1IAP 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: [email protected] 2 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 3 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 4 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. 5 an organized immunization program came into exis tence in the year 1974 under the banner of the World Health Organization (WHO). The program started with BCG. The WHO also endorsed global efforts at immunization through Universal Childhood Immunization (UCI) in 1990 . At the global level. thereby reducing the number of potential beneficiaries. 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. sp o ke of preventing certain infectious diseases t h rough immunization. as applicable) and at least 85% coverage of infants.Historical Aspects Though Dhanvantri. The vaccines recommen d ed were BCG. Under the UIP. diphtheria. DTP. a change of strategy was considered necessary. In this program the emphasis was s hifted from the under-five to under-one age group. 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. such as poliomy elitis.it did not include measles vaccine. Since then many other vaccines have been developed in rapid succession. 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. This was christened as the 'Expanded Program on Immunization' (EPI). the govern ment also aimed to establish logistics of vaccine production and supply as well as training of medical and p aramedical personnel. OPV was added only in 1979 and measles later on. 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. Since switching over to UIP in India there has been a significant decline in many of the vaccine preventable diseases. extending coverage to all corners of a country and spreading services to reach the less privileged sections o f the society. The vaccines included were BCG. wh o o p ing cough and measles. Measles and TT. It considerab ly reduced the denominator for percentage coverage. Supplemen t ary immunization activities against poliomyelit is were started in 1995-96. It was first given to a child in 1885. Ty p h oid vaccin e continued to be a part of our national immunization schedule until 1985. 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. OPV. It should be noted that UIP envisaged 100% coverage of pregnant women with 2 doses of tetanus toxoid (or a booster dose. which was used for post-exposure prophylaxis. DTP. The Government of India subsequently set up a " Technology Mission on Vaccination and Immunization of Vulnerable Po pulation. 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. to improve vaccine product ion technologies and to . OPV and Measles for infant s an d TT for pregnant women. In 2002. t h e father of Indian Medicine.the name given to a declaration sponsored by UNICEF as part of the 40th anniversary of the United Nations in October 1985. Louis Pasteur developed a h ig h ly effective vaccine against rabies. and to achieve self-sufficiency in the production of vaccines. 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. neonatal tetanus. but this could not be achieved for several years and independent evaluations showed very low coverage rates in many parts of our country. 6 In 1985. DTP and Typhoid vaccines . The EPI program focused on children below 5 years of age and pregnant women. Hepatitis B vaccination was initiated in selected areas targeting the urban poor. Th erefore. the EPI was s upplanted by the Universal Immunizat ion Program (UIP). The term "Exp anded" referred to the provision of adding more antigens to vaccinatio n s chedules. and iv) the introduction of district level monitoring system. Program coverage of 85% was envisaged. Efforts were undertaken to initiate research for the development of newer vaccines. u n d erstand the epidemiology of diseases.g. the WHO also set a target for universal Hepatitis B immunization. malaria and tuberculosis v) making immunization coverage an integral part of international development initiatives. 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. World Bank and the Rockefeller Foundation. CVI aimed at development of newer vaccines. Training of mid-level managers. The GAVI Ind ia Project has been instrumental in launching free Hepatitis B immunizatio n in some of the urban slums. Bill and Melinda Gates Foundation. Gujarat.g o v ern men t al organizations and the governments of 74 d ev eloping nations. Madhya Pradesh. GAVI organizes its activities through a vaccin e fund. Unfortunately last report of National family and health survey released in 3rd week of Nov '06 do not confirm this improvement. India has recently accepted its inclusion in National schedule and the coverage will expand in a phased manner. Rockefeller Foundation). where it was claimed that EPI had indeed been a global success with 80% reported coverage with the six vaccines. Bihar. Oriss a. It aimed to incorporate Hepatitis B vaccine in the immunization schedules o f all member countries by 1997. since 1999. improvement in vaccine production technolo g ies and vaccine quality. The focus of GPV is on sustaining high vaccine coverage. However unfortunately less than 50% of t h e countries have actually introduces Hepatitis B vaccine in their National Schedule. 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. Assam and West Bengal. These developments were highlighted in 1990 at the Summit for Children. In 1992. n o n . developing global surv eillance network and evolving eradication strategies. UNICEF. These newer initiatives have improved overall coverage in these districts. The project was started in 50 poorly performing districts of 8 priority states of Uttar Pradesh. availability of new vaccines and delivery mechanisms and advances in cold chain technologies iv) improving surveillance and monitoring mechanisms. 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. Rajasthan. The "Global Alliance for Vaccines and Immunization" (GAVI) was set up in 1999 as an international coalition of multination al funding agencies (e. 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. A surv ey conducted in 2002 under the RCH showed that immunization coverage rates in India have been d eclining. 7 . v accin e man u fact u re r s . is an integral component of this project. 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. It has also endeavored to promote safe injection practices and use of auto-disable syringes for immunization as part of a countrywide initiative. which will induce a protective immune response without suffering from the disease. active and passive. Vaccines mimic infection with the respective pathogen. pertusis vaccine. 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. safety Ph as e II Trial: Human volunteers . For instan ce. In general. 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. Most of the currently used childhood vaccines do not interfere with the vaccine "take" of one another.for tolerance. or subunits (e. inactivated polio vaccine). Th is way the drop out rates may also decrease. modified exotoxins called "toxoids" (e. first to ensure recovery and then to offer protection from disease if the same patho gen were to be encountered again. safety Further.e. similarly. before a vaccine is act u ally marketed it undergoes sterility. safety Phase III Trial: For field efficacy. the ultimate express ion of immunity is predominantly humoral. purity and potency tests at the level of the manufacturer and the Drugs Controller General of India. whole inactivated org anisms (e. whole cell typhoid vaccine.Basic Immunology The Greek work "immune" means "to be protected". BCG elicits CMI without an easily demonstrable humoral component. BCG and OPV can be given from the day of . oral polio vaccines. polysaccharide antigens of Salmonella typhi or Haemophilus influenzae type b and the surface proteins of hepatitis B virus). The process by which t h is acquired immunity is obtained is known as 'immunization'. diphtheria toxoid. say for instance DTP. Vaccines are selected based on three important criteria viz. varicella vaccine.g. Protection offered by the introduction of various antigens or ready-made antibodies is called acquired immunity. If the antigen preferentially stimulates Th1 series of T helper lymphocytes. 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. but without the asso ciated risk of developing the disease. When specific antigens evoke the required immune response in the system it is called active immunization. measles vaccine). therefore. tetanus toxoid). 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. hence they stimulate B cells directly without T helper cell modulation. if required. oral typhoid vaccine. Pathogenic infectious ag en t s induce disease and the host immune system responds with immunity . This is of two types. therefore. This results predominan t ly in a IgM response wit h out IgG production or induction of immunological memory. antibody) immunity or cell mediated immunity (CMI) or both. All vaccines are subjected to the following trials before being licensed: Phase I Trial: Human volunteers . if Th2 series is preferentially stimulated. 8 BCG.g. A vaccine is composed of one or more antigens of the pathogen. the interval between two doses of the same v accine. rabies vaccine. a strong lymphocytic respons e is obtained. Measles vaccine. The consequent immune response may be manifested through hu moral (i. MMR vaccine is given only after 12 months of age. should be at least 4 weeks. These can be.for immu n e response. safety and efficacy. live measles vaccine may be inhibited in the presence of detectable maternal antibody in the infant's circu lation. should only be given after at least 9 months of age . given simultaneously and several antigens can be g iv en the same day. Carbohydrate antigens are T cell independent. necessity. Vaccines consist of attenuated live organisms (eg. 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. preferably 8 weeks.g. very little objective evidence to show t h at this immunosuppression is clinically significant. the disease likely to be prevented. pneumococcal HBsAg Acellular pertussis 9 . There is. 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. If the opportunity to give BCG / Hepatitis B was not available in the neonatal period. meningococcal. anticipated adverse reactions and due date for the next session of immunization. whole cell killed typhoid IPV. t h e n umber of doses needed. Some of the viral vaccines (e. Hib. however. it may be given at 6 weeks. 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. process of inducing immune response which may be humoral or cellular. Seroprotection: a stage of protection from disease. attenuated Live virus. HAV Tetanus. Seroconversion: change from antibody negative state to antibody positive state. diphtheria. Types of Vaccines Type of Antigen Examples Live bacteria.birth until 2 weeks of age. Terminology Vaccination: Immunization: process of inoculating the vaccine/antigen.g. measles. rabies. s imultaneously with DTP and OPV. Td Typhoid Vi. s o that there would be 4 weeks gap until the next contact for immunization at 6 weeks. varicella Pertussis. Ty21a OPV. attenuated Inactivated bacteria Inactivated virus Toxoid Capsular polysaccharide Viral subunit Bacterial subunit BCG. MMR. due to the presence of detectable antibody. Antibody titer: the reciprocal of the highest serum dilution at which antibody has been detected. OPV2 DTP3. New Delhi) 10 . of India (1994) National Child Survival and Safe Motherhood Program. M in is t ry of Health and Family Welfare. ** 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. 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. OPV1 (BCG if not given at birth) DTP2.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. OPV0 for institutional deliveries DTP1. OPV3 Measles DTP. DT or TT vaccines (Source: Govt. than against the development of pulmonary tuberculosis where it has a protective efficacy of less than 50%. No treatment is required for this co ndition.1 ml of reconstituted vaccine irrespective of the age and weight of the baby. The vaccine contains 0. If no reaction is seen at the local site even after 12 weeks. 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 vaccine should be used within 4 hours with the left-over being discarded after the session. Therefore. One should 11 ensure maintenance of cold chain during transport and storage. Antitubercular therapy is of no benefit in such situations and should not be administered. which increases to a size of 4-8 mm. it could be given up to the age of 5 years. stain for acid-fast bacilli may b e p o sitive. as sudden gush of air in the vacuum sealed ampoule may lead to spillage of th e contents. without losing its potency. In some children the . a papule develops after 2-3 weeks. I p s i l a t eral axillary / cerv ical ly mphadenopathy may develop a few weeks/months after BCG vaccination. Guindy. Sterile normal saline should be used for reconstitution.local antiseptics are unnecessary. using a Tuberculin syringe and a 26G need le. Injection of BCG should be strictly intradermal. These are bovine vaccine bacilli and should not be misconstrued as being suggestive of tuberculous disease. Th e recommended dose is 0. The lon g n ecked BCG ampoule should be cut carefully by gradual filing at the junction of its neck and body. Adverse reactions . It should also be noted that if fine needle aspiration cytology of the nodes is carried out. it is an in dication to repeat BCG presuming that BCG has not taken up.1-0. Subcutaneous administration of BCG is associated with an increased incidence of BCG aden it is . This papule often heals with ulceration and results in a s car after 6-12 weeks. In lyophilized form it can be stored at 2-80 C for up to 12 months. 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. The vaccine is light and heat sensitive and deteriorates on exposure to ult ra violet rays.The ulcer at vaccination site may persist for a few weeks before formation of the final scar. Although the preferred time o f vaccination is soon after birth. once reconstituted.4 million live viable bacilli per dose. at the injection site indicates successful intradermal administrat ion of the vaccine. 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. As t h e vaccine contains no preservative. The injected site usually shows no visible change for several days Subsequently. The nodes regress spontaneously after a few months.Commonly Used Vaccines A. bacterial contamination may occur with repeated use. The selected site may be swabbed clean using sterile saline . The convex aspect of the left shoulder is preferred for easy visualization of the BCG scar. 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. A wheal of 5 mm. Secondary infection at the vaccination site may require an t imicro b i a l s . It is supplied as a lyophilized (freeze-dried) preparation in vacuum sealed multi-dose dark colored ampoules. Tamil Nadu till recently. by the end of 5-6 weeks. If this repeat dose is also not retained. OPV should be stored at -200 C at the state and district level and in the freezer at the clinic level. Oral Polio Vaccine Oral polio vaccine (OPV) remains the vaccine of choice for polio eradication in India. become an increasingly contentious issue for all pediatricians . clinical surveillance and appropriate virological investigations in all children with acute flaccid paralys is (AFP) are the cornerstones of polio eradication.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. when excellent clinical and virological surveillance exists and the coverage of routine OPV is more than 80%. 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. II and III respectively. Disseminated BCG infection is extremely unusual but may occur in children with cellular immunodeficiency.again. at 16-18 months and 5 years. However. Nearly 50 cases of VAPP are reported to occur in India annually. VAPP is more common than paralysis due to wild polioviruses and has. It is a suspension of over 1 million particles of poliovirus types 1. A high level of gut immunity ensures that vaccinated children would not participate in the chain of transmission of wild (pathogenic) polioviruses. d u ring infancy and 2 more repeat doses. The second major problem with u s e of OPV is the emergence of circulating Vaccine Derived Polio Viruses (cVDPVs). Approximately half of all VAPP cases are associated with the Type 2 OPV strain. Surgical removal of the nodes or repeated needle aspiration is the treatment of choice . t h e vaccine viruses reach the intestines where they must establish infection (vaccine virus "take") before an immune response may occur. " 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. 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 . OPV "take" rates may be somewhat variable.nodes may even liquefy and result in an ab s cess. namely magnesium chloride. It is supplied with a stabilizing agent. 2 and 3. A d eq u at e immu n izat io n . The vaccine. In addition to the routine OPV doses . 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 . which are mutants that re-acquire wild virus-like properties and have been associated with outbreaks of paralytic polio. therefore. like any other vaccine its use is associated with certain risks. For reasons that are not clearly understood. By mid-2006 polio has been elimin ated from all countries other than India. Nigeria. is quite stable under refrigeration. Niger and Egypt. OPV has been associated with occurrence of Vaccine Associat ed Paralytic Poliomyelitis (VAPP) Today. Breastfeeding and mild d iarrh ea are n o co n t rain d icat io n t o OPV adminis t rat ion. The vaccine 12 must reach the outreach facility at 2-80 C in vaccine carriers with ice packs. therefore. as we move towards p o lio eradication. 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 . 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 . IAP recommends at least 5 routine doses of OPV. the dose should be given again. neith er of the doses s hould be counted and the vaccine shou ld b e re-administered at a later visit. It has been estimated that the global VAPP burden is in the range of 250-800 cases an nually. 90% and 70% for Types I. If a substantial amount of OPV is vomited or regurgitated wit hin 5-10 minutes of administration. Afghanstan. Pakistan. When OPV is given by mout h . Seroconversion rates after three doses of OPV average 73%. antitubercular therapy is not recommended in this s it u at ion also. 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. consider incorporating IPV in the national immunization schedule in a phased . As the number of wild poliovirus cases in the country decreases. Development of sensitive surveillance. Core strategies for eradication of polio include: • • • • Maintaining high routine infant immunization coverage with OPV.when polio vaccine coverage rates decline but OPV use continues. The government sh o uld. However in our country the later schedule of 3 primary doses is better logistically as it can be given along with DTP at 6. Organization of mop-up campaigns.e. Ideal age to give first dose of IPV is 8 weeks an d the interval between two doses should also be 8 weeks. possible in testinal immunity. It is highly immunogenic. Inactivated Polio Vaccine (IPV) IPV is formaldehyde killed poliovirus grown in monkey kidney cell/human diploid cells. 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). At the same time. important to ensure complete coverage with OPV during NIDs so that no wild poliovirus remains in circulation. 2 and 3 polioviruses respectively. 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. Old IPV contained 20. 8 and 32 D antigen units of type 1. 2 and 3 respectively. so as t o eliminate the risk of VAPP and the emergence o f cVDPVs. All curren tly used IPV vaccines are enhanced potency IPV (elIPV) which cotains 40. 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. However if 3 primary doses are given. Currently term IPV means eIPV. cVDPV can result in large outbreaks. It is. W hereas VAPP occurs in individual cases. Conducting mass campaigns (i. 10 and 14 weeks followed b y a booster at 15 months. 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. 8 and 32 D antigen units of types 1. 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. a gradual transition to IPV should be encouraged. 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. The duration and extent of spread of cVDPVs are dependent on the magnitude of the immunity gap. It is now licensed to be used in India by Drug controller of India. therefore. pulse immunization against polio). The vaccine is very safe. 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. 1. However in post-polio eradication era. looking at the huge requirement of the number of doses. 3. 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. 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.Th e vaccine is very safe. neomycin and polymyxin B. DTPw Vaccine The combination of diphtheria t o xoid. however. IAP recommends that India should switch over to IPV. 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. Whole cell pertus s is vaccine has been incriminated in the 14 induction of a neurological reaction in v ery rare instances. IPV is also the vaccine of choice in patients with immunodeficiency and th e preferred vaccine in children with symptomatic HIV infection. 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. Cerebral palsy. These outbreaks of cVDPV were curtailed by strengthening routine immunization and giving 2 or more rounds of SIAs using OPV. it will be unethical and unsafe to reintroduce OPV in such areas. IPV can also be an additional tool to eradicate wild polio from last few high risk difficult districts. however. As IPV contains trace amounts of streptomycin. the pertussis vaccine (even after 3 doses) has a protective efficacy of about 70-90% only. 2. Convulsions following DTPw v accine are distinctly rare. Tetanus an d diphtheria toxoids are adsorbed on insoluble aluminium salts which act as adjuvants and enhance the antitoxin responses to both the antigens. While the two toxoids are highly immunogenic (95-100%). For children who develop persistent inconsolable cry of more t h an 3 hours . developmental delay). It is one of the oldest combination vaccines and has been in continuous use for more than 55 years. 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. 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. 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.Local (pain and redness) and systemic (fever) side-effects of the DTPw vaccine are almost entirely due to the pertussis component. 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.g. in its routine immunization program gradually in post-polio eradication era. preferably as IPV-DTP. Looking at the above problems.manner. Adverse reactions . Progressive/evolving n eurological illnesses. Following concept s should be kept in mind while deciding India specific guidelines for post-polio eradication immunization. It will be unwise to discontinue use of polio immunization altogether after zero polio status is achieved due to fear of cVDPV and iVDPV. 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. Adverse reactions . are a relative contraindication to first dose of DTPw immunization. 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. and may only represent n o t h ing more sinister than fever triggered seizures. 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.fever > 40. There is. and if frozen accidentally. These vaccin es s hould never be frozen. five component DTPa containing agglutinogens 2 and 3 in ad d ition to PT. hyperpyrexia . however. In case immediate anaphylaxis occurs after DTwP administration. DTaP can be recommended in such circumstances as this vaccine is less reactogenic. The DTPw or DTPa vaccines can be administered up to the age of 7 years. Td should be given. further doses of DTPw and DTaP are contraindicated. DTPa Vaccine may u ndoubtedly have fewer minor side-effects (like fever. two component DTPa containing pertussis toxin (PT) and filamentous haemagglutinin (FHA). These are. three co mponent DTPa containing pertact in in addition to PT and FHA. 15 . • • The IAP COI unequivocally endorses the continued use o f DTPw vaccine because of its proven efficacy an d safety.hypo responsive episode HHE (collapse/shock like stage) within 48 hours of DTPw admin is t ration. • If parents are not willing for DTPw administration after the adverse reaction with the previous dose.50 C or hypotonic . 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. Acellular Pertussis Vaccine (DTPa) DTPa vaccines are of various types depending on the number of constituent components viz. therefore. Pertussis vaccine should not be given in such cases and instead DT should be administered in the future.5 ml by intramuscular injection. FHA and pertactin. as is true with any vaccine. Dose: 0. the overall efficacy of DTPa vaccines is comparable to the DTPw vaccine.three in infancy with two boosters at 18 months and 5 years. further DTwP/DTPa should be avoided because of uncertainty about which component of these vaccines has caused the reaction. DTPa vaccines are also by no means more effective than the whole cell pertussis vaccine. DTP must be injected intramuscularly and the preferred site is th e anterolateral as p ect of the thigh. seizures with or without fever within 72 h ours of admin is tration of DTPw. DTP and DT vaccines need to be stored at 2-80C. it should be discarded. not recommended for universal immunization in our country at present. The IAP COI recommends 5 doses of DTP . 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. After the age of 7 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.duration. no bar to offering these vaccines to children from families who opt for the slight advantage of fewer minor side-effects. If encephalopathy (major alteration of sensorium or illness with seizures lasting > 24 hours) occurs within 7 days of DTPw administration. In dications: Unimmunised or inadequately immunized individuals with burns. 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. The practice of giving TT after every injury should be discouraged. headache and chills may occur. Bo o s t ers of this vaccine may be given at 10 and 16 years and thereafter every 10 years. Adverse reactions: Local pain. For pregnant women who have not been previously immunized. roadside injuries and compound fractures. flush in g . mainly IgG. 16 . Dose: for Prophylaxis: 250-500 IU IM. primary TT immunization consists of two doses given 4 weeks apart. A single dose of TT would suffice for subsequent pregnancies that occur in the next 5 years. 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). After completing the full course of seven doses. 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. 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. obtained from the plasma of healthy donors. In children and adults: 500-1000 IU IM and/or 250-500 IU intrathecal. there is no need for additional doses during pregnancy at least for the next 10 years. 2 doses of TT would again be necessary. fever. thereafter. Therapeutic: tetanus neonatorum: 500-1000 IU IM or 250 IU intrathecal.Tetanus Toxoid This vaccine contains Tetanus Toxoid 5 LF. For previously unimmunized schoo l age children. Td Vaccine (Tetanus Toxoid. It is a highly heat stable and effective vaccine. 17 . If measles vaccine was missed altogether in infancy. the vaccine efficacy may be reduced. The vaccine is given as a 0. MMR vaccine may be given between 15-18 months of age. most co u n t ries use MMR instead of single antigen measles vaccine. etc. OPV and Hib. Some children may develop a short lasting fever 7-10 days after vaccination often accompanied by a macular rash. which have been used for vaccination. Mah arashtra.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. or even longer. however. For infants given measles vaccine at 9-12 months. The vaccine may be stored frozen or refrigerated. In case of an outbreak. In the clinic these vaccines can be stored between 2 to 8 0 C. therefore strict asepsis should be maintained while diluting and aspirating contents from the multi-dose vial.5 ml dose. In order to achieve t he best balance between these competing deman d s o f early protection and high seroconversion. If measles vaccine is given in t h e presence of measu rable titers of maternal antibody. Most infants are protected fro m measles by the maternally acquired antibodies until about 6-8 months of life. This infection mimics wild measles virus infection but is usually asymptomatic. vaccine should be used within 4 hours. There is no upper age limit for this vaccine. The vaccine can be given along with other vaccines like DTP. it resu lt s in sub-clinical or attenuated infection and multiplication of virus within the body. It is supplied freeze-dried and has a shelf life of 1-2 years. Moraten and Edmonston B. The v accine should be injected subcutaneously. Reconstituted vaccine should not be frozen . It may be noted that the states like Delhi. the diluent is available separately. Vaccines Recommended Against Diseases Not Covered Under EPI MMR Vaccine Globally. preferably over the upper arm / anterolateral thigh. It is administered subcutaneously in the upper arm/anterolateral thigh. 5000 TCID50 of mu mp s and 1000 TCID50 of ru b ella v iru s . are likely to include MMR in its universal immunization program. Vaccinees do not shed the virus. Paracetamol may be given to control/reduce fever. 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. 18 . It is dispensed in single as well as multi-dose formulations. MMR vaccine contains 1000 TCID50 of measles. Once reconstituted. After reconstitution the vaccine is very heat-labile and should be used within 4 hours. Measles v accine does not contain any preservative. B. one dose of MMR can be given at or after 12 months. wit h the unused vaccine being discarded. Being a live attenuated virus vaccine. completed 9 months of age has been recommended as the appropriate age for measles v accination in India. Other strains. Measles and MMR vaccines are supplied in lyophilized formulation and should be frozen for long-term storage. the vaccine can be given to infants as young as 6 months with a recommendation for an additional MMR/Measles at 12-15 months. The IAP COI recommend s administration of MMR to all children. Goa h ave included and few states like Tamilnadu. include Schwarz. Th e vaccines should be p rotected from light. Some cases of staphylococcal sepsis/toxic shock syndrome associated with use of this vaccine have occurred from bacterial contamination of the vaccine. Rubella Vaccine Rubella vaccine currently available commercially is derived from RA 27/3 vaccine strain grown in human diploid/chick embryo cell cultures.000 d o ses of vaccines used. 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. Vaccinees do not shed the virus. There is no evidence that mumps vaccination is associated with development of either au t is m or Crohn's Disease. Seroprevalence of ru bella antibodies in majority of pregnant women in few studies in India support this view. 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%.Mumps Vaccine The mumps component in MMR vaccine contains live attenuated mumps virus not less than 5000 TCID50 per dose. Vaccines are derived from Leningrad-Zagreb. This has been shown to occur using mathematical models. It is available either as a monovalent vaccine as a part of combination vaccine . Jerryl Lynn. 19 . CRS can be significantly reduced. It is a highly immunogenic vaccine with seroconversion rates of 95% It provides long term and probably life long protection. as the latter is usually benign an d inconsequential. Direct evidence from some Latin American countries als o corroborates these concerns. RIT 4385 or Urab e A M9 strains and are grown in chick embryo/human diploid cell cultures. Monovalent mumps vaccine or combination with rubella as MR vaccine is not available in our country. There is paucity of reliable data on occurrence of CRS in India. On the basis of what ever information is available CRS incidence is qu it e low in India. This is suggestive of wide circulation of wild rubella virus in yo u n g children. Vaccinees do not shed the virus. By controlling the incidence of rubella infections. 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. There is no difference in efficacy between various strains of mumps vaccine.MMR. Hence all the mumps vaccines are equally safe. It contains live attenuated virus not less than 1000 TCID50. 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. Aseptic meningitis is known to occur following mumps vaccine. 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. a shift in epidemiology of rubella is quite possible. vaccine failures are uncommon.000 to 1 in 100. though the incidence quoted is as rare as 1 in 10. 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. 6 and 14 weeks or birth. higher the chances of becoming a chronic carrier. An ideal HB vaccine schedule should. The vaccine is hig h ly immunogenic and seroconversion rates are greater than 95% after a three dose schedule. HB v accine is a highly purified recombinant DNA vaccine produced in the yeast species Hansenula polymorpha. cirrhosis of liver and hep atocellular carcinoma. 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. none of the above schedules needs a booster. one can still use 0 . The vaccine should not be frozen . As on now. If the mother is known to be HBsAg negative. Antibody titers greater than 10 mIU/ml are considered protective. it is important that HB v accination should begin within a few hours of birth so that perinatal transmission can be prevented. The dose may be increased when vaccinating immunocompromized individuals e. It is believed that as many as 90% of those who are infected at birth go on to become chronic carriers. HB vaccine may be given in any of the follo win g schedules: 1.e. It is for this reason that the World Health Organization has recommended u niversal Hepatitis B vaccination.g.6wks .6 months schedule. patients on chemotherapy for malignant conditions or those with chronic ren al failure awaiting hemodialysis. In case birth dose has been missed. Saccharomyces cerevisiae or Pichia pastoris. 6 and 14 weeks 6. 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. Any one of the following schedules may be used for this purpose. 6 wks and 6 months. address vertical as well as h orizontal modes of transmission of the virus.if frozen accidentally. 30% of the chronic carriers go on to develop chronic liver disease. At the same time birth dose has to be given to cover for the vertical route. It should be injected intramuscularly in the anterolat eral thigh. In fect ion with HBV is one of the most important causes of chronic hepatitis.10. 3.g. It is adjuvanted with aluminiu m salts and should be stored at 2-80 C. 1 and 6 months Birth.14 wks schedule for public measure. DTP wh ich is given at 6. As many as 150 countries have n ow included HBV in their national immunization sch ed u les .14 wks sched u le can be followed. 10 and 14 weeks/6 months as there is no special requirement to start vaccinat ion at birth itself. In office practice. ch ild to child) route and the vertical route (i.Hepatitis B Vaccine In India. 10 and 14 weeks Immunologically 0 . If the mother's HBsAg stat u s is not known. Younger the age of acquisitio n of HBV infection. The usual pediatric dose (< 12 years o f ag e) is 0.e. 6 . d u e to operational issues at a national level one has to piggy back on the available contacts for routine immunization i. HB vaccine can be g iv en along with DTP at 6. 10 and 14 weeks of age. If the mother is HBsAg positive (and especially HBeAg 20 . through sexual contact or nosocomially. therefore. In Ju n e 2002. Infection with HBV may occur perinatally (v ertical transmission). 1-4% of individuals are found to be chronic carriers of Hepatitis B Virus (HBV). However now that HB vaccination is integrated into the existing immun ization program (UIP) in India. Hence IAP COI recommends 0 . Adult dose is twice the pediatric dose.6 . birth. 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. Birth. during early childhood (the so-called horizontal spread ).5 ml corresponding to 10µg of the antigenic component. mother to child) are the major routes of transmission of hepatitis B.1 . Pregnant women should be counseled and encouraged to opt for HBsAg screening. from the d ata available. It should be noted t h at in our country horizontal route (e. the it should be discarded. These are all preventable by early childhood immunization. 2. The program will be expanded to include additional cities and districts within a certain timeframe.g.positive). There would occur anamnestic response with the titers going up should there occur contact with th e v irus again in future. Special Precauti ons : HBIG should never be administered intravenously. selection of districts was based on achievement of targets of 80% or more DTPw-3 coverage under routine immunization based on evaluation surveys. Neonates: 100-200 IU. 6 weeks and 6months) using two separate syringes and separate sites for injection. it is easier to combine HB vaccine program with the DTP vaccine. therefore. as it presumably gives longer lasting immunity. 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. 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. This should be administered as soon as following exposure. Adverse Reactions: Transient. preferably within 48 hours though it can be administered even if the patient reports late up to 7 day s after exposure. It was introduced in 15 cities an d 32 districts in the initial phase. 1 and 2 months with an additional dose between 9-12 months. along with HB vaccine (at birth. Under this program. However this view is being challenged as HB vaccine is a T-cell dependent vaccine. 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. the vaccine is being provided free of cost to infants living in u rb an slums. HB vaccine may be given at 0. 21 . It is envisaged that HB vaccination will be introd u ced in all districts of India by 2007. ho wev er. 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. If HBIG is not available (o r is unaffordable). For older children and adults the preferred schedule is 0. '0' being the elected date for the first dose. the baby should be given Hepatitis B Immune Globulin (HBIG) within 24 hours of birth. not necessary under usual circumstances. 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. The first dose should be administered as soon as after birth up to within 5 days of birth. the titers at the end of immunization schedule may not be important so far as it is well above the protective level. 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 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. As logistically. Boosters of HB vaccine are. HB vaccination is now being integrated into t he existing immunization program in India. 1 and 6 months. 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. Children:. HBIG does n o t interfere with antibody response to simultaneous HB vaccine.32-48 IU/kg bod y wt . 6 and 14 weeks or birth. by a needle-stick injury. in the case of extremely preterm babies. mild pain at the site of injection and itching may be seen in a small proportion of recipients. vaccination should commence only after initial stabilization. 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. Dose: Adult s : 1000-2000 IU. The vaccine efficacy has been estimated to be 50-70% in a meta-analysis of the randomized co ntrolled trials available. It may interfere with the interpretation of the Widal test. Pediatric dose of the vaccine is 0. The vaccine s h ould be stored at 2-80 C. 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 can be given intramuscularly or subcutaneously. A pure S. Adverse effects are mild and include pain and swelling at injection site. typhi vaccine is less reactogenic than the combined TA/TAB vaccines.25 ml in children aged 6 month s -10 years and 0. It should never be frozen. The vaccine appears to be protective through the induction of antibodies against cell wall somatic (O) and flagellar (H) antigens. Unfortunately. The vaccine is available as an isotonic phenolated buffer solution. 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. 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. It h as reasonable efficacy o f 50-60% in children and low reactogenicity. 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. is now reasonably priced. given subcutaneously. Oral Live Attenuated Ty21a Vaccine: 22 . local pain and malaise due to the endotoxins in bacterial cell wall. Protection begins within two weeks of vaccination and the biological marker is anti-Vi antibodies. 4 o r more weeks apart. Revaccination is necessary every 2-3 years to sustain an o ptimum immune response and should be done preferably before the onset of summer. It should never be frozen. Heat-killed. The vaccin e is very safe and is reasonably effective if revaccination can be carried out on a regular basis. Both vaccin es contain Salmonella typhi 1000 million organisms per ml. containing 25µg of the polysaccharide.5 ml in order children. which during natural infection inhibits p hagocytosis and serum bactericidal activity an d is responsible for virulence of the bacteria. However now only Vi typhoid The Whole Cell Inactivated Typhoid Vaccine (TA/TAB) vaccine is available commercially. The vaccine should be stored at 2-80 C. Use of these vaccines may be associated with fever. the dose is 0. Th ree vaccines were available for clinical use till recently.these antibodies can act as a biological marker of the vaccine. Protection begins 4 weeks after vaccination. Cost of the vaccine though a limiting factor in past.Typhoid Vaccines Enteric fever is endemic in India and is a major public health problem. 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.5 ml. The vaccine is supplied in an enteric coated formulation as the bacteria are acid labile. It is highly efficacious vaccine. In spite of these apparent differences. 2 doses between 6-12 months and 1 dose between 12-15 mon t h s . with a booster at 18 months. It is genetically stable and is not known to revert to virulence. Hib capsular polysaccharide vaccine is a very effective and safe vaccine. 23 . Immunization needs to be repeated every 3-5 years The vaccine should be stored at 2-80C. these three vaccines when used in the recommended doses have similar efficacy. Hib vaccination is given routinely in the d eveloped countries for last many years. Protection begins within a week after completion of the course and the protective efficacy is as good as other available typhoid vaccines. On the other hand. meningitis and bacteremia. 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. 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". 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. The vaccine is given on an empty stomach in three sittings. Recently published data of the Invasive Bacterial Infections Surveillance (IBIS) group from six referral hospitals in India (Lancet. It provides protection by inducing local gut immunity but there is no biological marker of this vaccine. Hib vaccine is stored at 2-80 C. 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. 2003) show that Hib is a common cause of meningit is in our country. the protective efficacy being 95%. If vaccination is delayed until 15 months. the vaccine is not necessary for children above 5 years. Unfortunately this vaccine is also not available now in our country. The IAP COI reco mmen d s use of Hib vaccine for all children .Salmonella typhi Ty21a is a live attenuated strain with a mutation in gal E gen e and lacks the enzyme UDP-gal 4 epimerase. 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. Antimicrobials active against S. on alternate days. It is for this reason that while 3 doses of HbOC and PRP-T are recommended for primary vaccination. It can be given to children six years of age and above as the capsules have to be swallowed intact. A number of PRP conjugate Hib vaccines are available of which t wo are available in India viz. The efficacy has been shown to 50-60% with the capsule form and near 90% with th e liquid form (not available commercially). 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. As Hib d isease is essentially confined to infants and young children. The vaccination schedule for Hib consists of three doses when initiated below 6 months. only 2 doses of PRP-OMP are recommended for this purpose. Majority of cases occur in children below 2 years of ag e. a single dose may suffice. HbOC (with CRM 197 mutant diph t h eria toxin as conjugate) and PRP-T (with tetanus toxoid as conjugate). 24 . The vaccine can be administered to any healthy individual above the age of 12 months who has not had varicella previously. Varicella vaccin e is also recommended in household contacts of immunocompromised children. Hence IAP COI recommends to use this vaccine after the age o f 15 months. military personnel and health care professionals. s ch o ol teachers. The vaccine is stored at 2-80C and can be administered subcutaneously or intramuscularly. The immunity appears to be long lasting. 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. pregnancy should be avoided for at least 4 weeks after vaccination. adults and pregnant women.It includes fever. pain redness and swelling at vaccination site. 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 is a highly effective vaccine and protective immunity. It has to be given by intramuscular injection and the dose is 125 units/10 kg body weight. 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.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. It should be given to the neonate if the mother develops varicella 5 days before to 2 days after delivery. Takahashi et al developed a live attenuated vaccine from the Oka strain in Japan in the early seventies. day care center workers. 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.it should be noted. that the efficacy of the vaccine in preventing varicella under such circumstances is not very clear. When used in adult females.g. When used for post-exposure prophylaxis it should be administered within 72 hours of varicella exposure . Adverse reactions . The vaccine has been in clinical use in Japan since 1989 and in the United States since 1995.5 ml and the minimum infectious virus content should be 1000 Plaque Forming Units. Though vaccine manufacturers recommend to use this vaccine at 12 months. HIV infection (but with C4 counts above 15% of the age related norms). after which two doses (at 4-8 weeks interval) are required. Complications of varicella may be mo re commonly seen in immunocompromised individuals. 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 IAP COI opines that varicella vaccine is not recommended fo r universal immunization in India at present. breakthrough infections can be less if used after 15 months of age. however. It is indicated in children with chronic lung/heart disease. The vaccine is not recommended for ch ild ren below 12 months of age. humoral immunodeficiencies. develops in 95-99% individuals. The vaccine is administered subcutaneously. vaccine ass o ciated rash. One has to emphasize the generally benign nature of an d rarity of complications with varicella infection in young children. humoral as well as cellular. The recommended dose is 0. It may also be considered in children attendin g crèches and day care centers. A single dose is sufficient b elo w 13 years of age. It should be protected from light and needs to be used within 30 minutes of its reconstitution. 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. The vaccine is stored at 2-80C. p neumococci are classified into 85 different serotypes. 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. in those with underlying chronic liver disease. According to results of the Invasive Bacterial Infection Surveillance (IBIS) study. however. It is given in a two dose schedule. The virus is formalin inactivated and adjuvanted with aluminimum hydroxide. 18. 4. may continue t o remain anicteric and may develop non-specific symptoms like any other viral in fection. 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. 14. It also leads to conditions like otitis media and sinusitis. 19. Thou g h prevalence of penicillin resistance is almost negligible at present . 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. 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. In adults hepatitis A is frequently symptomatic and mortality is much higher than in children. The disease severity increases irrespective of age. this organism is believ ed to be the commonest cause of bacterial pneumonia. Of these. In developing countries. 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).in t h e latter case the vaccine must be given within 10 days. It may be offered to household contacts of patients with acute HA virus infection . especially those who are leav ing home for further studies. 5. 5 and 7.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. Based on the capsular polysaccharide antigen. 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. which may have morbidity but little or no mortality. it may not always be effective under such circumstances when the contact has had the same source of infection as the index patient. It appears that the serotypes causing invasive disease in developed countries are different from the ones which are found in developing countries. 19 and 23. 6 months apart. It is recommended in all patients with chronic liver d isease (who are HAV seronegative) and family contacts of patients with chronic liver disease.g. 11. 15. 1. about 10 serotypes account for most 25 infections. The IAP COI o p ines that HA vaccine is not recommended for universal immunization in India at present. non-resident Indians) visiting endemic areas. The common pathogenic stereotypes reported in children in Western countries are 1. It may also be considered in children attending crèches and day care centers and in travelers from abroad (e. 4. Peak incidence of pneumococcal disease is between 2 to 24 months of age. Serotypes 1& 5 accounted for 29% of disease in India. 6. 14. Adverse reactions: It includes local pain and local induration. Inactivated HA vaccines d eriv ed from HM 175/GBM strains and g ro wn on MRC5 human diploid cell lines are now available. 9. In February 2000 this vaccine (PCV-7 Prevnar) was licensed in US fo r ad ministration to children below 5 yrs of age. 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.5 ml. suggesting s trong herd effect.. children who are at highest risk of invasive disease. It is capable of preventing almo s t 85% of in vasive disease (pneumonia. 14. 33F. fortunately this has not been seen significantly in the invasive diseases studies. 5. 22F. High risk group: There are certain children who are at high risk of severe invasive pneumococcal disease with high mortality. and 23F. This includes children with Sickle cell d is eas e. 10A. 3.5 ml and the vaccine is given intramuscularly or subcutaneously. 9N. Conjugation of polysaccharide with protein CRM197 makes it immunogenic below 2 years of age. For children above 2 years. 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. The dose is 0.7 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. 11A. 18C. Though there has been replacement of t h e vaccine serotypes by non-vaccine serotypes in the nasal carriage studies. 9V. 23F. 6B. The heptavalent conjugate vaccine (PCV-7) contains the following sero t y p es -4. 15B. 19F. 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. cerebrospinal fluid rhinorrhea etc. Immunization. diabetes etc. as p len ia. 8. Revaccination is recommended after 5 years. a dose of 23 valent unconjugated pneumococcal vaccine is also recommended to be given after one priming dose of conjugated vaccine. 6B. 12F. Conjugate vaccine should not be frozen. malaise. The dose is 0. 9V. 26 . cardiovascular diseases or diabetes. is not effective for prevention of otitis media.Injection site so reness. Since the introdu ct io n of PCV-7 in the childhood vaccine schedule in US. as it is an unconjugated polysaccharide vaccine it does not result in immunological memory. 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. Similar herd effect was seen in the form of overall reduction in the disease caused by drug resistant serotypes in the community.80 C. It may be offered to those with underlying chronic illnesses like renal diseases. Each dose is 05 ml containing 25ug polysaccharide of each of the 23 serotypes co n tained in the vaccines. men in g it is an d bacteremia) caused by pneumococci. 7F. Two types of pneumococcal vaccines are currently available . For such children IAP COI recommends age appropriate doses of 7 valent conjugated pneumococcal vaccine routinely till 5 years of age. It is als o recommen d ed for HIV infected children. 14. thereby highlighting the need for an effective vaccine. 19F. This vaccine may be us ed in h igh-risk groups above the age of 2 years. and the vaccine is given intramu scularly. Healthy children: Th e IAP COI does not recommend u s e o f this vaccine for universal immunization in our country at present. 18C. Adverse reactions . 17F.the 23-valent unconjugated polysaccharide v accine and the 7-valent conjugate polysaccaharide vaccine. Pneumococcal vaccines are s tored at 2. However. however. PCV .1. low grade fever. 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. 2. primary immu n o d eficien cy s y n d ro me s . nephrotic syndrome. This vaccine is poorly immunogenic in children below two years of age i. However there is a need for continuous surveillance for the serotype involved in invasive cases from time to time. sickle cell d isease and nephrotic syndrome. 4. It is coupled with a non-toxic variant of diphtheria toxin (CRM197) and has aluminium phosphate as the adjuvant.e. 20. The 23-valent polysaccharide vaccine contains the following serotypes . 19A.there is some evidence that the prevalence of resistance to penicillin amongst the p neumococci may be gradually increasing. It is recommended for children with asplenia. H I V. Immunity is serotype specific. The dose is 0. Revaccination may be considered after 3-5 years if the individual is still at risk. or C although group Y has been increasingly incriminated in recent reports. and W135 components. Y and W135. In India endemic cases are mainly due to type B. Meningococcal group C conjug at e vaccine. are not very immunogenic in children below 2 years of age. prior to splenectomy and those asplenia and sickle cell anemia. close household contact) it may be offered to even younger infants but the protective efficacy is likely to be low in this age group. The IAP COI does not recommen d t h is vaccine for universal immunization in our country at present. It is the only bacterium capable of causing large scale epidemics of meningitis. En d emic disease occurs worldwide and is mostly caused by serogroups B. Meningococcal vaccine is indicated fo r use (as an adjunct along with chemoprophylaxis) in close contacts of patients with t h e d isease. Severe meningococcal disease is associated with high case-fat ality rates (5-15%) even where adequate medical facilities are available. It may be considered in child ren with complement deficiency. A. Unconjugated meningococcal vaccines.three doses are g iven at 4-8 weeks interval along with the routine childhood immunizations. do not induce immunological memory. moreover. Chemoprophylactic measures are in general insufficient for t he control of this disease because secondary cases comprise only 1-2 % of all meningococcal cases. C. It can be given to children ab ove 2 years of age during disease epidemic and is administered subcutaneously or intramuscularly. The vaccine is stored at 2-80C. Adverse reactions . C. like all other polysaccharide vaccines. There are 12 kn o wn serogroups but majority of the disease causing is o lat es belong to serogroups A. In special circumstances (e. 27 . is efficacious even in the youngest children. Meningococcal vaccine is mandatory for all Haj pilgrims and is necessary for residential students in some of the universities abroad. A conjugate group C vaccine has also been marketed in developed countries. endemic disease occurs primarily in children and adolescents.D. The group C. Some of the recent outbreaks in Western Asia have been due to W135. especially in the African meningitis belt which extends acro s s A frica from Senegal to Ethiopia. on the other hand. Two doses of the vaccine suffice for children in age group 6-12 months and one dose in older children. 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. Epidemic disease is typically associated with type A (occasionally type C) and usually occurs in cycles every 7-14 years. Y and 135). Immu n ity following meningococcal infection is s erogroup specific. with highest attack rates in infants aged 3-12 months. The recommended single dose of the reconstituted vaccine contains 50 µg of each of the individual polysaccharides. 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 . Y. Severe meningococcal disease occurs p rimarily in children and adolescents.either bivalent (A and C) or tetrav alent (A. As a rule. during group A epidemic to close household contacts .5 ml. 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. Unconjugated meningococcal vaccines are based on combinations of group-specific capsular polysaccharides . B. with highest attack rates in infants aged 3-12 months.g.Fever and pain at injection site. Vaccines Used in Special Circumstances Meningococcal Vaccines Neisseria meningitides accounts for 30-40% cases of meningitis in children up to the age 15 years. Primary immunization consists of three doses given on 0. 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. In India.5ml at all ages. Korea and India This live attenuated vaccine constitutes to over 50% of global production of all JE vaccine. S.g. Adverse reactions: Include fever. It is given subcutaneously . Now it is also licensed for use in Nepal.Japanese Encephalitis Vaccines Japanese encephalitis (JE) is one of the most important causes of viral encephalitis in Asia. This vaccine is not available in commercial market in India. The vaccine may also be offered to visitors to endemic areas if the duration of stay is likely to exceed four weeks. SA-14-14-2 live JE vaccine was used man ufactured by Chengdu institute of Biological Products.0 being the elected date. Anap h y lactic reactions are known to occur with this vaccine. this 28 .g. (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. It is given by subcutaneous route.e. 7 and 30 days . Andhra Pradesh. and 1 ml in older children. 2 in Assam and one each in West Bengal and Karnataka were targeted this year.5 ml in ch ildren 1-3 years. China. UP recorded 96% coverag e ag ainst all expectations. Currently three types of JE vaccines are available e. 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. As per a WHO report no serious adverse effects (other than anaphylaxis) have been reported over 20-y ear period (1979 . 7 d is t rict s in UP. Use of Sa-14-14-2 live JE vaccine in India in 2006: Recognizing the need to control JE in high ly endemic districts. Commercially available vaccine is imported.0. Chengdu. JE vaccination remains the single most important control measure. Initial studies done on this vaccine demonstrated an efficacy of about 80% with single dose and 98% with 2 doses. It was g iven as single dose subcutaneously usin g A D syringe. several cases of acute encephalitis temporally linked to JE vaccinat ion have also been reported. more recent studies have shown efficacy reaching 99% even with single dose. Dose is 0. From next year this vaccine will be included in the routine immunization schedule for the new birth cohorts in these areas. It was given in a campaign mode to children aged 1-15 years. This vaccine is produced in In d ia at the Central Research Institute. similar campaign is planned for ot h er areas in coming years. The whole campaign was carried out from 15th May to 15th July 2006.1998). However with the availability of the Sa-14-14-2 live vaccine. JE is believed to be responsible for approximately 2000-3000 clinical cases and 500-600 deaths every year. However. Mouse Brain-Derived Inactivated JE Vaccine vaccine has been given up. 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. however they have stopped manufacturing of this vaccine recently and are trying to switch over to vero cell cultured vaccine. local tenderness and redness in 20% of recipients. As there is no anti-viral drug treatment. This vaccine was also produced by s o me international vaccine manufacturers like A ventis Pasteur (now Sanoffi Aventis). Karnataka). Ut t ar Pradesh. malaise. 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. Kasauli. nearly 86% of the target was achieved. In recent years. 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. 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). however it has been used for public health by Govt. of India in 2006. Based on the success and safety of this year. GOI has initiated a pilot project of immunizing children from h y perendemic districts against JE in 2006. 3) B/ Sh anghai/361/2002 . 29 . Vaccines are usually trivalent. 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. and are currently not used. Current inactivated influenza vaccines are produced from virus grown in emb ryonated hen's eggs. and are of three types : wh o le v iru s . highly purified influenza virus. Influenza vaccine is highly immu n ogenic and is associated with minimal side effects. diabetes mellitus and t h o se on long term aspirin therapy. This vaccine is cu rrently recommended for u s e only in high-risk children and adolescents e.g . When used for the first time the vaccine is given in 2 doses in children 6 months to 8 years of age. 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. s u b unit surface-antigen formulations. especially type A. s p lit -p ro d u ct . Influenza vaccine is also recommended to be giv en for severe cases of asthma who need oral corticosteroids frequently. Most influenza vaccines are split-product vaccines. is characterized by frequent mutations . s ickle cell d is eas e. p roduced from detergent treat ed .5 ml thereafter. in ch ildren below three years and 0. Whole-virus vaccines are associated with increased adverse reactions. HIV infection. especially in children.antigenic drifts and antig en ic shifts. have reduced efficacy against antigenically drifted viruses and are ineffective against unrelated strains. 2) A/Fujian/411/2002 (H3N2) . immunodeficiency. or s u rface-an t ig en v accin es containing purified hemagglutinin and neuraminidase. the dose being 0. Revaccination is d o ne with a single annual dose. The vaccine is effective for only a short period. containing 15 µg each of two influen za A subtypes (H1N1 and H3N2) and one influenza B strain. Vaccines elicit a relatively strain-specific humoral response. only one dose is sufficient above 8 years. 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. There are three antigenic types (A.like strain [variant B/Jingsu/10/2003].116)]. The vaccine is administered intramuscularly. therefore. 1) A/New Caledonia/20/99 (H1N1) like strain [variant A/New Caledonia/20/99 (IVR . s y s temic lupus erythematosus.hemagglutinin and neuraminidase Influenza virus. It is of the utmost importance. which is given before the peak influenza season.Influenza Vaccine Influenza virus is an ortho my xovirus. usually 6 month s to 1 year and a new vaccine is brought every year. that the vaccine should incorporate t h e current strain p revalent during that time.25 ml. individuals with chronic pulmonary an d card iac d is eas e. B and C) with several subtypes of each based on two surface an t ig ens .like strain [varian t A/Wyoming/3/2003 (X-147)]. Combination vaccines should not be viewed as being more effective than vaccines given separately.g. in the latter case the manufacturer's instructions should be followed strictly. Many parents opt for one single injection of combination vaccines at a given visit. available alone (DT. unless specifically recommended by the manufacturer. This concept differs from that of simultaneous vaccines. which. inactivated (IPV) or live oral (OPV) trivalent polio vaccine and MMR vaccine. The first combination vaccine was trivalent influenza vaccine. 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. are physically separate. The number of vaccines in the immunization schedule is increasing every year with the result that these schedules are getting increasingly more complex. 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. This was followed by hexavalent pneumococcal vaccine in 1947 and DTP vaccine in 1948. rather than g etting a large number of simultaneous injections. Combination vaccines in common use include diphtheria and tetanus toxoid.Combination Vaccines A combination vaccine consists of two or more separate immunogens that have been physically combined in a single preparation. although ad ministered concurrently. The IA P COI endorses the use of combination vaccines.g. The combining of multiple related o r unrelated antigens into a single vaccine is not a new concept. dT) or with pertussis vaccine (DTP). 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 . poliovirus vaccines) or of multiple pathogens (e. DTP v accine). 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. A number of combination vaccines are now available in the Indian market. Rab ies is caused by the bite of a rabid animal. These include the 2-1-1 intramuscular schedule (Zagreb schedule) . The following schedules as recommended by • • • • Purified Chick Embryo Cell (PCEC) vaccine 1 ml per dose. Post exposure prophylaxis In order to remove as much of the rabies virus as possible. The intradermal schedules have the obviou s advantage of being inexpensive and have b een used successfully in Thailand. Scratches or licks on mucous membranes by affected animals have also been kn o wn to transmit the virus. 3. 14 and 30 as per the Essen protocol. Rabies vaccine is administered intramuscularly in anterolateral thigh on days 0. Intramuscular injection of RIG is not recommended. followed by one ID dose o n days 30 and 90 . the 8-4-1-1 intradermal schedule (Oxford schedule) .Rabies Vaccines The disease is caused by a single stranded RNA virus belonging to the family Rhabdoviridae.1 ml per dose. Human Diploid Cell Vaccine (HDCV) . Rabies vaccine should never be injected in the gluteal region.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. 3 and 7. with day '0' being the day of commencement of vaccination. Rabies is endemic in our country . trunk. Skin testing is recommended before using ERIG but is not n ecessary when using HRIG. 7. 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. Several other schedules of rabies vaccination have been proposed.1 ml of PCEC vaccine is given ID at eight sites on day 0. It is almost always fat al. it must be insured that RIG has been infiltrated in the wound prior to suturing. Nerve tissue vaccine This is no longer recommended because of its poor efficacy and life threatening adverse effects in the form of neuroparalytic reactions. one IM dose on day 7 and one IM dose on day 21. When suturing is unavoid ab le for purpose of hemostasis. A sixth dose on day 90 is optional and may be offered to patients with severe debility or those who are immunosuppressed. at four sites on day 7 and at one site only on days 30 and 90. The dose of human rabies immunoglobulin (HRIG) is 20 U/kg while that of equine rabies immunoglobulin (ERIG) is 40 U/kg.0.0. Philippines and Sri Lanka. which is usually a dog in our country.ID dose is 1/5th the IM d o s e. Purified Duck Embryo Vaccine (PDEV) .5 ml per dose. All tissue culture vaccines have almost equal efficacy and any one of these can be used. 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 . Any suturing of wound should be avoided. head and face (wound category 3). The incubation period averages 4-6 weeks but can be very variable and may range from five days to more than one year.two IM doses on day 1. Based on the recommendations of the expert group as well as WHO. immediately cleanse the wound with soap and flush thoroughly under running water for 10 minutes .1 ml per dose. Children are given the same dose as ad ults. Purified Vero Cell Vaccine (PVRV) . 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. Then treat with 70% alcohol or tincture iodine or povidone iodine. dose is 40 U/kg body weight). HRIG is a liquid or freeze-dried preparation containing immunoglobulins (mainly IgG) and is obtained from the p las ma of donors immunized against. In case of ERIG.25 units. 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. Any of the tissue culture vaccines can be given for this purpose . For Re-Exposure after completed (and documented) pre or post exposure prophylaxis two doses are given o n days 0 and 3. From the eight day onwards. postmen). sensitization may occur after repeated injections.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). 7 and 28. The vaccine is stored at 2-80C. 32 .three doses are given intramuscularly on days 0. it should be administered as early as possible but no later than the seventh day after the first dose of vaccine was given. skin testing is recommended prior to use. Rabies Immunoglobulin (RIG) There are 2 types of RIG: (1) Human rabies immunoglobulin (HRIG . Side-effects include local pain and induration.g. It contains specific an t irabies antibodies that neutralize the rabies virus and provide passive protection. In case RIG dos e (q uantity) is insufficient for adequate infiltration of extensive or multiple wound. This should be offered to in d iv iduals in high risk occupations (e. low grade fever. it may be diluted with equal volume of normal saline so th at all the wounds can be thoroughly infiltrated. Pre-exposure prophylaxis Pre-exposure prophylaxis became a reality only after the availability of MTCVs. A booster is given one year after primary immunization and every five years thereafter.do s e is 20 U/kg body weight) (2) Equine rab ies immunoglobulin (ERIG . Antirabies antibody titers > 0.1ml for ID should have at leas t 0. veterinary surgeons. The unit dose of 0.5 IU/ml are considered protective. 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. This ID administration is not recommended in individu al practice. Adverse reactions: Tenderness/stiffness at t h e injection site. RIG is not indicated since an antibody response to the vaccine is presumed to have occurred. dog breeders. wildlife workers. If RIG could not be given when antirabies vaccination was began . RIG is indicated in all cases of category three wounds where it should be infiltrated thoroughly into and around the wound. Also it does not make economic sense to practice it for individual cases. licks on intact skin Nibbling of uncovered skin. 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. if the animal is euthanised and found to be negative for rabies by appropriate laboratory technique III Single or multiple transdermal bites or scratches. or. minor scratches or abrasions without bleeding. 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.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. or. contamination of mucous membrane with saliva (i.e. licks) 33 .. 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. OPV B1 .18 months 2 years 5 years 10 years 16 years BCG. OPV3. OPV2. MMR Typhoid+ DTPw B2 / DTPa B2. Hepatitis B1 DTPw1 / DTPa1 . over 13 years of age 2 doses at 4-8 weeks interval + 2 doses at 6. Hib B1 . OPV0 . OPV1. followed by a booster dose at 15 months 34 .12 months interval * 3 primary doses at 6. and 14 weeks. Hib1 DTPw2 / DTPa2 .IAP Immunization Time Table Age Vaccine Birth 6 weeks 10 weeks 14 weeks 9 months 15. Hepatitis B3 *. Hib3 Measles DTPw B1 / DTPa B1. Hib2 DTPw3 / DTPa3 . Hepatitis B2. 10. epidemics). 14 weeks/ 6 months. Revaccination may be carried out every 3-4 years. Further. 10.g. Continue using OPV till we eradicate polio in our country. the baby should be given Hepatitis B Immune Globulin (HBIG) within 24 hours of birth. 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. 1. Varicella.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. HB vaccine can be given along with DTP at 6. the 'Best Individual Practices' schedule for a given child and may be somewhat different from the National Immunization Schedule. This is because of the fact that the former is meant to be used for an individual.It should be noted that the IAP Immunization Time-Table is. Hepatitis A and Congujate Pneumococcal vaccines should be offered only after one to one discussion with parents. Acellular pertussis vaccines may undoubtedly have fewer side-effects (like fever. 9. 7. If the mother is known to be HBsAg negative. 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. Also. The manufacture's instructions should be followed strictly whenever "mixing" vaccines in the same syringe prior to injection. If the mother's HBsAg status is not known. Notes on the Time Table 3. the only typhoid vaccine available in our country is the Vi Polysaccharide vaccine. local reactions at injection site and irritability). measles vaccine may be given earlier than 9 months followed by MMR at 12-15 months. IPV can be used additionally for individual protection. The IAP endorses the continued use of whole cell pertussis vaccine because of its proven efficacy and safety. in effect. 6. OPV must be given to children < 5 years of age at the time of each supplementary immunization activity. as pediatricians we must be conscious of the fact that the immunization needs of children in a country are quite dynamic . 4. but this minor advantage does not justify the inordinate cost involved in the routine use of this vaccine. 8. along with HB vaccine. If the mother is HBsAg positive (and especially HBeAg positive). 5. the interval between the two doses of TT should be at least one month. For Non EPI and Newer Vaccines. Under special circumstances (e. it is advisable to start vaccination soon after birth to prevent perinatal transmission of the disease. Combination vaccines can be used to decrease the number of pricks being given to the baby and to decrease the number of clinic visits. Also refer to the individual vaccines notes for recommendations. however. rather than for the pediatric community as public health measure at large The two schedules are. At present. 35 . The IAP COI has based its recommendations based on the best available evidence at present. 2. not in conflict with each other. During pregnancy. Children awaiting splenectomy Children with loss of splenic function are at high risk of serious infections with encapsulated organisms. Immune attrition associated with viral replication may particularly interfere with memory responses. Very low birth weight / preterm babies can be given immunizations after initial stabilization. Killed vaccines are safe but may be incompletely effective in such situations. Children receiving corticosteroids Children receiving oral corticosteroids in high doses (e. Vaccination in children in children with HIV infection Children infected by HIV are particularly vulnerable to severe. all vaccines may be administered as per schedule according to the choronological age irrespective of birth weight or period of gestation. 36 . It must be emphasized that routine immunizations seem to be generally safe in such children. recurrent. immunization with pnueumococcal. Hib and meninggococcal vaccines should be initiated a few weeks prior to splenectomy.Immunization in Special Circumstances Immunization in preterm infants In general. Patients on topical or inhaled steroid therapy should not be denied their age appropriate vaccines. Consideration should be given to readministering childhood immunizations to such children when their immune status has improved following anti-retroviral therapy. 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. If surgical splenectomy is being planned. or unusual infections by vaccine preventable pathogens.g. 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.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. 10. 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 . Minor illness (e. HB MMR. HB OPV*. fever. DTPw / DTPa. respiratory infections) and malnutrition should not be construed as contradictions to immunization. however. 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. DTPw / DTPa. 38 . diarrhea.g. Any dose not given at the recommended age should be given at any subsequent visit when indicated and feasible. Typhoid DTPw / DTPa. Typhoid HB Typhoid Typhoid * OPV and BCG recommended up to 5 years of age. it is appropriate to start the schedule as for an unimmunized child. OPV* .Vaccination Schedule for an Unimmunized Child Age Less than 7 years More than 7 years First visiit BCG*. Lapsed immunization There is no need to restart a vaccine series regardless of the time that has elapsed between individual doses. However it is preferable to give it at a later visit if pat ient compliance is not a problem. Missed opportunity for immunization This is defined as a situation when a child visits a health care facility and is not immunized. In case of unknown or uncertain immunization status. HB Second visit (one month later) Third visit (one month later) Fourth visit (6 months after first visit) Every 3 years Td. HB Td. HB Measles / MMR. ** 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. 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. 39 . 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. this should always be done after careful counseling.Simultaneous administration of multiple vaccines Both killed and live vaccine can be administered simultaneously without decreasing the efficacy of the individual vaccines. However. 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. visitors comin g to India from Western Europe/North America are usually advised vaccination against typhoid and Hepatitis A. especially if the stay is likely to be prolonged. However. Uniform recommendation s are not possible because the epidemiolog y o f d is eas es d iffers in various geographical areas. 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. prudence demands that the vaccines be administered at different sites. For instance. and 6 months. duration of trip and nature and conditions of t rav el. Similarly. 1. 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. The physician should try and update routine immunizat ion and also provide destination specific immunizations. Neither inactivated n or live vaccines administered to a lactating woman affects the safety of breas t -feeding for infants.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. without rubbing. therefore. not a con t raindication for any vaccine. 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. 40 . Beast-feeding and Vaccination Breastfeeding does not adversely affect immunization and is. for at least 5 minutes. 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. If multi-dose vials are used. Do not use cotton balls stored wet in a multi-use container. use equipment designed for steam st erilization. If using an ampoule that requires a metal file to open. always pierce the septum with a sterile needle but do not leave the needle in place in the stopper of the vial. Anticipate and take measures to prevent sudden patient movement during and after injection. It is also know that the immune response of some of the vaccines (especially rabies) administered in the gluteal region is not optimum. To prevent reuse. St eam an d Temperature (TST) spot indicators. These are made from clean-burning plastics and emit very low levels of toxic fumes. Auto-disable (AD) syringes are single-use. The Government of India has decided to use AD syringes in Immunization program.the gluteal region must be avoided as sciatic nerve injury is a real risk especially in neonates. the syringe may be cut and the needle defanged using a syringe/needle destroyer. 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. Clean skin prior to injection with a disinfectant and wait for it t o dry. self-locking syringes designed in such a way that these are rendered unusable after single use. The needle must not be recapped or manually mutilated after use. Ev en small cuts should b e co vered. 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 . malnourished and struggling children. Always use a sterile syringe and needle for each injection and to reconstitute each unit of medication. 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. 41 . 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. 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. Avoid giving injections if skin is infected or compromised by a local infection (such as a skin lesion or weeping dermatitis ). protect fingers with a small gauze pad when opening the ampoule. These are now being promoted for rou tine immunization and may well become the norm in years to come. Whole cell killed typhoid vaccines are also ass ociated with particularly significant local reactions.no treatment other than symptomatic management is necessary. Anaphylactic reactions are distinctly unusual but have been reported following Measles. Yellow fever vaccines). DTP.the ulcers may sometimes take many weeks to heal. Local reactions are especially common aft er the adsorbed vaccines (e. 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. Many adverse effects may result from inappropriate vaccination technique or storage of the product. MMR. 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.g . It may be prudent not to ascribe all adverse reactions to a vaccine. yellow fever.g.g. Varicella and Inactivated Polio vaccines) or thiomerosal (e. influenza vaccines).Adverse Reactions Following Immunization A d v erse reactions following immunization can be broadly classified as local and systemic. Hib and Hepatitis vaccines. Although such occurrences are uncommon. which has been given in the recent past before ascertaining all facts about the case. Ulcer formation after BCG vaccination is normal and no intervention is usually required .g . 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. Varicella. Measles. certain antimicrobials (e. Neomycin in MMR. Such reactions may be secondary to allergy to egg (e.g. MMR. DTPw/DT) . 42 . TT vaccines). MMR. gelatin (e. 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 1.3 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.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. 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. The potency of a vaccine is maintained by 'cold chain' This term refers to the system of transporting. 3. if the cold chain is not maintained from the source of vaccine manufacture to the place of vaccination. In es s en ce. The essential components of a cold chain include: 1.safety and potency. 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 . 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. 5. Vaccine potency once lost cannot be restored. 4. it is considered to play a crucial role in the success of any immunization program However potent a vaccine may be. 2.The Cold Chain A vaccine has two characteristics . the vaccine efficacy will suffer. maintain a temperature recorders and alarm systems. are available in 2 sizes (140 & 300 liters) . Deep freezers: are used for storage of OPV/ c) Measles//MMR vaccines and preparation of ice-packs. in emergency situations. solid and thermetically (air tight) sealed boxes packed with frozen ice packs at the bottom.000 population).5 & 20L.in freezers (WIF): are established in all a) the states .the former is supplied to district headquart ers while the latter is supplied to PHCs. if n o t o p ened. should be kept away from heat and direct su n lig ht. deep freezers and refrigerators and b) the mobile chain represented by isothermic boxes and vaccine carriers. 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. state and regional levels which store vaccines for abou t 4-5 districts.000 population). no vaccine should be stored in the baffle tray or the door shelves. Walk in cold rooms (WIC): are used fo r bulk b) storage of vaccines at the man ufacturer.26 hours. are u sed for bulk storage of OPV and measles vaccines and for preparing frozen ice packs at state s t ores. Ice packs should be made from tap water . o n freezing there is formation of an inner lining of ice.5 & 32 CU Mt. 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. DTP/DT/TT/Hepatitis B vaccines should not be stored in deep freezers. should have ice-packs fo r freezer compartment and water bottles in the shelves.t h is should be used for storing OPV/Measles/MMR.The cold chain involves two complementary aspects: a) the set chain represented by the walk-in cold rooms. can also be used to store vaccines and frozen ice packs for up to 5 days. have a top opening lid and are availab le in 2 models -140 & 300 liters. 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. if the cold box is not opened at all. these help in maintaining low temperatures in case of power failure. cabinet temperature is maintained between -18 to -200C. 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. d) Ice lined refrigerators (ILR): may have either ice tubes or ice packs filled wit h water upto 90% of their volumes. the hold over time is more than 90 hours for a 5L. 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. freezers are provided with two identical cooling units and standby generator sets. All districts have been provided 2-5 large freezers whereas most of the PHCs have one small deep freezer.16. and 6 days for a 20L. In general a cold box of 5L can acco mmo date one month's supply of a PHC (30. vaccines should be placed in cartons or polythene bags and then placed in direct contact with fro zen ice packs. in case of power failure these freezers can maintain cabinet temperature for 18 . chamber in situations where OPV is to be stored for long duration (at -200C) or there is increased demand of ice-packs. periodic defrosting is necessary. this enables the temperature to stay within a safe range even when there is electricity supply for only 8-12 hours in a day. this is generally done whenever the layer of ice exceeds 5-6 mms. Domestic refrigerators: meant for vaccine e) storage should not be used for any ot h er p urpose. cold box at 430C ambient temperature. these are supplied to all peripheral centers and are used for transportation of large amounts of vaccines to outreach facilities . g) Vaccine carriers: are s maller versions of cold .1500 vaccine doses can be carried in a 5L box and 6000 doses in a 20L box. available in 2 sizes . 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.water should be filled in the icepack up to the level marked. maintain a temperature of -200C and are available in 2 sizes . in top opening ILRs the temperatures is least at the bottoms . sides and at the top. The freezing point for adsorbed DTP vaccine is between -5 to 10oC. 6. Day carriers: are smaller versions of vaccine h) carriers and are used to carry still small quantities of vaccines (e. if any. Ice packs are used to line the sides of cold boxes. Such vials should be discarded. DTP/DT/TT/Hepatitis B vials should be wrapped in plastic to avoid direct contact with ice. if the vaccine is not uniformly mixed or the sediments/ flocculations are still found settled at the bottom.g. At a temperature of 2-8oC. It takes about 110 to 130 minutes at -10oC. Interpretation of the colour change of VVM is as follows: . 16-20 vials) for distribution to outreach facilities. Freezing time depends on the number of doses in the vial and the temperature.boxes and are used to carry small quantities of vaccines (e. These can be used for deep freezers and ILRs . Even these v accines. it should be used for storage of OPV and Measles/MMR vaccines. If the VVM indicates proper storage of OPV in a given center. The latter vaccines should be kept frozen at -200C when stored fo r t h e long term . Alcohol stem t h ermometers are much more sensitive and accurat e t h an dial thermometers and can record temperatures fro m . vaccine carriers and day carriers. 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. HB and Hep A vaccines should never be frozen. Storage of vaccines All vaccines are safe at temperatures between 2-80C for at least 6 months.g. t h e dimensions are 163 x 90 x 33 mms. 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 use of day carriers is not encouraged. During shipment and transportat ion. the vaccine is likely to have been frozen at some time. Ice packs: are made of polyethylene and weigh i) approximately 80 gm. presently. Vaccines should be transported o n ly in cold boxes or vaccine carriers . vaccines in day carrier should be issued on the day of immunization only.12 months for OPV and 18-24 months for measles. No vaccines sh o uld ever be stored at the sub-centers.at this temperature these vaccines have a shelf life of 2 years. co ntain 0. which is the most thermo lab ile of all vaccines.50oC to +50oC.36 liters each) and an inner plastic lining.g. Dial t h ermometers are used to monitor the temperature in refrigerators/ice-lined refrigerators (ILRs) and are kept in every unit. can maintain temperatures for 2 days if the packs are frozen and lid is kept tightly clo sed. are completely mixed . Expiry dates of vials shou ld b e checked once a week. 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. can be kept at 2-80C for short er periods e.vacuum flasks should never be used for this purpose. wait for 15 minutes. life of 24 months. VVMs were first introduced on OPV vials supplied to UNICEF and WHO in 1996. have provision for only 2 frozen ice-packs. where vaccines are stored in bulk for longer periods. The VVM warn s t h e end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level. VVMs increas e the flexibility in handling of vaccines in the field. these contain 4 fully frozen ice packs (0. can be used to store vaccines for 6-8 hours. While storing vaccines fo llo w the "First-In-First-Out (FIFO)" and "First to Expire First-Out (FEFO)" rules. temperature and time sensitive monitor marks are used to check the cold chain. never add salt to the water. however. 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. Diluents should be stored at 2-8oC these should not be us ed b ey ond 4 hours. it can be presumed that oth er vaccines would also be potent. If a freezer is available. DTP / DT / TT / Typhoid (T-series vaccines). 6-8 vials) of vaccine. It is used especially for temperatures monitoring of OPV.36L of water. 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. id eally. Inner square is lighter than outer circle: If the expiry date has not passed. from the periphery after the immunization sess ion. the vials should be lifted from all levels . has failed to 'dry' successfully. 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. Supply of vaccines A ll UIP vaccines are available free of cost to all practitioner from lo cal health authorities. If all vaccines can be successfully 'dried'. National Institute of Communicable Disease (Delhi). Vaccum flasks should never be used for an outreach activity. This reduces wastage o f v accine and minimizes the risks of contamination/loss of potency. The VVM provides in formation about the heat exposure of the vial over a period of time . OPV sample testing is not required. However there may be other factors which can also affect the potency of vaccine (e. the utilizatio n report should be submitted periodically. Recen tly Government of India is following this recommendation.1. 47 . th e samples should be kept in a deep freezer/ILR before these are sent to the testing lab o ratory. However. When buying from market individual practitioners should ensure that vaccines are procured directly from a stockist with appropriate cold chain facilities. 2. 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. OPV would lose viability if kept at 22-25oC for more than a d ay .g. there will no longer be a need for maintenance of co ld chain . may be used in subsequent sessions at a given health facility if it has b een p reserved at 2-8oC. 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 .after that these are best discarded irrespective of whether these have been opened or not. The test t akes only 7 days. Measles vaccine loses viability quickly if kept at temperatures above 400C. CHC.i. PHC. 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. 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. Trehalose. rather than off the shelf from a nearby retailer. a disaccharide. however. Loss of potency depends upon the degree of temperature elevation as well as duration of exposure. One is allowed to collect profes s ional fees for the services rendered. Opened vials of OPV. district and reg ional stores. Inner square matches colour of outer circle or is darker than outer circle: vaccine should be discarded. 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. has long term stabilizing ability and can be effectively used for this purpose. Testing facilities are available at the Central Research Institute (Kasauli). The WHO recommends that in countries where VVM is being used for monitoring cold chain. When using multidose vials it may be ad v isable to schedule all immunizations to a fixed day every week. Vaccine vials should not be taken out to the field more than 3 times . Tetanus toxoid is the least heat sensitive vaccine. storage beyond the expiry date) and these may not be reflected in the VVM . vaccine can be used. Oral polio vaccine. 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.this will also result in substantial cost savings.e. Enterovirus Research Centre (Mumbai). The manufacturer's instructions regarding shelf life of a given vaccine must be rigorously followed. School of Tro p ical Medicine (Kolkata) and other centers. Open vials can also be sen t an d . however. One can send OPV vials for viab ilit y test with the help of the local health authorities. 4 years Many weeks St a b le fo r man y days at 45OC Rabies HDCV 3.4 years De c lin e o f D-antigen content for Type I after 20 days Many months Hepatitis B 2. Significant loss of viability within 13 days Variable Very u n s t ab le. This recommendation is based on the fact that: 1.24 mo n t h s . Significant loss of viability within 1 day at 41OC Pre c i s e lacking data Inactivated Polio Vaccine (IPV) 1. There is a risk of contamination as BCG vaccine contains no bacteriostatic agent. 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.Stability of Vaccines at Different Temperatures Vaccine 2.12 months 50% lo ss o f viability after 3 weeks Very u n s t ab le.25 in oC 35. 2. but there is a steady decrease in potency 1 year Variable.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. Concern over loss of viability.5 years 3 months 4 weeks No data available 48 . 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. suspicion and authority" Disease surveillan ce under the Universal Immunization Program refers t o the collection. At present most of the parts of the coun try have excellent and adequate surveillance. A g o o d surveillance system can det ect program failures and impending outbreaks and can also be used to assess vaccine efficacy. 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. Similarly while it may be possible to eradicate measles in the future. by immunizing all mothers wit h tetanus toxoid it is possible to at least eliminate neonatal tetanus. analysis and use of data on VPD to improve action to p rev ent these diseases As higher levels of vaccination coverage are achieved. Every case of AFP should be reported to local health authority. at the present time one can only hope to preven t measles mortality by preventing measles in the vast majority of immunized children.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.D. Acute Flaccid Paralysis (AFP) surveillance is an essential component of polio eradication. it may not be feasible to eradicat e the tetanus bacilli. 49 . The revised target for certification of polio eradication and neonatal tetanus elimination is the year 2007. The WHO had declared 3 district objectives for the year 2000 A. However. A min imum AFP rate of 1/100. the role of disease surveillance becomes increas ingly important to document the impact of a giv en immunization program. which are u biquitous. 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. 1) 2) 3) Polio eradication Neonatal tetanus elimination Measles reduction It is a pity that none of these targets have been met so far.Surveillance for Vaccine Preventable Disease (VPDS) Surveillance is a French word. 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. org www.path. 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.cd c.We are likely to g et many new combo vaccines also.o rg .childrensvaccine.unicef.Vaccination in Current Millenium The future holds lot of promise as far as prevention of disease through vaccination is concerned. 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.org. www.o rg . www.aap . www.o rg .immunizationinfo.in ejc t io n s afet y .org.org 50 . www. "Naked" DNA vaccines and administration of antigens through viral vectors/edible plants may completely revolutionize childhood vaccination programs. improved antigens and safe vaccines. We are likely to witness more refined vaccination techniques.org.v accin es . www. www.vaccinealliance. www. www.int/vaccines.g ov/nip.who. 2006 New Delhi)] The Indian A cademy of Pediatrics Committee on Immunization (IAP COI) conducted its deliberations and reviewed its stand on various policies. It is our considered opinion that. 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 . and July 28. till wild polio virus is eradicated from our country. It is a fact that except for the recent phased introduction in Hepatitis B vaccine in 51 . These include operationalizatio n of birth dose of OPV all over the country. Immunization Program is its Member Secretary. what the academy in its role of advocacy on behalf of children. and for which guidance is necessary. requests other agencies. given a couple of years ago. we must continue with this program and bring it to its logical conclusion. in sp it e of some operational hiccups. "Recommendations" are. the Go v ernment of India or other professional bodies. IAP Policies on Immunization. strengthening of routine immunization. All vaccines under UIP sh o u ld continue to be available free of charge to all eligible 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. "policies" are the decisions taken by the Academy in relation to the scientific principles and practice of immunization. no new vaccine has been introduced in the national program in the last 25 years. 2006 Mumbai. 2006 a few districts. 1 2005 New Delhi. "Policies" are expected to be pract iced by all members of Academy. Guidelines And Recommendations [Report of IAP COI Meetings ( July 16th & 17 2005. Guidelines usually pertain to newer vaccines or issue related to them.Update of IAP Immunization Policies. 'Guidelines" relate to those items wh ich are outside the purview of policy. guidelines an d reco mmendations pertaining to childhood immu n ization. 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. 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. Department of Family Welfare is t he Chairperson of the committee while the Assistant Commissioner. New Delhi. This followed a formal recommendation from the IAP. i. Oct. As has been enunciated earlier. in general. at least in areas with wild polio virus transmission continuing. April 2.e. better quality of SIAs and role of IPV in difficult areas where wild polio virus circulation is still continuing. The Secretary.should also be invited as a member of this committee. 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. less thermolab ile and has no chance of inducing vaccine induced paralysis. Tdap and Rota virus are the vaccines which are likely to be available in near future. in its routine immunization program in post-polio eradication era. preferably as IPV-DTP. On number of routine DTP/OPV doses The IAP COI endorses the use of five d o s es of DTP/OPV at 6. OPV is cheaper & being given orally and so mo re acceptable. iVDPV. However in post-polio eradication era. These outbreaks of cVDPV were curtailed by strengthening routine immunization and giving 2 or more rounds of SIAs using OPV. Pn eu mococcal PCV-7.. • It will be unwise to discontinue use of polio immunization altogether after zero polio status is achieved due to fear of cVDPV. Parents. 52 . • Looking at the above problems. Td should replace TT at 10 and 16 years. Of late IPV h as been shown to induce local g u t immunity as well as herd effect. OPV must be given to these children as birth dose and on the NIDs and SIAs. • 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. Following concepts should be kept in mind while deciding India specific guidelines for post-polio eradication immunization. looking at the huge requirement of the number of doses. Varicella an d Hepatitis A vaccines are still not recommended for routine use. 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. IAP recommends that India should switch over to IPV. should out-break of wild polio or cVDPP occur. 10 and 14 weeks and thereafter at 15-18 months and 5 years respectively. 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. 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. The cost and availability of vaccine can be a problem. HIB. 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. 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). 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. liv e attenuated SA-14-14-2 Japanese Encephalitis Vaccines are the new vaccines which have become available in India. should b e made aware of the availabilit y an d need of these vaccines. MMR and typhoid. it will be unethical and unsafe to reintroduce OPV in such areas. however. It will force us to depend on the stocks of WHO or any such agency for OPV vaccine. Where as IPV is more efficacious.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. 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. 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. An additional dose of OPV is to be given at birth to all where possible and one more additional dose along with measles vaccine. It should be given at around 15-18 months of age and at least 3 months after the measles 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. If vaccination is s t arted after 6 months of age. 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. 1 and 6 months Birth. as also to hospital staff likely to come in co n tact with pregnant mothers. along with HB vaccine. The injections should be given at two separate sites. only one dose need be given. 6 and 14 weeks/6 months 6. however.IAP COI stand on RECOMMENDED vaccines not covered under EPI against Hepatitis B. Of the 3 types of vaccines (viz. A booster is given at 15-18 months. Typhoid Vaccine Immunologically 0 . 10 an d 14 weeks along with DTP.6 months schedule of hepatitis B immunization has been most widely used and proven to be ideal. address vertical as well as horizontal modes of transmission of the virus.no boosters are required u n d er such circumstan ces. 10 and 14weeks/6 months MMR should be promo t ed as a universal vaccine.6 months schedule.14 wks schedule can be followed. in the case of extremely preterm babies. There is no upper age limit for this vaccine. vaccination should commence only after initial stabilization. Due to operational issues at a national level one has to piggy back on the av ailable contacts for routine immunization.1 . The vaccination schedule need not be changed for preterm babies. Hib Vaccine Hib vaccine should be offered to all children and may be given at 6. with a booster at around 18 months. If the mother is HBsAg positive (and especially HBeAg positive). 6 10. therefore. Boosters of HB vaccine are n o t n ecessary in immun o co mpentent individuals.14 wks schedule is recommended. irrespect ive of age. After 15 months of age only one dose of the vaccine needs to be given. prior to splenectomy and also in patients with sickle cell disease. IAP COI strongly recommends GOI to include . whole cell inactivated and oral Ty-21a). one can still use 0 .6wks . In office practice. only the Vi-polysacharide vaccine is freely available in our country at present. It is recommended to be given after the age of 2 years followed by revaccination every 3-5 years. hen ce 0 . HB vaccination is now been integrated into the existing immunization program (UIP) in India. MMR Vaccine Hepatitis B vaccine HB vaccine may be given in any of t h e following schedules: (i) (ii) (iii) Birth. HB vaccine may be given at 0. If HBIG is not available (or is unaffordable).6 . It should also be given to all adolescent girls and young women not previously immunized. An ideal HB vaccine schedule should. If vaccination is started between 12-15 months of age. only two doses (at 4-8 weeks interval) need be given as primary schedule with a booster at 15-18 months. Hib vaccine is also recommended for all high risk children. the baby should be given Hepatitis B Immune Globulin (HBIG) as soon as possible after birth. preferably within 24 Hours of birth. The vaccine need not be given after 5 years of age. The IAP COI recommends universal immunization 53 The IAP COI strongly recommends the use of typhoid vaccine for all children. In case birth dose has been missed. 1 and 2 month s with an additional optional dose between 9-12 months. Vi-polys ach aride. 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 . 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. There is only one Indian study con d u ct ed at Pune on this vaccine showing 95% seroconversion. 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. 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 . One has to emphasize the generally benign nature of and rarity of complications with Hepatitis A infection in young children. Boosters are not recommended at present. it may. It is indicated in children with ch ro nic lung/heart disease. Varicella vaccin e reco mmen d ed immu n ocompromised children. This vaccine should be subject ed to post marketing surveillance for efficacy and adverse reactions in India. It may also centers. be not always effective under such circumstances if the contact has the same source of infection as the index patient. IAP COI stand on vaccines that are given after discussion with parents: dose administered by subcutaneous route. Live attenuated Hepatitis A Vaccine The IAP COI opines that varicella vaccine is not recommended for universal immunization in India at present. HIV infection (but with CD 4 counts above 15% of the age related norms). The vaccine is given intramuscularly and the protectiv e efficacy is 94-100%. It may also be considered in children attending crèches and day care centers and in travelers from abroad (e. 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.g. non-resident Indians) visiting endemic areas. It is given in a 2-dose schedule. This vaccine has recently been licensed for use in India. 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.in the latter case the vaccine must be given within 10 days. 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. humoral immunodeficiency.this vaccine in UIP. However. 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. for 100% seroconversion second dose after 6 months n eed s to be considered as recommended in China. however. varicella in fection in young children. Varicella Vaccine Hepatitis A Vaccine Hepatitis A (HA) vaccine is not recommen d ed for universal immunization in India at present. considered in children attending crèches and day care The live attenuated Hepatitis A Vaccine has been licensed for use in China since 1992. The vaccine has not been studied extensively outside China. 1998). Use of acellular pertussis vaccine should. It is given by subcutaneous route. Convulsions with/without fever occurring within 3 days 2. however. From the av ailable safety data. t h erefo re. more recent studies have shown 55 Meningococcal vaccine (bivalent A. not reco mmen d ed for un iv ers al immunization in our country at present.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. day care center wo rkers.g. However it is recommended routinely in h ig h risk group children up to the age of 5 years. The v accine may be offered after explaining the parents on o ne to one "named child" b asis. However.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. PCV . 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. Korea and India This live attenuated vaccine constitutes to over 50% of global production of all JE vaccine. 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. Dose is 0. local reactions at injection site and irritability).the institutional set up e. These include: 1. W135) is indicated for use (as an adjunct along with chemoprophylaxis) in clos e co ntacts of patients . C. however. Persistent inconsolable crying for 3 or more hours within 48 hours 3. 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). 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. Acellular Pertussis Vaccine reactions to a previous dose of whole cell pertussis vaccine. school teachers. IAP Stand on vaccines for special circumstances efficacy reaching 99% even with single dose. military personnel and health care professionals. Collapse or shock-like state within 48 hours 4. after which a 2-dose schedule (4-8 weeks apart) is recommended. C or tetravalent A. Y. Init ial studies done on this vaccine demonstrated an efficacy of about 80% with single dose and 98% with 2 doses. Temperature > 40.5ml at all ages. As per a W HO report no serious adverse effects (other than anaphylaxis) have been rep o rt ed over 20 year period (1979 . China. There is . S. It is . This vaccin e is not available commercially in India. Acellular pertussis vaccines may undoubtedly have fewer minor side-effects (like fever. but this small advantage dose not justify the inordinate costs involved in the routine u s e of this vaccine. the vaccine was found to be extremely safe. it has been used this y ear in seven endemic districts after importing it from Chengd u Institute of Biologicals. So the Tdap vaccine is n ot recommended for universal use at present.complement deficien cy ) during epidemics It is recommended for those who are going for Haj pilgrimage. rate of intussusceptions was shown to occur after vaccine prevalent in India.g . 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. The first vaccine against rotavirus was tetravalent rhesus-human rotavirus vaccine (RRV-TV vaccine. 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. Almost all children get infected by the age of 5 yrs. t h o se with and hyposplenia/asplenia. In India the epidemiology of pertuss is is not well known and there is lack of information reg arding epidemiological shift. Other Rotavirus vaccine being developed are LLR vaccine in China which is in phase II / III trials and the newborn strain vaccine in India. Recently a new Pentavalent bovine-human reassortant vaccine from Merck (Rotateq) has been licensed in USA. Both these vaccines have been found to be safe and highly efficacious. Ro t ashield: Wyeth Lederle). 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. adolescents and adults though n o t great in numbers have relatively increas ed.000 children d ie each year in India due to rotavirus diarrhea. Another Rotavirus vaccine . the proportion of pertussis cases in older children. of the children hospitalized for rotavirus diarrhea. For prevention universal immu n ization appears to be the only answer. 75% < 9 months and nearly 100% < 2 y rs.with the disease. It is estimated that risk of death follo wing rotavirus diarrhea is 1 in 290 cases in 56 .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. IAP COI stand on future vaccines: developing countries 53% of rotavirus deaths occur in Africa & 42% in Asia. 50% were < 6 months. The Tdap vaccin e h as been incorporated as booster dose during adolescence in the immunization schedule of few developed countries. It is also indicated in high risk in d iv id u als (e . 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 100. 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. There the epidemiology has undergone a marked shift since the introduction of mass childhood vaccination programs. Trials of these vaccines have not been initiated in India so far. This provides booster to waning immunity in adolescents thus leading to individual protection and prevention of transmission of disease to susceptible infants and children. In India. This vaccine licensed in USA in 1998 and recommend ed for universal use had to be withdrawn when an increased administration. Rotavirus is common cause of d iarrhea all over the world. 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. Every vaccine given to a child must be documented on a card/ booklet. We are hopeful the companies would see reason and refrain from lay advertising. but with the following cautionary statements: 1. Parents must be instructed to keep the document safely and present it to their doctor whenever required.there is no upper age limit for this vaccine. Many parents opt for one single injection of combination vaccines at a given visit. 1 and 6 months sched u le as mentioned earlier under individual vaccines. 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. We recommended the IAP Health and 57 . Hepatitis A and varicella vaccines should be used in selected cases as mentioned above. HB vaccine may be offered in th e 0. MMR vaccine should be offered to all children who have not received it earlier . On Immunization Records Some of the multinational companies have been using the lay media (television. 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.Combination Vaccines adhered to strictly 2. The Academy encourages the use of typhoid vaccin e for all adolescents. The advantage of a combination vaccin e is the convenience of fewer clinic visits for the parents and fewer pricks for the child 4. electronic media and news p apers/magazines) for placing advertisements pertaining to optional/combination vaccines. 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. The manufacture's recommendations should be On Adolescent Vaccination Immunization card to be used for this purpose. if the child has not received it earlier. The IAP placed a formal complaint before th e Drug Controller General of India and the Union Health Ministry. A number of combination vaccines are now available in the Indian market. We opine that this is uneth ical. unless specifically recommended b y the manufacturer.table. The IAP COI endorses the use of combination vaccines. Extemporaneous " mixing" of vaccines in the same syringe (prior to injection) should not be done as far as possible. in the latter case the manufacture's instructions should be followed strictly 3. • The Government should actively consider inclusion of typhoid vaccine in the national immunization schedule. • 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. 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. The Academy suggests use of • • Vi-polysaccharide vaccine for this purpose. Govt of India The IAP COI has formulated several specific recommendations to other agencies pertaining to immunization. However we need to ensure adequate supplies of indigenously produced chick embryo/tissue culture vaccines at affordable costs. If the mother is HBsAg positive. now that it is licensed in the country. The Academy recommends that inactivated polio vaccine should be introduced in the routine immunization in a phased manner. The Academy supports the decision of the Government to discontinue production of animal brain rabies vaccine. 58 . the baby should be given HBIG plus HB vaccine soon after birth. 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). 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 Academy strongly recommends that Hepatitis B. 59 .