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IAP GUIDEBOOK ON IMMUNIZATION
Editors

Dr. Raju C Shah Dr. Nitin K Shah Dr. Shyam Kukreja

IAP Committee on Immunization 2005-2006

Chairperson: Dr. Raju C. Shah Co- Chairperson: Dr. Nitin K. Shah Convener: Dr.Shyam Kukreja Members: Dr. Rohit Agarwal Dr. Indra Shekhar Rao Dr. Shivananda Dr. Nigam P Narain Dr. Sangita Yadav Ex-officio members: Dr. Deepak Ugra Dr. Tapan Kumar Ghosh Dr. VN Yewale Dr. Naveen Thacker Dr AP Dubey Dr Surjeet Singh
Address for correspondence:

Indian Academy of Pediatrics Kailas Darshan, Keneddy Bridge Near Nana Chowk Mumbai India 400 007 Tel: +91-22-3889565 E-mail: iapcoff@bom5.vsnl.net.in
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Preface

Immunization is the single most successful child survival s t rat egy the world over. Immunization also reduces morbidity to great extent. Due to progress in molecular biology and genetic engineering a number of new vaccines have become available and many more are in the pipeline. Many of the developed countries have reduced their vaccine preventable disease burden by using this tool very effectively. As Pediatricians we must be conscious of the fact that the immunization needs of the children are quite dynamic. A vaccine which may not be considered important today may become n ecessary in future as more informat ion about the epidemiology of the disease becomes available. The inclusion of an y n ew v accine in the universal immunization program of a country depends on disease epidemiology, availability of safe vaccine, economic constraints and logistic problems. Unfortunately the limiting factor most of the times in developing countries like India is the affordability. There is always a need to update knowledge and co n cep t s es pecially in the field of immunization as there is continuous flow of new knowledge. Also one must try to objectively understand a difference between a public health measure paid for by the government and a personal safety measure instituted by the individual at one's own cost due to certain limitations. To get the most benefits for any vaccine (herd effect), adequate immunization coverage is required. Unfortunately, in our country the routine immunization coverage rates have slipped down over the last few years. This is a matter of great concern to all of us. This has been one of the major obstacles in polio eradication program. There is an urgent need to reinforce quality immunization services and our academy has always been at the forefront of this initiative. We are sure this updated guidebook will continue to serve as ready reckoner on issues concerning vaccines and immunization in our country.

Dr. Raju C Shah

Dr. Nitin K. Shah

Dr. Shyam Kukreja

Chairperson, IAPCOI 2005- 2006 President IAP 2005

Co-Chairperson, IAPCOI 2005-2006 President IAP 2006

Convener, IAP COI 2005- 2006

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Contents

Introduction Historical aspects Basic immunology National immunization schedule Commonly used vaccines Newer vaccines Vaccines used in special circumstances Combination vaccines IAP Immunization Time-Table Immunization in special circumstances Adverse reactions following immunization The cold chain Surveillance for vaccine preventable diseases Vaccination in the current millenium IAP COI meeting report and policy updates

5 6 8 10 11 24 27 30 34 36 42 44 49 50 51

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Introduction

Protect ion from preventable diseases, disabilities and death through immunization is the birth right of every child. Immunization is one of the most co s t-effective health intervention s known to mankind Over the last three decades, a lot of progress has been made globally as far as protection against the eight important vaccine preventable diseases is concerned - from less than 5% children who were protected against these diseases in the early 1970s, to as many as 75% being protected now. Small pox has been eradicated and we are at the threshold of eliminating polio.

consensus based on the current evidence from the literature. The IAP Immunization Time Table represents the 'best individual practices schedule' for a given child and would necessarily be at some variance from the National Immu n ization Schedule of the Government of India, which is meant for the public at large. With the availability of many newer vaccines, it is necessary that some of these should be considered for routine immunization and the immu nization schedule has to be changed accordingly.

An effective National Immunization strateg y can help decrease childhood morbidity and mortality, especially in developing countries. It must, however, be clear that immunization strategies may vary from co u n try to country depending on the local req u irements. This guide book represents the collective effo rts of the members of the Indian A cademy of Pediatrics Co mmittee on Immunization (IAP COI). We are aware that unanimity may not always be possible as far as the need and timing of certain newer vaccines are concerned, but we have made efforts t o arriv e at a

Unfortunately, there is lack of authentic data on epidemiology of most infectious diseases in our country. However that should not deter us from using some of these vaccines till such data is generated. Many decisions on incorporation of new vaccines in t he immunization program have, therefore, to be based on data from other parts of t h e world. This may appear unscientific to some, but is a reality and is the only way out at present.

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Experience with smallpox eradicat io n p ro g ram convinced the health policy makers that immunization was the most powerful and cost-effective measure for control of vaccine preventable diseases. the EPI was s upplanted by the Universal Immunizat ion Program (UIP). It should be noted that UIP envisaged 100% coverage of pregnant women with 2 doses of tetanus toxoid (or a booster dose. At the global level. In this program the emphasis was s hifted from the under-five to under-one age group. a change of strategy was considered necessary.it did not include measles vaccine. Ty p h oid vaccin e continued to be a part of our national immunization schedule until 1985. Louis Pasteur developed a h ig h ly effective vaccine against rabies. 6 In 1985. The term "Exp anded" referred to the provision of adding more antigens to vaccinatio n s chedules. and to achieve self-sufficiency in the production of vaccines. neonatal tetanus. thereby reducing the number of potential beneficiaries. extending coverage to all corners of a country and spreading services to reach the less privileged sections o f the society. The primary health care concept as enunciated in the 1978 Alma Ata Declaration in cluded immunization as one of the strategies for reaching the goal of 'Health for All' by the y ear 2000. The EPI program focused on children below 5 years of age and pregnant women. an organized immunization program came into exis tence in the year 1974 under the banner of the World Health Organization (WHO). The main objectives of UIP were: i) universal immunization and reduction in mortality and morbidity due to vaccine prev entable diseases ii) self-sufficiency in vaccine production iii) establishment of a functional cold chain system. OPV was added only in 1979 and measles later on. Efforts were undertaken to initiate research for the development of newer vaccines.the name given to a declaration sponsored by UNICEF as part of the 40th anniversary of the United Nations in October 1985. to improve vaccine product ion technologies and to .Historical Aspects Though Dhanvantri. The program started with BCG. the first successful vaccine in the modern era was developed b y Edward Jenner in 1796 when he used cowpo x inoculation (vaccination) to protect against smallpox. DTP and Typhoid vaccines . and iv) the introduction of district level monitoring system. Supplemen t ary immunization activities against poliomyelit is were started in 1995-96. as applicable) and at least 85% coverage of infants. The vaccines recommen d ed were BCG. In 2002. This was christened as the 'Expanded Program on Immunization' (EPI). Under the UIP. sp o ke of preventing certain infectious diseases t h rough immunization. wh o o p ing cough and measles. The UIP became an integral component of Child Survival and Safe Motherhood Program (CSSM) in 1992 and then part of Reproductive and Child Health Program (RCH) in 1997. The vaccines included were BCG. Hepatitis B vaccination was initiated in selected areas targeting the urban poor. the govern ment also aimed to establish logistics of vaccine production and supply as well as training of medical and p aramedical personnel. but this could not be achieved for several years and independent evaluations showed very low coverage rates in many parts of our country. Th erefore. The WHO also endorsed global efforts at immunization through Universal Childhood Immunization (UCI) in 1990 . DTP. Since switching over to UIP in India there has been a significant decline in many of the vaccine preventable diseases. OPV. The Government of India adopted the EPI in 1978 with the t win objectives of reducing the mortality and morbidity resulting from vaccine preventable diseases of childhood. Since then many other vaccines have been developed in rapid succession. OPV and Measles for infant s an d TT for pregnant women. Measles and TT. It was first given to a child in 1885. such as poliomy elitis. DTP. It considerab ly reduced the denominator for percentage coverage. Program coverage of 85% was envisaged. diphtheria. t h e father of Indian Medicine. especially Children" to cover all asp ect s of the immunization activity from research and development to actual delivery of services to the target population. which was used for post-exposure prophylaxis. The Government of India subsequently set up a " Technology Mission on Vaccination and Immunization of Vulnerable Po pulation.

Bill and Melinda Gates Foundation. World Bank and the Rockefeller Foundation. n o n .g o v ern men t al organizations and the governments of 74 d ev eloping nations. CVI aimed at development of newer vaccines. Unfortunately last report of National family and health survey released in 3rd week of Nov '06 do not confirm this improvement.u n d erstand the epidemiology of diseases. Training of mid-level managers. The Government of India h as recently lau n ched an Immunization Strengthening Project with the objectives of i) strengthening routine immunization with the aim of raising the percentage of fully immunized children t o ab ove 80% ii) eliminating polio and achieving polio eradication iii) reviewing and developing a new vision of the immunization program in the medium term keep in g in view the development of new epidemiological patterns. malaria and tuberculosis v) making immunization coverage an integral part of international development initiatives. Madhya Pradesh. Assam and West Bengal. It aimed to incorporate Hepatitis B vaccine in the immunization schedules o f all member countries by 1997. The "Global Alliance for Vaccines and Immunization" (GAVI) was set up in 1999 as an international coalition of multination al funding agencies (e. 7 . These developments were highlighted in 1990 at the Summit for Children. The project was started in 50 poorly performing districts of 8 priority states of Uttar Pradesh. the WHO also set a target for universal Hepatitis B immunization. It has also endeavored to promote safe injection practices and use of auto-disable syringes for immunization as part of a countrywide initiative. where it was claimed that EPI had indeed been a global success with 80% reported coverage with the six vaccines. These global efforts at immunization were launched under the banner "Children Vaccine Initiative" (CVI) in 1991 with support from several in t ernational agencies like the WHO. The main objectives of GAVI are as follows: i) impro v in g acces s t o s u s t ainable immunization services ii) expanding use of all existing safe and effective vaccines iii) accelerat ing the development and introduction of new vaccines iv) augmenting research and d ev elopment on vaccines against HIV. The focus of GPV is on sustaining high vaccine coverage. In 1992. availability of new vaccines and delivery mechanisms and advances in cold chain technologies iv) improving surveillance and monitoring mechanisms. Rockefeller Foundation). The GAVI Ind ia Project has been instrumental in launching free Hepatitis B immunizatio n in some of the urban slums. GAVI organizes its activities through a vaccin e fund. developing global surv eillance network and evolving eradication strategies. since 1999.g. v accin e man u fact u re r s . Rajasthan. improvement in vaccine production technolo g ies and vaccine quality. Gujarat. Bihar. is an integral component of this project. A surv ey conducted in 2002 under the RCH showed that immunization coverage rates in India have been d eclining. However unfortunately less than 50% of t h e countries have actually introduces Hepatitis B vaccine in their National Schedule. Oriss a. These efforts were further co nsolidated under the "Global Program on Vaccines and Immunization" (GPV) in 1993 reflecting the EPI and UCI init iative and combining these with the CVI. India has recently accepted its inclusion in National schedule and the coverage will expand in a phased manner. UNICEF. These newer initiatives have improved overall coverage in these districts. The National Institute of Health and Family Welfare has been identified as the nodal institute for coordination and implementation of the program an d the training shall be carried out through five regional inst it u tes. including persons actively involved in immunization program at the district and state level.

The consequent immune response may be manifested through hu moral (i. varicella vaccine. BCG elicits CMI without an easily demonstrable humoral component. BCG and OPV can be given from the day of . If the antigen preferentially stimulates Th1 series of T helper lymphocytes. if required. diphtheria toxoid. All vaccines are subjected to the following trials before being licensed: Phase I Trial: Human volunteers . pertusis vaccine. modified exotoxins called "toxoids" (e. Timing of vaccination depends upon the age at which the disease is anticipated as well as on the feasibility of administering the vaccine at that time. For instan ce. An interval of 4 weeks would obviously result in completion of the primary schedule at an earlier age an d may perhaps make it easier for the parents to remember their follo w-up appointments. say for instance DTP.Basic Immunology The Greek work "immune" means "to be protected". hence they stimulate B cells directly without T helper cell modulation. Most of the currently used childhood vaccines do not interfere with the vaccine "take" of one another. whole cell typhoid vaccine.for immu n e response. safety and efficacy. MMR vaccine is given only after 12 months of age. the ultimate express ion of immunity is predominantly humoral. polysaccharide antigens of Salmonella typhi or Haemophilus influenzae type b and the surface proteins of hepatitis B virus). whole inactivated org anisms (e. neonatal tetanus can only be prev en t ed through maternal immunization by ensuring adequate titers of transplacent al antibodies and not by immunization of the baby at birth. These can be. Th is way the drop out rates may also decrease. measles vaccine). tetanus toxoid). Vaccines consist of attenuated live organisms (eg. rabies vaccine. but without the asso ciated risk of developing the disease. therefore. and when antibodies are supplied readymade in th e form of immune g lo b u lins and sera it is known as passive immunization. preferably 8 weeks. a strong lymphocytic respons e is obtained. oral polio v accine and Hepatitis B vaccines can be given soon after birth as the maternally derived immunity apparently does not interfere with the vaccine "take" On the other hand. live measles vaccine may be inhibited in the presence of detectable maternal antibody in the infant's circu lation. first to ensure recovery and then to offer protection from disease if the same patho gen were to be encountered again. before a vaccine is act u ally marketed it undergoes sterility. Vaccines mimic infection with the respective pathogen. safety Phase III Trial: For field efficacy. antibody) immunity or cell mediated immunity (CMI) or both.g. similarly. 8 BCG. oral typhoid vaccine. necessity. Pathogenic infectious ag en t s induce disease and the host immune system responds with immunity . if Th2 series is preferentially stimulated.e. safety Further. inactivated polio vaccine). Carbohydrate antigens are T cell independent. Protection offered by the introduction of various antigens or ready-made antibodies is called acquired immunity. given simultaneously and several antigens can be g iv en the same day.g. A vaccine is composed of one or more antigens of the pathogen. therefore. the interval between two doses of the same v accine.for tolerance. should be at least 4 weeks. This results predominan t ly in a IgM response wit h out IgG production or induction of immunological memory. active and passive. which will induce a protective immune response without suffering from the disease. Vaccines are selected based on three important criteria viz. The process by which t h is acquired immunity is obtained is known as 'immunization'. should only be given after at least 9 months of age . In general. When specific antigens evoke the required immune response in the system it is called active immunization. oral polio vaccines. safety Ph as e II Trial: Human volunteers . This is of two types. purity and potency tests at the level of the manufacturer and the Drugs Controller General of India. Measles vaccine.g. or subunits (e.

Some of the viral vaccines (e. varicella Pertussis. process of inducing immune response which may be humoral or cellular. Types of Vaccines Type of Antigen Examples Live bacteria. measles. however. the disease likely to be prevented. If the opportunity to give BCG / Hepatitis B was not available in the neonatal period. Td Typhoid Vi. Seroconversion: change from antibody negative state to antibody positive state. Antibody titer: the reciprocal of the highest serum dilution at which antibody has been detected. varicella) may be associated with possible short lasting suppression of the immune system and it may be advisab le to avoid administratio n of other vaccines within 4 weeks of these. anticipated adverse reactions and due date for the next session of immunization. Ty21a OPV. s imultaneously with DTP and OPV. Geometric mean: the mean antibody titer in a g ro u p o f in d ividuals [usually titer from those who have seroconverted (GMT)] Each time a vaccine is given the doctor should explain to the mother the nature of vaccine. Hib. due to the presence of detectable antibody. attenuated Inactivated bacteria Inactivated virus Toxoid Capsular polysaccharide Viral subunit Bacterial subunit BCG. Terminology Vaccination: Immunization: process of inoculating the vaccine/antigen. pneumococcal HBsAg Acellular pertussis 9 . attenuated Live virus. Seroprotection: a stage of protection from disease. meningococcal. s o that there would be 4 weeks gap until the next contact for immunization at 6 weeks. whole cell killed typhoid IPV. HAV Tetanus. very little objective evidence to show t h at this immunosuppression is clinically significant. diphtheria.g. t h e n umber of doses needed. MMR.birth until 2 weeks of age. There is. it may be given at 6 weeks. rabies.

OPV3 Measles DTP. ** A second dose of TT vaccine should b e g iv en at an interval of one month if there is no clear history or documented evidence of previous immunization with DTPw. OPV1 (BCG if not given at birth) DTP2. DT or TT vaccines (Source: Govt. OPV2 DTP3. of India (1994) National Child Survival and Safe Motherhood Program. New Delhi) 10 . OPV0 for institutional deliveries DTP1. M in is t ry of Health and Family Welfare.National Immunization Schedule Age Birth 6 weeks 10 weeks 14 weeks 9 months 16-24 months 5-6 years 10 years 16 years For pregnant women Early in pregnancy One month after TT TT1 or booster TT2 Vaccines BGG. OPV DT* TT** TT *A second d o s e of DT vaccine should be given at an interval of one month if there is no clear history or documented evidence of previous immunization with DTPw.

4 million live viable bacilli per dose. It continues to be the only effective vaccine against tuberculosis The two common strains in use are Copenhagen (Danish 1331) and Pasteur of which the former was produced in India at the BCG Laboratories. I p s i l a t eral axillary / cerv ical ly mphadenopathy may develop a few weeks/months after BCG vaccination. at the injection site indicates successful intradermal administrat ion of the vaccine. The injected site usually shows no visible change for several days Subsequently. Although the preferred time o f vaccination is soon after birth. This papule often heals with ulceration and results in a s car after 6-12 weeks. Therefore. Th e recommended dose is 0. the vaccine should be used within 4 hours with the left-over being discarded after the session. which increases to a size of 4-8 mm. It is supplied as a lyophilized (freeze-dried) preparation in vacuum sealed multi-dose dark colored ampoules. The vaccine contains 0. As t h e vaccine contains no preservative. Secondary infection at the vaccination site may require an t imicro b i a l s . Sterile normal saline should be used for reconstitution. Tamil Nadu till recently. The nodes regress spontaneously after a few months. stain for acid-fast bacilli may b e p o sitive.local antiseptics are unnecessary. The selected site may be swabbed clean using sterile saline .Commonly Used Vaccines A. than against the development of pulmonary tuberculosis where it has a protective efficacy of less than 50%.1 ml of reconstituted vaccine irrespective of the age and weight of the baby. It should also be noted that if fine needle aspiration cytology of the nodes is carried out. No treatment is required for this co ndition. Injection of BCG should be strictly intradermal. It was the result of painstaking efforts by t h e French microbiologist Albert Calmette and the veterinary surgeon Camille Guerin who performed 231 repeated subcultures over 13 years. A wheal of 5 mm. without losing its potency. a papule develops after 2-3 weeks. Subcutaneous administration of BCG is associated with an increased incidence of BCG aden it is . In some children the . once reconstituted. The lon g n ecked BCG ampoule should be cut carefully by gradual filing at the junction of its neck and body. Vaccines Against Diseases Covered Under EPI BCG Vaccine Bacillus Calmette Guerin vaccine is derived from the bovine tuberculosis strain and was first developed in 1921. BCG induces cell-mediated immunity but t h e protective efficacy is a matter of debate and is very difficult to q u an t ify BCG vaccine is more effective against t h e development of hematogenous spread of Mycobacterium tuberculosis (which results in milliary and meningeal forms of the disease against which it has a protective efficacy of 50-80%).The ulcer at vaccination site may persist for a few weeks before formation of the final scar. One should 11 ensure maintenance of cold chain during transport and storage. If no reaction is seen at the local site even after 12 weeks. by the end of 5-6 weeks. bacterial contamination may occur with repeated use. In lyophilized form it can be stored at 2-80 C for up to 12 months. Antitubercular therapy is of no benefit in such situations and should not be administered. These are bovine vaccine bacilli and should not be misconstrued as being suggestive of tuberculous disease. The convex aspect of the left shoulder is preferred for easy visualization of the BCG scar. using a Tuberculin syringe and a 26G need le. as sudden gush of air in the vacuum sealed ampoule may lead to spillage of th e contents. The vaccine is light and heat sensitive and deteriorates on exposure to ult ra violet rays. it is an in dication to repeat BCG presuming that BCG has not taken up. it could be given up to the age of 5 years. Guindy.1-0. Adverse reactions .

as we move towards p o lio eradication. However. OPV has been associated with occurrence of Vaccine Associat ed Paralytic Poliomyelitis (VAPP) Today. By mid-2006 polio has been elimin ated from all countries other than India. like any other vaccine its use is associated with certain risks. Nearly 50 cases of VAPP are reported to occur in India annually. If a substantial amount of OPV is vomited or regurgitated wit hin 5-10 minutes of administration. when excellent clinical and virological surveillance exists and the coverage of routine OPV is more than 80%. Approximately half of all VAPP cases are associated with the Type 2 OPV strain. Seroconversion rates after three doses of OPV average 73%.OPV is an excellent vaccin e and the WHO Global Polio Eradicat io n Initiative is at the threshold of achieving its goal of eradicating wild polioviruses. " Pulse OPV doses" every year on Nat io n al Immunization Days (NIDs) and sub-National Immunization Days (sNIDs) until the age of 5 years are also mandatory. namely magnesium chloride. 2 and 3. at 16-18 months and 5 years. It is a suspension of over 1 million particles of poliovirus types 1. Afghanstan. Disseminated BCG infection is extremely unusual but may occur in children with cellular immunodeficiency. VAPP is more common than paralysis due to wild polioviruses and has. Surgical removal of the nodes or repeated needle aspiration is the treatment of choice . OPV "take" rates may be somewhat variable. The vaccine 12 must reach the outreach facility at 2-80 C in vaccine carriers with ice packs. antitubercular therapy is not recommended in this s it u at ion also.nodes may even liquefy and result in an ab s cess. therefore. 90% and 70% for Types I. It has been estimated that the global VAPP burden is in the range of 250-800 cases an nually. Pakistan. the dose should be given again. The vaccine. which are mutants that re-acquire wild virus-like properties and have been associated with outbreaks of paralytic polio. become an increasingly contentious issue for all pediatricians . Niger and Egypt. It is supplied with a stabilizing agent. A d eq u at e immu n izat io n . For developing cou n t ries OPV is still the vaccine of choice for eradicating wild poliovirus and would continu e t o be used until wild poliovirus circulation ceases. It is for this reason that multiple doses of OPV are necessary before 90-95% of children develop immune responses to all three poliovirus typ es . A high level of gut immunity ensures that vaccinated children would not participate in the chain of transmission of wild (pathogenic) polioviruses. II and III respectively. IAP recommends at least 5 routine doses of OPV. Nigeria. The risk of VAPP would continue to be there as long as we are using OPV as the preferred vaccine against poliomyelitis. cVDPVs usually aris e in communities with low population immunity especially . t h e vaccine viruses reach the intestines where they must establish infection (vaccine virus "take") before an immune response may occur. clinical surveillance and appropriate virological investigations in all children with acute flaccid paralys is (AFP) are the cornerstones of polio eradication.again. is quite stable under refrigeration. When OPV is given by mout h . d u ring infancy and 2 more repeat doses. therefore. neith er of the doses s hould be counted and the vaccine shou ld b e re-administered at a later visit. Breastfeeding and mild d iarrh ea are n o co n t rain d icat io n t o OPV adminis t rat ion. Polio elimination is defined as no case of paralytic poliomyelitis by the wild poliovirus in one calendar year with other criteria being the s ame as in eradication . For reasons that are not clearly understood. If this repeat dose is also not retained. Polio eradication is defined as no case of paralytic poliomyelitis by wild polioviru s in last three calendar years along with absence of wild poliovirus in the community. Adverse reactions . OPV should be stored at -200 C at the state and district level and in the freezer at the clinic level. The second major problem with u s e of OPV is the emergence of circulating Vaccine Derived Polio Viruses (cVDPVs). Oral Polio Vaccine Oral polio vaccine (OPV) remains the vaccine of choice for polio eradication in India. In addition to the routine OPV doses .

Old IPV contained 20. All curren tly used IPV vaccines are enhanced potency IPV (elIPV) which cotains 40.e. pulse immunization against polio). 8 and 32 D antigen units of types 1. As the number of wild poliovirus cases in the country decreases.when polio vaccine coverage rates decline but OPV use continues. 2 and 3 respectively. Seroconversion rates are 90-95% after two doses given after the age of 2 months and at 2 months interval and 99% after three doses given even when it is started at 6 weeks of age and given an 4 weeks interval It produces excellent humoral immunity as well as local pharyngeal and. It is. therefore. In any case the b irt h d o se of OPV must be given and all the OPV doses on the days of NIDs / SIAs should be given to all the children. Organization of mop-up campaigns. Conducting mass campaigns (i. 2 and 3 polioviruses respectively. it is inevitable that one would have to shift fro m OPV to IPV in the next few years. IPV can be used in combination with DTwP and Hib vaccines without compromising seroconversion or increasing side effects. Scientifically and immunologically schedule of giving two doses of IPV starting at 2 months of age and given at 2 months interval followed by a booster at around 15 mo n t h s is similar to a schedule of giving 3 doses starting from 6 weeks of age and given at 4 weeks interval followed b y a booster at 15 months (even in developing countries). It is now licensed to be used in India by Drug controller of India. However if 3 primary doses are given. Ideal age to give first dose of IPV is 8 weeks an d the interval between two doses should also be 8 weeks. 10 and 14 weeks followed b y a booster at 15 months. therefore. vaccine could be started at 6 weeks of age and 13 could be given at 4 weeks interval without any compromise in the seroconversion rates. 8 and 32 D antigen units of type 1. important to ensure complete coverage with OPV during NIDs so that no wild poliovirus remains in circulation. However in our country the later schedule of 3 primary doses is better logistically as it can be given along with DTP at 6. cVDPV can result in large outbreaks. The duration and extent of spread of cVDPVs are dependent on the magnitude of the immunity gap. Inactivated Polio Vaccine (IPV) IPV is formaldehyde killed poliovirus grown in monkey kidney cell/human diploid cells. Core strategies for eradication of polio include: • • • • Maintaining high routine infant immunization coverage with OPV. It is highly immunogenic. possible in testinal immunity. As lo n g as OPV is in use it is mandatory that very high immunization coverage is maintained so as to decrease the risk of emergence of cVDPV. At the same time. Polio Eradication Why do we need pulse immunization against polio? Simultaneous administration OPV to all susceptible infants and children interferes with circulation of wild poliovirus in the community. The government sh o uld. It has been suggested that mass OPV campaigns should be s ynchronized with the cessation of OPV use o n ce eradication of wild poliovirus has been achieved. Development of sensitive surveillance. so as t o eliminate the risk of VAPP and the emergence o f cVDPVs. a gradual transition to IPV should be encouraged. The vaccine is very safe. W hereas VAPP occurs in individual cases. Currently term IPV means eIPV. consider incorporating IPV in the national immunization schedule in a phased .

the pertussis vaccine (even after 3 doses) has a protective efficacy of about 70-90% only. Adverse reactions . Whole cell pertus s is vaccine has been incriminated in the 14 induction of a neurological reaction in v ery rare instances. These outbreaks of cVDPV were curtailed by strengthening routine immunization and giving 2 or more rounds of SIAs using OPV. It will be unwise to discontinue use of polio immunization altogether after zero polio status is achieved due to fear of cVDPV and iVDPV. Hence India should preempt the emergence of cVDPV and has to become self sufficient in stock-piling enough polio vaccine now to meet any such unforeseen eventuality in future. allerg ic reactions may be seen in in d iv id u als wit h hypersen s it iv it y t o t h es e antimicrobials. It will force us to depend on the stocks of WHO or any such agency for OPV vaccine should out-break of wild polio or cVDPP occur. It will be unethical and unsafe to continue to use OPV after zero wild polio case and zero transmission status is achieved due to risk of VAPP following OPV. However in post-polio eradication era. there has been no conclusive proof for this and the vaccine should not be denied to children with seizure disorders or st ab le neurological conditions (e.g. neomycin and polymyxin B. As IPV contains trace amounts of streptomycin. The results of the National Childhood Encephalopathy Study (NCES) in the United Kingdom clearly show that there is no causal relationship between administration of DTPw vaccine and development of chronic neurological disease in children. Following concept s should be kept in mind while deciding India specific guidelines for post-polio eradication immunization. Progressive/evolving n eurological illnesses. preferably as IPV-DTP. Cerebral palsy. India should encourage indigenous manufacturer to produce enough IPV so that it becomes affordable so that is will be possible to switch to IPV in due course. It is one of the oldest combination vaccines and has been in continuous use for more than 55 years. Convulsions following DTPw v accine are distinctly rare. it will be unethical and unsafe to reintroduce OPV in such areas. Past experience from some countries has shown that countries which have eradicated wild polio virus and have slackened in their routine polio immunization programs have experienced cVDPV outbreaks. Looking at the above problems. For children who develop persistent inconsolable cry of more t h an 3 hours . looking at the huge requirement of the number of doses.manner. IAP recommends that India should switch over to IPV. Post-polio eradication scene and polio immunization: IA P believes that it will be unsafe and unethical t o continue to use OPV in post-p o lio eradication era. 1. are a relative contraindication to first dose of DTPw immunization. DTPw Vaccine The combination of diphtheria t o xoid. however. Tetanus an d diphtheria toxoids are adsorbed on insoluble aluminium salts which act as adjuvants and enhance the antitoxin responses to both the antigens. Adverse reactions . tetanus toxoid and whole cell killed pertussis vaccine (DTPw) is popularly known as the "triple antigen" DTP is the core vaccine in all childhood immunization services. 3. While the two toxoids are highly immunogenic (95-100%). in its routine immunization program gradually in post-polio eradication era. 2.Local (pain and redness) and systemic (fever) side-effects of the DTPw vaccine are almost entirely due to the pertussis component. developmental delay). however. IPV is also the vaccine of choice in patients with immunodeficiency and th e preferred vaccine in children with symptomatic HIV infection. IPV can also be an additional tool to eradicate wild polio from last few high risk difficult districts. and may only represent n o t h ing more sinister than fever triggered seizures.Th e vaccine is very safe.

hyperpyrexia . Pertussis vaccine should not be given in such cases and instead DT should be administered in the future. The IAP COI recommends 5 doses of DTP . • • The IAP COI unequivocally endorses the continued use o f DTPw vaccine because of its proven efficacy an d safety. no bar to offering these vaccines to children from families who opt for the slight advantage of fewer minor side-effects. therefore. not recommended for universal immunization in our country at present. These are. DTPa vaccines are also by no means more effective than the whole cell pertussis vaccine. local reactions at injection site and irritability) but this minor advantage can not justify the inord in at e costs involved in the routine use of this vaccine. DTP must be injected intramuscularly and the preferred site is th e anterolateral as p ect of the thigh.fever > 40.duration. five component DTPa containing agglutinogens 2 and 3 in ad d ition to PT. In case immediate anaphylaxis occurs after DTwP administration. it should be discarded.hypo responsive episode HHE (collapse/shock like stage) within 48 hours of DTPw admin is t ration. 15 . These vaccin es s hould never be frozen. the decision to administer further doses of DTPw should be carefully evaluated and discussed with the parents These events were regarded as absolute contraindications in the past. further doses of DTPw and DTaP are contraindicated.three in infancy with two boosters at 18 months and 5 years. They are now considered mere precaut ions because these events generally do not recur with the next dose and they have not been proven to cause permanent sequelae If a similar adverse reaction recurs with the subsequent dose only then pertussis vaccine is contraindicated for future administration. the overall efficacy of DTPa vaccines is comparable to the DTPw vaccine. Dose: 0. further DTwP/DTPa should be avoided because of uncertainty about which component of these vaccines has caused the reaction. as is true with any vaccine. There is.5 ml by intramuscular injection. and if frozen accidentally. DTPa Vaccine may u ndoubtedly have fewer minor side-effects (like fever.50 C or hypotonic . DTaP can be recommended in such circumstances as this vaccine is less reactogenic. Td should be given. DTP and DT vaccines need to be stored at 2-80C. two component DTPa containing pertussis toxin (PT) and filamentous haemagglutinin (FHA). • If parents are not willing for DTPw administration after the adverse reaction with the previous dose. seizures with or without fever within 72 h ours of admin is tration of DTPw. Acellular Pertussis Vaccine (DTPa) DTPa vaccines are of various types depending on the number of constituent components viz. Though a five component DTPa vaccine may be expected to elicit a more robust immune response as compared to two and three component DTPa vaccines. If encephalopathy (major alteration of sensorium or illness with seizures lasting > 24 hours) occurs within 7 days of DTPw administration. After the age of 7 years. however. The DTPw or DTPa vaccines can be administered up to the age of 7 years. three co mponent DTPa containing pertact in in addition to PT and FHA. FHA and pertactin.

2 doses of TT would again be necessary. For pregnant women who have not been previously immunized. In dications: Unimmunised or inadequately immunized individuals with burns. two doses of TT at least one month apart should b e given during pregnancy so that protective antibodies in ad equate titers are transferred to the newborn for prevention of neonataltetanus. The second dose of TT should be administered at least 2 weeks before delivery. roadside injuries and compound fractures. Bo o s t ers of this vaccine may be given at 10 and 16 years and thereafter every 10 years. A single dose of TT would suffice for subsequent pregnancies that occur in the next 5 years. flush in g . In children and adults: 500-1000 IU IM and/or 250-500 IU intrathecal. Td Vaccine (Tetanus Toxoid.Tetanus Toxoid This vaccine contains Tetanus Toxoid 5 LF. mainly IgG. Thereafter a single booster every 10 years wo u ld be s u fficient to extend immunity for another 10 years boosters should not be given more frequently than this. Tetanus Immunoglobulin (TIG) It is a liquid preparation containing immunoglobulins. Reduced Dose Diphtheria) Td contains the usual dose of tetanus toxoid and only 2 units of diphtheria toxoid. It is a highly heat stable and effective vaccine. It is recommended for use in children above 7 years of age IAP COI recommends the routine use of Td at the age of 10 and 16 yrs (in other words Td should replace TT boosters at 10 and 16 years). headache and chills may occur. Adverse reactions: Local pain. Dose: for Prophylaxis: 250-500 IU IM. The practice of giving TT after every injury should be discouraged. For previously unimmunized schoo l age children. 16 . fever. obtained from the plasma of healthy donors. After completing the full course of seven doses. primary TT immunization consists of two doses given 4 weeks apart. thereafter. Therapeutic: tetanus neonatorum: 500-1000 IU IM or 250 IU intrathecal. there is no need for additional doses during pregnancy at least for the next 10 years.

17 .

therefore strict asepsis should be maintained while diluting and aspirating contents from the multi-dose vial. the vaccine can be given to infants as young as 6 months with a recommendation for an additional MMR/Measles at 12-15 months. it resu lt s in sub-clinical or attenuated infection and multiplication of virus within the body. Moraten and Edmonston B. MMR vaccine may be given between 15-18 months of age. If measles vaccine was missed altogether in infancy. It may be noted that the states like Delhi. are likely to include MMR in its universal immunization program. It is supplied freeze-dried and has a shelf life of 1-2 years. Vaccines Recommended Against Diseases Not Covered Under EPI MMR Vaccine Globally. most co u n t ries use MMR instead of single antigen measles vaccine. Vaccinees do not shed the virus. B. preferably over the upper arm / anterolateral thigh. There is no upper age limit for this vaccine. the diluent is available separately. vaccine should be used within 4 hours. or even longer. For infants given measles vaccine at 9-12 months. 5000 TCID50 of mu mp s and 1000 TCID50 of ru b ella v iru s . It is administered subcutaneously in the upper arm/anterolateral thigh. Most infants are protected fro m measles by the maternally acquired antibodies until about 6-8 months of life. In the clinic these vaccines can be stored between 2 to 8 0 C. one dose of MMR can be given at or after 12 months. The vaccine can be given along with other vaccines like DTP. OPV and Hib. include Schwarz. This infection mimics wild measles virus infection but is usually asymptomatic. Being a live attenuated virus vaccine. etc. Th e vaccines should be p rotected from light. MMR vaccine contains 1000 TCID50 of measles. Reconstituted vaccine should not be frozen . the vaccine efficacy may be reduced. 18 . Once reconstituted. The v accine should be injected subcutaneously. The vaccine may be stored frozen or refrigerated. completed 9 months of age has been recommended as the appropriate age for measles v accination in India. Some cases of staphylococcal sepsis/toxic shock syndrome associated with use of this vaccine have occurred from bacterial contamination of the vaccine.5 ml dose. In order to achieve t he best balance between these competing deman d s o f early protection and high seroconversion. Paracetamol may be given to control/reduce fever. The IAP COI recommend s administration of MMR to all children. It is dispensed in single as well as multi-dose formulations. however. It should als o b e given to all adolescent g irls not previously immunized and to hospital staff likely to come in contact with pregnant mothers. Some children may develop a short lasting fever 7-10 days after vaccination often accompanied by a macular rash. If measles vaccine is given in t h e presence of measu rable titers of maternal antibody. Measles v accine does not contain any preservative. Other strains. Goa h ave included and few states like Tamilnadu. Measles and MMR vaccines are supplied in lyophilized formulation and should be frozen for long-term storage. which have been used for vaccination. After reconstitution the vaccine is very heat-labile and should be used within 4 hours.Measles Vaccine Measles vaccine used in our country is derived from the live attenuated Edmon s t o n Zagreb strain grown in human dip lo id cell culture. The vaccine is given as a 0. wit h the unused vaccine being discarded. In case of an outbreak. Mah arashtra.

As a pediatrician one should be aware that rubella vaccination is mainly directed at preventing congenital rubella syndrome (CRS) and not at preventing rubella infection per se. vaccine failures are uncommon.000 d o ses of vaccines used. It contains live attenuated virus not less than 1000 TCID50. It is a highly immunogenic vaccine with seroconversion rates of 95% It provides long term and probably life long protection. This is suggestive of wide circulation of wild rubella virus in yo u n g children. Jerryl Lynn. By controlling the incidence of rubella infections. Seroprevalence of ru bella antibodies in majority of pregnant women in few studies in India support this view. Monovalent mumps vaccine or combination with rubella as MR vaccine is not available in our country. Vaccinees do not shed the virus. Hence MMR though a co s t effective vaccine should not be introduced through public health facilities in areas wh ere co v erag e fo r routine immunization is consistently less than 80%. There is paucity of reliable data on occurrence of CRS in India. RIT 4385 or Urab e A M9 strains and are grown in chick embryo/human diploid cell cultures. Vaccinees do not shed the virus. Haphazard use of rubella vaccine (monovalent or as a constituent of MMR) in young children through public health measure with sub-optimal coverage of the target population may be counter-productive as it may shift the epidemiology of rubella to the rig h t with more clinical cases occurring in young adu lt s leading to paradoxical increase in cases of CRS. as the latter is usually benign an d inconsequential. The clinical s everity of the vaccine induced aseptic meningitis is very mild and often may go unnoticed and all the cases recover without any permanent sequelae. Rubella Vaccine Rubella vaccine currently available commercially is derived from RA 27/3 vaccine strain grown in human diploid/chick embryo cell cultures.Mumps Vaccine The mumps component in MMR vaccine contains live attenuated mumps virus not less than 5000 TCID50 per dose.MMR. There is no difference in efficacy between various strains of mumps vaccine. Normally use of rubella vaccine (monovalent or as a constituent of MMR) in young ch ildren through individual p ract itioners alone would not lead shift of epidemiology in adolescents and adults as the coverage of target populat io n is miniscule by private practitioners In case MMR is incorporated in universal program and adequate coverage is not achieved. though the incidence quoted is as rare as 1 in 10. 19 . This has been shown to occur using mathematical models. It is available either as a monovalent vaccine as a part of combination vaccine .000 to 1 in 100. a shift in epidemiology of rubella is quite possible. Hence all the mumps vaccines are equally safe. Aseptic meningitis is known to occur following mumps vaccine. Direct evidence from some Latin American countries als o corroborates these concerns. CRS can be significantly reduced. On the basis of what ever information is available CRS incidence is qu it e low in India. There is no evidence that mumps vaccination is associated with development of either au t is m or Crohn's Disease. Vaccines are derived from Leningrad-Zagreb.

If the mother is known to be HBsAg negative. 6 . In Ju n e 2002. 30% of the chronic carriers go on to develop chronic liver disease. patients on chemotherapy for malignant conditions or those with chronic ren al failure awaiting hemodialysis. The vaccine should not be frozen . the Government of India also initiated the incorporation of HB vaccine as a univ ersal vaccine through a pilot program which will be scaled up in a phased manner.6 months schedule. An ideal HB vaccine schedule should. one can still use 0 . However now that HB vaccination is integrated into the existing immun ization program (UIP) in India. Pregnant women should be counseled and encouraged to opt for HBsAg screening. higher the chances of becoming a chronic carrier. through sexual contact or nosocomially. 1-4% of individuals are found to be chronic carriers of Hepatitis B Virus (HBV). As many as 150 countries have n ow included HBV in their national immunization sch ed u les . cirrhosis of liver and hep atocellular carcinoma.6 .e. If the mother's HBsAg stat u s is not known.10. 1 and 6 months Birth. mother to child) are the major routes of transmission of hepatitis B. Infection with HBV may occur perinatally (v ertical transmission). 6 and 14 weeks or birth. the it should be discarded.g. Younger the age of acquisitio n of HBV infection.14 wks sched u le can be followed. Th e p urpose of Hepatitis B vaccination is to prevent chronic in fection and development of chronic liver disease / hepatocellular carcinoma later in life. As on now. birth. 6 and 14 weeks 6. The vaccine is hig h ly immunogenic and seroconversion rates are greater than 95% after a three dose schedule. it is important that HB v accination should begin within a few hours of birth so that perinatal transmission can be prevented. In office practice. 3. d u e to operational issues at a national level one has to piggy back on the available contacts for routine immunization i. 10 and 14 weeks of age.if frozen accidentally. therefore. The dose may be increased when vaccinating immunocompromized individuals e. Saccharomyces cerevisiae or Pichia pastoris. Antibody titers greater than 10 mIU/ml are considered protective. Adult dose is twice the pediatric dose. It is adjuvanted with aluminiu m salts and should be stored at 2-80 C.14 wks schedule for public measure. In fect ion with HBV is one of the most important causes of chronic hepatitis.6wks . This 6-10-14 wks schedule may be easier to implement in the context of the national immunization program as higher vaccination coverage may be achieved with earlier administration of vaccines.Hepatitis B Vaccine In India. It should be noted t h at in our country horizontal route (e. HB vaccine may be given in any of the follo win g schedules: 1. DTP wh ich is given at 6.1 .5 ml corresponding to 10µg of the antigenic component. address vertical as well as h orizontal modes of transmission of the virus. In case birth dose has been missed. ch ild to child) route and the vertical route (i. Birth. from the d ata available. 2. It is believed that as many as 90% of those who are infected at birth go on to become chronic carriers.e. HB vaccine can be g iv en along with DTP at 6. during early childhood (the so-called horizontal spread ). 10 and 14 weeks Immunologically 0 . The usual pediatric dose (< 12 years o f ag e) is 0. It is for this reason that the World Health Organization has recommended u niversal Hepatitis B vaccination. 6 wks and 6 months. 10 and 14 weeks/6 months as there is no special requirement to start vaccinat ion at birth itself.g. HB v accine is a highly purified recombinant DNA vaccine produced in the yeast species Hansenula polymorpha. At the same time birth dose has to be given to cover for the vertical route. Any one of the following schedules may be used for this purpose.6 months schedule of hepatitis B immunization has been most widely used and proven to be ideal with high antibody titers at the end of the v accination. If the mother is HBsAg positive (and especially HBeAg 20 . Hence IAP COI recommends 0 . These are all preventable by early childhood immunization. It should be injected intramuscularly in the anterolat eral thigh. none of the above schedules needs a booster.

The first dose should be administered as soon as after birth up to within 5 days of birth. the vaccine is being provided free of cost to infants living in u rb an slums. It was introduced in 15 cities an d 32 districts in the initial phase. Hepatitis B Immunoglobulin (HBIG) HBIG provides immediate passive immunity and is recommended in situations wherein there has been acute expos u re t o HBsAg infected material e. 6 and 14 weeks or birth. selection of districts was based on achievement of targets of 80% or more DTPw-3 coverage under routine immunization based on evaluation surveys. Dose: Adult s : 1000-2000 IU. not necessary under usual circumstances. It is envisaged that HB vaccination will be introd u ced in all districts of India by 2007. HBIG does n o t interfere with antibody response to simultaneous HB vaccine. For older children and adults the preferred schedule is 0. the baby should be given Hepatitis B Immune Globulin (HBIG) within 24 hours of birth. Boosters of HB vaccine are. in the case of extremely preterm babies. by a needle-stick injury. It is for t h is reason that individuals who have had recent accidental exposure to hepatitis B virus should be given combined passive-active immunization. 21 . as it presumably gives longer lasting immunity.32-48 IU/kg bod y wt . 1 and 2 months with an additional dose between 9-12 months. preferably within 48 hours though it can be administered even if the patient reports late up to 7 day s after exposure. There would occur anamnestic response with the titers going up should there occur contact with th e v irus again in future. along with HB vaccine (at birth. Under this program. This should be administered as soon as following exposure.positive). the titers at the end of immunization schedule may not be important so far as it is well above the protective level. Lastly HBIG is indicated in o ncology patients who may not respond adequately to Hepatitis B vaccine as they are immune compromised follo win g the malignancy as well its therapy. it can be given in 0-6-14 weeks schedule too The vaccination schedule need not be changed for preterm and small-for-dates babies. HB vaccination is now being integrated into t he existing immunization program in India. Neonates: 100-200 IU. An additional d o se of 32-48 IU/kg of body weight may also be given between 2-3 months after initial dose. It is also useful in prevention of mo t her to child transmission and transmission following sexual exp o s u re like in rape cases. As logistically. The program will be expanded to include additional cities and districts within a certain timeframe. If HBIG is not available (o r is unaffordable). vaccination should commence only after initial stabilization. HB vaccine may be given at 0. It has been suggested by many authorities that in infancy the third dose of HB vaccine should be given at least 16 weeks after the firs t d ose & at least 8 weeks after the second dose and not before 6 months of chronological age. '0' being the elected date for the first dose.g. Children:. it is easier to combine HB vaccine program with the DTP vaccine. therefore. However this view is being challenged as HB vaccine is a T-cell dependent vaccine. Special Precauti ons : HBIG should never be administered intravenously. Clinical trials h ave demonstrated 90% reduction in risk of transmis s ion following such exposure if HBIG is used alon g wit h Hepatitis B vaccine. In immunocompetent individuals HB vaccine induces an effective immunological memory that lasts life-long and protects against symptomatic acute illness and development of chronic HB infection on exposure to the virus. mild pain at the site of injection and itching may be seen in a small proportion of recipients. 1 and 6 months. ho wev er. Adverse Reactions: Transient. 6 weeks and 6months) using two separate syringes and separate sites for injection.

It can be given intramuscularly or subcutaneously. typhi vaccine is less reactogenic than the combined TA/TAB vaccines. The vaccin e is very safe and is reasonably effective if revaccination can be carried out on a regular basis. Oral Live Attenuated Ty21a Vaccine: 22 . Th ree vaccines were available for clinical use till recently. The vaccine should be stored at 2-80 C.25 ml in children aged 6 month s -10 years and 0. The vaccine efficacy has been estimated to be 50-70% in a meta-analysis of the randomized co ntrolled trials available. It should never be frozen. The vaccine s h ould be stored at 2-80 C. local pain and malaise due to the endotoxins in bacterial cell wall.5 ml. is now reasonably priced. given subcutaneously. A pure S. Protection begins 4 weeks after vaccination.Typhoid Vaccines Enteric fever is endemic in India and is a major public health problem.5 ml in order children.these antibodies can act as a biological marker of the vaccine. containing 25µg of the polysaccharide. It is effective even in child ren below 2 years of age and can be given to infants > 6 months of age Primary vaccination requires two d o s es . It may interfere with the interpretation of the Widal test. It should never be frozen. Unfortunately. Revaccination is necessary every 2-3 years to sustain an o ptimum immune response and should be done preferably before the onset of summer. Both vaccin es contain Salmonella typhi 1000 million organisms per ml. Pediatric dose of the vaccine is 0. phenol-preserved or the acetone inactivated lyophilized whole cell Salmonella t yphi vaccines were inexpensive products that have been in use in India for a long time. Use of these vaccines may be associated with fever. However now only Vi typhoid The Whole Cell Inactivated Typhoid Vaccine (TA/TAB) vaccine is available commercially. Adverse effects are mild and include pain and swelling at injection site. The p rotective efficacy of acetone inactivated preparation is more than that of the phenol preserved vaccine but the former is more difficult to prepare and is associated with more side-effects. It is not very effective in children below two years of age because it is an unconjugated polysaccharide vaccine as available in our country at present. 4 o r more weeks apart. which during natural infection inhibits p hagocytosis and serum bactericidal activity an d is responsible for virulence of the bacteria. this vaccine is not being manufactured in India at present The Vi-Capsular Polysaccharide Vaccine Th e vaccine consists of purified Vi-cap s u lar polysaccharide. The vaccine appears to be protective through the induction of antibodies against cell wall somatic (O) and flagellar (H) antigens. It h as reasonable efficacy o f 50-60% in children and low reactogenicity. Cost of the vaccine though a limiting factor in past. Heat-killed. the dose is 0. The vaccine is available as an isotonic phenolated buffer solution. Protection begins within two weeks of vaccination and the biological marker is anti-Vi antibodies.

The efficacy of all typhoid vaccines at best is 50-70% Hib Conjugate Vaccines Haemophilus influenzae type b (Hib) is an important invasive pathogen cau sing invasive diseases like pneumonia. It can be given to children six years of age and above as the capsules have to be swallowed intact. with a booster at 18 months. on alternate days. the protective efficacy being 95%. It is highly efficacious vaccine. Countries with sensitive disease surveillan ce systems have shown significant declines in in v asive Hib disease following the incorporation o f this vaccine in their national immunization programs. only 2 doses of PRP-OMP are recommended for this purpose. It is genetically stable and is not known to revert to virulence. Unfortunately this vaccine is also not available now in our country. The capsule should never be op en ed before ingestion. It is particularly recommended to be given p rior to splenectomy and in patients with sickle cell disease. On the other hand. As Hib d isease is essentially confined to infants and young children. The efficacy has been shown to 50-60% with the capsule form and near 90% with th e liquid form (not available commercially). HbOC (with CRM 197 mutant diph t h eria toxin as conjugate) and PRP-T (with tetanus toxoid as conjugate). PRP-OMP shows an increase in antibody level after the first dose itself with only marginal increases after the second and third doses. The interval between two doses should b e at least 4 weeks. Protection begins within a week after completion of the course and the protective efficacy is as good as other available typhoid vaccines. meningitis and bacteremia. Hib vaccine is stored at 2-80 C.Salmonella typhi Ty21a is a live attenuated strain with a mutation in gal E gen e and lacks the enzyme UDP-gal 4 epimerase. these three vaccines when used in the recommended doses have similar efficacy. A number of PRP conjugate Hib vaccines are available of which t wo are available in India viz. Immunization needs to be repeated every 3-5 years The vaccine should be stored at 2-80C. Majority of cases occur in children below 2 years of ag e. PRP-OMP (wit h meningococcal outer membrane protein as conjugate) is no t available in India HbOC and PRP-T vaccines show only a marginal increase in antibody levels aft er the first dose with a marked increase after the secon d and even better response after the third dose. Recently published data of the Invasive Bacterial Infections Surveillance (IBIS) group from six referral hospitals in India (Lancet. The IAP COI reco mmen d s use of Hib vaccine for all children . It provides protection by inducing local gut immunity but there is no biological marker of this vaccine. 23 . Hib vaccination is given routinely in the d eveloped countries for last many years. The vaccination schedule for Hib consists of three doses when initiated below 6 months. Antimicrobials active against S. The vaccine is supplied in an enteric coated formulation as the bacteria are acid labile. the vaccine is not necessary for children above 5 years. a single dose may suffice. Typhi should not be used 3 days before and 7 days after oral typhoid vaccine administration as these may interfere with the v accin e "take". 2003) show that Hib is a common cause of meningit is in our country. It is for this reason that while 3 doses of HbOC and PRP-T are recommended for primary vaccination. The vaccine is given on an empty stomach in three sittings. If vaccination is delayed until 15 months. Hib capsular polysaccharide vaccine is a very effective and safe vaccine. In spite of these apparent differences. 2 doses between 6-12 months and 1 dose between 12-15 mon t h s .

Complications of varicella may be mo re commonly seen in immunocompromised individuals.g. adults and pregnant women. Varicella vaccin e is also recommended in household contacts of immunocompromised children.It includes fever. HIV infection (but with C4 counts above 15% of the age related norms). The immunity appears to be long lasting. It is a highly effective vaccine and protective immunity. The IAP COI opines that varicella vaccine is not recommended fo r universal immunization in India at present. Varicella vaccine is also indicated in susceptible adolescents and adults if they are inmates of or working in the ins t itutional set up e.C) Vaccines That Need to Be Given After Discussion With Parents Varicella Vaccine Chicken pox is usually a self limiting and generally b enign disease affecting mostly children and youn g adults. The recommended dose is 0. A single dose is sufficient b elo w 13 years of age. Though vaccine manufacturers recommend to use this vaccine at 12 months. The vaccine is not recommended for ch ild ren below 12 months of age. It may be offered to children fro m h igh socio-economic strata of society after explaining the pros and cons to the parents on a one-to-one "named child" basis. vaccine ass o ciated rash. that the efficacy of the vaccine in preventing varicella under such circumstances is not very clear.it should be noted. leukemia (but in remission and off chemotherapy for atleast 3-6 months) and those on long term salicylates/high dose lone t erm oral steroids. military personnel and health care professionals. day care center workers. When used in adult females. develops in 95-99% individuals. after which two doses (at 4-8 weeks interval) are required. It may be prescribed to adolescents who have not had varicella in past (or are known to be varicella IgG neg ative) especially if they are leaving h o me for studies in a residential school/college. It may also be considered in children attendin g crèches and day care centers. The vaccine can be administered to any healthy individual above the age of 12 months who has not had varicella previously. pain redness and swelling at vaccination site. s ch o ol teachers. It has to be given by intramuscular injection and the dose is 125 units/10 kg body weight. Varicella zoster immunoglobulin (VZIG) is used for passive post-exposure prophylaxis in immunodeficient individuals who have been exposed to varicella or herpes zoster and are unlikely to have d et ectable antibody levels. The vaccine is administered subcutaneously. The vaccine is stored at 2-80C and can be administered subcutaneously or intramuscularly. humoral as well as cellular. Varicella vaccines in use today are all derived from the original Oka strain but the virus contents may vary from one manufacturer to anoth er. humoral immunodeficiencies. breakthrough infections can be less if used after 15 months of age. It is indicated in children with chronic lung/heart disease. Takahashi et al developed a live attenuated vaccine from the Oka strain in Japan in the early seventies. It should be protected from light and needs to be used within 30 minutes of its reconstitution. When used for post-exposure prophylaxis it should be administered within 72 hours of varicella exposure . The vaccine has been in clinical use in Japan since 1989 and in the United States since 1995. 24 . however.5 ml and the minimum infectious virus content should be 1000 Plaque Forming Units. It should be given to the neonate if the mother develops varicella 5 days before to 2 days after delivery. Hence IAP COI recommends to use this vaccine after the age o f 15 months. One has to emphasize the generally benign nature of an d rarity of complications with varicella infection in young children. Adverse reactions . pregnancy should be avoided for at least 4 weeks after vaccination.

The virus is formalin inactivated and adjuvanted with aluminimum hydroxide. 5 and 7. the common serotypes responsible for invasive disease in children below five y ears of age in India include 6. It may be prescribed to adolescents who have not had viral hepatitis in past (or are known to be HAV-IgG negative). Peak incidence of pneumococcal disease is between 2 to 24 months of age. however. It appears that the serotypes causing invasive disease in developed countries are different from the ones which are found in developing countries. about 10 serotypes account for most 25 infections. 5. 18. 6 months apart. 19. Adverse reactions: It includes local pain and local induration. 14. It also leads to conditions like otitis media and sinusitis. may continue t o remain anicteric and may develop non-specific symptoms like any other viral in fection. it may not always be effective under such circumstances when the contact has had the same source of infection as the index patient. It may be offered to children from high s o cio-economic strata of society after explaining the pros and cons to the parents on a one-to one "named child" basis. 11. The IAP COI o p ines that HA vaccine is not recommended for universal immunization in India at present. Inactivated HA vaccines d eriv ed from HM 175/GBM strains and g ro wn on MRC5 human diploid cell lines are now available. In developing countries. The common pathogenic stereotypes reported in children in Western countries are 1. Thou g h prevalence of penicillin resistance is almost negligible at present . Based on the capsular polysaccharide antigen. One has to emphasize the generally benign nature of disease and very small number of children developing complications with Hepatitis A infection in young children. It has been suggested that the vaccine can be used any time after 18 months of age when the maternally derived antibody levels have declined. According to results of the Invasive Bacterial Infection Surveillance (IBIS) study. The disease severity increases irrespective of age. The adult formulation should be used after t h e recommended cut-off age of 15 years according to one manufacturer and 18 years according to the other The vaccine is given intramuscularly and the protective efficacy is 94-100% Immunity appears to be long lasting and boosters are not recommended at present. The vaccine is stored at 2-80C.Hepatitis A Vaccine Hepatitis A virus (HAV) infection is a relatively benign infection in young ch ildren as many of them have completely asymptomatic sub-clinical infection For instance as many as 50% of children between 2-5 years and 85% of those below 2 years who acquire HAV infection.g. Pneumococcal Vaccines Streptococcus pneumoniae is a common cau s e of invasive bacterial diseases responsible for a significant proportion of potentially fatal con d it io n s like pneumonia and meningitis in children. p neumococci are classified into 85 different serotypes. Serotypes 1& 5 accounted for 29% of disease in India. 15. non-resident Indians) visiting endemic areas. 19 and 23. Of these. this organism is believ ed to be the commonest cause of bacterial pneumonia. It is recommended in all patients with chronic liver d isease (who are HAV seronegative) and family contacts of patients with chronic liver disease. which may have morbidity but little or no mortality. 4. 14. especially those who are leav ing home for further studies. It is given in a two dose schedule.in t h e latter case the vaccine must be given within 10 days. 9. In adults hepatitis A is frequently symptomatic and mortality is much higher than in children. 4. 6. in those with underlying chronic liver disease. It may also be considered in children attending crèches and day care centers and in travelers from abroad (e. It may be offered to household contacts of patients with acute HA virus infection . 1.

12F. 3. and 23F. Immunization. It is als o recommen d ed for HIV infected children.5 ml. Immunity is serotype specific. This includes children with Sickle cell d is eas e. sickle cell d isease and nephrotic syndrome. suggesting s trong herd effect. nephrotic syndrome. 11A. This vaccine is poorly immunogenic in children below two years of age i. The vaccine may be offered to healthy children above the age of 6 weeks t ill 2 years after explaining the parents on one to one "named child" basis. Similar herd effect was seen in the form of overall reduction in the disease caused by drug resistant serotypes in the community. 19F. 19F. 33F. 7F. 14. 14. Conjugation of polysaccharide with protein CRM197 makes it immunogenic below 2 years of age.there is some evidence that the prevalence of resistance to penicillin amongst the p neumococci may be gradually increasing. fortunately this has not been seen significantly in the invasive diseases studies. Pneumococcal vaccines are s tored at 2. men in g it is an d bacteremia) caused by pneumococci. For such children IAP COI recommends age appropriate doses of 7 valent conjugated pneumococcal vaccine routinely till 5 years of age. 10A. The development of this v accine was prompted by the observation that young children below 2yrs of age are dis p ro p ortionately affected by the serious pneumococcal infection and recognition of the fact that available 23 valent polysaccharide vaccine was non immunogenic in t h is age group 2 yrs. 17F. and the vaccine is given intramu scularly. a dose of 23 valent unconjugated pneumococcal vaccine is also recommended to be given after one priming dose of conjugated vaccine. primary immu n o d eficien cy s y n d ro me s . Though there has been replacement of t h e vaccine serotypes by non-vaccine serotypes in the nasal carriage studies. PCV . 9V. 9V. In February 2000 this vaccine (PCV-7 Prevnar) was licensed in US fo r ad ministration to children below 5 yrs of age. children who are at highest risk of invasive disease. 8. 6B. It is coupled with a non-toxic variant of diphtheria toxin (CRM197) and has aluminium phosphate as the adjuvant. It is capable of preventing almo s t 85% of in vasive disease (pneumonia.e. The dose is 0.. 22F. Each dose is 05 ml containing 25ug polysaccharide of each of the 23 serotypes co n tained in the vaccines. High risk group: There are certain children who are at high risk of severe invasive pneumococcal disease with high mortality. However there is a need for continuous surveillance for the serotype involved in invasive cases from time to time. 18C. diabetes etc.1. Conjugate vaccine should not be frozen. It is recommended for children with asplenia. malaise. For children above 2 years. as it is an unconjugated polysaccharide vaccine it does not result in immunological memory. The 23-valent polysaccharide vaccine contains the following serotypes . 6B. 5. Since the introdu ct io n of PCV-7 in the childhood vaccine schedule in US.5 ml and the vaccine is given intramuscularly or subcutaneously. 15B.the 23-valent unconjugated polysaccharide v accine and the 7-valent conjugate polysaccaharide vaccine. 23F. 4. however. This vaccine may be us ed in h igh-risk groups above the age of 2 years. 18C. Healthy children: Th e IAP COI does not recommend u s e o f this vaccine for universal immunization in our country at present. 20. Two types of pneumococcal vaccines are currently available . The heptavalent conjugate vaccine (PCV-7) contains the following sero t y p es -4. Conjugate vaccine is used in a 3-dose schedule in infancy at 4-8 weeks interval followed by a booster at 15-18 months of age and has protective efficacy of 95-99% ag ain st invasive pneumococcal disease caused by the serotypes covered by the vaccine. as p len ia. is not effective for prevention of otitis media. 2. there has been a dramatic reduction in the in cidence of invasive pneumococcal disease not only in the children who are vaccinated but also non-vaccinated young children in their contact and a milder but statistically sign ificant decrease in invasive disease in their adult contacts. Revaccination is recommended after 5 years. 9N. 19A.7 covers approximately 50 to 55% percent of pneumococcal serotypes responsible for invasive pneumococcal disease in India offering about 50 to 55% protection in infants & ch ild ren in India.Injection site so reness. cardiovascular diseases or diabetes.80 C. 26 . H I V. The dose is 0. Adverse reactions . However. cerebrospinal fluid rhinorrhea etc. c h i l d r e n w i t h s ev ere cardio-respiratory illness and children with chro nic illn es ses like renal diseases. thereby highlighting the need for an effective vaccine. It may be offered to those with underlying chronic illnesses like renal diseases. low grade fever.

C. on the other hand. Meningococcal group C conjug at e vaccine. with highest attack rates in infants aged 3-12 months.D. like all other polysaccharide vaccines. A conjugate meningococcal serogroup C vaccine has been part of ro u t in e immunization in the United Kingdom since Novemer 1999 as it is t h e commonest cause of meningococcal disease in children there . Two doses of the vaccine suffice for children in age group 6-12 months and one dose in older children. do not induce immunological memory. are not very immunogenic in children below 2 years of age. It is also recommended during disease outbreaks (caused by serogroups included in the vaccine) and prior to travel to the high endemicity meningococcal belt in the African continent. The IAP COI does not recommen d t h is vaccine for universal immunization in our country at present. 27 .three doses are g iven at 4-8 weeks interval along with the routine childhood immunizations. Vaccines Used in Special Circumstances Meningococcal Vaccines Neisseria meningitides accounts for 30-40% cases of meningitis in children up to the age 15 years. The vaccine is stored at 2-80C. Unconjugated meningococcal vaccines are based on combinations of group-specific capsular polysaccharides . B. In India endemic cases are mainly due to type B. Severe meningococcal disease is associated with high case-fat ality rates (5-15%) even where adequate medical facilities are available. Y. Chemoprophylactic measures are in general insufficient for t he control of this disease because secondary cases comprise only 1-2 % of all meningococcal cases. prior to splenectomy and those asplenia and sickle cell anemia. It can be given to children ab ove 2 years of age during disease epidemic and is administered subcutaneously or intramuscularly. endemic disease occurs primarily in children and adolescents. It is the only bacterium capable of causing large scale epidemics of meningitis. or C although group Y has been increasingly incriminated in recent reports. Immu n ity following meningococcal infection is s erogroup specific. In India also almo s t all epidemics were of type A Such group A epidemics are usually due to a single strain of the pathogen. A conjugate group C vaccine has also been marketed in developed countries. with highest attack rates in infants aged 3-12 months. A. close household contact) it may be offered to even younger infants but the protective efficacy is likely to be low in this age group. Meningococcal vaccine is mandatory for all Haj pilgrims and is necessary for residential students in some of the universities abroad. Unconjugated meningococcal vaccines. Revaccination may be considered after 3-5 years if the individual is still at risk. It may be considered in child ren with complement deficiency. Meningococcal vaccine is indicated fo r use (as an adjunct along with chemoprophylaxis) in close contacts of patients with t h e d isease. Some of the recent outbreaks in Western Asia have been due to W135. As a rule. especially in the African meningitis belt which extends acro s s A frica from Senegal to Ethiopia. C. The recommended single dose of the reconstituted vaccine contains 50 µg of each of the individual polysaccharides. There are 12 kn o wn serogroups but majority of the disease causing is o lat es belong to serogroups A. The dose is 0. moreover.Fever and pain at injection site. during group A epidemic to close household contacts .5 ml. Y and W135.g. In special circumstances (e. Adverse reactions . The group C. Y and 135). and W135 components. En d emic disease occurs worldwide and is mostly caused by serogroups B.either bivalent (A and C) or tetrav alent (A. is efficacious even in the youngest children. Epidemic disease is typically associated with type A (occasionally type C) and usually occurs in cycles every 7-14 years. Severe meningococcal disease occurs p rimarily in children and adolescents.

of India in 2006. The whole campaign was carried out from 15th May to 15th July 2006. Cell culture derived live SA-14-14-2 vaccine Th is v accine is based on a stable neuro-attenuated strain of JE virus (SA-14-14-2). (a) mouse brain-derived and inactivated Nakayama Strain vaccine (b) cell culture-derived inactivated vaccine and (c) cell culture-derived live attenu at ed vaccine. Chengdu.1998). However with the availability of the Sa-14-14-2 live vaccine. Now it is also licensed for use in Nepal. It was g iven as single dose subcutaneously usin g A D syringe. Initial studies done on this vaccine demonstrated an efficacy of about 80% with single dose and 98% with 2 doses. nearly 86% of the target was achieved. 7 and 30 days . A booster dose is recommended after 1 year and subsequently at three year intervals. Inactivated Primary Hamster Kidney Cell derived Vaccine This vaccine made from Primary Hamster Kidney cell line was used in China in millions o f doses. China. Primary immunization consists of three doses given on 0. UP recorded 96% coverag e ag ainst all expectations. It is given subcutaneously . Use of Sa-14-14-2 live JE vaccine in India in 2006: Recognizing the need to control JE in high ly endemic districts. As there is no anti-viral drug treatment. Korea and India This live attenuated vaccine constitutes to over 50% of global production of all JE vaccine. Dose is 0. SA-14-14-2 live JE vaccine was used man ufactured by Chengdu institute of Biological Products.5 ml in ch ildren 1-3 years. local tenderness and redness in 20% of recipients. Kasauli. In recent years. several cases of acute encephalitis temporally linked to JE vaccinat ion have also been reported.Japanese Encephalitis Vaccines Japanese encephalitis (JE) is one of the most important causes of viral encephalitis in Asia. Based on the success and safety of this year. Adverse reactions: Include fever.0. S. 22 deaths were reported but none were causally related to the vaccine as cleared by an expert committee set up to monitor the adverse effects. This vaccine is not available in commercial market in India. more recent studies have shown efficacy reaching 99% even with single dose. Ut t ar Pradesh. However. JE vaccination remains the single most important control measure.5ml at all ages. JE is believed to be responsible for approximately 2000-3000 clinical cases and 500-600 deaths every year. It is given by subcutaneous route. however it has been used for public health by Govt. 2 in Assam and one each in West Bengal and Karnataka were targeted this year. Anap h y lactic reactions are known to occur with this vaccine. This vaccine was also produced by s o me international vaccine manufacturers like A ventis Pasteur (now Sanoffi Aventis). malaise. This vaccine is produced in In d ia at the Central Research Institute. Contrary to popular belief JE vaccine should n ot be used as an "outbreak response vaccine" It should rather be given to all children 1-15 y ears of age living in highly endemic areas (e. Mouse Brain-Derived Inactivated JE Vaccine vaccine has been given up. and 1 ml in older children.0 being the elected date. As per a WHO report no serious adverse effects (other than anaphylaxis) have been reported over 20-y ear period (1979 . From next year this vaccine will be included in the routine immunization schedule for the new birth cohorts in these areas. GOI has initiated a pilot project of immunizing children from h y perendemic districts against JE in 2006. this 28 . The vaccine may also be offered to visitors to endemic areas if the duration of stay is likely to exceed four weeks.g. In India. Commercially available vaccine is imported. Karnataka). Currently three types of JE vaccines are available e. Andhra Pradesh.e. 7 d is t rict s in UP. however they have stopped manufacturing of this vaccine recently and are trying to switch over to vero cell cultured vaccine. It was given in a campaign mode to children aged 1-15 years. It was firs licensed for use in 1988 in People's Republic of Ch in a and over sixty million doses per year are being used there.g. There were 504 adverse effects following the campaign of which 482 were minor adverse effects. 11 million children were target ed as b eneficiaries and 9 million children actually received the vaccine i. similar campaign is planned for ot h er areas in coming years.

the dose being 0. The vaccine is administered intramuscularly. B and C) with several subtypes of each based on two surface an t ig ens . 3) B/ Sh anghai/361/2002 . Revaccination is d o ne with a single annual dose. Influenza vaccine is highly immu n ogenic and is associated with minimal side effects. usually 6 month s to 1 year and a new vaccine is brought every year. s y s temic lupus erythematosus. 2) A/Fujian/411/2002 (H3N2) . or s u rface-an t ig en v accin es containing purified hemagglutinin and neuraminidase. It is of the utmost importance. especially in children. Most influenza vaccines are split-product vaccines. There are three antigenic types (A. s ickle cell d is eas e.116)]. that the vaccine should incorporate t h e current strain p revalent during that time. individuals with chronic pulmonary an d card iac d is eas e. have reduced efficacy against antigenically drifted viruses and are ineffective against unrelated strains. Vaccines elicit a relatively strain-specific humoral response. s p lit -p ro d u ct . HIV infection. highly purified influenza virus.like strain [variant B/Jingsu/10/2003]. The vaccine is effective for only a short period. Influenza vaccine is also recommended to be giv en for severe cases of asthma who need oral corticosteroids frequently. especially type A. therefore. s u b unit surface-antigen formulations. containing 15 µg each of two influen za A subtypes (H1N1 and H3N2) and one influenza B strain. Current inactivated influenza vaccines are produced from virus grown in emb ryonated hen's eggs. in ch ildren below three years and 0. When used for the first time the vaccine is given in 2 doses in children 6 months to 8 years of age. Vaccines are usually trivalent. Whole-virus vaccines are associated with increased adverse reactions. p roduced from detergent treat ed . The present vaccine contains 15 µg of hemagglutinin o f each of the three WHO reco mmended strains (Northern Hemisphere) for the season 2004-2005. diabetes mellitus and t h o se on long term aspirin therapy.25 ml. is characterized by frequent mutations . 29 .5 ml thereafter. 1) A/New Caledonia/20/99 (H1N1) like strain [variant A/New Caledonia/20/99 (IVR . This vaccine is cu rrently recommended for u s e only in high-risk children and adolescents e.antigenic drifts and antig en ic shifts. The influenza vaccine is therefore unique as the precise composition has to be changed periodically in anticipation of the prevalent influenza strain expected to circulate in a given year.hemagglutinin and neuraminidase Influenza virus. and are currently not used.g .like strain [varian t A/Wyoming/3/2003 (X-147)]. only one dose is sufficient above 8 years. and are of three types : wh o le v iru s . which is given before the peak influenza season. The WHO reviews vaccine composition biannually and updates antigenic content depen d ing on prevalent circulating subtypes based on the data obtained from its chain of reference laboratories from world over to provide antigenically well-matched vaccines.Influenza Vaccine Influenza virus is an ortho my xovirus. immunodeficiency.

are physically separate. The IA P COI endorses the use of combination vaccines. rather than g etting a large number of simultaneous injections. This was followed by hexavalent pneumococcal vaccine in 1947 and DTP vaccine in 1948. This concept differs from that of simultaneous vaccines.g. Many parents opt for one single injection of combination vaccines at a given visit. Current status of new combination vaccines Already developed DTPw + Hib DTPw + Hepatits B DTPw + IPV DTPw + IPV + Hib DTPw + Hib + Hepatits B DTPw + Hib + IPV DTPw + IPV DTPa + IPV DTPa + Hib DTPa + Hib + Hepatits B + IPV Hepatitis A + Hepatitis B MMR + Varicella Under development DTPa + Hib + IPV + Hepatitis B + Hepatitis A Available for use in India DTPw + Hib DTPw + HB DTPw + Hib + HB DTPa + Hib HA + HB • 30 . A number of combination vaccines are now available in the Indian market. although ad ministered concurrently. Use of combination vaccines is also likely to result in logistic advantages reduced burden on the cold chain and reduced storage requirements and syringes/needles apart from easier record keeping. dT) or with pertussis vaccine (DTP). Combination vaccines should not be viewed as being more effective than vaccines given separately. but with the following cautionary statements: • • The manufacturer's recommendations should be adhered to strictly “Mixing" of vaccines in the same syringe (prior to injection) should not be done as far as possible. in the latter case the manufacturer's instructions should be followed strictly. inactivated (IPV) or live oral (OPV) trivalent polio vaccine and MMR vaccine.g.Combination Vaccines A combination vaccine consists of two or more separate immunogens that have been physically combined in a single preparation. which was developed as far back as 1945. These immunogens may pertain to the many antigens/ serotypes of the given pat h o g en (e. available alone (DT. The combining of multiple related o r unrelated antigens into a single vaccine is not a new concept. DTP v accine). unless specifically recommended by the manufacturer. which. The first combination vaccine was trivalent influenza vaccine. The number of vaccines in the immunization schedule is increasing every year with the result that these schedules are getting increasingly more complex. Combination vaccines in common use include diphtheria and tetanus toxoid. poliovirus vaccines) or of multiple pathogens (e.

India accounts for almost 50% of mortality in the world There are two types of vaccines available in India Modern tissue culture vaccines (MTCV) severe b it es or bites in the upper extremities. with day '0' being the day of commencement of vaccination.1 ml per dose. The intradermal schedules have the obviou s advantage of being inexpensive and have b een used successfully in Thailand. Purified Duck Embryo Vaccine (PDEV) . When suturing is unavoid ab le for purpose of hemostasis.0.5 ml per dose. Skin testing is recommended before using ERIG but is not n ecessary when using HRIG. Rabies vaccine is administered intramuscularly in anterolateral thigh on days 0. Philippines and Sri Lanka. The dose of human rabies immunoglobulin (HRIG) is 20 U/kg while that of equine rabies immunoglobulin (ERIG) is 40 U/kg. Rab ies is caused by the bite of a rabid animal. Nerve tissue vaccine This is no longer recommended because of its poor efficacy and life threatening adverse effects in the form of neuroparalytic reactions. A sixth dose on day 90 is optional and may be offered to patients with severe debility or those who are immunosuppressed.ID dose is 1/5th the IM d o s e. Post exposure prophylaxis In order to remove as much of the rabies virus as possible. which is usually a dog in our country. Scratches or licks on mucous membranes by affected animals have also been kn o wn to transmit the virus.1 ml per dose. the Drug Controller General of India (DCGI) has recently decided to allow ID route administration o f tissue culture based anti rabies vaccine fo r post exposure prophylaxis in a phased manner. Several other schedules of rabies vaccination have been proposed. 3. Rabies vaccine should never be injected in the gluteal region.0. at four sites on day 7 and at one site only on days 30 and 90.1 ml of PCEC vaccine is given ID at eight sites on day 0. trunk. 7. The following schedules as recommended by • • • • Purified Chick Embryo Cell (PCEC) vaccine 1 ml per dose.two IM doses on day 1. Children are given the same dose as ad ults. Intramuscular injection of RIG is not recommended. the 2-2-2-1-1 intrad ermal schedule (Thai Red Cross TRC-ID schedule) in which two ID doses are given on days 1. Human Diploid Cell Vaccine (HDCV) . Any suturing of wound should be avoided. immediately cleanse the wound with soap and flush thoroughly under running water for 10 minutes . one IM dose on day 7 and one IM dose on day 21. Rabies immunoglobulin (RIG) should be infiltrated in and around the wo u n d in case of all Day of Vaccination Thai Red Cross Regime Updated TRC Regime D0 2 2 D3 2 2 31 D7 2 2 D14 0 0 D28 1 2 D90 1 0 . Then treat with 70% alcohol or tincture iodine or povidone iodine. 14 and 30 as per the Essen protocol. the 8-4-1-1 intradermal schedule (Oxford schedule) . followed by one ID dose o n days 30 and 90 . head and face (wound category 3). Based on the recommendations of the expert group as well as WHO. It is almost always fat al. it must be insured that RIG has been infiltrated in the wound prior to suturing. 3 and 7. The incubation period averages 4-6 weeks but can be very variable and may range from five days to more than one year. Purified Vero Cell Vaccine (PVRV) . Rabies is endemic in our country . These include the 2-1-1 intramuscular schedule (Zagreb schedule) .Rabies Vaccines The disease is caused by a single stranded RNA virus belonging to the family Rhabdoviridae. All tissue culture vaccines have almost equal efficacy and any one of these can be used.

wildlife workers. postmen). Also it does not make economic sense to practice it for individual cases. The unit dose of 0. HRIG is a liquid or freeze-dried preparation containing immunoglobulins (mainly IgG) and is obtained from the p las ma of donors immunized against. Pre-exposure prophylaxis Pre-exposure prophylaxis became a reality only after the availability of MTCVs. dog breeders. Antirabies antibody titers > 0. From the eight day onwards. It contains specific an t irabies antibodies that neutralize the rabies virus and provide passive protection. 32 . In case RIG dos e (q uantity) is insufficient for adequate infiltration of extensive or multiple wound.1ml for ID should have at leas t 0. In case of ERIG.three doses are given intramuscularly on days 0. A booster is given one year after primary immunization and every five years thereafter. This ID administration is not recommended in individu al practice. RIG is not indicated since an antibody response to the vaccine is presumed to have occurred. it may be diluted with equal volume of normal saline so th at all the wounds can be thoroughly infiltrated. Any of the tissue culture vaccines can be given for this purpose . veterinary surgeons. Adverse reactions: Tenderness/stiffness at t h e injection site. 7 and 28. skin testing is recommended prior to use. The vaccine is stored at 2-80C. low grade fever. The remaining part if an y is to be injected IM into the deltoid region or anterolateral aspect of thigh away from the sit e o f vaccine administration to avoid vaccine neutralization.g. Side-effects include local pain and induration. For Re-Exposure after completed (and documented) pre or post exposure prophylaxis two doses are given o n days 0 and 3. If RIG could not be given when antirabies vaccination was began .ICMR are permitted in the 1st phase (Table below) Vaccines reco mmended in the first phase of ID route administration are purified verocell rabies vaccine (Senofi Pasteur) and purified chick embryo cell vaccine (Chiron Behring). sensitization may occur after repeated injections. Rabies Immunoglobulin (RIG) There are 2 types of RIG: (1) Human rabies immunoglobulin (HRIG .5 IU/ml are considered protective. The criteria for selection of Antirabies centre for ID use are • • • Attendance of minimum 50 patient per day for post exposure prophylaxis Have adequately trained staff to give ID inoculation Can maintain cold chain and ensure adequate supply of disposable syringes and needles.25 units. it should be administered as early as possible but no later than the seventh day after the first dose of vaccine was given. This should be offered to in d iv iduals in high risk occupations (e.dose is 40 U/kg body weight).do s e is 20 U/kg body weight) (2) Equine rab ies immunoglobulin (ERIG . RIG is indicated in all cases of category three wounds where it should be infiltrated thoroughly into and around the wound.

if the animal is euthanised and found to be negative for rabies by appropriate laboratory technique III Single or multiple transdermal bites or scratches.. licks) 33 . or. licks on broken skin None if reliable case history is available Administer vaccine immediately Stop treatment if animal remains healthy throughout an observation period of 10 days. contamination of mucous membrane with saliva (i. or. licks on intact skin Nibbling of uncovered skin.e. if the animal is euthanised and found to be negative for rabies by appropriate laboratory technique Administer rabies immunoglobulins and vaccine immediately Stop treatment if animal remains healthy throughout an observation period of 10 days.WHO Recommendations for Management of Animal Bites Category Type of contact with suspected or confirmed domestic or wild animals* or animal unavailable for observation Recommended treatment I II Touching or feeding of animals. minor scratches or abrasions without bleeding.

18 months 2 years 5 years 10 years 16 years BCG. OPV3. OPV0 .IAP Immunization Time Table Age Vaccine Birth 6 weeks 10 weeks 14 weeks 9 months 15. 10. Hib1 DTPw2 / DTPa2 . Hepatitis B1 DTPw1 / DTPa1 . OPV1. followed by a booster dose at 15 months 34 . Hib2 DTPw3 / DTPa3 . over 13 years of age 2 doses at 4-8 weeks interval + 2 doses at 6. Hib3 Measles DTPw B1 / DTPa B1. Hepatitis B3 *. OPV B2 Td# / TT Td# / TT Pregnant women: 2 doses of Td # / TT * Third dose of Hepatitis B can be given at 6 months age +Revaccination every 3-4 years # Td preferred over TT Vaccines that can be given after discussion with parents Age Vaccine More than 15 months More than 18 months More than 6 weeks Varicella vaccine# Hepatitis A vaccine+ Pneumococcal conjugate vaccine* # Below 13 years of age one dose. and 14 weeks. OPV B1 . MMR Typhoid+ DTPw B2 / DTPa B2.12 months interval * 3 primary doses at 6. Hepatitis B2. OPV2. Hib B1 .

Also refer to the individual vaccines notes for recommendations. 14 weeks/ 6 months. Also. local reactions at injection site and irritability). The manufacture's instructions should be followed strictly whenever "mixing" vaccines in the same syringe prior to injection. 35 . At present. If the mother's HBsAg status is not known. 2. Combination vaccines can be used to decrease the number of pricks being given to the baby and to decrease the number of clinic visits. in developing countries affordability of the vaccines is a critical issue and any decision on incorporation of a new vaccine in the immunization schedule has to take this fact into consideration. Continue using OPV till we eradicate polio in our country. 5. but this minor advantage does not justify the inordinate cost involved in the routine use of this vaccine. Notes on the Time Table 3.It should be noted that the IAP Immunization Time-Table is. The IAP endorses the continued use of whole cell pertussis vaccine because of its proven efficacy and safety. If the mother is known to be HBsAg negative. 9. IPV can be used additionally for individual protection. 1. The IAP COI has based its recommendations based on the best available evidence at present. It is heartening to note that some of the recommendations of the IAP COI in the past have been instrumental in changing governmental policies and also the immunization schedules being followed by some states. not in conflict with each other. epidemics). Hepatitis A and Congujate Pneumococcal vaccines should be offered only after one to one discussion with parents. 8. Revaccination may be carried out every 3-4 years. as pediatricians we must be conscious of the fact that the immunization needs of children in a country are quite dynamic . it is advisable to start vaccination soon after birth to prevent perinatal transmission of the disease. the baby should be given Hepatitis B Immune Globulin (HBIG) within 24 hours of birth. 6. the 'Best Individual Practices' schedule for a given child and may be somewhat different from the National Immunization Schedule. Varicella. along with HB vaccine. 7. the only typhoid vaccine available in our country is the Vi Polysaccharide vaccine. If the mother is HBsAg positive (and especially HBeAg positive). 10. For Non EPI and Newer Vaccines. the interval between the two doses of TT should be at least one month. Under special circumstances (e. During pregnancy. Acellular pertussis vaccines may undoubtedly have fewer side-effects (like fever. OPV must be given to children < 5 years of age at the time of each supplementary immunization activity. Further. measles vaccine may be given earlier than 9 months followed by MMR at 12-15 months. HB vaccine can be given along with DTP at 6.a vaccine which may not be considered important today may become necessary in future as more information about the epidemiology of the disease becomes available. 4. however. rather than for the pediatric community as public health measure at large The two schedules are. This is because of the fact that the former is meant to be used for an individual. in effect.g.

Immune attrition associated with viral replication may particularly interfere with memory responses. Patients on topical or inhaled steroid therapy should not be denied their age appropriate vaccines. but the immune response following vaccination would depend upon the degree of immunodeficiency at that point of time. Prednisolone 1-2 mg/kg/day) for more than 14 days should not receive live virus vaccines until the steroid has been discontinued for at least one month. all vaccines may be administered as per schedule according to the choronological age irrespective of birth weight or period of gestation. or unusual infections by vaccine preventable pathogens. 36 . It must be emphasized that routine immunizations seem to be generally safe in such children. Killed vaccines are safe but may be incompletely effective in such situations. Vaccination in children in children with HIV infection Children infected by HIV are particularly vulnerable to severe. If surgical splenectomy is being planned. recurrent. Children awaiting splenectomy Children with loss of splenic function are at high risk of serious infections with encapsulated organisms. Hib and meninggococcal vaccines should be initiated a few weeks prior to splenectomy. immunization with pnueumococcal.Immunization in Special Circumstances Immunization in preterm infants In general. Children receiving corticosteroids Children receiving oral corticosteroids in high doses (e.g. Consideration should be given to readministering childhood immunizations to such children when their immune status has improved following anti-retroviral therapy. Very low birth weight / preterm babies can be given immunizations after initial stabilization.

14 weeks) Yes (at 6 and 9 weeks) Yes Yes (as for uninfected children) Yes Yes Yes Yes ( > 6 months of age) Yes (2 doses at 6-8 weeks interval) Yes No Yes Yes / IPV Yes Yes (CD4% >15%) Yes (double each dose) Yes Yes Yes Yes Yes (2 doses at 6-8 weeks interval. CD4% > 15%) Yes Vaccination schedule for children not immunized in time It may be noted that vaccination catch-up regimens may be difficult to construct for older children and must necessarily de individualized. 37 .IAP Recommendations for Immunization of HIV Infected Children Vaccine Asymptomatic HIV Infection Symptomatic HIV Infection BCG DTPw / DTPa OPV Measles MMR Hepatitis B Hib Typhoid Vi Pneumococcal Influenza Varicella Hepatitis A Yes (at birth) Yes (at 6. 10. 14 weeks) Yes (at 6. The following table depicts the suggested schedule which may be followed in cases of children who have not been offered any immunization. 10.

** Varicella vaccine one dose up to 13 years and hepatitis A vaccine two doses 0 and 6 months to be offered only after discussing with parents on a one to one basis It may be noted that Measles/MMR vaccines may as well be given at the first visit itself (along with t he other vaccines) if compliance is likely to be a problem. fever.Vaccination Schedule for an Unimmunized Child Age Less than 7 years More than 7 years First visiit BCG*. DTPw / DTPa.g. In case of unknown or uncertain immunization status. Minor illness (e. diarrhea. Immunizations should be given at the next visit as if the usual interval had elapsed and the immunization scheduled should be completed at the next available opportunity. Typhoid HB Typhoid Typhoid * OPV and BCG recommended up to 5 years of age. HB Second visit (one month later) Third visit (one month later) Fourth visit (6 months after first visit) Every 3 years Td. HB OPV*. respiratory infections) and malnutrition should not be construed as contradictions to immunization. DTPw / DTPa. HB Measles / MMR. HB MMR. OPV* . Lapsed immunization There is no need to restart a vaccine series regardless of the time that has elapsed between individual doses. Missed opportunity for immunization This is defined as a situation when a child visits a health care facility and is not immunized. Any dose not given at the recommended age should be given at any subsequent visit when indicated and feasible. it is appropriate to start the schedule as for an unimmunized child. HB Td. Typhoid DTPw / DTPa. However it is preferable to give it at a later visit if pat ient compliance is not a problem. however. 38 .

if not given earlier Vi Polysaccharide vaccine every 3 years One dose up to 13 years and 2 doses (at 4 to 8 weeks interval) after 13 years of age if not given earlier.Simultaneous administration of multiple vaccines Both killed and live vaccine can be administered simultaneously without decreasing the efficacy of the individual vaccines. and 6 months. visitors comin g to India from Western Europe/North America are usually advised vaccination against typhoid and Hepatitis A. Similarly. vaccines commonly recommended for Indian travelers include yellow fever vaccine for those intending to go to destinations in South America an d Subsaharan Africa (except in infants les s t han 9 months and pregnant ladies) and meningococcal vaccine for those intending to go on a Haj pilgrimage. However. Vaccination Schedule in Adolescents Vaccine Age Td MMR vaccine Hepatitis B Typhoid vaccine Varicella vaccine* Booster at 10 and 16 years One dose if not given earlier 3 doses (20 mcg) 0. Uniform recommendation s are not possible because the epidemiolog y o f d is eas es d iffers in various geographical areas. The physician should try and update routine immunizat ion and also provide destination specific immunizations. For instance. especially if the stay is likely to be prolonged. 39 . 1. However. Immunization of adolescents Adolescents should be considered an appropriate age for "top-up" immunization as well as for adminis tration of certain vaccines which may not have been indicated earlier. Hepatitis A vaccine* Two doses 0 and 6 months if not given earlier * Only after discussing with parents on a one to one basis Immunization for travelers The risk of travelers contracting infectious d is ease depends on the region/country to be visited. prudence demands that the vaccines be administered at different sites. this should always be done after careful counseling. duration of trip and nature and conditions of t rav el.

therefore. Neither inactivated n or live vaccines administered to a lactating woman affects the safety of breas t -feeding for infants. not a con t raindication for any vaccine. 40 . There is no risk of transmissio n of Hepatitis B virus from an HBsAg carrier mother to her baby through breast milk if HB vaccination is started at birth.Vaccination of children with bleeding disorders or those receiving anticoagulants Needles less than 23G should be used for injection and the parents should be asked to apply firm and sustained pressure. for at least 5 minutes. Beast-feeding and Vaccination Breastfeeding does not adversely affect immunization and is. without rubbing.

These are now being promoted for rou tine immunization and may well become the norm in years to come. St eam an d Temperature (TST) spot indicators. malnourished and struggling children. the syringe may be cut and the needle defanged using a syringe/needle destroyer. self-locking syringes designed in such a way that these are rendered unusable after single use. The Government of India has decided to use AD syringes in Immunization program. protect fingers with a small gauze pad when opening the ampoule. To prevent reuse.Injection Safety Issues Injectio n s afety is an important issue for any immunization program Wash or disinfect hands prio r to preparing injection material. 41 . Do not use cotton balls stored wet in a multi-use container. Auto-disable (AD) syringes are single-use. Avoid giving injections if skin is infected or compromised by a local infection (such as a skin lesion or weeping dermatitis ). Clean skin prior to injection with a disinfectant and wait for it t o dry. These are made from clean-burning plastics and emit very low levels of toxic fumes. Always use a sterile syringe and needle for each injection and to reconstitute each unit of medication. All in t ramuscular injections in children should be given only on th e anterolateral aspect of thigh at the junction o f t h e middle and lower third . It is also know that the immune response of some of the vaccines (especially rabies) administered in the gluteal region is not optimum. Prepare each injection in a clean designated area where blood or body fluid contamination is unlikely. Document the quality of the s t erilizat ion process using time. Ev en small cuts should b e co vered. always pierce the septum with a sterile needle but do not leave the needle in place in the stopper of the vial. It is not often appreciated that the nerv e is within the reach of the standard needle even when the injection is given in the upper outer quadrant of the buttock. If using an ampoule that requires a metal file to open. Anticipate and take measures to prevent sudden patient movement during and after injection. Syringes and needles should be disposed of carefully in leak-proof and puncture proof contain ers an d n eedles and waste management should be given due attention. If multi-dose vials are used. The needle must not be recapped or manually mutilated after use. If single use syring es an d needles are not available. It is important for health personnel to understand that 'sharps' must be immediately co n t ained in a 'sharps' box. use equipment designed for steam st erilization.the gluteal region must be avoided as sciatic nerve injury is a real risk especially in neonates.

MMR. It should be noted that it might often be difficult to prove a definite cause-effect relationship between a vaccine an d a given complication. certain antimicrobials (e. Varicella. DTP.no treatment other than symptomatic management is necessary. Each member of the Academy is requested to report any case of suspected adverse reaction follo wing immunization to IAP committee on immunization through IAP office.g . Neomycin in MMR. Many adverse effects may result from inappropriate vaccination technique or storage of the product. Such reactions may be secondary to allergy to egg (e. TT vaccines).g . It may be prudent not to ascribe all adverse reactions to a vaccine. yellow fever.g. Whole cell killed typhoid vaccines are also ass ociated with particularly significant local reactions.the ulcers may sometimes take many weeks to heal. 42 .g. which has been given in the recent past before ascertaining all facts about the case. Measles.g. Although such occurrences are uncommon. MMR. gelatin (e. every physician who is dealing with immunization should anticipate and be prepared to manage these events whenever they occur It is mandatory for every immunization clinic t o h ave an emergency kit for resuscitation. Local reactions are especially common aft er the adsorbed vaccines (e. MMR. Varicella and Inactivated Polio vaccines) or thiomerosal (e.Adverse Reactions Following Immunization A d v erse reactions following immunization can be broadly classified as local and systemic. influenza vaccines). DTPw/DT) . Yellow fever vaccines). Ulcer formation after BCG vaccination is normal and no intervention is usually required . Hib and Hepatitis vaccines. Anaphylactic reactions are distinctly unusual but have been reported following Measles.

3 cms size Ba c t e ria l abscess M o d era t e t o s ev ere l o c al reaction Seizures wit h fever (rare) Any vaccine After days to weeks fluctuant to firm Any vaccine No n fluctuant swelling / redness 3-10 cms in size at the injection site DTP Measles Always generalised • Anticonvulsants • IV fluids (if need be) 43 .5. no treatment • If soft or fluctuant. inconsolable crying • Sedation with Triclofos 50 mg/ Kg • Paracetamol 10-15 mg/ Kg per dose • Feeding advice • IV fluids • Antimicrobials cloxacillin 50-100 mg? Kg per day • Steroids • Supportive therapy • If firm.Adverse Reactions Following Immunization Adverse Reaction Vaccine Symptoms Management Anaphylaxis Any vaccine Within minutes • Adrenaline • Cardiopulmonary resuscitation • IV volume expanders • Hysrocortisone • Dopamine/ Dobutamine • Acute decompensation of circulatory shock • Hypovolemic shock • Laryngospasm /edema • Acute respiratory distress H y p o t en s i v e hyporesponsive episode DTP • Acute pallor • Transient decreased level or loss of consciousness • Decrease or loss of muscle tone • IV fluids • Oxygen Incessant crying DTP • Within 48-72 hours of immunization • Excessive. aspiration/ surgical excision • ATT not indicated • Antibiotics • Antipyretics • Drainage Paracetamol T o xic Sh o ck Syndrome Measles vaccine contamination • • • • • Within 30 minutes to few hours Mounting fever Vomiting Diarrhoea Septic Shock Lymphadenitis BCG • Within 2 to 6 months • Firm to soft axillary lymphadenitis 1.

the vaccine efficacy will suffer. Personnel responsible for vaccine distribution Appropriate equipment to store and transport vaccines Appropriate transport facilities Maintenance of equipment Monitoring Order of sensitivity of vaccines to heat Most sensitive BCG (after reconstitution) OPV Measles (both before and after reconstitution) Hepatitis B DTP DT BCG (before reconstitution) Least sensitive Tetanus toxoid Sensitivity of vaccines to freezing Vaccines damaged by freezing Vaccines that can be frozen without harm DTP DT TT Hepatitis B Hib Td Typhoid (whole cell killed vaccine) Hepatitis A OPV Measles/ MMR BCG (before reconstitution) 44 . In es s en ce. 2. Vaccine potency once lost cannot be restored. if the cold chain is not maintained from the source of vaccine manufacture to the place of vaccination. 5. storing and distributing vaccines in a potent state at the recommen d ed t emp erat ure from the point of manufacture to the point of use. The essential components of a cold chain include: 1. 4. The potency of a vaccine is maintained by 'cold chain' This term refers to the system of transporting. 3.The Cold Chain A vaccine has two characteristics . it is considered to play a crucial role in the success of any immunization program However potent a vaccine may be.safety and potency.

Deep freezers: are used for storage of OPV/ c) Measles//MMR vaccines and preparation of ice-packs. Cold boxes can also be used in h ealth centers for storage of vaccines and ice packs in case of electricity failure or breakdown of other cold chain equipment. In general a cold box of 5L can acco mmo date one month's supply of a PHC (30. freezers are provided with two identical cooling units and standby generator sets. The vaccines can be placed as follows: • Freezer compartment: OPV / Measles / MMR Top shelf: BCG / Measles / MMR Middle shelf: DTP / DT / TT/ Typhoid/ Hepatitis A / Hib Lower shelf: Hepatitis B / Varicella Crispator: Diluents Baffle tray: should be kept empty Equipment Walk. vaccines should be placed in cartons or polythene bags and then placed in direct contact with fro zen ice packs. The Electrolux type of ILR (Model TCW 1151) can also be used as a freezer by a changeover switch inside the compressor 45 • • • • • f) Cold boxes or isothermic boxes: are well insulated. A b o u t 25-30 ice packs (8-10 kg ice) and 35-40 ice packs (12-14 kg ice) can be frozen in one day in 140L and 300L deep freezers respectively.16.000 population).water should be filled in the icepack up to the level marked. this enables the temperature to stay within a safe range even when there is electricity supply for only 8-12 hours in a day.the former is supplied to district headquart ers while the latter is supplied to PHCs. should be kept away from heat and direct su n lig ht. the hold over time is more than 90 hours for a 5L.000 population). in case of power failure these freezers can maintain cabinet temperature for 18 . maintain a temperature recorders and alarm systems.5 & 20L. and 6 days for a 20L. in emergency situations. maintain a temperature of -200C and are available in 2 sizes . The usual temperature within the main compartment of a domestic refrigerator is between 4-100C while t h at of the freezer compartment is between 0 to -40C. state and regional levels which store vaccines for abou t 4-5 districts. solid and thermetically (air tight) sealed boxes packed with frozen ice packs at the bottom. Walk in cold rooms (WIC): are used fo r bulk b) storage of vaccines at the man ufacturer. cold box at 430C ambient temperature.26 hours. d) Ice lined refrigerators (ILR): may have either ice tubes or ice packs filled wit h water upto 90% of their volumes.1500 vaccine doses can be carried in a 5L box and 6000 doses in a 20L box. while a cold box of 20L capacity can accommodate one month's supply for a CHC (100. DTP / DT/ TT/ Hepatitis B vaccines should be kept near the top in a s ep arate container to avoid accidental freezing.t h is should be used for storing OPV/Measles/MMR. periodic defrosting is necessary. DTP/DT/TT/Hepatitis B vaccines should not be stored in deep freezers. these are supplied to all peripheral centers and are used for transportation of large amounts of vaccines to outreach facilities . Ice packs should be made from tap water .5 & 32 CU Mt. in top opening ILRs the temperatures is least at the bottoms . this is generally done whenever the layer of ice exceeds 5-6 mms. deep freezers and refrigerators and b) the mobile chain represented by isothermic boxes and vaccine carriers. if the cold box is not opened at all. Domestic refrigerators: meant for vaccine e) storage should not be used for any ot h er p urpose. have a top opening lid and are availab le in 2 models -140 & 300 liters. should have ice-packs fo r freezer compartment and water bottles in the shelves. cabinet temperature is maintained between -18 to -200C. no vaccine should be stored in the baffle tray or the door shelves. All districts have been provided 2-5 large freezers whereas most of the PHCs have one small deep freezer. can also be used to store vaccines and frozen ice packs for up to 5 days. these help in maintaining low temperatures in case of power failure.The cold chain involves two complementary aspects: a) the set chain represented by the walk-in cold rooms. chamber in situations where OPV is to be stored for long duration (at -200C) or there is increased demand of ice-packs. o n freezing there is formation of an inner lining of ice. g) Vaccine carriers: are s maller versions of cold . are available in 2 sizes (140 & 300 liters) . if n o t o p ened. are u sed for bulk storage of OPV and measles vaccines and for preparing frozen ice packs at state s t ores. available in 2 sizes .in freezers (WIF): are established in all a) the states . sides and at the top.

HB and Hep A vaccines should never be frozen. Temperature monitoring should be done twice a day in the case of ILRs and deep freezer and once a day in the case of walk-in coolers. life of 24 months. which is the most thermo lab ile of all vaccines.g. temperature and time sensitive monitor marks are used to check the cold chain. Vaccines should be transported o n ly in cold boxes or vaccine carriers . No vaccines sh o uld ever be stored at the sub-centers. At a temperature of 2-8oC. presently. 6. have provision for only 2 frozen ice-packs. Interpretation of the colour change of VVM is as follows: . however.boxes and are used to carry small quantities of vaccines (e. DTP/ DT/TT/ Hepatitis B/Hepatitis A/Varicella and Hib vaccines have a shelf 46 The Vaccine Vial Monitor (VVM) is a time an d temperature sensitive colored label that provides an indication of the cumulative heat to wh ich the vial has been exposed. vaccine carriers and day carriers. Day carriers: are smaller versions of vaccine h) carriers and are used to carry still small quantities of vaccines (e.g. Expiry dates of vials shou ld b e checked once a week. DTP/DT/TT/Hepatitis B vials should be wrapped in plastic to avoid direct contact with ice.vacuum flasks should never be used for this purpose.50oC to +50oC. Alcohol stem t h ermometers are much more sensitive and accurat e t h an dial thermometers and can record temperatures fro m . the use of day carriers is not encouraged.at this temperature these vaccines have a shelf life of 2 years. Storage of vaccines All vaccines are safe at temperatures between 2-80C for at least 6 months. can maintain temperatures for 2 days if the packs are frozen and lid is kept tightly clo sed. Diluents should be stored at 2-8oC these should not be us ed b ey ond 4 hours.36L of water. can be kept at 2-80C for short er periods e. If a freezer is available. While storing vaccines fo llo w the "First-In-First-Out (FIFO)" and "First to Expire First-Out (FEFO)" rules. Dial t h ermometers are used to monitor the temperature in refrigerators/ice-lined refrigerators (ILRs) and are kept in every unit. The freezing point for adsorbed DTP vaccine is between -5 to 10oC. these contain 4 fully frozen ice packs (0. wait for 15 minutes. These can be used for deep freezers and ILRs .g. Ice packs: are made of polyethylene and weigh i) approximately 80 gm. 16-20 vials) for distribution to outreach facilities. It is recommended that vaccines should not be stored for more than 3 months at the district lev el and for more than 1 month at the level of primary health center. it should be used for storage of OPV and Measles/MMR vaccines. It takes about 110 to 130 minutes at -10oC. During shipment and transportat ion. It is used especially for temperatures monitoring of OPV. Such vials should be discarded. Ice packs are used to line the sides of cold boxes. t h e dimensions are 163 x 90 x 33 mms. VVMs increas e the flexibility in handling of vaccines in the field. VVMs were first introduced on OPV vials supplied to UNICEF and WHO in 1996. Freezing time depends on the number of doses in the vial and the temperature. The VVM warn s t h e end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level. it can be presumed that oth er vaccines would also be potent.36 liters each) and an inner plastic lining. A break in the cold chain is indicated if temperature rises above +8oC or falls below +2oC in the case of ILR and other refrigerators and above -180C in the case of deep freezers. the vaccine is likely to have been frozen at some time. 6-8 vials) of vaccine. If the VVM indicates proper storage of OPV in a given center. if any. The latter vaccines should be kept frozen at -200C when stored fo r t h e long term . are completely mixed . can be used to store vaccines for 6-8 hours. DTP / DT / TT / Typhoid (T-series vaccines). if the vaccine is not uniformly mixed or the sediments/ flocculations are still found settled at the bottom. where vaccines are stored in bulk for longer periods. vaccines in day carrier should be issued on the day of immunization only.12 months for OPV and 18-24 months for measles. co ntain 0. never add salt to the water. Even these v accines. The "Shake Test" can be used to determine if these vaccine has been frozen at any time: shake the vial so t h at the sediments.

The WHO recommends that in countries where VVM is being used for monitoring cold chain. Vaccine vials should not be taken out to the field more than 3 times . Samples from different immunization sites should be collected in vaccine/day carriers with fully frozen ice packs and transported to the headquarters by o b s erv ing "reverse cold chain" If delays in transportation are anticipated. has long term stabilizing ability and can be effectively used for this purpose.this will also result in substantial cost savings. Enterovirus Research Centre (Mumbai). there will no longer be a need for maintenance of co ld chain .after that these are best discarded irrespective of whether these have been opened or not.e. Tetanus toxoid is the least heat sensitive vaccine. may be used in subsequent sessions at a given health facility if it has b een p reserved at 2-8oC. the utilizatio n report should be submitted periodically. Open vials can also be sen t an d . OPV has been taken as an indicator of quality of cold chain as t h is v accine is more heat labile than other vaccines and is easier to test. Opened vials of OPV. When buying from market individual practitioners should ensure that vaccines are procured directly from a stockist with appropriate cold chain facilities. Vaccum flasks should never be used for an outreach activity. rather than off the shelf from a nearby retailer. CHC. a disaccharide. National Institute of Communicable Disease (Delhi). When using multidose vials it may be ad v isable to schedule all immunizations to a fixed day every week. vaccine can be used. If all vaccines can be successfully 'dried'. id eally. The test t akes only 7 days. 2. however. Oral polio vaccine. PHC. from the periphery after the immunization sess ion. OPV vials u sed in the field setting or an outreach facilit y o r during a pulse immunization session must be discarded at the end of the day. The Future Advances in sugar-glass drying technology now allow manufacturing of vaccines which can be stored and tran s p orted at tropical room temperatures. This reduces wastage o f v accine and minimizes the risks of contamination/loss of potency. One is allowed to collect profes s ional fees for the services rendered. OPV sample testing is not required. district and reg ional stores. the vials should be lifted from all levels . Reconstituted measles vaccine should be kept protected from heat and light during an immunization session and the left-over discarded after the session.the change in colour is gradual but irreversible. Testing facilities are available at the Central Research Institute (Kasauli).g. However there may be other factors which can also affect the potency of vaccine (e. Inner square is lighter than outer circle: If the expiry date has not passed. Recen tly Government of India is following this recommendation. Trehalose. Vaccine vials (single/multi-dose) should be gently shaken before use to ensure that the co n t en ts are clear and not granular or flaky. However. has failed to 'dry' successfully.1. Supply of vaccines A ll UIP vaccines are available free of cost to all practitioner from lo cal health authorities. Measles vaccine loses viability quickly if kept at temperatures above 400C. storage beyond the expiry date) and these may not be reflected in the VVM .i. The VVM provides in formation about the heat exposure of the vial over a period of time . Dried measles vaccine stabilized with trehalose has been found viable after 2 months at room temperature while DTPa can withstand a temperature of 600C for 12 weeks . however. Inner square matches colour of outer circle or is darker than outer circle: vaccine should be discarded. OPV would lose viability if kept at 22-25oC for more than a d ay . Loss of potency depends upon the degree of temperature elevation as well as duration of exposure. The manufacturer's instructions regarding shelf life of a given vaccine must be rigorously followed. One can send OPV vials for viab ilit y test with the help of the local health authorities. th e samples should be kept in a deep freezer/ILR before these are sent to the testing lab o ratory. School of Tro p ical Medicine (Kolkata) and other centers. 47 .

This recommendation is based on the fact that: 1.4 years Many weeks St a b le fo r man y days at 45OC Rabies HDCV 3. 2.Stability of Vaccines at Different Temperatures Vaccine 2. but does n o t e xceed 2 weeks Variable 10% lo s s o f potency per day Freeze dried BCG vaccine Re c o n s t it u te d BCG vaccine 2030% of viability after 3 months Variable Unstable Should be used within 4 hours.12 months 50% lo ss o f viability after 3 weeks Very u n s t ab le.25 in oC 35. but there is a steady decrease in potency 1 year Variable. F r e e ze d r i e d measles vaccine 2 years 1 month 1 week 50% lo s s o f viab ilit y in 2-3 days at 41OC R ec o n s t i t u t e d measles vaccine OPV Should be u sed within 4 hours 6.4 years De c lin e o f D-antigen content for Type I after 20 days Many months Hepatitis B 2. Concern over loss of viability. There is a risk of contamination as BCG vaccine contains no bacteriostatic agent.24 mo n t h s . Significant loss of viability within 13 days Variable Very u n s t ab le. Significant loss of viability within 1 day at 41OC Pre c i s e lacking data Inactivated Polio Vaccine (IPV) 1.5 years 3 months 4 weeks No data available 48 .8 Temperature 22.37 > 37 D T / TT (a s mo n o v a le n t v accines or as co mp o n en ts of combined vaccine) Pertussis vaccine 3-7 years Many months At least 6 weeks 2 weeks at 45OC 18.

suspicion and authority" Disease surveillan ce under the Universal Immunization Program refers t o the collection.Surveillance for Vaccine Preventable Disease (VPDS) Surveillance is a French word. which are u biquitous. Every case of AFP should be reported to local health authority.D. A sensitive surveillance system is required to direct program resources to areas of greatest need and to ident ify areas for special or more intensive interventions. 1) 2) 3) Polio eradication Neonatal tetanus elimination Measles reduction It is a pity that none of these targets have been met so far. the role of disease surveillance becomes increas ingly important to document the impact of a giv en immunization program. Similarly while it may be possible to eradicate measles in the future. 49 . analysis and use of data on VPD to improve action to p rev ent these diseases As higher levels of vaccination coverage are achieved. Acute Flaccid Paralysis (AFP) surveillance is an essential component of polio eradication. Any sat isfactory national immunization program should result in gradual decline of the VPDs. All cases of VPDs should be reported to the local health authority within 48-72 hours for taking prompt action at the field level.000 children below 15 years o f ag e is required to ensure that adequate surveillance exists at the ground level. which means "watching with attentio n. The nomenclat u re used for control of the three diseases is rather specific because while it is possible to eradicate polio v irus from the planet. by immunizing all mothers wit h tetanus toxoid it is possible to at least eliminate neonatal tetanus. A g o o d surveillance system can det ect program failures and impending outbreaks and can also be used to assess vaccine efficacy. The WHO had declared 3 district objectives for the year 2000 A. at the present time one can only hope to preven t measles mortality by preventing measles in the vast majority of immunized children. At present most of the parts of the coun try have excellent and adequate surveillance. However. The revised target for certification of polio eradication and neonatal tetanus elimination is the year 2007. A min imum AFP rate of 1/100. it may not be feasible to eradicat e the tetanus bacilli.

www.org. www.aap . We are likely to witness more refined vaccination techniques.cd c.o rg .childrensvaccine.who. Some vaccines which may soon become available for clin ical use are as follows: Bacterial vaccines Viral Vaccines Rotaviurs vaccine Respiratory Syncitial Virus vaccine Dengue fever vaccines HIV vaccine Hepatitis C vaccine Protozoal vaccines Enterotoxicogenic E.Vaccination in Current Millenium The future holds lot of promise as far as prevention of disease through vaccination is concerned.int/vaccines.org www.in ejc t io n s afet y . www. www. www.org.immunizationinfo.path.o rg .o rg .unicef.We are likely to g et many new combo vaccines also. www.org. coli vaccine Shigella vaccine Cholera vaccine Streptococcal vaccine for rheumatic fever Helicobacter pylori vaccine Malaria vaccine Websites for additional information The following websites may provide useful information www.vaccinealliance.v accin es . "Naked" DNA vaccines and administration of antigens through viral vectors/edible plants may completely revolutionize childhood vaccination programs.g ov/nip. improved antigens and safe vaccines.org 50 . www. www.

at least in areas with wild polio virus transmission continuing.Update of IAP Immunization Policies. 1 2005 New Delhi. The IAP COI ap p reciates that the IAP is represented on this important committee by its incu mb ent President and recommends that the Chairperson/Convener of the IAP COI . we must continue with this program and bring it to its logical conclusion.should also be invited as a member of this committee. This followed a formal recommendation from the IAP. Guidelines And Recommendations [Report of IAP COI Meetings ( July 16th & 17 2005. till wild polio virus is eradicated from our country. Immunization Program is its Member Secretary. Oct. IAP Policies on Immunization. Guidelines usually pertain to newer vaccines or issue related to them. what the academy in its role of advocacy on behalf of children. On Universal Immunization Program (UIP) The Academy fully supports the Government of India in the use o f oral polio vaccine (OPV) for the pulse immunization program against polio. in general. better quality of SIAs and role of IPV in difficult areas where wild polio virus circulation is still continuing. "Recommendations" are. Department of Family Welfare is t he Chairperson of the committee while the Assistant Commissioner. 'Guidelines" relate to those items wh ich are outside the purview of policy. 2006 New Delhi)] The Indian A cademy of Pediatrics Committee on Immunization (IAP COI) conducted its deliberations and reviewed its stand on various policies. guidelines an d reco mmendations pertaining to childhood immu n ization. i. "policies" are the decisions taken by the Academy in relation to the scientific principles and practice of immunization. in sp it e of some operational hiccups. The IAP continues to endorse and reiterate its support to th e n at io n al immunization schedule while recognizing the fact that much more needs to be done for meeting the current immunization requiremen t s of the children of our country. given a couple of years ago. These include operationalizatio n of birth dose of OPV all over the country. All vaccines under UIP sh o u ld continue to be available free of charge to all eligible children. and for which guidance is necessary. It is a fact that except for the recent phased introduction in Hepatitis B vaccine in 51 . As has been enunciated earlier. the Go v ernment of India or other professional bodies. On Polio Eradication Goals and SIAs On NTAGI The IAP welcomes the establis h ment of the National Technical Advisory Group o n Immunization (NTAGI) by the Government o f India. The Secretary. requests other agencies. "Policies" are expected to be pract iced by all members of Academy. strengthening of routine immunization. 2006 a few districts.e. 2006 Mumbai. April 2. It is our considered opinion that. no new vaccine has been introduced in the national program in the last 25 years. IAP advocates that some st ep s are required to be taken to overcome the last hurdles in achieving the goals of polio eradication as fast as possible. and July 28. New Delhi.

OPV is cheaper & being given orally and so mo re acceptable. Past experience from some countries has shown that countries which have eradicated wild polio virus and have slackened in their routine polio immunization programs have experienced cVDPV outbreaks. On number of routine DTP/OPV doses The IAP COI endorses the use of five d o s es of DTP/OPV at 6. preferably as IPV-DTP. These outbreaks of cVDPV were curtailed by strengthening routine immunization and giving 2 or more rounds of SIAs using OPV. However in post-polio eradication era. however. It will force us to depend on the stocks of WHO or any such agency for OPV vaccine. MMR and typhoid. Hence India should Practitioner keen to use this vaccine may use the vaccine as 3 primary doses followed b y o ne booster dose with DTwP / DTaP. Post-polio eradication scene and polio immunization: IAP believes that it will be unsafe and u n et hical to continue to use OPV in post-po lio eradication era. Following concepts should be kept in mind while deciding India specific guidelines for post-polio eradication immunization. 10 and 14 weeks and thereafter at 15-18 months and 5 years respectively. India should encourage indigenous manufacturer to produce enough IPV so that it becomes affordable so that it will be possible to switch to IPV in due course.Inactivted Polio Vaccine (IPV) (Role of IPV vis a vis OPV) preempt the emergence of cVDPV and has to become self sufficient in stock-piling enough polio vaccine now to meet any such unforeseen eventuality in future. Td should replace TT at 10 and 16 years. HIB. liv e attenuated SA-14-14-2 Japanese Encephalitis Vaccines are the new vaccines which have become available in India. Pn eu mococcal PCV-7. looking at the huge requirement of the number of doses.. On Vaccines not covered in EPI The IAP COI suggests that the UIP s h o uld be supplemen ted by the following vaccines: Hepatitis B (HB). OPV must be given to these children as birth dose and on the NIDs and SIAs. It should be noted that we continue to endorse the use of DTP (rather than DT as in t h e national program) and OPV at 5 years. Varicella an d Hepatitis A vaccines are still not recommended for routine use. in its routine immunization program in post-polio eradication era. • It will be unethical and unsafe to continue to use OPV after zero wild polio case and zero transmission status is achieved due to risk of VAPP and cVDPV following OPV. it will be unethical and unsafe to reintroduce OPV in such areas. The cost and availability of vaccine can be a problem. Coverage of children less than 2 years in high risk areas with 2-3 doses of IPV can b e an additional tool to eradicate polio from our country. Of late IPV h as been shown to induce local g u t immunity as well as herd effect. IAP recommends that India should switch over to IPV. should b e made aware of the availabilit y an d need of these vaccines. 52 . Tdap and Rota virus are the vaccines which are likely to be available in near future. An additional dose of OPV is to be given at birth to all where possible and one more additional dose along with measles vaccine. However it is less efficacious in tropical country like India due to in terference with other enteroviruses and other unknown factors It also needs strict co ld chain maintenance. Parents. should out-break of wild polio or cVDPP occur. less thermolab ile and has no chance of inducing vaccine induced paralysis. Where as IPV is more efficacious. iVDPV. • Looking at the above problems. • It will be unwise to discontinue use of polio immunization altogether after zero polio status is achieved due to fear of cVDPV.

6 10. preferably within 24 Hours of birth.6 months schedule.no boosters are required u n d er such circumstan ces.6 .6wks . 10 and 14weeks/6 months MMR should be promo t ed as a universal vaccine. Hib Vaccine Hib vaccine should be offered to all children and may be given at 6. the baby should be given Hepatitis B Immune Globulin (HBIG) as soon as possible after birth.1 . whole cell inactivated and oral Ty-21a). A booster is given at 15-18 months. as also to hospital staff likely to come in co n tact with pregnant mothers. irrespect ive of age. 1 and 6 months Birth. only two doses (at 4-8 weeks interval) need be given as primary schedule with a booster at 15-18 months. If HBIG is not available (or is unaffordable). The injections should be given at two separate sites. 1 and 2 month s with an additional optional dose between 9-12 months. vaccination should commence only after initial stabilization. In office practice. HB vaccination is now been integrated into the existing immunization program (UIP) in India.IAP COI stand on RECOMMENDED vaccines not covered under EPI against Hepatitis B. An ideal HB vaccine schedule should. There is no upper age limit for this vaccine.14 wks schedule can be followed. IAP COI strongly recommends GOI to include . Due to operational issues at a national level one has to piggy back on the av ailable contacts for routine immunization. MMR Vaccine Hepatitis B vaccine HB vaccine may be given in any of t h e following schedules: (i) (ii) (iii) Birth. It is recommended to be given after the age of 2 years followed by revaccination every 3-5 years. If vaccination is started between 12-15 months of age. along with HB vaccine. The purpose of Hepatitis B vaccination is to prevent chronic infection and development o f chronic liver disease / hepatocellular carcin o ma later in life. 6 and 14 weeks/6 months 6. with a booster at around 18 months.6 months schedule of hepatitis B immunization has been most widely used and proven to be ideal. Vi-polys ach aride. therefore. The IAP COI recommends universal immunization 53 The IAP COI strongly recommends the use of typhoid vaccine for all children. The vaccine need not be given after 5 years of age. prior to splenectomy and also in patients with sickle cell disease. After 15 months of age only one dose of the vaccine needs to be given. If vaccination is s t arted after 6 months of age. Typhoid Vaccine Immunologically 0 . Hib vaccine is also recommended for all high risk children. Of the 3 types of vaccines (viz. hen ce 0 . only one dose need be given. 10 an d 14 weeks along with DTP. It should be given at around 15-18 months of age and at least 3 months after the measles vaccine. HB vaccine may be given at 0.14 wks schedule is recommended. If the mother is HBsAg positive (and especially HBeAg positive). only the Vi-polysacharide vaccine is freely available in our country at present. in the case of extremely preterm babies. It should also be given to all adolescent girls and young women not previously immunized. The vaccination schedule need not be changed for preterm babies. The government should explore the possibility of manufacturing this vaccine in the public sector on large scale so that t h e costs are brought down. one can still use 0 . Boosters of HB vaccine are n o t n ecessary in immun o co mpentent individuals. however. In case birth dose has been missed. address vertical as well as horizontal modes of transmission of the virus.

It may be offered to children from high socio-economic strata of society after explaining the pros and cons to the parents on a one-to one "named child" basis. HA vaccine is indicated fo r all patients with chronic liver disease as well as household contacts of patients with chronic liver disease as well as household contacts of patients with HA virus infection . considered in children attending crèches and day care The live attenuated Hepatitis A Vaccine has been licensed for use in China since 1992.in the latter case the vaccine must be given within 10 days. This vaccine has recently been licensed for use in India. It may be offered t o children after ag e of 15 months from high socio-economic strata of society after explaining the pros and cons to the parents on a one-to-one "named child" basis. be not always effective under such circumstances if the contact has the same source of infection as the index patient. non-resident Indians) visiting endemic areas. This vaccine should be subject ed to post marketing surveillance for efficacy and adverse reactions in India. Varicella Vaccine Hepatitis A Vaccine Hepatitis A (HA) vaccine is not recommen d ed for universal immunization in India at present. There is only one Indian study con d u ct ed at Pune on this vaccine showing 95% seroconversion. HIV infection (but with CD 4 counts above 15% of the age related norms). IAP COI stand on vaccines that are given after discussion with parents: dose administered by subcutaneous route. varicella in fection in young children. However. however. Live attenuated Hepatitis A Vaccine The IAP COI opines that varicella vaccine is not recommended for universal immunization in India at present. It is indicated in children with ch ro nic lung/heart disease. 6 months apart after the age of 18 months The adult formulation should be used after the recommended cut-off age: 15 years according to one manufacturer and 18 years according to the other. The vaccine is given intramuscularly and the protectiv e efficacy is 94-100%. Boosters are not recommended at present. It may be prescribed to adolescents who have not had varicella in past (o r are known to be varicella IgG negative) especially if ther are leaving home for studies in a residential school/college. It may also centers. It may also be considered in children attending crèches and day care centers and in travelers from abroad (e. One has to emphasize the generally benign nature of and rarity of complications with Hepatitis A infection in young children. One has to emphasize the gen erally benign natu re of and rarity of complications with. The manufacturer claims 92 to 100 percent seroconversion with single Varicella vaccine is also indicated in susceptible adolescents and adults if they inmates of or working in 54 . humoral immunodeficiency. it may. Varicella vaccin e reco mmen d ed immu n ocompromised children. leukemia (but in remission and off chemotherapy for at leas t 6-12 weeks) and those on long term is als o of be in hous e h o ld c o n t act s s alicy lat es/steroids. for 100% seroconversion second dose after 6 months n eed s to be considered as recommended in China. It is given in a 2-dose schedule. It may be prescribed to adolescents who have not had viral hepatitis in past (or are known to be HAV-IgG negative) especially if they are leaving home for studies in a residential school/college.g. The vaccine has not been studied extensively outside China.this vaccine in UIP.

school teachers. Convulsions with/without fever occurring within 3 days 2. local reactions at injection site and irritability).g. Korea and India This live attenuated vaccine constitutes to over 50% of global production of all JE vaccine. It was firs licensed for use in 1988 in People's Republic of China and over sixty million doses per year are being used there. Now it is also licensed for use in Nepal. C. military personnel and health care professionals. PCV . However it is recommended routinely in h ig h risk group children up to the age of 5 years. the vaccine was found to be extremely safe. This vaccin e is not available commercially in India. day care center wo rkers. Temperature > 40.7 co v ers only 50 to 55 percent of pneumococcal seroty p es responsible for serious invasive pneumococcal diseas e in infants & children in India. more recent studies have shown 55 Meningococcal vaccine (bivalent A. however. However. It is given by subcutaneous route. C or tetravalent A. it has been used this y ear in seven endemic districts after importing it from Chengd u Institute of Biologicals.5ml at all ages. t h erefo re. These include: 1. not reco mmen d ed for un iv ers al immunization in our country at present. There is .50C within 48 hours Conjugate Pneumococcal Vaccines (PCV-7) The IAP COI endorses the continued use of whole cell p ertussis vaccine (as DTPw) because of its pro v en efficacy and safety. but this small advantage dose not justify the inordinate costs involved in the routine u s e of this vaccine. Acellular pertussis vaccines may undoubtedly have fewer minor side-effects (like fever. The v accine may be offered after explaining the parents on o ne to one "named child" b asis. IAP Stand on vaccines for special circumstances efficacy reaching 99% even with single dose. From the av ailable safety data. China. Acellular Pertussis Vaccine reactions to a previous dose of whole cell pertussis vaccine. Collapse or shock-like state within 48 hours 4. Persistent inconsolable crying for 3 or more hours within 48 hours 3. no bar to offering these vaccines to children from families who opt for the vaccine for the slight advantage of fewer minor side-effects. A single dose suffices between the ages of 1-13 years. W135) is indicated for use (as an adjunct along with chemoprophylaxis) in clos e co ntacts of patients . Dose is 0. It is .1998). however. S. Y. As per a W HO report no serious adverse effects (other than anaphylaxis) have been rep o rt ed over 20 year period (1979 . Init ial studies done on this vaccine demonstrated an efficacy of about 80% with single dose and 98% with 2 doses. after which a 2-dose schedule (4-8 weeks apart) is recommended. be considered in children who have had s ig n ificant The IAP COI does not recommend use of this vaccine for universal immu n ization for healthy children in our country at present. Meningococcal Vaccines Live Japanese Encephalitis (JE) Vaccine (SA-14-14-2) This vaccine is bas ed on a stable neuro-attenuated strain of JE virus (SA-14-14-2).the institutional set up e. Use of acellular pertussis vaccine should.

a live at t enuated human (G1P8) monovalent vaccine from GSK (RIX 4414 Rotarix) has recently been licensed in Latin American countries and some A s ian Countries. Recently a new Pentavalent bovine-human reassortant vaccine from Merck (Rotateq) has been licensed in USA. In India. This vaccine may be of particular use for children who have missed their 2nd booster of the DPT and are more than 7 years of age. Other Rotavirus vaccine being developed are LLR vaccine in China which is in phase II / III trials and the newborn strain vaccine in India. IAP COI stand on future vaccines: developing countries 53% of rotavirus deaths occur in Africa & 42% in Asia.g . 50% were < 6 months. For prevention universal immu n ization appears to be the only answer. There is need to know the efficacy of these vaccines in India before any recommendations can be mad e on the use of existing vaccines. Ro t ashield: Wyeth Lederle). There the epidemiology has undergone a marked shift since the introduction of mass childhood vaccination programs. Both these vaccines have been found to be safe and highly efficacious. It is estimated that 100. the proportion of pertussis cases in older children. This provides booster to waning immunity in adolescents thus leading to individual protection and prevention of transmission of disease to susceptible infants and children. adolescents and adults though n o t great in numbers have relatively increas ed. So the Tdap vaccine is n ot recommended for universal use at present. There is a great diversity of Ro t avirus strains Rota Virus Vaccine Tdap In the western world it is being felt that there is a need to vaccinate adolescents and adult s with pertussis vaccine. Almost all children get infected by the age of 5 yrs. The Tdap vaccin e h as been incorporated as booster dose during adolescence in the immunization schedule of few developed countries. In India the epidemiology of pertuss is is not well known and there is lack of information reg arding epidemiological shift. t h o se with and hyposplenia/asplenia. of the children hospitalized for rotavirus diarrhea. Trials of these vaccines have not been initiated in India so far.with the disease. Another Rotavirus vaccine .complement deficien cy ) during epidemics It is recommended for those who are going for Haj pilgrimage. making them the source of transmission to very young infants who are unimmunized or partially immunized and this age group is more vulnerable to dis eas e related complications and mortality. It is estimated that risk of death follo wing rotavirus diarrhea is 1 in 290 cases in 56 . 75% < 9 months and nearly 100% < 2 y rs. The first vaccine against rotavirus was tetravalent rhesus-human rotavirus vaccine (RRV-TV vaccine. Rotavirus is common cause of d iarrhea all over the world. As rotavirus d iarrhea occurs in spite of highest standards of hygiene it cannot be prevented by public health measures like s afe water supply and good sanitations. It is also indicated in high risk in d iv id u als (e . This vaccine licensed in USA in 1998 and recommend ed for universal use had to be withdrawn when an increased administration. rate of intussusceptions was shown to occur after vaccine prevalent in India.000 children d ie each year in India due to rotavirus diarrhea.

but with the following cautionary statements: 1. electronic media and news p apers/magazines) for placing advertisements pertaining to optional/combination vaccines. We opine that this is uneth ical. This led to the issuance o f a letter by the Drug Controller to the concern ed companies requesting them for the withdrawal of these advertisements.Combination Vaccines adhered to strictly 2. The advantage of a combination vaccin e is the convenience of fewer clinic visits for the parents and fewer pricks for the child 4. The IAP placed a formal complaint before th e Drug Controller General of India and the Union Health Ministry. The manufacture's recommendations should be On Adolescent Vaccination Immunization card to be used for this purpose. Every vaccine given to a child must be documented on a card/ booklet. rather than come repeatedly for the various individual vaccines or take multiple pricks on a single day for vaccines that are now in cluded in the immunization time. On Advertisements in the Lay Media The Academy endorses the continued use of Td/tetanus toxoid at 10 and 16 years and thereafter every 10 years. A number of combination vaccines are now available in the Indian market. The IAP COI endorses the use of combination vaccines. Parents must be instructed to keep the document safely and present it to their doctor whenever required. We are hopeful the companies would see reason and refrain from lay advertising. Hepatitis A and varicella vaccines should be used in selected cases as mentioned above. Many parents opt for one single injection of combination vaccines at a given visit. MMR vaccine should be offered to all children who have not received it earlier . Combination vaccines should not be viewed as being more effective than vaccines given separately The number of vaccines in the immunization schedule is increasing every year and this tren d is likely to continue for the next few years.there is no upper age limit for this vaccine. in the latter case the manufacture's instructions should be followed strictly 3. if the child has not received it earlier. unless specifically recommended b y the manufacturer. 1 and 6 months sched u le as mentioned earlier under individual vaccines.table. The Academy encourages the use of typhoid vaccin e for all adolescents. On Immunization Records Some of the multinational companies have been using the lay media (television. HB vaccine may be offered in th e 0. We recommended the IAP Health and 57 . Extemporaneous " mixing" of vaccines in the same syringe (prior to injection) should not be done as far as possible.

HIB and M M R Vaccines should be included in the national immunization schedule with immediate effect.IAP 2006 Recommendations for other agencies including Ministry of Health and Family Welfare. • The IAP recommends that the Academy should be represented on NTAGI by incumbent President and the Chairperson/Convener of IAP COI • • At 5 years of age booster immunization should be done with DTP rather than DT. 58 . the baby should be given HBIG plus HB vaccine soon after birth. The Academy recommends that inactivated polio vaccine should be introduced in the routine immunization in a phased manner. now that it is licensed in the country. • The Government should actively consider inclusion of typhoid vaccine in the national immunization schedule. The Academy supports the decision of the Government to discontinue production of animal brain rabies vaccine. If the mother is HBsAg positive. Govt of India The IAP COI has formulated several specific recommendations to other agencies pertaining to immunization. The Academy suggests use of • • Vi-polysaccharide vaccine for this purpose. • The Academy strongly recommends that Hepatitis B. However we need to ensure adequate supplies of indigenously produced chick embryo/tissue culture vaccines at affordable costs. Intradermal route of cell cultured vaccine as per the recent approval and the guidelines of the Drug Controller General of India should be encouraged and the minimum number of vaccinees stipulated in the guidelines should be brought down to 10 (the number of doses obtained from one vial of vaccine). The Academy again reiterates its previous recommendation to the Federation of Obstetric and Gynecologic Societies of India to adopt a policy of routine testing of all pregnant women for HBV infection.

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