IAP Guide Book on Immunization - Indian Academy of Pediatrics

175 Pages·2011·1.2 MB·English

IAP Guide Book on
Immunization
IAP Committee on Immunization 2009-2010
Editors :
Dr. Vijay Yewale
Dr. Panna Choudhury
Dr. Naveen Thacker
® Copyright: IAP Committee on Immunization
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.iapcoi.com
(All rights reserved)
Acknowledgement :
The editors gratefully acknowledge the contributions of all committee members and
expert reviewers.
Academic grant from :
Bharat Biotech, Chiron Panacea Vaccines, GSK Biologicals, MSD, Novartis,
Pfizer-Wyeth, Sanofi Pasteur
Disclaimer :
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).
Publishers : Indian Academy of Pediatrics
IAP Guide Book on
Immunization
IAP Committee on Immunization 2009-2010
Editors :
Dr. Vijay Yewale
Dr. Panna Choudhury
Dr. Naveen Thacker
2
Disease Surveillance by the IAP Committee on Immunization
www.idsurv.org (Case reporting made SARAL)
IAP Committee on Immunization (IAPCOI) in collaboration with the IAP Kutch branch
and Child Health Foundation (CHF) has started “Infectious Disease Surveillance (IDsurv)
Project” for Childhood vaccine preventable diseases.
Objectives
• To develop an early warning system for pediatric vaccine preventable diseases in India
• To generate data on burden of vaccine preventable diseases in India
Who can participate?
At present pediatricians are encouraged to become part of this network. They can
register through the website www.IDsurv.org . A confirmatory email and sms with username
and password will be sent once request is scrutinized.
What diseases are covered under IDsurv Project?
At present following diseases are being reported under IDsurv Project?
(cid:131) Acute Bacterial Meningitis (cid:131) Chicken Pox (cid:131) Diphtheria
(cid:131) Dengue (cid:131) Enteric Fever (cid:131) Measles
(cid:131) Mumps (cid:131) Pertussis (cid:131) Pneumonia
Registration
If you are a new user you will need to register with idsurv.org. After you complete the registration
form, your application would be reviewed and your password would be sent to you via email
and sms.
Reporting a case
You can report a case in the following ways
1. Through website idsurv.org after logging into your account.
2. Through sms from your registered mobile number.
3. Through mobile website m.idsurv.org
4. Through IVR (Integrated Voice Recognition System)
Reporting a case through website
Log in to your account. Click on Report a case. Fill up the form and click on submit.
Reporting a case through sms: SMS appropriate codes to 09223050808 For help on sms
codes please check the resources area/ SMS icon on the website idsurv.org.
Reporting case through mobile website: Log in to your account on m.idsurve.org. Click on
report a case and fill up the form and click on submit.
Reporting case through IVR: check on IVR icon on www.idsurv.org
Viewing/ updating cases reported by you:
After logging in your account you can click on View/Update cases reported by me. You can
view all the cases reported by you. Click on a case to change/update information submitted
by you. Note that this will contain the cases reported by you through all the mediums i.e.
website, sms, IVR and mobile website.
Feedback to the reporting pediatrician
The reporting pediatrician will be sent a report on the cases reported by him/her on a weekly basis
For further details please visit www.idsurv.org
IAP Guide Book on Immunization
3
PREFACE
Immunization is one of the most cost-effective health interventions known to mankind.
With immunization, small pox has been eradicated and polio eradication is also in sight.
The Indian Academy of Pediatrics (IAP) publishes a Guide Book on Immunization,
for the guidance of its members. It is meant to guide vaccination efforts in India,
taking into account the disease prevalence, health priorities, and resource allocation
possible. This guidebook presents the key recommendations of the IAP Committee
on Immunization (IAPCOI) 2009-10. IAPCOI is committed to provide unbiased,
rational, ethical, practical yet balanced guidelines to its members on the various
issues related to vaccines and vaccination practices in India.
The recommendations here are the ‘best individual practice schedule’ for a given
child and would necessarily be at some variance from the National Immunization
Schedule of the Government of India, which is meant for the public at large. The
IAPCOI recommendations thus go beyond the national immunization program and
cater primarily to the pediatricians in office practice. The recommendations are
formulated after review of available literature and detailed discussion amongst IAPCOI
members. Though an attempt has been made to include the Indian data that is
available, such India specific epidemiological data is often not available. In the
absence of such data, the disease burden and the results of vaccine studies from
countries with similar socio-economic-cultural background is taken into account while
making recommendations. Review articles published in indexed medical journals,
World Health Organization (WHO) position papers and recommendations from the
Advisory committee on Immunization Practices of USA (ACIP) are the main resource
documents for this edition. Lack of local information or evidence should not be taken
as evidence of absence of the disease and should not be a deterrent against
formulating policies. The IAPCOI stresses the need to collect local epidemiological
data for vaccine preventable diseases so that future recommendations are more robust.
IAPCOI has tried to bring out recommendations in an earnest and unbiased way to
promote what is best for the population that is catered to. It is also important to
understand that immunization is a dynamic subject and recommendations may need
to be revised periodically based on available information. From time to time, updates
to the recommendations of the latest Guidebook will be published by the Immunization
Committee of the Indian Academy of Pediatrics and updated on the website
www.iapcoi.com. We hope that this updated guidebook will continue to serve as a
ready-reckoner on issues concerning vaccines and immunization in our country.
Dr. Panna Choudhury Dr. Naveen Thacker Dr. Vijay Yewale
Chairperson Co-Chairperson Convener
IAP Committee on Immunization, 2009-10
IAP Guide Book on Immunization
4
IAPCOI has formulated consensus guidelines on
appropriate use of licensed vaccines in office
practice. However, members may use their own
discretion while using them in a given situation.
IAP Guide Book on Immunization
5
CONTENTS
1. Introduction.............................................................................................6
2. Basic Immunology and Elementary Epidemiology .................................11
3. Practical Aspects of Immunization......................................................... 23
4. Cold Chain............................................................................................ 28
5. Adverse Events following Immunization................................................39
6. Immunization Schedule......................................................................... 43
7. Individual Vaccines................................................................................ 47
8. Adolescent Immunization....................................................................141
9. Immunization in Special Situations...................................................... 143
10. Licensing procedure and inclusion of a vaccine in the NIP in India..... 151
11. Internet Resources for Immunization Information................................157
12. Ready Reckoner for Vaccines currently available in India................... 158
13. Annexures
i. IAP Immunization Time Table 2011..............................................164
ii. IAP Immunization Schedule 2011................................................165
iii. List of vaccine brands available in India.......................................167
IAP Guide Book on Immunization
6
INTRODUCTION
Immunization in India - Past, Present and Future
Immunization is a proven tool for controlling and even eradicating disease. An
immunization campaign carried out by the World Health Organization (WHO) from
1967 to 1977 eradicated smallpox. Eradication of poliomyelitis is within reach. Since
Global Polio Eradication Initiative in 1988, infections have fallen by 99%, and some
five million people have escaped paralysis. Although international agencies such as
the World Health Organization (WHO) and the United Nations Children’s Fund
(UNICEF) and now Global Alliance for Vaccines and Immunization (GAVI) provide
extensive support for immunization activities, the success of an immunization
programme in any country depends more upon local realities and national policies.
A successful immunization program is of particular relevance to India, as the country
contributes to one-fourth of global under five mortality with a significant number of
deaths attributable to vaccine preventable diseases. There is no doubt that substantial
progress has been achieved in India with wider use of vaccines, resulting in prevention
of several diseases. However lot remains to be done and in some situations, progress
has not been sustained (Table I).
Table I: Vaccine preventable diseases: India reported cases (Year wise).
Vaccine preventable diseases 1980 1985 1990 1995 2000 2005 2008
Diphtheria 39,231 15,685 8,425 2,123 5,125 10,231 6,081
Measles 114,036 161,216 89,612 37,494 38,835 52,454 48,181
Pertussis 320,109 184,368112,416 4,073 31,431 13,955 44,180
Polio 18,975 22,570 10,408 3,263 265 66 559
Tetanus (Neonatal) - - 9,313 1,783 3,287 891 811
Tetanus (Total) 45,948 37,647 23,356 - 8,997 3,543 3,714
Source: WHO vaccine-preventable diseases: monitoring system 2010 global summary
Successful immunization strategy for the country goes beyond vaccine coverage in
that self reliance in vaccine production, creating epidemiological database for
infectious diseases and developing surveillance system are also integral parts of the
system. It is apparent that the present strategy focusses on mere vaccine coverage.
The history of vaccine research and production in India is almost as old as the history
of vaccines themselves. During the latter half of the 19th century, when institutions
for vaccine development and production were taking root in the Western world, the
IAP Guide Book on Immunization
7
British rulers in India promoted research and established about fifteen vaccine
institutes beginning in the 1890s. Prior to the establishment of these institutions,
there were no dedicated organizations for medical research in India. Haffkine’s
development of the world’s first plague vaccine in 1897 (which he developed at the
Plague Laboratory, Mumbai, India, later named the Haffkine Institute) and Manson’s
development of an indigenous Cholera vaccine at Kolkata during the same period
bear testimony to the benefits of the early institutionalisation of vaccine research
and development in India. Soon, Indian vaccine institutes were also producing Tetanus
toxoid (TT), Diphtheria toxoid (DT), and Diphtheria, Pertussis, and Tetanus toxoid
(DPT). By the time Indians inherited the leadership of the above institutions in the
early 20th century, research and technological innovation were sidelined as demands
for routine vaccine production took priority. However, after independence, it took
three decades for India to articulate its first official policy for childhood vaccination, a
policy that was in alignment with the WHO’s policy of “Health for All by 2000” (famously
announced in 1978 at Alma Atta, Kazakhstan). The WHO’s policy recommended
universal immunization of all children to reduce child mortality under its Expanded
Programme of Immunization (EPI). In line with Health for All by 2000, in 1978 India
introduced six childhood vaccines (Bacillus Calmette-Guerin, TT, DPT, DT, Polio,
and Typhoid) in its EPI. Measles vaccine was added much later, in 1985, when the
Indian government launched the Universal Immunization Programme (UIP) and a
mission to achieve immunization coverage of all children and pregnant women by
the1990s. Even though successive governments have adopted self-reliance in
vaccine technology and self-sufficiency in vaccine production as policy objectives in
theory, the growing gap between demand and supply meant that in practice, India
had increasingly resort to imports. In fact, government of India had withdrawn
indigenous production facilities for oral polio vaccine that existed earlier in Conoor,
Tamilnadu and at Haffkine’s institute in Mumbai for trivial reasons. At Conoor after
making several batches of good quality OPV, one batch of OPV has failed to pass
the neurovirulence test. This happens with all manufacturers, and if a facility has to
be closed down for such reason there would have been no OPV in the world today.
Thus, oral polio vaccine has been imported in India for last several years. Similarly
decision of production of inactivated polio vaccine in the country was revoked more
than two decades ago for no known reasons. Many vaccine manufacturing units
have suspended production or closing down in recent years for minor reasons. One
wonders who is benefitting by the closure of facilities for manufacturing vaccines in
public sector.
The vaccination coverage at present with EPI vaccines is far from complete despite
the long-standing commitment to universal coverage. While gains in coverage proved
to be rapid throughout the 1980s, taking off from a below 20% coverage to about
60% coverage for some VPDs, subsequent gains have been limited. Estimates from
IAP Guide Book on Immunization
8
the 2005-2006 Indian National Family Health Survey (NFHS-3) indicate that only
43.5% of children aged 12-23 months were fully vaccinated (received BCG, measles,
and 3 doses of DPT and polio vaccines), and 5% had received no vaccinations at all.
Given an annual birth cohort of 24 million surviving infants and an under 5 year
mortality rate of 74/1000, this results in over 12.5 million under-immunized children
each year.
There is also a tremendous, heterogeneity in state and district level immunization
coverage in India. In the recent District Level Health Survey-3 (2007-‘08) full
immunization coverage of children varies from 30% in Uttar Pradesh, 41% in Bihar,
62% in Orissa to 90% in Goa. Tamil Nadu, Kerala and Pondicherry have above 80
percent coverage (Table II).
TABLE II: Percent of Children age 12-23 months (born during 3 years prior to
the survey) who received full vaccination, BCG, three doses of DPT, three doses
of polio and measles in DLHS-3 survey (2007-08).
State/UT Full BCG Three doses Three doses Measles
vaccination of DPT vaccine of Polio Vaccine Vaccine
Andhra Pradesh 67.1 97.5 79 82.1 88.6
Bihar 41.4 81.5 54.4 53.1 54.2
Chhattisgarh 59.3 94.8 71.4 69.7 79.9
Goa 89.8 98.4 91.5 94.1 94.1
Jharkhand 54.1 85 62.6 64.4 70.5
Karnataka 76.7 96.9 84.8 90.3 85.2
Kerala 79.5 99.1 87.1 86.6 87.9
Madhya Pradesh 36.2 84.2 47.4 55.1 57.7
Orissa 62.4 94.2 74.3 78.8 81.1
Pondicherry 80.4 96.6 88.3 88.3 91.1
Rajasthan 48.8 82.8 55.6 63.9 67.5
Sikkim 77.8 98.4 88.7 86.5 92.5
Tamil Nadu 82.6 99.6 90.5 91.1 95.5
Uttar Pradesh 30.3 73.4 38.9 40.4 47
West Bengal 75.8 96.2 83.6 83.8 82.8
Sources:
1. Sharma S. Immunization coverage in India. Working Paper Series No. E/283/2007. www.iegindia.org/
workpap/wp283.pdf accessed on 12th June, 2010
2. Nath B, Singh JV, Awasthi S, Bhushan V, Kumar V, Singh SK. A study on determinants of immunization
coverage among 12-23 months old children in urban slums of Lucknow District, India. Indian J Med
Sci 2007; 61: 598-606.
3. Universal Immunization Program Review. www.whoindia.org/LinkFiles Routine_Immunization_UP.pdf
accessed on June 12, 2010.)
IAP Guide Book on Immunization