VK Paul, Member (Health), Niti Aayog on Tuesday informed that Bharat Biotech is all set begin the phase II and III clinical trials for COVID-19 vaccine Covaxin in children in the age group of 2 to 18 years in the next 10-12 days.
“Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days,” Paul said during a press conference. DGCI gave a nod to Covaxin to conduct the clinical trials in children on May 11.
Delhi High Court on Wednesday refused to pass an interim order on permission granted by the Drugs Controller General of India (DCGI) to Bharat Biotech for conducting the phase II/III clinical trial of its Covaxin COVID-19 vaccine on the 2-18 age group.
A PIL to set aside the permission granted by DGCI was heard on Wednesday by the Delhi High Court which required the Center’s stand on it.
However, a notice has been issued to the Centre and Bharat Biotech by a bench of Chief Justice DN Patel and Justice Jyoti Singh seeking their stand by July 15 on the petition.
The Court declined to pass any interim order to stay the trial as required by the petitioner, Sanjeev Kumar. However, it was said that the trial will be conducted on 525 healthy volunteers.
In the trial, the vaccine will be administered by intramuscular route in two doses at day 0 and day 28. Covaxin, which has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing COVID-19 vaccination drive.’
The Niti Ayog official further stated that the anti-COVID drug ‘2DG’ developed by the Defence Research and Development Organisation (DRDO) has been granted permission for emergency use by the DCGI. He also mentioned that the anti-COVID drug will be examined by the COVID-19 National Task Force for adding it to the treatment protocol.