forms and consolidation of sub centre microplans during meeting at SC; ™™ Be aware of Health and ICDS sector boundaries for joint planning, implementation and monitoring of immunization activities; ™™ Contribute in development of communication plan; ™™ Ensure that the AWWs are regularly trained in immunization/mobilization. 1.4 Reasons for low immunization coverage Low immunization coverage puts the entire community and area at risk of disease. This low coverage can be because of drop-outs or left-outs. Drop-outs – those beneficiaries who have been identified and have been receiving vaccines but do not complete the vaccinations as per the schedule. Left-outs – those beneficiaries who have not been identified or listed and are not receiving any vaccination. There are many factors that influence the immunization coverage. Listed in the table below are some of the issues identified by the health service providers across many states. Table 1.2 Common issues affecting the immunization coverage Immunization services zz vacant SCs (some areas remain without immunization services) zz weak tracking of children (large number of dropout and leftout children) zz fixed timing of sessions (not suitable for the some communities) zz stock out of vaccines, diluents, AD syringes, hubcutters, immunization cards etc. Staffing zz vacancies of ANMs and doctors zz irrational distribution of ANMs Training zz lack of supervision and guidance by MOs zz absence of regular training and refresher training zz poor availability of trainers and quality of training Planning zz weak or absent RI microplans, absence of validation of areas zz lack of involvement of MOs in RI microplanning zz lack of involvement of other departments like Integrated Child Development Services (ICDS) and urban bodies zz difficulties in urban areas planning Community zz poor understanding and misconceptions about immunization in the involvement and community (weak interpersonal communication skills or lack of efforts to communication meet the community members) zz four key messages not delivered (fear of minor reactions and AEFIs not addressed) zz IEC material not displayed at session site In addition to the above, geographical, cultural and social factors have an impact on the communities faith in the immunization delivery system and thus also affects immunization coverage. 8  Immunization Handbook for Health Workers (2018) Unit 2: Diseases prevented by vaccination Learning Objectives At the end of the unit, you should be able to: zz List diseases that are preventable by immunization under the Universal Immunization Programme (UIP). zz Describe their mode of spread and how they can be recognized and prevented. Contents ¾¾Diseases prevented by Immunization under UIP Programme. ¾¾Their mode of spread and how they can be recognized and prevented. The following are the targeted vaccine preventable diseases under Universal Immunization Program: 1. Tuberculosis diseases (bacterial meningitis, pneumonia 2. Hepatitis B and others) 3. Polio 8. Diarrhoeas due to rotavirus 4. Diphtheria 9. Pneumococcal disease 5. Pertussis 10. Measles 6. Tetanus 11. Rubella 7. Haemophilus Influenzae Type B related 12. Japanese Encephalitis 2.1 Tuberculosis Tuberculosis (TB) is caused by the bacterium (Mycobacterium tuberculosis). It usually attacks the lungs but can also affect other parts of the body including the bones, joints and brain. TB can cause serious illness and death. a) How to recognize the disease? zz A child with fever and / or cough for more than 2 weeks, with loss of weight / no weight gain; AND zz History of contact with a suspected or diagnosed case of active TB disease within the last 2 years. b) How is it spread? TB is spread from one person to another through the air, often when an infected person coughs or sneezes. TB spreads rapidly, especially in areas where people are living in crowded conditions, have poor access to health care and/or are malnourished. A person can contract bovine tuberculosis, another variety of TB by consuming raw milk from infected cattle. c) How is the disease prevented? Vaccination with Bacillus Calmette-Guerin (BCG) as per the schedule will prevent serious forms of childhood tuberculosis. 10 2.2 Hepatitis B Hepatitis B is caused by a virus that affects the liver. Infants who get infected during birth or before Unit 2 one year of age, 90% develop chronic disease. It is a highly infectious disase (50-100 times more infectious than HIV) and is the leading cause of jaundice, cirrhosis or liver cancer. a) How to recognize the disease? An acute illness typically including acute jaundice, dark urine, anorexia, malaise, extreme fatigue and right upper quadrant tenderness. b) How is it spread? The disease spreads through contact with infected blood or other body fluids in various situations: a) from mother to child during birth; b) during social interaction between children with cuts, scrapes, bites and/or scratches; c) from person to person during sexual intercourse; and d) through unsafe injections and/or transfusions, or needle stick accidents with infected blood. c) How is the disease prevented? By vaccinating children with HepB vaccine as per the Immunization schedule (contained in Pentavalent vaccine), we can prevent infection and its complications. 2.3 Poliomyelitis Poliomyelitis, or polio, is a highly infectious disease caused by poloivirus types 1, 2 or 3. It mainly affects children of less than five years of age. One in 200 infections causes irreversible paralysis when the virus attacks the spinal cord nerve cells that control the muscles. India continues to be polio free since 2011. It is important that all polio vaccinations and immunization campaigns continue until the world is polio free. a) How to recognize the disease? Sudden onset of weakness and floppiness in any part of the body in a child less than 15 yrs of age or paralysis in a person of any age in whom polio is suspected. b) How is it spread? Polio is transmitted by the faecal-to-oral route. In areas with poor sanitation, it enters the body through the mouth when people eat food or drink water that is contaminated with faeces. c) How is the disease prevented? Vaccination with the oral polio vaccine (OPV) and inactivated polio vaccine (IPV) administered as per the immunization schedule will effectively prevent infection. d) Why AFP should still be reported? As the world is not yet polio free, it is important that all AFP cases be reported even though India is polio free. Surveillance for polio must continue to ensure that we will be able to detect cases if they occour. 11  Immunization Handbook for Health Workers (2018) 2.4 Diphtheria Diphtheria is caused by the bacterium (Corynebacterium diphtheriae). Diphtheria is an infectious disease that commonly affects the throat and the tonsils, forming a membrane that can lead to obstructed breathing and death. a) How to recognize the disease? An illness of the upper respiratory tract characterized by the following: laryngitis or pharyngitis or tonsillitis, AND adherent membranes of tonsils, pharynx and/or nose. b) How is it spread? The bacteria causing diphtheria inhabit the mouth, nose and throat of an infected person. It spreads from person to person by coughing and sneezing. c) How is the disease prevented? Giving DPT (contained in Pentavalent vaccine) and DPT boosters as per the immunization schedule is the most effective method of prevention. 2.5 Pertussis (whooping cough) Pertussis or whooping cough, is a disease of the respiratory tract caused by Bordetella pertussis bacteria that live in mouth, nose and throat. It is highly communicable disease characterized by repeated cough that may lead to pneumonia and other complications leading to death especially in infants and young children. a) How to recognize the disease? A person with a cough lasting at least two weeks with at least one of the following: a) paroxysms (i.e. fits) of coughing; b) inspiratory whooping; c) post-tussive vomiting (i.e. vomiting immediately after coughing); d) without other apparent causes. b) How is it spread? Pertussis spreads very easily from person to person in droplets produced by coughing or sneezing. c) How is the disease prevented? Giving DPT (contained in Pentavalent vaccine) and DPT boosters as per the immunization schedule will prevent pertussis. 2.6 Tetanus Tetanus is caused by the bacterium Clostridium tetani, which is present in soil everywhere. Infection with this bacterium occurs when soil enters a wound or cut. A toxin released by the bacterium causes severe, painful muscle spasms that can lead to death. Neonatal tetanus (in newborns) and maternal tetanus (in mothers) is a serious problem in areas where home deliveries conducted without sterile procedures are common. a) How to recognize the disease? Neonatal Tetanus: Any neonate with a normal ability to suck and cry during the first 2 days of life, and who thereafter cannot suck normally between 3 and 28 days of age and becomes stiff or has convulsions/spasms (jerking of the muscles), or both. 12 b) How is it spread? Tetanus is not transmitted from person to person. In people of all ages, the bacterium can enter a wound or cut from items such as dirty nails, knives, tools, wood splinters, dirty tools used during Unit 2 childbirth, or deep puncture wounds from animal bites. In newborn babies, infection can occur when delivery occurs on dirty mats or floors, a dirty tool is used to cut the umbilical cord, dirty material is used to dress the cord or when the hands of the person delivering the baby are not clean. c) How is the disease prevented? Vaccinating pregnant women with TT during pregnancy with the primary doses and booster doses wehre needed, prevents Matenal and Neonatal Tetanus. All children must also receive TT/DPT (contained in Pentavalent Vaccine / DPT boosters) as per the immunization schedule to prevent tetanus in other age groups. 2.7 Haemophilus influenzae type b disease Haemophilus influenzae is a bacterium found commonly in the nose and throat of children. There are six types of Haemophilus influenzae. Out of these six types, Haemophilus influenzae type b, or Hib, causes 90% of all serious Haemophilus influenzae infections. Hib can lead to severe pneumonia and meningitis in children aged less than 5 years. a) How to recognize the disease? Clinical signs and symptoms of pneumonia include fever, chills, cough, rapid breathing and chest wall retractions. Children with meningitis can have fever, headache, sensitivity to light, neck stiff ness and sometimes confusion or altered consciousness. b) How is it spread? The disease spreads from person to person in droplets released when sneezing and coughing. Healthy children carrying the virus in their noses and throats can also infect others. c) How is the disease prevented? By vaccinating children with Hib vaccine (contained in Pentavalent vaccine) as per the Immunization schedule, we can prevent Hib infection and its complications. 2.8 Rotavirus gastroenteritis Rotavirus gastroenteritis is a highly infectious diarrhoeal disease caused by rotavirus infecting the small intestines. It causes severe diarrhoea in infants and young children. Infants between three and 12 months of age may die due to severe dehydration. a) How to recognize the disease? Clinical symptoms and signs range from mild loose stools to severe watery diarrhoea and vomiting leading to dehydration. b) How is it spread? The disease spreads by the faecal-to-oral route. It is stable in the environment and can spread via contaminated food, water and objects. c) How is the disease prevented? By vaccinating children with rotavirus vaccine as per the Immunization schedule, we can prevent infection and its complications. Remember to give ORS during any diarrhoea. 13  Immunization Handbook for Health Workers (2018) 2.9 Pneumococcal disease a) What is pneumococcal disease? Pneumococcal disease is a group of diseases caused by a bacterium Streptococcus pneumoniae (also known as pneumococcus). The most serious of these diseases are pneumonia, meningitis, and blood stream infections. Streptococcus pneumoniae is the leading cause of bacterial pneumonia in children under 5 years of age. b) What diseases does pneumococcus cause? Diseases that are often caused by pneumococci include: zz Pneumonia, zz Bacteraemia, sepsis: bloodstream infection, zz Bacterial meningitis: infection of the membranes and fluid that covers and protects the spinal cord and brain zz Middle ear infection (otitis media) zz Sinusitis, Bronchitis c) How is pneumococcal disease spread? Pneumococcus spreads from person to person (coughing, sneezing or close contact). Many people have pneumococcus in their nasopharynx for days or weeks at a time. In most cases the pneumococcus disappears from the nasopharynx without causing any symptoms, but sometimes disease develops. d) Who is at increased risk of pneumococcal disease? Young children and elderly individuals are most at risk. zz The children most at risk of pneumococcal disease are: ™™ Children under 5 years of age, especially those under 2 years of age ™™ Immunocompromised children ™™ Those with influenza or other respiratory virus infections can get a second infection with pneumococcus. ™™ Malnutrition, lack of breastfeeding, exposure to indoor smoke and crowded living conditions. ™™ Poor and marginalized populations with poor access to health care. e) How is the disease prevented? These diseases can be prevented by administering PCV in three doses - 2 primary doses and at 6 & 14 weeks and 1 booster dose at 9 months of age along with MR first dose. 2.10 Measles/Rubella Measles is a highly infectious disease caused by a virus. It is an important cause of death among children who are poorly nourished and live in crowded conditions. Complications include dehydration due to severe diarrhoea, malnutrition, inflammation of middle ear, pneumonia, blindness and encephalitis (brain infection). Rubella is generally a mild disease in children but when infection occurs in early pregnancy, it has the potential to cause spontaneous abortions, fetal deaths, still births and serious congenital defects (congenital rubella syndrome – CRS) in the child causing lifelong disabilities. 14 a) How to recognize the disease? Any person with fever and maculopapular rash, i.e. non-vesicular AND cough, coryza (runny nose), or conjunctivitis (red eyes) Unit 2 b) How is it spread? The virus is spread through nose and throat secretions of infected people and in airborne droplets released when an infected person sneezes or coughs. c) How is the disease prevented? The Measles/Rubella containing vaccine (MR) is effective in preventing measles and should be given according to the immunization schedule. 2.11 Japanese Encephalitis Japanese encephalitis (JE) is an infection of the brain caused by a virus. It is prevalent in certain geographical areas in some of the states. JE is fatal in 20-30% of cases, with young children (less than 10 years) having a greater risk of severe disease and death. a) How to recognize the disease? A person of any age, at any time of the year with acute onset of fever and change in mental status (including symptoms as confusion, disorientation, coma or inability to talk) AND/OR new onset of seizures (excluding simple febrile seizures). b) How is it spread? JE virus is spread by mosquitoes. The virus normally infects birds and domestic animals, especially pigs, which serve as its reservoirs. Humans may contract the disease when a mosquito that has bitten an infected animal then bites a person. c) How is the disease prevented? Following the campaigns targeting all children in the age group of 1-15 years in the high risk districts, the vaccine is integrated into the UIP of the district. Children between 9 months - 2 years are targeted for two doses of JE. 15  Unit 3 Unit 3: National Immunization Schedule and Frequently Asked Questions 17  Immunization Handbook for Health Workers (2018) Unit 3: National Immunization Schedule and Frequently Asked Questions Learning Objectives At the end of the unit, you should be able to: zz List vaccines administered in the National Immunization Programme, the due ages for vaccination, the number of doses along with the site and route of administration. zz Answer the Frequently Asked Questions (FAQs) on the Immunization schedule Contents ¾¾National Immunization Schedule (NIS) ¾¾Frequently Asked Questions (FAQs) on the Immunization schedule The goal of Universal Immunization Programme is to administer vaccines safely to: Pregnant women As early as possible - appropriate TT doses Infants & children At birth - HepB, BCG, OPV Before age 1 year - for Full Immunization ƒƒ 3 doses of OPV, 3 doses of Rotavirus (where applicable), 3 doses of Pentavalent, 2 doses of fractional IPV, 3 doses of PCV (where applicable), MR vacccine -1st dose , JE 1st dose (where applicable) Before age 2 years - for Complete Immunization ƒƒ MR vaccine - 2nd dose, DPT booster, OPV booster, PCV booster (where applicable) and JE - 2nd dose (where applicable) Fig 3.1 Different needle positions for vaccine administration 18 3.1 National Immunization Schedule Table 3.1. National Immunization Schedule for infants, children and pregnant women For Pregnant Women Vaccine Due age Max age Dose Diluent Route Site TT-1 Early in Give as 0.5 ml NO Intra- Upper Arm pregnancy early as muscular Unit 3 possible in pregnancy TT-2* 4 weeks after 0.5 ml NO Intra- Upper Arm TT-1* muscular TT- Booster If received 2 0.5 ml NO Intra- Upper Arm TT doses in muscular a pregnancy within the last 3 years* For Infants Vaccine Due age Max age Dose Diluent Route Site YES (0.05 ml until Manufacturer 1 month) till one year supplied Intra- Upper Arm - BCG At birth 0.1ml of age diluent dermal LEFT Beyond age 1 (Sodium month chloride) Antero- Hepatitis B - within 24 Intra- lateral side At birth 0.5 ml NO Birth dose hours muscular of mid-thigh - LEFT within the OPV-0 At birth first 15 2 drops - Oral Oral days At 6 weeks, till 5 years OPV 1, 2 & 3 10 weeks & 2 drops - Oral Oral of age 14 weeks Pentavalent 1, 2 & 3** Antero- (Diphtheria+ At 6 weeks, 1 year of Intra- lateral side Pertussis + 10 weeks & 0.5 ml NO age muscular of mid-thigh Tetanus + 14 weeks** - LEFT Hepatitis B + Hib) Fractional IPV At 6 & 14 1 year of Intra- Upper Arm (Inactivated 0.1 ml NO weeks age dermal - RIGHT Polio Vaccine) Rotavirus‡ At 6 weeks, (Where 1 year of 10 weeks & 5 drops NO Oral Oral applicable) age 14 weeks At 6 weeks & Pneumococcal 14 weeks Antero- Conjugate At 9 1 year of Intra- lateral side of Vaccine 0.5 ml NO completed age muscular mid-thigh (PCV) (Where months - - RIGHT applicable) booster 19  Immunization Handbook for Health Workers (2018) YES At 9 Measles / Manufacturer completed 5 years of Sub- Upper Arm - Rubella 1st 0.5 ml supplied months-12 age cutaneous RIGHT dose ## diluent months. (Sterile water) YES - Japanese Manufacturer Encephalitis – At 9 supplied 1 @ 15 years of Sub- Upper Arm - months-12 0.5 ml diluent (Where age cutaneous LEFT months@ (Phosphate applicable) Buffer Solution) 5 years of Vitamin A At 9 months age 1 ml - Oral Oral (1st dose) ( 1 lakh IU) For Children Vaccine When to give Max age Dose Diluent Route Site Antero- 16-24 7 years of Intra- lateral side DPT Booster-1 0.5 ml NO months age muscular of mid-thigh – LEFT YES Manufacturer Measles / 16-24 5 years of supplied Sub- Upper Arm - Rubella 2nd 0.5 ml months age diluent cutaneous RIGHT dose ## (Sterile water) 16-24 OPV Booster 5 Years 2 drops NO Oral Oral months YES Japanese Manufacturer Encephalitis – supplied 2@ 16-24 till 15 years Sub- Upper Arm - 0.5 ml diluent (Where months @ of age cutaneous LEFT (Phosphate applicable) Buffer Solution) At 16 Vitamin A $ months. up to the 2 ml (2nd to 9th Then, one age of 5 (2 lakh IU) - Oral Oral dose) dose every 6 years months. 7 Years of Intra- DPT Booster-2 5-6 years 0.5 ml NO Upper Arm age muscular 10 years & Intra- TT 16 Years 0.5 ml NO Upper Arm 16 years muscular * Give TT-2 or Booster doses before 36 weeks of pregnancy. However, give these even if more than 36 weeks have passed. Give TT to a woman in labour, if she has not previously received TT. ** Pentavalent vaccine is introduced in place of DPT and HepB 1, 2 and 3. ‡ Rotavirus vaccine is being introduced in phases. ## MR vaccine introduced in phases replacing measles vaccine in the UIP schedule. If first dose delayed beyond 12 months ensure minimum 1 month gap between 2 MR doses. @ JE Vaccine has been introduced in select endemic districts. If first dose delayed beyond 12 months ensure minimum 3 months gap between 2 JE doses. $ The 2nd to 9th doses of Vitamin A can be administered to children 1-5 years old during biannual rounds, in collaboration with ICDS. ¾¾ Human Papilloma Virus (HPV) Vaccine – presently not in schedule. ¾¾ Td - Tetanus diphtheria to replace TT - to be added in schedule 20 3.2 Frequently Asked Questions on the Immunization schedule a) General queries Why are vaccines administered at specific sites on the body? Vaccines are administered at specific sites on the body to maintain uniformity and for helping you or anyone in checking that the vaccine was given. e.g BCG on left upper arm. Unit 3 Why should there be a minimum gap of 4 weeks between two doses of most vaccines? There should be a minimum of 4 weeks gap between two doses because decreasing the interval between doses may not achieve the needed antibody production to give protection. How long can a bottle of Vitamin A be used, once opened? A Vitamin A bottle, once opened, should be used within 8 weeks. Write the date of opening on the bottle. It is important that the date of opening is clearly written on the bottle. It must be kept away from direct sunlight. What is the dose of Zinc to be used along with ORS in the treatment of diarrhoea? The dose of zinc for infants aged 2–6 months is 10 mg of dispersible tablet in expressed breast milk for 14 days. For children 6 months to 5 years of age, it is 20 mg of dispersible tablet for 14 days. b) Vaccine schedule related queries If a child is brought late for a subsequent dose, should one re-start with the first dose of a vaccine? No, do not restart the schedule again; pick up where the schedule was left off. For example, If a child who has received BCG, penta1 and OPV1 at 5 months of age returns at 11 months of age, then vaccinate the child with penta 2, OPV2 , measles, Rotavirus vaccine (where applicable) and JE (where applicable). If a child who has never been vaccinated is brought in at 9 completed months but before 12 completed months of age, then, can all the due vaccines be given to a child on the same day? Yes, all the due vaccines can be given during the same session but at recommended injection sites, using separate AD syringes. It is safe and effective to give BCG, penta, OPV, IPV, MR, RVV (where applicable), PCV (where applicable) JE (where applicable) vaccines and Vitamin A at the same time to a 9-month-old child who has never been vaccinated. If more than one injection has to be given in one limb then ensure that the distance between the two injection sites is at least 1 inch apart. If a child who has never been vaccinated is brought in immediately after completing 12 months of age, (beyond one year) what vaccines would you give? As per the national immunization schedule this child need not be given – BCG, Hepatitis B, Rotavirus, Penta and IPV. This child should be administered DPT 1, OPV 1, Measles 1, JE 1(if applicable) and also Vitamin A solution. The subsequent doses of DPT and OPV should be given at an interval of 4 weeks. Administer Measles 2, JE 2 (If applicable), Vitamin A and a booster dose of DPT at recommended age as per national immunization schedule. Which vaccines can be given to a child between 1 and 5 years of age who has never been vaccinated? Such a child will not receive BCG, Hepatitis B, Rotavirus, Penta and IPV. Give DPT1, OPV1, measles 1, JE 1 (where applicable) and 2ml of Vitamin A solution. Then follow with the second and third doses of DPT and OPV at 1-month intervals. 21  Immunization Handbook for Health Workers (2018) Give Measles 2 as per the schedule /1 month later*. Give booster dose of OPV/DPT at a minimum of 6 months after administering OPV 3/DPT 3. Also give Vit A at 6 months interval till 5 years of age. *Note: In an unvaccinated child more than 16 months of age remember the interval between Measles 1 and Measles 2 is 4 weeks and for JE 1 and JE 2 (where applicable) the interval is 3 months. Which vaccines can be given to a child between 5 and 7 years of age who has never been vaccinated? Give of DPT 1, 2 and 3 at 1-month intervals. Give booster dose of DPT at a minimum of 6 months after administering DPT 3 up to the age of 7 years. Why are the DPT, HepB (birth dose), IPV and pentavalent vaccines given in the anterolateral mid-thigh and not the gluteal region (buttocks)? This is done to prevent damage to the sciatic nerve. Moreover, vaccine deposited in the fat of the gluteal region does not bring about the appropriate immune response to protect the child. c) BCG Why is BCG given only up to 1 year of age? Most children acquire natural clinical/sub-clinical tuberculosis infection by the age of 1 year. This protects against severe forms of childhood tuberculosis, e.g. TB meningitis and miliary disease. If no scar appears after administering BCG, should one re-vaccinate the child? There is no need to re-vaccinate the child even if there is no scar. Why do we give 0.05 ml dose of BCG to new borns (below 1 month of age)? This is because the skin of newborns is thin and an intra-dermal injection of 0.1 ml may break the skin or penetrate into the deeper tissue and cause local abscess and enlarged axillary lymph nodes. Dose of 0.05 ml is sufficient to elicit adequate protection. d) Hepatitis B What is the “birth dose” of hepatitis B? This refers to the dose given within 24 hours of birth. A child vaccinated with Hep B after more than 24 hours of birth is not considered to have received the birth dose. Why is the birth dose of hepatitis B vaccine given only within 24 hours of birth? The birth dose of hepatitis B vaccine is most effective in preventing peri-natal transmission of hepatitis B only if given within the first 24 hours. Why is hepatitis B vaccine given only till 1 year of age in the UIP schedule? Hepatitis B vaccine is given till 1 year of age because infections during first year of age have a 90% chance of becoming chronic as compared to 30% during 1–5 years and 6% after 5 years. Persons with chronic infection have 15–25% risk of dying prematurely due to HBV related liver cirrhosis and cancer. Adult Hep B vaccination is not part of the UIP. e) Pentavalent vaccine What is pentavalent vaccine? Pentavalent vaccine is a vaccine that contains five antigens (diphtheria + pertussis + tetanus+ hepatitis B + Haemophilus influenzae type b). 22 How is pentavalent vaccine more advantageous? zz The addition of Hib vaccine provides protection against Haemophilus influenzae type b related diseases (bacterial meningitis, pneumonia and others) zz The number of injections administered under UIP during the first year of life reduces. zz It does not require reconstitution. What vaccine will be given to a child who has received at least one dose of pentavalent vaccine Unit 3 before his/her first birthday? If a child has received at least one dose of pentavalent vaccine before his/her first birthday, the child should be administered the due pentavalent doses at a minimum interval of 4 weeks, at the earliest available opportunity. After introduction of pentavalent vaccine, will DPT and Hep B be required? Yes, Hep B birth dose (within 24 hours) for institutional deliveries and DPT boosters at 16–24 months and 5–7 years will continue as before introduction. f) Rotavirus vaccine – Introduced in Feb 2016 – roll out in phases How effective is the Rotavirus vaccine? The available Rotavirus Vaccines are observed to be effective in preventing severe rotavirus diarrhea by 54-60%. The protective effect of Rotavirus vaccine lasts through 2nd year of life. Will vaccination with Rotavirus vaccine prevent all diarrheas? No it does not prevent all diarrheas. Diarrhea is caused by many organisms of which Rotavirus is one of the leading causes for diarrhea in children. Rotavirus vaccine is effective in preventing diarrhea due to Rotavirus only. So the child may still get diarrhea due to other germs and causes even after receiving Rotavirus vaccine. What is the maximum age limit for giving the first dose of Rotavirus vaccine? The upper age limit for the first dose of Rotavirus vaccine is one year of age. If a child has received only the first dose of Rotavirus vaccine by 12 months of age, two more doses of the vaccine should be given at an interval of 4 weeks between the two doses to complete the course. Is a booster dose required for Rotavirus vaccine? No booster dose of Rotavirus vaccine is recommended. Only three doses at 6, 10 and 14 weeks are required to complete the schedule of vaccination for a child. Should Rotavirus vaccine be given to children who have already received first dose of OPV and Pentavalent vaccine? No, during the initial period of Rotavirus vaccine introduction, only the infants coming for the first dose of OPV and pentavalent vaccine will be administered Rotavirus vaccine. These children will be given 2nd and 3rd doses in subsequent visits as per the schedule. Infants, who are coming for their second or third dose of OPV and pentavalent vaccine, will complete the schedule with OPV and pentavalent vaccine only. Rotavirus vaccine is not to be started with second or third dose of OPV and Pentavalent vaccine. What should be done if a child has received one or two doses of Rotavirus vaccine in a private facility? If the parents want to vaccinate their child from the public sector after receiving one or two doses of Rotavirus vaccine in a private facility, a new course of Rotavirus vaccine must be started with all three doses at one month intervals provided the child is less than one year old. 23  Immunization Handbook for Health Workers (2018) g) Inactivated Poliovirus vaccine What is IPV? IPV refers to Inactivated Polio Vaccine administered by injection. Evidence suggests that this vaccine, when used along with OPV, increases the protection to the individual as well as the community. IPV together with OPV prevents re-emergence and reinfection of wild poliovirus (WPV). Will IPV (injection) replace OPV (drops)? No, IPV (injection) will not replace OPV (polio drops), since IPV is recommended for administration in addition to OPV. Is it safe to give IPV and OPV together? Yes, it is absolutely safe to give IPV and OPV together. It is also important – and best – for a child to receive both IPV and OPV. Together, these two vaccines provide safe and strong protection against polio. If a child only receives one of the vaccines it will not be as well protected as the child that has received both the vaccines. Primary doses of OPV (OPV1, OPV2 and OPV 3) should be completed as per schedule. When is IPV to be administered? IPV has to be administered as a two-dose fractional intradermal schedule at 6 & 14 weeks. How should you vaccinate if a child has not received the vaccine at 6th week? If missed, the Fractional IPV 1st dose should be given as early as possible after the 6th week. The 2nd dose must be given with 8 weeks interval. h) Measles / Rubella What are Measles / Rubella diseases? Measles is a highly infectious disease causing illness and death due to complications in the form of diarrhea, pneumonia or brain infection mostly among the children less than five years of age. Rubella is a mild disease but when infection occurs in early pregnancy, it has the potential to cause spontaneous abortions, fetal deaths, still births and serious congenital defects in the child causing lifelong disabilities. What is CRS? CRS, (Congenital Rubella syndrome) is a set of serious congenital defects a child may be born with when a pregnant women gets Rubella infection in early pregnancy , causing blindness, deafness, heart defects, mental retardation, liver disorders and other hematological disorder, incompatible with normal living. Why is Measles-Rubella vaccine given? This Measles –Rubella vaccine is given for preventing both measles and rubella disease in the child, as these diseases can be only prevented by vaccination. Does a child need to be vaccinated if she or he has history of any fever-rash illness including measles or rubella disease? Yes, every child must be vaccinated with two doses, as per the national immunization schedule with MR vaccine at the recommended ages, irrespective of any past fever-rash illness or measles/rubella disease. 24 If a child has received the Measles Rubella vaccine before 9 months of age, is it necessary to repeat the vaccine later? Yes, the Measles Rubella vaccine needs to be administered, according to the National Immunization Schedule, after the completion of 9 months until 12 months of age as 1st dose and at 16-24 months as 2nd dose in RI. If a child comes after 2 years for the first dose, then can he/she get the second dose? All efforts should be made to immunize all children at the right age i.e. first dose at completed 9 Unit 3 months to 12 months and second dose at 16-24 months. However if a child comes late (beyond 2 years),then two doses of the vaccine can be given at one month interval until 5 years of age under UIP. If a child has received all vaccines as per the national immunization schedule, dose she or he need to be vaccinated during supplementary MR campaigns? Yes, in addition to the recommended national immunization schedule the child (if eligible as per age group targeted) must be vaccinated with supplementary MR vaccines during campaigns. As measles and JE vaccine doses are recommended for the same age group, can they be given together? Yes, two live injectable vaccines can be administered simultaneously at different sites. Remember – if two live injectable vaccines are not given together as per schedule there must be a minimum interval of 28 days. i) Japanese Encephalitis What if someone misses receiving JE vaccine during catch-up campaigns? Those children aged 9 months to 15 years who have missed receiving JE vaccine during the catch-up campaigns can receive it at the nearest PHC/CHC or district hospital. If a child more than 9 months but less than 24 months who has never received any JE vaccine comes for immunization, how should JE vaccine be administered? The first dose should be given at first contact and the second dose should be given with an interval of 3 months following the first dose. J ) Pneumococcal Conjugate Vaccine (PCV) What should be done if a PCV dose is delayed? The two primary doses and one booster dose of PCV should be given during the first year of life. If the doses are delayed within the first year, Doses (both primary and booster) must be separated by a minimum interval of at least 2 months, to be given at the next scheduled immunization visit. In delayed cases beyond 1 year of age, due doses can be given to a child only if a child has received at least one dose of PCV before his/her first birthday. For those with at least one previous PCV dose, the series should be completed at the earliest available opportunity. Can only two PCV doses be given? No, two PCV doses are not sufficient to confer long lasting immunity, especially for protecting against pneumococcal colonization which is essential for the full public health benefit. 25  Immunization Handbook for Health Workers (2018) The benefit of the PCV booster dose is not only in providing additional duration of immunity against pneumocococcal disease, but it also serves to reduce carriage, thus having an indirect benefit for the other community members. Can PCV be given to a sick child? Yes, PCV can be safely administered to a child with immunodeficiency (e.g., HIV/AIDS, congenital or acquired immunodeficiency, sickle cell disease), malnutrition, or other underlying illnesses, using the same schedule as for any other child. These children are in particular need of PCV because their risk of pneumococcal disease is high. Children with mild acute illnesses can and should be immunized with PCV on time Are there any contraindications for use of PCV? The pneumococcal vaccine should not be given to the following persons: zz those who have had severe allergic reactions to a prior dose. zz those who are known to have had a severe reaction to another vaccine containing diphtheria toxoid. zz those who have a severe illness; vaccination should be delayed until the condition improves in part so as to not mistakenly attribute any clinical changes with the vaccination. 26  Immunization Handbook for Health Workers (2018) SOPs for using RI Form 9 This format collates the exact requirement of vaccines and logistics for each session site. This information is calculated using data from Form 8. Columns A and B should be in the same order as in Form 8. Columns C through L: Enter the number of vials/units of vaccine and vit A required for each session site. For the calculations, use the information from columns mentioned from Form 8 for each session site. Columns M, N and O: Calculate the requirement of syringes including reconstitution syringes. Calculation is based on the number of vials from Columns C to K of this format. Remember –Calculate reconstitution syringes only for BCG, measles/MR and JE. All wastage multiplication factors are given in the row below the names of antigens. Columns P to U: Enter the requirement of other logistics for each session site. Wastage multiplication factor (WMF) – This is for use in estimation of vaccine and logistics. It is calculated using the following equation: 100 divided by [100 – (wastage rate %)] E.g. if wastage rate is 15 %, then WMF is 100/ [100-15] 100/85 = 1.18 Permissible wastage rate percentage Number of doses Permissible wastage % WMF Hep B 1 10 1.11 BCG 1 50 2 DPT 2 booster 10 1.11 OPV 3+2 booster 10 1.11 Rotavirus 3 25 1.33 IPV 1 10 1.11 Pentavalent 3 10 1.11 MR 2 25 1.33 PCV 3 10 1.11 TT 2 10 1.11 JE 2 25 1.33 Syringes As per requirement 10 1.11 58  Immunization Handbook for Health Workers (2018) Unit 5: Managing the cold chain and the vaccine carrier Learning Objectives At the end of the unit, you should be able to: zz Define and describe the importance of the cold chain zz Describe which vaccines are sensitive to heat /light and freezing zz Demonstrate how to check vaccines for exposure to heat or freezing zz Demonstrate how to condition frozen ice packs and how to pack a vaccine carrier properly Contents ¾¾Cold chain and Vaccine Sensitivities ¾¾Checking vaccines for correct maintenance of cold chain ¾¾Guidelines for use of open vaccine vials in immunization programme ¾¾Cold chain equipment 5.1 The cold chain Cold Chain is a system of storing and transporting vaccines at recommended temperatures from the point of manufacture to the point of use. The key elements of the cold chain are: zz Personnel: to manage vaccine storage and distribution (vaccine and cold chain handler at each cold chain point). zz Equipment: to store and transport vaccine and monitor temperature. zz Procedures: to ensure correct utilization of equipment and ensure vaccines are stored and transported safely. As a health worker, you are responsible to manage the cold chain at the session site and sometimes at the cold chain point also. 5.2 Vaccine sensitivities Vaccines lose their potency due to exposure to heat (temperature above +8°C), cold (temperature below + 2°C) and light. The loss of potency due to either exposure to heat or cold is permanent and cannot be regained. Reconstituted BCG, measles/MR and JE vaccines are the most heat and light sensitive. Since these live vaccines do not contain preservatives, there is risk of contamination with staphylococcus aureus leading to toxic shock syndrome and, therefore, they should be used within 4 hours of reconstitution. These light sensitive vaccines are supplied in amber-coloured vials. Implementation of Open Vial Policy (OVP) allows reuse of partially used multi-dose vials of applicable vaccines under the UIP in subsequent sessions (both fixed and outreach) up to 4 weeks (28 days) subject to meeting certain conditions. This policy contributes to the reduction of vaccine wastage. (See guidelines under section 5.4) 68  Open Vial Policy YES NO VACCINE Hep B, OPV, DPT, pentavalent, TT, PCV and IPV. BCG, MR, RVV, JE Only those diluents that are provided with the vaccine by the manufacturer should be used. Keep diluents in an ILR at +2°C to +8°C at least 24 hours before use to ensure that the vaccine and diluent are at the same temperature when being reconstituted. Keep diluents with the vaccines in plastic zipper bag inside the vaccine carrier during transportation. Sensitivity of various vaccines to heat, light and freezing is given in Table 5.1. Table 5.1 Sensitivity of vaccines to heat, light and freezing Vaccine Exposure to heat/light Exposure to cold Heat and light sensitive vaccines OPV Sensitive to heat Not damaged by freezing Measles/MR Sensitive to heat and light Not damaged by freezing BCG, RVV and JE Relatively heat stable, but sensitive to light Not damaged by freezing. Unit 5 Freeze sensitive vaccines HepB/Penta/PCV Relatively heat stable Freezes at -0.5°C (Should not be frozen) IPV, DPT and TT Relatively heat stable Freezes at -3°C (Should not be frozen) At the PHC level, all vaccines are kept in the ILR for a period of one month at temperature of +2°C to +8°C Vaccines sensitive to heat Vaccines sensitive to freezing zz BCG (after reconstitution) Most zz HepB Most zz OPV zz PCV zz IPV zz Penta zz Measles, MR zz IPV zz Rotavirus zz DPT zz JE zz TT zz DPT zz BCG (before reconstitution) zz TT, zz Penta, HepB, PCV Least Least 5.3 Checking vaccines for correct maintenance of cold chain Vaccines need to be checked both for damage from excessive heat as well as from freezing. However, the physical appearance of a vaccine may remain unchanged even after it is damaged. Checking vaccines for heat damage Vaccine Vial Monitor (VVM) is a label containing a heat sensitive material to record cumulative heat exposure over time. The combined effect of time and temperature cause the inner square of the VVM to darken gradually and irreversibly. Before opening a vial, check the status of the VVM (Figure 5.1). If the VVM shows change in colour to the end point, then discard the vaccines. 69  Immunization Handbook for Health Workers (2018) Fig. 5.1 Checking the vaccines for heat damage Checking vaccines for cold damage (freezing) DPT, TT, IPV, HepB, PCV and Penta vaccines lose their potency if frozen. Moreover, the risk of adverse events following immunization, such as sterile abscesses, may increase. Discard the vial if it is frozen or it contains floccules after shaking. Shake Test is not applicable for IPV Shake test - Test vial zz Take a vaccine vial you suspect that may have been frozen – This is “TEST” vial. Shake test - Control vial zz Take a vaccine vial of the same antigen, same manufacturer, and same batch number as the suspect vaccine vial you want to test. zz Freeze solid this vial at -20°C overnight in the DF, and this is the ‘CONTROL’ vial and label accordingly to avoid its usage. zz Let it thaw. Do NOT heat it. zz Hold the Control and the Test vials together between thumb and forefinger, and vigorously shake the vials for 10-15 seconds. zz Place both vials to rest on a flat surface, side-by-side and observe them for 30 minutes. zz Compare for rate of sedimentation. zz If the sedimentation rate in the ‘Test vial” is slower than in the “Frozen vial”, the vaccine has not been damaged, it has passed the shake test. Use the vaccine batch – it is not damaged. zz If the sedimentation rate is similar in both vials or if sedimentation is faster in the “Test” vial than in the “Frozen” vial, the vaccine is damaged, it failed in shake test. Do NOT use. Notify your supervisor. 70  Fig. 4.10: Shake Test Passed - Fig. 4.11: Shake Test Failed - Vaccine usable Do not use Vaccine Control Vial Test Vial Control Vial Test Vial Sedimentation Vaccines returned from RI session should be kept in separate and clearly marked bags/containers as per the guidelines Vials that are expired, frozen or with VVM beyond the end point, should not be placed Unit 5 in the cold chain as they may be confused with those containing potent vaccines. Vials from suspected AEFI cases must be clearly marked in seperate bags / containers. Table 5.2. Dos and Dont’s in cold chain and vaccine sensitivities Dos Dont’s zz Keep all vaccines in ILR at +2°C to +8°C at PHC zz Do not keep in the cold chain: zz Use diluent provided by the manufacturer with {{ Expired vials, the vaccine {{ Frozen vials or zz Keep diluents in ILR at +2°C to +8°C at least 24 {{ Vials with VVM beyond the end point hours before use zz Do not use Rotavirus vaccine or reconstituted zz Use reconstituted Rotavirus vaccine, BCG, BCG, JE and Measles/MR vaccines after 4 hours. Measles/MR and JE vaccine within 4 hours zz Do not dispose damaged or empty vials in the zz Discard all damaged vials for disinfection and village or surroundings of the session site. disposal 5.4 Guidelines for use of open vaccine vials in immunization programme Open Vial Policy is only applicable to DPT, TT, Hep B, OPV, Hib containing pentavalent vaccine (Penta), PCV and injectable inactivated poliovirus vaccine (IPV). Conditions that must be fulfilled for the use of open vial policy Any vial of the applicable vaccines opened/used in a session (fixed or outreach) can be used at more than one immunization session up to 4 weeks (28 days) provided that: Use if- zz The expiry date has not passed; zz The vaccines are stored under appropriate cold-chain conditions both during transportation and storage in cold-chain storage point; zz The vaccine vial septum has not been submerged in water or contaminated in any way; zz Aseptic technique has been used to withdraw vaccine doses, i.e. needle/septum has not been contaminated in any way; 71  Immunization Handbook for Health Workers (2018) zz The VVM has not reached/crossed the discard point. zz Date and time is written on vial Mark for discard or disposal any vaccine vial in case any one of the following conditions are met: zz Expiry date has passed; zz VVM has reached/crossed discard point (for freeze-dried vaccine, before reconstitution only) or vaccine vials without VVM or disfigured VVM; zz No label/partially torn label and/or writing on label not legible; zz If date and time is not mentioned on vial zz Any vial thought to be exposed to non-sterile procedure for withdrawal; zz Open vials that have been under water or vials removed from a vaccine carrier that has water; zz Vaccine vial is frozen or contains floccules or any foreign body; zz There is breakage in the continuity of the vials (cracks/leaks); zz There is any AEFI from any of the vials; if so, do not use it, and retain it safely. Inform MO and/ or supervisor. zz Open Vial Policy does not apply to measles/MR, Rotavirus, BCG and JE vaccines. Cold-chain maintenance during vaccine distribution zz Maintain temperature of ILR between +2°C and +8°C for storage of vaccines and diluents. Monitor temperature twice daily regularly including on Sundays/holidays. zz Note the name of the manufacturer, batch number and expiry date of the vaccine and diluent in the stock register. zz Ensure proper recording and reporting of vaccine distribution and usage. zz Keep stock up to date, do not over-stock or under-stock vaccines and diluents. zz Multi-dose vials from which at least one dose has been removed may be at risk of contamination of the vial septum. Never allow these vials to be submerged in water (from melted ice for example) to keep the septum clean and dry. Note: Well-sealed conditioned and wiped clean ice packs should be used in vaccine carriers and water should not be allowed to accumulate where the vials are stored. Vaccine vials must be transported in properly locked plastic zipper bag. zz Keep the “returned, partially used” vials in a separate box and label these clearly. zz Observe EARLY EXPIRY FIRST OUT (EEFO) policy for issuing vaccines. If the vaccines are of same expiry date, the partially used vaccine vials should be re-issued. The vial opened earlier, as recorded on the label of the vial, should be issued first. zz Contingency plan or emergency vaccine storage plan has to be in place in case of any emergencies such as power failure, equipment breakdown, etc. 5.5 Cold chain equipment Cold chain equipment, both electrical and non-electrical, is used for storing vaccines and/or transporting them at appropriate temperatures. ILR point or Cold Chain point: An ILR or cold chain point is any centre (PHC or CHC) with an Ice Lined Refrigerator for storage of vaccines and a Deep Freezer for preparation of frozen ice packs. There is usually a generator as power back up. The function of the ILR point is to receive, store and further distribute vaccines, diluents and other logistics to another ILR point or directly to the session sites. 72 Ice Lined Refrigerator (ILR): maintains a cabinet temperature between +2°C to +8°C; is used to store UIP vaccines at the PHC and district. ILR with top opening lid prevents loss of cold air during door opening; can keep vaccines safe with as little as 8 hours electricity supply in a 24-hour period. Fig. 5.2 Storing vaccines in the ILR NEVER keep any vials that are expired, frozen or with VVMs beyond the end point in the cold chain, as they may be confused Unit 5 with those containing potent vaccines. Keep them in the red bag for disinfection and disposal. IDENTIFY A DRY SPACE FOR STORING EXPIRED/UNUSABLE VACCINES BEFORE FINAL DISPOSAL In case basket is not available, two layers of empty ice packs can be laid flat on the bottom of the ILR to avoid contact with the inside floor of the cabinet; Vaccines should never be kept on the floor of the ILR. Table 5.3. Dos and Dont’s for ILR use Dos Dont’s zz Keep all vaccines including those returned under zz Do not store any other drugs/Non-UIP vaccines open vial policy, in the basket supplied along in the ILR. with the ILR. zz Do not open the ILR frequently zz Store diluents at +2°C to +8°C at least 24 hours zz Do not keep food or drinking water before use zz Do not keep vaccines, which have expired and zz Leave space in between the vaccine boxes. have crossed the discard point of VVM. zz Place a thermometer in the basket in between zz Do not disturb the thermostat setting unless the vaccines. needed. zz Keep freeze sensitive vaccines at the top of the zz Do not place heavy weight on ILR. basket. zz Do not store excess stock of vaccines i.e. more zz Keep heat sensitive vaccines in the bottom of the than the maximum stock. basket. zz Do not store any reconstituted vaccine vials. zz Arrange vaccines as per their expiry dates. (Early expiry should be above the further expiry ones). 73  Immunization Handbook for Health Workers (2018) Deep Freezer (DF): maintains cabinet temperature between -15°C to -25°C. Unlike the ILR the DF has little or limited holdover time, depending on the number of frozen icepacks in it and the frequency of opening. At the PHC level, Deep freezer is used only for preparation of icepacks. Fig. 5.3 Freezing Ice-packs in Deep Freezer Fig. 5.4 Brick Layered ice packs in deep freezer Table 5.4 Dos and Dont’s for DF use Dos Dont’s zz Use DF only for preparation of icepacks at the zz Do not keep any vaccine in the DF at subdistrict sub-district level cold chain points (PHC / CHC / level. Sub-Centre) zz Never keep diluents in the deep freezer. Voltage Stabilizer: electronic equipment that ensures a constant output voltage of 220 Volts, whatever the input voltage, thus safeguards equipment from excessive voltage variation. Each ILR or DF should be connected to the mains through its own independent voltage stabilizer with proper earthing. Cold Box: an insulated box, used for Fig. 5.5 Packing a cold box transportation and emergency storage of vaccines and icepacks. It is available in 2 sizes, large and small. It is used to: zz Collect and transport large quantities of vaccines. zz Store vaccines for transfer up to five days, if necessary for outreach sessions or when there is power cut. zz Store vaccines in case of breakdown of ILR as a contingency measure. zz Also used for storing frozen icepacks, e.g. during emergency and before campaigns. Packing a cold box: zz Place conditioned icepacks at the bottom and sides of the cold box. zz Load the vaccines in cardboard cartons or polythene bags. zz Never place freeze sensitive vaccines in direct contact with the icepacks. Surround them with OPV/BCG/JE vaccines. zz Keep a thermometer in the cold box. 74 zz Place 2 rows of conditioned icepacks above the vaccine vials. zz Place plastic sheet to cover the icepacks kept on top to ensure full hold over time. zz Securely close the lid of the cold box. zz Do not open the cold box unless needed. Vaccine Carrier: It is an insulated box used for carrying vaccines (16-20 vials) and diluents from PHC/Cold chain point to session sites and to bring back the open vials (under the open vial policy) from the session sites to the cold-chain point on same day after the session for storage and subsequent use. Vaccine carrier (with 4 conditioned icepacks) maintains the inside temperature between +2°C to +8°C for 12 hours, if not opened frequently. Packing a vaccine carrier: zz Confirm that there are no cracks in the walls of the vaccine carrier. zz Take out the required number of icepacks from the deep freezer. zz Keep them out side for conditioning and wiped them dry before placing into carrier. zz Place four conditioned icepacks into the vaccine carrier along the sides. Wrap vaccine vials and diluent ampoules in thick paper (e.g. plain white paper) before putting Unit 5 zz in polythene bag so as to prevent them from touching the icepacks. Place some packing material between `T’ series vaccine and the icepacks to prevent them from touching the icepacks. zz Place the plastic bag in the centre away from the icepacks. zz Place foam pad on top of the icepacks. zz If more than one vaccine carrier is being carried, keep the whole range of the vaccines required for the day’s use in each carrier so that only one carrier is opened at a time. Fig. 5.6 Correct packing of the Vaccine Carrier 1 2 Prepare Ice-Packs for Freezing Condition frozen Ice-Packs n Fill the Ice-Packs with n Place frozen Ice-Packs in water to mark. Check the open till there is liquid water level before every water inside the ice packs use. Do NOT add salt to n Check if an Ice-Pack is this water conditioned, by shaking it n Fit the stopper and screw and listening for movement on the cap tightly of ice inside the ice pack n Make sure the Ice-Pack n Unconditioned Ice-Packs does not leak may DAMAGES freeze n Wipe the Ice-Pack dry sensitive vaccines (DPT, TT, and place in the Deep IPV, Penta, PCV and HepB) Freezer 3 Pack the Vaccine Carrier n Place four conditioned Ice-Packs against the sides of the carrier n Place the plastic bag containing all vaccines and diluents in the centre of the carrier Place foam pad at the top of Ice packs 75  Immunization Handbook for Health Workers (2018) Table 5.5 Dos and Dont’s in using a vaccine carrier Dos Dont’s zz Place vaccines & diluents in cartons or polythene zz Never use day carriers, which contain 2 icepacks bags to ensure labels are protected. or thermos flasks for routine immunization. zz Use well-sealed conditioned icepacks in the zz Never use any screwdriver or any other sharp vaccine carrier. shaft to open the lid of vaccine carrier. zz Ensure collection of vaccines in the vaccine zz Do not drop, knock or sit on the vaccine carrier. carrier on the session day itself. zz Do not leave the vaccine carrier in the sunlight. zz Close the lid tightly and securely. zz Do not leave the lid open once packed. zz Keep the interior of the vaccine carrier clean and dry after every use. Icepacks: are plastic containers filled with water. These are hard frozen in the deep freezer. They are placed inside a vaccine carrier and cold box to improve and maintain the holdover time; also used in ILR as inside lining to improve & maintain holdover time during electricity failure. About 20-25 icepacks (8-10 Kg. Ice) and 35-40 icepacks (12-14 Kg. Ice) can be frozen in one day in small and large deep freezers respectively. Standard icepacks used in UIP for cold box and vaccine carrier are of 0.4 litre capacity. Table 5.6 Dos and Dont’s in using icepacks Dos Dont’s zz Fill water only up to the level mark on the side zz Do not use icepacks that are cracked and to leave 10mm room for expansion as water are without cap Space for air freezes. or cork. Max water level zz While filling, keep the ice pack vertically up zz Do not use icepacks Cap & Cork wards under the tap so that it will overflow after with leakage; reaching the desired level. discard them. zz Fit the stopper and screw on the cap tight. zz Never add salt to zz Check and ensure that icepack does not leak. the water as it lowers the zz Clean the outer surface of icepacks with dry temperature to cloth before putting into the deep freezer. sub-zero level, zz Keep icepacks horizontally (not flat) in a ciss- which is not cross manner in DF. recommended. zz Keep gap / breathing space between icepacks for zz Do not refill freezing to be faster & uniform. icepack every time zz Ensure that icepacks are frozen ROCK solid. before use, same water can be used Reconstituted BCG and Measles vial repeatedly. Conditioning of frozen Icepacks: Icepacks come out of the freezer at a temperature of about -20°C. They need to be kept at room temperature f