1 min read.Updated: 04 Jan 2021, 03:25 PM IST Edited By Meghna Sen
The Hyderabad-based firm has completed its Phase 1 and 2 trials, wherein the vaccine was already used on children over 12 years and was found safe
The firm is now conducting Phase 3 trials
The Drugs Controller General of India (DCGI) has approved Bharat Biotech's coronavirus vaccine, Covaxin, for children above the age of 12 years during the clinical trial mode, day after it received a nod for emergency use in India.
The drug regulator clarified the age requisites for active immunisation in a document while giving permission to manufacture Covaxin.
The Hyderabad-based firm has completed its Phase 1 and 2 trials, wherein the vaccine was already used on children over 12 years and was found safe. The firm is now conducting Phase 3 trials.
Bharat Biotech's Covaxin was "safe and provides a robust immune response", said DCGI's VG Somani.
DCGI also asked the drug firm to submit updated safety, efficacy and immunogenicity data from the ongoing Phase I, II and Ill clinical trials till the completion of trials.
"Phase 1 and Phase 2 clinical trials were conducted on about 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe," Somani said.
Covaxin is yet to complete late-stage human clinical trials in the country and no efficacy rate has yet been made public.
The DCGI had on Sunday approved 'Covaxin' and 'Covishield' for restricted use in emergency situations in the country, paving the way for a massive inoculation drive.
Both the vaccines will be administered in two doses, the DCGi said in the permission letter.
Congress question nod to Covaxin
Earlier on Sunday, senior Congress leaders raised concerns over DCGI granting permission for the restricted use of Bharat Biotech's Covid-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
However, the drug regulator, while announcing approval to the Bharat Biotech vaccine, said Covaxin is "safe and gives a robust immune response". The drug regulator also asserted that no vaccine with even the slightest safety concern would be approved for administration and said the vaccines are 110% safe.
Covaxin has been indigenously developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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