Clinical trial of the new rotavirus vaccine from the Serum Institute of India shows that the vaccine increases the incidence of diarrhoea instead of decreasing it.
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 NEJM has this week published a letter in response to the original article, which shows that there was a significantly higher rate of gastroenteritis and diarrhoea 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-diarrhoea 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.
Adverse Effects with Rotavac (Bharat Biotech India)
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 three 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 Prime Minister's Office (PMO).
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."
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. GSK recently tested its vaccine in Bangladesh and the outcome was similar.
Rotarix (GSK) in Bangladesh
, a peer-reviewed weekly medical journal, recently published the results of the Rotarix trial in Bangladesh. The PLoS Comments by Deepak Jain and Deepak Mittal
point out that the purpose of the vaccine is to reduce the overall burden of disease from diarrhoea and diarrhoea deaths. However, there were more cases of children reporting diarrhoea among those vaccinated with Rotarix in Bangladesh, although this increase in diarrhoea was not statistically significant. The fact remains that this vaccine did not reduce diarrhoea among the vaccinated - in spite of its exorbitant cost. The authors have not responded to the comments till now.
It all boils down to making a profit. Misrepresenting research findings, cherry picking data, and concealment of adverse events in clinical trials are now seemingly acceptable practices.
(Jacob Puliyel is a member of the National Technical Advisory Group on Immunisation, Government of India. The views expressed are his own.)