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IAP Guidebook on immunization 2007

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IAP Guidebook on immunization

IAP Guidebook on immunization

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  • 1. 1
  • 2. IAP GUIDEBOOK ON IMMUNIZATION Editors Dr. Raju C Shah Dr. Nitin K Shah Dr. Shyam Kukreja IAP Committee on Immunization 2005-2006 Chairperson: Dr. Raju C. Shah Co- Chairperson: Dr. Nitin K. Shah Convener: Dr.Shyam Kukreja Members: Dr. Rohit Agarwal Dr. Indra Shekhar Rao Dr. Shivananda Dr. Nigam P Narain Dr. Sangita Yadav Ex-officio members: Dr. Deepak Ugra Dr. Tapan Kumar Ghosh Dr. VN Yewale Dr. Naveen Thacker Dr AP Dubey Dr Surjeet Singh Address for correspondence: Indian Academy of Pediatrics Kailas Darshan, Keneddy Bridge Near Nana Chowk Mumbai India 400 007 Tel: +91-22-3889565 E-mail: iapcoff@bom5.vsnl.net.in 2
  • 3. 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 Co-Chairperson, IAPCOI Convener, IAP COI 2005- 2006 2005-2006 President IAP 2005 President IAP 2006 3
  • 4. Contents Introduction 5 Historical aspects 6 Basic immunology 8 National immunization schedule 10 Commonly used vaccines 11 Newer vaccines 24 Vaccines used in special circumstances 27 Combination vaccines 30 IAP Immunization Time-Table 34 Immunization in special circumstances 36 Adverse reactions following immunization 42 The cold chain 44 Surveillance for vaccine preventable diseases 49 Vaccination in the current millenium 50 IAP COI meeting report and policy updates 51 4
  • 5. Introduction Protect ion from preventable diseases, disabilities and consensus based on the current evidence from the death through immunization is the birth right of every literature. The IAP Immunization Time Table child. Immunization is one of the most co s t-effective represents the 'best individual practices schedule' for a health intervention s known to mankind Over the last given child and would necessarily be at some variance three decades, a lot of progress has been made globally from the National Immu n ization Schedule of the as far as protection against the eight important vaccine Government of India, which is meant for the public at preventable diseases is concerned - from less than 5% large. With the availability of many newer vaccines, it children who were protected against these diseases in is necessary that some of these should be considered for the early 1970s, to as many as 75% being protected routine immunization and the immu nization schedule now. Small pox has been eradicated and we are at the has to be changed accordingly. threshold of eliminating polio. Unfortunately, there is lack of authentic data on An effective National Immunization strateg y can help epidemiology of most infectious diseases in our country. decrease childhood morbidity and mortality, especially However that should not deter us from using some of in developing countries. It must, however, be clear that these vaccines till such data is generated. Many immunization strategies may vary from co u n try to decisions on incorporation of new vaccines in t he country depending on the local req u irements. This immunization program have, therefore, to be based on guide book represents the collective effo rts of the data from other parts of t h e world. This may appear members of the Indian A cademy of Pediatrics unscientific to some, but is a reality and is the only way Co mmittee on Immunization (IAP COI). We are aware out at present. 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 5
  • 6. Historical Aspects Though Dhanvantri, t h e father of Indian In 1985, the EPI was s upplanted by the Universal Medicine, sp o ke of preventing certain infectious Immunizat ion Program (UIP). The main objectives of diseases t h rough immunization, the first successful UIP were: i) universal immunization and reduction in vaccine in the modern era was developed b y Edward mortality and morbidity due to vaccine prev entable Jenner in 1796 when he used cowpo x inoculation diseases ii) self-sufficiency in vaccine production iii) (vaccination) to protect against smallpox. Louis establishment of a functional cold chain system, and iv) Pasteur developed a h ig h ly effective vaccine against the introduction of district level monitoring system. In rabies, which was used for post-exposure prophylaxis. this program the emphasis was s hifted from the It was first given to a child in 1885. Since then many under-five to under-one age group, thereby reducing the other vaccines have been developed in rapid succession. number of potential beneficiaries. It considerab ly reduced the denominator for percentage coverage. The Experience with smallpox eradicat io n p ro g ram vaccines recommen d ed were BCG, DTP, OPV and convinced the health policy makers that immunization Measles for infant s an d TT for pregnant women. It was the most powerful and cost-effective measure for should be noted that UIP envisaged 100% coverage of control of vaccine preventable diseases. At the global pregnant women with 2 doses of tetanus toxoid (or a level, an organized immunization program came into booster dose, as applicable) and at least 85% coverage exis tence in the year 1974 under the banner of the of infants. Under the UIP, the govern ment also aimed World Health Organization (WHO). This was to establish logistics of vaccine production and supply christened as the 'Expanded Program on Immunization' as well as training of medical and p aramedical (EPI). The term "Exp anded" referred to the provision personnel. The Government of India subsequently set of adding more antigens to vaccinatio n s chedules, up a " Technology Mission on Vaccination and extending coverage to all corners of a country and Immunization of Vulnerable Po pulation, especially spreading services to reach the less privileged sections Children" to cover all asp ect s of the immunization o f the society. The EPI program focused on children activity from research and development to actual below 5 years of age and pregnant women. The delivery of services to the target population. vaccines included were BCG, DTP, OPV, Measles and TT. The primary health care concept as enunciated in Since switching over to UIP in India there has been a the 1978 Alma Ata Declaration in cluded immunization significant decline in many of the vaccine preventable as one of the strategies for reaching the goal of 'Health diseases, such as poliomy elitis, neonatal tetanus, for All' by the y ear 2000. The Government of India diphtheria, wh o o p ing cough and measles. The UIP adopted the EPI in 1978 with the t win objectives of became an integral component of Child Survival and reducing the mortality and morbidity resulting from Safe Motherhood Program (CSSM) in 1992 and then vaccine preventable diseases of childhood, and to part of Reproductive and Child Health Program (RCH) achieve self-sufficiency in the production of vaccines. in 1997. Supplemen t ary immunization activities The program started with BCG, DTP and Typhoid against poliomyelit is were started in 1995-96. In 2002, vaccines - it did not include measles vaccine. OPV was Hepatitis B vaccination was initiated in selected areas added only in 1979 and measles later on. Ty p h oid targeting the urban poor. vaccin e continued to be a part of our national The WHO also endorsed global efforts at immunization immunization schedule until 1985. Program coverage through Universal Childhood Immunization (UCI) in of 85% was envisaged, but this could not be achieved 1990 - the name given to a declaration sponsored by for several years and independent evaluations showed UNICEF as part of the 40th anniversary of the United very low coverage rates in many parts of our country. Th erefore, a change of strategy was considered Nations in October 1985. Efforts were undertaken to initiate research for the development of newer vaccines, necessary. to improve vaccine product ion technologies and to 6
  • 7. u n d erstand the epidemiology of diseases. These augmenting research and d ev elopment on vaccines developments were highlighted in 1990 at the Summit against HIV, malaria and tuberculosis v) making for Children, where it was claimed that EPI had indeed immunization coverage an integral part of international been a global success with 80% reported coverage with development initiatives. The GAVI Ind ia Project has the six vaccines. In 1992, the WHO also set a target for been instrumental in launching free Hepatitis B universal Hepatitis B immunization. It aimed to immunizatio n in some of the urban slums. It has also incorporate Hepatitis B vaccine in the immunization endeavored to promote safe injection practices and use schedules o f all member countries by 1997. However of auto-disable syringes for immunization as part of a unfortunately less than 50% of t h e countries have countrywide initiative. actually introduces Hepatitis B vaccine in their A surv ey conducted in 2002 under the RCH showed National Schedule. India has recently accepted its that immunization coverage rates in India have been inclusion in National schedule and the coverage will d eclining, since 1999. The Government of India h as expand in a phased manner. recently lau n ched an Immunization Strengthening These global efforts at immunization were launched Project with the objectives of i) strengthening routine under the banner "Children Vaccine Initiative" (CVI) immunization with the aim of raising the percentage of in 1991 with support from several in t ernational fully immunized children t o ab ove 80% ii) eliminating agencies like the WHO, UNICEF, World Bank and the polio and achieving polio eradication iii) reviewing and Rockefeller Foundation. CVI aimed at development of developing a new vision of the immunization program newer vaccines, improvement in vaccine production in the medium term keep in g in view the development technolo g ies and vaccine quality. These efforts were of new epidemiological patterns, availability of new further co nsolidated under the "Global Program on vaccines and delivery mechanisms and advances in cold Vaccines and Immunization" (GPV) in 1993 reflecting chain technologies iv) improving surveillance and the EPI and UCI init iative and combining these with monitoring mechanisms. The National Institute of the CVI. The focus of GPV is on sustaining high Health and Family Welfare has been identified as the vaccine coverage, developing global surv eillance nodal institute for coordination and implementation of network and evolving eradication strategies. The the program an d the training shall be carried out "Global Alliance for Vaccines and Immunization" through five regional inst it u tes. Training of mid-level (GAVI) was set up in 1999 as an international coalition managers, including persons actively involved in of multination al funding agencies (e.g. Bill and immunization program at the district and state level, is Melinda Gates Foundation, Rockefeller Foundation), an integral component of this project. The project was v accin e man u fact u re r s , n o n - g o v ern men t al started in 50 poorly performing districts of 8 priority organizations and the governments of 74 d ev eloping states of Uttar Pradesh, Bihar, Madhya Pradesh, nations. GAVI organizes its activities through a Rajasthan, Oriss a, Gujarat, Assam and West Bengal. vaccin e fund. The main objectives of GAVI are as These newer initiatives have improved overall coverage follows: i) impro v in g acces s t o s u s t ainable in these districts. Unfortunately last report of National immunization services ii) expanding use of all existing family and health survey released in 3rd week of Nov safe and effective vaccines iii) accelerat ing the '06 do not confirm this improvement. development and introduction of new vaccines iv) 7
  • 8. Basic Immunology The Greek work "immune" means "to be protected". BCG, oral polio v accine and Hepatitis B vaccines can Protection offered by the introduction of various be given soon after birth as the maternally derived antigens or ready-made antibodies is called acquired immunity apparently does not interfere with the vaccine immunity. The process by which t h is acquired "take" On the other hand, live measles vaccine may be immunity is obtained is known as 'immunization'. This inhibited in the presence of detectable maternal is of two types, active and passive. When specific antibody in the infant's circu lation. Measles vaccine, antigens evoke the required immune response in the therefore, should only be given after at least 9 months system it is called active immunization, and when of age ; similarly, MMR vaccine is given only after 12 antibodies are supplied readymade in th e form of months of age. immune g lo b u lins and sera it is known as passive Timing of vaccination depends upon the age at which immunization. the disease is anticipated as well as on the feasibility of Pathogenic infectious ag en t s induce disease and the administering the vaccine at that time. For instan ce, host immune system responds with immunity , first to neonatal tetanus can only be prev en t ed through ensure recovery and then to offer protection from maternal immunization by ensuring adequate titers of disease if the same patho gen were to be encountered transplacent al antibodies and not by immunization of again. A vaccine is composed of one or more antigens the baby at birth. of the pathogen, which will induce a protective immune Vaccines are selected based on three important criteria response without suffering from the disease. viz. necessity, safety and efficacy. All vaccines are Vaccines consist of attenuated live organisms (eg. oral subjected to the following trials before being licensed: polio vaccines, oral typhoid vaccine, varicella vaccine, Phase I Trial: Human volunteers - for tolerance, safety measles vaccine), whole inactivated org anisms (e.g. pertusis vaccine, whole cell typhoid vaccine, rabies Ph as e II Trial: Human volunteers - for immu n e vaccine, inactivated polio vaccine), modified exotoxins response, safety called "toxoids" (e.g. diphtheria toxoid, tetanus toxoid), or subunits (e.g. polysaccharide antigens of Salmonella Phase III Trial: For field efficacy, safety typhi or Haemophilus influenzae type b and the surface Further, before a vaccine is act u ally marketed it proteins of hepatitis B virus). undergoes sterility, purity and potency tests at the level Vaccines mimic infection with the respective pathogen, of the manufacturer and the Drugs Controller General but without the asso ciated risk of developing the of India. disease. The consequent immune response may be Most of the currently used childhood vaccines do not manifested through hu moral (i.e. antibody) immunity interfere with the vaccine "take" of one another. These or cell mediated immunity (CMI) or both. If the antigen can be, therefore, given simultaneously and several preferentially stimulates Th1 series of T helper antigens can be g iv en the same day, if required. In lymphocytes, a strong lymphocytic respons e is general, the interval between two doses of the same obtained; if Th2 series is preferentially stimulated, the v accine, say for instance DTP, should be at least 4 ultimate express ion of immunity is predominantly weeks; preferably 8 weeks. An interval of 4 weeks humoral. Carbohydrate antigens are T cell independent; would obviously result in completion of the primary hence they stimulate B cells directly without T helper schedule at an earlier age an d may perhaps make it cell modulation. This results predominan t ly in a IgM easier for the parents to remember their follo w-up response wit h out IgG production or induction of appointments. Th is way the drop out rates may also immunological memory. BCG elicits CMI without an decrease. BCG and OPV can be given from the day of easily demonstrable humoral component. 8
  • 9. birth until 2 weeks of age, s o that there would be 4 immune system and it may be advisab le to avoid weeks gap until the next contact for immunization at 6 administratio n of other vaccines within 4 weeks of weeks. If the opportunity to give BCG / Hepatitis B was these. There is, however, very little objective evidence not available in the neonatal period, it may be given at to show t h at this immunosuppression is clinically 6 weeks, s imultaneously with DTP and OPV. Some of significant. the viral vaccines (e.g. measles, varicella) may be associated with possible short lasting suppression of the Terminology Vaccination: process of inoculating the vaccine/antigen. Immunization: process of inducing immune response which may be humoral or cellular. Seroconversion: change from antibody negative state to antibody positive state. Seroprotection: a stage of protection from disease, due to the presence of detectable antibody. Antibody titer: the reciprocal of the highest serum dilution at which antibody has been detected. 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 anticipated adverse reactions and due date for the next to the mother the nature of vaccine, t h e n umber of session of immunization. doses needed, the disease likely to be prevented, Types of Vaccines Type of Antigen Examples Live bacteria, attenuated BCG, Ty21a Live virus, attenuated OPV, MMR, varicella Inactivated bacteria Pertussis, whole cell killed typhoid Inactivated virus IPV, rabies, HAV Toxoid Tetanus, diphtheria, Td Capsular polysaccharide Typhoid Vi, Hib, meningococcal, pneumococcal Viral subunit HBsAg Bacterial subunit Acellular pertussis 9
  • 10. National Immunization Schedule Age Vaccines Birth BGG, OPV0 for institutional deliveries 6 weeks DTP1, OPV1 (BCG if not given at birth) 10 weeks DTP2, OPV2 14 weeks DTP3, OPV3 9 months Measles 16-24 months DTP, OPV 5-6 years DT* 10 years TT** 16 years TT For pregnant women Early in pregnancy TT1 or booster One month after TT TT2 *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. ** 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, DT or TT vaccines (Source: Govt. of India (1994) National Child Survival and Safe Motherhood Program, M in is t ry of Health and Family Welfare, New Delhi) 10
  • 11. Commonly Used Vaccines A. Vaccines Against Diseases Covered Under EPI BCG Vaccine Bacillus Calmette Guerin vaccine is derived from the ensure maintenance of cold chain during transport and bovine tuberculosis strain and was first developed in storage. Th e recommended dose is 0.1 ml of 1921. It was the result of painstaking efforts by t h e reconstituted vaccine irrespective of the age and weight French microbiologist Albert Calmette and the of the baby. Injection of BCG should be strictly veterinary surgeon Camille Guerin who performed 231 intradermal, using a Tuberculin syringe and a 26G repeated subcultures over 13 years. It continues to be need le. The convex aspect of the left shoulder is the only effective vaccine against tuberculosis The two preferred for easy visualization of the BCG scar. The common strains in use are Copenhagen (Danish 1331) selected site may be swabbed clean using sterile saline and Pasteur of which the former was produced in India - local antiseptics are unnecessary. at the BCG Laboratories, Guindy, Tamil Nadu till A wheal of 5 mm. at the injection site indicates recently. successful intradermal administrat ion of the vaccine. BCG induces cell-mediated immunity but t h e Subcutaneous administration of BCG is associated with protective efficacy is a matter of debate and is very an increased incidence of BCG aden it is . The injected difficult to q u an t ify BCG vaccine is more effective site usually shows no visible change for several days against t h e development of hematogenous spread of Subsequently, a papule develops after 2-3 weeks, which Mycobacterium tuberculosis (which results in milliary increases to a size of 4-8 mm. by the end of 5-6 weeks. and meningeal forms of the disease against which it This papule often heals with ulceration and results in a has a protective efficacy of 50-80%), than against the s car after 6-12 weeks. Although the preferred time o f development of pulmonary tuberculosis where it has a vaccination is soon after birth, it could be given up to protective efficacy of less than 50%. the age of 5 years. If no reaction is seen at the local site even after 12 weeks, it is an in dication to repeat BCG The vaccine contains 0.1-0.4 million live viable bacilli presuming that BCG has not taken up. per dose. It is supplied as a lyophilized (freeze-dried) preparation in vacuum sealed multi-dose dark colored Adverse reactions - The ulcer at vaccination site may ampoules. The lon g n ecked BCG ampoule should be persist for a few weeks before formation of the final cut carefully by gradual filing at the junction of its neck scar. No treatment is required for this co ndition. and body, as sudden gush of air in the vacuum sealed Secondary infection at the vaccination site may require ampoule may lead to spillage of th e contents. The an t imicro b i a l s . I p s i l a t eral axillary / cerv ical vaccine is light and heat sensitive and deteriorates on ly mphadenopathy may develop a few weeks/months exposure to ult ra violet rays. Sterile normal saline after BCG vaccination. Antitubercular therapy is of no should be used for reconstitution. As t h e vaccine benefit in such situations and should not be contains no preservative, bacterial contamination may administered. The nodes regress spontaneously after a occur with repeated use. Therefore, once reconstituted, few months. It should also be noted that if fine needle the vaccine should be used within 4 hours with the aspiration cytology of the nodes is carried out, stain for left-over being discarded after the session. acid-fast bacilli may b e p o sitive. These are bovine vaccine bacilli and should not be misconstrued as being In lyophilized form it can be stored at 2-80 C for up to suggestive of tuberculous disease. In some children the 12 months, without losing its potency. One should 11
  • 12. nodes may even liquefy and result in an ab s cess. s it u at ion also. Disseminated BCG infection is Surgical removal of the nodes or repeated needle extremely unusual but may occur in children with aspiration is the treatment of choice - again, cellular immunodeficiency. antitubercular therapy is not recommended in this Oral Polio Vaccine Oral polio vaccine (OPV) remains the vaccine of choice must reach the outreach facility at 2-80 C in vaccine for polio eradication in India. It is a suspension of over carriers with ice packs. Breastfeeding and mild 1 million particles of poliovirus types 1, 2 and 3. It is d iarrh ea are n o co n t rain d icat io n t o OPV supplied with a stabilizing agent, namely magnesium adminis t rat ion. If a substantial amount of OPV is chloride. The vaccine, therefore, is quite stable under vomited or regurgitated wit hin 5-10 minutes of refrigeration. administration, the dose should be given again. If this repeat dose is also not retained, neith er of the doses When OPV is given by mout h , t h e vaccine viruses s hould be counted and the vaccine shou ld b e reach the intestines where they must establish infection re-administered at a later visit. (vaccine virus "take") before an immune response may occur. A high level of gut immunity ensures that Adverse reactions - OPV is an excellent vaccin e and vaccinated children would not participate in the chain the WHO Global Polio Eradicat io n Initiative is at the of transmission of wild (pathogenic) polioviruses. For threshold of achieving its goal of eradicating wild reasons that are not clearly understood, OPV "take" polioviruses. By mid-2006 polio has been elimin ated rates may be somewhat variable. Seroconversion rates from all countries other than India, Pakistan, after three doses of OPV average 73%, 90% and 70% Afghanstan, Nigeria, Niger and Egypt. For developing for Types I, II and III respectively. It is for this reason cou n t ries OPV is still the vaccine of choice for that multiple doses of OPV are necessary before eradicating wild poliovirus and would continu e t o be 90-95% of children develop immune responses to all used until wild poliovirus circulation ceases. However, three poliovirus typ es . IAP recommends at least 5 like any other vaccine its use is associated with certain routine doses of OPV, d u ring infancy and 2 more risks. repeat doses; at 16-18 months and 5 years. In addition to the routine OPV doses , " Pulse OPV doses" every OPV has been associated with occurrence of Vaccine Associat ed Paralytic Poliomyelitis (VAPP) Today, as year on Nat io n al Immunization Days (NIDs) and sub-National Immunization Days (sNIDs) until the age we move towards p o lio eradication, VAPP is more common than paralysis due to wild polioviruses and of 5 years are also mandatory. has, therefore, become an increasingly contentious Polio eradication is defined as no case of paralytic issue for all pediatricians . The risk of VAPP would poliomyelitis by wild polioviru s in last three calendar continue to be there as long as we are using OPV as the years along with absence of wild poliovirus in the preferred vaccine against poliomyelitis. It has been community, when excellent clinical and virological estimated that the global VAPP burden is in the range surveillance exists and the coverage of routine OPV is of 250-800 cases an nually. Nearly 50 cases of VAPP more than 80%. Polio elimination is defined as no case are reported to occur in India annually. Approximately of paralytic poliomyelitis by the wild poliovirus in one half of all VAPP cases are associated with the Type 2 calendar year with other criteria being the s ame as in OPV strain. eradication . A d eq u at e immu n izat io n , clinical The second major problem with u s e of OPV is the surveillance and appropriate virological investigations in all children with acute flaccid paralys is (AFP) are emergence of circulating Vaccine Derived Polio Viruses (cVDPVs), which are mutants that re-acquire the cornerstones of polio eradication. wild virus-like properties and have been associated with OPV should be stored at -200 C at the state and district outbreaks of paralytic polio. cVDPVs usually aris e in level and in the freezer at the clinic level. The vaccine communities with low population immunity especially 12
  • 13. when polio vaccine coverage rates decline but OPV use suggested that mass OPV campaigns should be continues. The duration and extent of spread of s ynchronized with the cessation of OPV use o n ce cVDPVs are dependent on the magnitude of the eradication of wild poliovirus has been achieved, so as immunity gap. As lo n g as OPV is in use it is t o eliminate the risk of VAPP and the emergence o f mandatory that very high immunization coverage is cVDPVs. At the same time, a gradual transition to IPV maintained so as to decrease the risk of emergence of should be encouraged. cVDPV. W hereas VAPP occurs in individual cases, cVDPV can result in large outbreaks. It has been Polio Eradication Why do we need pulse immunization against polio? • Maintaining high routine infant immunization coverage with OPV. Simultaneous administration OPV to all susceptible • Conducting mass campaigns (i.e. pulse infants and children interferes with circulation of wild immunization against polio). poliovirus in the community. It is, therefore, important • Development of sensitive surveillance. to ensure complete coverage with OPV during NIDs so • Organization of mop-up campaigns. that no wild poliovirus remains in circulation. Core strategies for eradication of polio include: Inactivated Polio Vaccine (IPV) IPV is formaldehyde killed poliovirus grown in monkey could be given at 4 weeks interval without any kidney cell/human diploid cells. Old IPV contained 20, compromise in the seroconversion rates. 8 and 32 D antigen units of types 1, 2 and 3 Scientifically and immunologically schedule of giving polioviruses respectively. All curren tly used IPV two doses of IPV starting at 2 months of age and given vaccines are enhanced potency IPV (elIPV) which at 2 months interval followed by a booster at around 15 cotains 40, 8 and 32 D antigen units of type 1, 2 and 3 mo n t h s is similar to a schedule of giving 3 doses respectively. Currently term IPV means eIPV. It is starting from 6 weeks of age and given at 4 weeks highly immunogenic. Seroconversion rates are 90-95% interval followed b y a booster at 15 months (even in after two doses given after the age of 2 months and at developing countries). However in our country the later 2 months interval and 99% after three doses given even schedule of 3 primary doses is better logistically as it when it is started at 6 weeks of age and given an 4 can be given along with DTP at 6, 10 and 14 weeks weeks interval It produces excellent humoral immunity followed b y a booster at 15 months. In any case the as well as local pharyngeal and, possible in testinal b irt h d o se of OPV must be given and all the OPV immunity. The vaccine is very safe. It is now licensed doses on the days of NIDs / SIAs should be given to all to be used in India by Drug controller of India. the children. IPV can be used in combination with DTwP and Hib As the number of wild poliovirus cases in the country vaccines without compromising seroconversion or decreases, it is inevitable that one would have to shift increasing side effects. Ideal age to give first dose of fro m OPV to IPV in the next few years. The IPV is 8 weeks an d the interval between two doses government sh o uld, therefore, consider incorporating should also be 8 weeks. However if 3 primary doses are IPV in the national immunization schedule in a phased given, vaccine could be started at 6 weeks of age and 13
  • 14. manner. IPV can also be an additional tool to eradicate rounds of SIAs using OPV. However in wild polio from last few high risk difficult districts. post-polio eradication era, it will be unethical and unsafe to reintroduce OPV in IPV is also the vaccine of choice in patients with such areas. It will force us to depend on the immunodeficiency and th e preferred vaccine in stocks of WHO or any such agency for OPV children with symptomatic HIV infection. vaccine should out-break of wild polio or cVDPP occur. Hence India should preempt Post-polio eradication scene and polio immunization: the emergence of cVDPV and has to become IA P believes that it will be unsafe and unethical t o self sufficient in stock-piling enough polio continue to use OPV in post-p o lio eradication era. vaccine now to meet any such unforeseen Following concept s should be kept in mind while eventuality in future. deciding India specific guidelines for post-polio 3. Looking at the above problems, IAP eradication immunization. recommends that India should switch over to IPV, preferably as IPV-DTP, in its routine 1. It will be unethical and unsafe to continue to immunization program gradually in use OPV after zero wild polio case and zero post-polio eradication era. India should transmission status is achieved due to risk of encourage indigenous manufacturer to VAPP following OPV. produce enough IPV so that it becomes 2. It will be unwise to discontinue use of polio affordable so that is will be possible to immunization altogether after zero polio switch to IPV in due course, looking at the status is achieved due to fear of cVDPV and huge requirement of the number of doses. iVDPV. Past experience from some countries has shown that countries which Adverse reactions - Th e vaccine is very safe. As IPV have eradicated wild polio virus and have contains trace amounts of streptomycin, neomycin and slackened in their routine polio polymyxin B, allerg ic reactions may be seen in immunization programs have experienced in d iv id u als wit h hypersen s it iv it y t o t h es e cVDPV outbreaks. These outbreaks of antimicrobials. cVDPV were curtailed by strengthening routine immunization and giving 2 or more DTPw Vaccine The combination of diphtheria t o xoid, tetanus toxoid induction of a neurological reaction in v ery rare and whole cell killed pertussis vaccine (DTPw) is instances; however, there has been no conclusive proof popularly known as the "triple antigen" DTP is the core for this and the vaccine should not be denied to vaccine in all childhood immunization services. It is children with seizure disorders or st ab le neurological one of the oldest combination vaccines and has been in conditions (e.g. Cerebral palsy, developmental delay). continuous use for more than 55 years. Tetanus an d The results of the National Childhood Encephalopathy diphtheria toxoids are adsorbed on insoluble aluminium Study (NCES) in the United Kingdom clearly show that salts which act as adjuvants and enhance the antitoxin there is no causal relationship between administration responses to both the antigens. While the two toxoids of DTPw vaccine and development of chronic are highly immunogenic (95-100%), the pertussis neurological disease in children. Convulsions following vaccine (even after 3 doses) has a protective efficacy of DTPw v accine are distinctly rare, and may only about 70-90% only. represent n o t h ing more sinister than fever triggered seizures. Progressive/evolving n eurological illnesses, Adverse reactions - Local (pain and redness) and however, are a relative contraindication to first dose of systemic (fever) side-effects of the DTPw vaccine are DTPw immunization. For children who develop almost entirely due to the pertussis component. Whole persistent inconsolable cry of more t h an 3 hours cell pertus s is vaccine has been incriminated in the 14
  • 15. duration, hyperpyrexia - fever > 40.50 C or hypotonic dose only then pertussis vaccine is contraindicated for - hypo responsive episode HHE (collapse/shock like future administration. stage) within 48 hours of DTPw admin is t ration, seizures with or without fever within 72 h ours of DTP and DT vaccines need to be stored at 2-80C. These vaccin es s hould never be frozen, and if frozen admin is tration of DTPw, the decision to administer further doses of DTPw should be carefully evaluated accidentally, it should be discarded. DTP must be injected intramuscularly and the preferred site is th e and discussed with the parents These events were regarded as absolute contraindications in the past. They anterolateral as p ect of the thigh. The IAP COI recommends 5 doses of DTP - three in infancy with two are now considered mere precaut ions because these boosters at 18 months and 5 years. The DTPw or DTPa events generally do not recur with the next dose and vaccines can be administered up to the age of 7 years. they have not been proven to cause permanent sequelae After the age of 7 years, Td should be given. If a similar adverse reaction recurs with the subsequent Acellular Pertussis Vaccine (DTPa) DTPa vaccines are of various types depending on the DTaP are contraindicated. Pertussis vaccine number of constituent components viz. two component should not be given in such cases and instead DTPa containing pertussis toxin (PT) and filamentous DT should be administered in the future. haemagglutinin (FHA); three co mponent DTPa • In case immediate anaphylaxis occurs after containing pertact in in addition to PT and FHA; five DTwP administration, further DTwP/DTPa component DTPa containing agglutinogens 2 and 3 in should be avoided because of uncertainty about which component of these vaccines has caused ad d ition to PT, FHA and pertactin. Though a five the reaction, as is true with any vaccine. component DTPa vaccine may be expected to elicit a more robust immune response as compared to two and The IAP COI unequivocally endorses the continued use three component DTPa vaccines, the overall efficacy of o f DTPw vaccine because of its proven efficacy an d DTPa vaccines is comparable to the DTPw vaccine. safety. DTPa Vaccine may u ndoubtedly have fewer Dose: 0.5 ml by intramuscular injection. minor side-effects (like fever, local reactions at injection site and irritability) but this minor advantage • If parents are not willing for DTPw can not justify the inord in at e costs involved in the administration after the adverse reaction with routine use of this vaccine. DTPa vaccines are also by the previous dose, DTaP can be recommended no means more effective than the whole cell pertussis in such circumstances as this vaccine is less vaccine. These are, therefore, not recommended for reactogenic. universal immunization in our country at present. • If encephalopathy (major alteration of sensorium or illness with seizures lasting > 24 There is, however, no bar to offering these vaccines to hours) occurs within 7 days of DTPw children from families who opt for the slight advantage administration, further doses of DTPw and of fewer minor side-effects. 15
  • 16. Tetanus Toxoid This vaccine contains Tetanus Toxoid 5 LF. It is a immunized, two doses of TT at least one month apart highly heat stable and effective vaccine. Bo o s t ers of should b e given during pregnancy so that protective this vaccine may be given at 10 and 16 years and antibodies in ad equate titers are transferred to the thereafter every 10 years. After completing the full newborn for prevention of neonataltetanus. The second course of seven doses, there is no need for additional dose of TT should be administered at least 2 weeks doses during pregnancy at least for the next 10 years. before delivery. A single dose of TT would suffice for Thereafter a single booster every 10 years wo u ld be subsequent pregnancies that occur in the next 5 years; s u fficient to extend immunity for another 10 years - thereafter, 2 doses of TT would again be necessary. For boosters should not be given more frequently than this. previously unimmunized schoo l age children, primary The practice of giving TT after every injury should be TT immunization consists of two doses given 4 weeks discouraged. apart. For pregnant women who have not been previously Tetanus Immunoglobulin (TIG) It is a liquid preparation containing immunoglobulins, Dose: for Prophylaxis: 250-500 IU IM. mainly IgG, obtained from the plasma of healthy Therapeutic: tetanus neonatorum: 500-1000 IU IM or donors. 250 IU intrathecal. In dications: Unimmunised or inadequately immunized In children and adults: 500-1000 IU IM and/or 250-500 individuals with burns, roadside injuries and compound IU intrathecal. fractures. Adverse reactions: Local pain, fever, flush in g , headache and chills may occur. Td Vaccine (Tetanus Toxoid, Reduced Dose Diphtheria) Td contains the usual dose of tetanus toxoid and only 2 words Td should replace TT boosters at 10 and 16 units of diphtheria toxoid. It is recommended for use in years). children above 7 years of age IAP COI recommends the routine use of Td at the age of 10 and 16 yrs (in other 16
  • 17. 17
  • 18. Measles Vaccine Measles vaccine used in our country is derived from the of virus within the body. This infection mimics wild live attenuated Edmon s t o n Zagreb strain grown in measles virus infection but is usually asymptomatic. human dip lo id cell culture. Other strains, which have Some children may develop a short lasting fever 7-10 been used for vaccination, include Schwarz, Moraten days after vaccination often accompanied by a macular and Edmonston B. It is supplied freeze-dried and has a rash. Paracetamol may be given to control/reduce fever. shelf life of 1-2 years, or even longer. The vaccine may Vaccinees do not shed the virus. be stored frozen or refrigerated. After reconstitution the Most infants are protected fro m measles by the vaccine is very heat-labile and should be used within 4 maternally acquired antibodies until about 6-8 months hours, wit h the unused vaccine being discarded. of life. If measles vaccine is given in t h e presence of Reconstituted vaccine should not be frozen . Measles measu rable titers of maternal antibody, the vaccine v accine does not contain any preservative, therefore efficacy may be reduced. In order to achieve t he best strict asepsis should be maintained while diluting and balance between these competing deman d s o f early aspirating contents from the multi-dose vial. Some protection and high seroconversion, completed 9 cases of staphylococcal sepsis/toxic shock syndrome months of age has been recommended as the associated with use of this vaccine have occurred from appropriate age for measles v accination in India. In bacterial contamination of the vaccine. The v accine case of an outbreak, however, the vaccine can be given should be injected subcutaneously, preferably over the to infants as young as 6 months with a recommendation upper arm / anterolateral thigh. for an additional MMR/Measles at 12-15 months. Being a live attenuated virus vaccine, it resu lt s in sub-clinical or attenuated infection and multiplication B. Vaccines Recommended Against Diseases Not Covered Under EPI MMR Vaccine Globally, most co u n t ries use MMR instead of single all children. It should als o b e given to all adolescent antigen measles vaccine. MMR vaccine contains 1000 g irls not previously immunized and to hospital staff TCID50 of measles, 5000 TCID50 of mu mp s and 1000 likely to come in contact with pregnant mothers. There TCID50 of ru b ella v iru s . It is administered is no upper age limit for this vaccine. It may be noted subcutaneously in the upper arm/anterolateral thigh. It that the states like Delhi, Goa h ave included and few is dispensed in single as well as multi-dose states like Tamilnadu, Mah arashtra, etc. are likely to formulations; the diluent is available separately. The include MMR in its universal immunization program. vaccine is given as a 0.5 ml dose. Measles and MMR For infants given measles vaccine at 9-12 months, vaccines are supplied in lyophilized formulation and MMR vaccine may be given between 15-18 months of should be frozen for long-term storage. In the clinic age. If measles vaccine was missed altogether in these vaccines can be stored between 2 to 8 0 C. Th e vaccines should be p rotected from light. Once infancy, one dose of MMR can be given at or after 12 months. The vaccine can be given along with other reconstituted, vaccine should be used within 4 hours. vaccines like DTP, OPV and Hib. The IAP COI recommend s administration of MMR to 18
  • 19. Mumps Vaccine The mumps component in MMR vaccine contains live Aseptic meningitis is known to occur following mumps attenuated mumps virus not less than 5000 TCID50 per vaccine, though the incidence quoted is as rare as 1 in dose. Vaccines are derived from Leningrad-Zagreb, 10,000 to 1 in 100,000 d o ses of vaccines used. The Jerryl Lynn, RIT 4385 or Urab e A M9 strains and are clinical s everity of the vaccine induced aseptic grown in chick embryo/human diploid cell cultures. meningitis is very mild and often may go unnoticed and Vaccinees do not shed the virus. There is no evidence all the cases recover without any permanent sequelae. that mumps vaccination is associated with development Hence all the mumps vaccines are equally safe. of either au t is m or Crohn's Disease. There is no Monovalent mumps vaccine or combination with difference in efficacy between various strains of mumps rubella as MR vaccine is not available in our country. vaccine. Rubella Vaccine Rubella vaccine currently available commercially is constituent of MMR) in young children through public derived from RA 27/3 vaccine strain grown in human health measure with sub-optimal coverage of the target diploid/chick embryo cell cultures. It is available population may be counter-productive as it may shift either as a monovalent vaccine as a part of the epidemiology of rubella to the rig h t with more combination vaccine - MMR. It contains live clinical cases occurring in young adu lt s leading to attenuated virus not less than 1000 TCID50. It is a paradoxical increase in cases of CRS. This has been highly immunogenic vaccine with seroconversion shown to occur using mathematical models. Direct rates of 95% It provides long term and probably life long protection; vaccine failures are uncommon. evidence from some Latin American countries als o Vaccinees do not shed the virus. corroborates these concerns. As a pediatrician one should be aware that rubella Normally use of rubella vaccine (monovalent or as a vaccination is mainly directed at preventing congenital constituent of MMR) in young ch ildren through rubella syndrome (CRS) and not at preventing rubella individual p ract itioners alone would not lead shift of infection per se, as the latter is usually benign an d epidemiology in adolescents and adults as the coverage inconsequential. By controlling the incidence of rubella of target populat io n is miniscule by private infections, CRS can be significantly reduced. There is practitioners In case MMR is incorporated in universal paucity of reliable data on occurrence of CRS in India. program and adequate coverage is not achieved, a shift On the basis of what ever information is available CRS in epidemiology of rubella is quite possible. Hence incidence is qu it e low in India. This is suggestive of MMR though a co s t effective vaccine should not be wide circulation of wild rubella virus in yo u n g introduced through public health facilities in areas children. Seroprevalence of ru bella antibodies in wh ere co v erag e fo r routine immunization is majority of pregnant women in few studies in India consistently less than 80%. support this view. Haphazard use of rubella vaccine (monovalent or as a 19
  • 20. Hepatitis B Vaccine In India, 1-4% of individuals are found to be chronic schedules: carriers of Hepatitis B Virus (HBV). Infection with 1. Birth, 1 and 6 months HBV may occur perinatally (v ertical transmission), 2. Birth, 6 and 14 weeks during early childhood (the so-called horizontal 3. 6, 10 and 14 weeks spread ), through sexual contact or nosocomially. It should be noted t h at in our country horizontal route Immunologically 0 - 1 - 6 months schedule of hepatitis (e.g. ch ild to child) route and the vertical route (i.e. B immunization has been most widely used and proven mother to child) are the major routes of transmission of to be ideal with high antibody titers at the end of the hepatitis B. v accination. However now that HB vaccination is Younger the age of acquisitio n of HBV infection, integrated into the existing immun ization program higher the chances of becoming a chronic carrier. It is (UIP) in India, d u e to operational issues at a national believed that as many as 90% of those who are infected level one has to piggy back on the available contacts for at birth go on to become chronic carriers. In fect ion routine immunization i.e. DTP wh ich is given at 6, 10 with HBV is one of the most important causes of and 14 weeks of age. At the same time birth dose has to chronic hepatitis, cirrhosis of liver and hep atocellular be given to cover for the vertical route. Hence IAP COI carcinoma. 30% of the chronic carriers go on to recommends 0 - 6 - 14 wks schedule for public develop chronic liver disease. These are all preventable measure. In case birth dose has been missed, 6 - 10- 14 by early childhood immunization. It is for this reason wks sched u le can be followed. In office practice, one that the World Health Organization has recommended can still use 0 - 6wks - 6 months schedule. As on now, u niversal Hepatitis B vaccination. As many as 150 from the d ata available, none of the above schedules countries have n ow included HBV in their national needs a booster. immunization sch ed u les . In Ju n e 2002, the Th e p urpose of Hepatitis B vaccination is to prevent Government of India also initiated the incorporation of chronic in fection and development of chronic liver HB vaccine as a univ ersal vaccine through a pilot disease / hepatocellular carcinoma later in life. An ideal program which will be scaled up in a phased manner. HB vaccine schedule should, therefore, address vertical HB v accine is a highly purified recombinant DNA as well as h orizontal modes of transmission of the vaccine produced in the yeast species Hansenula virus. polymorpha, Saccharomyces cerevisiae or Pichia Pregnant women should be counseled and encouraged pastoris. It is adjuvanted with aluminiu m salts and to opt for HBsAg screening. If the mother is known to should be stored at 2-80 C. The vaccine should not be be HBsAg negative, HB vaccine can be g iv en along frozen - if frozen accidentally, the it should be with DTP at 6, 10 and 14 weeks/6 months as there is no discarded. It should be injected intramuscularly in the special requirement to start vaccinat ion at birth itself. anterolat eral thigh. The usual pediatric dose (< 12 This 6-10-14 wks schedule may be easier to implement years o f ag e) is 0.5 ml corresponding to 10µg of the in the context of the national immunization program as antigenic component. Adult dose is twice the pediatric higher vaccination coverage may be achieved with dose. The vaccine is hig h ly immunogenic and earlier administration of vaccines. seroconversion rates are greater than 95% after a three dose schedule. Antibody titers greater than 10 mIU/ml If the mother's HBsAg stat u s is not known, it is are considered protective. The dose may be increased important that HB v accination should begin within a when vaccinating immunocompromized individuals few hours of birth so that perinatal transmission can be e.g. patients on chemotherapy for malignant conditions prevented. Any one of the following schedules may be or those with chronic ren al failure awaiting used for this purpose; birth, 6 and 14 weeks or birth, 6 hemodialysis. wks and 6 months. HB vaccine may be given in any of the follo win g If the mother is HBsAg positive (and especially HBeAg 20
  • 21. positive), the baby should be given Hepatitis B Immune after initial stabilization. Globulin (HBIG) within 24 hours of birth, along with For older children and adults the preferred schedule is HB vaccine (at birth, 6 and 14 weeks or birth, 6 weeks and 6months) using two separate syringes and separate 0, 1 and 6 months, '0' being the elected date for the first dose. sites for injection. If HBIG is not available (o r is unaffordable), HB vaccine may be given at 0, 1 and 2 In immunocompetent individuals HB vaccine induces months with an additional dose between 9-12 months. an effective immunological memory that lasts life-long and protects against symptomatic acute illness and It has been suggested by many authorities that in development of chronic HB infection on exposure to the infancy the third dose of HB vaccine should be given at virus. Boosters of HB vaccine are, therefore, not least 16 weeks after the firs t d ose & at least 8 weeks necessary under usual circumstances. after the second dose and not before 6 months of chronological age, as it presumably gives longer lasting HB vaccination is now being integrated into t he immunity. However this view is being challenged as existing immunization program in India. It was HB vaccine is a T-cell dependent vaccine, the titers at introduced in 15 cities an d 32 districts in the initial the end of immunization schedule may not be phase; selection of districts was based on achievement important so far as it is well above the protective level. of targets of 80% or more DTPw-3 coverage under There would occur anamnestic response with the titers routine immunization based on evaluation surveys. going up should there occur contact with th e v irus Under this program, the vaccine is being provided free again in future. As logistically, it is easier to combine of cost to infants living in u rb an slums. The program HB vaccine program with the DTP vaccine, it can be will be expanded to include additional cities and given in 0-6-14 weeks schedule too The vaccination districts within a certain timeframe. It is envisaged that schedule need not be changed for preterm and HB vaccination will be introd u ced in all districts of small-for-dates babies; in the case of extremely preterm India by 2007. babies, ho wev er, vaccination should commence only Hepatitis B Immunoglobulin (HBIG) HBIG provides immediate passive immunity and is Adverse Reactions: Transient, mild pain at the site of recommended in situations wherein there has been injection and itching may be seen in a small proportion acute expos u re t o HBsAg infected material e.g. by a of recipients. needle-stick injury. Clinical trials h ave demonstrated 90% reduction in risk of transmis s ion following such Special Precauti ons : HBIG should never be exposure if HBIG is used alon g wit h Hepatitis B administered intravenously. vaccine. HBIG does n o t interfere with antibody Dose: Adult s : 1000-2000 IU; Children:- 32-48 IU/kg response to simultaneous HB vaccine. It is for t h is bod y wt . This should be administered as soon as reason that individuals who have had recent accidental following exposure, preferably within 48 hours though exposure to hepatitis B virus should be given combined it can be administered even if the patient reports late up passive-active immunization. It is also useful in to 7 day s after exposure. Neonates: 100-200 IU. The prevention of mo t her to child transmission and first dose should be administered as soon as after birth transmission following sexual exp o s u re like in rape up to within 5 days of birth. An additional d o se of cases. Lastly HBIG is indicated in o ncology patients 32-48 IU/kg of body weight may also be given between who may not respond adequately to Hepatitis B vaccine 2-3 months after initial dose. as they are immune compromised follo win g the malignancy as well its therapy. 21
  • 22. Typhoid Vaccines Enteric fever is endemic in India and is a major public vaccine is available commercially. health problem. Th ree vaccines were available for clinical use till recently. However now only Vi typhoid The Whole Cell Inactivated Typhoid Vaccine (TA/TAB) Heat-killed, phenol-preserved or the acetone inactivated The vaccine appears to be protective through the lyophilized whole cell Salmonella t yphi vaccines were induction of antibodies against cell wall somatic (O) inexpensive products that have been in use in India for and flagellar (H) antigens- these antibodies can act as a long time. The p rotective efficacy of acetone a biological marker of the vaccine. It may interfere with inactivated preparation is more than that of the phenol the interpretation of the Widal test. It is effective even preserved vaccine but the former is more difficult to in child ren below 2 years of age and can be given to prepare and is associated with more side-effects. Both infants > 6 months of age Primary vaccination requires vaccin es contain Salmonella typhi 1000 million two d o s es , 4 o r more weeks apart, given organisms per ml. Protection begins 4 weeks after subcutaneously. Pediatric dose of the vaccine is 0.25 ml vaccination. Use of these vaccines may be associated in children aged 6 month s -10 years and 0.5 ml in with fever, local pain and malaise due to the endotoxins order children. The vaccine should be stored at 2-80 C. in bacterial cell wall. A pure S. typhi vaccine is less It should never be frozen. Revaccination is necessary reactogenic than the combined TA/TAB vaccines. The every 2-3 years to sustain an o ptimum immune vaccin e is very safe and is reasonably effective if response and should be done preferably before the onset revaccination can be carried out on a regular basis. The of summer. vaccine efficacy has been estimated to be 50-70% in a Unfortunately, this vaccine is not being manufactured meta-analysis of the randomized co ntrolled trials in India at present available. The Vi-Capsular Polysaccharide Vaccine Th e vaccine consists of purified Vi-cap s u lar polysaccharide vaccine as available in our country at polysaccharide, which during natural infection inhibits present. Cost of the vaccine though a limiting factor in p hagocytosis and serum bactericidal activity an d is past, is now reasonably priced. The vaccine is available responsible for virulence of the bacteria. It h as as an isotonic phenolated buffer solution; the dose is reasonable efficacy o f 50-60% in children and low 0.5 ml. containing 25µg of the polysaccharide. It can be reactogenicity. Protection begins within two weeks of given intramuscularly or subcutaneously. The vaccine vaccination and the biological marker is anti-Vi s h ould be stored at 2-80 C. It should never be frozen. antibodies. It is not very effective in children below two Adverse effects are mild and include pain and swelling years of age because it is an unconjugated at injection site. Oral Live Attenuated Ty21a Vaccine: 22
  • 23. Salmonella typhi Ty21a is a live attenuated strain with sittings, on alternate days. The capsule should never be a mutation in gal E gen e and lacks the enzyme op en ed before ingestion. Protection begins within a UDP-gal 4 epimerase. It is genetically stable and is not week after completion of the course and the protective known to revert to virulence. The efficacy has been efficacy is as good as other available typhoid vaccines. shown to 50-60% with the capsule form and near 90% Immunization needs to be repeated every 3-5 years with th e liquid form (not available commercially). It The vaccine should be stored at 2-80C. Antimicrobials provides protection by inducing local gut immunity but there is no biological marker of this vaccine. The active against S. Typhi should not be used 3 days before and 7 days after oral typhoid vaccine administration as vaccine is supplied in an enteric coated formulation as these may interfere with the v accin e "take". the bacteria are acid labile. It can be given to children Unfortunately this vaccine is also not available now in six years of age and above as the capsules have to be our country. swallowed intact. The vaccine is given on an empty stomach in three The efficacy of all typhoid vaccines at best is 50-70% Hib Conjugate Vaccines Haemophilus influenzae type b (Hib) is an important response after the third dose. On the other hand, invasive pathogen cau sing invasive diseases like PRP-OMP shows an increase in antibody level after the pneumonia, meningitis and bacteremia. Majority of first dose itself with only marginal increases after the cases occur in children below 2 years of ag e. Hib second and third doses. It is for this reason that while vaccination is given routinely in the d eveloped 3 doses of HbOC and PRP-T are recommended for countries for last many years. Countries with sensitive primary vaccination, only 2 doses of PRP-OMP are disease surveillan ce systems have shown significant recommended for this purpose. In spite of these declines in in v asive Hib disease following the apparent differences, these three vaccines when used in incorporation o f this vaccine in their national the recommended doses have similar efficacy. immunization programs. Recently published data of the The vaccination schedule for Hib consists of three doses Invasive Bacterial Infections Surveillance (IBIS) group when initiated below 6 months, 2 doses between 6-12 from six referral hospitals in India (Lancet, 2003) show months and 1 dose between 12-15 mon t h s , with a that Hib is a common cause of meningit is in our booster at 18 months. The interval between two doses country. should b e at least 4 weeks. If vaccination is delayed Hib capsular polysaccharide vaccine is a very effective until 15 months, a single dose may suffice. It is highly and safe vaccine. A number of PRP conjugate Hib efficacious vaccine, the protective efficacy being 95%. vaccines are available of which t wo are available in As Hib d isease is essentially confined to infants and India viz. HbOC (with CRM 197 mutant diph t h eria young children, the vaccine is not necessary for toxin as conjugate) and PRP-T (with tetanus toxoid as children above 5 years. Hib vaccine is stored at 2-80 C. conjugate). PRP-OMP (wit h meningococcal outer The IAP COI reco mmen d s use of Hib vaccine for all membrane protein as conjugate) is no t available in children . It is particularly recommended to be given India HbOC and PRP-T vaccines show only a marginal increase in antibody levels aft er the first dose with a p rior to splenectomy and in patients with sickle cell disease. marked increase after the secon d and even better 23
  • 24. C) Vaccines That Need to Be Given After Discussion With Parents Varicella Vaccine Chicken pox is usually a self limiting and generally are leaving h o me for studies in a residential b enign disease affecting mostly children and youn g school/college. It is indicated in children with chronic adults. Complications of varicella may be mo re lung/heart disease, humoral immunodeficiencies, HIV commonly seen in immunocompromised individuals, infection (but with C4 counts above 15% of the age adults and pregnant women. Takahashi et al developed related norms), leukemia (but in remission and off a live attenuated vaccine from the Oka strain in Japan chemotherapy for atleast 3-6 months) and those on long in the early seventies. The vaccine has been in clinical term salicylates/high dose lone t erm oral steroids. use in Japan since 1989 and in the United States since Varicella vaccin e is also recommended in household 1995. The vaccine can be administered to any healthy contacts of immunocompromised children. It may also individual above the age of 12 months who has not had be considered in children attendin g crèches and day varicella previously. care centers. When used for post-exposure prophylaxis it should be administered within 72 hours of varicella Varicella vaccines in use today are all derived from the exposure - it should be noted, however, that the efficacy original Oka strain but the virus contents may vary of the vaccine in preventing varicella under such from one manufacturer to anoth er. The recommended circumstances is not very clear. Varicella vaccine is dose is 0.5 ml and the minimum infectious virus also indicated in susceptible adolescents and adults if content should be 1000 Plaque Forming Units. The they are inmates of or working in the ins t itutional set vaccine is administered subcutaneously. A single dose up e.g. s ch o ol teachers, day care center workers, is sufficient b elo w 13 years of age, after which two military personnel and health care professionals. doses (at 4-8 weeks interval) are required. The vaccine is not recommended for ch ild ren below 12 months of The vaccine is stored at 2-80C and can be administered age. Though vaccine manufacturers recommend to use subcutaneously or intramuscularly. It should be this vaccine at 12 months, breakthrough infections can protected from light and needs to be used within 30 be less if used after 15 months of age. Hence IAP COI minutes of its reconstitution. recommends to use this vaccine after the age o f 15 months. It is a highly effective vaccine and protective Adverse reactions - It includes fever, vaccine ass o ciated rash, pain redness and swelling at immunity, humoral as well as cellular, develops in 95-99% individuals. The immunity appears to be long vaccination site. When used in adult females, pregnancy should be avoided for at least 4 weeks after lasting. vaccination. The IAP COI opines that varicella vaccine is not recommended fo r universal immunization in India at Varicella zoster immunoglobulin (VZIG) is used for passive post-exposure prophylaxis in immunodeficient present. One has to emphasize the generally benign nature of an d rarity of complications with varicella individuals who have been exposed to varicella or herpes zoster and are unlikely to have d et ectable infection in young children. It may be offered to children fro m h igh socio-economic strata of society antibody levels. It should be given to the neonate if the mother develops varicella 5 days before to 2 days after after explaining the pros and cons to the parents on a one-to-one "named child" basis. It may be prescribed to delivery. It has to be given by intramuscular injection adolescents who have not had varicella in past (or are and the dose is 125 units/10 kg body weight. known to be varicella IgG neg ative) especially if they 24
  • 25. Hepatitis A Vaccine Hepatitis A virus (HAV) infection is a relatively benign recommended for universal immunization in India at infection in young ch ildren as many of them have present. One has to emphasize the generally benign completely asymptomatic sub-clinical infection For nature of disease and very small number of children instance as many as 50% of children between 2-5 years developing complications with Hepatitis A infection in and 85% of those below 2 years who acquire HAV young children. It may be offered to children from high infection, may continue t o remain anicteric and may s o cio-economic strata of society after explaining the develop non-specific symptoms like any other viral pros and cons to the parents on a one-to one "named in fection. In adults hepatitis A is frequently child" basis. It may be prescribed to adolescents who symptomatic and mortality is much higher than in have not had viral hepatitis in past (or are known to be children. The disease severity increases irrespective of HAV-IgG negative), especially those who are leav ing age, in those with underlying chronic liver disease. home for further studies. It is recommended in all patients with chronic liver d isease (who are HAV Inactivated HA vaccines d eriv ed from HM 175/GBM seronegative) and family contacts of patients with strains and g ro wn on MRC5 human diploid cell lines chronic liver disease. It may be offered to household are now available. The virus is formalin inactivated and contacts of patients with acute HA virus infection - in adjuvanted with aluminimum hydroxide. It has been t h e latter case the vaccine must be given within 10 suggested that the vaccine can be used any time after days; however, it may not always be effective under 18 months of age when the maternally derived antibody such circumstances when the contact has had the same levels have declined; It is given in a two dose schedule, source of infection as the index patient. It may also be 6 months apart. The adult formulation should be used considered in children attending crèches and day care after t h e recommended cut-off age of 15 years centers and in travelers from abroad (e.g. non-resident according to one manufacturer and 18 years according Indians) visiting endemic areas. to the other The vaccine is given intramuscularly and the protective efficacy is 94-100% Immunity appears to The vaccine is stored at 2-80C. be long lasting and boosters are not recommended at present. Adverse reactions: It includes local pain and local induration. The IAP COI o p ines that HA vaccine is not Pneumococcal Vaccines Streptococcus pneumoniae is a common cau s e of infections. The common pathogenic stereotypes invasive bacterial diseases responsible for a significant reported in children in Western countries are 1, 4, 5, 6, proportion of potentially fatal con d it io n s like 9, 11, 14, 15, 18, 19 and 23. It appears that the pneumonia and meningitis in children. It also leads to serotypes causing invasive disease in developed conditions like otitis media and sinusitis, which may countries are different from the ones which are found have morbidity but little or no mortality. In developing in developing countries. According to results of the countries, this organism is believ ed to be the Invasive Bacterial Infection Surveillance (IBIS) study, commonest cause of bacterial pneumonia. Peak the common serotypes responsible for invasive disease incidence of pneumococcal disease is between 2 to 24 in children below five y ears of age in India include 6, months of age. Based on the capsular polysaccharide 1, 19, 14, 4, 5 and 7. Serotypes 1& 5 accounted for antigen, p neumococci are classified into 85 different 29% of disease in India. Thou g h prevalence of serotypes. Of these, about 10 serotypes account for most penicillin resistance is almost negligible at present 25
  • 26. there is some evidence that the prevalence of resistance invasive pneumococcal disease caused by the serotypes to penicillin amongst the p neumococci may be covered by the vaccine. The dose is 0.5 ml. and the gradually increasing, thereby highlighting the need for vaccine is given intramu scularly. Pneumococcal an effective vaccine. vaccines are s tored at 2- 80 C. Conjugate vaccine should not be frozen. Two types of pneumococcal vaccines are currently available - the 23-valent unconjugated polysaccharide Since the introdu ct io n of PCV-7 in the childhood v accine and the 7-valent conjugate polysaccaharide vaccine schedule in US, there has been a dramatic vaccine. Immunity is serotype specific. reduction in the in cidence of invasive pneumococcal disease not only in the children who are vaccinated but The 23-valent polysaccharide vaccine contains the also non-vaccinated young children in their contact and following serotypes - 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, a milder but statistically sign ificant decrease in 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, invasive disease in their adult contacts, suggesting 23F, 33F. It is capable of preventing almo s t 85% of s trong herd effect. Similar herd effect was seen in the in vasive disease (pneumonia, men in g it is an d form of overall reduction in the disease caused by drug bacteremia) caused by pneumococci. Immunization, resistant serotypes in the community. Though there has however, is not effective for prevention of otitis media. been replacement of t h e vaccine serotypes by Each dose is 05 ml containing 25ug polysaccharide of non-vaccine serotypes in the nasal carriage studies, each of the 23 serotypes co n tained in the vaccines. fortunately this has not been seen significantly in the However, as it is an unconjugated polysaccharide invasive diseases studies. However there is a need for vaccine it does not result in immunological memory. continuous surveillance for the serotype involved in This vaccine is poorly immunogenic in children below invasive cases from time to time. two years of age i.e. children who are at highest risk of invasive disease. The dose is 0.5 ml and the vaccine is Healthy children: Th e IAP COI does not recommend given intramuscularly or subcutaneously. This vaccine u s e o f this vaccine for universal immunization in our may be us ed in h igh-risk groups above the age of 2 country at present. PCV - 7 covers approximately 50 to years. Revaccination is recommended after 5 years. It 55% percent of pneumococcal serotypes responsible for is recommended for children with asplenia, sickle cell invasive pneumococcal disease in India offering about d isease and nephrotic syndrome. It is als o 50 to 55% protection in infants & ch ild ren in India. recommen d ed for HIV infected children. It may be The vaccine may be offered to healthy children above offered to those with underlying chronic illnesses like the age of 6 weeks t ill 2 years after explaining the renal diseases, cardiovascular diseases or diabetes. parents on one to one "named child" basis. The heptavalent conjugate vaccine (PCV-7) contains High risk group: There are certain children who are at the following sero t y p es -4, 6B, 9V, 14, 18C, 19F, and high risk of severe invasive pneumococcal disease with 23F. It is coupled with a non-toxic variant of diphtheria high mortality. This includes children with Sickle cell toxin (CRM197) and has aluminium phosphate as the d is eas e, as p len ia, primary immu n o d eficien cy adjuvant. Conjugation of polysaccharide with protein s y n d ro me s , H I V, c h i l d r e n w i t h s ev ere CRM197 makes it immunogenic below 2 years of age. cardio-respiratory illness and children with chro nic In February 2000 this vaccine (PCV-7 Prevnar) was illn es ses like renal diseases, diabetes etc., nephrotic licensed in US fo r ad ministration to children below 5 syndrome, cerebrospinal fluid rhinorrhea etc. For such yrs of age. The development of this v accine was children IAP COI recommends age appropriate doses prompted by the observation that young children below of 7 valent conjugated pneumococcal vaccine routinely 2yrs of age are dis p ro p ortionately affected by the till 5 years of age. For children above 2 years, a dose of serious pneumococcal infection and recognition of the 23 valent unconjugated pneumococcal vaccine is also fact that available 23 valent polysaccharide vaccine was recommended to be given after one priming dose of non immunogenic in t h is age group 2 yrs. Conjugate conjugated vaccine. vaccine is used in a 3-dose schedule in infancy at 4-8 weeks interval followed by a booster at 15-18 months of Adverse reactions - Injection site so reness, malaise, age and has protective efficacy of 95-99% ag ain st low grade fever. 26
  • 27. D. Vaccines Used in Special Circumstances Meningococcal Vaccines Neisseria meningitides accounts for 30-40% cases of memory. The group C, Y, and W135 components, meningitis in children up to the age 15 years. It is the moreover, are not very immunogenic in children below only bacterium capable of causing large scale epidemics 2 years of age. Meningococcal group C conjug at e of meningitis. There are 12 kn o wn serogroups but vaccine, on the other hand, is efficacious even in the majority of the disease causing is o lat es belong to youngest children. serogroups A, B, C, Y and W135. Epidemic disease is Meningococcal vaccine is indicated fo r use (as an typically associated with type A (occasionally type C) adjunct along with chemoprophylaxis) in close contacts and usually occurs in cycles every 7-14 years, especially of patients with t h e d isease. It may be considered in in the African meningitis belt which extends acro s s child ren with complement deficiency, prior to A frica from Senegal to Ethiopia. In India also almo s t splenectomy and those asplenia and sickle cell anemia. all epidemics were of type A Such group A epidemics It is also recommended during disease outbreaks are usually due to a single strain of the pathogen. Some (caused by serogroups included in the vaccine) and of the recent outbreaks in Western Asia have been due prior to travel to the high endemicity meningococcal to W135. En d emic disease occurs worldwide and is belt in the African continent. Meningococcal vaccine is mostly caused by serogroups B, A, or C although group mandatory for all Haj pilgrims and is necessary for Y has been increasingly incriminated in recent reports. residential students in some of the universities abroad. In India endemic cases are mainly due to type B. As a rule, endemic disease occurs primarily in children and The IAP COI does not recommen d t h is vaccine for adolescents, with highest attack rates in infants aged universal immunization in our country at present. It 3-12 months. Severe meningococcal disease occurs can be given to children ab ove 2 years of age during p rimarily in children and adolescents, with highest disease epidemic and is administered subcutaneously or attack rates in infants aged 3-12 months. Severe intramuscularly. In special circumstances (e.g. during meningococcal disease is associated with high group A epidemic to close household contacts , close case-fat ality rates (5-15%) even where adequate household contact) it may be offered to even younger medical facilities are available. Chemoprophylactic infants but the protective efficacy is likely to be low in measures are in general insufficient for t he control of this age group. The dose is 0.5 ml. Revaccination may this disease because secondary cases comprise only 1-2 be considered after 3-5 years if the individual is still at % of all meningococcal cases. risk. The vaccine is stored at 2-80C. Immu n ity following meningococcal infection is A conjugate meningococcal serogroup C vaccine has s erogroup specific. Unconjugated meningococcal been part of ro u t in e immunization in the United vaccines are based on combinations of group-specific Kingdom since Novemer 1999 as it is t h e commonest capsular polysaccharides - either bivalent (A and C) or cause of meningococcal disease in children there - three tetrav alent (A, C, Y and 135). The recommended doses are g iven at 4-8 weeks interval along with the single dose of the reconstituted vaccine contains 50 µg routine childhood immunizations. Two doses of the of each of the individual polysaccharides. A conjugate vaccine suffice for children in age group 6-12 months group C vaccine has also been marketed in developed and one dose in older children. countries. Adverse reactions - Fever and pain at injection site. Unconjugated meningococcal vaccines, like all other polysaccharide vaccines, do not induce immunological 27
  • 28. Japanese Encephalitis Vaccines Japanese encephalitis (JE) is one of the most important vaccine has been given up. causes of viral encephalitis in Asia. In India, JE is believed to be responsible for approximately 2000-3000 Cell culture derived live SA-14-14-2 vaccine clinical cases and 500-600 deaths every year. As there is no anti-viral drug treatment, JE vaccination remains Th is v accine is based on a stable neuro-attenuated the single most important control measure. Contrary to strain of JE virus (SA-14-14-2). It was firs licensed for popular belief JE vaccine should n ot be used as an use in 1988 in People's Republic of Ch in a and over "outbreak response vaccine" It should rather be given sixty million doses per year are being used there. Now to all children 1-15 y ears of age living in highly it is also licensed for use in Nepal, S. Korea and India endemic areas (e.g. Andhra Pradesh, Ut t ar Pradesh, This live attenuated vaccine constitutes to over 50% of Karnataka). The vaccine may also be offered to visitors global production of all JE vaccine. Dose is 0.5ml at all to endemic areas if the duration of stay is likely to ages. It is given by subcutaneous route. Initial studies exceed four weeks. done on this vaccine demonstrated an efficacy of about 80% with single dose and 98% with 2 doses. However, Currently three types of JE vaccines are available e.g. more recent studies have shown efficacy reaching 99% (a) mouse brain-derived and inactivated Nakayama even with single dose. As per a WHO report no serious Strain vaccine (b) cell culture-derived inactivated adverse effects (other than anaphylaxis) have been vaccine and (c) cell culture-derived live attenu at ed reported over 20-y ear period (1979 - 1998). This vaccine. vaccine is not available in commercial market in India, however it has been used for public health by Govt. of Mouse Brain-Derived Inactivated JE Vaccine India in 2006. This vaccine is produced in In d ia at the Central Use of Sa-14-14-2 live JE vaccine in India in 2006: Research Institute, Kasauli. Commercially available Recognizing the need to control JE in high ly endemic vaccine is imported. It is given subcutaneously - 0.5 ml districts, GOI has initiated a pilot project of in ch ildren 1-3 years, and 1 ml in older children. immunizing children from h y perendemic districts Primary immunization consists of three doses given on against JE in 2006. 7 d is t rict s in UP, 2 in Assam and 0, 7 and 30 days - 0 being the elected date. A booster one each in West Bengal and Karnataka were targeted dose is recommended after 1 year and subsequently at this year. SA-14-14-2 live JE vaccine was used three year intervals. man ufactured by Chengdu institute of Biological Products, Chengdu, China. It was given in a campaign Adverse reactions: Include fever, malaise, local mode to children aged 1-15 years. It was g iven as tenderness and redness in 20% of recipients. In recent single dose subcutaneously usin g A D syringe. The years, several cases of acute encephalitis temporally whole campaign was carried out from 15th May to 15th linked to JE vaccinat ion have also been reported. July 2006. 11 million children were target ed as Anap h y lactic reactions are known to occur with this b eneficiaries and 9 million children actually received vaccine. This vaccine was also produced by s o me the vaccine i.e. nearly 86% of the target was achieved. international vaccine manufacturers like A ventis UP recorded 96% coverag e ag ainst all expectations. Pasteur (now Sanoffi Aventis), however they have There were 504 adverse effects following the campaign stopped manufacturing of this vaccine recently and are of which 482 were minor adverse effects. 22 deaths trying to switch over to vero cell cultured vaccine. were reported but none were causally related to the vaccine as cleared by an expert committee set up to Inactivated Primary Hamster Kidney Cell derived monitor the adverse effects. Based on the success and safety of this year, similar campaign is planned for Vaccine ot h er areas in coming years. From next year this This vaccine made from Primary Hamster Kidney cell vaccine will be included in the routine immunization line was used in China in millions o f doses. However schedule for the new birth cohorts in these areas. with the availability of the Sa-14-14-2 live vaccine, this 28
  • 29. Influenza Vaccine Influenza virus is an ortho my xovirus. There are three Vaccines elicit a relatively strain-specific humoral antigenic types (A, B and C) with several subtypes of response, have reduced efficacy against antigenically each based on two surface an t ig ens - hemagglutinin drifted viruses and are ineffective against unrelated and neuraminidase Influenza virus, especially type A, strains. The influenza vaccine is therefore unique as the is characterized by frequent mutations - antigenic drifts precise composition has to be changed periodically in and antig en ic shifts. It is of the utmost importance, anticipation of the prevalent influenza strain expected therefore, that the vaccine should incorporate t h e to circulate in a given year. The vaccine is effective for current strain p revalent during that time. Current only a short period, usually 6 month s to 1 year and a inactivated influenza vaccines are produced from virus new vaccine is brought every year. The WHO reviews grown in emb ryonated hen's eggs, and are of three vaccine composition biannually and updates antigenic types : wh o le v iru s , s p lit -p ro d u ct , s u b unit content depen d ing on prevalent circulating subtypes surface-antigen formulations. Whole-virus vaccines are based on the data obtained from its chain of reference associated with increased adverse reactions, especially laboratories from world over to provide antigenically in children, and are currently not used. Most influenza well-matched vaccines. vaccines are split-product vaccines, p roduced from Influenza vaccine is highly immu n ogenic and is detergent treat ed , highly purified influenza virus, or associated with minimal side effects. When used for the s u rface-an t ig en v accin es containing purified first time the vaccine is given in 2 doses in children 6 hemagglutinin and neuraminidase. months to 8 years of age; only one dose is sufficient Vaccines are usually trivalent, containing 15 µg each of above 8 years. Revaccination is d o ne with a single two influen za A subtypes (H1N1 and H3N2) and one annual dose, which is given before the peak influenza influenza B strain. The present vaccine contains 15 µg season. The vaccine is administered intramuscularly, of hemagglutinin o f each of the three WHO the dose being 0.25 ml. in ch ildren below three years reco mmended strains (Northern Hemisphere) for the and 0.5 ml thereafter. This vaccine is cu rrently season 2004-2005. recommended for u s e only in high-risk children and adolescents e.g . individuals with chronic pulmonary 1) A/New Caledonia/20/99 (H1N1) like strain [variant an d card iac d is eas e, s ickle cell d is eas e, A/New Caledonia/20/99 (IVR - 116)]; immunodeficiency, HIV infection, s y s temic lupus 2) A/Fujian/411/2002 (H3N2) - like strain [varian t erythematosus, diabetes mellitus and t h o se on long A/Wyoming/3/2003 (X-147)]; term aspirin therapy. Influenza vaccine is also recommended to be giv en for severe cases of asthma 3) B/ Sh anghai/361/2002 - like strain [variant who need oral corticosteroids frequently. B/Jingsu/10/2003]. 29
  • 30. Combination Vaccines A combination vaccine consists of two or more separate immunogens that have been physically combined in a single preparation. These immunogens may pertain to Current status of new combination vaccines the many antigens/ serotypes of the given pat h o g en (e.g. poliovirus vaccines) or of multiple pathogens (e.g. DTP v accine). This concept differs from that of Already developed simultaneous vaccines, which, although ad ministered concurrently, are physically separate. The combining of DTPw + Hib multiple related o r unrelated antigens into a single DTPw + Hepatits B vaccine is not a new concept. The first combination vaccine was trivalent influenza vaccine, which was DTPw + IPV developed as far back as 1945. This was followed by DTPw + IPV + Hib hexavalent pneumococcal vaccine in 1947 and DTP vaccine in 1948. Combination vaccines in common use DTPw + Hib + Hepatits B include diphtheria and tetanus toxoid, available alone (DT, dT) or with pertussis vaccine (DTP); inactivated DTPw + Hib + IPV (IPV) or live oral (OPV) trivalent polio vaccine and DTPw + IPV MMR vaccine. DTPa + IPV The number of vaccines in the immunization schedule is increasing every year with the result that these DTPa + Hib schedules are getting increasingly more complex. Many DTPa + Hib + Hepatits B + IPV parents opt for one single injection of combination vaccines at a given visit, rather than g etting a large Hepatitis A + Hepatitis B number of simultaneous injections. Use of combination vaccines is also likely to result in logistic advantages - MMR + Varicella reduced burden on the cold chain and reduced storage requirements and syringes/needles apart from easier record keeping. A number of combination vaccines are Under development now available in the Indian market. The IA P COI DTPa + Hib + IPV + Hepatitis B + Hepatitis A endorses the use of combination vaccines, but with the following cautionary statements: • The manufacturer's recommendations should Available for use in India be adhered to strictly • “Mixing" of vaccines in the same syringe (prior DTPw + Hib to injection) should not be done as far as DTPw + HB possible, unless specifically recommended by the manufacturer; in the latter case the DTPw + Hib + HB manufacturer's instructions should be followed strictly. DTPa + Hib • Combination vaccines should not be viewed as being more effective than vaccines given HA + HB separately. 30
  • 31. Rabies Vaccines The disease is caused by a single stranded RNA virus severe b it es or bites in the upper extremities, trunk, belonging to the family Rhabdoviridae. It is almost head and face (wound category 3). Intramuscular always fat al. Rab ies is caused by the bite of a rabid injection of RIG is not recommended. The dose of animal, which is usually a dog in our country. human rabies immunoglobulin (HRIG) is 20 U/kg Scratches or licks on mucous membranes by affected while that of equine rabies immunoglobulin (ERIG) is animals have also been kn o wn to transmit the virus. 40 U/kg. Skin testing is recommended before using The incubation period averages 4-6 weeks but can be ERIG but is not n ecessary when using HRIG. Any very variable and may range from five days to more suturing of wound should be avoided. When suturing is than one year. Rabies is endemic in our country - India unavoid ab le for purpose of hemostasis, it must be accounts for almost 50% of mortality in the world insured that RIG has been infiltrated in the wound prior to suturing. There are two types of vaccines available in India Rabies vaccine is administered intramuscularly in Modern tissue culture vaccines (MTCV) anterolateral thigh on days 0, 3, 7, 14 and 30 as per the Essen protocol, with day '0' being the day of • Purified Chick Embryo Cell (PCEC) vaccine - commencement of vaccination. A sixth dose on day 90 1 ml per dose. is optional and may be offered to patients with severe • Human Diploid Cell Vaccine (HDCV) - 1 ml debility or those who are immunosuppressed. Children per dose. are given the same dose as ad ults. Rabies vaccine • Purified Vero Cell Vaccine (PVRV) - 0.5 ml should never be injected in the gluteal region. per dose. Several other schedules of rabies vaccination have been • Purified Duck Embryo Vaccine (PDEV) - 1 ml proposed. These include the 2-1-1 intramuscular per dose. schedule (Zagreb schedule) - two IM doses on day 1, one IM dose on day 7 and one IM dose on day 21; the All tissue culture vaccines have almost equal efficacy 2-2-2-1-1 intrad ermal schedule (Thai Red Cross and any one of these can be used. TRC-ID schedule) in which two ID doses are given on days 1, 3 and 7, followed by one ID dose o n days 30 and 90 - ID dose is 1/5th the IM d o s e; the 8-4-1-1 Nerve tissue vaccine intradermal schedule (Oxford schedule) - 0.1 ml of This is no longer recommended because of its poor PCEC vaccine is given ID at eight sites on day 0, at efficacy and life threatening adverse effects in the form four sites on day 7 and at one site only on days 30 and of neuroparalytic reactions. 90. The intradermal schedules have the obviou s advantage of being inexpensive and have b een used Post exposure prophylaxis successfully in Thailand, Philippines and Sri Lanka. In order to remove as much of the rabies virus as Based on the recommendations of the expert group as possible, immediately cleanse the wound with soap and well as WHO, the Drug Controller General of India flush thoroughly under running water for 10 minutes . (DCGI) has recently decided to allow ID route Then treat with 70% alcohol or tincture iodine or administration o f tissue culture based anti rabies povidone iodine. Rabies immunoglobulin (RIG) should vaccine fo r post exposure prophylaxis in a phased be infiltrated in and around the wo u n d in case of all manner. The following schedules as recommended by Day of Vaccination D0 D3 D7 D14 D28 D90 Thai Red Cross Regime 2 2 2 0 1 1 Updated TRC Regime 2 2 2 0 2 0 31
  • 32. 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 Rabies Immunoglobulin (RIG) (Senofi Pasteur) and purified chick embryo cell vaccine There are 2 types of RIG: (Chiron Behring). The unit dose of 0.1ml for ID should have at leas t 0.25 units. The criteria for selection of (1) Human rabies immunoglobulin (HRIG - do s e is 20 Antirabies centre for ID use are U/kg body weight) • Attendance of minimum 50 patient per day for (2) Equine rab ies immunoglobulin (ERIG - dose is 40 post exposure prophylaxis U/kg body weight). • Have adequately trained staff to give ID RIG is indicated in all cases of category three wounds inoculation where it should be infiltrated thoroughly into and • Can maintain cold chain and ensure adequate around the wound. The remaining part if an y is to be supply of disposable syringes and needles. injected IM into the deltoid region or anterolateral aspect of thigh away from the sit e o f vaccine This ID administration is not recommended in individu al practice. Also it does not make economic administration to avoid vaccine neutralization. It contains specific an t irabies antibodies that neutralize sense to practice it for individual cases. the rabies virus and provide passive protection. In case RIG dos e (q uantity) is insufficient for adequate Pre-exposure prophylaxis infiltration of extensive or multiple wound, it may be Pre-exposure prophylaxis became a reality only after diluted with equal volume of normal saline so th at all the availability of MTCVs. This should be offered to the wounds can be thoroughly infiltrated. in d iv iduals in high risk occupations (e.g. veterinary If RIG could not be given when antirabies vaccination surgeons, wildlife workers, dog breeders, postmen). was began , it should be administered as early as Any of the tissue culture vaccines can be given for this possible but no later than the seventh day after the first purpose - three doses are given intramuscularly on days dose of vaccine was given. From the eight day onwards, 0, 7 and 28. A booster is given one year after primary RIG is not indicated since an antibody response to the immunization and every five years thereafter. vaccine is presumed to have occurred. The vaccine is stored at 2-80C. Side-effects include HRIG is a liquid or freeze-dried preparation containing local pain and induration. immunoglobulins (mainly IgG) and is obtained from For Re-Exposure after completed (and documented) pre the p las ma of donors immunized against. In case of or post exposure prophylaxis two doses are given o n ERIG, skin testing is recommended prior to use. days 0 and 3. Antirabies antibody titers > 0.5 IU/ml are Adverse reactions: Tenderness/stiffness at t h e considered protective. injection site, low grade fever; sensitization may occur after repeated injections. 32
  • 33. WHO Recommendations for Management of Animal Bites Type of contact with suspected Category or confirmed domestic or wild Recommended treatment animals* or animal unavailable for observation I Touching or feeding of animals, None if reliable case history is licks on intact skin available II Nibbling of uncovered skin, Administer vaccine immediately minor scratches or abrasions Stop treatment if animal without bleeding, licks on remains healthy throughout an broken skin observation period of 10 days, or, if the animal is euthanised and found to be negative for rabies by appropriate laboratory technique III Single or multiple transdermal Administer rabies bites or scratches, contamination immunoglobulins and vaccine of mucous membrane with saliva immediately Stop treatment if (i.e., licks) animal remains healthy throughout an observation period of 10 days, or, if the animal is euthanised and found to be negative for rabies by appropriate laboratory technique 33
  • 34. IAP Immunization Time Table Age Vaccine Birth BCG, OPV0 , Hepatitis B1 6 weeks DTPw1 / DTPa1 , OPV1, Hepatitis B2, Hib1 10 weeks DTPw2 / DTPa2 , OPV2, Hib2 14 weeks DTPw3 / DTPa3 , OPV3, Hepatitis B3 *, Hib3 9 months Measles 15- 18 months DTPw B1 / DTPa B1, OPV B1 , Hib B1 , MMR 2 years Typhoid+ 5 years DTPw B2 / DTPa B2, OPV B2 10 years Td# / TT 16 years 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 Varicella vaccine# More than 18 months Hepatitis A vaccine+ More than 6 weeks Pneumococcal conjugate vaccine* # Below 13 years of age one dose, over 13 years of age 2 doses at 4-8 weeks interval + 2 doses at 6- 12 months interval * 3 primary doses at 6, 10, and 14 weeks, followed by a booster dose at 15 months 34
  • 35. It should be noted that the IAP Immunization HB vaccine can be given along with DTP at 6, Time-Table is, in effect, the 'Best Individual 10, 14 weeks/ 6 months. If the mother's HBsAg Practices' schedule for a given child and may be status is not known, it is advisable to start somewhat different from the National Immunization vaccination soon after birth to prevent perinatal Schedule. This is because of the fact that the former transmission of the disease. If the mother is is meant to be used for an individual, rather than for HBsAg positive (and especially HBeAg the pediatric community as public health measure at positive), the baby should be given Hepatitis B large The two schedules are, however, not in conflict Immune Globulin (HBIG) within 24 hours of with each other. Also, as pediatricians we must be birth, along with HB vaccine. conscious of the fact that the immunization needs of 3. For Non EPI and Newer Vaccines, Varicella, children in a country are quite dynamic - a vaccine Hepatitis A and Congujate Pneumococcal which may not be considered important today may vaccines should be offered only after one to one become necessary in future as more information discussion with parents. Also refer to the about the epidemiology of the disease becomes individual vaccines notes for recommendations. available. Further, in developing countries 4. Combination vaccines can be used to decrease affordability of the vaccines is a critical issue and any the number of pricks being given to the baby decision on incorporation of a new vaccine in the and to decrease the number of clinic visits. The immunization schedule has to take this fact into manufacture's instructions should be followed consideration. The IAP COI has based its strictly whenever "mixing" vaccines in the recommendations based on the best available same syringe prior to injection. evidence at present. It is heartening to note that some 5. At present, the only typhoid vaccine available of the recommendations of the IAP COI in the past in our country is the Vi Polysaccharide vaccine. have been instrumental in changing governmental Revaccination may be carried out every 3-4 policies and also the immunization schedules being years. followed by some states. 6. Under special circumstances (e.g. epidemics), measles vaccine may be given earlier than 9 Notes on the Time Table months followed by MMR at 12-15 months. 1. The IAP endorses the continued use of whole 7. During pregnancy, the interval between the two cell pertussis vaccine because of its proven doses of TT should be at least one month. efficacy and safety. Acellular pertussis vaccines 8. Continue using OPV till we eradicate polio in may undoubtedly have fewer side-effects (like our country. IPV can be used additionally for fever, local reactions at injection site and individual protection. irritability), but this minor advantage does not 9. OPV must be given to children < 5 years of age justify the inordinate cost involved in the at the time of each supplementary routine use of this vaccine. immunization activity. 2. If the mother is known to be HBsAg negative, 35
  • 36. Immunization in Special Circumstances Immunization in preterm infants In general, all vaccines may be administered as per Very low birth weight / preterm babies can be given schedule according to the choronological age immunizations after initial stabilization. irrespective of birth weight or period of gestation. Children receiving corticosteroids Children receiving oral corticosteroids in high doses Killed vaccines are safe but may be incompletely (e.g. Prednisolone 1-2 mg/kg/day) for more than 14 effective in such situations. Patients on topical or days should not receive live virus vaccines until the inhaled steroid therapy should not be denied their age steroid has been discontinued for at least one month. appropriate vaccines. Children awaiting splenectomy Children with loss of splenic function are at high risk with pnueumococcal, Hib and meninggococcal of serious infections with encapsulated organisms. If vaccines should be initiated a few weeks prior to surgical splenectomy is being planned, immunization splenectomy. Vaccination in children in children with HIV infection Children infected by HIV are particularly vulnerable attrition associated with viral replication may to severe, recurrent, or unusual infections by vaccine particularly interfere with memory responses. preventable pathogens. It must be emphasized that Consideration should be given to readministering routine immunizations seem to be generally safe in childhood immunizations to such children when their such children, but the immune response following immune status has improved following anti-retroviral vaccination would depend upon the degree of therapy. immunodeficiency at that point of time. Immune 36
  • 37. IAP Recommendations for Immunization of HIV Infected Children Vaccine Asymptomatic HIV Infection Symptomatic HIV Infection BCG Yes (at birth) No DTPw / DTPa Yes (at 6, 10, 14 weeks) Yes OPV Yes (at 6, 10, 14 weeks) Yes / IPV Measles Yes (at 6 and 9 weeks) Yes MMR Yes Yes (CD4% >15%) Hepatitis B Yes (as for uninfected Yes (double each dose) children) Hib Yes Yes Typhoid Vi Yes Yes Pneumococcal Yes Yes Influenza Yes ( > 6 months of age) Yes Varicella Yes (2 doses at 6-8 weeks Yes (2 doses at 6-8 weeks interval) interval, CD4% > 15%) Hepatitis A Yes Yes Vaccination schedule for children not immunized in time It may be noted that vaccination catch-up regimens table depicts the suggested schedule which may be may be difficult to construct for older children and followed in cases of children who have not been must necessarily de individualized. The following offered any immunization. 37
  • 38. Vaccination Schedule for an Unimmunized Child Age Less than 7 years More than 7 years First visiit BCG*, OPV* , DTPw / DTPa, Td, HB HB Second visit (one month later) OPV*, DTPw / DTPa, HB Td, HB Third visit (one month later) Measles / MMR, Typhoid MMR, Typhoid Fourth visit (6 months after first DTPw / DTPa, HB HB visit) Every 3 years Typhoid Typhoid * OPV and BCG recommended up to 5 years of age. ** 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. However it is preferable to give it at a later visit if pat ient compliance is not a problem. Lapsed immunization There is no need to restart a vaccine series regardless scheduled should be completed at the next available of the time that has elapsed between individual doses. opportunity. In case of unknown or uncertain Immunizations should be given at the next visit as if immunization status, however, it is appropriate to the usual interval had elapsed and the immunization start the schedule as for an unimmunized child. Missed opportunity for immunization This is defined as a situation when a child visits a contradictions to immunization. Any dose not given health care facility and is not immunized. Minor at the recommended age should be given at any illness (e.g. fever, diarrhea, respiratory infections) subsequent visit when indicated and feasible. and malnutrition should not be construed as 38
  • 39. Simultaneous administration of multiple vaccines Both killed and live vaccine can be administered individual vaccines. However, prudence demands simultaneously without decreasing the efficacy of the that the vaccines be administered at different sites. 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. However, this should always be done after careful counseling. Vaccination Schedule in Adolescents Vaccine Age Td Booster at 10 and 16 years MMR vaccine One dose if not given earlier Hepatitis B 3 doses (20 mcg) 0, 1, and 6 months, if not given earlier Typhoid vaccine Vi Polysaccharide vaccine every 3 years Varicella vaccine* One dose up to 13 years and 2 doses (at 4 to 8 weeks interval) after 13 years of age if not given earlier. Hepatitis A vaccine* Two doses 0 and 6 months if not given earlier * Only after discussing with parents on a one to one basis Immunization for travelers The risk of travelers contracting infectious d is ease include yellow fever vaccine for those intending to go depends on the region/country to be visited, duration of to destinations in South America an d Subsaharan trip and nature and conditions of t rav el. Uniform Africa (except in infants les s t han 9 months and recommendation s are not possible because the pregnant ladies) and meningococcal vaccine for those epidemiolog y o f d is eas es d iffers in various intending to go on a Haj pilgrimage. Similarly, visitors geographical areas. The physician should try and comin g to India from Western Europe/North America update routine immunizat ion and also provide are usually advised vaccination against typhoid and destination specific immunizations. For instance, Hepatitis A, especially if the stay is likely to be vaccines commonly recommended for Indian travelers prolonged. 39
  • 40. Vaccination of children with bleeding disorders or those receiving anticoagulants Needles less than 23G should be used for injection and pressure, without rubbing, for at least 5 minutes. the parents should be asked to apply firm and sustained Beast-feeding and Vaccination Breastfeeding does not adversely affect immunization transmissio n of Hepatitis B virus from an HBsAg and is, therefore, not a con t raindication for any carrier mother to her baby through breast milk if HB vaccine. Neither inactivated n or live vaccines vaccination is started at birth. administered to a lactating woman affects the safety of breas t -feeding for infants. There is no risk of 40
  • 41. Injection Safety Issues Injectio n s afety is an important issue for any region must be avoided as sciatic nerve injury is a real immunization program Wash or disinfect hands prio r risk especially in neonates, malnourished and to preparing injection material. Avoid giving injections struggling children. It is not often appreciated that the if skin is infected or compromised by a local infection nerv e is within the reach of the standard needle even (such as a skin lesion or weeping dermatitis ). Ev en when the injection is given in the upper outer quadrant small cuts should b e co vered. Always use a sterile of the buttock. It is also know that the immune syringe and needle for each injection and to reconstitute response of some of the vaccines (especially rabies) each unit of medication. If single use syring es an d administered in the gluteal region is not optimum. needles are not available, use equipment designed for It is important for health personnel to understand that steam st erilization. Document the quality of the 'sharps' must be immediately co n t ained in a 'sharps' s t erilizat ion process using time, St eam an d box. The needle must not be recapped or manually Temperature (TST) spot indicators. mutilated after use. To prevent reuse, the syringe may Prepare each injection in a clean designated area where be cut and the needle defanged using a syringe/needle blood or body fluid contamination is unlikely. Clean destroyer. Syringes and needles should be disposed of skin prior to injection with a disinfectant and wait for carefully in leak-proof and puncture proof contain ers it t o dry. Do not use cotton balls stored wet in a an d n eedles and waste management should be given multi-use container. If multi-dose vials are used, always due attention. pierce the septum with a sterile needle but do not leave the needle in place in the stopper of the vial. If using an Auto-disable (AD) syringes are single-use, self-locking syringes designed in such a way that these are rendered ampoule that requires a metal file to open, protect fingers with a small gauze pad when opening the unusable after single use. These are made from clean-burning plastics and emit very low levels of toxic ampoule. Anticipate and take measures to prevent fumes. These are now being promoted for rou tine sudden patient movement during and after injection. immunization and may well become the norm in years All in t ramuscular injections in children should be to come. The Government of India has decided to use given only on th e anterolateral aspect of thigh at the AD syringes in Immunization program. junction o f t h e middle and lower third - the gluteal 41
  • 42. Adverse Reactions Following Immunization A d v erse reactions following immunization can be allergy to egg (e.g . Measles, MMR, yellow fever, broadly classified as local and systemic. Although such influenza vaccines), gelatin (e.g. MMR, Varicella, occurrences are uncommon, every physician who is Yellow fever vaccines), certain antimicrobials (e.g . dealing with immunization should anticipate and be Neomycin in MMR, Varicella and Inactivated Polio prepared to manage these events whenever they occur vaccines) or thiomerosal (e.g. DTP, TT vaccines). It is mandatory for every immunization clinic t o h ave It should be noted that it might often be difficult to an emergency kit for resuscitation. prove a definite cause-effect relationship between a Local reactions are especially common aft er the vaccine an d a given complication. It may be prudent adsorbed vaccines (e.g. DTPw/DT) - no treatment other not to ascribe all adverse reactions to a vaccine, which than symptomatic management is necessary. Whole cell has been given in the recent past before ascertaining all killed typhoid vaccines are also ass ociated with facts about the case. Many adverse effects may result particularly significant local reactions. Ulcer formation from inappropriate vaccination technique or storage of after BCG vaccination is normal and no intervention is the product. usually required - the ulcers may sometimes take many Each member of the Academy is requested to report weeks to heal. any case of suspected adverse reaction follo wing Anaphylactic reactions are distinctly unusual but have immunization to IAP committee on immunization been reported following Measles, MMR, Hib and through IAP office. Hepatitis vaccines. Such reactions may be secondary to 42
  • 43. Adverse Reactions Following Immunization Adverse Vaccine Symptoms Management Reaction Anaphylaxis Any vaccine Within minutes • Adrenaline • Cardiopulmonary • Acute decompensation of circulatory resuscitation shock • IV volume expanders • Hypovolemic shock • Hysrocortisone • Laryngospasm /edema • Dopamine/ • Acute respiratory distress Dobutamine H y p o t en s i v e DTP • Acute pallor • IV fluids hyporesponsive • Transient decreased level or loss of • Oxygen episode consciousness • Decrease or loss of muscle tone Incessant crying DTP • Within 48-72 hours of immunization • Sedation with • Excessive, inconsolable crying Triclofos 50 mg/ Kg • Paracetamol 10-15 mg/ Kg per dose • Feeding advice T o xic Sh o ck Measles vaccine • Within 30 minutes to few hours • IV fluids Syndrome contamination • Mounting fever • Antimicrobials • Vomiting cloxacillin 50-100 • Diarrhoea mg? Kg per day • Septic Shock • Steroids • Supportive therapy Lymphadenitis BCG • Within 2 to 6 months • If firm, no treatment • Firm to soft axillary lymphadenitis • If soft or fluctuant, 1.5- 3 cms size aspiration/ surgical excision • ATT not indicated Ba c t e ria l Any vaccine After days to weeks • Antibiotics abscess • Antipyretics fluctuant to firm • Drainage M o d era t e t o Any vaccine No n fluctuant swelling / redness 3-10 Paracetamol s ev ere l o c al cms in size at the injection site reaction Seizures wit h DTP Always generalised • Anticonvulsants fever (rare) • IV fluids (if need be) Measles 43
  • 44. The Cold Chain A vaccine has two characteristics - safety and potency. The potency of a vaccine is maintained by 'cold chain' Order of sensitivity of vaccines to heat This term refers to the system of transporting, storing Most sensitive and distributing vaccines in a potent state at the recommen d ed t emp erat ure from the point of BCG (after reconstitution) manufacture to the point of use. In es s en ce, it is OPV considered to play a crucial role in the success of any immunization program However potent a vaccine may Measles (both before and after reconstitution) be, if the cold chain is not maintained from the source Hepatitis B of vaccine manufacture to the place of vaccination, the vaccine efficacy will suffer. Vaccine potency once lost DTP cannot be restored. The essential components of a cold chain include: DT 1. Personnel responsible for vaccine distribution BCG (before reconstitution) 2. Appropriate equipment to store and transport Tetanus toxoid Least sensitive vaccines 3. Appropriate transport facilities 4. Maintenance of equipment 5. Monitoring Sensitivity of vaccines to freezing Vaccines damaged by freezing Vaccines that can be frozen without harm DTP OPV DT Measles/ MMR TT BCG (before reconstitution) Hepatitis B Hib Td Typhoid (whole cell killed vaccine) Hepatitis A 44
  • 45. The cold chain involves two complementary aspects: chamber in situations where OPV is to be stored for a) the set chain represented by the walk-in cold long duration (at -200C) or there is increased demand rooms, deep freezers and refrigerators and of ice-packs. b) the mobile chain represented by isothermic boxes and vaccine carriers. e) Domestic refrigerators: meant for vaccine storage should not be used for any ot h er p urpose; should be kept away from heat and direct su n lig ht; should have ice-packs fo r freezer compartment and water bottles in the shelves; these help in maintaining Equipment low temperatures in case of power failure; no vaccine should be stored in the baffle tray or the door shelves; a) Walk- in freezers (WIF): are established in all periodic defrosting is necessary; this is generally done the states ; are u sed for bulk storage of OPV and whenever the layer of ice exceeds 5-6 mms. The usual measles vaccines and for preparing frozen ice packs at temperature within the main compartment of a state s t ores; maintain a temperature of -200C and are domestic refrigerator is between 4-100C while t h at of available in 2 sizes - 16.5 & 32 CU Mt; freezers are the freezer compartment is between 0 to -40C. provided with two identical cooling units and standby The vaccines can be placed as follows: generator sets. • Freezer compartment: OPV / Measles / b) Walk in cold rooms (WIC): are used fo r bulk MMR storage of vaccines at the man ufacturer, state and • Top shelf: BCG / Measles / MMR regional levels which store vaccines for abou t 4-5 • Middle shelf: DTP / DT / TT/ Typhoid/ districts; maintain a temperature recorders and alarm Hepatitis A / Hib systems. • Lower shelf: Hepatitis B / Varicella • Crispator: Diluents c) Deep freezers: are used for storage of OPV/ • Baffle tray: should be kept empty Measles//MMR vaccines and preparation of ice-packs; DTP/DT/TT/Hepatitis B vaccines should not be stored f) Cold boxes or isothermic boxes: are well in deep freezers; have a top opening lid and are insulated, solid and thermetically (air tight) sealed availab le in 2 models -140 & 300 liters; cabinet boxes packed with frozen ice packs at the bottom, sides temperature is maintained between -18 to -200C; in and at the top; available in 2 sizes - 5 & 20L; these are case of power failure these freezers can maintain supplied to all peripheral centers and are used for cabinet temperature for 18 - 26 hours, if n o t o p ened. transportation of large amounts of vaccines to outreach All districts have been provided 2-5 large freezers facilities - 1500 vaccine doses can be carried in a 5L whereas most of the PHCs have one small deep freezer. box and 6000 doses in a 20L box; vaccines should be A b o u t 25-30 ice packs (8-10 kg ice) and 35-40 ice placed in cartons or polythene bags and then placed in packs (12-14 kg ice) can be frozen in one day in 140L direct contact with fro zen ice packs; in emergency and 300L deep freezers respectively. situations, can also be used to store vaccines and frozen d) Ice lined refrigerators (ILR): may have either ice packs for up to 5 days; the hold over time is more ice tubes or ice packs filled wit h water upto 90% of than 90 hours for a 5L, and 6 days for a 20L, cold box their volumes; o n freezing there is formation of an at 430C ambient temperature, if the cold box is not inner lining of ice; this enables the temperature to stay opened at all. In general a cold box of 5L can within a safe range even when there is electricity acco mmo date one month's supply of a PHC (30,000 supply for only 8-12 hours in a day; are available in 2 population), while a cold box of 20L capacity can sizes (140 & 300 liters) - the former is supplied to accommodate one month's supply for a CHC (100,000 district headquart ers while the latter is supplied to population). PHCs; in top opening ILRs the temperatures is least at Cold boxes can also be used in h ealth centers for the bottoms - t h is should be used for storing storage of vaccines and ice packs in case of electricity OPV/Measles/MMR; DTP / DT/ TT/ Hepatitis B failure or breakdown of other cold chain equipment. Ice vaccines should be kept near the top in a s ep arate packs should be made from tap water - water should be container to avoid accidental freezing. The Electrolux filled in the icepack up to the level marked. type of ILR (Model TCW 1151) can also be used as a freezer by a changeover switch inside the compressor g) Vaccine carriers: are s maller versions of cold 45
  • 46. boxes and are used to carry small quantities of vaccines life of 24 months. Diluents should be stored at 2-8oC - (e.g. 16-20 vials) for distribution to outreach facilities; these should not be us ed b ey ond 4 hours. Vaccines these contain 4 fully frozen ice packs (0.36 liters each) should be transported o n ly in cold boxes or vaccine and an inner plastic lining; can maintain temperatures carriers - vacuum flasks should never be used for this for 2 days if the packs are frozen and lid is kept tightly purpose. clo sed. DTP/DT/TT/Hepatitis B vials should be It is recommended that vaccines should not be stored wrapped in plastic to avoid direct contact with ice. for more than 3 months at the district lev el and for h) Day carriers: are smaller versions of vaccine more than 1 month at the level of primary health carriers and are used to carry still small quantities of center. No vaccines sh o uld ever be stored at the vaccines (e.g. 6-8 vials) of vaccine; have provision for sub-centers. Expiry dates of vials shou ld b e checked only 2 frozen ice-packs; can be used to store vaccines once a week. While storing vaccines fo llo w the for 6-8 hours; vaccines in day carrier should be issued "First-In-First-Out (FIFO)" and "First to Expire on the day of immunization only; presently, the use of First-Out (FEFO)" rules. day carriers is not encouraged. During shipment and transportat ion, temperature and i) Ice packs: are made of polyethylene and weigh time sensitive monitor marks are used to check the cold approximately 80 gm; t h e dimensions are 163 x 90 x chain. Dial t h ermometers are used to monitor the 33 mms; co ntain 0.36L of water; never add salt to the temperature in refrigerators/ice-lined refrigerators water. Ice packs are used to line the sides of cold boxes, (ILRs) and are kept in every unit. Alcohol stem vaccine carriers and day carriers. t h ermometers are much more sensitive and accurat e t h an dial thermometers and can record temperatures fro m - 50oC to +50oC. These can be used for deep freezers and ILRs . 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, where Storage of vaccines vaccines are stored in bulk for longer periods. A break in the cold chain is indicated if temperature rises above All vaccines are safe at temperatures between 2-80C for +8oC or falls below +2oC in the case of ILR and other at least 6 months. If a freezer is available, it should be refrigerators and above -180C in the case of deep used for storage of OPV and Measles/MMR vaccines. freezers. The latter vaccines should be kept frozen at -200C when stored fo r t h e long term - at this temperature these vaccines have a shelf life of 2 years. Even these v accines, however, can be kept at 2-80C for short er periods e.g. 6- 12 months for OPV and 18-24 months The Vaccine Vial Monitor for measles. DTP / DT / TT / Typhoid (T-series vaccines), HB and (VVM) is a time an d temperature sensitive colored Hep A vaccines should never be frozen. The freezing label that provides an indication of the cumulative heat point for adsorbed DTP vaccine is between -5 to 10oC. to wh ich the vial has been exposed. VVMs were first Freezing time depends on the number of doses in the introduced on OPV vials supplied to UNICEF and vial and the temperature. It takes about 110 to 130 WHO in 1996. The VVM warn s t h e end user when minutes at -10oC. The "Shake Test" can be used to exposure to heat is likely to have degraded the vaccine determine if these vaccine has been frozen at any time: beyond an acceptable level. It is used especially for shake the vial so t h at the sediments, if any, are temperatures monitoring of OPV, which is the most completely mixed ; wait for 15 minutes; if the vaccine thermo lab ile of all vaccines. If the VVM indicates is not uniformly mixed or the sediments/ flocculations proper storage of OPV in a given center, it can be are still found settled at the bottom, the vaccine is likely presumed that oth er vaccines would also be potent. to have been frozen at some time. Such vials should be VVMs increas e the flexibility in handling of vaccines discarded. in the field. At a temperature of 2-8oC, DTP/ DT/TT/ Hepatitis Interpretation of the colour change of VVM is as B/Hepatitis A/Varicella and Hib vaccines have a shelf follows: 46
  • 47. 1. Inner square is lighter than outer circle: If the (Kasauli), National Institute of Communicable Disease expiry date has not passed, vaccine can be used. (Delhi), Enterovirus Research Centre (Mumbai), School of Tro p ical Medicine (Kolkata) and other 2. Inner square matches colour of outer circle or is centers. Samples from different immunization sites darker than outer circle: vaccine should be discarded. should be collected in vaccine/day carriers with fully The VVM provides in formation about the heat frozen ice packs and transported to the headquarters by exposure of the vial over a period of time - the change o b s erv ing "reverse cold chain" If delays in in colour is gradual but irreversible. However there may transportation are anticipated, th e samples should be be other factors which can also affect the potency of kept in a deep freezer/ILR before these are sent to the vaccine (e.g. storage beyond the expiry date) and these testing lab o ratory. The WHO recommends that in may not be reflected in the VVM . Loss of potency countries where VVM is being used for monitoring depends upon the degree of temperature elevation as cold chain, OPV sample testing is not required. well as duration of exposure. Tetanus toxoid is the least Recen tly Government of India is following this heat sensitive vaccine. recommendation. The manufacturer's instructions regarding shelf life of a given vaccine must be rigorously followed. Measles vaccine loses viability quickly if kept at temperatures The Future above 400C. Reconstituted measles vaccine should be Advances in sugar-glass drying technology now allow kept protected from heat and light during an manufacturing of vaccines which can be stored and immunization session and the left-over discarded after tran s p orted at tropical room temperatures. Trehalose, the session. OPV would lose viability if kept at 22-25oC a disaccharide, has long term stabilizing ability and can for more than a d ay . Opened vials of OPV, however, be effectively used for this purpose. Dried measles may be used in subsequent sessions at a given health vaccine stabilized with trehalose has been found viable facility if it has b een p reserved at 2-8oC. OPV vials after 2 months at room temperature while DTPa can u sed in the field setting or an outreach facilit y o r withstand a temperature of 600C for 12 weeks . Oral during a pulse immunization session must be discarded polio vaccine, however, has failed to 'dry' successfully. at the end of the day. Vaccine vials (single/multi-dose) If all vaccines can be successfully 'dried', there will no should be gently shaken before use to ensure that the longer be a need for maintenance of co ld chain - this co n t en ts are clear and not granular or flaky. Vaccine will also result in substantial cost savings. vials should not be taken out to the field more than 3 times - after that these are best discarded irrespective of whether these have been opened or not. Supply of vaccines When using multidose vials it may be ad v isable to schedule all immunizations to a fixed day every week. A ll UIP vaccines are available free of cost to all This reduces wastage o f v accine and minimizes the practitioner from lo cal health authorities. One is risks of contamination/loss of potency. One can send allowed to collect profes s ional fees for the services OPV vials for viab ilit y test with the help of the local rendered. However, the utilizatio n report should be health authorities. OPV has been taken as an indicator submitted periodically. of quality of cold chain as t h is v accine is more heat labile than other vaccines and is easier to test. The test When buying from market individual practitioners t akes only 7 days. Open vials can also be sen t an d , should ensure that vaccines are procured directly from id eally, the vials should be lifted from all levels - i.e. a stockist with appropriate cold chain facilities, rather from the periphery after the immunization sess ion, than off the shelf from a nearby retailer. Vaccum flasks PHC, CHC, district and reg ional stores. Testing should never be used for an outreach activity. facilities are available at the Central Research Institute 47
  • 48. Stability of Vaccines at Different Temperatures Vaccine Temperature in oC 2- 8 22- 25 35- 37 > 37 D T / TT (a s 3-7 years Many months At least 6 weeks 2 weeks at 45OC mo n o v a le n t v accines or as co mp o n en ts of combined vaccine) Pertussis vaccine 18- 24 mo n t h s , Variable, but does Variable 10% lo s s o f but there is a n o t e xceed 2 potency per day steady decrease in weeks potency Freeze dried BCG 1 year 20- 30% of Variable Unstable vaccine viability after 3 months Re c o n s t it u te d Should be used within 4 hours. This recommendation is based on the fact that: BCG vaccine 1. There is a risk of contamination as BCG vaccine contains no bacteriostatic agent. 2. Concern over loss of viability. F r e e ze d r i e d 2 years 1 month 1 week 50% lo s s o f measles vaccine viab ilit y in 2-3 days at 41OC R ec o n s t i t u t e d Should be u sed measles vaccine within 4 hours OPV 6- 12 months 50% lo ss o f Very u n s t ab le. Very u n s t ab le. viability after 3 Significant loss of Significant loss of weeks viability within 1- viability within 1 3 days day at 41OC Inactivated Polio 1- 4 years De c lin e o f Variable Pre c i s e data Vaccine (IPV) D-antigen content lacking for Type I after 20 days Hepatitis B 2- 4 years Many months Many weeks St a b le fo r man y days at 45OC Rabies HDCV 3- 5 years 3 months 4 weeks No data available 48
  • 49. Surveillance for Vaccine Preventable Disease (VPDS) Surveillance is a French word, which means "watching It is a pity that none of these targets have been met so with attentio n, suspicion and authority" Disease far. The revised target for certification of polio surveillan ce under the Universal Immunization eradication and neonatal tetanus elimination is the year Program refers t o the collection, analysis and use of 2007. The nomenclat u re used for control of the three data on VPD to improve action to p rev ent these diseases is rather specific because while it is possible to diseases As higher levels of vaccination coverage are eradicate polio v irus from the planet, it may not be achieved, the role of disease surveillance becomes feasible to eradicat e the tetanus bacilli, which are increas ingly important to document the impact of a u biquitous. However, by immunizing all mothers wit h giv en immunization program. A sensitive surveillance tetanus toxoid it is possible to at least eliminate system is required to direct program resources to areas neonatal tetanus. Similarly while it may be possible to of greatest need and to ident ify areas for special or eradicate measles in the future, at the present time one more intensive interventions. A g o o d surveillance can only hope to preven t measles mortality by system can det ect program failures and impending preventing measles in the vast majority of immunized outbreaks and can also be used to assess vaccine children. efficacy. Acute Flaccid Paralysis (AFP) surveillance is an Any sat isfactory national immunization program essential component of polio eradication. A min imum should result in gradual decline of the VPDs. All cases AFP rate of 1/100,000 children below 15 years o f ag e of VPDs should be reported to the local health authority is required to ensure that adequate surveillance exists within 48-72 hours for taking prompt action at the field at the ground level. At present most of the parts of the level. coun try have excellent and adequate surveillance. Every case of AFP should be reported to local health The WHO had declared 3 district objectives for the year authority. 2000 A.D. 1) Polio eradication 2) Neonatal tetanus elimination 3) Measles reduction 49
  • 50. Vaccination in Current Millenium The future holds lot of promise as far as prevention of disease through vaccination is concerned. We are likely Viral Vaccines to witness more refined vaccination techniques, Rotaviurs vaccine improved antigens and safe vaccines.We are likely to g et many new combo vaccines also. "Naked" DNA Respiratory Syncitial Virus vaccine vaccines and administration of antigens through viral Dengue fever vaccines vectors/edible plants may completely revolutionize childhood vaccination programs. Some vaccines which HIV vaccine may soon become available for clin ical use are as Hepatitis C vaccine follows: Protozoal vaccines Bacterial vaccines Malaria vaccine Enterotoxicogenic E. coli vaccine Shigella vaccine Websites for additional information Cholera vaccine The following websites may provide useful information - Streptococcal vaccine for rheumatic fever www.who.int/vaccines; www.immunizationinfo.org; Helicobacter pylori vaccine www.v accin es .o rg ; www.in ejc t io n s afet y .o rg ; www.vaccinealliance.org; www.aap .o rg ; www.cd c.g ov/nip; www.path.org; www.childrensvaccine.org www.unicef.org 50
  • 51. Update of IAP Immunization Policies, Guidelines And Recommendations [Report of IAP COI Meetings ( July 16th & 17 2005, New Delhi; Oct. 1 2005 New Delhi; April 2, 2006 Mumbai; and July 28, 2006 New Delhi)] The Indian A cademy of Pediatrics Committee on those items wh ich are outside the purview of policy, Immunization (IAP COI) conducted its deliberations and for which guidance is necessary. Guidelines usually and reviewed its stand on various policies, guidelines pertain to newer vaccines or issue related to them. an d reco mmendations pertaining to childhood "Recommendations" are, in general, what the academy immu n ization. As has been enunciated earlier, in its role of advocacy on behalf of children, requests "policies" are the decisions taken by the Academy in other agencies, the Go v ernment of India or other relation to the scientific principles and practice of professional bodies. immunization. "Policies" are expected to be pract iced by all members of Academy. 'Guidelines" relate to IAP Policies on Immunization, 2006 a few districts, no new vaccine has been introduced in On NTAGI the national program in the last 25 years. All vaccines The IAP welcomes the establis h ment of the National under UIP sh o u ld continue to be available free of Technical Advisory Group o n Immunization (NTAGI) charge to all eligible children. by the Government o f India. This followed a formal recommendation from the IAP, given a couple of years On Polio Eradication Goals and SIAs ago. The Secretary, Department of Family Welfare is The Academy fully supports the Government of India t he Chairperson of the committee while the Assistant in the use o f oral polio vaccine (OPV) for the pulse Commissioner, Immunization Program is its Member immunization program against polio. It is our Secretary. The IAP COI ap p reciates that the IAP is considered opinion that, in sp it e of some operational represented on this important committee by its hiccups, we must continue with this program and bring incu mb ent President and recommends that the it to its logical conclusion, i.e. till wild polio virus is Chairperson/Convener of the IAP COI .should also be eradicated from our country. IAP advocates that some invited as a member of this committee. st ep s are required to be taken to overcome the last hurdles in achieving the goals of polio eradication as On Universal Immunization Program (UIP) fast as possible. These include operationalizatio n of The IAP continues to endorse and reiterate its support birth dose of OPV all over the country, at least in areas to th e n at io n al immunization schedule while with wild polio virus transmission continuing; recognizing the fact that much more needs to be done strengthening of routine immunization; better quality for meeting the current immunization requiremen t s of of SIAs and role of IPV in difficult areas where wild the children of our country. It is a fact that except for polio virus circulation is still continuing. the recent phased introduction in Hepatitis B vaccine in 51
  • 52. preempt the emergence of cVDPV and has to become self sufficient in stock-piling enough Inactivted Polio Vaccine (IPV) polio vaccine now to meet any such unforeseen eventuality in future. (Role of IPV vis a vis OPV) • Looking at the above problems, IAP OPV is cheaper & being given orally and so mo re recommends that India should switch over to acceptable. However it is less efficacious in tropical IPV, preferably as IPV-DTP, in its routine country like India due to in terference with other immunization program in post-polio enteroviruses and other unknown factors It also needs eradication era. India should encourage strict co ld chain maintenance. Where as IPV is more indigenous manufacturer to produce enough IPV so that it becomes affordable so that it will efficacious, less thermolab ile and has no chance of be possible to switch to IPV in due course, inducing vaccine induced paralysis. Of late IPV h as looking at the huge requirement of the number been shown to induce local g u t immunity as well as of doses. herd effect. Coverage of children less than 2 years in Practitioner keen to use this vaccine may use the high risk areas with 2-3 doses of IPV can b e an vaccine as 3 primary doses followed b y o ne booster additional tool to eradicate polio from our country. The dose with DTwP / DTaP. OPV must be given to these cost and availability of vaccine can be a problem. children as birth dose and on the NIDs and SIAs. Post-polio eradication scene and polio immunization: IAP believes that it will be unsafe and u n et hical to On number of routine DTP/OPV doses continue to use OPV in post-po lio eradication era. The IAP COI endorses the use of five d o s es of Following concepts should be kept in mind while DTP/OPV at 6, 10 and 14 weeks and thereafter at deciding India specific guidelines for post-polio 15-18 months and 5 years respectively. An additional eradication immunization.. dose of OPV is to be given at birth to all where possible and one more additional dose along with measles • It will be unethical and unsafe to continue to use OPV after zero wild polio case and zero vaccine. It should be noted that we continue to endorse transmission status is achieved due to risk of the use of DTP (rather than DT as in t h e national VAPP and cVDPV following OPV. program) and OPV at 5 years. • It will be unwise to discontinue use of polio immunization altogether after zero polio status On Vaccines not covered in EPI is achieved due to fear of cVDPV, iVDPV. Past The IAP COI suggests that the UIP s h o uld be experience from some countries has shown that supplemen ted by the following vaccines: Hepatitis B countries which have eradicated wild polio (HB), HIB, MMR and typhoid. Td should replace TT at virus and have slackened in their routine polio immunization programs have experienced 10 and 16 years. Parents, however, should b e made cVDPV outbreaks. These outbreaks of cVDPV aware of the availabilit y an d need of these vaccines. were curtailed by strengthening routine Varicella an d Hepatitis A vaccines are still not immunization and giving 2 or more rounds of recommended for routine use. Pn eu mococcal PCV-7, SIAs using OPV. However in post-polio liv e attenuated SA-14-14-2 Japanese Encephalitis eradication era, it will be unethical and unsafe Vaccines are the new vaccines which have become to reintroduce OPV in such areas. It will force available in India. Tdap and Rota virus are the vaccines us to depend on the stocks of WHO or any such which are likely to be available in near future. agency for OPV vaccine, should out-break of wild polio or cVDPP occur. Hence India should 52
  • 53. IAP COI stand on RECOMMENDED vaccines not covered under EPI against Hepatitis B. Hepatitis B vaccine HB vaccine may be given in any of t h e following MMR Vaccine schedules: MMR should be promo t ed as a universal vaccine. It (i) Birth, 1 and 6 months should be given at around 15-18 months of age and at (ii) Birth, 6 and 14 weeks/6 months least 3 months after the measles vaccine. It should also (iii) 6, 10 and 14weeks/6 months be given to all adolescent girls and young women not previously immunized, as also to hospital staff likely to Immunologically 0 - 1 - 6 months schedule of hepatitis come in co n tact with pregnant mothers. There is no B immunization has been most widely used and proven upper age limit for this vaccine. to be ideal. HB vaccination is now been integrated into the existing immunization program (UIP) in India. Due Typhoid Vaccine to operational issues at a national level one has to piggy The IAP COI strongly recommends the use of typhoid back on the av ailable contacts for routine vaccine for all children. Of the 3 types of vaccines (viz. immunization, hen ce 0 - 6 - 14 wks schedule is Vi-polys ach aride, whole cell inactivated and oral recommended. In case birth dose has been missed, 6 - Ty-21a), only the Vi-polysacharide vaccine is freely 10- 14 wks schedule can be followed. In office practice, available in our country at present. It is recommended one can still use 0 - 6wks - 6 months schedule. to be given after the age of 2 years followed by The purpose of Hepatitis B vaccination is to prevent revaccination every 3-5 years. The government should chronic infection and development o f chronic liver explore the possibility of manufacturing this vaccine in disease / hepatocellular carcin o ma later in life. An the public sector on large scale so that t h e costs are ideal HB vaccine schedule should, therefore, address brought down. vertical as well as horizontal modes of transmission of the virus. Hib Vaccine If the mother is HBsAg positive (and especially HBeAg Hib vaccine should be offered to all children and may positive), the baby should be given Hepatitis B Immune be given at 6, 10 an d 14 weeks along with DTP. A Globulin (HBIG) as soon as possible after birth, booster is given at 15-18 months. If vaccination is preferably within 24 Hours of birth, along with HB s t arted after 6 months of age, only two doses (at 4-8 vaccine. The injections should be given at two separate weeks interval) need be given as primary schedule with sites. If HBIG is not available (or is unaffordable), HB a booster at 15-18 months. If vaccination is started vaccine may be given at 0, 1 and 2 month s with an between 12-15 months of age, only one dose need be additional optional dose between 9-12 months. given, with a booster at around 18 months. After 15 months of age only one dose of the vaccine needs to be Boosters of HB vaccine are n o t n ecessary in given- no boosters are required u n d er such immun o co mpentent individuals. The vaccination circumstan ces. The vaccine need not be given after 5 schedule need not be changed for preterm babies, in the years of age. Hib vaccine is also recommended for all case of extremely preterm babies, however, vaccination high risk children, irrespect ive of age, prior to should commence only after initial stabilization. splenectomy and also in patients with sickle cell The IAP COI recommends universal immunization disease. IAP COI strongly recommends GOI to include 53
  • 54. this vaccine in UIP. IAP COI stand on vaccines that are given after discussion with parents: dose administered by subcutaneous route. This vaccine Hepatitis A Vaccine has recently been licensed for use in India. There is Hepatitis A (HA) vaccine is not recommen d ed for only one Indian study con d u ct ed at Pune on this universal immunization in India at present. One has to vaccine showing 95% seroconversion. The vaccine has emphasize the generally benign nature of and rarity of not been studied extensively outside China. This complications with Hepatitis A infection in young vaccine should be subject ed to post marketing children. It may be offered to children from high surveillance for efficacy and adverse reactions in India. socio-economic strata of society after explaining the However, for 100% seroconversion second dose after 6 pros and cons to the parents on a one-to one "named months n eed s to be considered as recommended in child" basis. It may be prescribed to adolescents who China. have not had viral hepatitis in past (or are known to be HAV-IgG negative) especially if they are leaving home Varicella Vaccine for studies in a residential school/college. The IAP COI opines that varicella vaccine is not HA vaccine is indicated fo r all patients with chronic recommended for universal immunization in India at liver disease as well as household contacts of patients present. One has to emphasize the gen erally benign with chronic liver disease as well as household contacts natu re of and rarity of complications with, varicella of patients with HA virus infection - in the latter case in fection in young children. It may be offered t o the vaccine must be given within 10 days; it may, children after ag e of 15 months from high however, be not always effective under such socio-economic strata of society after explaining the circumstances if the contact has the same source of pros and cons to the parents on a one-to-one "named infection as the index patient. It may also be considered child" basis. It may be prescribed to adolescents who in children attending crèches and day care centers and have not had varicella in past (o r are known to be in travelers from abroad (e.g. non-resident Indians) varicella IgG negative) especially if ther are leaving visiting endemic areas. home for studies in a residential school/college. It is given in a 2-dose schedule, 6 months apart after It is indicated in children with ch ro nic lung/heart the age of 18 months The adult formulation should be disease, humoral immunodeficiency, HIV infection (but used after the recommended cut-off age: 15 years with CD 4 counts above 15% of the age related norms), according to one manufacturer and 18 years according leukemia (but in remission and off chemotherapy for at to the other. The vaccine is given intramuscularly and leas t 6-12 weeks) and those on long term the protectiv e efficacy is 94-100%. Boosters are not s alicy lat es/steroids. Varicella vaccin e is als o recommended at present. reco mmen d ed in hous e h o ld c o n t act s of immu n ocompromised children. It may also be Live attenuated Hepatitis A Vaccine considered in children attending crèches and day care The live attenuated Hepatitis A Vaccine has been centers. licensed for use in China since 1992. The manufacturer Varicella vaccine is also indicated in susceptible claims 92 to 100 percent seroconversion with single adolescents and adults if they inmates of or working in 54
  • 55. the institutional set up e.g. school teachers, day care reactions to a previous dose of whole cell pertussis center wo rkers, military personnel and health care vaccine. These include: professionals. 1. Convulsions with/without fever occurring within 3 A single dose suffices between the ages of 1-13 years, days after which a 2-dose schedule (4-8 weeks apart) is 2. Persistent inconsolable crying for 3 or more hours recommended. within 48 hours Acellular Pertussis Vaccine 3. Collapse or shock-like state within 48 hours The IAP COI endorses the continued use of whole cell 4. Temperature > 40.50C within 48 hours p ertussis vaccine (as DTPw) because of its pro v en efficacy and safety. Acellular pertussis vaccines may Conjugate Pneumococcal Vaccines (PCV-7) undoubtedly have fewer minor side-effects (like fever, The IAP COI does not recommend use of this vaccine local reactions at injection site and irritability), but this for universal immu n ization for healthy children in our small advantage dose not justify the inordinate costs country at present. PCV - 7 co v ers only 50 to 55 involved in the routine u s e of this vaccine. It is , percent of pneumococcal seroty p es responsible for t h erefo re, not reco mmen d ed for un iv ers al serious invasive pneumococcal diseas e in infants & immunization in our country at present. There is , children in India. The v accine may be offered after however, no bar to offering these vaccines to children explaining the parents on o ne to one "named child" from families who opt for the vaccine for the slight b asis. However it is recommended routinely in h ig h advantage of fewer minor side-effects. risk group children up to the age of 5 years. Use of acellular pertussis vaccine should, however, be considered in children who have had s ig n ificant IAP Stand on vaccines for special circumstances efficacy reaching 99% even with single dose. As per a Live Japanese Encephalitis (JE) Vaccine W HO report no serious adverse effects (other than (SA-14-14-2) anaphylaxis) have been rep o rt ed over 20 year period (1979 - 1998). This vaccin e is not available This vaccine is bas ed on a stable neuro-attenuated commercially in India; it has been used this y ear in strain of JE virus (SA-14-14-2). It was firs licensed for seven endemic districts after importing it from use in 1988 in People's Republic of China and over Chengd u Institute of Biologicals, China. From the sixty million doses per year are being used there. Now av ailable safety data, the vaccine was found to be it is also licensed for use in Nepal, S. Korea and India extremely safe. This live attenuated vaccine constitutes to over 50% of global production of all JE vaccine. Dose is 0.5ml at all Meningococcal Vaccines ages. It is given by subcutaneous route. Meningococcal vaccine (bivalent A, C or tetravalent A, Init ial studies done on this vaccine demonstrated an C, Y, W135) is indicated for use (as an adjunct along efficacy of about 80% with single dose and 98% with 2 with chemoprophylaxis) in clos e co ntacts of patients doses. However, more recent studies have shown 55
  • 56. with the disease. It is also indicated in high risk during epidemics It is recommended for those who are in d iv id u als (e .g . t h o se with going for Haj pilgrimage. hyposplenia/asplenia,complement deficien cy ) and IAP COI stand on future vaccines: developing countries 53% of rotavirus deaths occur in Tdap Africa & 42% in Asia. It is estimated that 100,000 In the western world it is being felt that there is a need children d ie each year in India due to rotavirus to vaccinate adolescents and adult s with pertussis diarrhea. vaccine. There the epidemiology has undergone a marked shift since the introduction of mass childhood As rotavirus d iarrhea occurs in spite of highest vaccination programs, the proportion of pertussis cases standards of hygiene it cannot be prevented by public in older children, adolescents and adults though n o t health measures like s afe water supply and good great in numbers have relatively increas ed, making sanitations. For prevention universal immu n ization them the source of transmission to very young infants appears to be the only answer. who are unimmunized or partially immunized and this The first vaccine against rotavirus was tetravalent age group is more vulnerable to dis eas e related rhesus-human rotavirus vaccine (RRV-TV vaccine, complications and mortality. Ro t ashield: Wyeth Lederle). This vaccine licensed in The Tdap vaccin e h as been incorporated as booster USA in 1998 and recommend ed for universal use had dose during adolescence in the immunization schedule to be withdrawn when an increased rate of of few developed countries. This provides booster to intussusceptions was shown to occur after vaccine waning immunity in adolescents thus leading to administration. individual protection and prevention of transmission of Recently a new Pentavalent bovine-human reassortant disease to susceptible infants and children. vaccine from Merck (Rotateq) has been licensed in In India the epidemiology of pertuss is is not well USA. Another Rotavirus vaccine - a live at t enuated known and there is lack of information reg arding human (G1P8) monovalent vaccine from GSK (RIX epidemiological shift. So the Tdap vaccine is n ot 4414 Rotarix) has recently been licensed in Latin recommended for universal use at present. This vaccine American countries and some A s ian Countries. Both may be of particular use for children who have missed these vaccines have been found to be safe and highly their 2nd booster of the DPT and are more than 7 years efficacious. of age. Trials of these vaccines have not been initiated in India so far. There is a great diversity of Ro t avirus strains Rota Virus Vaccine prevalent in India. There is need to know the efficacy Rotavirus is common cause of d iarrhea all over the of these vaccines in India before any recommendations world. Almost all children get infected by the age of 5 can be mad e on the use of existing vaccines. Other yrs. In India, of the children hospitalized for rotavirus Rotavirus vaccine being developed are LLR vaccine in diarrhea, 50% were < 6 months, 75% < 9 months and China which is in phase II / III trials and the newborn nearly 100% < 2 y rs. It is estimated that risk of death strain vaccine in India. follo wing rotavirus diarrhea is 1 in 290 cases in 56
  • 57. adhered to strictly Combination Vaccines The number of vaccines in the immunization schedule 2. Extemporaneous " mixing" of vaccines in the same is increasing every year and this tren d is likely to syringe (prior to injection) should not be done as far as continue for the next few years. Many parents opt for possible, unless specifically recommended b y the one single injection of combination vaccines at a given manufacturer; in the latter case the manufacture's visit, rather than come repeatedly for the various instructions should be followed strictly individual vaccines or take multiple pricks on a single 3. The advantage of a combination vaccin e is the day for vaccines that are now in cluded in the convenience of fewer clinic visits for the parents and immunization time- table. A number of combination fewer pricks for the child vaccines are now available in the Indian market. The IAP COI endorses the use of combination vaccines, but 4. Combination vaccines should not be viewed as being with the following cautionary statements: more effective than vaccines given separately 1. The manufacture's recommendations should be Immunization card to be used for this purpose. Parents On Adolescent Vaccination must be instructed to keep the document safely and The Academy endorses the continued use of Td/tetanus present it to their doctor whenever required. toxoid at 10 and 16 years and thereafter every 10 years. HB vaccine may be offered in th e 0, 1 and 6 months On Advertisements in the Lay Media sched u le as mentioned earlier under individual Some of the multinational companies have been using vaccines, if the child has not received it earlier. MMR the lay media (television, electronic media and vaccine should be offered to all children who have not news p apers/magazines) for placing advertisements received it earlier - there is no upper age limit for this pertaining to optional/combination vaccines. We opine vaccine. The Academy encourages the use of typhoid that this is uneth ical. The IAP placed a formal vaccin e for all adolescents. Hepatitis A and varicella complaint before th e Drug Controller General of India vaccines should be used in selected cases as mentioned and the Union Health Ministry. This led to the issuance above. o f a letter by the Drug Controller to the concern ed companies requesting them for the withdrawal of these On Immunization Records advertisements. We are hopeful the companies would Every vaccine given to a child must be documented on see reason and refrain from lay advertising. a card/ booklet. We recommended the IAP Health and 57
  • 58. IAP 2006 Recommendations for other agencies including Ministry of Health and Family Welfare, Govt of India The IAP COI has formulated several specific Vi-polysaccharide vaccine for this purpose. recommendations to other agencies pertaining to • The Academy supports the decision of the immunization. Government to discontinue production of animal brain rabies vaccine. However we need to ensure • The IAP recommends that the Academy should be adequate supplies of indigenously produced chick represented on NTAGI by incumbent President and embryo/tissue culture vaccines at affordable costs. the Chairperson/Convener of IAP COI Intradermal route of cell cultured vaccine as per the • At 5 years of age booster immunization should be recent approval and the guidelines of the Drug done with DTP rather than DT. Controller General of India should be encouraged • The Academy recommends that inactivated polio and the minimum number of vaccinees stipulated in vaccine should be introduced in the routine the guidelines should be brought down to 10 (the immunization in a phased manner, now that it is number of doses obtained from one vial of vaccine). licensed in the country. • The Academy again reiterates its previous • The Academy strongly recommends that Hepatitis B, recommendation to the Federation of Obstetric and HIB and M M R Vaccines should be included in the Gynecologic Societies of India to adopt a policy of national immunization schedule with immediate routine testing of all pregnant women for HBV effect. infection. If the mother is HBsAg positive, the baby • The Government should actively consider inclusion should be given HBIG plus HB vaccine soon after of typhoid vaccine in the national immunization birth. schedule. The Academy suggests use of 58
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