1. The expert committee appears to have ignored the
basic principles of immunization for many vaccines especially the newer
ones. The estimates of the disease burden for many diseases are flawed.
The prominent being: pneumococcal pneumonia, cervical cancer due to HPV,
and rotaviral diarrhea. While reasonable estimates for many of these are
not available, extrapolating the data from the western world without
adjusting for Indian circumstances is not an acceptable substitute. The
principle of recommending the vaccine to those with highest risk has
been ignored and on the contrary recommending certain vaccines only for
those who can afford even when the disease epidemiology does not justify
the recommendation probably serves only the commercial interests.
2. There is no justification to have the
category-‘Vaccines which are to be given after one-to-one discussion
with the parents’. If the current evidence does not support the use of
vaccine, the same should be stated clearly. It is convenient to
categorize a few vaccines specifically for the office pediatricians, but
the committee has not issued any guidelines for the ‘one- one
discussion’. What should the parents be told- the vaccine is safe,
effective, but the current epidemiologic evidence does not support the
use of the vaccine. Does it imply that all vaccines that have been
developed and are proven to be safe will be categorized in this category
if the available evidence does not support the routine use of the
vaccine? For an expert committee, the decisions about the use of the
vaccines should be based on scientific merit. Therefore, mentioning the
issue of affordability in the recommendations is inappropriate.
3. The committee should have only 2 categories for
the recommended vaccines – one for healthy children and one for special
circumstances/ scenarios that are justified on the basis of the
scientific evidence. In addition, the committee should have listed the
vaccines the use of which cannot be recommended at this time. This
approach would have helped the government program to consider the
4. The reference for the statement in the article
‘Mucosal immunity as measured by stool excretion of virus after mOPV1
challenge is superior with combination of OPV and IPV as compared to IPV
alone’(3) is inappropriately used. The cited study(3) had compared the
mucosal immunity induced by enhanced-potency inactivated and oral polio
vaccines individually; there was no group that received the combination.
In this study, mucosal immunity produced by OPV and enhanced-potency
inactivated polio vaccine (E-IPV) was compared by challenging vaccinees
with type 1 OPV. Fewer OPV (25%) than E-IPV (63%) vaccinees excreted OPV
virus in stool after challenge. The mean stool virus titer was higher
and the duration of shedding longer among E-IPV excreters(3).
5. The statement ‘The risk of VAPP with this combined
OPV and IPV schedule is extremely low as the child receives OPV at the
time when he/she is protected against VAPP by maternal antibodies, is
again without any evidence. The cited reference(4) evaluates only the
use of OPV and not the combined OPV and IPV schedule.
6. If the committee is convinced about the greater
efficacy of the eIPV over OPV, the same should be stated clearly and a
recommendation be made to the government and the program. The committee
should have clearly stated the recommendation for use of only eIPV for
7. Table II inaccurately includes Hib as an EPI
vaccine. Similarly while Table II lists DTaP as a vaccine which is to be
given after one-to-one discussion with the parents, the same is included
in Table III as a recommended vaccine which again is misleading.
8. While varicella is listed as a category 3 vaccine,
in the text the committee ‘continues to recommend single dose of
varicella vaccine in children aged below 13 years.’, implying that it is
recommended for all children; which is inaccurate. Similar is the case
with Hepatitis A vaccine.
9. The recommendation of use of rabies vaccine as ‘a
pre-exposure prophylaxis for children at high risk of rabies’ without
defining ‘those at high risk’ is inappropriate.
10. It would have been appropriate for the committee
to grade the evidence collected as is the norm for evidence based
11. The listing of brands is not justified in a
recommendation paper. It is also a deviation from the committee’s
We raise these issues for an academic and a healthy
debate, the result of which is in the best interests of the children of
the country irrespective of their economic status and in tune with the
stated commitments of the IAP towards the improvement of the health and
well being of all children.
1. Indian Academy of Pediatrics Committee on
Immunization (IAPCOI). Consensus recommendations on immunization, 2008.
Indian Pediatr 2008; 45: 635-648.
2. Indian Academy of Pediatrics-Mission Statement.
on February 26, 2008.
3. Onorato IM, Modlin JF, McBean AM, Thoms ML, LosonsKy
GA, Bernier RH. Mucosal immunity induced by enhanced-potency inactivated
and oral polio vaccines. J Infect Dis 1999; 163: 1-6.
4. Kohler KA, Banerjee K, Gary Hlady W, Andrus JK,
Sutter RW. Vaccine-associated paralytic poliomyelitis in India during
1999: decreased risk despite massive use of oral polio vaccine. Bull World
Health Organ 2002; 80: 210-216.