The subject expert panel of the central drugs standards control organisation (CDSCO) is likely to undergo Bharat Biotech’s phase 3 clinical tests reports of Covaxin today that the manufacturer submitted to the national drugs regulator over the weekend, people acquainted with the proceeding stated.
“The required information has been presented, and the meeting of the expert committee is likely to occur today,” said an officer in the government aware of the development, on condition of anonymity.
Bharat Biotech also has a pre-submission meeting initiated with representatives of WHO (World Health Organisation) on Wednesday, June 23, for emergency use listing (EUL) of Covaxin, their antibody against Coronavirus infection (Covid-19).
Covaxin, India’s primary make-in-India antibody, has shown an potency of 78% in the final provisional Phase 3 analysis, HT reported earlier.
The first provisional analysis reports that was released in March was based on 43 cases, of which 36 cases of Covid-19 were discovered in the placebo group versus 7 cases detected in the BBV152 (Covaxin) group, resulting in a point estimate of vaccine vigor of 80.6%.
The second provisional trial came out in April based on accumulating more than 87 symptomatic cases of Covid-19, and also demonstrated that the potency against severe Covid-19 infection was 100%, with a consequence on reduction in hospitalisations.
The Phase 3 study registered 25,800 partakers in 18-98 years of age, consisting 10% over the age of 60, with testing conducted 14 days post second dose.
Covaxin was manufactured with seed strains obtained from the National Institute of Virology under the Indian Council of Medical Research. It was approved conditional emergency use authorisation on January 3 this year by India’s drugs regulator, Dr VG Somani, even though its efficiency data was still unreleased.
It is one of the two antibodies against Covid-19 that are now being used under the national Covid-19 vaccination programme. The other vaccine permitted for use is Covishield, which is the Oxford-AstraZeneca Covid-19 antibody locally developed by the Serum Institute of India.