Immunization

Revised National Immunization Schedule 2080

S.N	Vaccine	Age	Route	Frequency	Site	Dose	Prevent against
1	BCG (Bacillus Calmette Guerin)	At birth	Intradermal	Once	Rt. arm	0.05ml	Tuberculosis
2	Pentavalent Vaccine (Diphtheria, Pertussis, Tetanus, Hepatitis B and Hemophilus influenza B)	6, 10 and 14 weeks	Intramuscular	Thrice at 1 month interval	Lt. lateral mid-thigh	0.5ml	Diphtheria, pertussis, Tetanus, Hepatitis B and Haemophilus Influenza B
3	OPV (Oral Polio Vaccine)	6, 10 and 14 weeks	Oral	Thrice at 1 month interval	Oral	2 drops	Poliomyelitis
4	PCV (Pneumococcal Conjugate Vaccine	6, 10 weeks and 9 months	Intramuscular	Thrice	Rt. lateral mid-thigh	0.5ml	Pneumococcal diseases (Meninges, ear and chest infections)
5	Rotavirus vaccine	6, 10 weeks	Oral	Twice	Oral	1 tube 0.5ml	Rotavirus diarrhea
6	fIPV (Fractional Injectable Polio Vaccine)	Child under 1 year (14 weeks and 9 months) Child under 5 years (Missed dose): 2 doses should be separated by 8 weeks	Intradermal	Twice	Lt. upper arm	0.1 ml	Poliomyelitis
7	MR (Measles – Rubella)	9 and 15 months	Subcutaneous	Twice	Lt. upper arm	0.5 ml	Measles and Rubella
8	JE (Japanese Encephalitis)	12 months	Intramuscular	Once	Rt. lateral thigh upper	0.5 ml	Japanese Encephalitis
9	Typhoid Vaccine	15 months	Intramuscular	Once	Lt. lateral mid-thigh	0.5ml	Typhoid
10	Tetanus Diphtheria	Pregnant woman	Intramuscular	First dose after the knowledge of pregnancy, 2nd dose after 1 months (Subsequent pregnancies 1 dose)	Lt. upper arm	0.5ml	Tetanus Diphtheria

Immunity

Immunity refers to the ability of immune system to defend against diseases caused by microbes or foreign substances. Immunity depends upon various factors like host resistance, dosage of organism injected and virulence of the organisms. 

The power of resistance to infection may be natural i.e., it may be inherited or innate or it may be acquired as a result of previous infection or by inoculation. 

Immunity is the state of protection against disease, usually infectious disease, mediated by a collection of molecules, cells and tissues collectively called the immune system.

Immunity is conferred by the immune system, a complex network of lymphoid organs, including the bone marrow, thymus, spleen etc. Immunity is referred to the resistance exhibited by the host towards injury caused by microorganism and their products.

Classification of immunity

1. Innate/Natural Immunity

It is also called natural or native immunity, consist of mechanisms that exist before infection and are capable of rapid responses to microbes. This immunity is possessed by man and animal either from birth or is acquired during growth by virtue of its species racial or individual before the contact with and antigen.

Types of Natural immunity:

1. Species immunity: -Species immunity is the total immunity shown by all members of a species against pathogen; e.g. birds immune to tetanus.
2. Racial immunity: – Racial immunity is that in which various races show marked difference in their resistance to certain infectious disease. For examples; certain African race are more resistant to malaria and yellow fever where are Asian or Americans are susceptible to same infection.
3. Individual immunity: – We often see that all people exposed to infection do not develop the disease during epidemic. Among those who develop it, may suffer more severely than others; all these differences are due to individual peculiarities of the person.

2. Acquired immunity

a. Active immunity

Active immunity is the immunity which a person develops when s/he comes in contact with pathogenic organisms or with their products. The body stimulated to produce its own antibodies to fight against the infections. In most of the diseases once the antibodies have been developed the person is immune to further infection for longer or lifelong, such immunity providing disease or vaccinations are BCG, Polio, DPT, Measles etc.

Types of active immunity

• Natural active immunity- is acquired when a person gets diseases like chickenpox, measles etc. or is acquired by sub clinical infection e.g. poliomyelitis.
• Artificial active immunity- can be acquired by administration of vaccines which contain micro- organisms their toxoid or a combination of these two.

b. Passive immunity

Passive immunity can be acquired by an individual when antibodies produced in one body are transferred to another person.

• Passive natural immunity – Maternal antibodies are transferred to the fetus through the placenta or breast milk. These antibodies do not last for a long period so these antibodies protect the infant only for 3-9 months against certain diseases as tetanus, chickenpox, diphtheria, measles etc. This trans placental transmission depends upon the immunity against these diseases; no antibodies of that particular disease will pass through placenta to the fetus.
• Passive artificial immunity– The serum that contains specific antibodies gives immunity when injected into a suspected animal. This immunity is of short duration and is of particular value in treatment when antibodies are lacking in the blood of the patient during accident, injuries or in diseases like diphtheria and tetanus, passive immunization has been used for curative and prophylactic purposes e.g. Anti-tetanus serum for tetanus, Anti-D immunoglobulin for Rh iso-immunization and other immunoglobulin for various purposes. It also includes the post exposure vaccination of Hepatitis-B, meningitis, encephalitis etc.

Immune response

• Primary response:  Upon initial administration of an antigen to an individual with no prior exposure, there is a latent induction period lasting 3 to 10 days before antibodies emerge in the bloodstream. The initial antibody response is exclusively of the IgM type. Over the subsequent 2-3 days or more, the IgM antibody titre steadily increases, reaching a peak level before declining nearly as rapidly as it initially developed. In the presence of an adequate antigenic stimulus, IgG antibodies appears within a few days. IgG levels peak within 7-10 days and then gradually decline over weeks or months. The nature and magnitude of the primary response to an antigen are influenced by various factors, including the antigen dose, nature of the antigen, route of administration, presence of adjuvants, and the nutritional status of the host. For instance, small antigen doses may elicit only an IgM response, and successive small doses of antigen administered at appropriate intervals may also induce IgM antibody production.
• Secondary (booster) response: The response to a booster dose differs from the primary response in several ways: a shorter latent period, more rapid antibody production, increased antibody abundance, sustained higher levels of antibody response over an extended period, and antibodies with greater avidity or binding capacity to the antigen. The secondary response involves the production of both IgM and IgG antibodies. Collaboration between B and T cells is crucial for initiating a secondary response. While there is a brief production of IgM antibodies, there is a larger and more prolonged production of IgG antibodies. This accelerated response is attributed to immunological memory. The immune response, encompassing both primary and secondary responses, along with immunological memory, forms the basis of vaccination and revaccination.

National Immunization Programme of Nepal

National Immunization Programme (NIP) is the first priority program of Nepal. Launched as “Expanded Program on Immunization” in 2034 BS, national Immunization program has met several milestone during the past decades, including reduction of under 5 mortality goal (MDG 4).

The first diseases targeted by the EPI were diphtheria, whooping cough, tetanus, measles, poliomyelitis and tuberculosis. Global policies for immunization and establishment of the goal of providing universal immunization for all children by 1990 were established in 1977, this goal was considered an essential element of the WHO strategy to achieve health for all by 2000. Currently, 13 antigens are provided through national immunization program. The new initiatives of “Reaching Every Child” through declaring country as Fully Immunized initiated in 2012 has gained its height through community involvement and as of the date 18 districts and more than 1800 VDCs have been declared as fully immunized.

As of 2010, Nepal has been declared polio-free, and the country transitioned from using trivalent Oral Polio Vaccine (tOPV) to bivalent Oral Polio Vaccine (bOPV) on April 17, 2016 (Baisakh 5, 2073). This transition aligns with global efforts to enhance polio eradication strategies.

Immunization serves as a proven and effective tool for controlling and, in some cases, eradicating infectious diseases. Notably, a successful global immunization campaign led by the World Health Organization (WHO) between 1967 and 1977 resulted in the eradication of smallpox, marking a historic achievement in public health.

Furthermore, Nepal has sustained the maternal and neonatal tetanus elimination status since 2000, highlighting ongoing efforts to prevent and control vaccine-preventable diseases, particularly among mothers and newborns.

Immunization

Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against subsequent infection or disease.

Immunization is a process of protecting an individual from a disease through introducing of live, killed or weak organisms into the individual system.

Immunizing agents

The immunizing agents may be classified as vaccine, immunoglobulin and antisera.

Vaccines

Vaccine is a substance prepared from disease causing agent or its toxic produce that stimulated for the production of specific antibody. Vaccines may be prepared from live modified organisms, inactivated or killed organisms, extracted cellular fractions, toxoid or combination of these.

Types of vaccines

1. Live attenuated vaccines

Live vaccine e.g. BCG, measles, oral polio are prepared from live (generally attenuated) organisms. These organisms have been passed repeatedly in the laboratory in tissue culture and have lost their capacity to induce full blown disease but retain their immunogenicity.

b. Inactivated or killed vaccines

Inactivated vaccines are produced by growing virus or bacteria in culture media and then inactivating them with heath or chemicals (usually formalin) when injected into the body they stimulate active immunity. They are usually safe but generally less efficiency than live vaccines. Killed vaccine usually required primary series of 2 to 3 dose of vaccine to produce an adequate antibody response and in most cases booster injections are required. The duration of immunity varies from months to many years with the use of inactivated vaccines. Killed vaccines are typhoid, cholera, pertussis, influenza and hepatitis B etc.

c. Toxoids

They are prepared by detoxifying exotoxins from certain organisms that produce exotoxins e.g. diphtheria and tetanus bacilli. The toxins produced by these organisms are detoxicated and used in the preparation of vaccines. The antibodies produced neutralize the toxic moiety produced during infection rather than act upon the organism. Toxoids are highly effective and usually safe.

d. Cellular fractions

Some vaccines are prepared from extracted cellular fractions e.g. meningococcal vaccine from the polysaccharide part of cell wall and the pneumococcal vaccine from the polysaccharide contained in the capsule of the organism. These are safe and effective.

e. Combination

If more than one kind of immunizing agent is included in the vaccine, it is called mixed or combined vaccine. The aim of combined forms of vaccine is to simplify administration, reduce costs and minimize the number of contacts with the health center. The well-known combinations are:

• DPT (Diphtheria, Pertussis, Tetanus)
• DT (Diphtheria, Tetanus)
• DPT+ Hepatitis B+ Hib (Hemophilus influenza B)
• DP (Diphtheria, Pertussis,)
• DPT+ Hepatitis B
• DPT+ Typhoid vaccine
• MR (Measles, Rubella)
• MMR (Measles, Mumps, Rubella)

Immunoglobulin

The antibodies are localized in the immunoglobulin fraction of the serum immunoglobulin are divided into 5 main classes- IgG, IgM, IgA, IgD and IgE each class representing a different functional group. These antibodies circulate in the body and act directing by neutralizing the microbe or its toxin or rendering the microbe susceptible to attack by the polymorph nuclear leucocyte and the monocyte.

The five subclasses of antibodies are:

Immunoglobulin A (IgA) which is found in high concentration in the mucous membranes, particularly those lining the respiratory passages and gastrointestinal tract as well as in saliva and tears. It provides the primary defense mechanism at the mucous membranes against local infection

Immunoglobulin G (IgG) antibody is found in all body fluids. It can diffuse into the interstitial fluid and also transferred across the placenta and provide immune to newborn. Antibodies to gram positive pyogenic bacteria, anti-viral and anti-toxic antibodies are found exclusively among IgG globulins and protects against bacterial and viral infections.

Immunoglobulin M (IgM), which is found mainly in the blood and lymph fluid is the first antibody to be made by the body to fight a new infection. It represents antibody that is promptly formed with exposure to antigen. Its presence may be indicative of recent infection.

 Immunoglobulin E (IgE) which is associated mainly with allergic reaction when the immune system overreacts to environmental antigens such as pollen or pet dander. It is found in the lungs, skin and mucous membranes. 

Immunoglobulin D (IgD) which exists in small amounts in the blood, is the least understood antibody.

Antisera or antitoxins

Antiserum is passive immunization that was achieved by the administration of antisera or antitoxins prepared from non-human sources such as horses. Since diseases, antitoxins prepared from non-human sources (against tetanus, diphtheria, gas gangrene and snake bite) are still the mainstay of passive immunization. Administration of antisera may occasionally give rise to serum sickness and anaphylactic shock due to abnormal sensitivity of the recipient.

Contraindications of immunization

• Extensive skin infection or burns
• Immunosuppressive therapy e.g. corticosteroids drugs
• Agammaglobulinemia (low antibodies in blood lack of lymphocytes and lymph)
• Being moderately or severely (badly) ill with or without fever. History of a severe allergic reaction to previous dose (itching, rashes, convulsion etc.)
• Long-term treatment with steroid medicine.
• Weak immune system. The immune system is the part of the body that normally fights off sickness and disease. A weak immune system may be caused by cancer, HIV or AIDS, inborn immune deficiency, or taking medicines, such as chemotherapy.
• Severe reaction after eating eggs.

BCG vaccine

BCG (Bacillus Calmette-Guerin) is a vaccine against tuberculosis that is prepared from a strain of the attenuated (weakened) live bovine tuberculosis bacillus. BCG vaccine is discovered by two French Scientists, Calmette and Guerin in 1906 and became injectable in 1927.

Types of vaccine

• Liquid (fresh) vaccine
• Freeze dried vaccine.

Storage: Store away from sunlight and  cool dry place at 2-8°C. This vaccine need to be reconstituted with diluent, water before use. It may be used up within 4 hours and the remains should be discarded but in practice it is used within 6 hours.

Age: Soon after birth to1 year.

Dose: 0.05ml for newborn and 0.1ml above 1 year of age.

Side effect:

• Headache
• Fever (pyrexia)
• Hardening of skin at injection site, followed by a lesion that may ulcerate & heal over some months, leaving a small flat scar
• Swelling of the lymph nodes near the injection site
• Occasionally, an excessive response to the vaccine resulting in a discharging ulcer.

Nursing management

• Do not apply any oil or medication over the ulcerated area; instead, cover it with a clean, soft cloth.
• It heals by itself leaving behind a keloid mark.
• Ask the parents to return of abscess or enlargement of glands occurs.

Complication

BCG has been associated with adverse reactions which include prolonged severe reaction at the site of vaccination, suppurative lymphadenitis (occurs in 1-10% of vaccination). The risk of adverse reaction is related with using by BCG with different manufacture, the dose, the age of child, the method of immunization and the skill of vaccinator.

DPT (Diphtheria, pertussis and tetanus), Hepatitis B, Hib

The combine vaccine five in one consisting DPT+Hep B+ Hib (Diptheria, Pertusis, Tetanus, Hepatitis B and Hemophilus influenza type b) is known as pentavalent. It provides protection against diphtheria, pertussis, tetanus, hepatitis B and Haemophilus Influenza type b.

Storage: in a refrigerator between 2-8°C and use within a week. It loses its potency if kept at room temperature or if freeze.

Age: 6 weeks after birth to 1 year.

3 doses of pentavalent vaccine are to be administered at 6, 10 and 14 weeks of age.

Route: 0.5 ml intramuscular

Side effect:

• Fever within 24 hours
• local soreness, pain, warmth and swelling
• Abscess appears after a week or more due to wrong technique
• Anaphylaxis shock-convulsion

Nursing management

Nursing management guidelines for vaccine administration include the following:

1. Apply cold compression at the injection site.
2. Advise parents to return if fever persists for more than 36 hours or if vomiting occurs after vaccination.
3. In case of abscess formation, perform incision and drainage to release pus.
4. Ensure dressing is conducted using antiseptic techniques.
5. If a child experiences convulsions after vaccination, investigate the cause and consider avoiding the pertussis vaccine in future doses.
6. Inform parents of children with a family history of seizures about the increased risk of seizures following DPT administration. Provide instructions on appropriate medical care in the unlikely event of a seizure.
7. Recognize that due to the extended incubation period of Hepatitis B (up to 6 months or more), vaccination may not be effective in cases of prior exposure to the Hepatitis B virus.

Polio vaccine

Polio vaccines are vaccines used to prevent poliomyelitis. It is essential to immunize all infants to protect them against poliomyelitis.

Types

1. Oral polio vaccine
2. Inactivated polio vaccine (IPV)

1. OPV (Sabin type)

Oral polio vaccine was discovered by Albert Sabin in 1957. It contains live attenuated virus and given orally with the dose of 2 drops. This vaccine is commonly used worldwide. It is clear pink or pale liquid. It comes in a special small plastic bottle with a dropper cap. It gives 50% immune after 1 dose and 95% immune after 3 doses and provides immunity for long time.

There are different types of oral poliovirus vaccine, which may contain one (monovalent), a combination of two (bivalent) or all three (trivalent) different serotypes of attenuated vaccine.

Monovalent oral poliovirus vaccine (mOPV): Monovalent OPVs for type 1 (mOPV1) and type 3 (mOPV3) poliovirus were licensed again in 2005. They elicit the best immune response against the serotype they target of all the vaccines.

Bivalent oral poliovirus vaccine (bOPV): Bivalent OPV contains only attenuated virus of serotypes 1 and 3 in the same number as in the trivalent vaccine.

Trivalent oral poliovirus vaccine (tOPV): Prior to April 2016, the trivalent oral poliovirus vaccine (tOPV) was predominant vaccine used for routine immunization. It consists of mixture of live, attenuated polioviruses of all three serotypes called Sabin vaccine.

Storage: It can be frozen and refrozen without damage so it can be kept at -20°C in deep freeze. It is easily damaged by heat than other vaccines.

Age: 6 weeks, 10 and 14 weeks after birth to 1 year

Dose: 2 drops, orally (3 doses)

Side effects:

• Aspiration once wrong technique is used.
• Convulsion or shock rare.

2. IPV inactive polio vaccine/Salk type

The first polio vaccine was the inactivated polio vaccine, developed by Jonas Salk. This killed-virus vaccine protects against all three types of the poliovirus (types 1, 2, and 3). However, it is not particularly useful for controlling epidemics because immunity is not rapidly achieved; more than one dose is required to induce immunity. Furthermore, injections are to be avoided during epidemic times, as they are likely to precipitate paralysis.

Currently Inactivated Polio Vaccine (IPV) has stock out globally and has stopped temporarily and introduced as fractional IPV (fIPV) in 2018.

Fractional Inactivated polio vaccine

A fractional dose of IPV is a smaller dose of the same vaccine equal to 1/5 of a standard dose. Studies show that 2 doses of fractional dose IPV administered by intradermal injection produce an even stronger immune response than a single full IPV dose.

fIPV is given as an intradermal injection (ID), at a 10-15° angle, by the same technique as the BCG injection. Administer fIPV in the upper arm (opposite to that in which the BCG given).

Storage 2 to 8° C

Dose: 0.1 ml

Pneumococcal Conjugated Vaccine (PCV)s

PCV vaccine is given to protect infants against disease caused by the bacterium streptococcus such as pneumonia, acute middle ear infection, meningitis, septicemia etc.

Storage: store and transport between 2-8°C. Liquid vaccines, including the pneumococal vaccine, must not be frozen.

Age: Infant (under 12 month).

Dose/ Volume: 3 doses at (6^{th week}, 10^{th week} and 9 month)/volume of 0.5 ml in each vaccination.

Route/Site of administration: Intramuscular injection/Right lateral mid-thigh.

Side effects:

Mild side effect such as soreness, pain, swelling or redness at the injection site, fever.

Rota virus vaccine

It is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children. It is important to understand that rotavirus vaccine will not prevent or protect diarrhea or vomiting caused by other germs, but it is very effective in preventing diarrhea and vomiting caused by rotavirus. This means that even when children are fully immunized against rotavirus, they may still get diarrhea caused by other agents. Rotavirus vaccine is in a solution form for oral use. It comes in a tube specially designed for direct oral administration.

There are two brands of the rotavirus vaccine

— RotaTeq (RVS) and Rotarix (RVI).

Both vaccines are given orally and it is effective and safe. The only difference is the number of doses that need to be given. With RotaTeq, three doses are required and Rotarix only requires two doses.

Storage: Rotavirus vaccines must be stored between +20C and +8 0C.

Target age: 6 and 10 weeks of birth.

Indication: Used to protect against rotavirus infections

Route:- Oral

Side effects of the Rotavirus Vaccine

Mild side effects are as follows;

• Increased irritability
• Diarrhea
• Vomiting
• Mild fever
• Ear infection

The risk of serious side effects of Rotavirus vaccine is low but sometimes there is chance of a serious side effects and allergic reaction. Signs of an allergic reaction can include difficulty breathing, wheezing, hives, paleness, fast heart beat etc.

Serious side effects are as follows;

• Seizure
• Severe diarrhoea
• high fever (greater than 102°F)
• Redness of skin or eyes
• Pain in their stomach or chest
• Pain while urinating.

Health teaching

• Provide advice to parents on rotavirus disease and diarrhea prevention measures, including the importance of vaccination.
•  Explain potential side effects after immunization and encourage parents to visit the health center promptly if any concerns arise.
• Additionally, inform them about the next scheduled visit for administering the second dose of the vaccine and emphasize the importance of timely vaccination.

MR vaccine

The MR vaccine is a vaccine that protects against measles and rubella all of which are potentially serious diseases of childhood. This vaccine is replacing the currently given measles vaccine. It is live attenuated, safe and effective vaccine.

Storage: Protect from light and store in dark area at 2-8°C .Following reconstitution the vaccine can be used within 4 hours if that stored at 2-8° C

Age: 9-15 months of age at least following primary measles vaccine.

Dose: 0.5 ml subcutaneously

Side effect:

• Fever
• Mild rash
• Swelling of glands in the cheeks or neck (rare). If these, problem occurs it is usually within 7-12 days after the shot. They occur less often after the second dose.

Site of vaccination: Left upper arm

Dose of vaccine -2 dose

Quantity of vaccine 0.5 ml

Japanese Encephalitis (JE)

It is a vaccine that protects against Japanese encephalitis. The duration protection with the vaccine is not clear even it is more than 90% effective. It is recommended as part of routine immunization program to protect vulnerable populations through immunization. The vaccination campaigns against JE began in 2006 using live attenuated SA-14- 14-2 JE vaccine in high risk districts. As of 2010, the campaigns were completed in 23 districts. All persons above 1 year of age were vaccinated in 12 districts and persons above 1 year of age and below 15 years of age were vaccinated in 11 districts.

JE vaccine was introduced into the routine immunization program in 2009 the post JE campaign districts. As of 2010, 23 districts have introduced JE into routine immunization targeting children 12-23 months of age. The coverage ranges widely from 8-73%. (Source: Nepal cMYP 2012-2016)

Types of JE vaccine

The Japanese encephalitis (JE) vaccines currently available are either

• inactivated,
• live attenuated –many countries in Asia currently use this vaccine in their immunization program including Nepal
• live recombinant.

Storage: Store at 2-8 °C not longer than 2 hours and away from light after. If the vaccine is not used immediately after reconstitution it should be stored at at 2°C- 8°C not longer than 2 hours and away from light. After 2 hours it should be discarded. Never stored in freezer compartment.

Age: Between 1-2 years’ single dose

Dose: 0.5 ml above 1-2 years

Side effect:

• Soreness, redness, or swelling where the shot was given.
• Fever, headache, muscle pain, abdominal pain, rash, chills, nausea/vomiting, dizziness.
• If these problems occur, they usually begin soon after the shot and last for a couple of days..

Route/ Site of administration: It should be administered subcutaneously to the outer mid-thigh or upper arm depending on the age of the child.

Side effects from live attenuated vaccine

• Injection site reactions
• Fever, vomiting, abnormal crying, drowsiness, appetite loss and irritability, headache, muscle pain, flu-like symptoms and fatigue.

Typhoid vaccine (Typhoid Conjugated Vaccine)

There are currently three safe and effective types of typhoid vaccines available globally: typhoid conjugate vaccines (TCVs), live attenuated Ty21a, and a Vi capsular polysaccharide vaccine (ViCPS). 23,24 The latter two have been available since the early 1990s. 25 In 2017, WHO prequalified the first TCV and the Strategic Advisory Group of Experts (SAGE) recommended routine TCV vaccination for infants over 6 months of age in endemic settings, with children up to 15 years old targeted through catch-up campaigns. Typhoid conjugate vaccines (TCVs) is for preventing typhoid fever due to Salmonella typhi.

In 2017-18, TCV vaccination trials were conducted in Bangladesh, Malawi, and Nepal to generate evidence on the impact of a newly developed vaccine. Typhoid conjugate vaccines have been prequalified by WHO since December 2017 and are being introduced into childhood immunization programmes in typhoid endemic countries.

In routine immunization: At the age of 15 months

Storage: 2-8°C freeze sensitive

Dose: 1 dose (0.5ml)

Route of administration: Intramuscular injection in mid outer left thigh

Side effect: Fever, headache, redness, swelling, joint pain

Tetanus Diphtheria (TD)

Td vaccine in place of TT help to decrease diphtheria outbreaks. The use of Td rather TT is recommended during pregnancy to protect against maternal and neonatal tetanus & diphtheria during prenatal care. For pregnant women, 2 doses before delivery: the 1^st dose as soon as possible during pregnancy and the 2^nd dose at one month apart after the 1^st dose in first pregnancy, 1 dose in each subsequent pregnancy.

Storage: Between 2 °C and 8 °C. Do not freeze.

Route: Intramuscular injection into the deltoid muscle

Dose: 0.5 ml

Common Side Effects

• Pain, redness, or swelling where the shot was given
• Mild fever
• Headache
• Feeling tired
• Nauseas, vomiting, diarrhea, or stomach ache

Roles and responsibilities of Public Health Nurse in immunization program

Planning and implementation immunization session

Immunization aims at reduction in disease, morbidity and mortality. The full course of potent vaccine must be given at the right age to achieve maximum benefit. In collaboration with the health team member, the CHNs shoulder the responsibility to schedule immunization session and to ensure that they are conducted properly. It is important to cover all pregnant women and infants in the community to achieve National Immunization Program. The activities at various levels are as follows.

1. Enumeration of eligible: The CHN/health worker should prepare the list of beneficiaries in the area covered by him/her and send their list to the concerned authority well in advance. This will enable the latter to take an adequate quantity of materials and vaccine for the immunization sessions.

Estimation of beneficiaries

Number can be calculated by using following formula:

• Population X Birth Rate= Number of pregnant women
• Population X Birth Rate X 1-IMR=Number of infants surviving at 1year age. For: e.g. if the population served by a health center is 30, 000 the birth rate 30/1000 and IMR 74/1000 live births the excepted number of pregnant women and infants will be
• 30,000X0.03=900 (no of pregnant women)
• 30,000X0.03X (1-0.07) =837 (number of infants)

The estimation of the beneficiaries should be worked out at each level locally and compared with the list maintained by the health worker to ensure to completeness of registration. At any given time, 100% of the total estimated annual number of infants and 60% pregnant women should be registered.

2. Identifying nonparticipants and dropouts: After enumerating the eligible, the health workers should identify nonparticipants in their area and also find out the dropouts. If any the reason for the same and make special efforts to motivate these beneficiaries.

3. Meet with the community: The community should be informed and motivated enough to come for immunization till the completion of the full course, by meeting its members. In the meeting, the nurse must explain the local endemic problems, importance and benefits of the immunization and objectives of the National Immunization Programme. This also helps in enumeration of eligible and conducting the immunization sessions.

4. Identification of influence: The identification of influence must be done by the health worker judiciously.by virtue of their position and popularity an influencer can motivate the community for accepting immunization.

5. Identify communication site: The health workers must identify the communication site where people gather for work or at leisure. This helps to give health education and motivate the people to adopt health practices by discussion with health personnel or by displaying A>V aids for education and motivation. Detailed information about immunization session should be displayed beforehand at the site and at prominent places by putting up broads etc.

6. Schedule for immunization sessions: The session should be scheduled at a time and place, convenient to the community. Advance information of the sessions should be given to the community. The session should take place inside a building or in the shade at a time of the day when the temperature in not maximum. All efforts must be made to hold the session on that fixed day. Immunization should never be undertaken by paying house to house visits. Always conduct immunization, preferably in a room and if no room is available in a cool shaded place

7. Organize immunization sessions

The CHN should prepare themselves for the session a day earlier as follows:

• CHN should estimate the requirements of the vaccine for session on the basis of list of beneficiaries and should carry the required vaccines in the vaccine carrier with frozen ice packs and reach the site of session on time.
• The vaccine requirements depend on the number of eligible beneficiaries and the number of sessions held. The calculation of the estimation of eligible already discussed in first point of the same substitute.

8. Materials and equipment

• Sufficient number of sterile syringes and needles
• Sterile forceps
• Sufficient quantity of each vaccine in the vaccine carrier
• Adequate quantity of ice cubes when require
• BCG kits
• Immunization cards
• Immunization register
• Soap and towel
• File to open ampules
• Bowl for keeping ice
• Cotton swabs
• Pen

Arrange the materials and equipment on immunization table.

The community health nurse should check the following before proceeding to the immunization session:

1. Whether ice packs in the vaccine carrier are frozen.
2. Exposure of vaccine carriers to direct sunlight is minimized
3. The DPT, DT and TT are not frozen to shake test. If frozen discard and replace with potent ones.
4. The exact number of ampules/vials required is carried to the session.
5. AD (Auto-Disable) syringes are recommended for immunization programmes because they are designed to prevent re-use by locking automatically after a single use.

The CHN should ensure that the session should be at ranged in a methodical way:

• Beneficiaries should be seated in an orderly way
• Entry of the register and immunization card should be made after giving the vaccination
• The date, of vaccine and age of infant/baby should be clearly entered
• The CHN should check the vaccine again for its label, dose, any damage of vial and potency
• The dosage of vaccine administration should be strictly according to quantity recorded on the vial by manufacturer. It should neither be more nor less.
• When using the vaccine, do not use a vial without a label; a cracked vial and without shaking thoroughly.
• Do not use the opened vials in subsequent sessions.
• Start immunization with the polio vaccine and then administer the other vaccine. Ensure that the child has swallowed the polio vaccine completely.
• Talk about the dangers of dropping out also explain minor reactions expected.
• The parents should be informed of the expected side effects so that they do not worry. If there is any anxiety, they should be encouraged to return to the health centers for consultation preventable diseases, benefits of immunization and the schedule for EPI.

Adverse Event Following Immunization (AEFI)

AEFI is defined as any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. Reported adverse events can either be true adverse events, i.e. actually a result of the vaccine or immunization process, or coincidental events that are not due to the vaccine or immunization process, but are temporally associated with immunization.

Cause-specific categorization of AEFIs

1. Vaccine product-related reaction: An AEFI that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product.
2. Vaccine quality defect-related reaction: – An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccine product, including its administration device as provided by the manufacturer.
3. Immunization error-related reaction – An AEFI that is caused by inappropriate vaccine handling, prescribing or administration and thus by its nature is preventable.
4. Immunization anxiety-related reaction: – An AEFI arising from anxiety about the immunization.
5. Coincidental event: – An AEFI that is caused by something other than the vaccine product, immunization error or immunization anxiety.

Different types of Adverse Events Following Immunization (AEFI)

1. Acute flaccid paralysis: acute onset of flaccid paralysis within 4 to 30 days of receipt of oral poliovirus (OPV) or within 4 to 75 days after contact with a vaccine recipient and neurological deficits remaining 60 days after onset or death.
2. Anaphylactoid reaction: exaggerated acute, allergic reaction, occurring within 2 hours after immunization, characterized by one or more of the following.

• Wheezing and shortness of breath due to bronchospasm
• Laryngospam/laryngeal edema
• One or more skin manifestations e.g. hives, facial edema or generalized edema (less severe allergic reaction do not need to be reported).

3. Anaphylaxis: severe immediate (within 1 hour) allergic reaction leading to circulatory failure with or without bronchospasm and/or laryngospasm/laryngeal edema.

4. Disseminated BCG infections: widespread infection occurring within 1 to 12 months after BCG vaccination and confirmed by isolation of mycobacterium bovis BCG strain. Usually in immune-compromised individuals.

5. Encephalopathy: acute onset of major illness characterized by any two of the following three conditions:

• Seizure
• Severe alteration in level of consciousness lasting for one day or more
• Distinct change in behavior lasting one day or more

Needs to occur within 48 hours of DPT vaccine or from 7 to 12 days after measles vaccine, to be related to immunization.

6. Fever: the fever can be classified as:

• Mild fever: 100.4°F- 102°F
• High fever102. °F – 104.7°F
• Extreme fever 104.7°F or higher

Only high and extreme fever should be reported.

7. Hypotonic, Hyporesponsive Episode (HHE): event of sudden onset occurring within 48 (usually less than 12) hours of vaccination and lasting from one minute to several hours, in children younger than 10 years of age. All of the following must be present.

• Limpness (hypotonic)
• Reduced responsiveness (hyporesponsive)
• Pallor or cyanosis or failure to observe/recall

8. Injection site abscess: fluctuant and draining fluid filled lesion at the site of injection. Bacterial if evidence of infection (e.g. purulent inflammatory signs, fever, including bacteria), sterile abscess if no evidence of bacterial infection on culture. Sterile abscesses are usually due to the inherent properties of vaccine.

9. Lymphadenitis (includes suppurative lymphadenitis): either at least are lymph node enlarged to > 1.5 cm in size (one adult finger width) or a draining sinus over a lymph node. Almost exclusively caused by BCG and then occurring with and to 6 months after receipt of BCG vaccine, on the same side as inoculation.

10. Seizures: – occurrence of generalized convulsion that are not accompanied by focal neurological sign or symptoms.

• Febrile seizure: if temperature elevated >100.4°F.
• Afebrile seizures: if temperature is normal.

11. Sepsis: – acute onset of severe generalized illness due to bacterial infection and confirmed (if possible) by positive culture. Needs to be reported as possible indicator of program error.

12. Severe local reaction: – redness and/or swelling centered at the site of injection and one or more of the following:

• Swelling beyond the nearest joint
• Pain, redness and swelling or more than 3 days’ duration
• Requires hospitalization

13. Toxic shock syndrome: – abrupt onset of fever, vomiting and watery diarrhea within a few hours of immunization often leading to death within 24-48 hours. Needs to be reported as possible indicator of program error.

Responsibilities of health service providers in preventing, managing and reporting AEFIs

1. Adverse events following immunization should be reported immediately to the relevant authorities or individuals responsible for handling such incidents.

2. Assist in the referral process for any suspected cases of adverse events following immunization. This may involve coordinating with healthcare facilities for further evaluation and treatment.
3. Adhere to best immunization practices. This may include following established protocols and guidelines to ensure the safety and effectiveness of the vaccination process.
4. Record specific details in the vaccinator’s logistics diary to facilitate the management of adverse events at the vaccination site. These details include:
   • Manufacturer’s name
   • Expiry date
   • Batch number
   • VVM (Vaccine Vial Monitor) status for new and partially used vaccines
   • Date on the label of partially used vaccine.
   • For reconstituted vaccines, note the date and time of opening on the label.
5. Treat minor/non-serious adverse events (such as mild symptoms like fever or pain) symptomatically.
6. For serious or severe cases, provide immediate first aid and refer the individual experiencing the adverse event to an appropriate health facility for prompt treatment and reporting.
7. Assist in the investigation of adverse events following immunization and take corrective actions based on the guidance received.
8. Training the staff in detecting, managing and reporting of AEFIs and differentiating between minor and serious/severe events. Encourage the staff to report AEFIs.
9. Ensure availability of emergency drugs and medical equipment to deal with an adverse event. Regularly check the emergency kits (functional status of equipment and expiry of drugs)
10. Ensure timely notification to the AEFI committee to investigate AEFI and for reporting to the National Immunization Committee.
11. Detailed information of all serious, severe and minor AEFIs should be recorded in AEFI register.

References:

Park, K. (2021). Park’s textbook of Preventive and Social Medicine (26th ed.). Bhanot Publishers.

For more details: Click here