Clinical trial data of rotavirus 116E vaccine in India have revealed several instances of side effects and these should be disclosed, the Delhi High Court was told on Tuesday.
Clinical trial data of rotavirus 116E vaccine in India have revealed several instances of side effects and these should be disclosed, the Delhi High Court was told on Tuesday.
The vaccine protects children from rotaviruses, which are the leading cause of severe diarrhoea among infants and young children. A bench of Chief Justice G Rohini and Justice Jayant Nath was also told that the vaccine was withdrawn from the US due to the number of side effects, but it was being sought to be included in the universal immunisation scheme of India.
The results of the Phase III clinical trials at Vellore had revealed around 581 instances of side effects, the petitioner, a doctor at St Stephen's Hospital in Delhi, told the court, which reserved its verdict after also hearing the side of the government.
The petitioner, Dr Jacob Puliyel has moved a petition seeking to restrain the government from moving on to phase IV trials in which over one lakh children would be administered the vaccine.
Puliyel in his plea has also sought directions to the government to provide complete data of the multi-centre clinical trials of the vaccine. Appearing for Puliyel, advocate Prashant Bhushan argued that trial was conducted between 2011-2013 at various places across the country, but its data was not disclosed.
Bhushan said that as per guidelines of World Health Organisation (WHO), results of clinical trials have to be put in the public domain without delay.
He also said the petitioner was seeking details of the side effects suffered by those who underwent the trial and also details of how many were administered placebos. Additional Solicitor General (ASG) Sanjay Jain, who appeared for the government, contended that WHO guidelines say the results of the trials are to be disclosed, which was done.
The guidelines were not binding and do not say that data has to be disclosed, he added.
Jain also said the vaccine, called Rotovac, was not only the first indigenously developed and manufactured vaccine in the country, but also cheap as one dose would cost only about Rs 60. The ASG said the rotavirus vaccines currently available in the market cost nearly Rs 1000 per dose.
According to the government rotavirus diarrhoea kills more than one lakh children under the age of five in India every year, a claim which has been opposed by Puliyel.
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