The subject expert committee of the central drugs standards control organisation (CDSCO) is likely to go through Bharat Biotech’s phase 3 clinical trials data of Covaxin today that the company submitted to the national drugs regulator over the weekend, people familiar with the matter said.
“The required data has been submitted, and the meeting of the expert panel is likely to take place today,” said an official in the government aware of the development, on condition of anonymity.
Bharat Biotech also has a pre-submission meeting scheduled with representatives of WHO (World Health Organisation) on Wednesday, June 23, for emergency use listing (EUL) of Covaxin, their vaccine against Coronavirus disease (Covid-19).
Covaxin, India’s first make-in-India vaccine, has shown an efficacy of 78% in the final interim Phase 3 analysis, HT reported earlier.
The first interim analysis result that was put out in March was based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus 7 cases observed in the BBV152 (Covaxin) group, resulting in a point estimate of vaccine efficacy of 80.6%.
The second interim analysis came out in April based on accruing more than 87 symptomatic cases of Covid-19, and also showed that the efficacy against severe Covid-19 disease was 100%, with an impact on reduction in hospitalisations.
The Phase 3 study enrolled 25,800 participants in 18-98 years of age, including 10% over the age of 60, with analysis conducted 14 days post second dose.
Covaxin was developed with seed strains received from the National Institute of Virology under the Indian Council of Medical Research. It was granted conditional emergency use authorisation on January 3 this year by India’s drugs regulator, Dr VG Somani, even though its efficacy data was still not out.
It is one of the two vaccines against Covid-19 that are currently being used under the national Covid-19 immunisation programme. The other vaccine allowed for use is Covishield that is the Oxford-AstraZeneca Covid-19 vaccine locally manufactured by the Serum Institute of India.