Highlights:
- Bharat Biotech’s Covaxin given approval for emergency use in India
- Covaxin’s cleared for trials on children above the age of 12 years
- Covaxin is now in Phase 3 trials
The Drugs Controller General of India (DCGI) has approved Covaxin, Bharat Biotech’s vaccine for the novel Coronavirus, for children who are above the age of 12 years during the clinical trial mode, one day after it received the green flag for emergency use in India.
The drug regulator of the country clarified that the age requisites for active immunisation in a document while giving permission to manufacture Covaxin.
The Hyderabad-based biotechnology firm has already completed Phase 1 and Phase 2 trials for Covaxin wherein the vaccine was used on children over 12 years and it was found safe.
As of now, Bharat Biotech is conducting Phase 3 trials on Covaxin.
V G Somani, Drugs Controller General of India, said, that Covixin from Bharat Biotech was “safe and provides a robust immune response”.
The DGCI had also asked the Hyderabad-based biotechnology firm to submit its updated safety, efficacy, and the immunogenicity data from the ongoing Phase I, II and lll of the clinical trials until the completion of the trials.
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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.”
He added, “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”.
The COVID-19 vaccine from Bharat Biotech is yet to complete late-stage human trials in India and also, as of now, no efficacy rate of the vaccine has been made public.
On Sunday, the DGCI approved Covaxin and Cobishield for restricted use in emergency situation in India, paving a way for a massive immunization drive.
Both the vaccines, approved for restricted use in emergency, will be administered in 2 doses, as per the permission letter from DGCI.
On Sunday, soon after the 2 vaccines received the nod from DGCI, senior Congress leaders started raising questions and concerns over the permission and asked the government to explain as to why the mandatory protocols and verification of data was dispensed with.
However, the drug regulator, at the time of announcing the approval of Bharat Biotech vaccine, said that Covaxin is “safe and gives a robust immune response”.
The drug regulator emphasised that no even a single vaccine which will have even the slightest safety concern would be approved for administration and said the vaccines are 110% safe.
Covaix has been developed indigenously by the Hyderabad-based biotechnology firm named Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR).
