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Vulnerable: overexposure to the poliovirus
is a key concern with the vaccine |
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When 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 |
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.
These
apprehensions 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.
Disagrees Puliyel: “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.”
Another question 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.”