NEW DELHI - India's Health Ministry this
month ignored widespread concern over the safety,
efficacy and cost of pentavalent vaccines and
approved inclusion of the prophylactic cocktail in
a universal immunization program in seven of its
Pentavalent vaccine doses, a
cocktail of five antigens in a single shot,
confers immunity against five pediatric diseases -
diphtheria, pertussis, tetanus, hepatitis B and
haemophilus influenza type b (Hib), with the last
one considered particularly problematic by some
Pentavalents, produced by several
manufacturers and promoted by the Global Alliance
on Vaccines and Immunization (GAVI), has had a
history of causing adverse reactions and deaths in India's
Bhutan, Sri Lanka and Pakistan.
National Technical Advisory Group on Immunization
(NTAGI), a body of experts selected by the Indian
government, in 2010 recommended limited
introduction of pentavalents in southern Kerala
and Tamil Nadu and evaluation of results over a
year before extension to other states.
Pentavalents were launched in Kerala and
Tamil Nadu in December 2011, and the results were
not encouraging. Kerala recorded four infant
deaths following vaccination, with symptoms
similar to what were seen in other South Asian
Public health activists in
Kerala, a state with 100% literacy and human
development indices similar to those of advanced
Western countries, quickly filed a public interest
litigation (PIL) in the Kerala High Court asking
for intervention in having the program called off
and a return to the existing health plan.
But despite infant deaths and two pending
PILs (with yet another being heard in the Delhi
High Court) against pentavalents, the Health
Ministry announced on April 16 that pentavalents
would be introduced in five more states - Gujarat,
Haryana, Karnataka, Goa, Jammu and Kashmir and
Puducherry in October.
In making the
decision, the government overlooked the NTAGI,
which has not even been convened since August 2010
when the body suggested limited introduction to
Kerala and Tamil Nadu.
"Going by what we
have seen in the neighboring countries and now in
the state of Kerala, pentavalents can, without
warning, cause children [to suffer]
hypersensitivity reactions and death," Jacob
Puliyel, an eminent pediatrician at St Stephen's
hospital in New Delhi and member of the NTAGI,
told Inter Press Service (IPS).
likened the situation to penicillin sensitivity
and said it bordered on criminality to be
administering pentavalents without first testing a
child for hypersensitivity. "Every child that is
being given a dose of pentavalent vaccine is a
potential victim of the adverse reaction," he
Puliyel was among the many eminent
physicians and public health activists in India
who wrote to World Health Organization (WHO)
director general Margaret Chan on April 3 asking
the health body to "re-evaluate" its
recommendation of pentavalent vaccines on the
grounds of safety.
Another signatory, Dr
Meera Shiva, an expert on pharmaceutical drugs
attached to the voluntary Medico Friends Circle,
told IPS that WHO had to delist a number of brands
of "prequalified" pentavalent vaccine, "but
adverse reactions persist and we have surely not
heard the last of them."
The letter to
Chan, written under the aegis of the All-India
Drug Action Network, an umbrella of public health
activist groups, suggested that the cause of the
vaccination-related deaths was likely to be
"hypersensitivity reaction as described in the
post mortem report on one of the children [who
died] in Kerala".
drug treatments meant for the management of
existing diseases, in prophylaxis with vaccines,
safety is of paramount importance. Vaccines that
frequently and unpredictably cause the death of
healthy children cannot be recommended," the
letter to Chan said.
specializing in vaccines said they were dismayed
at the move to approve pentavalents in as many as
seven of India's states, which account for 340
million of India's 1.2 billion people.
"Pentavalents are a test case for India's
new policy on vaccines that is in keeping with
liberalization and openly favors pharmaceutical
majors at the cost of India's public sector
vaccine units," said Madhavi Yennapu, a scientist
who specializes in vaccines at the central
government's National Institute of Science,
Technology and Development Studies.
of India's 23 public sector vaccination units,
once the mainstay of the country's immunization
programme, have been shut down one after another
over the last four years on the grounds that the
quality of their products was suspect.
Yennapu pointed to the draft National
Vaccination Policy, released last year, for clues
on why the government has not made any serious
attempt to revive the vaccine-manufacturing units
by enforcing quality standards, for instance.
The new policy demands that the "risk of
manufacturing vaccines by private manufacturers
must be cushioned by assistance from [the]
government" and suggests that it be made mandatory
for the government to support vaccine producers
with advance market commitments (AMCs).
Madhavi explained that AMCs provide
guaranteed markets for a vaccine even before
trials are conducted, with the government
committed to paying a supporting minimum price.
"Even if the vaccine turns out to be less
efficacious than the existing one the government
must honor the AMC by buying the new vaccine at
the agreed price.
"This means that AMC
funds must be deposited with the World Bank ahead
of vaccine delivery by countries that GAVI is
supposed to be helping with the introduction of
new vaccines," Madhavi told IPS. "Naturally, GAVI
would be looking at large countries like India,
Brazil and China to provide the AMCs."
a country like India, what is important is to "see
how many vaccines are needed to prevent how many
deaths and at what cost, rather than throw out
tried and tested vaccines in favor of a cocktail
[pentavalent] which not only has doubtful
advantages but has been shown to cause adverse
reactions," Madhavi said.
Madhavi, there is no hard scientific evidence to
show that India needs the Hib vaccine ."It is
clearly piggybacking on other vaccines and the
public made to pay for it."
diphtheria, tetanus, pertussis (DPT) vaccine costs
about 30 US cents for all the doses needed to
immunize a child, while immunization with
pentavalents will cost more than US$10. "We need
to ask ourselves if introducing the new vaccine is
really worth all the public money being spent on
it," Madhavi said.