Coronavirus Vaccination: Bharat Biotech's 'Covaxin' gets DCGI nod to conduct trials on children above age of 12
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 trials 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.
Meanwhile, All India Institute of Medical Sciences (AIIMS) director Dr Randeep Singh Guleria has also dismissed rumours about the safety of Covaxin, saying it "is shown to be safe and they have robust data from Phase I and Phase II trials to show that it's a safe vaccine".
"In an emergency situation when there is a sudden increase in cases and we need to vaccinate, Bharat Biotech vaccine will be used. It can also be used as a backup when we are not sure how efficacious the Serum Institute vaccine is going to be," he said while speaking to news agency ANI.
"Approval clearly says 'emergency situation' keeping in mind the circulating variant strains and at the same time, they have to continue the trial and get the data in. Once that data comes in, we will be more confident as far as safety and efficacy is concerned," he noted.
Posted By: Aalok Sensharma