The Hyderabad-based firm is conducting Phase III trials. The vaccine is yet to complete late-stage human clinical trials in India.
Out of the two vaccines, Bharat Biotech's coronavirus vaccine 'Covaxin', which received emergency approval only in "clinical trial mode", has been approved for conducting trials on children above the age of 12 years by the Drugs Controller General of India (DCGI).
According to reports, the vaccine has already been used on children above 12 in phase 1 and 2 trials and has been found safe. The Hyderabad-based firm is conducting Phase III trials. The vaccine is yet to complete late-stage human clinical trials in India.
“CDSCO (Central Drugs Standard Control Organization) has decided to accept the recommendations of the expert committee and, accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in an emergency situation," said DCGI Dr VG Somani, who also heads CDSCO, the regulator for medical products in India.
Union Health Minister Dr Harsh Vardhan had clarified yesterday that emergency approval for Covaxin is different from the one given for Covishield because Covaxin's use will be in clinical trial mode, which means, all its recipients will be tracked and monitored as if they are participating in a trial.
Some experts expressed shock at the authorization given to Bharat Biotech despite the lack of efficacy data. Government officials, however, said that the vaccine would only be used as a backup in the wake of the situation following the discovery of the new mutant strain.
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Last Updated Jan 4, 2021, 3:27 PM IST