E-DRUG: Polio and paralysis in India
Polio vaccine and paralysis in the media
Dr Gopal Dabade,
Dharwad 580002, INDIA
Issue Date: Saturday, July 14, 2007
Cover-up cloud on vaccine
Doctors suspect paralysis link, officials pooh-pooh
G.S. MUDUR New Delhi, July 13:
India?s polio eradication managers introduced a new polio vaccine into the
country two years ago without informing the public that the vaccine was still
new and experimental at the time, a medical team has claimed.
In a letter that will appear in the leading medical journal The Lancet on
Saturday, a doctor and two public health specialists have questioned the manner
in which this vaccine was introduced, claiming it involved ?serious ethical
The doctors have also questioned whether there is a connection between an
observed rise in unexplained paralysis among children in UP and Bihar and the
introduction of this vaccine.
Health officials have rubbished this concern as baseless, arguing that the
rise in paralysis is due to a dramatically intensified surveillance system in
which even ?mild weakness in a limb? may initially be classified as acute
In a new strategy to tackle polio in areas where the wild poliovirus has
persisted despite multiple doses of the standard oral polio vaccine, India had
introduced a monovalent oral polio vaccine (mOPV1) in some parts of the country
The decision to introduce the vaccine was taken in consultation with
international health agencies because mOPV1 which targets only type 1 of polio
was expected to be more effective than the standard trivalent-OPV which
protects against type 1, 2, and 3. A study published earlier this year had
indeed showed that mOPV1 was three times more effective than the trivalent OPV.
When mOPV1 was introduced into the immunisation programme, scientists found
that each dose protected 30 per cent of children instead of 11 per cent
protection offered by the traditional vaccine.
But sections of the medical community who have been expressing their concerns
about how mOPV1 was introduced in India have now articulated their views in The
?No informed consent was taken, nor was the public told that the vaccine was
experimental. In fact, the truth was carefully hidden from the public and
doctors in India,? Jacob Puliyel, a paediatrician at the St. Stephen?s Hospital
in New Delhi, and his co-authors said. ?Efforts were made to give the
impression that the monovalent vaccine was not new but just the monovalent
vaccine used in the 1960s.?
Health officials have asserted that the monovalent vaccine was ?not new? and
had been used previously. A National Polio Surveillance Project (NPSP) official
also told The Telegraph today that mOPV1 is ?essentially not new?.
?This vaccine had been used earlier in South Africa, Brazil and Uganda until
the 1980s and 1990s,? Hamid Jafari, project manager of the NPSP said. ?A
similar vaccine was also tested in India earlier,? he said.
However, in a paper earlier this year, Indian, NPSP, and World Health
Organisation officials had described mOPV1 as ?a new vaccine that possesses
five times the potency of the licensed monovalent vaccines used in the 1960s?.
The officials said an advisory committee on polio eradication had recommended
the ?rapid development, licensing, and introduction? of a new mOPV1. The
vaccine was first approved in France, introduced in Egypt and brought into
India in April 2005.
?Our objection is over the deception of telling the public that it was an old
vaccine,? Puliyel told The Telegraph. ?Is this ethical practice in medicine??
?If this was not a new vaccine, why would it require regulatory approval and
a clinical trial,? asked Joseph Mathew, a paediatrician at the Postgraduate
Institute of Medical Education and Research in Chandigarh.
Mathew and another pediatrician Santosh Mittal had said earlier this year
that a ?phase four? clinical trial had been built into the introduction of the
mOPV1 in India.
The count of unexplained paralysis has risen in UP and Bihar to 12 per
100,000 over the past three years, several times higher than the expected
average of less than 2 per 100,000. But NPSP officials have said this increase
has nothing to do with the vaccine, but is the result of improved surveillance.
?These concerns have no basis. The vaccine has been used in 20 other
countries now, and nowhere is there any evidence for any side effects despite
extensive post marketing surveillance,? Jafari said.