AN INTRODUCTION TO THE COLD CHAIN

VERSION 1.1 1999

PREFACE
This guideline is a supplement to the MSF Holland Logistic Guideline, published in Amsterdam. It deals with Cold Chain Management. You are kindly invited to send all your comments and recommendations about the contents and set-up of this guideline to the Field Support Unit, Amsterdam. 1999 Field Support Unit Amsterdam June 1999

Other Guidelines published by the FSU

A practical Format Guide for Logistic Reporting - Co-days Edition Communication Guideline - 2nd Edition Drug Purchase Policy - 1st Edition Energy Guideline - 1st Edition Logadmin Kit - 2.0 for Windows 3.1x Logadmin Kit - 3.0 for Windows NT Logistic Management of Drug Distribution Programmes - 2nd Edition Logistics in Perspective - Workshop Edition Monitoring & Evaluating Logistics - 2nd Edition Order Management - 5th edition Satellite Voice/Data or Inmarsat Mini-M - Revised 2nd Edition Stock & Warehouse Management - 4th Edition Transport & Freight Management - 4th Edition

TABLE OF CONTENTS
1. Vaccines And How To Look After Them............................................5 1.1 Immunity............................................................................5 1.2 The Six Target Diseases...........................................................5 1.3 What Vaccines Are Made Of......................................................6 1.4 What Damages Vaccines..........................................................7 1.4.1 Heat, Sunlight And Freezing................................................7 1.4.2 Chemicals - Disinfectants, Antiseptics, Spirit, Detergents And Soap 7 1.5 Temperature.......................................................................8 1.6 The Live Vaccines.................................................................8 1.6.1 Polio Vaccine..................................................................8 1.6.2 Measles Vaccine..............................................................9 1.6.3 Bcg Vaccine...................................................................9 1.7 The Killed Vaccines..............................................................10 1.7.1 Diphtheria Toxoid...........................................................10 1.7.2 Pertussis Vaccine............................................................10 1.7.3 Tetanus Toxoid..............................................................10 1.7.4 Damages......................................................................11 1.8 The Cold Chain...................................................................12 1.9 In A Refrigerator.................................................................12 1.10 Checking The Temperature...................................................13 2. Waste Disposal........................................................................16 3. Vaccine Storage And Handling Checklist..........................................17 4. Main Vaccines.........................................................................18 4.1 Calculating Vaccine Requirements...........................................19 4.1.1 EPI (Expanded Programme on Immunisation)...........................19 4.1.2 Vaccination Campaigns....................................................20 4.2 Calculating Parenteral Supplies (I.E. Syringes And needles)............21 4.3 Calculating Cold Storage Space Requirements..............................22 4.4 Calculating Ice Pack Requirements...........................................22 4.5 MSF Vaccination Kit..............................................................23 5. Winterisation Of The Cold Chain ...............................................24 5.1 Introduction.......................................................................24 5.1.1 Vaccines......................................................................24 5.1.2 Refrigerators.................................................................24 5.1.3 Power Cuts...................................................................25 6. The WHO (World Health Organisation) Policy ...................................27 7. Colour Coding Of Vaccine Vials ..................................................29 8. A Mini Size Data Logger.............................................................30 9. A Bit Of Theory On (US Oriented) Immunisation................................31

9.1 Why Immunize?...................................................................31 9.2 What Immunisations, When And Whom To Immunise......................32 10. Recommended Immunization Schedule.........................................34 11. Introduction To The MSF PEP (Post Exposure Profylaxis) Guideline........35 11.1 Risk Of Health Care Workers For Infection With HIV, HBV and HVC....35 12. How It Works......................................................................37 12.1 Refrigeration....................................................................37 12.1.1 Compression System ......................................................37 12.1.2 Absorption System ........................................................38 12.1.3 Refrigerants ................................................................38 12.1.4 Refrigerants And The Environment ....................................39 13. Immunisation & Cold Chain Glossary............................................41

1.Vaccines And How To Look After Them...

1.1 Immunity
If you have had measles, you cannot have it again. You have become immune to measles. When you have an infection, your body learns to make antibodies against the micro-organism (virus or bacteria) that causes the infection. The antibodies kill the organism and prevent it from growing again . The antibodies work only against that particular infection, not against others. For the first few months of its life, a baby is protected against many infections by its mother's antibodies. These come from the mother's blood and cross the placenta into the baby's body before birth. There are also antibodies in breast milk, especially in colostrum (the first breast milk), which help to protect a baby against diarrhoea and other infections. At birth the baby begins to make its own antibodies.

1.2 The Six Target Diseases

There are six important diseases that are very serious, and which can kill or disable many children - even though other children survive and become immune. These six diseases are: Poliomyelitis Measles Diphtheria Pertussis (whooping cough) Tetanus Tuberculosis (TB).

They can be prevented by immunisation. To immunise a person, you give a vaccine - that is, a weakened or killed form of the same micro-organism which causes the disease. The vaccine makes the child's/person's body produce antibodies, but will not cause the disease.

The child/person becomes immune, without becoming ill. Vaccines are given by injection or by mouth. The Expanded Programme on Immunisation aims to immunise all children against these six diseases before their first birthday. In 1974, when the Expanded Programme on Immunisation (EPI) was launched by the World Health Organisation (WHO), less than 5% of the worlds children were immunised against the initial six target diseases diphtheria, tetanus, whooping cough, polio, measles and tuberculosis during their first year of life. By 1990 almost 80% of the 130 million children born each year were immunised before their first birthday. Within two decades the EPI was preventing the deaths of at least 3 million children a year. In addition, at least 750.00 fewer children were blinded, crippled, mentally retarded or otherwise disabled. Other vaccines you may encounter when working in MSFs projects: Hepatitis A Hepatitis B Yellow fever Typhoid fever Rabies Meningococcal meningitis Japanese encephalitis

1.3 What Vaccines Are Made Of

Manufacturers make vaccines from micro-organisms similar to the ones that cause disease, or from the toxins (poisons) that bacteria produce. But the micro-organisms or toxins must be changed so that they cannot harm people. Manufacturers can use: KILLED micro-organisms, pertussis in DPT (=Diphtheria Pertussis Tetanus vaccine) see: 1.7 The killed vaccines LIVE micro-organisms that are attenuated, that is made weak (measles, polio and tuberculosis).

 TOXOIDS, which are inactivated harmless toxins (tetanus toxoid: TT and diphtheria toxoid: DT)

1.4 What Damages Vaccines

You can easily damage vaccines if you do not look after them carefully. If a vaccine is in good condition, and able to make a child immune, it is POTENT . If a vaccine is damaged, and not able to make a child immune, then it has LOST ITS POTENCY. All vaccines lose their potency after a certain time, even with good care. Vaccines have an EXPIRY DATE printed on the label. After that date, the vaccine has lost much or all of its potency, even if it has been looked after carefully. 1.4.1 Heat, Sunlight And Freezing Heat and sunlight damage all vaccines - but especially polio, measles and BCG (=TB vaccine). Freezing damages DPT, tetanus toxoid, Japanese encephalitis, and hepatitis vaccines. The safest thing to do is to keep ALL vaccines at the correct low temperature and out of sunlight. If a vaccine is damaged by heat, sunlight or freezing, you cannot make it potent again. It does not help to put the vaccine back at the correct temperature or in the dark after the damage is done. Discard the vaccine, destroy it by incineration and bury the remains. 1.4.2 Chemicals - Disinfectants, Antiseptics, Spirit, Detergents And Soap Disinfectants and antiseptics will kill unwanted micro-organisms. We use spirit, detergents and soap to clean. These chemicals can damage vaccines. If you clean or sterilise instruments in a chemical, some of the chemical may remain on the instruments. If there is any chemical on a syringe or needle, it can damage a vaccine. To sterilise immunisation equipment, one must use HEAT (steam or boiling water).

If syringes and needles have been in contact with disinfectants, antiseptics, spirit, detergent or soap, WASH THEM VERY THOROUGHLY and sterilise them with steam or boiling water before use.

1.5 Temperature
Water changes into ice at zero degrees centigrade (0C). Eutectic icepacks have a different colour: green or blue (they are not filled with water but with a special liquid) and may be still liquid at -4C. This is dangerous for DTP vaccine, which is not to be frozen. Do not use these icepacks! The correct temperature to store vaccines in a health centre is between +2C and +8C, which in the tropics can only be found in a refrigerator. There is a safety margin, so dont throw away your vaccines when the temperature has been lower than 2 but not lower than 0C or higher than 8 but not higher than 12 for longer than a week. When in doubt consult your technical/medical dept, or local UNICEF expert.

1.6 The Live Vaccines

Polio Measles BCG 1.6.1 Polio Vaccine The micro-organism which causes polio is a virus. The vaccine that most countries use is made from a LIVE ATTENUATED (= weakened) VIRUS. Polio vaccine is a clear pink or pale orange liquid. It comes in a special small bottle with a dropper cap to give measured drops of polio vaccine. Polio vaccine is given ORALLY: Put two drops of vaccine straight from the bottle into the child's mouth. Oral polio vaccine (OPV) is damaged very quickly by heat. It is more easily damaged by heat than other vaccines. But OPV is not damaged by freezing - it can be frozen and refrozen without damage.

Some countries use a KILLED VIRUS polio vaccine which you give by injection (IPV= injectable polio vaccine). 1.6.2 Measles Vaccine The micro-organism that causes measles is a virus. Measles vaccine is made from LIVE ATTENUATED VIRUS. The vaccine comes as a lump of dry material at the bottom of a vial. It is freeze-dried. To use the vaccine, you must mix the dry vaccine with diluent water for injection (= reconstituting the vaccine). You give the reconstituted vaccine by injection. Measles vaccine is easily damaged by heat. The dry vaccine stays potent for a long time if you keep it cold. The dry vaccine is not damaged by freezing - it can be frozen and refrozen without damage. Reconstituted vaccine loses its potency very quickly, even if it is cold. It must be used it in the same immunisation session or discarded. 1.6.3 Bcg Vaccine BCG vaccine protects against tuberculosis (TB). It is made from a special weak but living kind of mycobacterium, (called B acillus C almette G urin). BCG is a LIVE BACTERIAL VACCINE. BCG is freeze-dried, like measles vaccine. BCG comes as a dry powder in the container/vial. Before you can use BCG, you must reconstitute the dry vaccine with diluent water. You inject reconstituted BCG into the top layers of the skin = intradermal. BCG is damaged most easily by sunlight. The containers are usually made of dark glass. Heat damages BCG, but not as quickly as it damages measles and polio vaccines. The dry vaccine stays potent for a long time if you keep it cold.

Dry vaccine is not damaged by freezing - it can be frozen and refrozen without damage. Reconstituted vaccine loses its potency more quickly. Because the diluent does not contain a preservative, bacteria may grow in it. You must use it in the same immunisation session, or discard it.

1.7 The Killed Vaccines

Diphtheria Pertussis Tetanus Dpt Vaccine DPT vaccine contains diphtheria toxoid, pertussis vaccine and tetanus toxoid. Its referred to as "triple vaccine". 1.7.1 Diphtheria Toxoid This is the "D" part of DPT vaccine. Diphtheria is caused by bacteria which produce a toxin. The vaccine is a toxoid, that is, inactivated diphtheria toxin. Diphtheria toxoid is damaged by freezing. It is also damaged by heat, but not as quickly as the live vaccines. 1.7.2 Pertussis Vaccine This is the P part of DPT vaccine. The micro-organisms that cause pertussis (or whooping cough) are bacteria. The vaccine is made from KILLED BACTERIA. Pertussis vaccine is damaged by heat, about as quickly as BCG. So the pertussis vaccine is the most easily damaged part of DPT. The limiting factor for the "triple vaccine". 1.7.3 Tetanus Toxoid This is the "T" part of DPT vaccine. It is also available as a separate vaccine TT, given to pregnant women to prevent neo-natal tetanus. Tetanus is caused by bacteria, which produce a toxin. The vaccine is a toxoid, that is, inactivated tetanus toxin.

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Tetanus toxoid is damaged by freezing. It is also damaged by heat, but more slowly than the other vaccines. DPT and tetanus toxoid are both liquid vaccines which you give by injection. 1.7.4 Damages To check if DPT or TT has been damaged by freezing: When DPT and TT vaccines have been standing, the liquid is clear, and there is a white sediment at the bottom. If you tip the container, the sediment moves easily. If you shake the container, the vaccine goes cloudy. The cloudiness is very smooth and not granular. The sediment begins to fall to the bottom again very slowly. DPT and TT vaccines are damaged most easily by freezing. If you see DPT or TT vaccine when frozen solid, you know that it is damaged. But you may not see the vaccine until after it has thawed or melted and has become liquid again. To find out if a liquid vaccine has been frozen and damaged some time before, you must do a simple test. The Shake Test Compare the vaccine that you suspect has been frozen and thawed with vaccine from the same manufacturer that YOU are SURE was never frozen. Shake the vials of vaccine; Inspect the contents carefully; Leave the vaccines to stand side by side for 15-30 minutes for the sediment to settle. Inspect the contents carefully on granular particles again. Check the properties of the liquid in the vials: smooth and cloudy starting to clear no sediment not smooth you can see granular particles thick sediment

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VACCINE NEVER FROZEN USE THIS VACCINE

VACCINE FROZEN AND THAWED DO NOT USE THIS VACCINE

1.8 The Cold Chain

Vaccines must stay cold all the way from the manufacturer to the end user = child/adult. The equipment and the people that keep vaccines cold from the manufacturer to the end user are together called: THE COLD CHAIN. Before vaccines reach the health centre they must be: Collected quickly from the airport; Stored at the correct low temperature in the refrigerator at the Central Store, the Regional Store and the District Store; Kept cold during transport from one store to another. Only then vaccines arrives at your health centre in good condition.

After vaccines reach the health centre: They have to be kept at the correct temperature in the refrigerator. They have to be carried to the immunisation session in a vaccine carrier with ice. They have to be put on ice (icepack) while vaccinating. Diluents do not have to be stored in the refrigerator. At the time of reconstitution diluents need to have the same temperature as the vaccine, to prevent killing the live vaccine by heat shock.

1.9 In A Refrigerator
One can keep vaccines in good condition in a refrigerator for two months; but you must make sure that the refrigerator works at the correct temperature. To make sure that the refrigerator works well you must: Load and use the refrigerator correctly; Check the temperature twice daily and defrost the refrigerator regularly.

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Parts of a refrigerator A refrigerator has two compartments: the main compartment and the freezer. The main compartment is where you store vaccines. The temperature in this compartment should be between +2C and +8C. The freezer compartment is used to freeze icepacks. The temperatures in this compartment should remain below -10C. A thermostat is used to regulate and control the temperature in the refrigerator. The knob in the main compartment serves to adjust the thermostat. The knob usually has numbers 1 to 6 or 1 to 7 on it and an arrow to show which number is in use. To make the refrigerator COLDER, turn the knob so that the arrow points to a HIGHER number. To make the refrigerator WARMER, turn the knob so that the arrow points to a LOWER number.

1.10 Checking The Temperature

To check the temperature of the main compartment, make sure you have: A thermometer (max/min); keep it in the main compartment; A stopwatch momitor card; A chart to record temperatures; put it on top of the refrigerator or on the outside of the door; One person who is in charge of the refrigerator. That person checks and records the temperature. But everyone who uses vaccines must know what the chart means. Dos: Check the temperature in the main compartment twice every day - when you arrive for work and when you leave. You should be able to recognise if the temperature is too high or too low and you should know what to do about it. Stand the vaccines on ice (icepack) while vaccinating. Donts

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 Do NOT put any food or drink in the vaccine refrigerator. Food and drinks can make the inside of the refrigerator too warm. Do NOT put any vaccine in the door shelves. The door is the warmest place in the refrigerator. Do NOT keep "EXPIRED" vaccines in the refrigerator. PARTLY USED vaccine you may keep and use (see WHO guideline on use of open vials - page 14), are always the vaccines that do not have to be reconstituted. For example: OPV (oral polio vaccine), DTP, TT, Hepatitis B, Hepatitis A. All diluted vaccines will have to be thrown away at the end of a vaccination session. If you have to keep them to show as an example, keep them somewhere else, outside the refrigerator. Mark them clearly. KEEP THE DOOR CLOSED Opening the door increases the temperature in the refrigerator. When you need to open the door, plan what you will do first. Then open the door, do what you have to do, and close the door again quickly. Do not open the door of an absorption refrigerator more than 2 or 3 times a day. An absorption refrigerator will only slowly replenish the cold lost by opening the door. It has a low cold yield, i.e. slow cold production. (see also How it works) Vaccine vial monitor A vaccine vial monitor (VVM) is a label made of heat sensitive material which is placed on a vaccine vial to register cumulative heat exposure over time. The combined effects of time and temperature cause the monitor to change colour, gradually and irreversibly. A direct relationship exists between the rate of colour change and temperature: The lower the temperature, the slower the colour change, The higher the temperature, the faster the colour change VVMs can be used on vaccine vials or ampoules. The VVM is a circle with a small square inside it. It can be printed on a product label or attached to the cap of the vaccine vial.

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 The inner square is made of heat sensitive material which is light at the starting point and becomes darker with exposure to heat. The discard point is reached when the colour of the inner square matches or is darker than the outer ring. To date the vaccine vial monitor is only used with OPV (oral polio vaccine)

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2.Waste Disposal
To prevent re-use of injection material and vaccine vials, material should be disposed of properly. Handling used sharps Never strip the needle from a used syringe. Never recap a used needle Always place syringe and needle in a safe disposal box immediately after use. Always supervise the transport & incineration of the syringes & needles in the disposal box and maintain records of disposal and destruction. MSF uses a 5 litre safety box for the collection of used sharps. The following formula may be used to estimate the number of litres of sharps waste which will be generated in EPI or a vaccination campaign. A= B= C= Estimation of used syringes: i.e. Total number of children to be immunised in vaccination campaign. Volume of used syringes A X 50/1000= Total volume in litres. Number of safety boxes required to hold sharps:For 5 litre boxes B / 5

For example: you plan to immunise 345.362 children. A = 345.362 B = 345.362 x 50 / 1000 = 17268 litres of sharps waste C = 17268 / 5 = 3454 rounded up = 3460 safety boxes of 5 litres. In a regular EPI program you have to burn (in the safe disposal box) or bury your used material. Crush the vials before you bury them. There is a risk that theyre being filled up with water and used again. During a vaccination campaign the first choice is burning. The syringes have to be burnt with the safe disposal box. Try to find an incinerator, some health facilities or hospitals have them or use an oil drum. Bury waste or the ashes on a depth of at least 1 (one) metre with 0.5 metre of soil on top.

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3.Vaccine Storage And Handling Checklist

Choose and train one person and one back-up to be responsible for the cold chain and cold storage. When applicable: install a lock/plug-guard on the electrical plug. Post warning notices at both the plug and at the circuit-breaker. Use preferably a maximum/minimum thermometer to monitor temperatures twice daily in both refrigerator and freezer. In the morning before work begins , check that the minimum temperature in the refrigerator is not below 2Celsius and the maximum is not above 8 Celsius. Make sure the freezer maintains an average temperature of -15 Celsius or below. In case of min/max thermometers reset them after each reading. Do not open an absorption refrigerator (gas, kerosene) more than two times a day. Do not store food or drinks in the refrigerator that is used for vaccine storage. Store icepacks in your freezer and bottled water at the bottom of the refrigerator to help maintain a stable temperature and prolong holdover time. Do not store vaccines in the refrigerator doors (the doors are the warmest place in the fridge). Store vaccines together by type and keep space between boxes for good air circulation. When you lack space: store Oral Polio Vaccine (OPV) in the freezer. Earliest Expiry, First Out. Store vaccines with shorter expiration dates to the front, longer expiration dates to the rear. (consequently overruling the "First In, First Out" principle). Defrost the freezer compartment when the layer of ice exceeds 5 millimetres. The beginning and length of any breakdown should be carefully noted and measures taken to protect the vaccines. When vaccines are out of the refrigerator, keep them cool with icepacks, do not let vaccines and diluents other than opv, measles, meningitis and yellow fever come in direct contact with icepacks (keep some cardboard in between) and protect measles and BCG from UV light.

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4.Main Vaccines
VACCINE TYPE THERMO SENSITIVITY HEAT ORAL EPI POLIO MEASLES EPI Liquid Freeze-dried +++ ++ + ++ + ++ ++ + STABILITY COLD Freezing no risk Freezing no risk Freezing no risk Freezing no risk Freezing no risk Destroyed by freezing Freezing no risk Destroyed by freezing Destroyed Destroyed by freezing Unknown Freezing

MENINGOCOCCAL Freeze-dried MENINGITIS BCG EPI YELLOW FEVER DPT EPI DPT POLIO JAPANESE ENCEPHALITIS IPV= EPI INJECTABLE POLIO VACCINE HEPATITIS A HEPATITIS B Freeze-dried Freeze-dried Toxoid Liquid Freeze dried Liquid

Liquid by freezing Liquid

+ + ++ ++

HAEMOPHILUS Liquid INFLUENZA TYPE B = HIB MUMPS Freeze dried

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no risk RUBELLA RABIES TETANUS EPI TOXOID Freeze dried Freeze dried Toxoid Liquid ++ + + Freezing no risk Freezing no risk Destroyed by freezing

!! STORE ALL VACCINES BETWEEN 2- 8C !! !! RECONSTITUTION AFFECTS STABILITY OF VACCINES !! + =Little sensitive to heat. +++ =Very sensitive to heat: minimise exposure to over 8C. Names of childhood diseases/vaccines
Nederlands Difterie Mazelen Bof Rode hond Kinkhoest Gele koorts Rabis Polio Tetanus English Diphtheria Measles Mumps Rubella, German measles Whooping cough, Pertussis Yellow fever Rabies Polio Tetanus, Lockjaw Franais Diphtrie Rougeole Oreillons Rubole Coqueluche Fivre jaune Rage Polio Ttanos Portugues Difteria Sarampo Caxumba, Parotidite, Papeira Rubela Tosse convulsa Coqueluche Febra Amarela Raiva Poliomielite, Paralisia infantil Ttano Espagnol Difteria Sarampin Parotiditis, Paperas Rubeola Tosferina, Tosconvulsina Fiebra Amarilla Rabia Poliomielitis, Parlises infantil Ttanos

4.1

Calculating Vaccine Requirements

4.1.1 EPI (Expanded Programme on Immunisation) In routine EPI vaccination programs:

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Total number of doses (all antigens1) to be administered in the supply period + reserve stock of 25% or 2 weeks consumption (depends on the length of your supply period) which ever is the greater. Supply intervals: The selected supply interval will influence the (cost) effectiveness of the programme. Too short an interval may increase the cost and create an unrealistic administrative burden. Too long an interval may put vaccine at risk and result in too much vaccine in the pipeline. Supply interval for clinics/health centres will depend on: reliability/cost of delivery/collection; speed of delivery; reliability of suppliers (including depots); reliability of refrigeration at the clinics; reliability of management at the clinics; value of vaccine stored; Indicative supply intervals for different levels: Province 3 months Sub-province 1 month Clinic 1 month

The following guide to calculate your vaccine requirements goes for mass immunisation campaigns; large amounts of people covered, in contrast with the earlier mentioned EPI, which is the regular day to day immunisation routine in a health centre or clinic.

4.1.2 Vaccination Campaigns The formula for calculating vaccine requirements is: Number of doses = target population x wastage multiplier + reserve stock. In case of a vaccination campaign, a wastage multiplier of 1.17 (which is approximately 15% wastage) should be used, augmented by 25% reserve stock.

All EPI vaccines

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For subsequent orders of vaccines, the wastage multiplier and reserve stock can be adjusted (usually downwards) based on wastage calculations done at vaccination sites. During vaccination campaigns high quantity dose vials (2050) should be used. To estimate the number of vials required divide the number of doses needed by 20-50 and round up. Always make an international order in # of doses, state the preferred vial size. Vials come in different volumes = different doses per vial. Example of a vaccine requirement calculation: Total population in a province/refugee camp: 123,233 Target population (0-59months) 17% of total population Vaccine wastage multiplier = 1.17 Vial size: 20 dose vials 123,233 x 0.17 x 1.17 (+25%) = 32162.32 32162.32 / 20 = 1608.11 = 1610 vials needed

4.2 Calculating Parenteral Supplies (I.E. Syringes And needles)

(parenteral = the route to administer drugs not through the alimentary canal but rather per injection) In addition to vaccines, EPI and vaccination campaigns require the following parenteral equipment: 5 ml syringes + 18g x 1,5(1,20 mm x 40 mm) needles (pink) for reconstitution 2 ml syringes + 23g x 1(0,60mm x 25 mm) needles (blue) for administering 0.5 ml autodestruct syringes with needle BCG syringe with needle Calculating quantities per order cycle: 2 ml syringes: # of doses to be administered + 10% (minus stock on hand or in pipeline) 0.5 ml autodestruct syringes: # of doses to be administered + 10% 23 g needles: # of doses to be administered, excluding BCG, + 10%

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5 ml syringes: # of vials to be reconstituted + 10% 18 g needles: # of vials to be reconstituted + 10% BCG syringes/needles: # of doses of BCG to be administered + 10%

4.3 Calculating Cold Storage Space Requirements

General guidelines for calculating vaccine storage requirements: the amount of cold chain space required for e.g. 1000 doses of OPV (oral polio vaccine) is 1 (one) litre. every 500 doses of other vaccines requires 1 litre of storage space. in a non-refugee situation, storage space at the most peripheral level is usually sufficient. the most serious problems of inadequate space occur at the regional, provincial or district level. temporary arrangements, such as the use of commercial freeze/cold rooms for vaccine storage or ice making, must be made in those areas with insufficient refrigerator or freezer space.

4.4

Calculating Ice Pack Requirements

Number of ice packs needed = number of vaccination sites x {the number of ice packs in the cold box + (number of ice packs used on the table x number of vaccinators per site)}. The number of packs will be adjusted after the first day, depending on ambient temperature. You can use the ice pack as long as there is ice in the pack: the temperature will then be 0C ! When all ice is melted the temperature of the pack will rise quickly!

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4.5 MSF Vaccination Kit

MSFs vaccination kit contains all the necessary cold chain equipment (refrigerators freezers, cold boxes, vaccine carriers), medical (syringes, needles, cotton, etc.), logistical and stationary equipment to vaccinate 10.000 people with 5 teams. See for a detailed description your purple Guide of kits and emergency items. Only the vaccine youll have to order separately.

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5.Winterisation Of The Cold Chain

Or how to treat your cold chain when ambient temperature drops below zero.

5.1 Introduction
The necessity of a cold chain in winter is obvious: to prevent vaccines from getting spoiled. During winter youll have to deal with two problems: 1. Irregular power supply and in some countries power outages that may last for days. 2. Very low ambient temperatures. 5.1.1 Vaccines The safe temperature range to store all vaccines is between 2 and 8C. This is valid during summer and winter. In summer the problem of keeping especially Oral Polio Vaccine cold enough is bugging you, while in winter to guard DPT, DT ,TT and Hepatitis B from freezing will be your main concern. 5.1.2 Refrigerators Thermostat(s) control the inside temperature of the fridge. When ambient temperature goes up, the thermostat has to be adjusted to a higher setting to prevent the inside of the fridge to become too warm. When the ambient temperature drops, you must adjust the thermostat to a lower setting. When you fail to do this, the temperature in the fridge may become dangerously low; even below 0C: DPT, DT, TT and Hepatitis B vaccines will be spoiled when this happens. When the temperature inside the fridge is lower than 2C and you cannot adjust the thermostat to a lower setting because it is already on Minimum , it is better to switch off the refrigerator. From than on you must keep a close watch on the temperature inside the fridge and switch it on as soon as the inside temperature starts to rise above 8C. IN FACT YOU ARE NOW PLAYING THE ROLE OF THE THERMOSTAT. This extra work is only acceptable for a short period of time.

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When the ambient temperature is very low for a long time, e.g. lower than 10C, it is better to take the DT, DPT, TT, Td (=diphtheria tetanus booster for adults) and HEP B out of the fridge and put them in a cold box and keep the box in a safe unheated room. When you leave those vaccines in the fridge you run the risk of freezing them. When you are afraid that the temperature inside your health facility will drop below zero, you should put the coldbox in a safe room where it never freezes, for example a basement. Youll have to fill all empty space in the coldbox with unfrozen icepacks to prevent the inside temperature from changing too quickly. Put a thermometer inside and take readings every day. Leave BCG and Measles in the main compartment of your still switched on refrigerator and keep OPV in the freezer (compartment). When the ambient temperature rises above 15C you should bring the vaccines from the cold box back to the refrigerator. The accompanying temperature monitor card should be filled out correctly. 5.1.3 Power Cuts In wintertime electricity supply is often bad, power outages may occur and continue for hours up to several days. With a power outage the inside temperature of the refrigerator will rise slowly. When you have an icelined refrigerator or many frozen icepacks in the freezing compartment, the inside temperature will almost remain constant as long as the water in the icepacks is frozen. ONLY WHEN ALL THE ICE IN THE ICEPACKS IS MELTED, THE INSIDE TEMPERATURE OF YOUR REFRIGERATOR WILL RISE QUICKLY ! Therefor fill all empty space in the freezer with icepacks or make sure that the icelining is complete. In addition you have to put plastic bottles with water in the main compartment or at the bottom of the fridge to increase your cold mass. It goes without saying that it is even more important not to open the fridge door except to take out vaccines or record temperature. Never put unfrozen (= warm) icepacks in the freezer during power cuts. With irregular electrical power supply, it is difficult to regulate the inside fridge temperature instantly with an adjustment of the thermostat. You should read from your temperature monitor chart over several days if the

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average inside temperature is too high or too low, and adjust your thermostat accordingly. Keep during power outages a very close look at the inside temperature. When the temperature becomes too high, even while you took all the necessary precautions; prepare to move your vaccines to a refrigerator in an area where they do have electrical power. With icepacks from that fridge/freezer, you can transport your vaccines to the working fridge. Take care of a good registration of the type and number of doses of vaccines you are bringing to your neighbours fridge.

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6.The WHO (World Health Organisation) Policy

(on the use of opened vials of vaccine in subsequent immunisation sessions ) This policy aims at cutting vaccine wastage by 30% and save $ 40.000.000 globally. WHO revised its policy, in the sense that certain vaccines may be used in subsequent immunisation sessions on the condition that: vaccines meet WHO standards for potency and temperature stability, and are packed according to ISO standards and contain the appropriate concentration of preservative (=supplied by UNICEF); sterile injection procedures are adhered to; the expiry date is not passed; the vaccine vial does not leave the health centre; The vaccines in question are: OPV, DTP, TT, DT and Hepatitis B. Be aware that: Reconstituted vaccines like measles, yellow fever, meningitis and BCG do not contain preservatives and must be discarded at the end of each immunisation session. Death due to toxic shock syndrome has resulted when reconstituted live virus vaccines which were kept reconstituted in stock were injected. This WHO policy is linked to the introduction of vials which are supplied with a vaccine vial monitor. Vaccine vial monitors (time/temperature indicators) will show if vials of OPV (Oral Polio Vaccine) have been exposed to unacceptable high temperatures. Every vial has its own monitor. We expect in the coming years a change to vaccine vial monitors supplied with the various vaccines. Measles vaccine will be supplied with VVMs following the successful introduction on Oral Polio. UNICEF supplies OPV with these monitors, as part of the vials label. When you get OPV with vaccine vial monitors in your project, you can use them in subsequent immunisation sessions.

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You may use opened vials of DTP, DT, TT and Hep B in subsequent immunisation sessions, even when they do not carry vaccine vial monitors. National and expat staff have to be trained to work according to this policy.

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7.Colour Coding Of Vaccine Vials

Vaccine vials have often been confused with other vaccines, and on occasion with other pharmaceuticals. Even in MSF this mistake occurred. Such confusions can have tragic consequences. Manufacturers have had their own colour codes to distinguish their products from one another, but these colours have often conflicted with the colours used by other manufacturers. UNICEF has requested all vaccine suppliers to conform to a standard colour. It is hoped that by standardisation of colour codes vaccines will be more easily identified. Colour coding will help identify vaccines but will not substitute for careful identification by health care and logistics staff. Keep vaccines separated from other pharmaceuticals and always look at the label before using. At any level in the supply line when you receive vaccines, dont take for granted that all levels before you have checked the labels against the order and packing list, so do it again. The colours chosen are: DPT TT DT Measles BCG Yellow Green Lime Orange/Red Blue

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8.A Mini Size Data Logger

Cold Chain temperature monitor The temperature monitor "Tiny TTM", has been developed by Remonsys Ltd, UK. It is battery-operated and small enough to fit inside a 35 mm plastic film container. It has a single, on-board thermistor sensor which covers a temperature range of -37C to +50C and is capable of monitoring up to 1800 readings at varying time intervals. It has an accuracy of +/- 0.2C and the recording time interval can be set from 0.5 seconds up to 4.8 hours. The duration of the recording will determine when the memory is full-- for instance, with a 30 minute interval, the memory will be full in 37 days. The data stored can be quickly downloaded by a special cable to the serial port of a computer. It can then be displayed in nice graphs and saved under different formats using software prepared for this purpose. The small size and design of the "Tiny TTM" makes it a useful supervisory tool and an extremely powerful monitor. At the moment the "Tiny TTM" is being used in Azerbaijan, Sudan and Brazil in cold chain programs. When your cold chain is not working properly and it is hard to put the finger on the faulty spot, you can order a "Tiny TTM" to help in fault finding. The current cost is approximately UK 100 for the hardware (the data logger itself) and UK 50 for the software and cable. You can get one on loan from Logistics /Field Support Unit temporarily.

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9.A Bit Of Theory On (US Oriented) Immunisation

The various recommendations for immunising infants, children and adults against diseases are based on medical knowledge, the availability of safe vaccines, other scientific knowledge, and on judgements by public health officials and doctors. Each vaccine has benefits and risks associated with its use, and no vaccine is completely safe or completely effective. Vaccines are beneficial because they prevent disease infection and the various results of that infection, which may be mild symptoms such as a body rash, or more serious problems such as paralysis or death. Depending on the vaccine the benefits may vary from partial protection to complete protection against the disease or its effects.The risks associated with vaccine usage range from common, trivial, and inconvenient side effects, such as mild swelling or low grade fever, to on rare occasions severe, and life-threatening conditions.The decision to use a vaccine is based on the benefits, costs and risks associated with the vaccine. For each vaccine, recommendations are developed for its use, and these describe who should receive it, when they should receive it, and how the vaccine should be given to a person. These vaccine recommendations are developed to apply to large populations, but therecommendations may vary for specific individuals or even between countries.Finally, the relative balance of benefits and risks may change as diseases are controlled or eradicated. For example, because smallpox has been eradicated throughout the world, the risk of side effects associated with the smallpox vaccine now exceeds the risk of smallpox; consequently, smallpox vaccinations are no longer routinely given to the general public.

9.1 Why Immunize?

Its effective Immunisation is one of the most effective ways to prevent disease. Because immunising children has proven to be so effective at preventing disease, immunisations against specific diseases are required by all 50 states and the District of Columbia in the US for children entering day care and/or school. The widespread use of vaccines has reduced the peak-level incidence of disease in the United States by at least 95%. The vaccination series consists of 2-5 doses of each of 5 vaccines.
Most vaccines protect 90% or more of the individuals vaccinated. In addition, most vaccines when used widely in communities indirectly protect other persons as well, including those too young for vaccination

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and those with legitimate medical contraindications to vaccination. This goes for anywhere in the world.

It saves lives Experience in the United States in recent years has illustrated both the effectiveness of immunisation and the tragic consequences of failure to vaccinate properly. Before the measles vaccine was approved in 1963, an average of over 500,000 cases of measles was reported each year, killing 400 to 500 people annually. By 1983, in the United States the number of cases of measles reported had dropped to a record low of l,497. However, a resurgence of measles between 1989 and 1991 (over 55,000 cases of measles, including 132 reported deaths) occurred primarily among unvaccinated pre-school children. In 1990, 64 individuals died of measles, the highest number in two decades. The biggest cause of the measles epidemic was the failure to vaccinate children on time at 12-15 months of age. It saves money In addition to lessening the human suffering brought about by disease, immunisation is cost-effective. It is estimated that every $1 spent on vaccinations for measles, mumps, and rubella represents a potential savings of many more dollars in treatment costs. The measles outbreak of 1989-1991 caused over 44,000 days of hospitalisation. Studies suggest that each 1,000 cases results in $3-4 million in direct medical treatment costs.

9.2 What Immunisations, When And Whom To Immunise

Which vaccinations against what diseases? Children should be vaccinated against ten diseases: TB, diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, measles, mumps, rubella and hepatitis B. All but tetanus (lockjaw) are contagious and can be transmitted from an infected person to an uninfected person.These vaccinations are necessary for a child to be adequately protected against ten serious childhood diseases that can lead to death: TB, infection of the lungs, highly contagious, and/or any other organ, which can cause death if untreated. Diphtheria, infection of the throat, mouth, and nose, which can cause heart failure or paralysis if untreated; Tetanus (lockjaw), an infection that attacks the nervous system and kills 3 out of 10 infected people;

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Pertussis (whooping cough), which is highly contagious and causes severe coughing and occurs mostly in children under 5 years; Polio, which causes paralysis and death; Measles, which is highly contagious, causes a rash and high fever and during the measles epidemic of 1989-1991 hospitalised 19% of persons with measles; Mumps, which causes fever, headache and inflammation of the salivary glands; three of every ten infected people develop meningitis and inflammation of the covering of the brain and spinal cord; Rubella, or "German measles", which causes fever and rash and causes severe birth defects when pregnant women are infected; Haemophilus influenzae type b (Hib disease), which was contracted by one out of every 200 children before the age of five before vaccines were available, affects blood, joints, bones and the covering of the heart; Hib disease was the most common cause of serious bacterial meningitis in children; Hepatitis B, which causes cirrhosis of the liver and liver cancer. When to vaccinate? Adequate immunisation against these diseases requires about five visits to a health care provider during the first two years of life. Approximately 80% of the vaccines needed to fully immunise child should be given at these five visits during the first two years of life.

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10. Recommended Immunization Schedule

These recommended ages are not absolute. All recommended vaccines can be given simultaneously. The basic schedule recommended by WHO (World Health Organisation), which differs substantially from the schedule used in the US and other countries in the western hemisphere, in the framework of the EPI (Expanded Programme on Immunisation) is as follows: Age Birth 6 weeks 10 weeks 14 weeks 9 months Vaccine BCG + oral Polio DTP + oral Polio DTP + oral Polio DTP + oral Polio Measles

>15 years Tetanus All other vaccines are either skipped: like MMR (Mumps Measles Rubella) or added like Hepatitis B and Hib (Haemophilus Influenza type b) to the schedule when the MOH (Ministry of health) of governments can afford them.

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11. Introduction To The MSF PEP (Post Exposure Profylaxis) Guideline

This subject is added as a reminder This guideline should be in your project library, the chemoprophylaxis which is described in it should be in your medical stock! {ask the medical officer who acts as your GP (general practitioner)}

11.1 Risk Of Health Care Workers For Infection With HIV, HBV and HVC
MSF works in many countries with a high prevalence of human immunodeficiency virus (HIV) and Hepatitis B (HBV) which poses a certain risk to its field staff. MSF aims to provide adequate information and the best possible measures of protection towards all its field staff. The organisation will also provide chemoprophylaxis for expatriates after percutaneous exposure to blood (PEB). A recent retrospective study by CDC (Centers for Disease Control and Prevention -Atlanta USA) showed that a treatment of AZT (Zidovudine) can have a protective effect up to 70 % (43 - 94) on transmission during needlestick incidents. With a triple treatment of Zidovudine, Lamivudine and a Protease-inhibitor this protective effect will be increased, but we are awaiting results of on-going studies. Following the recommendations, MSF has decided to make this prophylactic treatment available to expatriate staff in projects where there is an occupational risk. This document outlines possible risks and protection, describes the post exposure profylaxis (PEP) and related procedures and gives information on handling possible incidents of infection. It should be noted that this document will need regular updates related to field experiences and latest research developments on the prophylactic treatment. Health care workers (HCWs) are a risk group for infection with HIV (human immunodeficiency virus), HBV (hepatitis B virus) and HVC (hepatitis C virus). The risk of transmission through occupational exposure by accidental inoculation with infected blood or saliva are shown in the table below.

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Risk of transmission of bloodborne viruses to health care workers Human Immunodeficiency Virus (HIV) Percutaneous exposure: 0.3 % * Mucutaneous exposure: 0.05 % Hepatitis B virus (HBV) Percutaneous exposure: Hepatitis C virus (HCV) Percutaneous exposure:

9-30 %

3-10 %

* Risk for HIV infection exceeds 0.3 % for percutaneous exposure involving a larger blood volume and /or higher HIV titre in blood. As well with the increased number of exposure events, negligence of universal precautions and increased sero prevalence of population Procedures that have been identified as high risk are: Surgical procedures; especially emergency procedures and major surgery on areas anatomically difficult to approach. In studies it has been estimated that percutaneous exposure happens in 2-6% of the surgical procedures. Intravenous procedures (drips and blood taking); especially in emergency situations. Cleaning up after special procedures or routinely in all clinics; non-medical cleaning personnel is exposed to large amounts of blood or to stray needles. Besides the occupational exposure, sexual transmission and transmission through blood transfusion are an increased risk to HIV and other blood borne diseases. Further reading in the guideline.......

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12. How It Works

12.1 Refrigeration
Process of lowering the temperature in a given space and maintaining it. Storing perishable foods, pharmaceuticals, or other items under refrigeration is commonly known as cold storage. Such refrigeration checks both bacterial growth and adverse chemical reactions that occur in the normal atmosphere. In mechanical refrigeration, constant cooling is achieved by the circulation of a refrigerant in a closed system, in which it evaporates to a gas and then condenses back again to a liquid in a continuous cycle. If no leakage occurs, the refrigerant lasts indefinitely throughout the entire life of the system. All that is required to maintain cooling is a constant supply of energy, or power, and a method of dissipating waste heat. The two main types of mechanical refrigeration system are the compression system , used in domestic units for large cold-storage applications and for most air conditioning; and the absorption system, now employed largely for heat-operated air-conditioning units and to a lesser extent used for heat-operated domestic units or the specifically for vaccine storage built units. 12.1.1 Compression System Compression systems employ four elements in the refrigeration cycle: compressor, condenser, expansion valve and evaporator. In the evaporator the refrigerant is vaporised and heat is absorbed from the space being cooled and its contents. The vapour is next drawn into a motor-driven compressor and raised to high pressure, which raises its temperature . The resulting superheated, high-pressure gas is then condensed to liquid in an air-cooled condenser. From the condenser the liquid flows through an expansion valve, in which its pressure and temperature are reduced to the conditions that are maintained in the evaporator. Pros: high cold yield, easy to maintain, easy to repair. Cons: needs relative reliable electrical power supply.

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12.1.2 Absorption System A few household/vaccine storage units, called gas/kero/electric refrigerators, operate on the absorption principle. In such refrigerators a strong solution of ammonia in water is heated by a gas/kerosene flame or electric heating element in a container called a generator, and the ammonia is driven off as a vapour, which passes into a condenser. Changed to a liquid state in the condenser, the ammonia flows to the evaporator as in the compression system. Instead of the gas being inducted into a compressor on exit from the evaporator, however, the ammonia gas is reabsorbed in the partially cooled, weak solution returning from the generator, to form the strong ammonia solution. This process of reabsorption occurs in a container called the absorber, from which the enriched liquid flows back to the generator to complete the cycle. Absorption refrigeration is increasingly used in refrigeration units for comfort space cooling (airco systems), for which purpose refrigerant temperatures of 45 to 50 F (7.2 to 10 C) are suitable. Pros: can run on several energy sources: electricity, butane/propane, kerosene, direct solar. Cons: low cold yield, labour intensive maintenance, difficult to repair. 12.1.3 Refrigerants For every refrigerant there is a specific boiling or vaporisation temperature associated with each pressure, so that it is only necessary to control the pressure in the evaporator to obtain a desired temperature. A similar pressure-temperature relationship holds in the condenser. One of the most widely used refrigerants for many years was dichlorodifluoromethane, known as Refrigerant-12. This synthetic chlorofluorocarbon (CFC) would vaporise at -6.7 C (20 F) under a pressure of 246.2 kPa (35.7 psi), and after compression to 909.2 kPa (131.9 psi) would condense at 37.8 C (100 F). In small domestic refrigerators used for food storage, the condenser heat is dissipated into the kitchen or other room housing the refrigerator. With airconditioning units the condenser heat must be dissipated out of doors or directly into cooling water. In a domestic refrigeration system the evaporator, called the freezer, is always placed in an insulated space. In some cases this space constitutes the whole refrigerator cabinet. The compressor is usually oversized, so that if it ran continuously it would produce progressively lower temperatures. In order to maintain the interior of the box within the desired temperature range, the motor driving the compressor is controlled by a thermostatic switch.

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A frozen-food freezer resembles the household refrigerator except that its compressor and motor must be of sufficient size to handle the larger gas volume of the refrigerant at its lower evaporator pressure. For example, to maintain a temperature of -23.3 C (-10 F) an evaporator pressure of 132.3 kPa (19.2 psi) would be required with Refrigerant-12. 12.1.4 Refrigerants And The Environment Refrigerant-12 and the related CFCs Refrigerant-11 and Refrigerant-22, were the major compounds used in the cooling and insulation systems of home refrigeration units. It has been found, however, that CFCs are posing a major threat to the global environment through their role in the destruction of the ozone layer. In accordance with the Montreal Protocol, the manufacture of CFCs ceased in the European Union by the end of 1994 and was scheduled to end in most other industrialised countries by the end of 1995. The refrigeration industry is switching rapidly to alternatives that do not deplete the ozone layer. Like Refrigerant-134a which depletes the ozone layer just a little bit and Refrigerant-600 (carbohydrate, flammable gas) which depletes the ozone layer not at all.

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40

13. Immunisation & Cold Chain Glossary

Adjuvant An addition (auxiliary help) to the vaccine- Used in killed vaccines, either viral or bacterial, such as DPT, DT,TT, Hep B and certain brands of Hib. vaccines containing an adjuvant may not be used after freezing. Most infections leave a person protected for some time against a second attack of the disease because the micro-organisms causing the infection have stimulated the body to produce antibodies. Antibodies are special proteins in the blood which inhibit the organisms or toxins causing the disease. Those antibodies which inhibit the action of toxins are called antitoxins. The sites of maximum antibody formation are the Iymph nodes and spleen. Produced by the mother and transmitted to the foetus through the placenta or colostrum (see passive immunity). A substance which, when introduced into the body, stimulates the production of antibodies. Viruses, bacteria, bacterial toxins, red blood cells, tissue extracts, pollens, dust and many other substances may act as antigens. See antibody. Cumulative incidence rate (%) start count from moment of outbreak: see incidence The word "booster", which originated in colloquial speech, means "reinforcing", "augmenting" or "supplementing". Some vaccines have to be given several times at intervals of at least four weeks to achieve an adequate level of protection. These first doses of the vaccine [in the cases of DPT (diphtheria, pertussis and tetanus) and OPV (oral polio vaccine) three doses are given] are called the primary series. It is advisable to give an additional dose (booster dose) after some months or years to maintain adequate protection. For example, the primary series of tetanus toxoid in pregnant women comprises two doses, the second being given four weeks after the first. A third dose (booster) administered during a subsequent pregnancy or the following year protects all babies born within a period of at least five years.

Antibody

Maternal antibodies Antigen

Antitoxin Attack rate Booster dose

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Catchment population

The number of children served by the immunisation programme within the boundaries of the community served. Cohort A well-defined group of people who have had a common experience or exposure who are then followed up for the incidence of new diseases or events as in a cohort or prospective study. A group of people born during a particular period or year is called a birth cohort. Cold chain A system of people and equipment which ensures that heat sensitive pharmaceuticals such as vaccines reach potent and in correct quantity the 'end users': women, children and men who need it. This means that the temperature of these items must be maintained within a specified temperature range from the time of manufacture till the moment of administering. Cold life The amount of time it takes for the temperature inside a refrigerator, cold box or vaccine carrier to go from -3C to +10C. Control of disease A significant reduction in the number of new cases of a disease resulting from activities carried out by health authorities to check its spread, so that it no longer constitutes an important public health problem. These activities include case finding and treatment, immunisation, reduction in contacts with vectors and surveillance. Disinfection The state of being free from most pathogenic organisms, or of rendering them inert. Droplet infection An infection transmitted through tiny drops such as small particles of respiratory secretions which are expelled by coughing, sneezing or speaking and suspended in the air. Evaporation causes them to reduce into small particles which remain in the air for a long time, and thus transmit the microbial disease from one person another. Endemic The constant presence of cases of a disease or infectious agent within a given community or region. Epidemic This is the situation in which the number of cases of a disease in a community increases well above the usual level. The number of cases constituting an epidemic depends on the size and type of the community, its previous experience of the disease and the nature of the infecting agent. Eradication of a disease This is the situation in which no new cases occur because of activities designed to eliminate the

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Evaporator Flocculation

Gamma globulin

Immunity

Active immunity

Passive immunity

vectors or agents and to render all cases non-infective. The transmission of the disease is therefore stopped. The term "elimination" is preferred when the geographical area concerned is limited. "Eradication" is generally understood to refer to the global level. Smallpox is the only disease that has so far been eradicated from the world; concerted international action led to its disappearance by 1977. A part of the refrigerator which makes the refrigerator cold (often the evaporator is the freezing compartment). Granular particles (floccules) visible after certain frozen vaccines are shaken. They might not always be easily seen by the naked eye, but will sediment faster than unfrozen vaccine does. This product is a concentrate of antibodies derived from human or animal blood. It can be used to prevent or lessen the effects of measles, hepatitis, yellow fever, tetanus and mumps. Its use is restricted by cost and by its limited protective effect (two to six months). Immunity is the state of resistance of the body to agents foreign to it. Immunity does not necessarily mean complete lack of susceptibility; varying degrees of immunity are recognised (nil, partial or complete) which result in susceptibility, latent infection (or healthy carrier state) or insusceptibility. Immunity may be natural, actively acquired or passively acquired. Active immunity is acquired by contracting an infection (natural active immunity) or by administration of vaccines (bacterial, viral and toxoidal) either singly or in suitable combination. The person who contracts the infection or is immunised makes his/her own antibodies which remain in the body for a long time. This is the most desirable form of immunity; it is lost very slowly and, where appropriate, can be rapidly restored by a booster dose. In the case of passive immunity, ready-made antibodies are acquired by infection or injection (e.g., gamma globulin). Passive immunity is transmitted from mother to foetus through the placenta or colostrum (first milk of the mother) e.g. neonatal tetanus can be prevented by administering

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Herd immunity

tetanus toxoid to the mother. Passively acquired antibodies give short-term protection, usually lasting only two to six months. This is the situation in which susceptibles (non-immune subjects) are protected from a disease if a sufficient proportion of the community has become immune either through natural infection or through being immunised against that disease. Such protection is acquired because the probability of a susceptible coming into contact with the disease is greatly reduced. However, even when the level of herd immunity in a community is very high, susceptibles who do come into contact with the disease may obviously still contract it. The current interest in the concept of herd immunity is due to its usefulness in immunisation programs for estimating the minimum coverage which would lead to the control of a given disease in a given community (i.e., a considerable reduction in the number of cases for long periods) or even its elimination (i.e., the complete cessation of transmission of the disease). There is a relationship between the level of herd immunity and the characteristics of the particular population or community, the infectious bacterium or virus, and social and environmental factors. An important determinant of the level of herd immunity is the nature of the infecting agent, specifically its mode of spread and the duration and degree of contagiousness. Since measles is the most contagious of the EPI diseases, its control requires the highest level of herd immunity. Herd immunity is not applicable to tetanus since the bacillus is not directly transmitted from person to person or through vectors, and tetanus infection does not confer immunity. Other significant determining factors are population characteristics, including the size, composition and density of the population, the birth rate (i.e., the rate at which new susceptibles enter the community), and mobility within the community. A higher level of herd immunity is required in a densely populated urbanised area in a developing country or a high-birth-rate area than in scattered rural settlements or areas with low birth rates. There are thus no fixed levels of herd immunity applicable to the EPI diseases, since these depend on the mix of the various conditions relating

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Incidence

Jet injector

to the population, the disease and the physical and social environment. The ideal is to have every child protected by being fully immunised. In EPI programs, an 80% average rate is often taken as a working minimal level for all the vaccines. Such a coverage rate might produce an adequate level of herd immunity for most of the diseases, depending on the various parameters described above, with the exception of measles, which probably requires well over 90% coverage in most communities. The practical implication of the concept of herd immunity in developing countries is that immunisation programs must achieve very high coverage rates and incorporate a good system of disease surveillance to judge their effectiveness. This is the prerequisite if the vaccine-preventable diseases are to be controlled (and some possibly eradicated). The number of new cases of a health problem in a defined population during a given time period. Incidence is expressed as an absolute number (e.g., 30 cases). The incidence rate is a measure of frequency of new cases of a disease in a defined population during a given time period, usually a year. It is expressed as the number of new cases per 1,000 or per 100,000 of the population. This is an apparatus which projects fluid in a thin, high-speed jet which has enough force to penetrate the skin without requiring the use of a needle. Models which are cocked by means of a foot pump are used in mass programs. As many as 1,000 persons an hour can be immunised, although in practice average figures are lower, due to difficulties in organising immunisation sessions. Hand cocked models are also available, but are restricted to intradermal injections and generally intended for office use. Operators of jet injectors must be well trained. In mass programs, reserve injectors and an adequate supply of spare parts are required. The measles, DPT, meningitis and yellow fever vaccines can be administered by jet injector. At present Jet injectors are not used because of their inherent risk of contamination with Hep B and HIV. Manufacturers are developing a jet injector without the contamination risk. There should be a new jet injector on the market in 1998.

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Lead time Maximum stock Minimum stock Parenteral

Prevalence

Re-order level Replacement rate Seroconversion

Stability

Sterilised Toxoid

Is the difference between re-order and minimum stock. This is the time it takes from placing the order to receiving the stock. The amount of any vaccine, supplies or spare parts which should be in a store at the start of a new supply period. This is the reasonable minimum stock level which should always be available in the store, to meet any potential calculated problem. Not through the alimentary canal but rather by injection, sub-cutaneous, intra muscular, intra spinal, etc. (enteral = through the intestine, e.g. oral or per rectum) The number of all cases of a disease existing in a defined population at a specific point in time. Prevalence is expressed as number (e.g., 3,000 cases). The prevalence rate is a measure of the frequency of all cases of a disease existing in a defined population at a specific point in time. It is expressed as the number of cases existing per 1,000 or 100,000 of the population. Is minimum stock plus the quantity of stock required to cover the lead time necessary between ordering and delivering of the vaccines . The frequency with which vaccine, supplies or spare parts must be replaced because they have worn out or are depleted. Seroconversion studies assess the presence or absence of specific antibodies in the blood of children or adults following immunisation or natural infection. Such studies allow calculation of the proportion of the population who are seropositive (i.e., have protective antibodies against a given infectious disease) or seronegative (i.e., do not possess such anti bodies). The ability to resist physical disintegration. A vaccine that is stable will maintain potency for a longer period of time than an unstable vaccine when it is exposed to high temperatures, freezing temperatures, or light. The state of being free from (living) microorganisms. Some bacteria cause illness by producing substances (toxins) which act at a distance from the site of infection. In neonatal tetanus, the umbilical cord is usually the site of infection, but the toxin produces

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Live attenuated viral/bacterial vaccines

generalised effects on the muscles of the body. Toxoids are toxins modified by the application of chemicals such as formaldehyde, which destroy their ability to cause disease without affecting their capacity to produce antibodies. The diphtheria and tetanus vaccines are Toxoids. Live vaccines contain live bacteria or viruses. These organisms are treated in the laboratory to minimise their harmful effects while retaining their ability to stimulate the production of protective antibodies. Examples include BCG, oral polio (Sabin), measles, rubella, mumps and yellow fever vaccines. In their liquid state, live vaccines may be inactivated by heat or even by strong light. Vaccine stability can be improved by freeze drying, a process in which the vaccine is reduced to a powder by freezing and removing water vapour under vacuum. Freeze-dried vaccines are reconstituted before use with a diluent, commonly distilled water or saline. The diluent should be at almost the same temperature as the vaccine i.e. between +2C and +8C at the time of reconstitution, to prevent losing vaccine potency by thermal shock. Dead or killed vaccines are made from killed bacteria or viruses. DPT vaccine contains dead pertussis bacteria and diphtheria and tetanus toxoids. Other examples are the cholera, typhoid, polio (Salk) and influenza vaccines. Killed vaccines are less heat-sensitive than live vaccines. Examples are the Diphtheria and Tetanus Toxoids. This is a measure of the degree to which a vaccine protects the members of the community in which it is used. A comparison is made between the attack rates (i.e., the number of cases occurring per 100 of the defined population) in those who have been immunised, as against the non-immunised population. Example: Number immunised I

Inactivated viral/bacterial vaccines

Inactivated bacterial toxins/ toxoid vaccines Vaccine efficacy

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Number not immunised U Cases in the immunised population Ic Cases in the non-immunised population Uc Vaccine efficacy (V.E.) = 1(Uc/U-Ic/I)/(Uc/U) If I = 2,000 persons U = 200 persons Ic =15 cases Uc =10 cases

Vaccine potency

then V.E. = (10/200-15/2,000)/(10/200)= 0.85 or 85% In practice, vaccines are never either wholly effective or totally ineffective. Measles vaccine, administered correctly, is 80 to 95% effective. Studies on the clinical efficacy of vaccines provide useful information. They can assure health care providers that a vaccine is highly effective and contribute to building confidence in vaccination. If efficacy is lower than expected, the vaccine management and vaccine administration techniques should be carefully evaluated. The ability of a vaccine to protect from disease. A vaccine that has low potency will give less protection to the people who are immunised. A vaccine that has high potency will give more protection to the people who are immunised.

Bibl:

Universal child immunisation 1990/Unicef Who EPI guidelines

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Index
absorption refrigerator.......14, 17 absorption system..................37 Active immunity....................43 adjuvant.............................41 Adjuvant.............................41 ambient temperature. . . .22, 24, 25 antibodies..........5, 41, 43, 46, 47 Antibodies...........................41 Antigen...............................41 antiseptics.........................7, 8 Antiseptics............................7 Antitoxin.............................41 attack rate..........................47 Attack rate..........................41 bacteria.........5, 6, 10, 41, 46, 47 bacterial toxins................41, 47 BCG 7, 8, 9, 10, 17, 18, 21, 22, 25, 27, 34, 47 booster dose....................41, 43 Booster dose........................41 carbohydrate........................39 Catchment population.............42 CDC...................................35 CFC...................................38 chlorofluorocarbon.................38 cohort................................42 Cohort................................42 cold chain.........17, 22, 23, 24, 30 Cold chain...........................42 Cold life..............................42 cold storage....................17, 37 coldbox...............................25 Colour coding.......................29 compression system...........37, 38 Compression system...............37 Control of disease..................42 diarrhoea..............................5 diluent water.........................9 diphtheria. .6, 7, 10, 25, 32, 41, 47 Diphtheria.......5, 6, 10, 19, 32, 47 disinfectants..........................8 Disinfectants..........................7 Disinfection.........................42 doses..........20, 21, 22, 26, 31, 41 Droplet infection...................42 DTP vaccine...........................8 Endemic..............................42 EPI.....6, 16, 18, 19, 20, 21, 34, 44 epidemic....................32, 33, 42 Eradication of a disease...........42 evaporator.............37, 38, 39, 43 Evaporator...........................43 expiry date..........................27 Flocculation.........................43 freezer. . .13, 17, 22, 25, 26, 38, 39 freezing 7, 8, 9, 10, 11, 18, 19, 24, 25, 41, 43, 46, 47 Freezing......................7, 18, 19 gamma globulin.....................43 Gamma globulin....................43 Haemophilus...............32, 33, 34 health care workers................36 Health care workers...............35 Hepatitis A.......................6, 14 Hepatitis B...6, 14, 24, 27, 33, 34, 35, 36 herd immunity......................44 Herd immunity......................44 HIV...........................35, 36, 45 icepacks............8, 13, 17, 25, 26 immunity.............................43 Immunity.........................5, 43 inactivated.......................7, 10 Inactivated..........................47 incidence..............31, 41, 42, 45 Incidence............................45 IPV.................................9, 18 ISO standards........................27 Japanese encephalitis...........6, 7 jet injector..........................45 Jet injector..........................45 killed bacteria......................47 lead time............................46 Lead time............................46

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Live attenuated.....................47 Maternal antibodies................41 Maximum stock.....................46 measles..5, 6, 7, 9, 17, 19, 27, 32, 33, 43, 44, 45, 47 Measles 5, 8, 9, 19, 25, 27, 29, 33, 34, 48 meningitis..................27, 33, 45 Meningococcal meningitis..........6 minimum stock.....................46 Minimum stock......................46 MMR...................................34 MOH...................................34 monitor card........................25 mumps......................32, 43, 47 Mumps......................19, 33, 34 OPV.........8, 14, 17, 22, 25, 27, 41 parenteral...........................21 Parenteral.......................21, 46 passive immunity..............41, 43 Passive immunity...................43 pertussis............6, 10, 32, 41, 47 Pertussis..............5, 6, 10, 19, 33 polio. .6, 7, 8, 9, 14, 22, 32, 41, 47 Polio.......8, 17, 19, 24, 27, 33, 34 Poliomyelitis..........................5 post exposure profylaxis..........35 potency..............7, 9, 10, 27, 46 prevalence.................35, 36, 46 Prevalence...........................46 Rabies.............................6, 19 refrigerants..........................38 Refrigerants....................38, 39 refrigerator. .8, 12, 13, 14, 17, 22, 24, 25, 26, 38, 39, 42, 43 Refrigerator.........................12 Replacement rate..................46 rubella...........................32, 47 Rubella......................19, 33, 34 Seroconversion......................46 stability.........................27, 47 Stability..............................46 sterile injection....................27 Sterilised.............................46 stopwatch momitor card..........13 supply intervals.....................20

Supply intervals.....................20 temperature. .7, 8, 12, 13, 14, 17, 22, 24, 25, 26, 27, 30, 37, 38, 39, 42, 47 Temperature.....................8, 13 tetanus 6, 7, 10, 11, 25, 32, 41, 43, 44, 46, 47 Tetanus.5, 6, 10, 11, 19, 32, 34, 47 thermometer..............13, 17, 25 thermostat.................13, 24, 26 Thermostat..........................24 Tiny TTM.............................30 toxins......................6, 7, 41, 46 toxoid...............7, 10, 11, 44, 47 Toxoid..................10, 18, 19, 46 toxoid vaccines.....................47 treatment costs.....................32 TT vaccine...........................11 tuberculosis........................6, 9 Tuberculosis..........................5 Typhoid fever.........................6 Unicef................................48 UV light..............................17 vaccination campaign....16, 20, 21 Vaccine efficacy...............47, 48 vaccine potency....................47 Vaccine potency....................48 vaccine requirements..............20 vaccine vial monitor......14, 27, 28 Vaccine vial monitor..........14, 27 vaccines. 6, 7, 8, 9, 10, 11, 12, 13, 14, 17, 19, 20, 21, 22, 24, 25, 26, 27, 29, 31, 33, 34, 41, 42, 43, 45, 46, 47, 48 Vaccines. .5, 6, 7, 8, 10, 12, 24, 31 viral/bacterial......................47 virus...........5, 8, 9, 27, 35, 36, 44 Virus..................................36 who.13, 31, 35, 42, 43, 44, 46, 47, 48 WHO......................6, 14, 27, 34 yellow fever...........27, 43, 45, 47 Yellow fever.....................6, 19 Zidovudine...........................35

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