Bharat Biotech, which received emergency approval for its Covid-19 vaccine only in “clinical trial mode”, has been allowed to conduct its trials on children who are above the age of 12 years. The vaccine has already been used for children above 12 in the last round and has been found safe.
The Hyderabad-based firm is conducting Phase 3 trials.
Oxford-AstraZeneca coronavirus vaccine ‘Covishield’, manufactured by Pune-based Serum Institute of India (SII) has been approved for those above the age of 18. The DCGI had on Sunday approved Bharat Biotech’s ‘Covaxin’ and Serum’s ‘Covishield’ for emergency use in the country, paving the way for a massive inoculation drive.
So far, the Government has said the vaccination drive is intended only for adults but this provides hope that if there is sufficient data, then it can be extended fully to children in the future. The drug regulator clarified the age requisites for active immunisation in a document while giving permission to manufacture Covaxin.
Union Health Minister Dr Harsh Vardhan had clarified on Sunday that emergency approval for Covaxin is different from the one given for Serum Institute’s Covishield because Covaxin’s use will be in clinical trial mode. All its recipients will be tracked and monitored as if they are participating in a trial.
Bharat Biotech’s Covaxin was “safe and provides a robust immune response”, said DCGI’s VG Somani.
The DCGI has 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.