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 issues”.
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 flaccid paralysis.
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 in 2005.
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 Lancet .
“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.