This data is yet to be published in an internationally recognized, peer-reviewed journal. Bharat Biotech earlier said publication would only happen after the submission to the regulator.
Covaxin, the indigenous COVID-19 vaccine manufactured by Bharat Biotech has shown 77.8 percent efficacy in protecting against the virus, according to data from Phase III trials conducted on 25,800 participants across India, according to reports.
An expert panel of the country’s central drugs authority has reviewed and accepted the data of this vaccine, reports said.
Data from the Phase 3 trials of Covaxin show the vaccine against Covid-19 is 77.8% effective: sources.
— Teena Thacker (@Teensthack) June 22, 2021
The Hyderabad-based firm had submitted the results of its phase-3 trial efficacy data of Covaxin to the Drugs Controller General of India (DCGI) over the weekend.
The COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday reviewed the data and accepted it. Their recommendations have been sent to the DCGI now, a source said.
This data is yet to be published in an internationally recognized, peer-reviewed journal. Bharat Biotech earlier said publication would only happen after the submission to the regulator.
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Bharat Biotech is also expected to attend a “pre-submission” meeting on July 23 with the World Health Organisation (WHO), which will take the vaccine-maker closer to a WHO Emergency Use Listing for Covaxin (EUL).
Though the meeting will not be a detailed review of Covaxin, the vaccine-maker will have an opportunity to submit a summary on the overall quality of the jab, according to the WHO said a report in the Business Standard
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