The results of third phase trials Covaxin vaccine developed by Bharat Biotech are expected to be released in July.
Covaxin is the first indigenously developed Covid-19 vaccine in the country.
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Pharama company Bharat Biotech has said its service provider, IQVIA, has started final statistical analysis.
Raches Ella, who leads the Covid-19 projects at Bharat Biotech, said in a tweet that after submitting efficacy and 2-months of safety to Central Drugs Standard Control Organisation (CDSCO) in July, it is expected to instantly reach pre-print server.
Peer review will take another 2-4 months.
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Ella made a series of tweets on the status of the long awaited results from third phase.
He termed phase 3 trials as the largest efficacy trial conducted in the developing world with sample size of 25,800.
“The last participant (participant #25,800) received the second dose in Mid March, add two months (based on CDSCO/FDA requirements for 2-months post-dose-2 safety follow-up), and we are in Mid May with sufficient data for quality checks and analysis,” he tweeted.
Ella also revealed about the massive data generated from the trials.
“Data captured thus far: each participant has 30 separate forms and with 25,800 participants individual data pointsp.4 Lakh. Quality (query) checks completed 2.1 Lakh. Thanks to the courageous investigators and field staff (350), ensuring compliance in the midst of the second wave,” he said.