ANNEXURE 1. IAP Immunization Time Table Age (completed weeks/ months/years) Vaccines

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1 164 ANNEXURE 1 IAP Immunization Time Table 2011 Age (completed weeks/ months/years) Vaccines Birth BCG OPV0 HepB 1 6 weeks DTwP1/DTaP1 OPV1*/ OPV1 + IPV1 Hib1 HepB2 Rotavirus 1 *# PCV 1 10 weeks DTwP2/ DTaP2 OPV2*/ OPV2 + IPV2 Hib 2 Rotavirus 2 PCV 2 14 weeks DTwP3/ DTaP3 OPV3*/ OPV3 + IPV3 Hib3 Rotavirus 3 HepB3** PCV 3 9 month Measles 12 months Hepatitis A 1 15 months MMR1 Varicella PCV Booster 16 to 18 months DTwP B1/ DTaP B1 OPV4*/ OPV4 + IPVB1 Hib B1 18 months Hepatitis A 2 2 years Typhoid 1 # 5 years DTwP B 2 / DTaP B 2 OPV5 MMR2 $ Typhoid 2 Varicella 2 $$ 10 to 12 years Tdap/Td & * OPV alone if IPV cannot be given *# Rotavirus vaccine (2/3 doses (depending on the brand) at 4-8 weeks interval) ** The third dose of Hepatitis B can be given at 6 months $ The second dose of MMR vaccine can be given at any time 4-8 weeks after the first dose HPV^ $$ Varicella (2 nd dose may be given any time 3 months after the 1 st dose) # Typhoid revaccination every 3 years & Tdap preferred to Td, followed by repeat Td every 10 years ^ Only females, three doses at 0, 1-2 and 6 months

2 165 ANNEXURE 2 IAP Immunization Schedule 2011

3 166 1 BCG: birth or at first contact, catch up may be given up to 5 years. 2 Hep B: Acceptable schedules 0, 6, 14 weeks/ 0, 1, 6 months/ 6, 10, 14 weeks. 3 OPV: Additionally OPV on all NID s and SNIDS. 4 IPV: Primary schedule: 3 doses at 6, 10, 14 weeks or 2 doses at 8/10 and 16/18 weeks; Catch up: 2 dose 2 months apart 5 DTwP/DTaP/Tdap/Td: Catch up below 7 years: DTwP/DTaP at 0, 1 and 6 months; Catch up above 7 years: Tdap, Td, Td at 0, 1 and 6 months. 6 Hib: Catch up in 6-12 months; 2 doses 1 month apart and 1 booster; months: 1 primary and 1 booster; above 15 months single dose. 7 PCV: Catch up in 6-12 months: 2 doses 1 month apart and 1 booster; months: 2 doses 2 months apart. 8 Rotavirus: Two or three doses at 4-8 weeks interval depending on brand; vaccination should be completed before 8 months; initiation of catch up vaccination not permitted beyond 15 weeks. 9 Measles: At completed months/270 completed days; Catch up vaccination beyond 12 months should be MMR 10 MMR: MMR2 may be given at any time 4-8 weeks after 1st dose. 11 Varicella: 2 doses 16 months and 5 years in those below 13 years. 12 Hep A: Two doses 6 months apart. 13 Typhoid: Revaccination every 3 years. 14 HPV: Only females, three doses at 0, 1/2 (depending on brand) and 6 months. 15 PPV23: Revaccination only once after 3-5 years only in certain high risk patients. 16 Influenza: First time vaccination: 6 months to below 9 years to doses 1 month apart; 9 years and above single dose; Annual revaccination with single dose. 17 MPSV: Revaccination only once after 3 years in those at continued high risk. 18 JE: Live JE vaccine single life time dose; Inactivated vaccine three doses at 0, 7 and 30 days, boosters every 2-3 years. 19 Rabies: Pre-exposure prophylaxis: 0, 7 and 28 days; Post exposure prophylaxis: 0, 3, 7, 14 and 28 days. 20 Yellow fever: Single dose; revaccination every 10 years if indicated. 21 Cholera Vaccine: 2 doses 2 weeks apart for >1 year

4 167 ANNEXURE 3 List of Vaccine brands available in India VACCINE BRAND Marketed by BCG Tubervac Serum Institute of In India OPV Biomed GSK Biologicals Biopolio Bharat Biotech Primapol Chiron Panecea IPV Imovax Polprotec Chiron Panacea DTwP Triple Serum Institute of India DTaP Infanrix GSK Biologicals Tripacel DT Dual Serum Institute of India TT Tetanus Toxoid Serum Institute of India Abhaytox BETT Bilogical Evans Td Tdvac Serum Institute of India Tdap Boostrix GSK Biologicals Adacel Measles M Vac Serum Institute of India AbhayM Rubella R vac Serum Institute of India MMR Tressivac Serum Institute of India Priorix GSK Biologicals Hepatitis B Genevac B Serum Institute of India Engerix B GSK Biologicals Revac B Bharat Biotech Hib Hibpro Serum Institute of India Hibrix GSK Biologicals ActHib DTwP + Hib Qudrovax Serum Institute of India Tetra ActHib Easy four Chiron Panacea DTwP + HepB DTwP + HepB + Hib Pentavac SD Serum Institute of India Easy five Chiron Panacea Comvac 5 Bharat Biotech

5 168 VACCINE BRAND Marketed by DTaP + Hib DTap +Hib+ IPV Pentaxim Vi typhoid Typhbar Bharat Biotech Typhim Vi Typhrix GSK Biologicals Biotyph Biomed HPV quadrivalent Gardasil MSD HPV bivalent Cervarix GSK Biologicals PCV13 Prvenar 13 Pfizer-Wyeth PPV23 Pneumo 23 Pneumo Vax MSD Inactivated Hepatitis A Havrix GSK Biologicals Avaxim Hep A and Hep B Twinrix GSK Biologicals Live attenuated Hep A Biovac A Wockhardt Varicella Varilrix GSK Biologicals Okavax Human Monovalent Rotavirus Rotarix GSK Biologicals Bovine Human Pentavalent Rotateq MSD Rotavirus Trivalent Inactivated Influenza Vaxigrip Agripal Chiron Panacea Influvac Solvey Rabies Rabivac (HDCV) Serum Institute of India Rabipur (PCEC) Novartis Abhayrab (PVRV) Abhay Verorab Vaxirab (PDEV) Live JE MPSV- A +C+ Y + W135 Quadrimeningo Biomed Mencivax GSK Biologicals A + C Biomeningo Biomed Yellow Fever Stamaril Cholera Shanchol Shanta Biotech The Table provides commonly available licensed brands of the vaccine and the list is not exhaustive

6 169 INDEX A Adverse Events following Immunization 39 Adverse vaccine reactions 40 Controversies in vaccine safety 41 Introduction 39 Vaccine associated adverse event reporting system (VAERS) 42 Annexures IAP Immunization Time Table IAP Immunization Schedule List of Vaccine brands available in India 167 B Basic Immunology and Elementary Epidemiology 9 Basics of epidemiology 19 Determinants of intensity & duration of immune responses 15 Epidemiologic shift 22 First steps after immunization 13 Force of transmission and Basic Reproductive Number (Ro) 20 Herd immunity and Herd effect 22 How do vaccines work? 12 Humoral Vs Cell mediated immunity: 11 Immune Memory and need for boosters 17 Immune responses during early life immunization 17 Immune responses to vaccines 13 Immunology of Vaccination 11 Impact of vaccinology on disease epidemiology 19 Incidence and Prevalence of diseases 20 Phases in vaccine development 22 Primary Vs Secondary Immune responses 14 Section 1: Basic Immunology of Vaccination 11 Section 2: Elementary Epidemiology of Vaccination 19 Type of Vaccines 12 Vaccine characteristics and development 21 C Cold Chain 28 Cold box / Vaccine carriers 35 Cold chain equipment 31 Domestic refrigerator 32 Introduction 28 Storage of Vaccines 36 Temperature and light sensitivity of vaccines 28 Thermometers 30 Vaccine Monitoring Tools 29 Vaccine Vial Monitors 29 I Immunization in Special Situations 143 Catch up immunization 148 Immunization during illness 148 Immunization for travelers 149 Immunization in children with history of allergy 147 Immunization in pregnancy/ lactation 150

7 170 Immunization in preterm/low birth weight infants 143 Immunization in relation to antibody containing products 147 Immunization in the immunocompromised 143 Immunization of children with bleeding disorders or those receiving anticoagulants 150 Immunization of children with chronic diseases 147 Immunization of the elderly 148 Interchangeability of brands 148 Lapsed immunization/ preponed immunization/ unknown immunization status 148 Immunization of Adolescents 141 IAP Recommendations for Adolescent immunization in special circumstances 142 IAP Recommendations for Adolescents travellers 142 IAP Recommendations for Catch up Immunization in Adolescents 141 IAP Recommended vaccines for Adolescents 141 Immunization Schedule 43 Expanded Program of Immunization (EPI) and Universal Immunization Program (UIP) 43 IAP Immunization Schedule 44 National Immunization Schedule 43 Individual Vaccines 47 Bacillus Calmette Guerin (BCG) Vaccine 47 Cholera Vaccines 130 Combination Vaccines 78 DT Vaccine 61 DTaP VACCINE 58 DTwP VACCINE 56 Hemophilus Influenzae Type B (Hib) Conjugate Vaccines 70 Hepatitis A Vaccines 104 Hepatitis B (Hep B) Vaccine 74 Human Papilloma Virus (HPV) Vaccines 84 Influenza Vaccines 123 Japanese Encephalitis Vaccines 137 Measles Vaccine 65 Meningococcal Vaccines 131 MMR Vaccine 69 Pneumococcal Vaccines 90 Polio Vaccines 49 Rabies Vaccines 119 Rota Virus Vaccines 112 Rubella Vaccine 67 Td VACCINE 62 Tdap VACCINE 62 Tetanus Toxoid (TT) 60 Typhoid Vaccines 81 Varicella Vaccine 107 Yellow Fever Vaccine 139 Internet Resources for Immunization Information 157 Introduction 6 Immunization in India - Past, Present and Future 6 L Licensing procedure and inclusion of a vaccine in the NIP in India 151 Assessment of efficacy, quality and safety of the vaccine 154 Assessment of other interventions available 154 Assessment of public health priority 153 Economic/ financial issues 154

8 171 Introduction of a new vaccine in the NIP 152 Issues in decision making 152 National Regulatory Authority (NRA) & licensing procedure 151 Programmatic strength 156 Vaccine presentation 155 Vaccine supply, availability and quality 155 P Practical Aspects of Immunization 23 Communicating with parents/care givers 23 Injection procedure 24 Medicolegal aspects 27 Record keeping 26 R Ready Reckoner for Vaccines currently available in India 158

9 175 IAP COMMITTEE ON IMMUNIZATION (IAPCOI) Chairperson Dr. Panna Choudhury Co-Chairperson Dr. Naveen Thacker Convener Dr. Vijay Yewale Immediate Past Convener Dr. Tanu Singhal Members Dr. Vipin Vashishta Dr. Sangeeta Yadav Dr. Baldev Prajapati Dr. S. Balasubramaniam Dr. Nupur Ganguly Ex-Officio Members Dr. Y.K. Amdekar (IAPCOI Chairperson, ) Dr. Deepak Ugra Dr. T.U. Sukumaran Dr. Rohit Agrawal Dr. Tanmay Amladi Dr. Indrashekhar Rao Dr. Ritabrata Kundu Dr. Digant Shastri Dr. Pravin Mehta

10 176 Address for correspondence: Indian Academy of Pediatrics Kailas Darshan, Kennedy Bridge, Near Nana Chowk, Mumbai, India