The Indian Academy of Pediatrics Committee on
Immunization (IAPCOI) conducted its deliberations in New Delhi on 4th
and 5th October, 2003 (Members, who participated in the deliberation,
are listed in Annexure I). We reviewed our stand on various policies,
guidelines and recommenda-tions pertaining to childhood immunization.
As has been enunciated earlier, "policies" are the decisions taken by
the Academy in relation to the scientific principles and practice of
immunization. "Policies" are, expected to be practiced by all members
of the Academy. "Guidelines" relate to those items which are outside
the purview of policy, and for which guidance is necessary. Guidelines
usually pertain to newer vaccines or issues related to them.
"Recommendations" are, in general, what the academy in its role of
advocacy on behalf of children, requests other agencies to do. These
agencies may include international funding agencies, the Government of
India or other professional bodies.
It should be noted that the IAP immunization
time-table is, in effect, the ‘best individual practices’ schedule and
may be somewhat different from the national immunization schedule.
This is because of the fact that the former is meant to be used for an
‘individual’ patient, rather than for the pediatric community at large
as in the case of the latter. The two schedules are, however, not in
conflict with each other. Also, as pediatricians we must be conscious
of the fact that the immunization needs of children in a country are
quite dynamic - a vaccine which may not be considered important today
may become necessary after some time as more information about the
epidemiology of the disease becomes available. Further, in developing
countries affordability of the vaccines is a critical issue and any
decision on incorporation of a new vaccine in the immunization
schedule has to take this into consideration. The IAPCOI has based its
deliberations on the best available evidence and we hope that this
would become a regular feature of such meetings in the future.
It is heartening to note that some of the
re-commendations of the IAPCOI in the past have been instrumental in
changing govern-mental policies and also the immunization schedules
being followed by some states.
IAP Policies on Immunization, 2003
1. On NTAGI
The IAP welcomes the establishment of the National
Technical Advisory Group on Immunization (NTAGI) by the Government of
India. This followed a formal recommendation from the IAP, given a
couple of years ago. The Secretary, Department of Family Welfare is
the Chairperson of the Committee while the Assistant Commissioner,
Immunization Program is its Member Secretary. The IAPCOI now
recommends that the IAP should be represented on this important
committee by its incumbent President and the Chairperson/Convener of
the IAPCOI.
2. On Universal Immunization Program (UIP)
The IAP continues to endorse and reiterates its
support to the national immunization schedule while recognizing the
fact that much more needs to be done for meeting the current
immunization require-ments of the children of our country. It is a
fact that except for the recent phased introduction of Hepatitis B
vaccine in a few districts, no new vaccine has been introduced in the
national program since the last 25 years. All vaccines under UIP
should continue to be available free of charge to all eligible
children.
3. On Pulse Immunization against Polio
The Academy fully supports the Government of India
in the use of oral polio vaccine (OPV) for the pulse immunization
program against polio. It is our considered opinion that, in spite of
some operational hiccups, we must continue with this program and bring
it to its logical conclusion, i.e., till wild polio virus is
eradiacted from our country.
4. On DPT/OPV
The IAPCOI endorses the use of five doses of DPT/OPV
at 6,10 and 14 weeks and thereafter at 15-18 months and 5 years
respectively. An additional dose of OPV is to be given at birth to all
institutional deliveries. It should be noted that we continue to
endorse the use of DPT (rather than DT as in the national program) at
5 years.
5. On "Newer" Vaccines
The IAPCOI suggests that the UIP should be
supplemented by the following vaccines: Hepatitis B (HB), MMR and
Typhoid. Another important vaccine which merits active consideration
is Hemophilus influenzae type b (Hib), but affordability would be an
issue here. Parents, however, should be made aware of the availability
of these vaccines.
Varicella and Hepatitis A vaccines are still not
recommended for routine use.
(a) Hepatitis B vaccine: We wish to emphasize the
fact that in our country horizontal transmission of Hepatitis B virus
also appears to be an important mode of transmission of the disease
along with the vertical i.e., mother-to-child.
HB vaccine may be given in any of the following
schedules:
(i) 0, 6 and 14 weeks
(ii) 0, 1 and 6 months
(iii) 6, 10 and 14 weeks
If the mother is known to be HBsAg negative, HB
vaccine can be given along with DPT at 6, 10 and 14 weeks. In the
latter case, there is no special requirement to start vaccination at
birth itself. This schedule may be easier to implement in the context
of the national immunization program, but for an optimum immune
response the recommended interval between second and third doses of HB
vaccine should be at least 8 weeks.
If the mother is HBsAg positive (and especially
HbeAg positive), the baby should be given Hepatitis B Immune Globulin
(HBIG) within 24 hours of birth, along with HB vaccine. The injections
should be given at two separate sites. If HBIG is not available (or is
unaffordable), HB vaccine may be given at 0, 1 and 2 months with an
additional optional dose between 9-12 months.
Boosters of HB vaccine are not necessary in
immunocompetent individuals. The vaccination schedule need not be
changed for preterm and small-for-dates babies; in the case of
extremely preterm babies, however, vaccination should only commence
after initial stabilization.
(b) MMR vaccine: This vaccine should be promoted as
a universal vaccine. It should be given between 15-18 months of age
i.e., at least 3 months after the measles vaccine. It should also be
given to all adolescent girls not previously immunized as also to
hospital staff likely to come in contact with pregnant mothers. There
is no upper age limit for this vaccine.
(c) Typhoid vaccine: The IAPCOI strongly recommends
the use of typhoid vaccine for all children. Of the 3 types of
vaccines available (viz., Vi-polysacharide, whole cell inactivated and
oral Ty-21a), only the Vi-polysacharide vaccine is freely available in
our country at present. It can be given to children above 2 years of
age and boosters are required after 3-5 years. The government should
explore the possibility of manufacturing this vaccine in the public
sector on large scale so that the costs are brought down.
(d) Hib vaccine: Hib vaccine should be offered to
all children and may be given at 6,10 and 14 weeks along with DPT. A
booster is given at 15-18 months. If vaccinations are started after 6
months of age, only two doses (at 2 months interval) need be given as
primary schedule with a booster at 15-18 months. If vaccination is
started between 12-15 months of age, only one dose need be given, with
a booster at around 18 months. After 15 months of age only one dose of
the vaccine needs to be given - no boosters are required under such
circumstances.
Hib vaccine is also recommended for all children,
irrespective of age, prior to splenectomy and also in patients with
sickle cell disease.
At present the cost of this vaccine is prohibitive.
IAP Guidelines on "Newer" Vaccines, 2003
The IAP Guide Book on Immunization was last updated
in the year 2001. We hope to revise it and publish the updated version
shortly. It would have more complete informa-tion on the suggested IAP
immunization time-table and the "newer" vaccines. This update pertains
to some of the deliberations of the IAPCOI pertaining to "newer"
vaccines and related maters.
1. Hepatitis A vaccine
Hepatitis A (HA) vaccine is not recommended for
universal immunization in India at present. One has to emphasize the
generally benign nature of and rarity of complications with, Hepatitis
A infection in young children. It may be offered to children from high
socio-economic strata of society after explaining the pros and cons to
the parents on a one-to-one "named child" basis. It may be prescribed
to adolescents who have not had viral hepatitis in childhood (or are
known to be HAV-IgG negative) and are leaving home for studies in a
residential school/college. HA vaccine is indicated for all patients
with chronic liver disease as well as household contacts of patients
with HA virus infection - in the latter case the vaccine must be given
within 10 days; it may, however, be not always effective under such
circumstances if the contact has the same source of infection as the
index patient. It may also be considered in children attending creches
and day care centers and in travellers from abroad (e.g., non-resident
Indians) visiting endemic areas.
It is given in a 2-dose schedule, 6 months apart.
The recommended dose is 720 ELU for children in the age group 2-19
years and 1440 ELU thereafter.
2. Varicella vaccine
The IAPCOI opines that varicella vaccine is not
recommended for universal immuniza-tion in India at present. One has
to emphasize the generally benign nature of and rarity of
complications with, varicella infection in young children. It may be
offered to children from high socio-economic strata of society after
explaining the pros and cons to the parents on a one-to-one "named
child" basis. It may be prescribed to adolescents who have not had
varicella in childhood (or are known to be varicella IgG negative) and
are leaving home for studies in a residential school/college. It is
indicated in children with chronic lung/heart disease, humoral
immunodeficiencies, HIV infection (but with CD 4 counts above 25% of
the age related norms), leukemia (but in remission for at least 1
year) and those on long term salicylates/steroids. Varicella vaccine
is also recommended in household contacts of immunocompromized
children. It may also be considered in children attending creches and
day care centres.
Varicella vaccine is also indicated in susceptible
adolescents and adults if they are inmates of or working in the
institutional set up e.g., school teachers, day care center workers,
military personnel, health care professionals etc.
A single dose suffices between the ages of 1-13
years, after which a 2-dose schedule (4-8 weeks apart) is recommended.
3. Acellular pertussis vaccine
The IAPCOI endorses the continued use of whole cell
pertussis vaccine (as DPT) because of its proven efficacy and safety.
Acellular pertussis vaccines may undoubtedly have fewer side-effects
(like fever, local reactions at injection site and irritability), but
this minor advantage does not offset the inordinate costs involved in
the routine use of this vaccine. Acellular pertussis vaccines are
also, by no means, more effective than the whole cell pertussis
vaccine. These are, therefore, not recommended for universal
immunization in our country at present. There is, however, no bar to
offering these vaccines to children from well-off families who opt for
the prohibitive costs for the slight advantage of fewer minor
side-effects.
Use of acellular pertussis vaccine should, however,
be considered in children who have had significant reactions to a
previous dose of whole cell pertussis vaccine. These include:
(i) convulsions with/without fever occurring
within 3 days.
(ii) persistent inconsolable crying for 3 or more
hours within 48 hours.
(iii) collapse or shock-like state within 48
hours.
(iv) temperature >40.5 ºC within 48 hours.
4. Inactivated Polio vaccine (IPV)
The IAPCOI recommends that the Government should
immediately license the use of inactivated polio vaccine in India. As
the number of wild polio virus cases in the country decreases, it is
inevitable that one would have to gradually shift from OPV to IPV in
the next few years. The government should, therefore, consider
incorporating IPV gradually in the national immunization schedule in a
phased manner, starting from the states where polio has been
eliminated.
IPV is also the vaccine of choice in patients with
humoral immunodeficiencies and the preferred vaccine in children with
HIV infection.
5. Japanese Encephalitis (JE) vaccine
JE vaccine should be used for universal
immunization of children aged 1-3 years in all hyperendemic districts
of our country. At present only limited supplies of the vaccine
(inactivated mouse brain - Nakayama strain) are available from the
Central Research Institute (CRI), Kasauli. The vaccine is supplied to
state governments directly by the CRI and cannot be procured from the
market for use of individual patients. Primary vaccination is done
with 3 doses given at 0, 7 and 30 days with boosters every 2 years
till 10-15 years of age. Contrary to common belief, this vaccine is
not meant to be used as an 'outbreak response' vaccine.
6. Pneumococcal and Meningococcal vaccines
Both these vaccines are not indicated for universal
immunization in our country at present. The 23-valent pneumococcal
vaccine (only unconjugated polysaccharide vaccine is available in
India at present) may be used for patients who are under consideration
for splenectomy or those with nephrotic syndrome (in remission), HIV
infection, cerebrospinal fluid rhinorrhea, sickle cell anemia,
asplenia, chronic lung/heart disease, diabetes mellitus and chronic
renal failure. Meningococcal (A and C) vaccine is indicated for use
(as an adjunct along with chemoprophylaxis) in close contacts of
patients with the disease. It is also indicated in high risk
individuals (e.g., those with hyposplenia/asplenia, complement
deficiency) during epidemics.
7. Combination vaccines
The number of vaccines in the immunization schedule
is increasing every year and this trend is likely to continue for the
next few years. Many parents opt for one single injection of
combination vaccines at a given visit, rather than come repeatedly for
the various individual vaccines that are now included in the
immunization time-table. A number of combination vaccines are now
available in the Indian market. The IAPCOI endorses the use of
combination vaccines, but with the following cautionary statements:
(a) the manufacturer’s recommendations should be
adhered to strictly;
(b) "mixing" of vaccines in the same syringe
(prior to injection) should not be done as far as possible, unless
specifically recommended by the manufacturer; in the latter case the
manufacturer's instructions should be followed strictly;
(c) the only advantage of a combination vaccine
is the convenience of fewer clinic visits for the parents and fewer
pricks for the child;
(d) combination vaccines should not be viewed as
being more effective than vaccines given separately.
8. Adolescent vaccination
The Academy endorses the continued use of tetanus
toxoid at 10 and 16 years and thereafter every 5 years. HB vaccine may
be offered in the 0, 1 and 6 or 0, 1 and 2 months schedule, as
mentioned earlier under individual vaccines, if the child has not
received it earlier. MMR vaccine should be offered to all children who
have not received it earlier - there is no upper age limit for this
vaccine. The Academy encourages the use of typhoid vaccine for all
adolescents. Hepatitis A and varicella vaccines should be used in
selected cases as mentioned above.
9. Immunization records
Every vaccine given to a child must be documented
on a card/booklet. We recommend the Immunization card of the IAP for
this purpose. Parents must be instructed to keep the document safely
and to present it to their doctor whenever required.
10. Advertisements in the lay media
Some of the multinational companies have been using
the lay media (television, electronic media and newspapers/magazines)
for placing advertisements pertaining to optional/combination
vaccines. We opine that this is unethical. The IAP placed a formal
complaint before the Drug Controller General of India and the Union
Health Ministry. This led to the issuance of a letter by the Drug
Controller to the concerned companies requesting them for the
withdrawal of these advertisements. These advertisements have not been
seen in the lay media after that. We are hopeful the companies would
continue to refrain from lay advertising in the future as well.
IAP Recommendations on Immunization, 2003
The IAPCOI has formulated several specific
recommendations to other agencies pertaining to immunization.
1. Recommendations to Ministry of Health,
Government of India
(a) The IAP recommends that the Academy should be
represented on NTAGI by its incumbent President and the Chairperson/
Convener of IAPCOI.
(b) At 5 years of age booster immunization should
be done with DPT rather than DT.
(c) The Academy recommends that inactivated polio
vaccine should be immediately licensed in the country and gradually
introduced in a phased manner, starting from the states where polio
has been eliminated.
(d) The Academy strongly recommends that
Hepatitis B and MMR vaccines should be included in the national
immunization schedule with immediate effect.
(e) The Government should actively consider
inclusion of typhoid vaccine in the national immunization schedule.
The Academy suggests use of Vi-polysaccharide vaccine for this
purpose. However, the whole cell inactivated typhoid vaccine may
also be acceptable, as it is much cheaper to produce. However, the
latter vaccine does have significant side-effects.
(f ) Another vaccine which needs serious
consideration for inclusion in the national immunization schedule,
while awaiting disease burden studies, is Hib vaccine. However at
present the cost of this vaccine is prohibitive.
(g) The Academy supports the decision of the
Government to discontinue production of animal brain rabies vaccine.
However we need to ensure adequate supplies of indigenously produced
chick embryo/tissue culture vaccines at affordable costs.
2. Recommendation to the Federation of Obstetric
and Gynecologic Societies of India
The Academy again reiterates its previous
recommendations to adopt a policy of routine testing of all pregnant
women for HBV infection. If the mother is HBsAg positive, the baby
should be given HBIG plus HB vaccine soon after birth.
Annexure I
Members of the Indian Academy of Pediatrics
Committee on Immunization (IAPCOI))
Chairperson: A.P. Dubey; Convener: Surjit Singh; Members: Mukesh
Agrawal, Sunil Gomber, Ritabrata Kundu, P. Ramachandran, and A.G.
Shingwekar; Co-opted Member: P.S. Patil; Ex-officio: A.K. Dutta, Tapan
Kumar Ghosh, H.P.S. Sachdev, Nitin Shah, Raju C. Shah, Naveen Thacker;
Invited Experts: T. Jacob John, Rakesh Sehgal; Special Invitees: Anju
Aggarwal, N.K. Arora, Panna Choudhury, Seema Kapoor, Prashant Mathur,
Jitender Nagpal, Sushma Nangia, Dheeraj Shah, Suvasini Sharma, Sangita
Yadav.
