IAP 2013–14 Guidebook on Immunization IAP Guidebook

426 Pages·2014·13.62 MB·English

IIIIAAAAPPPP
GGGGuuuuiiiiddddeeeebbbbooooooookkkk oooonnnn
IIIImmmmmmmmuuuunnnniiiizzzzaaaattttiiiioooonnnn
2222000011113333––––11114444
IAP Guidebook on Immunization 2013–14
© Indian Academy of Pediatrics 2014
All rights reserved. No part of this publication should be reproduced, stored
in a retrieval system, or transmitted in any form or by any means:
electronic, mechanical, photocopying, recording or otherwise, without the
prior written permission of the Indian Academy of Pediatrics.
Address for correspondence:
Indian Academy of Pediatrics,
Kailas Darshan, Kennedy Bridge, Near Nana Chowk,
Mumbai, India 400 007.
Tel: [phone]
E-mail: [email protected]
Website: www.iapindia.org
Edition :
2014
While every effort has been made to ensure accuracy of the contents,
the editors, publisher and printer will not be held responsible
for any inadvertent error(s).
Price :
$ 350.00
Typeset & Printed at:
Nandini Graphics
Gwalior
Publishers:
National Publication House,
Indian Academy of Pediatrics,
Gwalior.
ii | IAP Guidebook on Immunization 2013–14
IIIIAAAAPPPP
GGGGuuuuiiiiddddeeeebbbbooooooookkkk oooonnnn
IIIImmmmmmmmuuuunnnniiiizzzzaaaattttiiiioooonnnn
2222000011113333––––11114444
BByy
AAddvviissoorryy CCoommmmiitttteeee oonn VVaacccciinneess && IImmmmuunniizzaattiioonn PPrraaccttiicceess ((AACCVVIIPP))
Editors
Vipin M. Vashishtha
Panna Choudhury
C.P. Bansal
Vijay N. Yewale
Rohit Agarwal
Disclaimer
‘IAP ACVIP’ has formulated these guidelines on the most
optimum way of using available licensed vaccines in the
country to provide best possible protection to an
individual child in an office practice setting. However,
members may use their own discretion while using them
in a given situation within the framework suggested. They
may not necessarily be construed as the Academy's
approval of the particular product for wider, mass use in
national/sub-national large-scale programs.
From
the
IAP Office
“Vaccines are the tugboats of preventive health”.
– William Foege
Childhood vaccines are one of the great triumphs of modern
medicine. They are undoubtedly the most cost-effective
healthcare interventions. We often fail to realize that rupees
spent on a childhood vaccination not only helps save a life,
but also greatly reduces spending on future healthcare. The
success of smallpox eradication and now of polio eradication
programs in the country are testimony to this. IAP has
always accorded highest priority to vaccines and vaccination
issues. In fact, a separate subcommittee with complete
autonomy has been assigned the task of framing
recommendations on childhood vaccines and dealing with
other issues pertaining to pediatric immunization.
The IAP recommendations on immunization are the most
sought after publication of the Academy. Not only IAP
members and pediatricians follow them religiously, but also
public health experts, vaccine industry people, policy
makers, and healthcare professional dealing with preventive
medicine, need to consult them at some point of time.
Considering the huge stakes, the academy tries its level best
to ensure that these guidelines are evidence-based,
transparent, rational and ethical. Still there is criticism of
the recommendations, often labeled as 'biased', 'unfair', or
IAP Guidebook on Immunization 2013–14 | v
'influenced' by different quarters on many occasions in the
past. The constitution of the new committee on
immunization, IAP Advisory Committee on Vaccines and
Immunization Practices (ACVIP) must be seen as an earnest
attempt to avoid all these speculative controversies.
IAP now has a basket of publications related to
immunization. 'IAP Immunization Timetable' is revised every
year, the detailed recommendations are published in a
booklet form, 'IAP Guidebook on Immunization' every two
year, and a comprehensive discourse on almost every aspect
related to immunization with details is contained in a book
form, 'IAP Textbook of Vaccines'. The academy has now
empowered individual pediatrician and health professional
to access IAP's immunization guidelines on their own mobile
sets with facility to customize their patients' vaccination
schedule or set vaccine reminders for them with the launch
of interactive 'Mobile Apps'. However, the Guidebook on
Immunization still remains the most premium publication.
We are thankful to the editors and to all the committee
members for revising and bringing this publication in a new,
much more improved form. It would be our endeavor to make
this prestigious publication available to each member of the
academy at free of cost.
C.P. Bansal Rohit Agarwal Vijay N. Yewale Sailesh Gupta
(President 2013) (President 2012) (President 2014) (Hon. Secretary
General, 2011–13)
vi | IAP Guidebook on Immunization 2013–14
Preface
“…..So it's an absolute lie that has killed thousands of kids.
Because the mothers who heard that lie, many of them
didn't have their kids take either pertussis or measles
vaccine, and their children are dead today. And so the
people who go and engage in those anti-vaccine efforts --
you know, they, they kill children. It's a very sad thing,
because these vaccines are important.”
-Bill Gates commenting on the paper by
Dr. Wakefield, published in Lancet using
fraudulent data
Vaccination scene in India has been at crossroads as newer
vaccines are being regularly licensed in the country but
public sector catering to vast number of beneficiaries is
extremely slow to absorb it. Private sector is the main user of
newer vaccines but caters to only small section of well-to-do
populations. Controversies are plenty and financial motive
is the buzzword in vaccination practices. Many vaccination
policies are openly criticized by the media and handful of
disbelievers able to block the propagation of newer vaccines.
This is despite clear benefits of vaccination in eradication of
smallpox, near eradication of polio and significant reduction
of many diseases including measles-related deaths through
vaccination. Main reasons for this situation are lack of
awareness and demand for vaccines from the within,
absence of hard-core evidence, inability to present the
IAP Guidebook on Immunization 2013–14 | vii
evidence in a structured format, lack of transparency
including dealing with conflict of interest issues while
formulating immunization policies, etc. Further there is
exaggeration of adverse events associated with new vaccines
in the lay media and each serious event is blamed to the
vaccine. James A. Shannon, former director of the NIH had
once stated, “The only safe vaccine is a vaccine that is never
used”. Candidly, all vaccines do have inherent risk of AEFI,
but the benefits are undoubtedly immense, and clearly
outweigh the risks.
Recognizing the need of creditability, IAP constituted
'Advisory Committee on Immunization Practices'(ACVIP)
through a completely transparent and democratic process
and put in place very strict code of conduct to take care of
conflict of interest issues.
Process involved for framing this guidebook involved an
exhaustive review of published literature including standard
textbooks, vaccine trials, recommendations of various
international health agencies, World Health Organization
(WHO) position papers on vaccines, literature from the
vaccine industry, post-marketing surveillance reports, cost-
effective analysis, epidemiology of disease in India and if
available Indian studies on vaccine efficacy, immunogenicity
and safety. The current committee has tried its level best to
issue recommendations based entirely on available
indigenous data on the vaccine preventable diseases and
vaccines as far as possible. The committee met in person to
discuss many issues. At this meeting, the members of the
Committee and some invited experts discussed the issues
related to vaccines in exhaustive detail. Decisions are taken
on crucial matters through a democratic process and the
minutes of every meeting are recorded. Efforts are made to
issue guidelines based on consensus decisions, however if
unanimity is not achieved, voting is resorted on specific
recommendations. The Academy is committed to base its
recommendation on 'evidence-based process' and started
viii | IAP Guidebook on Immunization 2013–14
this process by providing Rotavirus disease burden based on a
systematic review supported by IAP. In this edition, we have
tried to split all our recommendations in two sections,
individual use and public health perspectives. The key
recommendations are provided in the end of the chapter as
boxed items.
It is to be recognized that recommendations in this book are
the 'best individual practice guidelines' on available vaccines
in the Indian market for a given child and at variance from the
Universal Immunization Schedule of the Government of India,
which is meant for the public at large. However, core message
remains that no child should be denied vaccination and that
licensed newer vaccine should be made affordable and
available to needy children in equitable manner. The text has
been extensively referenced for the first time for a guidebook to
instill confidence in statements made and provide readers
with an opportunity to cross-check the facts mentioned. We
hope that this updated guidebook will empower the
pediatricians and vaccine providers in their immunization
practices immensely in most situations. Reviewers need to be
acknowledged for putting hard work and making possible to
publish the book in time. We do sincerely hope that
publication of these guidelines of the Academy shall empower
not only the pediatricians but also all healthcare professionals
to practice vaccination in a more confident and rational ways
to shrink the huge burden of VPDs in the country.
Vipin M. Vashishtha
Panna Choudhury
C.P. Bansal
Vijay N. Yewale
Rohit Agarwal
IAP Guidebook on Immunization 2013–14 | ix