Bharat Biotech allowed conducting trial on children above 12 years

Bharat Biotech’s Covaxin was “safe and provides a robust immune response”, said DGCI

Bharat Biotech, 'Covaxin' received nod for emergency use, and 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 already 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.

Somani said “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.”

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