IAP Textbook of VACCINES: January 2014
IAP Textbook of VACCINES: January 2014
IAP Textbook of VACCINES: January 2014
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VACCINES
Editors
Academic Editors
Panna Choudhury MBBS DCH MD FIAP FIMSA FRSTMH FAMS Vijay N Yewale MD DCH
Consultant Pediatrician Consultant
Vice Chairman, Child Health Foundation Dr Yewale Multispecialty Hospital for Children
Executive Director, Indian Academy of Pediatrics Navi Mumbai, Maharashtra, India
New Delhi, India
Associate Editors
Foreword
Stanley A Plotkin
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© 2014, Editors
The views and opinions expressed in this book are solely those of the original contributor(s)/author(s) and do not necessarily represent
those of editor(s) of the book.
All rights reserved. No part of this publication may be reproduced, stored or transmitted in any form or by any means, electronic,
mechanical, photocopying, recording or otherwise, without the prior permission in writing of the publishers.
All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their
respective owners. The publisher is not associated with any product or vendor mentioned in this book.
Medical knowledge and practice change constantly. This book is designed to provide accurate, authoritative information about the
subject matter in question. However, readers are advised to check the most current information available on procedures included and
check information from the manufacturer of each product to be administered, to verify the recommended dose, formula, method and
duration of administration, adverse effects and contraindications. It is the responsibility of the practitioner to take all appropriate safety
precautions. Neither the publisher nor the author(s)/editor(s) assume any liability for any injury and/or damage to persons or property
arising from or related to use of material in this book.
This book is sold on the understanding that the publisher is not engaged in providing professional medical services. If such advice or
services are required, the services of a competent medical professional should be sought.
Every effort has been made where necessary to contact holders of copyright to obtain permission to reproduce copyright material. If any
have been inadvertently overlooked, the publisher will be pleased to make the necessary arrangements at the first opportunity.
Inquiries for bulk sales may be solicited at: jaypee@jaypeebrothers.com
IAP Textbook of Vaccines
First Edition: 2014
ISBN: 978-93-5090-947-8
Printed at
Dedication
This endeavor of the Academy is dedicated to:
“The children of this great country—The future of our nation”
IAP Committee on Immunization
(IAPCOI), 2011-13
CHAIRPERSONS
Rohit Agrawal
TU Sukumaran
CONVENER
Vipin M Vashishtha
MEMBERS
Amarjeet Chitkara
Manjori Mitra
S Sanjay
SG Kasi
Suhas V Prabhu
ADVISORS
Nitin K Shah
Raju C Shah
Naveen Thacker
A Parthasarathy
EX-OFFICIO
Panna Choudhury (Chairman, IAPCOI, 2009-11)
Vijay N Yewale (Convener, IAPCOI, 2009-11)
Sailesh Gupta, Honorary Secretary General, IAP
Ritabrata Kundu, Chairperson, Infectious Diseases Chapter of IAP
Abhay K Shah, Secretary, Infectious Diseases Chapter of IAP
IAP Advisory Committee of Vaccines
and Immunization Practices
(ACVIP), 2013-14
CHAIRPERSON
CP Bansal
CO-CHAIRPERSONS
Rohit Agarwal
Vijay N Yewale
CONVENER
Vipin M Vashishtha
MEMBERS
Shashi Vani
Anuradha Bose
Ajay Kalra
AK Patwari
Surjit Singh
CONSULTANTS
Narendra K Arora
Naveen Thacker
Rajesh Kumar
Ajay Gambhir
VG Ramachandran
HP Sachdev
RAPPORTEUR
Panna Choudhury
Editorial Board
Editor-in-Chief
Vipin M Vashishtha MD FIAP
Director and Consultant Pediatrician
Mangla Hospital and Research Center
Bijnor, Uttar Pradesh, India
Editors
Academic Editors
Associate Editors
CP Bansal MD PD DAP FIAP A Parthasarathy MD DCH MNAMS
Director and Consultant Pediatrician Distinguished Professor
Shabd Pratap Hospital The Tamil Nadu Dr MGR Medical University
Gwalior, Madhya Pradesh, India Retired Senior Clinical Professor of Pediatrics
Madras Medical College
Deputy Superintendent
Institute of Child Health and Hospital for Children
Chennai, Tamil Nadu, India
Contributors
Panna Choudhury MBBS DCH MD FRSTMH FIMSA FIAP FAMS Sean Patrick Fitzwater MHS
Consultant Pediatrician Research Associate
Vice-Chairman, Child Health Foundation Johns Hopkins Bloomberg School of Public Health
Executive Director, Indian Academy of Pediatrics Department of International Health
New Delhi, India Baltimore, USA
T Jacob John MBBS DCH FRCP FIAP Puneet Kumar MBBS MIAP
Formerly, Professor and Head Consultant
Department of Virology Kumar Child Clinic
Christian Medical College Dwarka, New Delhi, India
Vellore, Tamil Nadu, India
Ritabrata Kundu MD
Jacob John MBBS MD Professor, Department of Pediatric Medicine
Associate Professor Institute of Child Health
Department of Community Health Kolkata, West Bengal, India
Christian Medical College
Vellore, Tamil Nadu, India Kathryn E Lafond MPH
Influenza Division
Geoffrey David Kahn MSPH Centers for Disease Control and Prevention
Research Associate Atlanta, Georgia, USA
Johns Hopkins Bloomberg School of Public Health
Department of International Health Chandrakant Lahariya MD DNB MNAMS PGDHHM
Baltimore, USA Formerly, Assistant Professor
Department of Community Medicine
Ajay Kalra MD DCH MNAMS FIAP GR Medical College
Erstwhile Professor, SN Medical College, Agra Gwalior, Madhya Pradesh, India
Head of the Department
Rural Institute of Medical Sciences, Saifai Renu B Lal MD
Consultant, Child Health, Agra, Uttar Pradesh, India Influenza Division, National Center for Immunization and
Respiratory Diseases
Deepak Kamat MD PhD FAAP Centers for Disease Control and Prevention
Professor of Pediatrics Atlanta, Georgia, USA
Vice-Chair of Education, Department of Pediatrics
Wayne State University, Children’s Hospital of Michigan Mukta Mantan
Detroit, USA Professor, Department of Pediatrics
Maulana Azad Medical College
Gagandeep Kang MD New Delhi, India
Professor
Department of Gastrointestinal Sciences Ambika Mathur MD PhD
Christian Medical College Program Director, Interim Dean
Vellore, Tamil Nadu, India Graduate School, Wayne State University
Detroit, USA
SG Kasi MBBS DCH MD
Consultant Pediatrician Premasish Mazumdar MBBS MD DM (Neonatology)
Member, IAPCOI 2011-12 Specialist, Premature and Newborn Diseases
Bengaluru, Karnataka, India
Amit Jaggi Memorial Hospital
Agra, Uttar Pradesh, India
Satyena Katewa DCH DNB MBBS
Consultant
Parang N Mehta MD
Pediatric Oncologist
Consultant Pediatrician
Bone Marrow/Stem Cell Transplant
Mehta Hospital
BLK Super Specialty Hospital
Surat, Gujarat, India
New Delhi, India
Amrit Koirala BSc Medical Laboratory Technology (Pursuing MSc Pravin J Mehta MD DCH
Medical Microbiology) Consulting Pediatrician
Student, Christian Medical College Jack-N-Jill Nursing Home and Hindusabha Hospital
Vellore, Tamil Nadu, India Mumbai, Maharashtra, India
xvi
IAP Textbook of Vaccines
Lalitha Mendis MBBS (Cey) MD (Col) PhD (Lond) Dp Bact (Manch) F R Leon Ochiai DPhil MHS
Nat Acad Sciences SL Hon Fell CGP-SL Research Scientist
Emeritus Professor International Vaccine Institute
Department of Microbiology Seoul, South Korea
University of Colombo
Colombo, Sri Lanka Sameer Parekh BHMS MBA
Manager, Medical Affairs and Clinical Trials
Geeta MG MD Serum Institute of India Ltd
Additional Professor Pune, Maharashtra, India
Department of Pediatrics
Government Medical College A Parthasarathy MD DCH MNAMS
Kozhikode, Kerala, India Distinguished Professor
The Tamil Nadu Dr MGR Medical University
Saheli Misra MBBS MRCP (UK) DNB Retired Senior Clinical Professor of Pediatrics
Assistant Professor Madras Medical College
Institute of Child Health Deputy Superintendent
Kolkata, West Bengal, India Institute of Child Health and Hospital for Children
Chennai, Tamil Nadu, India
Monjori Mitra DCH DNB
Associate Professor Alberta Di Pasquale PhD (Vaccinology)
Institute of Child Health Director, Early Projects Global Medical Affairs
Kolkata, West Bengal, India GlaxoSmithKline Biologicals
London, UK
Archisman Mohapatra MBBS MD
Resident Yash Paul MBBS DCH
Department of Community Medicine, IMS (BHU) Consultant Pediatrician
Varanasi, Uttar Pradesh, India Maharaja Agrasen Hospital
Jaipur, Rajasthan, India
Sally Mossman PhD
Head of Viral Vaccine Program Harish K Pemde MD
GlaxoSmithKline Biologicals Professor, Department of Pediatrics
Rixensart, Belgium Lady Hardinge Medical College
Kalawati Saran Children’s Hospital
PV Murthy DCH MD New Delhi, India
Consultant Pediatrician
Venturi Clinic, Bengaluru, Karnataka, India VG Ramachandran MBBS MD
Professor, Department of Microbiology
Pritesh Nagar MBBS MD University College of Medical Sciences and GTB Hospital
Academic Coordinator and In-Charge ICUS New Delhi, India
Department of Pediatrics
Aditya Hospital, Hyderabad, Andhra Pradesh, India Gautam Rambhad MD
Associate Director
Christopher Nelson MD Medical Services
Director, Coalition against Typhoid Secretariat Wyeth Limited
Sabin Vaccine Institute Mumbai, Maharashtra, India
Washington DC, USA
Amit Rawat MD (Pathology) PDCC (Laboratory Immunology)
Jennifer Carroll O’Brien MD MPH Assistant Professor
Assocaite Professor Department of Pediatric Allergy and Immunology
University of Rochester Medical Center Advanced Pediatric Center
Brown Square Health Center Postgraduate Institute of Medical Education and Research
Rochester, New York, USA Chandigarh, India
xvii
Contributors
Diseases 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 Europe
is lagging behind in some respects, even there, epidemics of diseases, for which we have vaccines are
unusual. That is not to say that the picture is completely rosy. Failure to vaccinate is a problem in isolated
populations and some of our vaccines do not give high efficacy, owing to poor immune responses in
particular patient groups or incomplete knowledge about the correlates of protection.
India and neighboring countries have presented special problems. Until recently, governmental interest
in the introduction of new vaccines has been limited, perhaps because of a focus on polio eradication. In
addition, the vast number of potential vaccinees does not make either routine or campaign distribution
easy. Fortunately, the situation is changing for several reasons: the growing interest of physicians, the manifest importance of
Asian vaccine manufacturers, and a greater understanding by governments that vaccination carries economic as well as health
benefits.
Like politics, all vaccination must be local. Although the sixth edition of an international vaccine textbook, which I had
the honor to edit, was published last year (Vaccines, Elsevier), disease epidemiology, vaccine schedules, medical practice, and
vaccine administration differ according to local practices. Thus, a book that focuses on vaccination in Asia, where the majority of
the world’s population lives will serve an important purpose, and I hope it will be read widely throughout this huge geographical
area. Moreover, Asian physicians and scientists should contribute even more to the body of knowledge concerning vaccination
in all its aspects, from basic immunology to vaccine development and clinical trials. In that way, vaccine science will grow and
benefit people in all corners of the world.
Stanley A Plotkin MD
Emeritus Professor of Pediatrics, University of Pennsylvania
Emeritus Professor, Wistar Institute
Adjunct Professor, Johns Hopkins University
Pennsylvania, USA
From the Desk of IAP President, 2013
Indian Academy of Pediatrics (IAP) has always accorded a very high priority to the various issues related
to pediatric immunization in the country—be it framing recommendations for practicing fraternity
or issuing guidelines on the need of inclusion of a particular vaccine in the national immunization
schedule or training of program managers involved with delivery of vaccines in the field. The Academy
has also played a proactive role in taking on misinformation campaign against vaccines in media. We, as an
academic 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, the
Academy has never shrugged off its responsibility of a serious civil society organization, committed to
the wellbeing of the children of this country. The amount of significance accorded to immunization can
be gauged by the fact that a separate subcommittee of the Academy, now rechristened as Advisory Committee of Vaccines
and Immunization Practices (ACVIP), has been purposely constituted to deal with all the issues related to the practice of
immunization in the country for last many years.
The Academy is regularly publishing its recommendations on licensed vaccines and other aspects related to the pediatric
immunization in the form of a compact booklet, IAP Guidebook on Immunization. This book is one of the most sought after
publications of the Academy. Not only the practicing pediatricians, but even the vaccine manufacturers and policy makers
cite the recommendations contained in the book. However, the need of a comprehensive book on the contemporary Indian
scenario of vaccine-preventable diseases, vaccines, and practice of vaccination was felt for quite some time. As Chair of the
ACVIP, and also as President of the Academy in this Golden Jubilee year, I think this book is a perfect gift by the committee
to all the stakeholders involved in the field of immunization in the country and abroad. I am pretty sure that this venture shall
fulfill the great void in our understanding of vaccine sciences and would serve as a reference material to all concerned. In the
last, I congratulate all the contributors from the country and abroad, and the editors who have worked very hard to bring out
this precious publication.
There seems no exaggeration in William Foege’s words when he uttered, “Vaccines are the tugboats of preventive health”. Apart
from sanitation and safe water, no other intervention seems as powerful as vaccination in providing insulation to humankind
from dreadful diseases. Vaccination has been so effective in taking on some of the formidable diseases that people became
complacent 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 is
applicable only for the children residing in less than half of the globe. For majority living in far more hostile and challenging
conditions of the third world, the VPDs are still very much on the horizon. In fact, the children of the less developed countries
need the umbrella of modern vaccination much more than their counterparts of developed world. The full potential of modern-
day vaccines in making humankind disease-free, cannot be exploited until they are employed in the regions of the globe where
their 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 responsible
for 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 the
overall program in many fields is still far from satisfactory. Coverage of many traditional vaccines remains disconcertingly low
and many new vaccines that protect against today’s some of the greatest threats to children, including pneumococcal disease
and rotavirus have yet to be introduced into NIP. There are many barriers to achieve desired results; paucity of trained health
professionals and workers in the field of vaccination is one of them. Furthermore, there is scarcity of good quality training and
reliable 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 safety
may be detrimental to a well-established vaccination program of any nation. However, it may prove to be fatal to a developing
country’s ongoing vaccination initiatives as experienced in India in recent times. This phenomenon is growing worldwide and
needs to be tackled with deft risk communication. One must not forget James Shannon’s words, “The only safe vaccine is a
vaccine that is never used.”
The Indian Academy of Pediatrics has been at the forefront of advocacy and training pertaining to vaccination, particularly
in the private sector of the country. It has been periodically issuing its recommendations for both public and private health
care sectors in the form of bundled guidelines contained in a ‘Guidebook of Immunization’. However, the need of a publication
containing detailed region-specific information on the epidemiology of VPDs and vaccines has been felt for quite long. This
endeavor 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 vaccinology
including currently available licensed vaccines and general aspects of immunization. Sections are also devoted to vaccines in the
pipeline 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 neighboring
South-Central and South-Eastern Asian countries. Special emphasis is provided to disease epidemiology and vaccine needs of
India and neighboring countries. This publication should also serve as a reference material for international health agencies,
government health establishments, vaccine developers, immunization program managers, and vaccine funding agencies. At
the same time, the book should also be of great utility to postgraduate students, faculty members of medical institutions, and
practicing pediatricians of the country.
xxiv
IAP Textbook of Vaccines
A galaxy of national and international experts in the field of immunization has contributed enthusiastically to this project.
We are grateful to all of them for sparing their invaluable time for the book and sharing their vast expertise in the respective
fields of immunization. We apologize for irksome requests and ultimatums, if any in order to meet the deadline. We do sincerely
hope this edition will be considered as a useful resource in the field for all those who recognize the need and the value of vaccines
in the arena of child health.
Vipin M Vashishtha
Rohit Agrawal
TU Sukumaran
Nitin K Shah
Naveen Thacker
Panna Choudhury
Vijay N Yewale
CP Bansal
A Parthasarathy
Acknowledgments
The editors are highly thankful to the dedicated team of publishers, particularly Dr Neeraj Choudhary and Ms Madhvi Thakur
for their untiring efforts that culminated in publication of this book in time. The assistance provided by Dr Ajay Kalra and
Dr Chandrakant Lahariya in reviewing many manuscripts is also thankfully acknowledged.
Contents
SECTION 3: VACCINES IN DEVELOPMENT, NEW VACCINE STRATEGIES AND VACCINES IN THE PIPELINE
Chapter 52: Respiratory Syncytial Virus Vaccines and Parainfluenza Virus Vaccines 472
Dhanya Dharmapalan, Vijay N Yewale
Chapter 53: New Technologies for Vaccine Development 475
Anil Dutta, Nathalie Garçon, Sally Mossman
Chapter 63: New Thinking on the Value of Vaccination—Globally and in India 563
Till Bärnighausen, David E Bloom, Elizabeth T Cafiero, Jennifer Carroll O’Brien
Chapter 64: Role of National Technical Advisory Group for Immunization and
National Regulatory Authority in Vaccination Programs and Practices 572
Archisman Mohapatra, Narendra K Arora
Chapter 69: Web Sites Containing Reliable Information Regarding Immunization 602
Jeeson C Unni
Appendices
1. National Immunization Schedule for Infants, Children and Pregnant Women 609
2. IAP Immunization Timetable 2013 610
3. IAP Recommended Immunization Schedule for Children Aged 0-18 Years (With Range), 2013 612
Index 619