This article summarizes the lack of evidence supporting the introduction of combination vaccines like the pentavalent vaccine into India's universal immunization program. It argues that there is no documented high disease burden from diseases targeted by these vaccines in India. The article claims combination vaccines were invented by industry primarily to extend market monopolies rather than improve public health. It critiques the push for these vaccines as prioritizing private market interests over equitable healthcare.

1. Pentavalent and other New Combination Vaccines: Solutions in Search of Problems
Y. Madhavi & N. Raghuram1
This reprinted article is unedited version published in the Indian Journal of Medical
Research (IJMR), Oct 2010, 132:15-16.
The pentavalent vaccine and many other combination vaccines waiting to enter Universal
immunization Programme (UIP) have brought into sharp focus the gaping gap between
lofty slogans of ‘evidence based medicine’ and the actual dynamics that drive policy on
the ground1-4. Notwithstanding the theatrics of the ‘experts’ of the World Health
Organization (WHO) and the Global Alliance for Vaccines and Immunization (GAVI)
globally and National Technical Advisory Group on Immunization (NTAGI) here in
India, it is becoming increasingly obvious that the pentavalent vaccine, like many other
recent combination vaccines, is a solution searching for problems.
Whither Evidence-Based Medicine?
The fact of the matter is that there is no scientifically valid evidence of a high enough
disease burden due to Influenzae type b (Hib) or Hepatitis-B (HepB) that justifies
universal vaccination in India5-7. Indeed, every attempt to find such evidence for HiB in
India and elsewhere in Asia has failed4. In the absence of evidence for individual
vaccines, it defies logic how one can justify combining them into a pentavalent vaccine.
It also begs the question as to whether the industry made these combination vaccines in
response to specific public health demands, if so who articulated them and with what
evidence from which countries. It seems that there was no need for any such evidence, as
long as ‘expert’ recommendations behind closed doors were unquestioningly accepted by
all concerned. Unfortunately, increasing awareness and rising dissent against medicines-
sans-evidence is forcing the policy makers to find post-facto evidence that is becoming
increasingly difficult to manufacture. By now, it is obvious to all concerned, except to the
determined ‘experts’ who drive our immunization policies, that there has never really
been a real public health demand for many of these new vaccines, let alone their
combinations.
1
National Institute of Science,Technology and Development Studies (NISTADS), New Delhi & School of
Biotechnology, Indraprastha University, Delhi, respectively. For correspondence
<y_madhavi01@hotmail.com>

2. Marketing Tricks or Innovations for Health?
Indeed, combination vaccines were invented precisely to overcome the poor penetration
of the individual vaccines in the global market, as well as to overcome the expiry of their
patents and establish eternal market monopolies. Scientific evidences indicate that
combination vaccines bring no new health benefit to the immunized people8-11, except the
convenience of not having to take each vaccine separately, provided all those vaccines
are actually needed. The issue of safety and efficacy of combination vaccines were often
cause for concern12. For instance, MMR in combination with Varicella vaccine reported
to have enhanced febrile seizures in children13-14, and Hepatitis A vaccine is not
protective enough when combined with typhoid vaccine15. It is a marketing trick, which
is no more scientific than the logic behind the bundling of Television channels or online
journals. Just as many not-so-popular channels or journals need a piggy back ride on a
popular channel or a journal in a bundle, every dubious new vaccine needs a Diphtheria
Tetanus Pertussis (DTP), measles or some other essential vaccine to get a back door entry
into the Universal Immunization Programme (UIP)16. Pushing Hib,Hep-B , Mumps
Measles Rubella (MMR), rotaviral, Human Papilloma Virus (HPV), etc through
combination vaccines among people who don't need them (using UIP vaccines as
piggybacks) is no better than beaming religious channels using news channels as
piggybacks.
It is also obvious why our ideologues of out-of-pocket financing of the increasingly
privatized health industry suddenly need centralized government procurement of vaccines
and are no longer content with doctoring customer ‘choice’. The sustainability of global
(read Multinational Company) vaccine industry depends on adoption of new vaccines
into the national immunization of large countries like India17-18, because the present
prices make them unaffordable even in relatively affluent country markets. A more
honest and straightforward way would be to recommend Indian government aid to
support vaccination of needy children in such countries, rather than giving Indian
children unnecessary vaccines to bring down global prices. But it is hard for the rich to
accept donations from the poor, when they are so used to robbing them in benevolent
style. So much for equity!
Equity for Health or Market?
Why is it that ‘equity’ argument is often given only when it comes to government
spending on vaccines? Why not for all other health care services or other basic amenities
such as food, shelter, water and clean environment, which are ruled by market forces?
Why are health concerns so muted when it comes to OPV induced paralytic cases? Is the

3. government. or NTAGI willing to take responsibility and compensate for vaccine induced
paralytic cases? Why don’t we have proper vaccine injury compensation in this country?
Why should our immunization experts enjoy so much immunity from the unhealthy
consequences of their advice for health? In any case, the hollowness of the ‘equity’
argument becomes obvious when we consider that the total coverage of ‘universal’
immunization is below 50% of the children in India, even for the most essential and
affordable vaccines. If you don’t have bread, eat cake!
Public Sector Abuse for Medicine sans Evidence?
Another side of the equity argument is that manufacturing these combination vaccines in
public sector units (PSUs) would bring down their prices and make them more affordable
to all. This would have been a welcome move (lest we too be branded as anti-vaccine),
provided the public health need for these new vaccines is firmly established.
Unfortunately, even well meaning minds in the government committed to reviving the
crucial role of PSUs in Indian vaccine security seem to be lost in supply side arguments
without firmly establishing the demand for these vaccines based on disease burden. This
is inspite of having all the human, financial and technological resources to document
disease burden scientifically. This is the fundamental tragedy of medicine-sans-evidence
policy that rules in Indian vaccines.
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