Hyderabad: There’s reassuring news for those who had doubts about the efficacy and safety of Covaxin, one of the two vaccines being administered in India as of now.
Bharat Biotech, manufacturers of the indigenously-developed coronavirus vaccine, said on Wednesday that Covaxin has demonstrated an interim efficacy of 81 per cent in Phase 3 clinical trials.
The Drugs Controller General of India (DCGI) had approved Covaxin and Covishield (the Oxford vaccine being manufactured in Serum Institute of India, Pune) for restricted use in an emergency situation in January 3.
The approval of Covaxin, however, was without efficacy data as Bharat Biotech had not vaccinated enough participants for Phase 3 trials.
Phase 3 trials, jointly initiated by Indian Council of Medical Research (ICMR) and Bharat Biotech in mid-November 2020, was conducted among a total of 25,800 individuals across 21 cities.
Bharat Biotech informed that the first interim analysis, based on 43 cases, showed that severe adverse events occurred at low levels and were balanced between vaccine and placebo groups.
Phase 3 trial results are significant as Bharat Biotech had approached the Central Drugs Standard Control Organisation (CDSCO) for approval to conduct late-stage clinical trials of Covaxin in children aged 5-18, reported The Indian Express.
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