Surrounded by mango
groves, village Rahimabad is situated 10 kilometers off the Lucknow-Sitapur
highway in the Khairabad block of Sitapur district. Rahimabad is in
news for a dubious reason. A two-year-old girl of this village, Saniya,
suffers from Type I polio despite being administered more than seven
doses of the new polio monovalent vaccine (MOPVI), which is made specially
for the Type I poliovirus. The vaccine was introduced in mid-2005 and
tom-tommed as the final step in the eradication of polio from India.
Before its introduction, a trivalent vaccine was in use that simultaneously
targeted the three poliovirus strands found in India, Type I, II and
III, by introducing into the body live viruses of all the three strands
to develop immunity.
five times more potent vaccine was introduced without informed
consent, nor was the public told the vaccine was experimental,’
says Dr Jacob Puliyel
not the only case. There are 15 cases of Type I polio spread across
Uttar Pradesh (There are also 41 cases of Type II polio which takes
the total count to 56). While there has been no reported Type I case
in the endemic Moradabad, the new cases have been reported from eastern
and central Uttar Pradesh; so instead of just a region, cases of wild
polio are being reported from all over Uttar Pradesh now.
mother, Noorjahen, is furious. “She is having polio drops ever
since she was four days old. She has had over a dozen doses of the polio
drops. We came to know about her polio when she got a high fever. She
could barely manage to stand, could not walk at all, after the fever.
We took her to the local hospital where they did a stool test. We were
later told that she has polio,” she recounts. “There must
be some thing wrong with the polio drops if even after so many doses
my child has contracted polio. The government should test medicines
before they are used. Pata nahin bachchoo ko kya pila rahin hain!”
(Don’t know what they are making my child drink), she adds.
Mistrust is not
only rife among the patients’ families, it has also gripped the
doctors and field operatives overseeing the vaccination project. Add
to this the latest controversy about the MOPVI vaccine, introduced in
India by the World Health Organisation (who), and the organisation’s
National Polio Surveillance Project (NPSP), and you get a sense of the
callousness plaguing the polio campaign.
authors of the Lancet study differ with the who’s project
manager, Dr Hamid Jafari, on critical questions
THE VACCINE NEW?
>> “The vaccines assessed were licenced
for administration in India by the national regulatory authority,
the Drugs Controller General of India.”
>> “It is not a new vaccine. It was
used in other countries before the trivalent vaccine. There
are studies on it done even in India.”
Jafari asserts that the vaccine is not new, the authors
say it is under licence from the government of India, so
the responsibility lies with the government
IT LINKED TO THE RISE IN ACUTE FLACCID PARALYSIS?
>> “The increase in afp cases began before
mopv1 was introduced, and occurred across India, including
states where mopvi has not been used. The introduction of
mopvi is not, therefore, the cause of the increase in cases
of afp. When we are into the business of polio eradication
we are interested in polio and nothing else.”
>> “This is due to better reporting and
surveillance. We know by our 50 years of experience that the
polio vaccines are safe.”
the authors deny a connection and say they are only concerned
with wild polio cases, Jafari simply glosses over it. What
is crucial is the lack of any study to support either claim
When the MOPVI was
launched in India in mid-2005, there was no mention that it was a new
vaccine, and therefore no need was felt to examine whether it had been
tested. The impression created at the time was that this vaccine had
earlier been used in the 60s and 70s in some other countries. The project
manager of the NPSP, Dr Hamid Jafari, confirmed this while talking to
In contrast to
this position, the April 21, 2007, issue of the renowned medical journal,
Lancet, carried a study titled “Protective efficacy of a monovalent
oral Type 1 poliovirus vaccine: a case-control study by Grassly NC,
Wenger J, Durrani S, Bahl S, Deshpande JM, Sutter RW, Heymann DL and
Aylward RB”. On pages 1356-1362 it says: “A high-potency
monovalent oral type 1 poliovirus vaccine (mopv-i) was developed in
2005 to tackle persistent poliovirus transmission in the last remaining
infected countries. Our aim was to assess the efficacy of this vaccine
This clearly means
that the MOPVI is a new, untested vaccine and its use was part of an
experiment. This news has outraged the Indian medical community. If
this vaccine was new, did the who and NPSP test its safety? Head of
the pediatrics department of Delhi-based St Stephen’s Hospital,
Jacob Puliyel, took up the matter with Lancet. In his strong-worded
letter to Lancet’s editor, he wrote: “We are shocked and
dismayed that Lancet should have published the paper on the protective
efficacy of monovalent oral Type I poliovirus...having overlooked the
serious ethical issues involved.” He went on to write, “What
was introduced, according to this article, was a new vaccine that was
five times more potent than previous vaccines, presumably also with
the increased likelihood of adverse effects. No informed consent was
taken, nor was the public told that the vaccine was experimental. Efforts
were made to give the impression that the monovalent vaccine was not
of Acute Flaccid Paralysis have risen in UP since the new vaccine
Lancet asked the
authors of the article to respond to the questions raised by Puliyel.
In their reply, the authors bypassed the question whether the vaccine
was new or not, and put the onus of use of this vaccine squarely on
the government of India. “The vaccines assessed were licenced
for administration in India by the national regulatory authority, the
Drugs Controller General of India. The MOPVI formulation assessed in
our study has been used since mid-2005 by the Government of India, and
now in over 20 countries around the world.”
When Tehelka asked
the same question to Jafari, he said it wasn’t a new vaccine.
Then why does this paper in Lancet say so? “It has been interpreted
wrongly,” Jafari said.
Puliyel had another
serious objection. He said administering MOPVI without examining its
potential harmful effects amounts to experimentation on human subjects.
The question that npsd and who have to answer is why polio drops that
are five times more potent, which means they carry five times more of
the live poliovirus, was indiscriminately administered. Would this not
result in overexposure to the live poliovirus and possibly result in
vaccine-induced polio? “The oversight body that introduced this
experimental vaccine should also have monitored adverse effects,”
wrote Puliyel to Lancet. Further, he mentioned: “In the absence
of proper post-vaccination surveillance of adverse effects, we have
to rely on indirect evidence of possible adverse effects available from
the NPSP. Data from Uttar Pradesh (where Grassly and colleagues show
improved vaccine efficacy) show an increase in the incidence of non-polio
Acute Flaccid Paralysis (AFP, or the weakness of limbs) since the introduction
of the monovalent vaccine.” Doctors in UP are worried about this
development. “We want the nature of AFP in these cases to be investigated.
It could be due to over exposure to the polio vaccine,” said a
senior doctor in Lucknow who has overseen the polio immunisation programme
in UP for years.
overexposure to the poliovirus is a key concern with
the vaccine was launched in mid-2005, there was no mention that
it was a new vaccine, and therefore no need was felt to examine
whether it had been tested
are not without reason. Of the 10,264 reported cases of AFP, 209 were
cases of polio. Of the remaining 10,055 only 2,553 were followed up.
NPSP data reveal that approximately 4,800 cases had residual paralysis
or died after acquiring in 2005 non-polio AFP. “The situation
was even worse in 2006 after just six doses of MOPVI. It is not surprising
that NPSP is not keen on the follow up of these cases,” says Puliyel.
In their reply
to Lancet, the study’s authors have ruled out this possibility
completely. Interestingly, they cite no study to support their assertion.
The increase in AFP cases is attributed to better surveillance and reporting.
“The increase in AFP cases began before MOPVI was introduced,
and occurred across India, including states where MOPVI has not been
used. The introduction of MOPVI is not, therefore, the cause of the
increase in cases of AFP,” the authors wrote.
“This cannot be ruled out unless tested.” In their reply
to Lancet, the authors have written: “Poliomyelitis cases are
confirmed only when the poliovirus is identified in the stools of a
patient with Acute Flaccid Paralysis (AFP). However, it is impossible
to collect stool samples from all such patients.” They have also
said: “When we are into the business of polio eradication we are
interested in polio and nothing else.”
Jafari said the
question of overexposure does not exist. “Each time a vaccine
is given, it strengthens the child’s immunity against subsequent
doses,” Jafari said. But he failed to explain why infants like
Saniya, who have had multiple vaccination, have contracted polio. On
the question of whether the rising cases of AFP are a possible fallout
of overexposure to polio vaccines, Jafari said, “We know by our
50 years of experience in polio vaccination that the vaccines are safe.
There are many studies in place, even in India.” None of these
“studies” was quoted in the detailed reply to Lancet.
Then why does polio
survive in the Hindi heartland? As usual, the who blames the state government
and its poor health infrastructure. Dr LB Prasad, director general of
UP’s Directorate of Family Welfare, counters: “Our job is
to give vaccines to every child in Uttar Pradesh. We have approximately
a 90-percent coverage against the required 80 percent. Each child has
received multiple doses.”
is why are local authorities always held responsible for any failure?
Did the who care to check the efficacy of its own vaccine? “We
are constantly looking at the efficacy aspect of the vaccines,”
said Jafari. “That is what led to the introduction of MOPVI.”
But if that is the case, why are children, who have been vaccinated
more then 20 times, still carrying polio? “The efficacy of the
vaccine depends on climate conditions, hygiene, population density,
etc. They may not be 100 percent effective,” concedes Jafari.
While Jafari does not consider efficacy the real issue, Principal Secretary
of the UP’s Health department, Arun Mishra, informed Tehelka:
“The efficacy of the MOPVI is being tested by the Indian Council
of Medical Research. The results are awaited.”