The Central Drugs Standard Control Organisation (CDSCO) on Sunday approved two vaccines developed by the Serum Institute of India (SII) and Bharat Biotech for public use. The formal approval came after a subject expert committee (SEC) of the CDSCO recommended that permission be granted “for restricted use in emergency situation in public interest.”
V.G. Somani, CDSCO head, read out a prepared statement according approval but did not take questions. Permission was also given to Zydus Cadilla to begin phase-3 trials of its DNA vaccine candidate.
This allows the vaccines to be rolled in the coming weeks.
Neither company has completed phase-3 trials in India but the SEC relied on data from phase-1 and phase-2 trials, that tests if the vaccine is safe and generates adequate antibodies, and — the committee opined — this suggested that the vaccine was safe and well-tolerated in limited groups of volunteers.
In the case of SII, the committee relied on data from the phase-3 trial from 23,000 or so participants in overseas trials. Interim data from a trial on 1,600 volunteers in India showed that the efficacy was “comparable,” the statement noted.
In the case of Bharat Biotech's Covaxin, only data from studies on animals and phase-2 data on 800 volunteers were studied.
Both firms are expected to continue their clinical trials and keep submitting data.
Mr. Somani did not discuss or furnish details on conditions that the companies would have to adhere to in respect of being accorded approval.