Bharat Biotech, the manufacturer of Covaxin, may not be given full licensure for its COVID vaccine just yet, said a senior health official, saying the vaccine will continue to be used under emergency authorisation.
While the company refused to comment on the latest development, Union Health Ministry officials said the authorities have sought more data from follow up studies.
The company earlier this week had submitted data from phase-3 trials to the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). The yet-to-be published data submitted showed that Covaxin had demonstrated 77.8% efficacy in its phase-3 trial, which was conducted on 25,800 subjects.
“The proposal seeking full licensure for Covaxin, was looked into and we have sought more details. Till then Covaxin will continue to be available to public under the earlier emergency authorisation,” said an official.
Allocation transparent
Meanwhile the Health Ministry on Thursday denied…