The subject expert committee of the central drugs standards control organisation (CDSCO) will be reviewing the data of Covaxin’s phase 3 clinical trials cinducted by Bharat Biotech as the company submitted it to Drugs Controller General of India (DCGI) over the weekend, according to sources aware about the development.
An official, who wants to be anonymous said, “The required data has been submitted, and the meeting of the expert panel is likely to take place today.”
Bharat Biotech has scheduled for a pre-submission meeting with the World Health Organization (WHO’s) representatives on June 23, Wednesday for their Covid-19 vaccine, Covaxin to be placed under emergency use listig (EUL).
Covaxin has proven to have 78 % efficacy in the final interim phase 3 analysis.
In March, the first interim analysis result was released according to 43 cases, from which 36 were observed with the placebo group comparing to 7 cases under BBV152 group, which leads to vaccine efficacy estimated to be 80.6%.
In April, the second interim analysis was presented according to over 87 symptomatic cases of Covid-19, and revealed that efficacy against severe Covid-19 disease was 100 %, which would reduce the hospitalizations.
In the phase 3 study, 25,800 participants from 18-98 yeats of age group were enrolled, and the analysis was carried out 14 days after the second dose.
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