It has completed its phase 1 and 2 trials, wherein the vaccine was already used on children over 12 years and was found safe.
Bharat Biotech, whose vaccine 'Covaxin' received nod for emergency use, will be allowed to conduct its trials on children who are above the age of 12 years. The Drugs Controller General of India (DCGI) clarified the age requisites for active immunisation in a document while giving permission to manufacture Covaxin.
It 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 Drugs Controller General of India VG Somani. The vaccine is yet to complete late-stage human clinical trials in India and no efficacy rate has yet been made public.
DCGI also asked the company to submit updated safety, efficacy and immunogenicity data from the ongoing Phase I, II & 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.
Senior Congress leaders earlier raised concerns over India's drugs regulator 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.