‘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.

 

The authors of the Lancet study differ with the who’s project manager, Dr Hamid Jafari, on critical questions IS THE VACCINE NEW? LANCET >> “The vaccines assessed were licenced for administration in India by the national regulatory authority, the Drugs Controller General of India.” WHO >> “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.” While 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 IS IT LINKED TO THE RISE IN ACUTE FLACCID PARALYSIS? LANCET >> “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.” WHO >> “This is due to better reporting and surveillance. We know by our 50 years of experience that the polio vaccines are safe.” While 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 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.

Vulnerable: overexposure to the poliovirus is a key concern with the vaccine

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.”