CHAPTER 2

Contents :
Immunity 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 Six Common Misconceptions about Immunization Definitions of AEFI Few Other Definitions 18 Classification of AEFI Causes of AEFI Description of AEFI Errors Which Led to AEFI Cold Chain Reporting of AEFI Managing Adverse Common Events Immunization Procedures Barrier of Immunization Training International Workshop Regarding Immunization AEFI Reported Cases in Bangladesh 20 21 22 32 33 39 43 48 53 55 56 58 16 17 17

LITERATURE REVIEW

2.1.

Immunity9.

Immunity is a term that originally implied exemption from military service or taxes. It was introduced into medicine to refer to those people who did not get further attacks of smallpox or plague once they had had the disease. In a wide sense the term refers to the resistance of a host organism to invasive pathogens or their toxic products. It is divided into following two main types:

a. Non-specific Immunity (sometimes called Innate Immunity): It includes the

general protective reaction of the organism against invasion.

b. Specific Immunity: This is a specific reaction of the body against non-self

foreign agents, in which its immune products react specifically with the stimulating agent. It is conventionally divided into passive and active immunity, both of which may be either natural or artificial.

Passive Immunity.

Passive immunity involves either the transfer of antibodies or in

some diseases, of sensitized white blood cells, from an immune to a non-immune person. Natural passive immunity is transferred from mother to child across the placenta (and in the colostrum in subhuman primate species). Artificial transfer is the therapeutic use of various antitoxines or gammaglobulins, as in the treatment of tetanus, diphtheria, gas gangrene, snake bite, and immuno-deficiency states. The passive immunity is shortlived, depending on the life-span of the antibody or the transferred cells in the recipient. Once they disappear, the host is again susceptible to the disease. Temporary passive immunization can be produced by administration of an antibody in the form of immunoglobulin in some conditions

Active Immunity.

When a foreign substance is encountered, one of two responses is

observed. Most commonly, there is an active immune response with production of specific antibodies and sensitized cells. Less frequently, an antigen-specific non response
2

referred to as a state of immunologic tolerance may result. An active immune response can follow natural clinical or sub-clinical infection or be induced artificially, by vaccination. There are three essential characteristics of active immunity: a. Recognition b. Specificity c. Memory 2.3. Definitions of AEFI. An adverse event following immunization (AEFI)

is an unwanted or unexpected event occurring after the administration of vaccine(s). Such an event may be caused by the vaccine(s) or may occur by chance after vaccination (ie. it would have occurred regardless of vaccination). Most vaccines cause minor adverse events such as low-grade fever, pain or redness at the injection site. The frequency of adverse events can be classified as follows: very common (>10%), common (110%), uncommon (0.11%), rare (0.010.1%) and very rare (<0.01%)4. WHO defines an adverse event following immunization as: "a medical incident that takes place after immunization causes concern and is believed to be caused by the immunization."10

There are three key aspects to this definition51.

a.

Firstly, it is deliberately loose to encourage reporting of events. This is because it does not restrict the type of event (other than being a health consequence) nor limit the time window after immunization, nor attempt to determine whether the immunization may have been responsible, i.e. it is events, not reactions, that are reported.

b.

Secondly, it describes a belief about causality that requires investigation. The belief that immunization was responsible may turn out to be correct, incorrect, or impossible to assess.

c.

Thirdly, describing an event as an AEFI does not and must not imply causality. (There is only a belief of causality). Only after investigation, it may be possible to assign causality.

Within this framework an AEFI can be either:

a.

Caused by the vaccine or immunization process (causally associated) or

3

b.

A coincidental event that, by chance, happened after immunization

(temporally associated).

In other words, an AEFI is any untoward medical occurrence in a vaccine that follows

immunization and that does not necessarily have a causal relationship with the administration of the vaccine. The adverse event may be any unfavorable and/or unintended sign, abnormal laboratory finding, symptom or disease7. Again an AEFI or vaccine associated adverse event (VAE) is defined as an untoward, temporally associated event following immunization that might or might not be caused by the vaccine or the immunization process.

2.4.

Few Other Definitions7. Serious AEFI is an AEFI that:

Serious AEFI. (1) (2) (3)

Results in death; Is life threatening? Requires in-patient hospitalization or prolongation of an existing

hospitalization; (4) (5) (6) Results in persistent or significant disability/incapacity; Causes a congenital anomaly/birth defect; Is medically important. Life threatening event is an event/a reaction in which the

Life-Threatening Event:

client was at risk of death at the time of the event/reaction; it does not refer to an event/a reaction that hypothetically might have caused death if it were more severe. Example: anaphylaxis. Medically Important Events: Medical and scientific judgment should be exercised in deciding whether other situations should be considered as serious such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the client or may require intervention to prevent one of the other outcomes listed in the definition above. These should also be considered

serious. Examples of such events are intensive treatment in an emergency room or at home for allergic broncho spasm or convulsions that do not result in hospitalization. Unusual or Unexpected AEFI: An event that is not identified in nature, severity, or

frequency among the currently known adverse effects associated with the administration of the product. For example, first reports of intussusceptions following rotavirus immunization. Please refer to the current product information or labeling. Serious AEFI versus Severe: The term "severe" is not synonymous with serious,

and it is used to describe the intensity (severity) of a specific event (as in mild, moderate or severe). The event itself, however, may be of relatively minor medical significance (such as severe headache). Seriousness (not severity), which is based on client/event outcome or action criteria, serves as guide for defining regulatory reporting obligations. Adverse Event versus Adverse Reaction: An Adverse Event is a noxious and unintended response to a vaccine that occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease. An Adverse Reaction, in contrast to an Adverse Event, is characterized by the fact that a causal relationship between the drug and the occurrence is suspected.

2.5

Classification of AEFI:

An AEFI can be classified as:

Table-1 Classification of AEFI8 Types Vaccine Reaction Definition Example due to

An event caused or precipitated by the Anaphylaxis the inherent properties of the vaccine.

vaccine when given correctly. This is due to measles vaccine

Program Error

An event caused by an error in vaccine Bacterial Abscess due to preparation, handling or administration. un-sterile injection.

Coincidental An event that occurs after immunization but Pneumonia 4 days after is not caused by the vaccine. This is due to a oral chance association. Injection Reaction polio vaccine administration. spell in a

Event from anxiety about or pain from the Fainting injection itself rather than the vaccine.
5

teenager

after

immunization. Unknown Events cause cannot be determined. Child dies within 24 hours. In other way, it can be classified into following headings: a. Vaccine-Induced Event. (1) (2) (3) (4) b. Non-specific inflammatory responses (injection site reaction, fever) Immune-mediated response (anaphylaxis) Consequence of replication of microbial agents in vaccine (febrile rash) Direct toxic effect of vaccine component or contaminant

Vaccine Potentiated Event. (1) (2) (3) Vasovagal response (syncope) Hyperventilation Stress-related

c.

Immunization Error. (1) (2) (3) (4) Inappropriate transportation or storage Failure to adhere to recommended schedule Use of expired product or wrong diluents Incorrect: dosage, injecting equipment, sterile technique, route or site of

injection d. Other Event. (1) (2) (3) (4) (5) (6) e. Infection Reaction to concomitant medication Response to environmental allergen or toxin Manifestation of complication of birth injury or inherited condition Trauma Psychogenic illness Cause of the event cannot be determined.
6

Unknown.

Based on casual association, AEFI may also be classified as (i) definitely (ii) Probably (iii) Possibility (iv) unlikely to be related to the vaccine. Again it can be also classified as serious or non serious.

2.6.

Causes of AEFI10.

There are four possible causes of an AEFI:

a. Vaccine Reaction: An event caused by some component of the vaccine - the active component of the vaccine itself, the preservative, the stabilizer or other. The majority of vaccine reactions is "common" and expected, mild, settle without treatment and have no long-term consequences. More serious reactions are very rare and are usually of a fairly predictable (albeit extremely low) frequency. b. Program Error: An event caused by an error in vaccine preparation, handling or administration. c. Coincidence: An event where something happens after the immunization but is not caused by the vaccine or the program. d. Injection Reaction: An event arising from anxiety about the injection. This

reaction is unrelated to the content of the vaccine. 2.7

Description of Types of AEFI51

Vaccine Reactions.

These reactions are caused by a constituent of the vaccine.

In some cases this will be the vaccine antigen (the substance that generates immunity), and is thus a side effect of the immunological process of generating immunity. In other cases it will be caused by other vaccine constituents (e.g. preservatives, stabilizers, antibiotics, or residual substance from the manufacturing process) or the adjuvant that is added to boost the vaccines immunogenicity.

Category of Vaccine Reactions. a. b.

It is of two types:

Common, usually minor and self-limiting Rare and more serious

The reason that there are only these two types of vaccine reaction is that any vaccine that caused a serious reaction that was even relatively common would either not be licensed for use or withdrawn when the frequency of the serious adverse event is identified. An example of this was the withdrawal of the first rotavirus vaccine because it was found to
7

cause intussusception in about 1 in 10,000 vaccinees. Similarly, oral polio vaccine (OPV) is no longer used in most industrialized countries because it carries a risk of about 1 in 2 - 3 million of causing polio. However, the current use of OPV in developing countries and its previous use in other countries, reflects the fact that the vaccine risks need to be balanced against the risk of the disease and the cost of the alternative (inactivated vaccine in the case of OPV).

Common Vaccine Reactions.

The common reactions are caused by the bodys

response to the vaccine antigen(s) and the other vaccine constituents. In general they occur within 24-48 hours of vaccination and are self-limiting. However reactions following live vaccines (e.g. MMR) may be delayed and resemble a mild version of the disease.

Table-2: Symptoms and Signs Caused by MMR Vaccination and Day of Peak Occurrence
Symptoms or Sign Maximum Difference in Rate (%) Local Erythema(>2 cm) Other Local Reaction Mild Fever (< 38.50C rectal) Moderate Fever (< 38.60C -39.50C ) Mild Fever (>39.50C l) Irritability Drowsiness Diarrhoea Arthropathy Nausea and/or Vomitting 0.8 0.4 2.7 2.9 1.4 4.1 2.5 0.7 0.8 -0.82 8 0.1-1.4 0-1.4 0-6.1 1.6-4.3 0.7-2.1 2.1-6-1 1.4-3.6 0-1.7 0.2-1.3 -1.6-0
1

CI 95%

Peak Frequency (Days after Vaccination) 2 2 10 9 10 10 11 11 7-9 7-8

Between MMR group and placebo group More in placebo injected children

Reference: Peltola H, Heinonen OP. Frequency of true adverse reactions to measlesmumps-rubella vaccine. A double-blind placebo-controlled trial in twins. Lancet 1986;1(8487):939-42 Common reactions are usually a local reaction at the site of injection and/or systemic symptoms. For the local reaction there is pain, swelling and/or redness at the injection site, which can vary in severity and last for up to for a few days. The systemic symptoms can include fever and a range of non-specific symptoms (e.g. irritability, malaise, offcolour, loss of appetite). For live virus vaccines, the systemic symptoms can be a mild form of the disease (e.g. fever, rash for measles vaccine). The common reactions usually take place within a day or so of immunization - except for live attenuated vaccines such as measles/MMR, where reactions occur 6 to 12 days after immunization (the time taken for the vaccine virus to replicate). Common reactions are usually only last a few hours to a few days. The frequency and severity of these common reactions vary by vaccine and by person.

Table-3: Vaccine

Summary of Common Minor Vaccine Reactions with Management Local Reaction (Pain, Fever Swelling, Redness) Irritability, Malaise and Non-Specific Symptoms

BCG1 Hepatitis B

Common Adult uo to 30% Children up to 50%

Rare 1-6%

Rare Rare

Measles1 OPV DPT2 Treatment

Upto 10% None Up to 50% Cold cloth

Up to 5% Lass than 1% Up to 50% at Give extra fluid Wear clothing Tepid sponge or bath
Paracetamol3

Up to 5% Lass than 1%4 Up to 60% Give extra fluid

injection Site
Paracetamol3

cool Paracetamol3

Local reactogenicity varies from one vaccine product to another, depending on

the strain and number of viable bacilli

2

With whole cell pertussis vaccine. A cellular pertussis vaccines rate lower. Paracetamol Dose: up to 15mg/kg every 4 hours, maximum of 4 doses in 24

hours.
4

Diarroea, Headache and/ or muscle pain.

Reference: Epidemiological Unit, Ministry of Health, nutrition& Welfare, Sri Lanka, Immunization Handbook, National Extended Programme on Immunization, Sri Lanka2002, Funded by World Health Organization.

Rare Vaccine Reactions.

While there is some similarity between the common

reactions caused by all vaccines, the rare more serious reactions tend to be more specific
10

to each vaccine. Most of the rare and more serious vaccine reactions (e.g. seizures, thrombocytopaenia, hypotonic hypo-responsive episodes, persistent inconsolable screaming) do not lead to long-term problems. Anaphylaxis, while potentially fatal, is treatable without leaving any long-term effects. Although encephalopathy is included as a possible rare reaction to measles or DTP vaccine, it is not certain that these vaccines in fact cause encephalopathy (brain inflammation).

Table-4: Summary of Rare, Serious Vaccine Reactions, Onset interval and Rate Vaccine Reaction Onset Interval BCG Suppurative lymphadenitis 2-6 months Number of doses per Reactions per reaction 1 in 1-10, 000 million doses 100-1000

BCG osteitis

1-12 months

1 in 3,000 to 1 in 100 0.01-300 million

Disseminated BCG infection Hep B Anaphylaxis

1-12 months 0-1 hour

~in 1 million

0.19-1.56 1-2

1 in 6-900,000

Measles1 Febrile seizures

6-12 days

1 in 3000

330

Thrombocytopaenia (low platelets)

15-35 days

in 30,000

30

Anaphylactoid allergic) reaction

(severe 0-2 hours

~in 100,000

~10

11

Anaphylaxis

0.1 hour

~in 1,000,000

~1

Encephalopathy OPV Vaccine

6-12 days

<1 in 1,000,000 1 in 2.4-3 million

<1 ~0.42

associated 4-30 days

paralytic poliomyelitis DPT Persistent (>3 hours) 0-24 hours 0 in 15 to 1 in 1,000 1,000-60,000

inconsolable screaming

Seizures

0-2 days

in 1,750 to 1 in 12,500

80-5703

Hypotonic, responsive (HHE)

hypoepisode

0-24 hours 1 in 1,000-33,000 30-990

Anaphylaxis

0-1 hour

1 in 50,000

20

Encephalopathy
1

0-2 days

0-1 in 1 million

0-1

Approximately 90% of those receiving a second dose are already immune.

Reactions do not occur if the child/women are already immune. This is not the case for anaphylaxis where this type of reaction is more likely on the second or subsequent doses.
2

The risk of VAPP is higher after the first dose (1.4-3.4 Per Million Doses)

compared with the second and third doses (0.17 Per Million Doses)
3

Seizures mostly febrile and risk depends on age, with much lower risk in infants

under the age of 4 months. Reference: Epidemiological Unit, Ministry of Health, nutrition& Welfare, Sri Lanka, Immunization Handbook, National Extended Programme on Immunization, Sri Lanka2002,Funded by World Health Organization.

12

Program Errors.

Programme errors result from errors and accidents in vaccine

preparation, handling, or administration. They are preventable with good practice, appropriate facilities and equipment. Vaccinator technique in choosing the site for the injection, the depth of the injection, and the speed of injection may affect the rate and extent of local reactions. A programme error may lead to a cluster of events associated with a particular provider, health facility, or even a single vial of vaccine that has been inappropriately prepared or contaminated. Programme errors can also affect many vials (e.g. by freezing vaccine during transport, leading to an increase in local reactions and loss of effect). Globally, the most common programme errors are non-sterile injections leading to bacterial or viral infections. Injection technique can also lead to increased local reactions for example giving intramuscular injections too superficially.

Program Errors Leading to Adverse Events:

Failure to comply with strict

procedures to assure sterility of injections may lead to cross-infections such as hepatitis B and C and HIV. Vaccines used in national immunization programs are extremely safe and effective, although adverse events can occur following immunization. In addition to the vaccines themselves, the process of immunization (program error) can be a potential cause of an adverse event.

Table-5: Program Errors Leading to Adverse Events8 Program Errors Non-sterile injection: a. Reuse of disposable syringe or needle b. Improperly sterilized syringe or needle c. Contaminated vaccine or diluents Infection (local suppuration at injection site, abscess, cellulites, systemic infection, sepsis, toxic shock syndrome,transmission of blood borne virus like HIV, hepatitis B Possible Adverse Event

d. Reuse of reconstituted vaccine at or hepatitis C) subsequent session

13

Vaccine prepared incorrectly: a. Vaccine reconstituted with incorrect Local Reaction or abscess from inadequate diluents. shaking

b. Drugs or other substance substituted for Effect of incorrect diluents or drug, e.g, vaccine or diluents. Immunization injected in wrong site: a. Subcutaneous instead of intradermal for BCG b. Too superficial for toxoid vaccine (DPT, DT, TT) c. Buttocks Vaccine transported or stored incorrectly Contraindications ignored Sciatic nerve damage ( and ineffective vaccine) Increased local reaction from frozen vaccine (and ineffective vaccine) Avoidable severe vaccine reaction e.g., anaphylaxis in case of known history of allergy. Local reaction or injection site abscess muscle relaxation, insulin.

Reference: Epidemiological Unit, Ministry of Health, nutrition& Welfare, Sri Lanka, Immunization Handbook, National Extended Programme on Immunization, Sri Lanka2002,Funded by World Health Organization. Injection Reactions. Individuals can react in anticipation and as a result of the pain of any injection. This reaction is unrelated to the content of the vaccine. Some individuals may be needle-phobic, aggravating such reactions. The injection reaction can lead to a group event. The event is essentially a psychological reaction that spreads between individuals of the group (who are usually primed for this by high levels of anxiety), when a member of the group suffers a reaction such as a faint or other vaccine reaction.

Fainting (vaso-vagal reactions) is a relatively common injection reaction, but usually only affects children aged over five years. Fainting does not require any
14

management beyond placing the patient in a recumbent position, preferably the recovery position. The likelihood of faints can be anticipated when immunising older children, and reduced by minimising stress in those awaiting injection through short waiting times, comfortable room temperatures, preparation of vaccine out of recipients view, and privacy during the procedure. Avoiding injury from the fall is important, and those at particular risk should be immunised while lying down; the faint however can occur many minutes after the immunization.

Hyperventilation as a result of anxiety about the immunization leads to specific symptoms of light-headedness, dizziness, tingling around the mouth and in the hands, and sometimes chest pain.

Younger children tend to react in a different way, with vomiting a common anxiety symptom. Breath-holding may occur, which can end in a brief period of unconsciousness during which breathing resumes. They may also scream to prevent the injection or run away. Clear explanations about the immunization and calm, confident delivery will decrease the level of anxiety about the injections and thus reduce the likelihood of an injection reaction.

It is important to be able to distinguish the loss of consciousness resulting from a fainting (vasovagal) injection reaction to that of anaphylaxis.

Table: 6 Vasovagal Injection to Anaphylaxis Faint Onset Usually at the time or soon after the injection System Skin Pale, sweaty, cold and clammy Respiratory Normal to deep breaths Red, raised, and itchy rash; swollen eyes, face; generalized rash Noisy breathing from airways obstruction (wheeze or stridor)
15

Anaphylaxis Usually some delay between 5-30 minutes after injection

Cardiovascular

Bradycardia Transient hypotension

Tachycardia Hypotension Abdominal cramps LOC, little response once prone

Gastrointestinal Neurological

Nausea/Vomiting Transient LOC, good response once prone

Distinguishing anaphylaxis from a faint (vasovagal reaction) Source: Immunization Safety Surveillance: guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization. Manila: World Health Organization, 1999. Coincidental Events. This is probably the most important type of AEFI, in terms

of impact on immunization program. It is the main cause for the continuing controversy about immunization safety. The distinction between the event happening after immunization and being caused by immunization is not easy to make, and many people find it hard to understand. The automatic assumption is that when B follows A, it is that A caused B. Because large numbers of immunizations are given every day, it is inevitable that in the days following immunization many people will suffer major health events. Most vaccines are given early in life, when infections and other illnesses are common, including manifestations of an underlying congenital or neurological condition. The health event is likely to be blamed on the immunization, simply because of the temporal association between the events that, in fact, reflect chance and coincidence and not a real causal relationship. Examples of false allegations caused by coincidental events

One good example is the association between immunization and

Sudden Infant Death Syndrome (SIDS or cot death). The incidence of SIDS peaks around the age when infant immunizations are delivered. So, many SIDS cases will occur in children who have been recently immunized. Inevitably, when a previously healthy child dies a cause is sought. In some cases there will, purely by chance, have been an immunization, shortly before the death. The only way to clarify if such an event is in fact due to a chance association is through careful studies. In the case of SIDS, controlled studies have shown that the association of SIDS and immunization is purely coincidental and not causal.
16

More recently, there has been much concern around MMR vaccine

causing autism that started from a report of 12 cases with a variable temporal association. Despite many controlled studies that have failed to find a link, many parents remain convinced that their childs autism was due to the vaccine. This association has arisen because MMR is usually given early in the second year of life at a time when autism is recognized.

Anticipating Coincidental Events.

It is possible to predict how often one

would expect to see a coincidental association between a health event and immunization. Using the expected incidence (number of cases per population to be vaccinated per time period) of the health event. For example, assume that one million children aged 1-15 years are immunized in a mass campaign and the background mortality rate for this population is 3 per 1000 per year. Then, 250 deaths can be expected in the month after immunization and 8 deaths on the day of the immunization, simply by coincidence. These deaths will be temporally associated with, even though entirely unrelated to, immunization. A similar calculation is shown in the Table below for infant (aged under one-year) deaths in selected Western Pacific countries for the number of deaths temporally associated with routine DTP immunization (calculated in 1999).

Table 7: Routine DTP Immunization45

Infant mortality Per 1000 live births Calculation =IMR*1,000 N Number of births per year month after immunization =(IMR*N/12)* (nv*ppv /12) *12 Australia Cambodia China 5.7 89.6 36.4 257 874 406 676 20 781 652 331 8199 170 202 week after immunization =(IMR*N/52)* (nv*ppv /52)*52 76 1892 39 277 day after immunization =(IMR*N/365)* (nv*ppv/365)*365 11 270 5596 Number of infant deaths during one year in:

17

New Zealand Philippines

6.68

57 587

86

20

48.9

1 981 529

21 802

5031

717

Coincidental deaths temporally linked to DPT immunization NOTE: Assumes uniform distribution of deaths and children who are near to death will still be immunized. Infant mortality and births from 1998 Western Pacific Region Health Data Bank. IMR= Infant mortality rate per live birth (can substitute for rate of any event). N = Number in population (births used as proxy for numbers aged under one year). nv = number of immunization doses: assumed here to be three visits. ppv = proportion of population vaccinated: assumed here to be 90% for each dose. Note: in calculation of deaths the first line of equation shows number of total deaths in period, second line adjusts for exposure to vaccine within that period, multiplied by the number of periods in the year. 2.8 Errors which can lead to AEFI a. b. c. d. e. f. Too much vaccine given in one dose. Improper immunization site or route. Syringes and needles improperly sterilized. Vaccine reconstituted with incorrect diluent. Wrong amount of diluent used. Drug inadvertently substituted for vaccine or diluent (can result from

inattention when reading labels on vials resulting in mistaking content). g. Vaccine prepared incorrectly for use e.g. an absorbed vaccine not being

shaken properly before use. h. i. j. Vaccine or diluent contaminated. Vaccine stored incorrectly. Contraindications ignored e.g. a child who experienced a serious reaction

after a previous dose of a vaccine is immunized with the same vaccine. k. Reconstituted vaccine used beyond six hours after reconstitution or not
18

thrown out at the end of an immunization session and used at a subsequent one.

2.9

Cold Chain9:

The cold chain is the name given to a system of people

and equipment which ensure that the correct quantity of potent vaccine reaches the women and children who need it from the point of production. The cold chain system is necessary because vaccines are delicate substances that lose potency if they are exposed to temperatures that are too warm or too cold. High levels of immunization coverage are useless if the vaccine that was used is not potent. Figure 2 illustrates the entire cold chain system. There are many steps between the manufacturer of the vaccine and the woman or child in need of immunization. Vaccine must stay at the correct temperature throughout the entire cold chain system when it is transported, when it is stored in a refrigerator or cold store, and when it is used at an immunization session.

Essential Elements.

The two essential elements of the cold chain system are:

a. People to manage vaccine distribution; b. Equipment to store and transport vaccine. The basic cold chain equipment includes: Refrigerators, freezers and cold rooms Cold boxes, Vaccine carriers, Day-carriers and Thermos flasks; Thermometers; Vehicles.

Cold Chain and Logistics (CCL) System45.UNICEF supports national immunization programs in several ways. One critical area is CCL system, as vaccines are biological products that must be kept within a narrow temperature range, usually 2-8 degrees Centigrade (36-45 F). The cold chain refers to the storage and transport equipment that enables vaccine to be kept at this temperature from the point of manufacture to the point of use in an immunization session or a clinic. The CCL system includes: (1) A management information system capable of collecting and reporting data;
19

(2) A stock inventory control system to ensure proper management of all supplies; (3) Storage and warehousing of adequate capacity and quality to ensure their integrity; (4) A distribution/maintenance system for efficient transport to every immunization session; and (5) Sufficient number of trained personnel at every level, with adequate supervision.

Storage of Vaccine Maintaining the Cold Chain9: Vaccines should be stored in cold rooms and/or in refrigerators and deep-freezers maintained at +20C80 C and 200C (depending on the type of vaccine). a. If the temperature is maintained above +80C: 1. Bottles of water (or ice packs filled with water) should be stored in every spare space in the refrigerator, except for one-half of the volume which is needed for air circulation. This helps to stabilize the temperature and prevent wide fluctuations during the day. 2. Ensure that the door of the refrigerator/freezer is opened as few times as possible. The ice packs should be pre-cooled at night in the refrigerator before inserting them in the freezer (except for solar refrigerators, where ice packs should be inserted in the morning). b. If the temperature is maintained below 00 C: 1. Bottles of water (or ice packs filled with water) should be stored in every

spare space in the refrigerator, except for one-half of the volume which is needed for air circulation. This helps to stabilize the temperature and stops it from fluctuating widely during the day. 2. Temperature could be adjusted by turning the temperature control switch

button (Thermostat) in the equipment.

20

3. Windows or ventilators should be kept closed at night to keep the store-room warmer if necessary. 4. If these actions do not ensure that the internal temperature is maintained correctly, the refrigerator should be replaced. c. Storage of different vaccines 1. It is best to store

rooms/freezers/refrigerators.

COLD CHAIN

the

different

vaccines

in

different

cold-

2. The maximum stock of vaccine, diluentsTRNASPORT IN COLD BOX and water bottles (if used) should only take up one-half of the total space available in the refrigerator/freezer. If more than half the space is used, air will not circulate around the vaccine to
Potency maintain the correct temperature in all parts of the refrigerator/freezer. AIRPORT Testing

MANUFACTURER

3. Bottles of water (or ice packs filled with water) should be stored in the refrigerator to keep the refrigerator cool specially if there is frequent interruptions to the energy/power supply.

CENTRAL MEDICAL STORE

COLD BOXES

COLD ROOM -200C COLD ROOM +40C to 80C

DIVISIONAL MEDICAL STORE

COLD BOXES

REFREGERATOR

DISTRICT MEDICAL STORE

VACCINE USE ON ICE/ICE CARRIER VAILS IN THERMOS FLASK WATER t

REFREGERATOR

HEALTH CENTRE
VACCINE CARRIER

THERMOS FLASK

VACCINATOR/MOTHER &CHILD
21

Figure 2 Cold Chain System

Maintenance of Refrigerators/Freezers9

At the stores, if there are more than one

refrigerator/freezer it is better to house them in one room or a separate part of a room. A person should be identified to be responsible for the day to day maintenance of these. He/she should observe the following: a. The room is well ventilated; b. Each refrigerator/freezer is protected from outside heat; c. Direct rays of the sun do not fall on the refrigerator/freezer;
22

d. Each refrigerator/freezer has a different plug point and care should be taken to ensure that the plug is not accidentally disconnected; e. Refrigerator/freezer doors and lids are kept firmly closed; f. Each refrigerator/freezer is defrosted regularly and kept clean. Whenever a layer of ice measuring several millimeters (5 at most) forms on the freezer compartment, the refrigerators should be defrosted; g. Each refrigerator/freezer has a maintenance chart - Refrigerator Record; h. Any problems should be brought to the notice of the relevant officers immediately. A note should be prominently displayed as to whom to be contacted; i. An alternate place to store vaccine during an emergency (an emergency plan)

should be identified and prominently displayed. This place should be identified at the onset in consultation with the DPDHS/RE/MO (MCH)/MOH depending on the stores involved; j. Inventory of equipment is checked annually. During Transport. a. Vaccine stocks should be distributed to the clinic centres packed in

vaccine carriers/day carriers/flasks Figure 5 (do not take excess stocks). b. These should be used even when the clinic is held in a room adjoining the

storage point. c. The correct number of cold packs or the correct amount of ice should be

used to maintain the cold life of the vaccine during transport to and from the clinic and duration of the clinic. d. The vaccine carrier/day carrier/flask should be taken close to the

refrigerator/deep freezer. Packing of Vaccines in Cold boxes/Day Carriers/Thermos flasks Health workers should: a. Remove the ice packs from the freezer; b. Wait for them to be free of frost (approximately 10-15 minutes); c. Place fully frozen ice packs around the inside walls of the the carrier;
23

d. If pieces of ice are used they should be packed in a bag. Amount of ice should be sufficient to ensure cold life of the vaccine carrier/day carrier/thermos flask; e. Stack vaccine and diluents in the vaccine carrier/day carrier/thermos flask; f. Place two layers of frozen ice packs/pieces of ice on top; g. Take precautions to prevent vulnerable vaccines from being frozen (for example, keep them in their packaging/wrap a paper around them); h. Secure the lid tightly. CCL Taskforce at New York45. UNICEF has convened a CCL Taskforce of

partners involved in immunization to enhance and coordinate the collective support provided to national governments. The CCL Taskforce Workshop held in New York from 2-4 November 2009 sought to reach a consensus on the approach and key actions needed to address CCL needs over the next year or so. Workshop members adopted the vision, goals and outcomes articulated at the first CCL Taskforce meeting, held in November 2007. The CCL Taskforce has established four subgroups to advance the work program, viz. (1) Guidance, (2) Monitoring, (3) Advocacy, and (4) Integration. Vision of the CCL Taskforce45. The capacity of National Immunization Programs

is strengthened so that every individual can benefit from vaccines of assured quality delivered in the right amount at the right time through efficient logistics, proper vaccine management, and a well-functioning cold chain system. Outcomes of the Taskforce45.
a. b. c. d.

Adequate number of vaccines are available for every immunization session Vaccine wastage is minimized without affecting coverage Vaccines are stored and transported without temperature damage New vaccine introduction is not constrained by lack of storage/transport capacity

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e.

There is greatly increased coordination and a commitment towards effective integration with procurement and management of other priority health commodities.

2.10

Reporting of AEFI:

Reasons for Reporting about AEFI: Following are the causes for reporting about AEFI: a. b. c. d. To ensure that the vaccines used in our country are safe To maintain public confidence in immunization programs It is a health care professional responsibility It is a legal requirement in many Bangladeshis jurisdictions

WHO should Report: Following personnel may report: a. All vaccine providers b. c. All health care professionals caring for patients who may have had an AEFI All vaccine manufacturers to whom an AEFI report is submitted When an AEFI is severe (death, hospitalization for > 3 days,

WHEN to Report:

congenital abnormality, life threatening), unexpected (in terms of type or frequency) and of concern (to the patient, his/her caregiver(s) or AEFI reporter). When an AEFI occurs within a timeframe that is generally consistent with one or more of the following: a. immunizing agent: 30 days after live vaccine/7 days after killed or subunit

vaccine b. plausible biologic mechanism: up to 8 weeks for immune-mediated events c. reporter suspects the AEFI may be linked to immunization .

WHAT to Report5: Following should be reported in details: a. b. Patient unique identifier, date of birth and sex Immunization Event province/territory where given, date, all vaccines

given including name, manufacturer, lot number, administration site and route, as well as the number in series of vaccine doses if relevant
25

c.

Adverse Event description, including time of first onset following

immunization, duration, health care utilization, treatment and outcome d. AEFI e. Associated Event acute illness, current medication, injury, exposure to Relevant Medical History underlying disease, known allergies, prior

environmental toxins. f. Reporter details.

When an AEFI form needs to be completed: An AEFI form should only be completed for reportable events that are: a. b. OR c. unusual / unexpected (regardless of severity) . serious in nature; OR required an urgent medical attention (not resulting in hospitalization);

Major Adverse Events6: Any reaction that requires immediate medical intervention and/or hospitalization, which may include: a. Anaphylaxis b. Acute Encephalopathy c. Paralysis d. Guillian Barre Syndrome It is normally reported within one working day.

Moderate Adverse Events6: It is normally reported within 5 working days. a. Fever as high as 400C b. Chills/Shivers c. Hives d. Pronounced Drowsiness
26

e. Prolonged Crying or irritability f. Significant nodules/lumps g. Abscesses at injection site

What not to Report6:

It is not required to report the following minor adverse

events that occur frequently following immunization: a. Local redness and/or induration at the injection site b. Local Tenderness c. Painful limb d. Crying, fretfulness, drowsiness, irritability, loss of appetite e. Swelling of lymph nodes near injection site, fever, arthralgia, myalgia f. With live vaccines (MMR, vericella), the reaction may resemble a mild form of disease with a fever and rash 5-14 days following immunization

Events that should be reported after immunization: that should be reported after immunization.

Table-1 shows the events

Table-8: Events that should be Reported After Immunization Occurring within 24 hours of immunization Anaphylactoid reaction (acute hypersensitivity reaction) Anaphylaxis Persistent (more than 3 hours) inconsolable screaming
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 Hypotonic hyporesponsive episode (HHE)

Toxic shock syndrome (TSS)1

Occurring within 5 days of immunization

Severe local reaction

Sepsis1

Injection site abscess (bacterial/sterile)1

Occurring within 15 days of immunization

Seizures, including febrile seizures (6-12 days for measles/MMR; 0-2 days for DTP) Encephalopathy (6-12 days for measles/MMR; 0-2 days for DTP)

Occurring within 3 month of immunization

o Acute flaccid paralysis (4-30 days for OPV recipient; 4-75 days for contact) o Brachial neuritis (2-28 days after tetanus containing vaccine) o Thrombocytopaenia (15-35 days after measles/ MMR)

Occurring between 1 and 12 month after BCG immunization No time limit

1

# Lymphadenitis1 # Disseminated BCG infection # Osteitis/Osteomyelitis Any death, hospitalisation, or other severe and unusual events that are thought by health1

Limit reporting to those events if only limited reporting capacity

Reference: Epidemiological Unit, Ministry of Health, nutrition& Welfare, Sri Lanka, Immunization Handbook, National Extended Programme on Immunization, Sri Lanka2002,Funded by World Health Organization. 2.11 Managing Common Adverse Events Management of an immediate AEFI8. There are four steps of the management of

AEFI and prevention of crisis. They are: a. b. c. Anticipate: Do not wait until crisis occurs. Prepare for unavoidable.

Train vaccination personnel at all levels to respond adequately. Confirm the all facts before making any public statement.
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d.

Prepare a plan to react to a crisis when it occurs.

Why to monitor AEFI? a. No vaccines are 100% safe and without any risks

e. It is important to know the risks and how to handle such an event when it occurs f. Informing people correctly on AEFI helps keep publics confidence in the immunization programmes g. Monitoring AEFI also helps improve the quality of service Advice to Parents on Common Adverse Events. Vaccine injections may result in soreness, redness, itching, swelling or burning at the injection site for 1 to 2 days. Paracetamol might be required to ease the discomfort. Managing Fever after Vaccination. Routine use of paracetamol at the time of

vaccination is no longer recommended. If an infant or child has a fever of >38.5C following vaccination, paracetamol can be given. The dose of paracetamol is 15 mg/kg/dose of paracetamol liquid, up to a maximum daily dose of 90 mg/kg per day in 4 to 6 divided doses for up to 48 hours. Preventing AEFI. The key to preventing uncommon or rare adverse events is to

screen each person to be vaccinated using pre-vaccination screening to ensure that the person does not have a condition which either increases the risk of an adverse event or is a contraindication to vaccination. The correct injection technique is also important. Observation after Vaccination. Recipients of vaccines should remain under

observation for a short interval to ensure that they do not experience an immediate adverse event. It is recommended that recipients remain in the vicinity of the place of vaccination for at least 15 minutes. Severe anaphylactic reactions usually have a rapid onset; most life-threatening adverse events begin within 10 minutes of vaccination. The most serious immediate AEFI is anaphylaxis. However, in adults and older children, the most common immediate adverse event is a vasovagal episode (fainting), either immediately or soon after vaccination. Because fainting after vaccination can lead to serious consequences, anyone who complains of giddiness or light-headedness before or
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after vaccination should be advised to lie down until free of symptoms. Most faints following vaccination occur within 5 minutes, and 98% occur within 30 minutes. Adults should, therefore, be warned of the risk of driving or operating machinery for at least 30 minutes after vaccination. Children who have had a serious adverse event (other than a contraindication, such as anaphylaxis) to a previous vaccine may subsequently be vaccinated under close medical supervision.

Anaphylaxis and Vasovagal Episodes.

Anaphylaxis

following

routine vaccination is very rare, but can be fatal. All immunization service providers must be able to distinguish between anaphylaxis, convulsions and fainting. Fainting (vasovagal episode) is relatively common after vaccination of adults and adolescents, but infants and children rarely faint. Sudden loss of consciousness in young children should be presumed to be an anaphylactic reaction, particularly if a strong central pulse is absent. A strong central pulse (eg. carotid) persists during a faint or convulsion. The features listed in Table 9 may be useful in differentiating these 2 conditions. If the diagnosis is unclear and anaphylaxis is considered, management for this should be instituted with the prompt administration of adrenaline.

Table 9: Clinical Features which may Assist Differentiation between a Vasovagal Episode and Anaphylaxis4
Vasovagal Episode ONSET Symptoms/Signs Skin Anaphylaxis

Immediate, usually within Usually within 15 minutes, minutes of or during but can occur within hours, vaccine administration. of vaccine administration. Generalised pallor, cool, clammy skin.
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Skin itchiness, generalised skin erythema (redness),

urticaria (wheals) or angioedema (localised oedema of the deeper layers of the skin or subcutaneous tissues). Respiratory Normal respiration; may be shallow, but not laboured. Cough, wheeze, stridor, or signs of respiratory distress (tachypnoea, cyanosis, rib recession).

Cardiovascular Bradycardia, weak/absent Tachycardia, weak/absent peripheral pulse, strong peripheral and carotid carotid pulse. pulse. Hypotension usually transient and corrects in supine position. Neurological Hypotension sustained and no improvement without specific treatment.

Feels faint, light-headed. Sense of severe anxiety and Loss of consciousness distress. improves once supine or head down position. Loss of consciousness no improvement once supine or head down position.

Immunization service providers should be able to recognize all the following symptoms and signs of anaphylaxis:

a.

Cutaneous, such as the rapid development of widespread urticarial lesions (circumscribed, intensely itchy weals with erythematous, raised edges and pale, blanched centres) and/or erythema and/or angioedema (soft tissue swelling usually affecting the face and/or limbs),

b.

Upper airway obstruction, such as hoarseness and stridor, resulting from angioedema of the hypopharynx, epiglottis and larynx,

c.

Lower airway obstruction, such as subjective feelings of retrosternal tightness, and dyspnoea with audible expiratory wheeze from bronchospasm,
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d.

Limpness and pallor, which are signs of hypotension in infants and young children,

e.

Profound hypotension in association with other signs of cardiovascular disturbance, such as sinus tachycardia or severe bradycardia, absent central pulses and reduced peripheral circulation, and/or

f.

Abdominal cramps, diarrhoea and/or vomiting. Anaphylaxis is a severe adverse event of rapid onset,

Signs of Anaphylaxis.

characterised by sudden respiratory compromise and/or circulatory collapse. Early signs include involvement of the skin, eg. generalised erythema, urticaria and/or angioedema and/or gastrointestinal tract, eg. diarrhoea, vomiting. In severe cases, there is circulatory collapse with alteration in the level of consciousness, hypotension and weak or absent pulses or marked respiratory compromise from upper airway oedema or bronchospasm.

Table 10: Clinical progression

Sign and Symptoms of Anaphylaxis9 Signs and symptoms Severity of attack

Mild, early warning signs

Itching of the skin, rash and swelling around injection site. Dizziness, general feeling of warmth Painless swellings in part of
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Mild

Mild to moderate

the body e.g. face or mouth. Flushed, itching skin, nasal congestion, sneezing, tears. Hoarseness, feeling sick, vomiting Swelling in the throat, difficulty in breathing, abdominal pain Wheezing, noisy, difficulty in breathing, collapse, low blood pressure, irregular or weak pulse Life Threatening Symptoms Severe Moderate to severe Moderate to severe

Reference: Epidemiological Unit, Ministry of Health, nutrition& Welfare, Sri Lanka, Immunization Handbook, National Extended Programme on Immunization, Sri Lanka2002,Funded by World Health Organization.

Management of Anaphylaxis. Rapid IM administration of adrenaline is the cornerstone of

treatment of anaphylaxis. Anaphylaxis occurs without warning, usually within 15 minutes of giving a vaccine. A protocol for the management of anaphylaxis, adrenaline, and 1 mL syringes must always be immediately at hand whenever vaccines are given. a. If the patient is unconscious, lie him/her on the left side and position to keep the airway clear. If the patient is conscious, lie supine in head down and feet up position (unless this results in breathing difficulties). b. Give adrenaline by IM injection (see below for dosage) for any signs of anaphylaxis with respiratory and/or cardiovascular symptoms or signs. Adrenaline is not required for generalised non-anaphylactic reactions (such as skin rash or angioedema). If in doubt, IM adrenaline should be given.
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c. If there is no improvement in the patients condition by 5 minutes, repeat doses of adrenaline every 5 minutes until improvement occurs. d. If oxygen is available, administer by facemask at a high flow rate. e. Call for assistance. Never leave the patient alone. f. Begin expired air resuscitation for apnoea, check for a central pulse. If pulse is not palpable, commence external cardiac massage (ECM). g. All cases should be admitted to hospital for further observation and treatment. h. Document the time and dose of adrenaline given. Experienced practitioners may choose to use an oral airway if the appropriate size is available, but its use is not routinely recommended unless the patient is unconscious. Antihistamines and/or hydrocortisone are not recommended for the emergency management of anaphylaxis.

Adrenaline Dose. Adrenaline 1:1000 contains 1 mg of adrenaline per mL of solution

in a 1 mL glass vial. Adrenaline 1 in 10 000 is no longer recommended for the treatment of anaphylaxis. The use of 1:1000 adrenaline is recommended because it is universally available. Use a 1 mL syringe to improve the accuracy of measurement when drawing up small doses. The recommended dose of 1:1000 adrenaline is 0.01 mL/kg body weight (equivalent to 0.01 mg/kg or 10 g/kg) up to a maximum of 0.5 mL, given by deep IM injection (not the deltoid). Adrenaline 1:1000 must not be administered intravenously. Table 11 lists the dose of 1:1000 adrenaline to be used if the exact weight of the individual is not known. Table 11: Doses of Intramuscular 1:1000 (one in one thousand) Adrenaline for Anaphylaxis4 Less than 1 year 12 years (approx. 10 kg) 23 years (approx. 15 kg) 46 years (approx. 20 kg) 710 years (approx. 30 kg) 1112 years (approx. 40 kg) 0.050.1 mL 0.1 mL 0.15 mL 0.2 mL 0.3 mL 0.4 mL

13 years and over (over 40 kg) 0.5 mL

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The dose of 1:1000 (one in one thousand) adrenaline may be repeated every 5 minutes as necessary until there is clinical improvement. 2.12 IMMUNIZATION PROCEDURES9. Following are the procedures to be

following during immunization:

a.

Pre-vaccination questionnaire.

Before vaccination, the doctor, the

nurse, the public health inspector or the public health midwife should make sure that the individual to be vaccinated does not have a condition (or a history of a previous condition) which could increase the risk of a severe reaction. One way to do this is to routinely inquire about such conditions. The following information is needed to assess the fitness of a person for vaccination. (Inform the parents, that the conditions listed below do not necessarily mean that their child cannot be vaccinated today. But they should inform the doctor if any of the following conditions are presents: The person to be vaccinated: is unwell today; is having treatment which lowers immunity (e.g. steroids such as

cortisone and prednisolone, radiotherapy, or chemotherapy); has had a severe reaction to any vaccine; has any severe allergies to vaccine components (e.g. neomycin); has a disease which lowers immunity (e.g. leukaemia, cancer); has had a vaccine containing live viruses within the last month

(e.g. measles, poliomyelitis, yellow fever or rubella vaccines), or an injection of immunoglobulin or a blood transfusion within the last three months; has a disease of the brain or the spinal cord

b.

Standard vaccination procedure

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(1) Before administering vaccines, the following procedures should be followed: (a) Check whether preparations have been made to respond immediately to adverse reactions; (b) Read the product information; (c) Ensure that valid consent is given; (d) Provide the parent or guardian with a pre-immunization questionnaire; (e) Check whether there are any contra-indications to vaccination from the pre-vaccination assessment; (f) Check the identity of the recipient; (g) Check the identity of the vaccine to be administered; (h) Ensure that vaccines have been stored correctly; (i) Check the vaccine to be administered for obvious signs of deterioration (check expiry date and note any particular matter or colour change that may indicate damage to the vaccine); (j) Ensure that the correct vaccines are being administered according to the schedule; (k) Administer the vaccine, using the correct technique (see details below on needle selection, needle angle, injection location, and position of the subject).

(2) After administering the vaccine, do the following:

(a) Give instructions, preferably in writing, to the parent or guardian regarding what to do in the event of common reactions or serious adverse reactions; (b)Record the vaccination in the child health development record and in the clinical notes. c. Storage. Vaccines that are not stored and transported correctly will lose

potency. The instructions of the product leaflet should be followed. The general rule
36

for most vaccines is that they should be refrigerated at +2oC to +8oC and NOT FROZEN. Some vaccines such as DTP, Hib, hepatitis B and hepatitis A vaccines are inactivated by freezing. d. Reconstitution. The vaccines should be used within the recommended time

period (with gentle shaking the dried cake/power is easily dissolved). They should be kept under proper cold chain conditions and protected from heat and sunlight. Note that reconstituted measles vaccine deteriorates rapidly at room temperature. A sterile 21 gauge needle should be used for reconstitution and a separate 23 gauge needle 25 mm in length should be used for administration of the vaccine. e. Cleaning of Skin. The injection site should be cleaned. After cleaning,

alcohol and other disinfecting agents must be allowed to evaporate before injection of vaccine since they can inactivate live vaccine preparations. Clean water could be used, if other cleaning agents are not available. f. Route of Administration. Almost all vaccines are given by intramuscular or

deep subcutaneous injection. The two major exceptions are Oral Polio Vaccine (OPV), which is given by mouth and never injected and BCG, which is given by intradermal injection. Although intramuscular or deep subcutaneous injection route can be used for most vaccines, the intramuscular route is generally recommended because of the difficulties that some health professionals experience with subcutaneous injection of vaccines. g. Standard Technique and Needle size for Injection of Vaccines. Persons administering vaccines should observe standard health and safety guidelines given by the Department of Health Services in order to minimize the risk of spread of infection and needle stick injury. A sterile reusable syringe and needle or a new, sterile, auto-disable syringe and needle should be used for each injection. A syringe or needle which has been used to inject a person should never come in contact with the vial. Auto-disable needles and syringes should be discarded into a safety box. The standard needle for vaccine injection is 23 gauge and 25 mm in length. Intradermal immunization (for BCG vaccination) should be given with a 25 gauge and 10 mm long needle. h. Needle angle for Intramuscular Injection. The needle should be inserted at an angle of 45 to 60 degrees into the vastus lateralis or deltoid muscle. For the vastus lateralis, the needle should point towards the knee and for the deltoid, the needle
37

should point towards the shoulder. Neural and vascular damage are more likely if the needle is inserted at a 90 degree angle. Insertion at 45 to 60 degrees may result in less tissue resistance as the needle penetrates the muscle. i. Recommended Sites of Injection for Vaccination. The anterolateral thigh is the preferred site for vaccination in infants and children under 12 months of age. The deltoid region is an alternative site for vaccination in older children and adults. The hepatitis B and rabies vaccines are less immunogenic if injected into the buttock. Therefore, these vaccines should not be injected into the buttock in subjects of any age. j. Drawing up Vaccines from Ampoules. For vaccines that are drawn through

rubber bung, or are reconstituted, a new needle should be used for administration. A needle or syringe, that has been used to inject a person, must never be used to draw vaccine from vaccine vial because of the risk of cross-contamination. k. Administration of two or more Vaccines on the Same Day. Administration of different antigens/vaccines on the same day is recommended. Inactivated vaccines and live attenuated virus vaccines, particularly those in the national EPI schedule (childhood schedule) can generally be given during the same visit. Vaccines that should be administered by injections should be given at different sites (e.g. DPT, M, MR and hepatitis B). More than one live attenuated virus vaccine may be given on the same day; but if only one is given, a second live attenuated vaccine should not be given within 4 weeks of the first vaccine because the response to the second vaccine may be diminished. In addition there is a specific interaction between some vaccines (e.g. yellow fever and cholera vaccines) and they should not be given within 4 weeks of each other. It is also recommended that a three week interval should be allowed between the administration of live virus vaccines (except O.P.V.) and BCG vaccine. Different vaccines should not be mixed in the same syringe unless it is clearly stated in the instructions of the manufacturer (given in the information schedule supplied by the vaccine supplier). Different vaccines given to a person on the same day should be injected at different sites using different syringes. l. Consent. Prior to vaccination, parents/guardian should be given adequate

information including type of vaccine, disease protected, number of doses needed for protection, contraindications, adverse events and what to do if adverse events occur to make an informed decision
38

m. Consent in Special Programs/mass Vaccination/school Programmes. In large scale school programs a valid consent from the parent or guardian should be obtained before administration of vaccine. Prior to vaccination, parents or guardian should be given adequate information in a leaflet to make an informed decision. If a childs health status or suitability for vaccination cannot be established, vaccination should be postponed. n. Recording of Vaccination. Each vaccination provider should record all relevant vaccination data on the child health development card or other immunization card. Parents and guardians should be encouraged to present the record at every time their child is seen by a health professional. The following should be recorded: (1)The date of vaccination; (2)Details of the vaccine given, including batch number (3)The name/signature of the person providing the vaccination (4)Any severe or moderate adverse event; (5)Date the next vaccination is due o. Immunization Registers. The health staff conducting the

immunization clinic (health unit, other clinics or hospital clinics) should enter the necessary information in the relevant registers according to the instructions given by the Department of Health Services. p. Adverse Events Following Immunization (AEFI).Recipients of vaccines

should remain under observation until they are seen to be in good health and not be experiencing an immediate adverse reaction. It is not possible to specify an exact length of time for post-vaccination observations but it is recommended that recipients should remain in the clinic/hospital for about 15 minutes. Parents or guardian should be provided with the necessary information before leaving the clinic on how to act if the child develops an adverse event following immunization. Children who have had a serious adverse event following vaccination may be subsequently vaccinated under close medical supervision in a hospital. q. Anaphylaxis. In infants and children, the most important immediate reaction to vaccination is anaphylaxis. The incidence of anaphylaxis reactions varied with the
39

type of vaccine. But the incidence of true anaphylaxis is only 1-3 cases per million vaccinations. Any member of the health staff carrying out vaccination procedures must be able to distinguish between anaphylaxis, convulsions and fainting. r. Reporting of AEFI. Adverse events following immunization with EPI vaccines including MR, and adult Td vaccines should be reported to the respective hospitals.

2.13.

Barriers for Immunization. Despite the availability of safe and effective

vaccines, and enormous progress in reducing vaccine-preventable diseases, the effective delivery and acceptance of vaccinations continue to be challenges for healthcare providers and healthcare systems. The growing number of vaccines, the complexity of the vaccination schedule, and the increasing focus to the public on vaccine safety add to the increasing difficulty of achieving and maintaining age-appropriate vaccinations. Overcoming these challenges is essential to further reduce and eliminate vaccinepreventable causes of morbidity and mortality in the country. It is clear that high national immunization rates should not cause complacency. Even with our currently high vaccination rates, vaccine-preventable diseases among children and adolescents remain important continuing causes of morbidity and mortality. Barriers that result in a lack of community or individual demand for immunizations include a weak public health policy (eg, one that does not require or enforce vaccination requirements for school entry) and misinformation or incomplete information about vaccines and the diseases they prevent. Barrier 1: Limited Access to Vaccination Services in Traditional Venues. Normally hospitals are ideal place for vaccinations. But in some area, due to geographical locations the hospitals are quite far and communication to hospital is not always that good. So sometimes, people are not willing to go. At the same time, it is very difficult to carry all accessories to provide vaccination. Because, some vaccine requires to keep in control temperature. Obviously, ensuring communication with hospital is essential. Barrier 2: Vaccine Shortages and Delays. Sometimes vaccine shortage, hinder the immunization program. For instances, Beginning in 2000, the U.S. experienced vaccine supply disruptions of unprecedented scope and magnitude. Although the early supply disruptions have been resolved, new problems have evolved. It appears that a fragile vaccine supply will be part of the immunization environment in the U.S. for the foreseeable future. There is no single reason for the supply disruptions. Four factors, which are somewhat interrelated, play a role: 1) business decisions to leave the market;
40

2) production problems; 3) adherence to requirements for current Good Manufacturing Practices; and 4) recommendations to remove thimerosal as a preservative. In 2002 and 2005, the National Vaccine Advisory Committee (NVAC) organized workshops to identify the reasons for vaccine shortages and develop strategies and solutions to prevent shortages in the future. The NVAC workshops, consisting of members of the various constituencies involved in vaccine supply, identified 5 general issues that need to be addressed to strengthen the vaccine supply in the U.S.: 1) providing incentives to maintain current vaccine manufacturers and encourage new manufacturers to enter the market; 2) streamlining regulatory authority; 3) strengthening liability protections for consumers, manufacturers, and providers; 4) implementing a more comprehensive program of vaccine stockpiles; and 5) developing an educational program that provides information to parents and vaccine recipients about the use and value of vaccines.

Barrier 3: Lack of Public Health Policy Requiring Immunizations. Enactment and enforcement of state immunization laws requiring immunization before school entry helped achieve the current high vaccination rates of school-age children. The effectiveness of school entry requirements is demonstrated by the higher percentages of children with up-to-date vaccinations when entering kindergarten compared to younger children, and the substantial increase in hepatitis B and second measles immunizations in states with middle school vaccination requirements. Childcare, school, and college entry vaccination requirements are beneficial for children and young adults and appear to be effective nationwide, regardless of race, ethnicity, and/or socioeconomic status. Barrier 4: The community or individuals in the community are uninformed or misinformed about the safety and importance of vaccinations. Community vaccine education programs can provide most or all of a population or subpopulation in a geographic area with knowledge and information that may change their behavior in favor of acceptance of vaccines. Education strategies include mailings, messages delivered through the schools and media, telephone calls, and posters. These interventions have the potential to reduce disparities in immunization rates between inner-city and suburban children, and among racial and ethnic minority populations. Barrier 5: Lack of specific information about what vaccines are needed or were given. Supplying patient-held medical records is an intervention that provides personal medical records to members of a target population or their families. Such records show
41

which vaccinations have been received. State and local health departments and many providers have encouraged the use of patient-held medical records to varying degrees. Patient-held medical records could result in increases in vaccination coverage by increasing knowledge about and demand for vaccinations among parents, by reducing missed opportunities to vaccinate in healthcare settings, or a combination of the two.

2.14

Training.

Training is always one kind of welfare. Because it builds

confidence among the trainees. Even periodical training also play significant role in gaining confidence.

a.

A national core committee for training in immunization should continue

to oversee and contribute to development of materials and methods for training in immunization. b. Performance indicators and expected performance for basic healthcare

workers should be defined. c. Pre-service/in-service training curricula should be re-designed to be

relevant to the expected performances of these cadres. This training should be competency-based, hands-on, practical, preferably including coached sessions in the field, before certification. There is an urgent need to train health workers on: (1) Micro planning for routine immunization (2) Injection safety and waste disposal (3) Immunization of children not immunized as per the schedule. d. Refresher training should be designed to meet the performance needs of

the basic healthcare workers. e. A team of master trainers should be trained at the national and regional

health training centres, who are not only knowledgeable and skilful in the subject matter but also competent in delivering competency-based training. All the available resources (government training centres, public and private schools of health professionals, NGOs, UN organizations, etc.) should be utilized to form such a team.
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2.15

International Workshop Regarding Immunization11

Workshop at Nepal. The Global Training Network Workshop on AEFI was held in Kathmandu, Nepal, from 4-10 November 2001. The objectives of the workshop were: (1) To provide participants with the skills, awareness and information needed to develop or strengthen national and sub-national vaccine safety systems, and (2) To encourage collaboration between national immunization programs, National Regulatory Authorities and with other key players to minimize and prevent risk of harm associated with immunization or perceived to be associated with immunization. The occasional severe adverse event or cluster of adverse events associated with the use of vaccines may rapidly become a serious threat to public health programs, if not handled correctly. In addition, as vaccine preventable diseases become less visible through effective immunization programs, the public tends to focus more on AEFIs than on the disease threat. It is essential that national monitoring and reporting systems for vaccine safety are efficient and adequately coordinated to deal with such events and that public concerns are addressed through sound communication strategy at national as well as community levels. The cornerstone of an AEFI system is rapid investigation and identification of causal factors. This becomes even more crucial during mass immunization campaigns.

The objectives of the training were as follows: a. To develop an appreciation for the importance of a national immunization safety program b. To develop or strengthen the detection and reporting system for AEFI within a country c. To investigate an AEFI or cluster of AEFIs d. To analyze and assess data on AEFIs e. To assess the need and carry out corrective action in response to an AEFI or cluster of AEFIs f. To evaluate actions taken in response to AEFIs
43

g. To understand the importance and the respective roles of NRA and national immunization programs and other role players in ensuring the safety of vaccines used in immunization programs h. To promote collaboration and communication between NRA, national immunization programs, the Ministry of Health, health professionals, the media, patients and parents and the public. i. To consider and present a draft plan of action by each country for strengthening the national immunization safety program for implementation. The workshop used various techniques to encourage participant interaction, learning, and sharing experiences. These include facilitator presentations, small group discussions, small group work sessions, case studies, role-playing, and individual country presentations. 2.16 AEFI Reported Cases in Bangladesh55: Bangladesh has developed the

surveillance system for AEFI in 1998-99 (CES 2000). In this regard preparation of AEFI surveillance manual, format development and training for fields staffs of several districts and upazilla level have completed. Regardless of the type of AEFI, national EPI authority have selected 6 types of events which are reportable and require further investigation. Those are called trigger events. Officially, surveillance and reporting of AEFI have been started in several districts and upazillas from April 2003.

In 2004, there were following reported four cases : a. Three suspected polio cases. In Rangpur (Rajshahi division) , Khulna (Khulna division) and Bandarban (Chittagong division) districts) b.One death of boy aged six in Khulna (Khulna Division) One boy dies after administration of Vitamin-A capsule in Munshiganj (Dhaka division) during NID In 2003, there were following cases reported10 a. 3 deaths in Jamalpur (Dhaka division) after measles vaccination b. Six more fell ill, later recovered c. All deceased were 10-month old
44

d. Two girls, one boy

45