Vaccine found aiding and abetting diarrhoea in clinical trial
New Delhi: It is a queer case of a vaccine doing just the opposite of what it was created for. It seems as if vaccine itself has got diarrhoea.
Clinical trial of the new Indian rotavirus vaccine from the Serum Institute of India shows that the vaccine increases the incidence of diarrhoea instead of decreasing it.
Dr Jacob M Puliyel, head of paediatrics at St. Stephens Hospital, Delhi is a well known Rota Virus whistle blower in India. Talking to Medicare News, Dr Puliyel says, ‘the expose by New England Journal of Medicine is an eye opener. The government must take note of it without delay or it can unleash deaths for children instead of saving them’
The vaccine was field tested in Niger in Western Africa. The results were published in the prestigious New England Journal of Medicine (NEJM). The authors report that vaccine efficacy was 66.7% against severe rotavirus diarrhoea. What was not highlighted was that diarrhoea caused by other agents increased significantly and the vaccinated children had more diarrhoea than those not vaccinated.
The New England Journal of Medicine published a letter last week in response to the original article which shows that there was a significantly higher rate of gastroenteritis and diarrhea in the vaccinated group compared to those given the placebo – an inert dummy vaccine. The NEJM letter points out that this vaccine could aggravate the problem it is meant to solve in resource-poor countries. An anti-diarrhea vaccine that increases the incidence of diarrhoea is unlikely to find a market.
This is not the first rotavirus vaccine that is under a cloud for not being upfront with trial data.
Another vaccine Rotavac, manufactured by Bharat Biotech was recently in the news for not disclosing adverse events in a vaccine trial. This vaccine was tested in 3 centres in India. It appears there was a significant increase in the incidence of intussusceptions – a potentially life threatening complication where the intestine telescopes into itself and can become gangrenous – at the Vellore centre. This data from Vellore has not been published in spite of repeated requests for it from various quarters including from the Indian Prime Minister’s office.
In response to a public interest litigation (PIL) filed in the Delhi High Court, lawyers for the opposite side argued that “… site specific data on safety is inappropriate for release as per protocol and its inappropriate interpretation or publication which would lead to disinformation about the product (that has been) developed by government with great effort and expense, and will give unfair advantage to multinational products which were never tested in India, (and) yet (were) licensed.”
This vaccine Rotavac has now been licensed in India and the vaccine is being administered in a Phase IV trial without informing parents of the risks observed in the randomized control trial in Vellore – a clear violation of basic ethical values.
This phenomenon of incomplete and inaccurate reporting of crucial clinical trial data is not limited to Indian manufacturers of vaccines. The GSK recently tested its vaccine in Bangladesh and the outcome was similar.