‘A five times more potent vaccine was introduced without informed consent, nor was the public told the vaccine was experimental,’ says Dr Jacob Puliyel

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.

Saniya’s is 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.

Saniya’s 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.

 

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 Tehelka.

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 in India.”

Cases of Acute Flaccid Paralysis have risen in UP since the new vaccine was introduced

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 new.”

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.

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