New Delhi | Jagran News Desk: The Drugs Controller General of India (DCGI) on Monday allowed Hyderabad-based Bharat Biotech’s ‘Covaxin’ to conduct clinical trials on children who are above the age of 12 years. The pharmaceutical firm is currently conducting the phase III trails of its COVID-19 vaccine.
Giving a licence to Bharat Biotech to manufacture ‘Covaxin’ for sale and distribution, the DCGI has also asked the pharmaceutical firm to submit updated “safety, efficacy and immunogenicity data” from the ongoing phase I, II and Ill clinical trials till the completion of trials.
The DCGI has also asked Bharat Biotech to submit its risk management plan and “updated prescribing information or package insert and summary of product characteristics for the whole virion inactivated coronavirus vaccine and also disseminate the necessary information, instructions and educational materials through their website”.
“The permission is subject to conditions of satisfactory evaluation and lot release by CDL, Kasauli. Further, each batch/lot of the whole virion inactivated coronavirus vaccine shall be released from CDL, Kasauli,” the DCGI letter read.
Covaxin, along with Oxford-AstraZeneca’s ‘Covishield’, was permitted for “restricted emergency use” in India. Though several experts have raised questions over its use, the DCGI has said that the vaccine was approved only after thorough inspection about safety and its effectiveness.
“We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It (people may get impotent) is absolute rubbish,” DCGI’s Dr V G Somani had said.
Courtesy – MSN