IAP Textbook Of VACCINES - ACVIP

xvContributorsT Jacob John MBBS DCH FRCP FIAPPuneet Kumar MBBS MIAPFormerly, Professor and HeadDepartment of VirologyChristian Medical CollegeVellore, Tamil Nadu, IndiaConsultantKumar Child ClinicDwarka, New Delhi, IndiaJacob John MBBS MDProfessor, Department of Pediatric MedicineInstitute of Child HealthKolkata, West Bengal, IndiaAssociate ProfessorDepartment of Community HealthChristian Medical CollegeVellore, Tamil Nadu, IndiaGeoffrey David Kahn MSPHResearch AssociateJohns Hopkins Bloomberg School of Public HealthDepartment of International HealthBaltimore, USAAjay Kalra MD DCH MNAMS FIAPErstwhile Professor, SN Medical College, AgraHead of the DepartmentRural Institute of Medical Sciences, SaifaiConsultant, Child Health, Agra, Uttar Pradesh, IndiaDeepak Kamat MD PhD FAAPProfessor of PediatricsVice-Chair of Education, Department of PediatricsWayne State University, Children’s Hospital of MichiganDetroit, USAGagandeep Kang MDProfessorDepartment of Gastrointestinal SciencesChristian Medical CollegeVellore, Tamil Nadu, IndiaSG Kasi MBBS DCH MDConsultant PediatricianMember, IAPCOI 2011-12Bengaluru, Karnataka, IndiaSatyena Katewa DCH DNB MBBSConsultantPediatric OncologistBone Marrow/Stem Cell TransplantBLK Super Specialty HospitalNew Delhi, IndiaAmrit Koirala BSc Medical Laboratory Technology (Pursuing MScMedical Microbiology)Student, Christian Medical CollegeVellore, Tamil Nadu, IndiaRitabrata Kundu MDKathryn E Lafond MPHInfluenza DivisionCenters for Disease Control and PreventionAtlanta, Georgia, USAChandrakant Lahariya MD DNB MNAMS PGDHHMFormerly, Assistant ProfessorDepartment of Community MedicineGR Medical CollegeGwalior, Madhya Pradesh, IndiaRenu B Lal MDInfluenza Division, National Center for Immunization andRespiratory DiseasesCenters for Disease Control and PreventionAtlanta, Georgia, USAMukta MantanProfessor, Department of PediatricsMaulana Azad Medical CollegeNew Delhi, IndiaAmbika Mathur MD PhDProgram Director, Interim DeanGraduate School, Wayne State UniversityDetroit, USAPremasish Mazumdar MBBS MD DM (Neonatology)Specialist, Premature and Newborn DiseasesAmit Jaggi Memorial HospitalAgra, Uttar Pradesh, IndiaParang N Mehta MDConsultant PediatricianMehta HospitalSurat, Gujarat, IndiaPravin J Mehta MD DCHConsulting PediatricianJack-N-Jill Nursing Home and Hindusabha HospitalMumbai, Maharashtra, India

xviIAP Textbook of VaccinesLalitha Mendis MBBS (Cey) MD (Col) PhD (Lond) Dp Bact (Manch) FNat Acad Sciences SL Hon Fell CGP-SLEmeritus ProfessorDepartment of MicrobiologyUniversity of ColomboColombo, Sri LankaGeeta MG MDAdditional ProfessorDepartment of PediatricsGovernment Medical CollegeKozhikode, Kerala, IndiaSaheli Misra MBBS MRCP (UK) DNBAssistant ProfessorInstitute of Child HealthKolkata, West Bengal, IndiaMonjori Mitra DCH DNBAssociate ProfessorInstitute of Child HealthKolkata, West Bengal, IndiaArchisman Mohapatra MBBS MDResidentDepartment of Community Medicine, IMS (BHU)Varanasi, Uttar Pradesh, IndiaSally Mossman PhDHead of Viral Vaccine ProgramGlaxoSmithKline BiologicalsRixensart, BelgiumPV Murthy DCH MDConsultant PediatricianVenturi Clinic, Bengaluru, Karnataka, IndiaPritesh Nagar MBBS MDAcademic Coordinator and In-Charge ICUSDepartment of PediatricsAditya Hospital, Hyderabad, Andhra Pradesh, IndiaChristopher Nelson MDDirector, Coalition against Typhoid SecretariatSabin Vaccine InstituteWashington DC, USAJennifer Carroll O’Brien MD MPHAssocaite ProfessorUniversity of Rochester Medical CenterBrown Square Health CenterRochester, New York, USAR Leon Ochiai DPhil MHSResearch ScientistInternational Vaccine InstituteSeoul, South KoreaSameer Parekh BHMS MBAManager, Medical Affairs and Clinical TrialsSerum Institute of India LtdPune, Maharashtra, IndiaA Parthasarathy MD DCH MNAMSDistinguished ProfessorThe Tamil Nadu Dr MGR Medical UniversityRetired Senior Clinical Professor of PediatricsMadras Medical CollegeDeputy SuperintendentInstitute of Child Health and Hospital for ChildrenChennai, Tamil Nadu, IndiaAlberta Di Pasquale PhD (Vaccinology)Director, Early Projects Global Medical AffairsGlaxoSmithKline BiologicalsLondon, UKYash Paul MBBS DCHConsultant PediatricianMaharaja Agrasen HospitalJaipur, Rajasthan, IndiaHarish K Pemde MDProfessor, Department of PediatricsLady Hardinge Medical CollegeKalawati Saran Children’s HospitalNew Delhi, IndiaVG Ramachandran MBBS MDProfessor, Department of MicrobiologyUniversity College of Medical Sciences and GTB HospitalNew Delhi, IndiaGautam Rambhad MDAssociate DirectorMedical ServicesWyeth LimitedMumbai, Maharashtra, IndiaAmit Rawat MD (Pathology) PDCC (Laboratory Immunology)Assistant ProfessorDepartment of Pediatric Allergy and ImmunologyAdvanced Pediatric CenterPostgraduate Institute of Medical Education and ResearchChandigarh, India

xviiContributorsAnupam Sachdeva MDArun Shah MD DCH FIAP FIAMSConsultant Pediatrician and DirectorPediatric Hematoncology andBone Marrow TransplantationSir Ganga Ram HospitalNew Delhi, IndiaConsultant PediatricianBrahampuraMuzaffarpur, Bihar, IndiaSiddhartha Saha MDPublic Health SpecialistIndia Influenza CenterCenters for Disease Control and PreventionAtlanta, Georgia, USASushant Sahastrabuddhe MBBS MPHAssociate Research ScientistInternational Vaccine InstituteSeoul, South KoreaMathuram Santosham MD MPHProfessorDirector, Health Systems ProgramDirector, Center for American Indian HealthProfessor, International Health and PediatricsJohns Hopkins UniversityBaltimore, USANitin K Shah MBBS MD DCHConsultant Pediatric HematoncologistPD Hinduja National Hospital andMedical Research CenterMumbai, Maharashtra, IndiaRaju C Shah MD FIAPProfessor and HeadDepartment of PediatricsGCS Medical CollegeAhmedabad, Gujarat, IndiaPratima Shah MBBS MDFormer ProfessorDepartment of PediatricsSBKS Medical CollegeAnkur Institute of Child HealthAhmedabad, Gujarat, IndiaAbhay K Shah MBBS (Gold Medalist)DPED (UNI First) MD (Gold Medalist)DirectorDr Abhay K Shah Children HospitalHonorary Secretary, ID Chapter of IAPPresident, IAP GujaratAhmedabad, Gujarat, IndiaHimani Shah MBBS MD FCPSConsultant PediatricianChandrajyoti HospitalMumbai, Maharashtra, IndiaHitt Sharma MBBS PGDCT PDCRAdditional DirectorDepartment of Medical Affairs andClinical TrialsSerum Institute of India LtdPune, Maharashtra, IndiaSangeeta Sharma MBBS MD (Pharmacology)HeadDepartment of PediatricsNational Institute of TB and Respiratory DiseasesMember Secretary, National Technical Working Group ofPediatric TBMinistry of Health and Family WelfareGovernment of IndiaNew Delhi, IndiaDigant D Shastri MD FIAP PGDHHMChief Consultant Pediatrician and CEOKillol Children HospitalNICU and Vaccination CenterSurat, Gujarat, IndiaSurjit Singh MD DCH (Lon) FRCP (Lon) FRCPCH (Lon) FIAP FAMSProfessor of Pediatrics and ChiefPediatric Allergy and Immunology UnitAdvanced Pediatric CenterPostgraduate Institute of Medical Education and ResearchChandigarh, IndiaTanu Singhal MSc (Tropical Medicine & International Health) MDConsultantPediatrics and Infectious DiseaseKokilaben Dhirubhai Ambani Hospital andMedical Research InstituteMumbai, Maharashtra, IndiaSanjay Srirampur MDHead, Department of PediatricsAditya HospitalHyderabad, Andhra Pradesh, India

xviiiIAP Textbook of VaccinesKamath SS MBBS DCH MDMedical Director and Consultant PediatricianWelcare HospitalKochi, Kerala, IndiaWayne Sullender MDVisiting ProfessorChildrens HospitalBirmingham, Alabama, USAA Sumanth MBBS DCH DNBPS Medical College, Karamsad, GujaratRetired Professor and HeadDepartment of Pediatrics and NeonatologyBJ Medical CollegeAhmedabad, Gujarat, IndiaVipin M Vashishtha MD FIAPDirector and Consultant PediatricianMangla Hospital and Research CenterBijnor, Uttar Pradesh, IndiaSenior Registrar, Department of PediatricsKanchi Kamakoti Childs Trust Hospital and the Childs TrustMedical Research FoundationChennai, Tamil Nadu, IndiaJignesh Ved MBBS MD PGDMMFernanda Tavares MDSanjay Verma MDDirectorTherapeutic Area HeadGlaxoSmithKline vaccinesWavre Nord, Wavre, BelgiumAssistant Professor, Department of PediatricsAdvanced Pediatric CenterPostgraduate Institute of Medical Education and ResearchChandigarh, IndiaNaveen Thacker MD FIAPMarc-Alain Widdowson MDDirector, Deep Children Hospital and Research CenterHead, Department of PediatricsSahyadri Ramkrishna Specialty HospitalKutch, Gujarat, IndiaNational Center for Immunizations and Respiratory DiseaseCenters for Disease Control and PreventionAtlanta, Georgia, USASatish Kamtaprasad Tiwari MD LLB FIAP IBCLCDirector ProfessorDepartment of PediatricsMaulana Azad Medical College and Associated HospitalsUniversity of DelhiNew Delhi, IndiaProfessor and HeadDepartment of PediatricsDr Panjabrao Deshmukh Memorial Medical College, AmravatiFounder PresidentIndian Medicolegal and Ethics AssociationAmaravati, Maharashtra, IndiaJeeson C Unni MD DCH FIAPConsultant PediatricianDr Kunhalu’s Nursing HomeCochin, Kerala, IndiaShashi N Vani MBBS MD FIAPEmeritus ProfessorDepartment of PediatricsSenior Medical AdvisorPfizer India LimitedMumbai, Maharashtra, IndiaSangeeta Yadav MD FIAPVijay N Yewale MD DCHConsultantDr Yewale Multispecialty Hospital for ChildrenNavi Mumbai, Maharashtra, IndiaRajeev Zachariah MD DCHWell Baby ClinicDepartment of Child HealthChristian Medical CollegeVellore, Tamil Nadu, India

ForewordDiseases preventable by vaccination are disappearing all over the world as vaccine coverage increases.Certain infectious diseases have been essentially eliminated from the Americas, and although Europeis lagging behind in some respects, even there, epidemics of diseases, for which we have vaccines areunusual. That is not to say that the picture is completely rosy. Failure to vaccinate is a problem in isolatedpopulations and some of our vaccines do not give high efficacy, owing to poor immune responses inparticular patient groups or incomplete knowledge about the correlates of protection.India and neighboring countries have presented special problems. Until recently, governmental interestin the introduction of new vaccines has been limited, perhaps because of a focus on polio eradication. Inaddition, the vast number of potential vaccinees does not make either routine or campaign distributioneasy. Fortunately, the situation is changing for several reasons: the growing interest of physicians, the manifest importance ofAsian vaccine manufacturers, and a greater understanding by governments that vaccination carries economic as well as healthbenefits.Like politics, all vaccination must be local. Although the sixth edition of an international vaccine textbook, which I hadthe honor to edit, was published last year (Vaccines, Elsevier), disease epidemiology, vaccine schedules, medical practice, andvaccine administration differ according to local practices. Thus, a book that focuses on vaccination in Asia, where the majority ofthe world’s population lives will serve an important purpose, and I hope it will be read widely throughout this huge geographicalarea. Moreover, Asian physicians and scientists should contribute even more to the body of knowledge concerning vaccinationin all its aspects, from basic immunology to vaccine development and clinical trials. In that way, vaccine science will grow andbenefit people in all corners of the world.Stanley A Plotkin MDEmeritus Professor of Pediatrics, University of PennsylvaniaEmeritus Professor, Wistar InstituteAdjunct Professor, Johns Hopkins UniversityPennsylvania, USA

From the Desk of IAP President, 2013Indian Academy of Pediatrics (IAP) has always accorded a very high priority to the various issues relatedto pediatric immunization in the country—be it framing recommendations for practicing fraternityor issuing guidelines on the need of inclusion of a particular vaccine in the national immunizationschedule or training of program managers involved with delivery of vaccines in the field. The Academyhas also played a proactive role in taking on misinformation campaign against vaccines in media. We, as anacademic body, have contributed a lot in the success of Global Polio Eradication Initiative in the country,and now giving technical support to the ongoing Measles and Rubella Elimination Initiative. In fact, theAcademy has never shrugged off its responsibility of a serious civil society organization, committed tothe wellbeing of the children of this country. The amount of significance accorded to immunization canbe gauged by the fact that a separate subcommittee of the Academy, now rechristened as Advisory Committee of Vaccinesand Immunization Practices (ACVIP), has been purposely constituted to deal with all the issues related to the practice ofimmunization in the country for last many years.The Academy is regularly publishing its recommendations on licensed vaccines and other aspects related to the pediatricimmunization in the form of a compact booklet, IAP Guidebook on Immunization. This book is one of the most sought afterpublications of the Academy. Not only the practicing pediatricians, but even the vaccine manufacturers and policy makerscite the recommendations contained in the book. However, the need of a comprehensive book on the contemporary Indianscenario of vaccine-preventable diseases, vaccines, and practice of vaccination was felt for quite some time. As Chair of theACVIP, and also as President of the Academy in this Golden Jubilee year, I think this book is a perfect gift by the committeeto all the stakeholders involved in the field of immunization in the country and abroad. I am pretty sure that this venture shallfulfill the great void in our understanding of vaccine sciences and would serve as a reference material to all concerned. In thelast, I congratulate all the contributors from the country and abroad, and the editors who have worked very hard to bring outthis precious publication.CP Bansal MD PD DAP FIAPPresident, Indian Academy of Pediatrics, 2013Director and Consultant PediatricianShabd Pratap HospitalGwalior, Madhya Pradesh, India

PrefaceThere seems no exaggeration in William Foege’s words when he uttered, “Vaccines are the tugboats of preventive health”. Apartfrom sanitation and safe water, no other intervention seems as powerful as vaccination in providing insulation to humankindfrom dreadful diseases. Vaccination has been so effective in taking on some of the formidable diseases that people becamecomplacent about vaccine-preventable diseases (VPDs) in many developed countries. It is kind of “out-of-sight, out-of-mind”situation for many VPDs owing to effective vaccination as quite eloquently described by David Neumann. Yet, this phrase isapplicable only for the children residing in less than half of the globe. For majority living in far more hostile and challengingconditions of the third world, the VPDs are still very much on the horizon. In fact, the children of the less developed countriesneed the umbrella of modern vaccination much more than their counterparts of developed world. The full potential of modernday vaccines in making humankind disease-free, cannot be exploited until they are employed in the regions of the globe wheretheir needs are felt the most.The need of the vaccines is felt the most in India, which accounts for 20% of the world’s child population, and responsiblefor 24% of all under-five deaths globally. India has been using vaccines since late 70s in its National Immunization Program(NIP) and currently running one of the largest mass immunization programs in the world. However, the performance of theoverall program in many fields is still far from satisfactory. Coverage of many traditional vaccines remains disconcertingly lowand many new vaccines that protect against today’s some of the greatest threats to children, including pneumococcal diseaseand rotavirus have yet to be introduced into NIP. There are many barriers to achieve desired results; paucity of trained healthprofessionals and workers in the field of vaccination is one of them. Furthermore, there is scarcity of good quality training andreliable resources in the field of vaccinology in the country.Resistance to vaccination is almost as old as Jenner’s smallpox vaccine. Misinformation campaigns against vaccine’s safetymay be detrimental to a well-established vaccination program of any nation. However, it may prove to be fatal to a developingcountry’s ongoing vaccination initiatives as experienced in India in recent times. This phenomenon is growing worldwide andneeds to be tackled with deft risk communication. One must not forget James Shannon’s words, “The only safe vaccine is avaccine that is never used.”The Indian Academy of Pediatrics has been at the forefront of advocacy and training pertaining to vaccination, particularlyin the private sector of the country. It has been periodically issuing its recommendations for both public and private healthcare sectors in the form of bundled guidelines contained in a ‘Guidebook of Immunization’. However, the need of a publicationcontaining detailed region-specific information on the epidemiology of VPDs and vaccines has been felt for quite long. Thisendeavor of the Academy in the form of a comprehensive textbook on vaccines must be viewed as an attempt to fill this void.The first edition of the book is in your hands for your perusal. It covers almost all the aspects related to modern vaccinologyincluding currently available licensed vaccines and general aspects of immunization. Sections are also devoted to vaccines in thepipeline along with newer vaccine techniques. A separate section of the book deals with issues related to vaccine policies, trials,ethics and regulatory needs.The book shall provide in-depth information to the professionals working in the field of vaccination in India and neighboringSouth-Central and South-Eastern Asian countries. Special emphasis is provided to disease epidemiology and vaccine needs ofIndia and neighboring countries. This publication should also serve as a reference material for international health agencies,government health establishments, vaccine developers, immuniz

Rohit Agrawal MBBS DCH MD Director, Chandrajyoti Children’s Hospital Consultant Pediatrician, Kohinoor Hospital Mumbai, Maharashtra, India Shilpa Khanna Arora MBBS MD . Anuradha Bose MBBS MD DCH MRCP FRCPCH Professor Department of Pediatrics Christian Medical College Vellore, Tamil Nadu, India